chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: mildly sore arm; felt washed out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Mar2021 (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 (product=COVID 19, brand=Pfizer, dose number=1, lot is Unknown: not available/not provided to reporter at the time of report completion), administration date: 24Feb2021, for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 18Mar2021, outcome "recovered" (2021), described as "mildly sore arm"; FATIGUE (non-serious) with onset 18Mar2021, outcome "recovered" (2021), described as "felt washed out". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  Additional information: It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown, prior to vaccination, if the patient was diagnosed with COVID-19 and since the vaccination, if the patient had been tested for COVID-19. The response to the query included that reporter first became aware of this report on the day it was reported, thursday, March 25th, was in a meeting with several other people and they were talking about their recent vaccines and side effects that they did or did not experience and asked if any had received the Pfizer vaccine and two confirmed that they did. Patient had mentioned her side effects. The other person stated that they had no side effects from the vaccine, asked patient to provide the details on when and where she received her shots and the side effects she experienced, which she did and then submitted the report with the information she provided. For more information from her, email her and reporter dont have any other contact information for her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Localized soreness in injection site muscle; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 14:00 (Lot number: EL3247) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid vaccine (Dose 1, Anatomical Location: Arm Left, Batch/lot number: EL3247, administration time: 14:00 ), administration date: 03Mar2021, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24Mar2021 21:00, outcome "recovering", described as "Localized soreness in injection site muscle". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Pfizer had permission to contact you about this report. Pfizer did not have permission to contact the patient's healthcare provider about this report. The patient did not 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. Upon follow up on (27Mar2021) the Agency recently received the attached report submitted by the patient via RA. Please help to confirm event "Localized soreness in injection site muscle" start date since provided as 23Mar2021, the administration date of dose 2 is 24Mar2021, so this event occurred before dose 2. Please help to confirm the date that you became aware of the adverse event in this report as this effects regulatory reporting timelines. Apologies, the patient entered the date of the symptom incorrectly. She intended to enter 9 pm Wednesday 24 March 2021, the evening after her vaccination. This was also the awareness date.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: tired; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Mar2021 (Lot number: EN6203) at the age of 74 years 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), outcome "unknown", described as "tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: throat started to feel funny; he felt like he bit into a lemon after the vaccine and his whole body felt weird; Worst chills he's ever had; Aches and pains; really exhausted for a couple days/tired; he just didn't feel good; 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 46 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm, administration date 03Mar2021 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Allergic to Penicillin" (ongoing), notes: Diagnosed when he was about 7 years old. It was unknown if the patient had prior vaccinations within 4 weeks. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. There were no concomitant medications. The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The vaccine was given somewhere between 16:00-19:00. The following information was reported: OROPHARYNGEAL DISCOMFORT (medically significant) with onset 03Mar2021, outcome "recovered" (Mar2021), described as "throat started to feel funny"; FEELING ABNORMAL (medically significant) with onset 03Mar2021, outcome "recovered" (Mar2021), described as "he felt like he bit into a lemon after the vaccine and his whole body felt weird"; CHILLS (non-serious) with onset 03Mar2021, outcome "recovered" (Mar2021), described as "Worst chills he's ever had"; PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Aches and pains"; FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "really exhausted for a couple days/tired"; MALAISE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "he just didn't feel good". Clinical course: The patient had a first dose of the vaccine and within 10 minutes of receiving, patient's throat started to feel funny. Patient felt like he bit into a lemon after the vaccine and his whole body felt weird. The medical staff gave the patient two shots of Benadryl. They were talking about giving him an epipen and sending him to the emergency room, but they did not do it; they just had him sit there a little while longer, decided he was okay to leave. The patient had what he described as the worst chills he was ever had while walking out to the car. He just did not feel good for about 2 days. He had aches and pains, he was really exhausted for a couple days after that. He was tired and had the kind of normal symptoms, but the initial symptoms that he experienced was what she was concerned about. He was fine after a few days. Therapeutic measures were taken as a result of oropharyngeal discomfort, feeling abnormal (two shots of Benadryl). The events did not result in emergency or physician's office visit.