chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: had fever max 100.8; chills; severe body aches; headaches; weakness; fatigue; This is a spontaneous report from a contactable other hcp (patient) reported that a 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 4176), via an unspecified route of administration on the left arm on 12Jan2021 13:15 at a single dose for covid-19 immunisation. Medical history included PCN allergy from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications included multivitamins, vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) and fish oil (FISH OIL). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ 1685) on 22Dec2020 13:00 on the left arm for covid-19 immunization and stated that had no issues after first vaccination. On 12Jan2021 21:00, the patient had fever max 100.8 (no unit reported), chills, severe body aches, headaches, weakness, and fatigue. The patient underwent lab tests and procedures which included body temperature: max 100.8 (no unit reported) on 12Jan2021 21:00. As treatment, patient received OTC NSAIDS. The outcome of the events was recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm was extremely sore; injection was in the right arm, about 6 hours later of the vaccination, there was mild tenderness; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248), via an unspecified route of administration in right arm on 12Jan2021 03:45 at a single dose for covid-19 immunization. Medical history included fibromyalgia, and allergies to Flexeril, benzalkomium chloride, iodoprophnyl butylcarbamate, Neosporin. Concomitant medication included prednisolone, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), magnesium, cobamamide (VITAMIN B12 [COBAMAMIDE]), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and colecalciferol (VITAMIN D [COLECALCIFEROL]).  The injection was in the right arm, about 6 hours later of the vaccination, on 12Jan2021, 22:00, there was mild tenderness. The following day, on 13Jan2021, the arm was extremely sore. 36 hours after the injection, the arm was no longer sore. The outcome of the events was recovered on 14Jan2021. No treatment was received for the events. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Heated nerve sensation / from the deltoid to shoulder to neck she started to have a nerve sensation; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient received Pfizer COVID-19 Vaccine yesterday, 11Jan2021. After vaccine was given, the administrator rubbed the site for at least 10 seconds very hard in a back and forth motion (The person that gave her the injection applied pressure and rubbed her arm very hard, She didn't see anyone else doing it like that on tv.). When waiting for the 10 minutes, caller noticed a nerve sensation going from the deltoid to the shoulder and to her neck. When she turned her head to that side, the sensation exacerbated. After 10 minutes it did dissipate. When she used the left arm she noticed the nerve sensation (She has been using her left arm quite a bit and has been having the nerve sensation, It is not unbearable, but she noticed it in the lower part of the arm). Patient wanted to know if the administrator was supposed to rub the injection site. Wants to know if the nerve sensation was due to the administration or the vaccine (According to the other person this doesn't sound like a normal thing with the vaccine. She is hoping she didn't hit a nerve). Did notice the nerve sensation was more like in the lower arm today and it was not as strong as it was yesterday. Stated the sensation was felt like a heated nerve sensation. Stated if USMI determines it's an issue with the COVID-19 Vaccine then she will allow for follow up. She would hate to relate it to the vaccine when it could be a simple thing. Does not want to deter people from getting the vaccine. The other agent she spoke to said out of 40,000 injections nobody had that issue. One person had a problem in the leg. Caller doesn't think it is a characteristic of the injection. She thinks it is more the administration. She thinks she better ask her physician regarding the physiology of that. Maybe it bruised a nerve. Caller declined to do a report. Doing a report may give a false sense about the injection. If she was feeling systemically sick she would. She is leaning more towards how it was administered. Outcome of the event was unknown.   No follow-up attempts are possible. Information about lot/batch number could not be requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Pain
Clinical narrative: Fatigue; Body aches; Headache; Weakness; This is a spontaneous report from a contactable Nurse (patient). This 28-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Ek4176) intramuscular on 12Jan2021 11:15 at single dose on Left arm for covid-19 immunisation.  The patient was not Pregnant at the time of vaccination. The patient medical history and the concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number=Ej1685) intramuscular on 22Dec2020 at single dose on Left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient experienced Fatigue, Body aches, Headache, Weakness on 13Jan2021 12:00 AM. The outcome was Recovering. No treatment received for the adverse event. All the events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller mentions that she received her second shot yesterday morning and she's got arm soreness and wanted to know if she can take Tylenol. The event was non-serious per the reporter. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Cough, Dyspnoea exertional, Fatigue
