chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Headache; Body aches; Right arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 45-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 09:15 (Lot number: EL3248) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot number: EL3248, Vaccine location: Right arm, Administration time: 07:30 AM), administration date: 02Mar2021, when the patient was 45 years old for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 24Mar2021 02:00, outcome "recovering", described as "headache", PAIN (non-serious) with onset 24Mar2021 02:00, outcome "recovering", described as "body aches", PAIN IN EXTREMITY (non-serious) with onset 24Mar2021 02:00, outcome "recovering", described as "Right arm was sore". Therapeutic measures were not taken as a result of headache, pain, pain in extremity.  Additional information: Patient did not have other vaccine in four weeks and other medications in two weeks. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. Patient had no known allergies. Patient received vaccine facility type in Workplace clinic. The night following the 2nd injection (about 16 hrs later), patient had a headache and body aches. Symptom persisted through the next day (36 hrs after injection). Right arm was sore, but not more than expected based on other shots.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node on left side near collar bone; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 10:30 (Lot number: EN6207) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "celiac disease" (unspecified if ongoing); "mild-moderate sleep apnea" (unspecified if ongoing); "gluten allergy" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 23Mar2021 18:00, outcome "not recovered", described as "swollen lymph node on left side near collar bone". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extremely tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 11:00 (Lot number: 3248) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GABAPENTIN; LEXAPRO. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot number: EL3248, Vaccine location: Right arm, Administration time: 03:30 PM), administration date: 03Mar2021, when the patient was 43 years old, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 24Mar2021 12:00, outcome "recovered" (2021), described as "Extremely tired". Therapeutic measures were not taken as a result of fatigue.  Additional information: Patient had not other vaccine in four weeks. Patient had received Gabapentin, Lexapro medications in two weeks. Patient had not covid prior vaccination. Patient had not covid tested post vaccination. Extremely tired the day after the shot; took a short nap in the middle of the day, but otherwise still able to function normally, was just very tired. The Pfizer US Drug safety unit recently received the attached report submitted by you via (website withheld). Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Pain in extremity
Clinical narrative: got the second dose in her left arm and only had soreness; 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 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 10:00 (Lot number: EN6207) at the age of 71 years as 2nd dose, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, batch/lot number: EN9266, Route: Intramuscular), administration date: 26Feb2021, when the patient was 71 years old, for Covid-19 immunization, reaction(s): "pain in the injections site".  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "got the second dose in her left arm and only had soreness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient stated she got the second dose in her left arm and only had soreness for a day or to and then went away. On 12Feb2021 the patient had Mammogram with unknown results and She has a 2nd mammogram scheduled on 31Mar2021. Reported she was diagnosed with high blood pressure when she was in her 40s. She said high blood pressure was inherent to her family. There was no  Prior Vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dry mouth, Heart rate, Heart rate increased, Thirst
Clinical narrative: anxious; dry mouth and feelings of thirst a few hours later. Elevated heart rate; dry mouth and feelings of thirst a few hours later.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 11:00 (Lot number: EP7534) at the age of 41 years as dose 1, single for covid-19 immunisation, prophylaxis. Relevant medical history included: "postpartum cardiomyopathy", start date: Jan2021 (ongoing); "seasonal allergies" (unspecified if ongoing); "heart rate" (unspecified if ongoing). Concomitant medication(s) included: CARVEDILOL taken for cardiac disorder (ongoing); CLARITIN [CLARITHROMYCIN] taken for seasonal allergy, start date: Mar2021 (ongoing). The following information was reported: DRY MOUTH (non-serious), THIRST (non-serious) all with onset 19Mar2021, outcome "recovered" (21Mar2021) and all described as "dry mouth and feelings of thirst a few hours later."; HEART RATE INCREASED (non-serious) with onset 19Mar2021, outcome "recovering", described as "Elevated heart rate"; ANXIETY (non-serious), outcome "unknown", described as "anxious". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: No prior vaccinations within 4 weeks. No AE(s) following prior vaccination. relevant tests were done.  There is product complaint regarding elevated heart rate while taking carvedilol. : Caller reported the carvedilol was dispensed in a pharmacy bottle and was unable to provide NDC number, lot number, or manufacturer.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Vaccination site pain