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Slightly sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) at the age of 77 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 22Mar2021, outcome "recovered" (23Mar2021), described as "Slightly sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient had no known allergies. 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; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Insomnia, Nasopharyngitis, Pain in extremity
Clinical narrative: Extremely cold within 2-3 hours of dose; Sore arm; Woke up hot in the middle of the night; Woke up hot in the middle of the night; This is a spontaneous report received from a contactable Consumer.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 12:00 (Lot number: EP7534) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 01, lot number: EN6198, administration time: 12:00 PM, vaccine location:Left arm), administration date: 28Feb2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 21Mar2021 14:30, outcome "recovered" (Mar2021), described as "Extremely cold within 2-3 hours of dose"; FEELING HOT (non-serious), INSOMNIA (non-serious) all with onset 21Mar2021, outcome "recovered" (Mar2021) and all described as "Woke up hot in the middle of the night"; PAIN IN EXTREMITY (non-serious) with onset 21Mar2021 14:30, outcome "recovered" (Mar2021), described as "Sore arm". Therapeutic measures were not taken as a result of nasopharyngitis, feeling hot, insomnia, pain in extremity.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dissociation, Enuresis, Fatigue, Gait inability, Illness
Clinical narrative: I lose some weight; I did not know where I was, I was like in a 'twilight thing' / felt like she was in another world; Couldn't hardly walk / could not walk; Couldn't get in and out of bed, couldn't sit in a chair; Wet the bed; Sore arm; I was very sick; Very tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Feb2021 17:00 (Lot number: EL9263) at the age of 82 years as dose 1, single and administered in arm right, administration date 13Mar2021 11:00 (Lot number: EL9264) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Ehlers-Danlos syndrome" (ongoing), notes: has had all her life; "Fall" (unspecified if ongoing); "Fractured left collar bone" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D2 (ongoing). Vaccination history included: Flu shots, reaction(s): "hurts a little where they give the shot". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Feb2021, outcome "recovered" (20Feb2021), described as "Sore arm"; DISSOCIATION (non-serious) with onset 20Feb2021, outcome "recovering", described as "I did not know where I was, I was like in a 'twilight thing' / felt like she was in another world"; GAIT INABILITY (non-serious) with onset 20Feb2021, outcome "recovering", described as "Couldn't hardly walk / could not walk"; MOBILITY DECREASED (non-serious) with onset 20Feb2021, outcome "recovering", described as "Couldn't get in and out of bed, couldn't sit in a chair"; ENURESIS (non-serious) with onset 20Feb2021, outcome "recovered", described as "Wet the bed"; ILLNESS (non-serious) with onset Feb2021, outcome "recovering", described as "I was very sick"; FATIGUE (non-serious) with onset Feb2021, outcome "not recovered", described as "Very tired"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "I lose some weight".  Additional information: The patient reported same events happened after both doses. The patient had no additional vaccines administered on same date of BNT162B2. The patient denied any testing, labs, treatments, emergency room, or physician office visits related to the events. The patient had not received any other vaccines within 4 weeks prior vaccination. The patient had sore arm with the second dose of vaccine on 13Mar2021 and recovered on 17Mar2021 and experienced wet the bed after the second dose of vaccine on 20Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Weight decreased
