chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Endotracheal intubation, Hypertension, Somnolence, Unresponsive to stimuli
Clinical narrative: Patient was in her usual state of health. On January 18th she got her first Pfizer COVID-19 vaccine at about 1030. the patient waited the prescribed 15 minutes afterward and then went to visit a great grandbaby.  After an hourlong visit, she went to Taco Bell for lunch. While eating in her daughter's car, she started feeling sleepy and asked to go home. Her daughter took her to the nearby fire station for a blood pressure check as the patient has a history of syncope with hypotension. Her BP was actually high on multiple readings that were confirmed with EMS. She did not have any wheezing, hives, or lip swelling. She was transported to the ER. Her BP was recorded as 221/113. She was treated with hydralazine 10mg and furosemide 40mg. She became unresponsive in the ER and was intubated emergently for airway protection.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Electroencephalogram normal, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Rash, headache, convulsions, fatigue, muscle weakness
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Imaging procedure, Laboratory test normal, Pain, Pyrexia, Seizure like phenomena
Clinical narrative: Rash, headache, convulsions, fatigue, muscle weakness
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Rash, headache, convulsions, fatigue, muscle weakness
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Muscular weakness, Rash, Seizure
Clinical narrative: Rash, headache, convulsions, fatigue, muscle weakness
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Amnesia, Blindness, Computerised tomogram head, Computerised tomogram normal, Diplegia
Clinical narrative: Rash, headache, convulsions, fatigue, muscle weakness
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Electrocardiogram normal, Feeling abnormal, Headache, Hypoaesthesia, Magnetic resonance imaging spinal normal
Clinical narrative: Rash, headache, convulsions, fatigue, muscle weakness
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Photopsia, Tremor
Clinical narrative: Rash, headache, convulsions, fatigue, muscle weakness
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Muscular weakness, SARS-CoV-2 test negative, Tremor
Clinical narrative: Rash, headache, convulsions, fatigue, muscle weakness
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Erythema, Pruritus
Clinical narrative: Both arms, upper chest, back of neck and cheeks became bright red and felt like a first-degree sunburn. Some slight itching. Had pre-treated with 25 mg of Benadryl prior to the vaccine and took an additional 25 mg of Benadryl when symptoms started
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Both arms, upper chest, back of neck and cheeks became bright red and felt like a first-degree sunburn. Some slight itching. Had pre-treated with 25 mg of Benadryl prior to the vaccine and took an additional 25 mg of Benadryl when symptoms started
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angioedema
Clinical narrative: Both arms, upper chest, back of neck and cheeks became bright red and felt like a first-degree sunburn. Some slight itching. Had pre-treated with 25 mg of Benadryl prior to the vaccine and took an additional 25 mg of Benadryl when symptoms started
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever - 102 Degrees, Joints aches & Severe Fatigue
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Pyrexia
Clinical narrative: Fever - 102 Degrees, Joints aches & Severe Fatigue
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Swollen tongue
Clinical narrative: given at other location, pt developed cough (she believes same as chronic, same as earlier in the day) and subjective swelling/pain of tongue (which she has had before x1 a week ago unrelated to immunizations) so treated by providers at site of immunization with IM Benadryl 50 mg and 0.3mg IM epinephrine 911 called to bring her to my ED for evaluation as suspected allergic reaction.  symptoms resolved by the time EMS evaluated and no symptoms in my ER.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Glossodynia, Swollen tongue
Clinical narrative: given at other location, pt developed cough (she believes same as chronic, same as earlier in the day) and subjective swelling/pain of tongue (which she has had before x1 a week ago unrelated to immunizations) so treated by providers at site of immunization with IM Benadryl 50 mg and 0.3mg IM epinephrine 911 called to bring her to my ED for evaluation as suspected allergic reaction.  symptoms resolved by the time EMS evaluated and no symptoms in my ER.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Swelling, Ultrasound scan
Clinical narrative: Patient contacted the office on 11/11/2020 reporting headache, muscle aches, tiredness, chills, and  shivering. temperature of 99 degrees and right supraclavicular swelling. After 2 days, all of the  symptoms except the right supraclavicular swelling had resolved. Patient was seen in the office  11/13/2020 and an area of right cystic fullness 5 x 4 cm was appreciated as well as a 2 cm lymph node. She was rechecked 12/17/2020. The lymph node was longer noted; the other swelling did not  improve. On 1/17/2021, she reported no improvement and an ultrasound was ordered (pending).