Clinical narrative: chills; arm used for injection was very sore; body aches; felt nauseous.; Headache; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 13:15 (Batch/Lot number: unknown) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies Tree fruit" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (Lot number : unknown , Left arm , DOSE 1, SINGLE, administration time: 01:30 PM), administration date: 23Feb2021, when the patient was 53 years old, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 16Mar2021 19:00, outcome "recovering", described as "chills"; VACCINATION SITE PAIN (non-serious) with onset 16Mar2021 19:00, outcome "recovering", described as "arm used for injection was very sore"; PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "body aches"; NAUSEA (non-serious) with onset Mar2021, outcome "recovering", described as "felt nauseous."; HEADACHE (non-serious) with onset Mar2021, outcome "not recovered", described as "Headache". Therapeutic measures were not taken as a result of chills, vaccination site pain, nausea. Therapeutic measures were taken as a result of pain, headache.  Additional information: The patient did not receive any other vaccine within four weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient felt better by Friday morning on 19Mar2021. The events did not result in doctor or other healthcare professional office/clinic visit, and the emergency room/department or urgent care. Therapeutic measures included treatment with Ibuprofen (ADVIL) which helped with body aches and headaches however they returned over time.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Defaecation urgency, Diarrhoea
Clinical narrative: Urgent need to have bowel movement; diarrhea/ loose, watery stool; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 09:45 (Lot number: EN6199) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (dose 1, single, administration time: 10:00 AM, lot number: EN5318, vaccine location: right arm), administration date: 02Mar2021, when the patient was 50 years old, for COVID-19 immunisation. The following information was reported: DEFAECATION URGENCY (non-serious) with onset 23Mar2021 17:45, outcome "unknown", described as "Urgent need to have bowel movement"; DIARRHOEA (non-serious) with onset 23Mar2021 17:45, outcome "unknown", described as "diarrhea/ loose, watery stool". Therapeutic measures were not taken as a result of defaecation urgency, diarrhoea.  Additional Information: The vaccine was administered at a Workplace clinic. The patient has no known allergies. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Events reported were not persistent. Since vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Nausea
Clinical narrative: nausea; chills; general feeling of unwell; This is a spontaneous report received from a 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 23Mar2021 11:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunization, reaction(s): "chills and aches from my fingertips to my toes", "general feeling of unwell", "chills and aches from my fingertips to my toes", "sore arm". The following information was reported: NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "nausea"; CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills"; MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "general feeling of unwell". Additional information: Patient got her second dose yesterday at 11. she had some nausea, chills, and general feeling of unwell. 2 weeks later she had a bout in the bathroom. Caller stated she had already reported this to the previous agent.  she asked yesterday, on phone and received some information. She reported adverse effects yesterday, minimal and nausea and that they could call her if they needed more information. She stated she wasn't having symptoms, she was trying get ahead of symptoms, She stated that her doctor said to take Advil before she gets symptoms, because it is harder to get rid of it once it starts. With the first Pfizer covid vaccine, she stated she had a really sore arm, the doctor said to take advil after the shot, this way to get ahead of any symptoms because they are hard to get on top of, and then she stated she took it after vaccination, 4 hours later than again before bed, she  took 3 doses. She stated she had 2nd dose of the Pfizer vaccine on Tuesday, and asked that she should be okay from not getting severe reactions or symptoms?, as she wanted to be around people. People are getting cysts around eyes when wearing mask and she  was having that problem too. how long after the second dose, do you have full protection? She stated she thought it was 2 weeks? But just read 7 days on Pfizer website. she is immunodeficient, and just wondering if she is aware.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Headache, Nausea
Clinical narrative: Mild chills; mild Nausea; headache; Significant fatigue; Although initially believed i was sore from moving furniture; I believe i have a sore gland in my left armpit; Peripheral coldness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 13:15 (Lot number: 3248) at the age of 49 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 1, Batch/lot number: EL3248, Time of vaccination:13:30, Anatomical location: Arm left), administration date: 02Mar2021, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 24Mar2021, outcome "recovering", described as "Mild chills"; NAUSEA (non-serious) with onset 24Mar2021, outcome "recovering", described as "mild Nausea"; HEADACHE (non-serious) with onset 24Mar2021, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset 24Mar2021, outcome "recovering", described as "Significant fatigue"; PAIN (non-serious) with onset 24Mar2021, outcome "unknown", described as "Although initially believed i was sore from moving furniture"; AXILLARY PAIN (non-serious) with onset 24Mar2021, outcome "unknown", described as "I believe i have a sore gland in my left armpit"; PERIPHERAL COLDNESS (non-serious) with onset 24Mar2021, outcome "unknown", described as "Peripheral coldness".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Patient had no allergies to medications, food, or other products.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Peripheral coldness