Clinical narrative: I lose some weight; I did not know where I was, I was like in a 'twilight thing' / felt like she was in another world; Couldn't hardly walk / could not walk; Couldn't get in and out of bed, couldn't sit in a chair; Wet the bed; Sore arm; I was very sick; Very tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Feb2021 17:00 (Lot number: EL9263) at the age of 82 years as dose 1, single and administered in arm right, administration date 13Mar2021 11:00 (Lot number: EL9264) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Ehlers-Danlos syndrome" (ongoing), notes: has had all her life; "Fall" (unspecified if ongoing); "Fractured left collar bone" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D2 (ongoing). Vaccination history included: Flu shots, reaction(s): "hurts a little where they give the shot". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Feb2021, outcome "recovered" (20Feb2021), described as "Sore arm"; DISSOCIATION (non-serious) with onset 20Feb2021, outcome "recovering", described as "I did not know where I was, I was like in a 'twilight thing' / felt like she was in another world"; GAIT INABILITY (non-serious) with onset 20Feb2021, outcome "recovering", described as "Couldn't hardly walk / could not walk"; MOBILITY DECREASED (non-serious) with onset 20Feb2021, outcome "recovering", described as "Couldn't get in and out of bed, couldn't sit in a chair"; ENURESIS (non-serious) with onset 20Feb2021, outcome "recovered", described as "Wet the bed"; ILLNESS (non-serious) with onset Feb2021, outcome "recovering", described as "I was very sick"; FATIGUE (non-serious) with onset Feb2021, outcome "not recovered", described as "Very tired"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "I lose some weight".  Additional information: The patient reported same events happened after both doses. The patient had no additional vaccines administered on same date of BNT162B2. The patient denied any testing, labs, treatments, emergency room, or physician office visits related to the events. The patient had not received any other vaccines within 4 weeks prior vaccination. The patient had sore arm with the second dose of vaccine on 13Mar2021 and recovered on 17Mar2021 and experienced wet the bed after the second dose of vaccine on 20Mar2021.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis
Clinical narrative: Slight cold/small cold; stuffy nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 03Mar2021 (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: NASOPHARYNGITIS (non-serious) with onset 21Mar2021, outcome "unknown", described as "Slight cold/small cold"; NASAL CONGESTION (non-serious) with onset 21Mar2021, outcome "unknown", described as "stuffy nose". Additional information: The patient's cold was "not bad" but "worse on Monday" (22Mar2021). The patient was supposed to receive his second dose on 24Mar2021 and wanted his appointment changed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bone disorder, Muscle disorder, Poor quality sleep, Vaccination site pain
Clinical narrative: Pain at the injection site which keeps the patient awake at night; Pain at the injection site which keeps the patient awake at night; injection site pain was unrelated to patient's medical history and was straight muscle or bone issue and was isolated; injection site pain was unrelated to patient's medical history and was straight muscle or bone issue and was isolated; 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 67 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 13Feb2021 10:00 (Lot number: EL3248) at the age of 67 years as dose 1, single and administered in left arm, administration date 06Mar2021 13:00 (Lot number: EN6199) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetic", start date: 2001 (ongoing); "Congestive Heart Failure", start date: 2020 (ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Feb2021, outcome "not recovered", POOR QUALITY SLEEP (non-serious) with onset Feb2021, outcome "not recovered" and all described as "Pain at the injection site which keeps the patient awake at night"; MUSCLE DISORDER (non-serious), BONE DISORDER (non-serious) all with onset Feb2021, outcome "not recovered" and all described as "injection site pain was unrelated to patient's medical history and was straight muscle or bone issue and was isolated". Therapeutic measures were taken as a result of vaccination site pain. Additional information: Unspecified treatment included something to rub on the vaccination site (as reported). The patient also received topical lidocaine patches, diclofenac sodium topical gel, and applied heat and cold on the site. The patient was also taking unspecified diabetes medication.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nasopharyngitis
Clinical narrative: sinus cold; was sick for like three days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (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: ILLNESS (non-serious), outcome "recovered", described as "was sick for like three days"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "sinus cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: dizziness; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) at the age of 18 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 24Mar2021 20:00, outcome "recovered" (Mar2021), described as "dizziness"; NAUSEA (non-serious) with onset 24Mar2021 20:00, outcome "recovered" (Mar2021), described as "Nausea".  Additional information: Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks from vaccination. The patient was diagnosed with COVID-19 prior to vaccination. She was not tested for COVID-19 after the vaccination. The patient did not have any allergies to medications, food, or other products. This adverse event report relates to my daughter. She received the vaccine on 24Mar.Apparently she started to feel dizziness and nausea that evening. As she was not in my home I did not become aware of the situation until my wife told me about the AE around noon on 25Mar. I reported it early in the day on 26Mar(9:52 am according to the report that you sent me).