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Swelling
Clinical narrative: Patient contacted the office on 11/11/2020 reporting headache, muscle aches, tiredness, chills, and  shivering. temperature of 99 degrees and right supraclavicular swelling. After 2 days, all of the  symptoms except the right supraclavicular swelling had resolved. Patient was seen in the office  11/13/2020 and an area of right cystic fullness 5 x 4 cm was appreciated as well as a 2 cm lymph node. She was rechecked 12/17/2020. The lymph node was longer noted; the other swelling did not  improve. On 1/17/2021, she reported no improvement and an ultrasound was ordered (pending).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Disorientation, Dizziness
Clinical narrative: I felt slightly light headed; I felt a slight disorientation; a very heavy feeling in the center of my chest; hip joint pain sever enough; This is a spontaneous report from a contactable consumer reported for himself. A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: PFREH9899), via an unspecified route of administration at left arm on 29Dec2020 16:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included ongoing Chronic hip joint pain. Concomitant medication included celecoxib at 100mg once daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Dec2020 at 16:30, after patient left the observation tent, while walking to his car, He felt slightly lightheaded. Upon reaching his car he felt a slight disorientation and a very heavy feeling in the center of his chest. These symptoms lasted until he reached home which was about a 15 min drive. Once at home he experienced hip joint pain sever enough that he had to stop being mobile. All symptoms disappeared within 1-2 hours except for the heaviness in the center of his chest. This lasted for about another hour. After that no more issues. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on 29Dec2020.
Sex: F
Vaccine: VARZOS
Symptoms: Neoplasm malignant, Paralysis, Viral titre increased
Clinical narrative: Rare type of cancer; Blood titer had 'gone a little bit berserk' with a blood titer of '3000' / Caller reports most recent ''blood shingles titers" 3060; Paralyzed/glued to floor; This spontaneous report was received from a nurse concerning to herself, who was a female patient of unknown age. No information regarding the patient's pertinent medical history, historical drugs, drug reactions, allergies, concurrent conditions or concomitant therapies was provided.         On an unspecified date in 2007, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for prophylaxis (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number and  expiration date were not provided) on recommendation from two oncologists, one internist, and one allergist.  On an unspecified date in 2007, within 8 days of receiving the mentioned vaccine,  the patient became 'paralyzed/glued to floor' which had happened in 15 to 20 minutes intervals. At event time, blood titer was determined by healthcare professional (HCP) to be 4.3 (unspecified units).              In Autumn 2020 (reported as ''last fall''), HCP drew blood at which time blood titer had 'gone a little bit berserk' with a blood titer of '3000' (unspecified units) (viral titre increased).  On an unspecified date (reported as ''most recent''), a blood shingles titers' result of 3060 (unspecified units) was reported (per caller, normal would be 160 (unspecified units) (viral titre increased).  On an unspecified date, patient experienced a rare type of cancer (neoplasm malignant). It was reported that, on an unknown date, patient was being treated with an unknown medication from an unknown manufacturer and patient was seeing a specialist for rare cancer treatment.  It was also reported that, HCP had recommended patient receive unknown COVID-19 vaccine on unknown, future date.   At the time of the report, the outcome of neoplasm malignant, viral titre increased and paralysis was unknown.  The causal relationship between all the events and zoster vaccine live (ZOSTAVAX) was not reported.  Upon internal review, neoplasm malignant and paralysis were considered serious due to medically significant criteria.
Age: 21.0
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered
Clinical narrative: No additional AE details available; an MMR II dose was administered to a patient today with expiration date of 17Dec2020; This spontaneous report was received from an office manager, referring to a 21-year-old patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 13-JAN-2021, the patient was vaccinated with one expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot  R036581, expiration date: 17-DEC-2020) as prophylaxis (expired product administered). The use of a sterile diluent (STERILE DILUENT) was reported (strength, dose, formulation, indication, route of administration, lot number and expiration date were not reported). No additional adverse effect (AE) details available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral
Clinical narrative: shingles; neuropathy; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age or gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. In or around March 2011, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not provided) for its intended purpose, the prevention of shingles. Shortly after being vaccinated, the pt suffered shingles (herpes zoster) and neuropathy (neuropathy peripheral). As a direct and proximate result of the pt's use of the defective zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using the company's product. The pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of company's conduct, the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the claimed events was not recovered, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).  The reporter considered herpes zoster and neuropathy peripheral to be disabling events.  Upon internal review, neuropathy peripheral was determined to be medically significant event.