Clinical narrative: Mild chills; mild Nausea; headache; Significant fatigue; Although initially believed i was sore from moving furniture; I believe i have a sore gland in my left armpit; Peripheral coldness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 13:15 (Lot number: 3248) at the age of 49 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 1, Batch/lot number: EL3248, Time of vaccination:13:30, Anatomical location: Arm left), administration date: 02Mar2021, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 24Mar2021, outcome "recovering", described as "Mild chills"; NAUSEA (non-serious) with onset 24Mar2021, outcome "recovering", described as "mild Nausea"; HEADACHE (non-serious) with onset 24Mar2021, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset 24Mar2021, outcome "recovering", described as "Significant fatigue"; PAIN (non-serious) with onset 24Mar2021, outcome "unknown", described as "Although initially believed i was sore from moving furniture"; AXILLARY PAIN (non-serious) with onset 24Mar2021, outcome "unknown", described as "I believe i have a sore gland in my left armpit"; PERIPHERAL COLDNESS (non-serious) with onset 24Mar2021, outcome "unknown", described as "Peripheral coldness".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Patient had no allergies to medications, food, or other products.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain
Clinical narrative: very nauseous; chills; achy; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right arm, administration date 15Mar2021 09:45 (Lot number: EN6206) at the age of 56 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Enlarged prostate" (ongoing); "Stevens Johnson syndrome" (unspecified if ongoing), notes: allergic to sulfa drugs; 10 years or 12 years prior; "allergic to sulfa drugs" (unspecified if ongoing), notes: developed Stevens Johnson syndrome, 10 years or 12 years prior. Concomitant medication included: CIALIS taken for prostatomegaly (ongoing). Vaccination history included: BNT162B2 (dose 1, Lot number: EN6198), administration date: 22Feb2021, when the patient was 56 years old, for COVID-19 immunisation; Shingrix vaccine (dose 1, a year prior), for immunisation, reaction: "not feeling well"; Shingrix vaccine (dose 2, a year prior), for immunisation, reaction: "not feeling well".The following information was reported: NAUSEA (non-serious) with onset 15Mar2021 16:00, outcome "not recovered", described as "very nauseous"; CHILLS (non-serious) with onset 15Mar2021 16:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 15Mar2021 16:00, outcome "recovered" (17Mar2021), described as "achy".No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza, Pain in extremity
Clinical narrative: recovering from the flu; Sore arm; fog inside my head now; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 24Mar2021 11:00 (Batch/Lot number: unknown) 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 1, Single), for COVID-19 immunisation. The following information was reported: INFLUENZA (non-serious) with onset 25Mar2021, outcome "unknown", described as "recovering from the flu"; PAIN IN EXTREMITY (non-serious) with onset 25Mar2021, outcome "unknown", described as "Sore arm"; FEELING ABNORMAL (non-serious) with onset 25Mar2021, outcome "unknown", described as "fog inside my head now". It was unknown if therapeutic measures were taken as a result of influenza, pain in extremity, feeling abnormal.  Additional Information: Patient was supposed to take some Advil and hope to feel better by the time the fog outside lifts. Workplace clinic is the facility where the most recent COVID-19 vaccine was administered. It was unknown that the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient has been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary pain, Back pain, Breast pain, Feeling abnormal
Clinical narrative: lower back muscle pain/ lower back hurt; feeling very weak/ really weak; very sore throat; lower back muscle pain/ pain in muscles; pain in muscles and in her arm her left arm; left arm was feeling very weak; not feeling well/ felt sick; pain in her whole body; felt bad; strong aches under her armpit and on the left breast; strong aches under her armpit and on the left breast; This is a spontaneous report received from contactable consumer from medical information team. The reporter is the patient.   