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Incredibly achy all over my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 11:30 (Lot number: EP6955) at the age of 41 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, Single, Product- COVID-19 Vaccine, Lot number- EL3247, Administration Date- 04Mar2021, Administration Time- 11:30 , Vaccine location: Left Arm), administration date: 04Mar2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 25Mar2021 22:00, outcome "recovering", described as "Incredibly achy all over my body". Therapeutic measures were not taken as a result of pain. Additional information: Patient was 41-years-old male and the age at vaccination was 41-years-old. The reported seriousness of the events was non-serious. Patient experienced incredibly achy all over his body on 25Mar2021 22:00 (10 hours and 30 minutes after vaccination). As the patient, he became aware of the adverse event on 25Mar2021 at 22:00. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. Patient had no known allergies to medications, food, or other products. The outcome of the event was resolving without any treatment.   No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Tremor, Vaccination site pain
Clinical narrative: Injection site soreness (mild); headache (severe); chills/shakes (moderate); chills/shakes (moderate); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 09:00 (Lot number: EL3247) at the age of 28 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Bipolar II" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE. Vaccination history included: Bnt162b2 (lot number=EL3247,, lot unknown=False,, administration time=10:00 AM,, vaccine location=Left arm,, dose number=1), administration date: 03Mar2021, when the patient was 28 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Mar2021 18:00, outcome "recovering", described as "Injection site soreness (mild)"; HEADACHE (non-serious) with onset 25Mar2021 18:00, outcome "recovering", described as "headache (severe)"; CHILLS (non-serious), TREMOR (non-serious) all with onset 25Mar2021 18:00, outcome "recovering" and all described as "chills/shakes (moderate)". Therapeutic measures were not taken as a result of vaccination site pain, headache, chills, tremor.  Additional information: Facility where the most recent COVID-19 vaccine was administered was workplace clinic. The patient didnot 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 been tested for COVID-19. Allergies to medications, food, or other products were none.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Joint range of motion decreased, Malaise, Pain in extremity
Clinical narrative: could barely lift the arm; left arm was numby; not been feeling well; left arm was achy/ aching legs and arms; 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 47 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 09Mar2021 (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: JOINT RANGE OF MOTION DECREASED (non-serious) with onset Mar2021, outcome "unknown", described as "could barely lift the arm"; HYPOAESTHESIA (non-serious) with onset Mar2021, outcome "unknown", described as "left arm was numby"; MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "not been feeling well"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "left arm was achy/ aching legs and arms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary pain, Back pain, Chills, Feeling hot
Clinical narrative: pain in her left arm pit (injection site was left arm)/ in her left armpit the lymph node; pain in her left arm pit (injection site was left arm)/ in her left armpit the lymph node; feeling really weak; chills that alternated with feeling very hot; chills that alternated with feeling very hot; tense upper back and muscle aches/ muscle ache in her upper back; tense upper back and muscle aches/ muscle ache in her upper back; muscle aches/ muscle ache in her upper back; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular, administered in the left arm, administration date 23Mar2021 (Lot number: ER8730) at the age of 66 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: controlled by the medication (oral pill), on medication for years; "tested COVID positive", start date: Nov2020 (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ASTHENIA (non-serious) with onset 24Mar2021, outcome "recovered" (24Mar2021), described as "feeling really weak"; FEELING HOT (non-serious), CHILLS (non-serious) all with onset 24Mar2021, outcome "recovered" (24Mar2021) and all described as "chills that alternated with feeling very hot"; BACK PAIN (non-serious), MUSCLE TIGHTNESS (non-serious) all with onset 24Mar2021, outcome "recovered" (24Mar2021) and all described as "tense upper back and muscle aches/ muscle ache in her upper back"; MYALGIA (non-serious) with onset 24Mar2021, outcome "recovered" (24Mar2021), described as "muscle aches/ muscle ache in her upper back"; AXILLARY PAIN (non-serious), LYMPH NODE PAIN (non-serious) all with onset 25Mar2021, outcome "not recovered" and all described as "pain in her left arm pit (injection site was left arm)/ in her left armpit the lymph node". The events "feeling really weak", "chills that alternated with feeling very hot", "tense upper back and muscle aches/ muscle ache in her upper back", and "pain in her left arm pit (injection site was left arm)/ in her left armpit the lymph node" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of asthenia, feeling hot, chills, back pain, muscle tightness, myalgia, axillary pain, lymph node pain.  Additional information: The patient spoke with her MD and they directed her to not receive the second dose because of the side effects. The patient mentioned she has blood pressure and that was controlled by the medication. She stated she's on medication for years (oral pill).  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Muscle tightness, Myalgia