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, Varicella
Clinical narrative: when she was 4 she had chicken pox and did not get the second dose of the vaccine; This spontaneous report was received from a consumer, referring to herself, a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unknown date, the patient got the first shot of varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, vaccination scheme, anatomical site of injection, route of administration, lot number and expiration date were not reported) as prophylaxis.  On an unknown date (reported as when she was 4), the patient had chicken pox and did not get the second dose (varicella).  The outcome of varicella and the causal relationship between the suspect therapy and varicella were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Not sure if the patient received the full dose; A spontaneous report was received from a health professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, not sure if the patient received the full dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 05 Jan 2021 at 10:15 am, during the administration of the vaccine, some of dose fell out onto the chair. The health professional was not sure if the patient received the full dose. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, not sure if the patient received the full dose, was considered resolved on 05 Jan 2021.; Reporter's Comments: This is a report from a HCW who was ' Not sure if the patient received the full dose '(incomplete dose administered) mRNA-1273, lot # 039K20A. There were no reported adverse events associated with this case of incomplete dose administered
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered the Moderna COVID 19 vaccine to a 17-year-old by mistake; A spontaneous report was received from a healthcare professional concerning a 17-years old, female patient who was administered the Moderna Covid-19 Vaccine (mRNA-1273) and experienced product administered to patient of inappropriate age.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an undisclosed date, the patient received their first of two planned doses of mRNA-1273 (Lot number given as 025L208 but reporter was unsure) intramuscularly for prophylaxis of COVID-19 infection and experienced product administered to patient of inappropriate age.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, product administered to patient of inappropriate age, was resolved on an undisclosed date.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # 025L208. There were no reported AEs associated with this case of product administered to patient of inappropriate age.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administerd dose from vials punctured and refirgerated for more than 6 hours; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 Vaccine, and  who experienced 3 or 4 employees have received doses from vials that have been open and refrigerated for more than 6 hours.   The patient's medical history was not provided  Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (LOT# unknown) on an undisclosed date intramuscularly for prophylaxis of COVID-19 infection.   A pharmacist reported that he was taking some days off and while he was off, three or four employees received the Moderna vaccine from vials that had been open and refrigerated longer than six hours. The pharmacist wanted to know if the six hour window was becuase of possible infection, lack of efficacy or some other reason.  He also questioned whether or not he needed to vaccinate his employees again. No adverse events were reported.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event, 3 or 4 employees have received doses from vials that have been open and refrigerated for more than 6 hours, was not provided.   The event, 3 or 4 employees have received doses from vials that have been open and refrigerated for more than 6 hours, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of out of specification product use for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of out of specification product use.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Product administered at inappropriate site, Product leakage
Clinical narrative: She noticed, after receiving the vaccine, that "an oily liquid, like a Vaseline" started to pour in her arm; She noticed, after receiving the vaccine, that "an oily liquid, like a Vaseline" started to pour in her arm; States being injected "very close to her shoulder" and she wants to know if it is correct; A spontaneous report was received from a healthcare facility with a 41-year-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced after receiving the vaccine, an oily liquid, like a Vaseline, started to pour in her arm and she also states being injected very close to her shoulder and she wants to know if it is correct.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   On 08-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (LOT 011020A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   Patient received the Moderna vaccine on 08-Jan-2021.  She reported that after receiving the injection, she noticed an oily liquid, like a Vaseline, started to pour in her arm.  Patient was also concerned that her injection was not given in the correct anatomical location as she stated that it was given very close to her shoulder.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, after receiving the vaccine, an oily liquid, like a Vaseline, started to pour in her arm and she also states being injected very close to her shoulder and she wants to know if it is correct, was not provided.   