chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Gait disturbance, Hyperhidrosis, Product use issue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 10:30 (Lot number: FF2587) at the age of 65 years as dose number unknown, single for Covid-19 immunisation. Relevant medical history included: "Donated kidney" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, start date: 28Sep2021, stop date: 28Sep2021; BABY ASPIRIN. The following information was reported: TREMOR (non-serious) with onset 28Sep2021 23:00, outcome "recovered" (2021), described as "Sever shakes"; HYPERHIDROSIS (non-serious) with onset 28Sep2021 23:00, outcome "recovered" (2021), described as "sweating"; THIRST (non-serious) with onset 28Sep2021 23:00, outcome "recovered" (2021), described as "thirst"; BODY TEMPERATURE INCREASED (non-serious) with onset 28Sep2021 23:00, outcome "recovered" (2021), described as "positive big temperature swings"; CHILLS (non-serious) with onset 28Sep2021 23:00, outcome "recovered" (2021), described as "Chilled"; SOMNOLENCE (non-serious), GAIT DISTURBANCE (non-serious) all with onset 28Sep2021 23:00, outcome "recovered" (2021) and all described as "Next day could not stay awake or walk very far"; PRODUCT USE ISSUE (non-serious) with onset 28Sep2021 23:00, outcome "unknown", described as "patient received Pfizer COVID-19 vaccine and flu vaccine on same day". Therapeutic measures were not taken as a result of tremor, hyperhidrosis, thirst, body temperature increased, chills, somnolence, gait disturbance. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received Baby aspirin within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. It was reported that sever shakes, sweating, thirst. Starting about 12 hours post shot shaking so bad water flying out of glass - positive big temperature swings. Chilled. Next day could not stay awake or walk very far. It was reported that no treatment was received for the adverse event. No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Thirst, Tremor
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 10:30 (Lot number: FF2587) at the age of 65 years as dose number unknown, single for Covid-19 immunisation. Relevant medical history included: "Donated kidney" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, start date: 28Sep2021, stop date: 28Sep2021; BABY ASPIRIN. The following information was reported: TREMOR (non-serious) with onset 28Sep2021 23:00, outcome "recovered" (2021), described as "Sever shakes"; HYPERHIDROSIS (non-serious) with onset 28Sep2021 23:00, outcome "recovered" (2021), described as "sweating"; THIRST (non-serious) with onset 28Sep2021 23:00, outcome "recovered" (2021), described as "thirst"; BODY TEMPERATURE INCREASED (non-serious) with onset 28Sep2021 23:00, outcome "recovered" (2021), described as "positive big temperature swings"; CHILLS (non-serious) with onset 28Sep2021 23:00, outcome "recovered" (2021), described as "Chilled"; SOMNOLENCE (non-serious), GAIT DISTURBANCE (non-serious) all with onset 28Sep2021 23:00, outcome "recovered" (2021) and all described as "Next day could not stay awake or walk very far"; PRODUCT USE ISSUE (non-serious) with onset 28Sep2021 23:00, outcome "unknown", described as "patient received Pfizer COVID-19 vaccine and flu vaccine on same day". Therapeutic measures were not taken as a result of tremor, hyperhidrosis, thirst, body temperature increased, chills, somnolence, gait disturbance. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received Baby aspirin within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. It was reported that sever shakes, sweating, thirst. Starting about 12 hours post shot shaking so bad water flying out of glass - positive big temperature swings. Chilled. Next day could not stay awake or walk very far. It was reported that no treatment was received for the adverse event. No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen supraclavicular lymph nodes on injection side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Sep2021 12:45 (Lot number: FF2588) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Batch/lot number: EW0217, Anatomical Location: Arm Left, Dose Number: 1, Time: 02:00 PM), administration date: 24Aug2021, when the patient was 40 years old, for Covid-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01Oct2021 02:00, outcome "not recovered", described as "Swollen supraclavicular lymph nodes on injection side". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Relevant past drug history reported as no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Seriousness was reported as no.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Hypoaesthesia, Tachycardia