Clinical narrative: pain in her left arm pit (injection site was left arm)/ in her left armpit the lymph node; pain in her left arm pit (injection site was left arm)/ in her left armpit the lymph node; feeling really weak; chills that alternated with feeling very hot; chills that alternated with feeling very hot; tense upper back and muscle aches/ muscle ache in her upper back; tense upper back and muscle aches/ muscle ache in her upper back; muscle aches/ muscle ache in her upper back; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular, administered in the left arm, administration date 23Mar2021 (Lot number: ER8730) at the age of 66 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: controlled by the medication (oral pill), on medication for years; "tested COVID positive", start date: Nov2020 (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ASTHENIA (non-serious) with onset 24Mar2021, outcome "recovered" (24Mar2021), described as "feeling really weak"; FEELING HOT (non-serious), CHILLS (non-serious) all with onset 24Mar2021, outcome "recovered" (24Mar2021) and all described as "chills that alternated with feeling very hot"; BACK PAIN (non-serious), MUSCLE TIGHTNESS (non-serious) all with onset 24Mar2021, outcome "recovered" (24Mar2021) and all described as "tense upper back and muscle aches/ muscle ache in her upper back"; MYALGIA (non-serious) with onset 24Mar2021, outcome "recovered" (24Mar2021), described as "muscle aches/ muscle ache in her upper back"; AXILLARY PAIN (non-serious), LYMPH NODE PAIN (non-serious) all with onset 25Mar2021, outcome "not recovered" and all described as "pain in her left arm pit (injection site was left arm)/ in her left armpit the lymph node". The events "feeling really weak", "chills that alternated with feeling very hot", "tense upper back and muscle aches/ muscle ache in her upper back", and "pain in her left arm pit (injection site was left arm)/ in her left armpit the lymph node" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of asthenia, feeling hot, chills, back pain, muscle tightness, myalgia, axillary pain, lymph node pain.  Additional information: The patient spoke with her MD and they directed her to not receive the second dose because of the side effects. The patient mentioned she has blood pressure and that was controlled by the medication. She stated she's on medication for years (oral pill).  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: feels really dizzy; 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 75 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 12:30 (Batch/Lot number: unknown) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (First dose, Upper left arm), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 25Mar2021, outcome "recovering", described as "feels really dizzy". Therapeutic measures were not taken as a result of dizziness. Additional information: It was reported that the patient was taking several pills a day and has been doing it for years but nothing relevant to dizziness. Patient wanted to know the event was a normal reaction with the vaccine. Patient had no other additional administered vaccines, no prior vaccinations within 4 weeks, and no family medical history relevant to adverse event  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: Fatigue, Headache, Illness, Vaccination site pain
Clinical narrative: arm sore at injection site; Headache; Tiredness; feeling ill; 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 24Mar2021 10:15 (Lot number: EN6203) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "perimenopause" (unspecified if ongoing); "depression" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: PROGESTERONE; ARMOUR THYROID; PROZAC; CETRIZINE. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot unknown: False, Administration date/time: 03Mar2021 10:00 AM, Anatomical Location : Arm Left, Dose Number:1), administration date: 03Mar2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "arm sore at injection site"; HEADACHE (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "Headache"; FATIGUE (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "Tiredness"; ILLNESS (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "feeling ill". Therapeutic measures were not taken as a result of vaccination site pain, headache, fatigue, illness.  Additional information: The patient was administered COVID-19 vaccine in clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received within 2 weeks of vaccination was Progesterone; Armor Thyroid; Prozac; OTC certirizi. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. No any allergies to medications, food, or other products. The response received for the query that aware of feeling ill on the 25Mar2021. The next day, on the 26Mar2021, felt better, returned to work & submitted the noted report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Sinus headache