The events, after receiving the vaccine, an oily liquid, like a Vaseline, started to pour in her arm and she also states being injected very close to her shoulder and she wants to know if it is correct, were considered recovered/resolved 08 Jan 2021.; Reporter's Comments: This case concerns a 41-year-old, female patient, who experienced an unexpected event of Product leakage, exposure of skin to the product and vaccine administered at inappropriate site. The event occurred after the administration of the first dose of mRNA-1273 (LOT 011020A). This report refers to a case of product administration error for mRNA-1273 (LOT 011020A).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Oropharyngeal pain
Clinical narrative: Fatigue; Chills; Headache; Nausea; Vertigo; Sore throat; This is a spontaneous report from a non-contactable other Health Care Professional (HCP).  A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date unknown), intramuscularly, on 04Jan2021 at 10:00 AM (at the age of 36 years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's medical history was not reported. No allergy information was reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Jn2021, the patient experienced fatigue, chills, headache, nausea, vertigo and sore throat. The events resulted in a physician office visit. Treatment information was not provided. The patient underwent lab tests and procedures which included sars-cov-2 test on an unspecified date after the vaccination the result of which was negative. The clinical outcomes of fatigue, chills, headache, nausea vertigo and sore were reported as recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: Fatigue; Chills; Headache; Nausea; Vertigo; Sore throat; This is a spontaneous report from a non-contactable other Health Care Professional (HCP).  A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date unknown), intramuscularly, on 04Jan2021 at 10:00 AM (at the age of 36 years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's medical history was not reported. No allergy information was reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Jn2021, the patient experienced fatigue, chills, headache, nausea, vertigo and sore throat. The events resulted in a physician office visit. Treatment information was not provided. The patient underwent lab tests and procedures which included sars-cov-2 test on an unspecified date after the vaccination the result of which was negative. The clinical outcomes of fatigue, chills, headache, nausea vertigo and sore were reported as recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Off label use, Product use issue
Clinical narrative: Not adverse- but possible side effect? She was nursing and her last period was in Feb2019, She started my mensural cycle the day of her vaccine.; She was nursing and her last period was in Feb2019; She was nursing and her last period was in Feb2019; This is a spontaneous report from a contactable other Health Professional (patient). This reporter reported information for both mother and baby. This is the maternal report. A 32-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 06Jan2021 13:30 at single dose in left arm for covid-19 immunization. Medical history included the patient had COVID prior vaccination. The patient's concomitant medications were not reported. Post vaccination, the patient had no COVID tested. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that it was not adverse, but possible side effect. She was nursing and her last period was in Feb2019, she started her mensural cycle the day of her vaccine (on 06Jan2021). No treatment was received for event "her last period was in Feb2019, she started her mensural cycle the day of her vaccine". The outcome of the event "her last period was in Feb2019, she started her mensural cycle the day of her vaccine" was recovered in Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046112 Baby case
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: unpleasant taste and smell after receiving COVID-19 vaccine yesterday/unusual smell and taste in my mouth, silvery, metallic; unpleasant taste and smell after receiving COVID-19 vaccine yesterday; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A 67-year-old male patient received first dose of bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had unpleasant taste and smell after receiving COVID-19 vaccine yesterday. The patient had his first covid vaccine on Friday. Later that evening (08Jan2021) he was experiencing an unusual smell and taste in my mouth, silvery, metallic, that became progressively stronger and continued today. He had an unusual smell in his nose and taste in his mouth that is kind of like silver or metal. He would like to know if that is normal or should he be concerned. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Fatigue, Lymphadenopathy