Clinical narrative: anxiety; fast heartbeat/ my heart beating faster; numbing of the big toe on the right side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 18 year-old male patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious) with onset Sep2021, outcome "unknown", described as "anxiety"; TACHYCARDIA (non-serious) with onset Sep2021, outcome "not recovered", described as "fast heartbeat/ my heart beating faster"; HYPOAESTHESIA (non-serious) with onset Sep2021, outcome "unknown", described as "numbing of the big toe on the right side".  Additional Information: It was reported that, after first dose of the vaccine, a couple days later he started feeling like heart beating faster like and he do not know like it might be due to anxiety but not sure if it could be something else. He stated that, it still continued to experience the fast heartbeat without thinking about the adverse event. But since then it was kind of beating a little bit faster than usual even when he do not think about the vaccine. Is report related to a study or programme: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Stress
Clinical narrative: last night her arm was very sore; she became "stressed" over it.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL [IBUPROFEN] taken for headache. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 Immunization, reaction(s): "Fatigue", "sore arm"; Bnt162b2 (Dose:2), for COVID-19 Immunization, reaction(s): "Arthralgia", "fatigue", "Myalgia", "sore for several days", "low grade fevers". The following information was reported: STRESS (non-serious) with onset 2021, outcome "unknown", described as "she became "stressed" over it."; PAIN IN EXTREMITY (non-serious) with onset 30Sep2021, outcome "unknown", described as "last night her arm was very sore".  Additional information included: The patient stated it seemed that after her booster dose she was had very similar symptoms she had after her 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 (Lot number: EL9269) as dose 1, single and administered in arm left, administration date 04Mar2021 12:05 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Back pain", start date: 2014 (ongoing), notes: Regenerative therapy 21Sep2021; "Leg pain" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL (500 mg) taken for back pain, pain in extremity (ongoing). The following information was reported: PAIN (non-serious), outcome "unknown", described as "pain".   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Sep2021 (Lot number: FF8835) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension; METOPROLOL TARTRATE taken for hypertension; HYDROCHLOROTHIAZIDE taken for hypertension; METFORMIN HCL taken for diabetes mellitus; GLIPIZIDE taken for diabetes mellitus. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Pfizer 1- EL0142), administration date: 12Jan2021, when the patient was 73 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, Pfizer 2- EL9265), administration date: 02Feb2021, when the patient was 73 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information : It was reported that patient had taken all three of shots. Patient took last one today and had mentioned that had finished the series and somebody says, how do you know that Pfizer didn't give you a placebo, well the shot patient got came from a pharmacy, they are the one that gave shot patient had doubt that he would give me a placebo but do Pfizer give placebo when you expecting a vaccine. It was reported that there is a product complaint and report is related to a study or programme. Patient had no complications from any injections and remain committed to telling others of what Pfizer is doing for communities all over the world, during this COVID PANDEMIC. Patient remembered when he was employed as a high school graduate back and in training lined up and received our injections as told to do by the medical community. We got so many injections, given to us by injection guns, one after another that was 55 years ago. It was reported that patient have had zero side effects of major concern with Pfizer and not with standing sore arm ex 3 . 1and 2 Nothing.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 44-year-old female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history included valvular heart disease (unspecified if ongoing). The patient's concomitant medications not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for immunisation. The patient had pain in extremity (mild upper arm soreness) and  fatigue (mild fatigue), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Headache, Heart rate, Heart rate increased
Clinical narrative: Headaches; Fatigue; Blood pressure it was 130/83; Heartbeat is 104; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization; Bnt162b2 (Dose 2, single), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headaches"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; HYPERTENSION (non-serious) with onset 2021, outcome "unknown", described as "Blood pressure it was 130/83"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "Heartbeat is 104". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Headaches; Fatigue; Blood pressure it was 130/83; Heartbeat is 104; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization; Bnt162b2 (Dose 2, single), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headaches"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; HYPERTENSION (non-serious) with onset 2021, outcome "unknown", described as "Blood pressure it was 130/83"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "Heartbeat is 104". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Fear of falling, Feeling abnormal, Gait disturbance