Clinical narrative: HA; Fatigue; DOE; Chest pressure; Fever 100.2; Sudden coughing spell; This is a spontaneous report from a contactable Nurse (patient). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number=EL3248) on 12Jan2021 18:00 at SINGLE DOSE on Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. Medical history included essential hypertension (Essential HTN), cardiac output (PLR). Concomitant medication received within 2 weeks of vaccination included lisinopril. The patient previously received first dose of BNT162B2 (Lot number=EL1284) on 23Dec2020 07:00 PM at SINGLE DOSE on Left arm for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Headache (HA), Fatigue, Dyspnea on effort (DOE), chest pressure, fever 100.2, sudden coughing spell that lasted hours during the night on 13Jan2021 06:30 AM. The outcome was Recovering. No treatment received for the adverse events. All the events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: HA; Fatigue; DOE; Chest pressure; Fever 100.2; Sudden coughing spell; This is a spontaneous report from a contactable Nurse (patient). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number=EL3248) on 12Jan2021 18:00 at SINGLE DOSE on Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. Medical history included essential hypertension (Essential HTN), cardiac output (PLR). Concomitant medication received within 2 weeks of vaccination included lisinopril. The patient previously received first dose of BNT162B2 (Lot number=EL1284) on 23Dec2020 07:00 PM at SINGLE DOSE on Left arm for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Headache (HA), Fatigue, Dyspnea on effort (DOE), chest pressure, fever 100.2, sudden coughing spell that lasted hours during the night on 13Jan2021 06:30 AM. The outcome was Recovering. No treatment received for the adverse events. All the events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Malaise
Clinical narrative: Initially a general ill feeling and then pain in the hip joint.; Initially a general ill feeling and then pain in the hip joint.; This is a spontaneous report from a contactable consumer. A 41-year-old female patient (NOT PREGNANT) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer) in Jan2021, via unknown route of administration at single dose (second dose); via unknown route of administration at single dose (first dose) in Jan2021 for unknown indication. Medical history and concomitant medications were unknown. There were unknown allergies. There was unknown if patient received other vaccine in four weeks and Other medications in two weeks. Patient experienced initially a general ill feeling and then pain in the hip joint in Jan2021. Patient did not receive any treatment. Patient did not have COVID prior vaccination and COVID tested was unknown post vaccination. The outcome of the events was recovered in Jan2021.  Information on the Lot/Batch Number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia, Tension headache
Clinical narrative: 2nd dose had fatigue; mild fever; body ache; tension headache; This is a spontaneous report from a contactable nurse reported for himself. A 49-year-old male patient received second dose of bnt162b2 (BNT162B2, Lot#: EJ1686), via an unspecified route of administration on 11Jan2021 on Right Arm at single dose for covid-19 immunisation. Medical history included Ulcerative Colitis. No allergies to medications, food, or other products. Concomitant medications included the patient received within 2 weeks of vaccination: Mesalamine. The patient previously took first dose of bnt162b2 (Lot#: EH9899) via Intramuscular on 21Dec2020 09:30 AM on Left arm at single dose for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced 2nd dose had fatigue, mild fever, body ache and tension headache from 12Jan2021 06:00 AM. The outcome of the events was recovered. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Location of injection information is available for all vaccines received on the same date.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: fatigue; aches; fever; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first shot of the COVID-19 vaccine. She experienced mild symptoms-fatigue, aches, fever that subsided. This patient said that whoever administered the vaccine told her if she had this type of reaction to the first shot, that she already had antibodies and didn't need the second shot. The outcome of the events was resolving.    information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: rapid test/antibody test at her work and she shows no antibodies on this test; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 as her first dose at single dose, via an unspecified route of administration on 11Jan2021 as her second dose at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took mycophenalate, hydroxychloroquin, dupixent, singulair, allegra and Pepcid, all for autoimmune disease, also took prednisone before and after her first dose of the vaccine. The patient stated that she took a rapid test/antibody test at her work and she showed no antibodies on this test. She was concerned that her use of steroids and other medications have affected her ability to produce the COVID-19 antibodies. She wanted more information on this and wanted to know if she should repeat the series. The outcome of event was unknown. Information of lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Pruritus; paresthesia across body, particularly extremities; This is a spontaneous report from a contactable physician. A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 13Jan2021 10:15 at a single dose on left arm for COVID-19 immunization. Medical history included hypertension (HTN). Concomitant medication included amlodipine besilate (NORVASC) and metoprolol tartrate (LOPRESSOR). About 8 hours after immunization, patient started to have pruritus and paresthesia across body, particularly extremities on 13Jan2021 06:00 PM. Therapeutic measures were taken as a result of the events which included Hydroxyzine Hcl (ATARAX). The outcome of the events was not recovered. The patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine in four weeks. AE resulted in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination. Not covid tested post vaccination.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Pain in extremity