Clinical narrative: Fever (103 lasting a day and a half); Nausea; Chills; Muscle aches and soreness; Malaise; Lymphadenopathy; Arm/under arm/pec soreness in vaccine arm; Fatigue; Sore throat; Dry cough; recevied first dose on 21Dec2020 10:15, then received second dose on 07Jan2021 07:45; recevied first dose on 21Dec2020 10:15, then received second dose on 07Jan2021 07:45; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via intramuscular on 07Jan2021 07:45 at single dose in left arm for covid-19 immunization. The patient had no medical history and no known allergies. Concomitant medication in two weeks included birth control. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via intramuscular on 21Dec2020 10:15 at single dose in left arm for covid-19 immunization. The patient had no other vaccine in four weeks. No covid tested post vaccination. The patient experienced fever (103 lasting a day and a half), nausea, chills, muscle aches and soreness, malaise, lymphadenopathy and soreness, arm/under arm/pec soreness in vaccine arm, fatigue, sore throat, dry cough on 07Jan2021 19:00. The patient did not receive any treatment for these events. The outcome of the events fever (103 lasting a day and a half), nausea, chills, muscle aches and soreness, malaise, lymphadenopathy and soreness, arm/under arm/pec soreness in vaccine arm, fatigue, sore throat, dry cough was recovered in Jan2021.   Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Off label use, Oropharyngeal pain
Clinical narrative: Fever (103 lasting a day and a half); Nausea; Chills; Muscle aches and soreness; Malaise; Lymphadenopathy; Arm/under arm/pec soreness in vaccine arm; Fatigue; Sore throat; Dry cough; recevied first dose on 21Dec2020 10:15, then received second dose on 07Jan2021 07:45; recevied first dose on 21Dec2020 10:15, then received second dose on 07Jan2021 07:45; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via intramuscular on 07Jan2021 07:45 at single dose in left arm for covid-19 immunization. The patient had no medical history and no known allergies. Concomitant medication in two weeks included birth control. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via intramuscular on 21Dec2020 10:15 at single dose in left arm for covid-19 immunization. The patient had no other vaccine in four weeks. No covid tested post vaccination. The patient experienced fever (103 lasting a day and a half), nausea, chills, muscle aches and soreness, malaise, lymphadenopathy and soreness, arm/under arm/pec soreness in vaccine arm, fatigue, sore throat, dry cough on 07Jan2021 19:00. The patient did not receive any treatment for these events. The outcome of the events fever (103 lasting a day and a half), nausea, chills, muscle aches and soreness, malaise, lymphadenopathy and soreness, arm/under arm/pec soreness in vaccine arm, fatigue, sore throat, dry cough was recovered in Jan2021.   Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue, Pyrexia, Vaccination site pain
Clinical narrative: Fever (103 lasting a day and a half); Nausea; Chills; Muscle aches and soreness; Malaise; Lymphadenopathy; Arm/under arm/pec soreness in vaccine arm; Fatigue; Sore throat; Dry cough; recevied first dose on 21Dec2020 10:15, then received second dose on 07Jan2021 07:45; recevied first dose on 21Dec2020 10:15, then received second dose on 07Jan2021 07:45; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via intramuscular on 07Jan2021 07:45 at single dose in left arm for covid-19 immunization. The patient had no medical history and no known allergies. Concomitant medication in two weeks included birth control. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via intramuscular on 21Dec2020 10:15 at single dose in left arm for covid-19 immunization. The patient had no other vaccine in four weeks. No covid tested post vaccination. The patient experienced fever (103 lasting a day and a half), nausea, chills, muscle aches and soreness, malaise, lymphadenopathy and soreness, arm/under arm/pec soreness in vaccine arm, fatigue, sore throat, dry cough on 07Jan2021 19:00. The patient did not receive any treatment for these events. The outcome of the events fever (103 lasting a day and a half), nausea, chills, muscle aches and soreness, malaise, lymphadenopathy and soreness, arm/under arm/pec soreness in vaccine arm, fatigue, sore throat, dry cough was recovered in Jan2021.   Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Epicondylitis, Pain in extremity
Clinical narrative: Persistent Right arm tennis elbow; Increased pain on movement/Pain from back of elbow to top of forearm; Increased pain on movement/Pain from back of elbow to top of forearm; This is a spontaneous report from a contactable nurse (patient self). A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ELO140), via an unspecified route of administration on 19Dec2020 11:00 at single dose on right arm for COVID-19 immunisation. Medical history included hypothyroidism and known allergies: sulfa drugs and clarithromycin (MACROBID). Concomitant medications included bupropion hydrochloride (WELLBUTRIN), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), estradiol (ESTROGEN), testosterone and progesterone (PROGESTON [PROGESTERONE]). The patient experienced persistent right arm tennis elbow. Increased pain on movement. Pain from back of elbow to top of forearm on 21Dec2020 08:00 with outcome of not recovered. No treatment was received for the events. Patient received 2nd dose of bnt162b2 (lot: ELO140) on 09Jan2021 on left arm.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Hyperglycaemia, Pain in extremity