Clinical narrative: I can not walk right anymore/ I can walk, but it is very difficult; I can not even climb in car or anything, it is really bad; It is just persisting, I can not push because I fall if I do; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 (Batch/Lot number: unknown) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Stroke" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Anatomical site of injection: Left arm), administration date: 28Mar2021, when the patient was 53 years old, for COVID-19 immunization.  The following information was reported: GAIT DISTURBANCE (non-serious) with onset 16Apr2021, outcome "not recovered", described as "I can not walk right anymore/ I can walk, but it is very difficult"; FEELING ABNORMAL (non-serious) with onset 16Apr2021, outcome "not recovered", described as "I can not even climb in car or anything, it is really bad"; FEAR OF FALLING (non-serious) with onset 16Apr2021, outcome "not recovered", described as "It is just persisting, I can not push because I fall if I do". Therapeutic measures were not taken as a result of gait disturbance, feeling abnormal, fear of falling.  Additional information: Patient got the first vaccine in March, got the second Vaccine in April. Now was due, this month to get that, the booster, but was afraid to get it. Because after patient got second shot in April, can not walk right anymore and can walk, but it was very difficult. When asked about medical history, patient reported had a stroke before, but do not take any medication anymore. When asked if still experiencing, patient replied can walk but can not even climb in car or anything, it was really bad. It was just persisting, patient can not push because patient fall if did anything. The patient just do not walk very much.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Extrasystoles, Heart rate irregular
Clinical narrative: Irregular heartbeats detected by my bloodpressure monitor; Sometimes double heartbeats and sometimes triple heartbeats; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Lot number: EN6198) at the age of 74 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "Allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; LEVOTHYROXINE; LISINOPRIL; OMEPRAZOL. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 08Mar2021 07:30, outcome "unknown", described as "Irregular heartbeats detected by my bloodpressure monitor"; EXTRASYSTOLES (non-serious) with onset 08Mar2021 07:30, outcome "unknown", described as "Sometimes double heartbeats and sometimes triple heartbeats". The events "irregular heartbeats detected by my bloodpressure monitor" and "sometimes double heartbeats and sometimes triple heartbeats" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate irregular, extrasystoles.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Erection increased
Clinical narrative: has been having erection for two days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 29Sep2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: ERECTION INCREASED (non-serious) with onset Sep2021, outcome "not recovered", described as "has been having erection for two days.".  Additional information: Patient took the pills two days ago 29Sep2021 and took the pill again yesterday 30Sep2021 and confirmed that it was pills that he took but did not provide the name of medication and denied it was Viagra.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal stiffness, SARS-CoV-2 test
Clinical narrative: Stiffness and muscle weakness on the right side of the face occurred next day.; Stiffness and muscle weakness on the right side of the face occurred next day.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 15:30 (Lot number: Ff2588) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pollen Allergy" (unspecified if ongoing), notes: Pollen. There were no concomitant medications. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), MUSCULAR WEAKNESS (non-serious) all with onset 29Sep2021 09:00, outcome "unknown" and all described as "Stiffness and muscle weakness on the right side of the face occurred next day.". The event "stiffness and muscle weakness on the right side of the face occurred next day." and "stiffness and muscle weakness on the right side of the face occurred next day." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of musculoskeletal stiffness, muscular weakness.  Additional Information: 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: Pharmacy or Drug Store. List of any other medications the patient received within 2 weeks of vaccination: None. Relevant medical history and concurrent conditions: None. Relevant past drug history: Pollen. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Serious-ness criteria-Congenital anomaly/birth defect: No. Stiffness and muscle weakness on the right side of the face occurred next day. Hospitalization Prolonged: No. Treatment Received: Unknown. Doctor or other healthcare professional office/clinic visit. Prior to vaccination, was the patient diagnosed with COVID-19? No. Since the vaccination, has the patient been tested for COVID-19? Yes. Results of tests and procedures for investigation of the patient: Date: 30Sep2021 Test: PCR Test Result: Unknown Lab Notes: Nasal Swab.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Varicose vein