Clinical narrative: The injection site is red; throbbing on and off and sometimes constantly; headache; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 33-years-old female patient received second dose of bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced the injection site was red, throbbing on and off and sometimes constantly, headache, all on an unspecified date with outcome of unknown. All events reported as non-serious.   Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: mild fever; severe body aches; headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no. and expiry date were not reported), via an unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced the following side effects: severe body aches, headache and mild fever on unspecified date. The patient would like to know if she can take painkillers for the events. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Chills, Headache, Pain
Clinical narrative: Heaviness in chest; Chills; Headache; Body aches; 20 Hours after vaccination; fever of 100.5; This is a spontaneous report from a contactable Nurse reported for herself. A 64-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 16:00 at single dose on left arm for COVID-19 immunisation. Medical history included Anxiety, GERD, gluten and lactose intolerant, no known allergies, no COVID prior to vaccination. There were no concomitant medications. There were no other vaccine in four weeks and no other medications in two weeks. The patient previously received the first dose of BNT162B2 in Dec2020 13:00 in Left arm for COVID-19 immunization. About 20 Hours (as reported) after vaccination, on 14Jan2021 at 11:00 AM, the patient experienced fever of 100.5, headache, body aches, heaviness in chest, chills. No treatment was received for the events. The patient had not recovered from the event. The patient didn't test COVID post vaccination.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Heaviness in chest; Chills; Headache; Body aches; 20 Hours after vaccination; fever of 100.5; This is a spontaneous report from a contactable Nurse reported for herself. A 64-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 16:00 at single dose on left arm for COVID-19 immunisation. Medical history included Anxiety, GERD, gluten and lactose intolerant, no known allergies, no COVID prior to vaccination. There were no concomitant medications. There were no other vaccine in four weeks and no other medications in two weeks. The patient previously received the first dose of BNT162B2 in Dec2020 13:00 in Left arm for COVID-19 immunization. About 20 Hours (as reported) after vaccination, on 14Jan2021 at 11:00 AM, the patient experienced fever of 100.5, headache, body aches, heaviness in chest, chills. No treatment was received for the events. The patient had not recovered from the event. The patient didn't test COVID post vaccination.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Fatigue, Lethargy
Clinical narrative: runny nose; slight cough; Lethargy; very tired; no appetite; Severe body aches; chills; fever; my lymph nodes under my injection arm became swollen and sore; my lymph nodes under my injection arm became swollen and sore; This is a spontaneous report from a contactable other HCP (patient). A 62-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: 0140) intramuscular in right arm on 11Jan2021 15:30 at single dose for COVID-19 immunization. She received the first dose of BNT162B2 (lot number: 0140) intramuscular in left arm on 21Dec2020 16:15 for COVID-19 immunization. Medical history included Sulfa and PCN allergy. There was no other medical history. There was no concomitant medications. There were no other medications in two weeks, no other vaccine in four weeks. The patient experienced severe body aches, chills, and fever starting approximately 8-10 hours after vaccine on 11Jan2021. These symptoms were accompanied by a runny nose and slight cough on 12Jan2021 08:00. Lethargy, very tired, no appetite also on 12Jan2021 08:00. Symptoms resolved with Tylenol, Nyquil, and one day of deep sleep. On the second day (Jan2021), her lymph nodes under her injection arm became swollen and sore. Patient is not pregnant. Events were recovered on Jan2021.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: runny nose; slight cough; Lethargy; very tired; no appetite; Severe body aches; chills; fever; my lymph nodes under my injection arm became swollen and sore; my lymph nodes under my injection arm became swollen and sore; This is a spontaneous report from a contactable other HCP (patient). A 62-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: 0140) intramuscular in right arm on 11Jan2021 15:30 at single dose for COVID-19 immunization. She received the first dose of BNT162B2 (lot number: 0140) intramuscular in left arm on 21Dec2020 16:15 for COVID-19 immunization. Medical history included Sulfa and PCN allergy. There was no other medical history. There was no concomitant medications. There were no other medications in two weeks, no other vaccine in four weeks. The patient experienced severe body aches, chills, and fever starting approximately 8-10 hours after vaccine on 11Jan2021. These symptoms were accompanied by a runny nose and slight cough on 12Jan2021 08:00. Lethargy, very tired, no appetite also on 12Jan2021 08:00. Symptoms resolved with Tylenol, Nyquil, and one day of deep sleep. On the second day (Jan2021), her lymph nodes under her injection arm became swollen and sore. Patient is not pregnant. Events were recovered on Jan2021.