Clinical narrative: hyperglycemia in the 400s; I have had no other problems following the vaccine other than a sore arm.; This is a spontaneous report from a contactable Other HCP (patient).   A 57-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EK9231) at single dose at left arm on 08Jan2021 10:45 for Covid-19 immunisation, administered at hospital.  Medical history included type 1 diabetes mellitus, allergies to adhesives. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication in two weeks included biotin (BIOTIN), insulin aspart (NOVOLOG INSULIN), ascorbic acid, bacopa monnieri, biotin, boron citrate, calcium, choline bitartrate, chromium, colecalciferol, copper, deanol, docosahexaenoic acid, electrolytes nos, folic acid, gamma-aminobutyric acid, huperzia serrata, inositol, iodine, iron, levoglutamide, magnesium, manganese, molybdenum, n-acetyltyrosin, nicotinic acid, pantothenic acid, phosphatidyl serine, pidolic acid, potassium, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopheryl acid succinate, trace elements nos, vaccinium myrtillus, vanadyl sulfate, vinpocetine, vitamin a nos, vitamin b12 nos, vitis vinifera, zinc (FOCUS FACTOR), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC). The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient experienced hyperglycemia in the 400s and a sore arm on 09Jan2021 14:30. She had no other problems following the vaccine. No fever. She cannot get her blood glucose level down. She has been at this range for 6 hours. The patient underwent lab tests and procedures which included blood glucose: 400. Treatment for event hyperglycemia was insulin pump continues increasing insulin. The outcome of events was not recovered. Post vaccination, the patient has not been tested for COVID-19. She was not sure if hyperglycemia was related to vaccine.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Body temperature, Chills, Feeling cold
Clinical narrative: heart rate was 123 when she woke up (resting); temperature showing 101.8; felt a little itchy around injection site; arm pain; felt sick; Massive headache; stomach cramps; joint pain; the back of her ribs hurt; nausea; couldn't get warm; chills; goosebumps; This is a spontaneous report from a contactable other HCP. A 24-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Jan2021 12:00 at single dose on right arm (Lot number: Eu9231) for covid-19 immunisation. Medical history included allergies to Rosemary, sage, and lavender. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). No other vaccine in four weeks. No covid prior vaccination. The patient previously received first dose of BNT162B2 (Lot number: EJ1685) on 12Dec2020 12:00 AM on right arm. The patient experienced felt a little itchy around injection site and arm pain on 09Jan2021 09:00 PM, when she got home and ready for bed she felt sick on 09Jan2021, massive headache, stomach cramps, joint pain, the back of her ribs hurt, nausea, couldn't get warm chills, goosebumps on 09Jan2021. Patient took ibuprofen at 2300. She woke up at 0224 (10Jan2021) with her heart racing and with a fever. Watch showing her heart rate was 123 when she woke up (resting), temperature was taken at 0250 (10Jan2021) showing 101.8 it felt like she was warmer though. Patient took more ibuprofen, ate something, and re temped yielding 100.8, heart rate dropped to 91, then 88 as of 0300. Outcome of events was recovering. No covid tested post vaccination.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Malaise, Musculoskeletal chest pain
Clinical narrative: heart rate was 123 when she woke up (resting); temperature showing 101.8; felt a little itchy around injection site; arm pain; felt sick; Massive headache; stomach cramps; joint pain; the back of her ribs hurt; nausea; couldn't get warm; chills; goosebumps; This is a spontaneous report from a contactable other HCP. A 24-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Jan2021 12:00 at single dose on right arm (Lot number: Eu9231) for covid-19 immunisation. Medical history included allergies to Rosemary, sage, and lavender. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). No other vaccine in four weeks. No covid prior vaccination. The patient previously received first dose of BNT162B2 (Lot number: EJ1685) on 12Dec2020 12:00 AM on right arm. The patient experienced felt a little itchy around injection site and arm pain on 09Jan2021 09:00 PM, when she got home and ready for bed she felt sick on 09Jan2021, massive headache, stomach cramps, joint pain, the back of her ribs hurt, nausea, couldn't get warm chills, goosebumps on 09Jan2021. Patient took ibuprofen at 2300. She woke up at 0224 (10Jan2021) with her heart racing and with a fever. Watch showing her heart rate was 123 when she woke up (resting), temperature was taken at 0250 (10Jan2021) showing 101.8 it felt like she was warmer though. Patient took more ibuprofen, ate something, and re temped yielding 100.8, heart rate dropped to 91, then 88 as of 0300. Outcome of events was recovering. No covid tested post vaccination.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Piloerection, Pyrexia, Vaccination site pain, Vaccination site pruritus