Clinical narrative: varicose veins; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing), notes: she takes thyroid medication. The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st dose.), for Covid-19 immunization. The following information was reported: VARICOSE VEIN (non-serious) with onset 2021, outcome "unknown", described as "varicose veins".  Additional Information: The patient did not trust Moderna as much and trust Johnson and Johnson. She just trust the Pfizer vaccine, she probably work for Pfizer one day. She noticed after second vaccine, all of a sudden within that same week I ended up with varicose veins, she always looking at legs never had them like that. Again, she rather have varicose veins than have Covid. The report was related to a study or programme. The reason for no lot number of Covid vaccine Caller did not know where her Covid vaccine card to provide those numbers. She declined date of birth, height and weight. Originally caller also declined ethnicity but later in the call she provided that. She had either the booster or the 2nd dose, but it must of been the 2nd dose, felt it very strong. The caller felt that the 2nd was stronger than the 1st but she feels the booster more intense. She takes thyroid medication but she did not think that was relevant. She will say that after getting the Pfizer vaccine that she noticed that her varicose veins got worse and that's weird because they have never stuck out the way they stick out now. She noticed this after the 2nd dose, not the 1st dose, so that's something that she needs to keep an eye on. She think that her 2nd dose was possibly, she can't remember exactly, but she thinks that it was maybe in late Apr2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick for a week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101312069 (Pfizer).  A 49 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "recovered" (2021), described as "sick for a week".  Additional information: The patient was in good shape, he was an active person. He was one of those people who didn't have any health concerns. He was pretty healthy and active. The patient had some side effects from his second Pfizer vaccine and he had it go on for almost 2 weeks. The patient felt the 2nd dose very strong. The patient was sick for at least a week with the second dose and he felt terrible after the second dose but he was good, he didn't have COVID. He said 10 days or 12 days, he had to take time off from work and he was fine now.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Both shots made me feel like I had Covid all over again; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 19:15 (Batch/Lot number: unknown) as dose 2, single and administered in arm left, administration date 08Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 30Sep2021, outcome "not recovered", described as "Both shots made me feel like I had Covid all over again". Therapeutic measures were not taken as a result of influenza like illness.  Additional information: patient reported that She set off the beepers when she walks in and out of facility. It happened right after her second dose at facility. She went the next day and it only went off when she walked out. But she went last night with only her wallet, and it went off when she walked in the store and when she walked out of the store as if she stole something. Both shots made her feel like her had Covid all over again. the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 82 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Sep2021 (Lot number: FF2588) at the age of 82 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, lot no unknown), administration date: 04Feb2021, when the patient was 82 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, lot no unknown), administration date: 25Feb2021, when the patient was 82 years old, for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 02Oct2021 06:00, outcome "not recovered", described as "Dizziness". Therapeutic measures were not taken as a result of dizziness.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not received any other medications within 2 weeks of vaccination. Patient not had covid prior vaccination and had not covid tested post vaccination. Patient not any known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not been tested for COVID-19. Patient reported other drug as Suspect Batch/lot number: EN6200 Date of start of drug 28Sep2021.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Inappropriate schedule of product administration