Sex: U
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: a painful, swollen axillary lymph node; a painful, swollen axillary lymph node; This is a spontaneous report from a contactable consumer and non-contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. A week after the first dose patient noticed a painful, swollen axillary lymph node that went away after 2-3 days. The outcome of the events was recovered on unspecified date.  Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 30Dec2020 at a single dose, with route of administration unspecified for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had some neck pain. The patient had received ibuprofen (ADVIL) and paracetamol (TYLENOL) as treatment for the neck pain. The outcome of the event, neck pain, was unknown.  Information about lot/batch has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: facial numbing; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old male patient received his first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EJ1685) intramuscularly at 10:45 13Jan2021 at left arm for Covid-19 immunization. The patient had no known allergies and had no medical history or concomitant medications. Approximately 20 minutes after administration of the vaccine (13:15PM), the patient began to experience facial numbing, the feeling as similar to the return of sensation after having a numbing agent (at the dentist, for instance). He was more aware than usual of an effort required to move his face. It was not unpleasant, apart from being concerning- He did not know when or if this symptom might pass. Within 90 minutes of onset the sensation was 90% resolved. There was minor sensation with smiling until awakening the next day (approximately 19 hours after administration). No treatment was received for the event. The patient had no Covid-19 before vaccination and had not tested for it. The event resolved at the time of reporting (unspecified date in Jan2021).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Oedema peripheral, Pruritus
Clinical narrative: this was maybe an allergic reaction; itching; her face was red; her arm, it was really red; her arm, it was really puffy; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular at deltoid left on an unspecified date at single dose for COVID-19 immunization. The patient medical history was none. The patient's concomitant medication included sertraline hydrochloride (ZOLOFT), biotin and multivitamin. On an unspecified date, the patient reported that she has a lot of itching going on, people were saying her face was red, she felt itchy, it was as if she could write her name on her arm, it was really red and puffy, her left eye stated to itch, but she did not want to scratch, she thought this was maybe an allergic reaction, her pathologist gave her two ZYRTEC, she was supposed to take one, and took another one as well. Course of event was reported as follows: the patient clarified that itching started during night, her scalp started itching a little, then stomach, then she was like ok. The next, she finished working out, got a shower, she did shower and continued to itch. At work, all of a sudden, her arms started itching, then legs started, then stomach and back started itching, her coworker said it was red, face was red. It was not intolerable, but uncomfortable. The patient outcome of the events was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Flank pain, Inappropriate schedule of product administration, Pain
Clinical narrative: Arm swelling with itchiness; Arm swelling with itchiness; warm to touch at site of injection; severe chills with shaking; severe chills with shaking; 103 fever/ approx 20hrs after injection, fever of 100 or greater for 24hrs with minimal relief with Tylenol; body aches; pains in left flank; the first dose on 20Dec2020/second dose on 12Jan2021; This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 32-year-old female patient (not pregnant) received the second dose of bnt162b2 via an unspecified route of administration on 12Jan2021 10:30 AM at single dose in Left arm for COVID-19 immunisation. Medical history included cardiogenic syncope, no COVID prior vaccination. Concomitant medications included birth control drugs, no other vaccine in four weeks. The patient previously received the first dose of bnt162b2 on 20Dec2020 03:00PM on Left arm for COVID-19 immunization, topiramate (TOPAMAX) and experienced drug allergy, morphine and experienced drug allergy (hives). The patient experienced arm swelling with itchiness and warm to touch at site of injection, severe chills with shaking, 103 fever, approx. 20 hours after injection, fever of 100 or greater for 24 hours with minimal relief with Tylenol, body aches and pains in left flank. The adverse events started from 12Jan2021, 06:00 PM. Therapeutic measures taken for fever included Tylenol, no treatment was received for other events. The outcome of the events was recovering. The patient didn't test COVID post vaccination.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Tremor, Vaccination site warmth