A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 24Mar2021 11:00 (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: BACK PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "lower back muscle pain/ lower back hurt"; ASTHENIA (non-serious) with onset Mar2021, outcome "unknown", described as "feeling very weak/ really weak"; OROPHARYNGEAL PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "very sore throat"; MYALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "lower back muscle pain/ pain in muscles"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "pain in muscles and in her arm her left arm"; MUSCULAR WEAKNESS (non-serious) with onset Mar2021, outcome "unknown", described as "left arm was feeling very weak"; MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "not feeling well/ felt sick"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "pain in her whole body"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "felt bad"; AXILLARY PAIN (non-serious), BREAST PAIN (non-serious) all with onset Mar2021, outcome "unknown" and all described as "strong aches under her armpit and on the left breast". The events "lower back muscle pain/ lower back hurt", "feeling very weak/ really weak", "very sore throat", "lower back muscle pain/ pain in muscles", "pain in muscles and in her arm her left arm", "left arm was feeling very weak", "not feeling well/ felt sick", "pain in her whole body", "felt bad", and "strong aches under her armpit and on the left breast" were evaluated at the physician office visit. Therapeutic measures were taken as a result of back pain, asthenia, oropharyngeal pain, myalgia, pain in extremity, muscular weakness, malaise, pain, feeling abnormal, axillary pain, breast pain.  Additional information: The patient's age was reported as 66 (unit unspecified). She went to gastroenterology and was told to take paracetamol (TYLENOL).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Muscular weakness, Myalgia, Oropharyngeal pain, Pain
Clinical narrative: lower back muscle pain/ lower back hurt; feeling very weak/ really weak; very sore throat; lower back muscle pain/ pain in muscles; pain in muscles and in her arm her left arm; left arm was feeling very weak; not feeling well/ felt sick; pain in her whole body; felt bad; strong aches under her armpit and on the left breast; strong aches under her armpit and on the left breast; This is a spontaneous report received from contactable consumer from medical information team. The reporter is the patient.   A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 24Mar2021 11:00 (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: BACK PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "lower back muscle pain/ lower back hurt"; ASTHENIA (non-serious) with onset Mar2021, outcome "unknown", described as "feeling very weak/ really weak"; OROPHARYNGEAL PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "very sore throat"; MYALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "lower back muscle pain/ pain in muscles"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "pain in muscles and in her arm her left arm"; MUSCULAR WEAKNESS (non-serious) with onset Mar2021, outcome "unknown", described as "left arm was feeling very weak"; MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "not feeling well/ felt sick"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "pain in her whole body"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "felt bad"; AXILLARY PAIN (non-serious), BREAST PAIN (non-serious) all with onset Mar2021, outcome "unknown" and all described as "strong aches under her armpit and on the left breast". The events "lower back muscle pain/ lower back hurt", "feeling very weak/ really weak", "very sore throat", "lower back muscle pain/ pain in muscles", "pain in muscles and in her arm her left arm", "left arm was feeling very weak", "not feeling well/ felt sick", "pain in her whole body", "felt bad", and "strong aches under her armpit and on the left breast" were evaluated at the physician office visit. Therapeutic measures were taken as a result of back pain, asthenia, oropharyngeal pain, myalgia, pain in extremity, muscular weakness, malaise, pain, feeling abnormal, axillary pain, breast pain.  Additional information: The patient's age was reported as 66 (unit unspecified). She went to gastroenterology and was told to take paracetamol (TYLENOL).  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
Clinical narrative: lower back muscle pain/ lower back hurt; feeling very weak/ really weak; very sore throat; lower back muscle pain/ pain in muscles; pain in muscles and in her arm her left arm; left arm was feeling very weak; not feeling well/ felt sick; pain in her whole body; felt bad; strong aches under her armpit and on the left breast; strong aches under her armpit and on the left breast; This is a spontaneous report received from contactable consumer from medical information team. The reporter is the patient.   A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 24Mar2021 11:00 (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: BACK PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "lower back muscle pain/ lower back hurt"; ASTHENIA (non-serious) with onset Mar2021, outcome "unknown", described as "feeling very weak/ really weak"; OROPHARYNGEAL PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "very sore throat"; MYALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "lower back muscle pain/ pain in muscles"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "pain in muscles and in her arm her left arm"; MUSCULAR WEAKNESS (non-serious) with onset Mar2021, outcome "unknown", described as "left arm was feeling very weak"; MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "not feeling well/ felt sick"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "pain in her whole body"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "felt bad"; AXILLARY PAIN (non-serious), BREAST PAIN (non-serious) all with onset Mar2021, outcome "unknown" and all described as "strong aches under her armpit and on the left breast". The events "lower back muscle pain/ lower back hurt", "feeling very weak/ really weak", "very sore throat", "lower back muscle pain/ pain in muscles", "pain in muscles and in her arm her left arm", "left arm was feeling very weak", "not feeling well/ felt sick", "pain in her whole body", "felt bad", and "strong aches under her armpit and on the left breast" were evaluated at the physician office visit. Therapeutic measures were taken as a result of back pain, asthenia, oropharyngeal pain, myalgia, pain in extremity, muscular weakness, malaise, pain, feeling abnormal, axillary pain, breast pain.  