Clinical narrative: I have a sore on my tongue; administration date=01Oct2021,dose number=2;rev dose administration date=27Jul2021,dose number=1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Oct2021 15:30 (Lot number: FE3592) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy: shellfish" (unspecified if ongoing), notes: known allergies: shellfish; "Allergy:milk" (unspecified if ongoing), notes: known allergies: milk; "alcohol" (unspecified if ongoing), notes: known allergies: alcohol. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]. Past drug history included: Hydrocodone, reaction(s): "Allergy:hydrocodone", notes: known allergies: hydrocodone; Tramadol, reaction(s): "Allergy: tramadol", notes: known allergies: tramadol; Oxycodone, reaction(s): "Allergy: oxycodone", notes: known allergies: oxycodone. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19,, Prev dose brand=Pfizer,Dose Number: 1, Batch/Lot No: EW0191, Location of injection: Arm Right), administration date: 27Jul2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: GLOSSODYNIA (non-serious) with onset 01Oct2021 19:30, outcome "not recovered", described as "I have a sore on my tongue"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 01Oct2021 15:30, outcome "unknown", described as "administration date=01Oct2021,dose number=2;rev dose administration date=27Jul2021,dose number=1". Therapeutic measures were not taken as a result of glossodynia.  Additional information: The patient had a sore on tongue that cannot be described by any other thing. It began as a very tiny sore several hours after the vaccine and had gotten larger through the night last night and through today. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, SARS-CoV-2 test
Clinical narrative: irregular periods; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 13:15 (Lot number: EW0150) at the age of 25 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6208, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 15Mar2021, when the patient was 25 years old, for COVID-19 immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 2021, outcome "unknown", described as "irregular periods". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation irregular.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Fatigue, Pain, Pain in extremity
Clinical narrative: tiredness; sore arm; aches and pains; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Oct2021 14:34 (Lot number: EW0187) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), intramuscular, administered in deltoid left, administration date 01Oct2021 (Lot number: UJ716AB, Expiration Date: 30Jun2022) as dose 1, 0.5 ml single. Relevant medical history included: "crohns disease-in remission" (unspecified if ongoing); "Denies current use of tobacco", stop date: 2011, notes: Denies current use of tobacco. Positive history of tobacco use cigarettes 1 pack per day X20.00 years quit 2011. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] (ongoing); CALCIUM 600 WITH VITAMIN D3 (ongoing); FISH OIL [COD-LIVER OIL] (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6198, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 06Mar2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 27Mar2021, when the patient was 67 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 02Oct2021 01:30, outcome "recovered" (Oct2021), described as "tiredness"; PAIN IN EXTREMITY (non-serious) with onset 02Oct2021 01:30, outcome "recovered" (Oct2021), described as "sore arm"; PAIN (non-serious) with onset 02Oct2021 01:30, outcome "recovered" (Oct2021), described as "aches and pains". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pain in extremity, pain. Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: no. Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Since the vaccination, has the patient been tested for COVID-19: No. known allergies: no. Did the patient provide information to you regarding the reported adverse event(s) with the use of the product? No. Patient is postmenopausal. Vital Signs: BP Temp F: 97.60 HR: temp scan. Encounter for immunization: Patient received both Pfizer Covid booster and Influenza vaccine without incident.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Colonoscopy, Electrocardiogram, Illness, Pain in extremity
Clinical narrative: sore arm; hand swell at injection site; couple of bouts of vertigo; ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Apr2021 11:00 (Lot number: ER8732) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ulcerative colitis", start date: 2005 (ongoing), notes: Blood infusion 4 points.; "Osteoporosis", start date: 2019 (ongoing); "Heart block", start date: 2019 (unspecified if ongoing), notes: Test: Hospital, start date: 2019, Results: Chest X-ray and EKG, Comments: Heart block. Concomitant medication(s) included: MERCAPTOPURINE taken for colitis ulcerative, start date: Nov2005 (ongoing); ALENDRONATE taken for osteoporosis, start date: Dec2019 (ongoing). Vaccination history included: Flu shot; Pneumonia shot (Pneumonia shot both kinds starting 2017), administration date: 2017. The following information was reported: VERTIGO (non-serious) with onset 2021, outcome "unknown", described as "couple of bouts of vertigo"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "ill"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "hand swell at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo, illness.  Additional information:Prior to vaccination, patient  was not diagnosed with COVID-19.Since the vaccination, patient has  been tested for COVID-19.Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site swelling, Vertigo