Clinical narrative: Arm swelling with itchiness; Arm swelling with itchiness; warm to touch at site of injection; severe chills with shaking; severe chills with shaking; 103 fever/ approx 20hrs after injection, fever of 100 or greater for 24hrs with minimal relief with Tylenol; body aches; pains in left flank; the first dose on 20Dec2020/second dose on 12Jan2021; This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 32-year-old female patient (not pregnant) received the second dose of bnt162b2 via an unspecified route of administration on 12Jan2021 10:30 AM at single dose in Left arm for COVID-19 immunisation. Medical history included cardiogenic syncope, no COVID prior vaccination. Concomitant medications included birth control drugs, no other vaccine in four weeks. The patient previously received the first dose of bnt162b2 on 20Dec2020 03:00PM on Left arm for COVID-19 immunization, topiramate (TOPAMAX) and experienced drug allergy, morphine and experienced drug allergy (hives). The patient experienced arm swelling with itchiness and warm to touch at site of injection, severe chills with shaking, 103 fever, approx. 20 hours after injection, fever of 100 or greater for 24 hours with minimal relief with Tylenol, body aches and pains in left flank. The adverse events started from 12Jan2021, 06:00 PM. Therapeutic measures taken for fever included Tylenol, no treatment was received for other events. The outcome of the events was recovering. The patient didn't test COVID post vaccination.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fatigue; body aches; Low grade fever; This is a spontaneous report from a contactable other healthcare professional. A 27-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection; lot/batch number and expiration date were unknown), intramuscularly on the left arm on 23Dec2020 and second dose, via an unspecified route of administration on 13Jan2021 (lot/batch number and expiration date were unknown); both at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included COVID-19 on an unknown date prior vaccination. The patient had no known allergies. There were no concomitant medications. The patient was not pregnant. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient had not tested for Covid post vaccination. On 24Dec2020, the patient experienced fatigue, body aches, and low grade fever. The patient did not receive any treatment for the events. The patient recovered from all the events on an unspecified date.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, Vaccination site pain
Clinical narrative: Arm pain at site; Fatigue; Nausea; Body aches; This is a spontaneous report from a contactable nurse reported for herself. This 63-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Et1685) intramuscular on 11Jan2021 13:15 at single dose for an COVID-19 immunization. Medical history included high blood pressure. Concomitant medication included atenolol Atenolol, Losartan, Calcium, plantago ovata (METAMUCIL), bifidobacterium lactis (PROBIOTIC). Patient received the first dose of BNT162B2 intramuscular in left arm on 21Dec2020 03:30 PM. No other vaccine in four weeks. On 12Jan2021, the patient experienced Arm pain at site, Fatigue, Nausea, Body aches. No treatment received. The outcome of events was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Tired; legs and arms felt sore; mild headache; fever 101.1; chills; This is a spontaneous report from a contactable pharmacist (patient). A 43-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer, lot number=EK9231) on 10Jan2021 03:30 PM (vaccine location=Left arm, dose number=2) at single dose via unknown route of administration for unknown indication. Medical history was not reported. Concomitant medications included ibuprofen (MOTRIN); vitamins NOS (MVI); calcium carbonate, colecalciferol (OSCAL D); vitamin c. Historical vaccine included patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer, lot number=Ek5730), on 19Dec2020 03:15 PM, (vaccine location=Left arm, dose number=1) via unknown route of administration at single dose for unknown indication. There were unknown allergies. Patient did not receive other vaccine in four weeks. Patient did not have covid prior vaccination and did not have covid tested post vaccination. Patient experienced Tired, legs and arms felt sore, mild headache, fever 101.1, chills on 11Jan2021 01:30 PM. Patient did not receive any treatment. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Tired; legs and arms felt sore; mild headache; fever 101.1; chills; This is a spontaneous report from a contactable pharmacist (patient). A 43-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer, lot number=EK9231) on 10Jan2021 03:30 PM (vaccine location=Left arm, dose number=2) at single dose via unknown route of administration for unknown indication. Medical history was not reported. Concomitant medications included ibuprofen (MOTRIN); vitamins NOS (MVI); calcium carbonate, colecalciferol (OSCAL D); vitamin c. Historical vaccine included patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer, lot number=Ek5730), on 19Dec2020 03:15 PM, (vaccine location=Left arm, dose number=1) via unknown route of administration at single dose for unknown indication. There were unknown allergies. Patient did not receive other vaccine in four weeks. Patient did not have covid prior vaccination and did not have covid tested post vaccination. Patient experienced Tired, legs and arms felt sore, mild headache, fever 101.1, chills on 11Jan2021 01:30 PM. Patient did not receive any treatment. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: body aches; a fever of 101; This is a spontaneous report from a contactable nurse (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number not provided), intramuscularly on 06Jan2021 10:00 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose in Dec2020 10:00 intramuscular at left arm for covid-19 immunization. The facility type vaccine was hospital. The patient medical history was not reported. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), emtricitabine, tenofovir disoproxil fumarate (TRUVADA). Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced body aches and a fever of 101 on 07Jan2021 14:00. He fully expected this immune response from his body and it only lasted 12-24 hours. Patient didn't receive treatment for the adverse events. The outcome of events was recovered in 08Jan2021. The events were reported as non-serious.  Information about Batch/Lot number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia, Rash erythematous
Clinical narrative: chills; muscle ache; low grade fever up to 100.3; a red flushed rash on neck and chest; This is a spontaneous report from a contactable nurse (patient). A 39-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 09Jan2021 12:00 at single dose in left arm for covid-19 immunization. The patient had no other medical history and no known allergies. Concomitant medication included vitamin D3 and daily multivitamin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), on 20Dec2020 07:30 in left arm for covid-19 immunization. The patient had no covid prior vaccination and no covid tested post vaccination. The patient reported that on 10Jan2021 02:00 about 14 hours after 2nd vaccine she had chills, muscle aches, and low grade fever up to 100.3 for the next 12 hours. Then she experienced a red flushed rash on neck and chest for about 12 hours after the previous symptoms. All symptoms gone after about 24 hours. The patient did not receive any treatments for events. The outcome of the events was recovered on 11Jan2021.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Mobility decreased
Clinical narrative: could not get up from the bed; she did not feel well; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in left arm single dose for prevent COVID on 18Dec2020 at 07:00am, at 41-year-old. Medical history included: seizures from 2014. Concomitant medication included: ongoing topiramate oral 50mg one tablet in the morning and two tablets in the evening for seizures; levetiracetam (KEPPRA). No additional vaccines administered on same date of BNT162B2. She was okay on 19Dec2020. After mid-day around noon (19Dec2020) she did not feel well, and it was hard for her to work on the 19th. She missed two days of work. On 20Dec2020 she could not get up from the bed. Emergency Room or Physician Office not visited. No relevant tests done. Action taken for BNT162B2 was not applicable. Outcome of the event was unknown.   Information about lot/batch number has been requested.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: he wasn't attracted to food for a day; arm began hurting at the right top of his arm and right shoulder area; planned in 2 weeks, will be his second COVID-19 Vaccine shot; This is a spontaneous report from a contactable Consumer(patient). The 94-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right arm on 08Jan2021 at single dose for COVID-19 immunization in a nursing home. Medical history included he was hospitalized with the COVID-19 Virus and pneumonia in Apr2020. He was in the hospital for 2 weeks, the hospital treated him one COVID-19 Vaccine (he doesn't know what they did in the hospital when he had the COVID-19 Virus in Apr2020), then he went to rehab for 6 weeks, he was gone from his residence for a total of 8 weeks, he also had throat problem, and a swallowing issue for a long time before he received the COVID-19 Vaccine, he had a constant clearing of his throat. He had tiny bits of bacon that may cling on to the edge of his throat, and block his swallowing temporarily. Once he cleared his throat, he went back to swallowing. When he cleared his throat, it took care of his swallowing problem, but not permanently. The patient's concomitant medications were not reported.  