Additional information: The patient's age was reported as 66 (unit unspecified). She went to gastroenterology and was told to take paracetamol (TYLENOL).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: she was "a little fuzzy"; This is a spontaneous report received from a contactable nurse from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing), notes: taking "13" antihistamines. Concomitant medications included: TYLENOL WITH CODEINE; KEFLEX [CEFALEXIN]; TYLENOL. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), for COVID-19 immunisation. The following information was reported: FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "she was "a little fuzzy"".  Additional information: The reporter mentioned that her pharmacist & dentist didn't know what's safe, and was seeking guidance on her medications: antihistamines for allergies, she mentioned she was "a little fuzzy" and was taking "13" antihistamines; codeine phosphate, paracetamol (TYLENOL WITH CODEINE), but wasn't working so instead used a gram of paracetamol (TYLENOL) as needed; she was prescribed an antibiotic (cefalexin [KEFLEX] 250 mg 4x a day).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperacusis, Hypoacusis, Vertigo
Clinical narrative: muffled hearing; hyperacusis; headaches; vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 16:00 (Lot number: EN6208) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (Dose 1; lot number: EN6198; administration time: 04:00 PM; vaccine location: Left arm), administration date: 25Feb2021, when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: HYPOACUSIS (non-serious) with onset 19Mar2021, outcome "recovering", described as "muffled hearing"; HYPERACUSIS (non-serious) with onset 19Mar2021, outcome "recovering", described as "hyperacusis"; HEADACHE (non-serious) with onset 19Mar2021, outcome "recovering", described as "headaches"; VERTIGO (non-serious) with onset 19Mar2021, outcome "recovering", described as "vertigo". The events "muffled hearing", "hyperacusis", "headaches" and "vertigo" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of hypoacusis, hyperacusis, headache, vertigo. Additional information: Clinical course: The patient experienced muffled hearing and hyperacusis for the next two days after the second dose. This led to headaches and vertigo. Prednisone was given as a treatment for the adverse events. 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 and since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: chills, extreme fatigue, arm pain, headache, fogginess, lightheaded; chills, extreme fatigue, arm pain, headache, fogginess, lightheaded; chills, extreme fatigue, arm pain, headache, fogginess, lightheaded; chills, extreme fatigue, arm pain, headache, fogginess, lightheaded; chills, extreme fatigue, arm pain, headache, fogginess, lightheaded; chills, extreme fatigue, arm pain, headache, fogginess, lightheaded; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 (Lot number: EL3248) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known_allergies" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose number:1, vaccine location: right arm, lot number: EN6203), administration date: 01Mar2021, when the patient was 43 years old, for COVID-19 Immunization.  The following information was reported: DIZZINESS (non-serious), CHILLS (non-serious), PAIN IN EXTREMITY (non-serious), HEADACHE (non-serious), FEELING ABNORMAL (non-serious) all with onset 25Mar2021, outcome "recovering" and all described as "chills, extreme fatigue, arm pain, headache, fogginess, lightheaded"; FATIGUE (non-serious) with onset 24Mar2021 20:30, outcome "recovering". Therapeutic measures were not taken as a result of dizziness, chills, fatigue, pain in extremity, headache, feeling abnormal.  Additional information: Patient had vaccine on 24th and fatigue started that night. The next day on the 25th is when the other symptoms started. Prior to the vaccination, patient not had COVID-19. The patient was not tested positive for COVID-19 post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. OTC allergy medications were received within 2 weeks of vaccination. Ethnicity information was available. Race information was available.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: chills, extreme fatigue, arm pain, headache, fogginess, lightheaded; chills, extreme fatigue, arm pain, headache, fogginess, lightheaded; chills, extreme fatigue, arm pain, headache, fogginess, lightheaded; chills, extreme fatigue, arm pain, headache, fogginess, lightheaded; chills, extreme fatigue, arm pain, headache, fogginess, lightheaded; chills, extreme fatigue, arm pain, headache, fogginess, lightheaded; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 (Lot number: EL3248) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known_allergies" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose number:1, vaccine location: right arm, lot number: EN6203), administration date: 01Mar2021, when the patient was 43 years old, for COVID-19 Immunization.  The following information was reported: DIZZINESS (non-serious), CHILLS (non-serious), PAIN IN EXTREMITY (non-serious), HEADACHE (non-serious), FEELING ABNORMAL (non-serious) all with onset 25Mar2021, outcome "recovering" and all described as "chills, extreme fatigue, arm pain, headache, fogginess, lightheaded"; FATIGUE (non-serious) with onset 24Mar2021 20:30, outcome "recovering". Therapeutic measures were not taken as a result of dizziness, chills, fatigue, pain in extremity, headache, feeling abnormal.  