Clinical narrative: sore arm; hand swell at injection site; couple of bouts of vertigo; ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Apr2021 11:00 (Lot number: ER8732) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ulcerative colitis", start date: 2005 (ongoing), notes: Blood infusion 4 points.; "Osteoporosis", start date: 2019 (ongoing); "Heart block", start date: 2019 (unspecified if ongoing), notes: Test: Hospital, start date: 2019, Results: Chest X-ray and EKG, Comments: Heart block. Concomitant medication(s) included: MERCAPTOPURINE taken for colitis ulcerative, start date: Nov2005 (ongoing); ALENDRONATE taken for osteoporosis, start date: Dec2019 (ongoing). Vaccination history included: Flu shot; Pneumonia shot (Pneumonia shot both kinds starting 2017), administration date: 2017. The following information was reported: VERTIGO (non-serious) with onset 2021, outcome "unknown", described as "couple of bouts of vertigo"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "ill"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "hand swell at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo, illness.  Additional information:Prior to vaccination, patient  was not diagnosed with COVID-19.Since the vaccination, patient has  been tested for COVID-19.Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date 28Sep2021 (Batch/Lot number: unknown) at the age of 50 years as dose 2, single and (Batch/Lot number: unknown) for 1 day as dose 1, single for covid-19 immunisation. Relevant medical history included: "feel discouraged", start date: 2001 (ongoing); "depressed", start date: 2001 (ongoing); "Rheumatoid arthritis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "recovering", described as "under the weather"; PAIN (non-serious) with onset 2021, outcome "recovering", described as "aches". Therapeutic measures were taken as a result of malaise, pain.  Additional information: Patient reports about 2 weeks into taking medication, he noticed "i was feeling a bit better" (no specific details provided), "since then i'm at a stand still". Patient strongly agrees with statement its been hard to cope with rheumatoid arthritis, and sometimes he feel discouraged and or depressed. This is not new to patient reports feeling this way as far back as 2001. Patient reports he received second covid vaccine 28Sep2021, and he feels "under the weather, aches and such", much like he did when he received the first dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo - full room spinning - started  12 hours post vaccination; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 11:00 (Lot number: 301308A) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Narcolepsy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3184, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 11Sep2021, when the patient was 38 years old, for Covid-19 Immunization. The following information was reported: VERTIGO (non-serious) with onset 02Oct2021 23:00, outcome "recovering", described as "vertigo - full room spinning - started  12 hours post vaccination". Therapeutic measures were not taken as a result of vertigo.  Additional information: Facility type vaccine was pharmacy or drug store. No pregnancy at time of Vaccination. No other vaccine in four weeks. Patient was not received treatment for AE. No covid prior vaccination. Covid was not tested post vaccination. No known allergies. Device date was 03Oct2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold
Clinical narrative: feeling very tired; she is feeling cold all day too; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 23Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "feeling very tired"; FEELING COLD (non-serious) with onset 2021, outcome "unknown", described as "she is feeling cold all day too".  Additional information: Clinical course reported as patient took the first Pfizer Covid 19 shot on 23Sep2021 and has been feeling very tired since. Recently she is feeling cold all day too.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: having bad headaches and can't even hold her head up; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 27Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "having bad headaches and can't even hold her head up".  Additional information: The husband of patient reported that he and his wife got he booster dose of the Pfizer Covid Vaccine on 27Sep2021. The reporter said that he had some shoulder discomfort. His wife was having a bad headache. The reporter was wanting to know if these were normal side effects. The reporter stated that his own shoulder discomfort had gone away; but his wife could not even hold her head.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.