Clinical narrative: heart rate was 123 when she woke up (resting); temperature showing 101.8; felt a little itchy around injection site; arm pain; felt sick; Massive headache; stomach cramps; joint pain; the back of her ribs hurt; nausea; couldn't get warm; chills; goosebumps; This is a spontaneous report from a contactable other HCP. A 24-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Jan2021 12:00 at single dose on right arm (Lot number: Eu9231) for covid-19 immunisation. Medical history included allergies to Rosemary, sage, and lavender. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). No other vaccine in four weeks. No covid prior vaccination. The patient previously received first dose of BNT162B2 (Lot number: EJ1685) on 12Dec2020 12:00 AM on right arm. The patient experienced felt a little itchy around injection site and arm pain on 09Jan2021 09:00 PM, when she got home and ready for bed she felt sick on 09Jan2021, massive headache, stomach cramps, joint pain, the back of her ribs hurt, nausea, couldn't get warm chills, goosebumps on 09Jan2021. Patient took ibuprofen at 2300. She woke up at 0224 (10Jan2021) with her heart racing and with a fever. Watch showing her heart rate was 123 when she woke up (resting), temperature was taken at 0250 (10Jan2021) showing 101.8 it felt like she was warmer though. Patient took more ibuprofen, ate something, and re temped yielding 100.8, heart rate dropped to 91, then 88 as of 0300. Outcome of events was recovering. No covid tested post vaccination.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Headache, Heart rate, Heart rate increased
Clinical narrative: fast heart rate; tingling in feet; mild tightness in the chest; shaking chills; sore arm; body aches; headaches; This is a spontaneous report from a contactable physician (reporting for herself).  A non-pregnant 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm on 23Dec2020 12:00 at a single dose for COVID-19 immunization.  Medical history included hashimoto thyroiditis and hypertension.  Concomitant medication included levothyroxine sodium (SYNTHROID), hydrochlorothiazide (HCTZ), biotin, cyanocobalamin, folic acid (MVI 3), influenza vaccine inact split 3v (FLULAVAL) taken for immunization on 03Dec2020.  On 23Dec2020 12:15, the patient experienced fast heart rate, tingling in feet, mild tightness in the chest, shaking chills, sore arm, body aches and headaches.  The patient underwent lab tests and procedures which included heart rate: fast on 23Dec2020.   There was no treatment given for any of the events.  The outcome of the events was recovered in Dec2020.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: fast heart rate; tingling in feet; mild tightness in the chest; shaking chills; sore arm; body aches; headaches; This is a spontaneous report from a contactable physician (reporting for herself).  A non-pregnant 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm on 23Dec2020 12:00 at a single dose for COVID-19 immunization.  Medical history included hashimoto thyroiditis and hypertension.  Concomitant medication included levothyroxine sodium (SYNTHROID), hydrochlorothiazide (HCTZ), biotin, cyanocobalamin, folic acid (MVI 3), influenza vaccine inact split 3v (FLULAVAL) taken for immunization on 03Dec2020.  On 23Dec2020 12:15, the patient experienced fast heart rate, tingling in feet, mild tightness in the chest, shaking chills, sore arm, body aches and headaches.  The patient underwent lab tests and procedures which included heart rate: fast on 23Dec2020.   There was no treatment given for any of the events.  The outcome of the events was recovered in Dec2020.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Migraine, Nausea, Pain
Clinical narrative: general body pain; migraine; nausea; a low grade fever of 99; it "hit her like a bus"; This is a spontaneous report from a contactable consumer (patient's sister).  A 41-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration on Jan2021 at the age of 41-year-old at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. She had no covid prior vaccination. Patient previously received first dose BNT162B2 on Dec2020 at single dose for covid-19 immunisation. She had received her second dose of vaccine and it "hit her like a bus", she experienced general body pain, migraine, nausea, and a low grade fever of 99 on Jan2021. Outcome of events was unknown.   Information on lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: general body pain; migraine; nausea; a low grade fever of 99; it "hit her like a bus"; This is a spontaneous report from a contactable consumer (patient's sister).  A 41-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration on Jan2021 at the age of 41-year-old at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. She had no covid prior vaccination. Patient previously received first dose BNT162B2 on Dec2020 at single dose for covid-19 immunisation. She had received her second dose of vaccine and it "hit her like a bus", she experienced general body pain, migraine, nausea, and a low grade fever of 99 on Jan2021. Outcome of events was unknown.   Information on lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: fatigue; Headache; This is a spontaneous report from a Non-contactable other healthcare professional (HCP). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided, NDC 59267-1000-1), intramuscular at right arm on 12Dec2020 14:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue and a headache for 2 days on an unknown date. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: body aches; full body chills; temp of 100.1; moderate headache; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (lot number unknown), via an unspecified route of administration in right arm, on 09Jan2021 08:00 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19.  No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient experienced body aches, full body chills, temp of 100.1 and moderate headache on 09Jan2021 10:00 PM. Treatment was received for the events included Tylenol, ibuprofen. The outcome of the events was recovering.  Information on the lot/batch number has been requested.