The patient experienced His arm began hurting at the right top of his arm and right shoulder area after receiving the COVID-19 Vaccine (where he received the COVID-19 Vaccine) on 08Jan2021. He said everything was OK, he was feeling some pain, but the pain was nothing to even keep him awake. The next day after receiving the vaccine(09Jan2021), he had no desire for any food, and didn't eat anything, he didn't want anything to eat/ he wasn't attracted to food for a day. He was having a recap of the effect of getting the Vaccine shot. He said the COVID-19 Vaccine shot affected his stomach's desires and so forth. He had been eating now for the past 2 days. There was no treatment received. He also clarified under the COVID-19 Vaccine program with Pfizer, the COVID-19 Vaccine shot planned in 2 weeks, will be his second COVID-19 Vaccine shot. He said the COVID-19 Vaccine is so new, and people are on a tight schedule to get the COVID-19 Vaccine shot. Outcome of arm began hurting and Appetite lost was recovered in Jan2021.   Information on the lot/batch number has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Feeling cold, Vaccination site pain
Clinical narrative: Weak; Chills and completely ice cold; Chills and completely ice cold; Really sore in injection arm; Joints hurt; This is a spontaneous report from a contactable consumer (patient). This 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 12:00 on arm Left at single dose for covid-19 immunisation. Lot number is EL3, then a number he cannot read, followed by 46. Medical history included type 2 diabetic. No concomitant medications. His joints hurt on 11Jan2021 in later afternoon. It is not worse, but not better. On 12Jan2021, chills and Woke up during night completely ice cold. Had to get a blanket and finally went back to sleep. Feels weak.  Doesn't know what happened. Still feels chill. After midnight on the 12Jan2021. Is a little bit better. He was really sore in injection arm on 11Jan2021. Outcome of the event Joints hurt was not recovered. Outcome of the events Chills and completely ice cold was recovering. Outcome of the event Really sore in injection arm was not recovered. Outcome of the event Weak was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Mild fever; 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), via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient got the first shot of the COVID-19 vaccine and is experiencing a mild fever. The event was considered non-serious. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Ear swelling, Feeling cold, Feeling drunk
Clinical narrative: Tender; Swollen glands, neck, face, and ear on left side/ glands on left side of neck were swollen; Swollen glands, neck, face, and ear on left side; Swollen glands, neck, face, and ear on left side; Swollen glands, neck, face, and ear on left side; Cold, chills, and felt like freezing to death; Cold, chills, and felt like freezing to death; Felt like drunk driving; Cold, chills, and felt like freezing to death; Severe headache; Dizziness; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 07Jan2021 11:45 at single dose for covid-19 immunisation. Medical history included rheumatoid arthritis (RA). The patient's concomitant medications were not reported. The patient experienced cold, chills, and felt like freezing to death, felt like drunk driving, severe headache and dizziness on 07Jan2021; swollen glands, neck, face, and ear on left side on 12Jan2021; tender on an unspecified date. The patient received COVID-19 Vaccine on 07Jan2021 at approximately 11:45. She felt like drunk driving: She waited the 15 minutes and was fine. Afterwards, she got into her truck and was literally weaving. Had to really concentrate to keep the truck in a straight line. She had severe headache: Did not go into work on Friday because headache was so bad. It was almost a migraine. She could still feel it, but it was not as severe. Patient known it's five days out, but yesterday (12Jan2021) she got up and glands on left side of neck were swollen. That side of her face and ear was swollen. It was very pronounced. She still swollen today (13Jan2021). Patient stated she worked with dementia and didn't know if she should go into work when she was still swollen and tender. The patient took Benadryl (Lot: P119936, Exp: Apr2023) as Equate Allergy Relief at 25mg, two capsules at night for the reaction. The patient had been taking it every night since she received the COVID-19 Vaccine. Headache was still there. This morning woke up with swollen glands, neck, ear, and face on the left side. The outcome of events "cold, chills, and felt like freezing to death" and dizziness was recovered on 10Jan2021; of event "Felt like drunk driving" was recovered on an unspecified date; of event severe headache was recovering; of event "Swollen glands, neck, face, and ear on left side" was not recovered; of event Tender was unknown.  Information on Lot/Batch number has been requested.