Additional information: Patient had vaccine on 24th and fatigue started that night. The next day on the 25th is when the other symptoms started. Prior to the vaccination, patient not had COVID-19. The patient was not tested positive for COVID-19 post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. OTC allergy medications were received within 2 weeks of vaccination. Ethnicity information was available. Race information was available.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache before getting the second dose of vaccine; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 25Mar2021, this case now contains all required information to be considered valid.  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 04Mar2021 (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: HEADACHE (non-serious), outcome "unknown", described as "Headache before getting the second dose of vaccine". Therapeutic measures were taken as a result of headache.  Additional Information: The patient had headache before the getting the second dose so he took 2 paracetamol (TYLENOL) 500s about 10 minutes after the vaccine and wanted to know will this affect the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Limb mass, Pain in extremity
Clinical narrative: headache; fatigue; soreness in the arm; he has a ball in the arm which he have never had before; This is a spontaneous report received from a non-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 Mar2021 (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: HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "not recovered", described as "fatigue"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "soreness in the arm"; LIMB MASS (non-serious), outcome "unknown", described as "he has a ball in the arm which he have never had before".  Additional information: Events did not result to physician office visit.  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: Fatigue, Pain
Clinical narrative: body aches; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 09:00 (Lot number: EP6955) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: Auto-immune like symptoms: migraines; "fatigue" (unspecified if ongoing), notes: Auto-immune like symptoms: Fatigue; "pain" (unspecified if ongoing), notes: Auto-immune like symptoms: pain; "cognitive impairment" (unspecified if ongoing), notes: Auto-immune like symptoms: cognitive impairment. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; VITAMIN B2 [RIBOFLAVIN]; VITAMIN B12 [VITAMIN B12 NOS]; MAGNESIUM; PROBIOTICS. Past drug history included: Aleve, reaction(s): "allergy", notes: known allergies. Vaccination history included: Bnt162b2 (First dose; Time: 09:00 AM; Anatomical location: Left arm; Lot No. EL3247), administration date: 01Mar2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 23Mar2021 21:00, outcome "recovering", described as "body aches"; FATIGUE (non-serious) with onset 23Mar2021 21:00, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of pain, fatigue.  Additional information: Clinical course: On 23Mar2021 21:00, 12 hours post dose 2, the patient experienced body aches and fatigue. Next day, on 24Mar2021, patient had continued body aches and on 25Mar2021, patient had increased fatigue. Patient's concomitant medication also included "Multi". 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 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Nausea, Pain in extremity, Vomiting
Clinical narrative: insomnia; soreness in the arm; nausea; vomiting; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 15:00 (Lot number: EN6199) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Batch/lot number: EN5318), administration date: 04Mar2021, when the patient was 42 years old, for Covid-19 Immunization. The following information was reported: INSOMNIA (non-serious) with onset 23Mar2021 21:00, outcome "recovered" (25Mar2021), described as "insomnia"; PAIN IN EXTREMITY (non-serious) with onset 23Mar2021 21:00, outcome "recovered" (25Mar2021), described as "soreness in the arm"; NAUSEA (non-serious) with onset 23Mar2021 21:00, outcome "recovered" (25Mar2021), described as "nausea"; VOMITING (non-serious) with onset 23Mar2021 21:00, outcome "recovered" (25Mar2021), described as "vomiting"; CHILLS (non-serious) with onset 23Mar2021 21:00, outcome "recovered" (25Mar2021), described as "chills". Therapeutic measures were not taken as a result of insomnia, pain in extremity, nausea, vomiting, chills.  Additional information: Other medications in two weeks reported centrum vitamins. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with Covid-19 prior to vaccination. Patient was not tested for Covid-19 since vaccination. Patient had not any allergies to medications, food, or other products. Patient received centrum vitamins in two weeks of vaccination.Vaccine Facility information available.The patient became aware of the 1st side effect (soreness in the arm) when it started at 9pm on 23Mar. She didn't keep track on when the other side effects (insomnia, nausea and vomiting, chills) started but they came in during the night. On Thursday morning (25Mar), all the side effects were gone.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Productive cough
Clinical narrative: headache; soreness; nausea; phlegm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; PAIN (non-serious), outcome "unknown", described as "soreness"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "phlegm".  Additional information: The patient's age was reported as 20, no unit provided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.