Clinical narrative: sinus headache; 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 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 09:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sinus troubles" (unspecified if ongoing); "high blood pressure" (not ongoing). Family history included: "Environmental allergy" (unspecified if ongoing), notes: She said allergies run on both sides of her family; "Drug allergy" (unspecified if ongoing), notes: She said allergies run on both sides of her family. The patient took concomitant medications. The following information was reported: SINUS HEADACHE (non-serious) with onset 23Mar2021, outcome "not recovered", described as "sinus headache". The event "sinus headache" was 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 sinus headache.  Additional information: There were no additional vaccines administered on the same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported she took approximately 2 weeks before (or maybe longer) "Organic Smooth Move" herbal supplement (UPC Number: 3291700200, Lot Number: MB0004783, Expiration Date: Sep2022) to help clean her colon. Patient further reported that she had been having a sinus headache for 4 days straight now. She said she believed the headache started on 23Mar2021, and she still had the headache today (26Mar2021). She called her doctor today (26Mar2021) and told her doctor about the headache. She said she hadn't taken anything because she had read not to take any medications, like paracetamol (TYLENOL) or anti-inflammatories. She said she read certain medications could mask allergy symptoms to the COVID-19 Vaccine. Event did not result to emergency room visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Feeling hot, Pain
Clinical narrative: arm was sore / her arm was killing her out of nowhere / her arm hurt out of nowhere; Chills; So cold; kidneys were in so much pain / Her kidneys were killing her; she was hurting really bad / body was hurting; body was on fire / patient got hot; tired; 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), administered in arm left, administration date 25Mar2021 09:00 (Lot number: E96199) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Kidney condition" (unspecified if ongoing), notes: Verbatim: Kidney condition. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, ), administration date: 04Mar2021, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Mar2021, outcome "not recovered", described as "arm was sore / her arm was killing her out of nowhere / her arm hurt out of nowhere"; CHILLS (non-serious) with onset 25Mar2021, outcome "unknown", described as "Chills"; FEELING COLD (non-serious) with onset 25Mar2021, outcome "not recovered", described as "So cold"; RENAL PAIN (non-serious) with onset 25Mar2021, outcome "not recovered", described as "kidneys were in so much pain / Her kidneys were killing her"; PAIN (non-serious) with onset 25Mar2021, outcome "not recovered", described as "she was hurting really bad / body was hurting"; FEELING HOT (non-serious) with onset 25Mar2021, outcome "not recovered", described as "body was on fire / patient got hot"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "tired". Therapeutic measures were taken as a result of pain in extremity, chills, feeling cold, renal pain, pain, feeling hot, fatigue. Additional information: The patient's age was reported as 42 (unit was unknown). Clinical course: On 25Mar2021 (reported as yesterday), a couple hours (reported as at 2:30) after receiving her second dose (reported as booster shot), the patient experienced arm was sore / her arm was killing her out of nowhere / her arm hurt out of nowhere and got chills right away, she was so cold, her kidneys were in so much pain, she was hurting really bad, and her body was on fire and her body was hurting. Her kidneys were killing her. Patient hoped it will resolve. It was reported that the patient was drinking lots of water. It was also reported that the patient was fine and was just really tired. Patient was reported to be having a really hard time right now. The patient used blankets and a heating pad as a treatment for the events and with applying this, the patient got hot.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021336057 Same reporter and drug; similar events; different patient.;US-PFIZER INC-2021336059 Same reporter and drug; similar events; different patient.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Renal pain
Clinical narrative: arm was sore / her arm was killing her out of nowhere / her arm hurt out of nowhere; Chills; So cold; kidneys were in so much pain / Her kidneys were killing her; she was hurting really bad / body was hurting; body was on fire / patient got hot; tired; 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), administered in arm left, administration date 25Mar2021 09:00 (Lot number: E96199) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Kidney condition" (unspecified if ongoing), notes: Verbatim: Kidney condition. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, ), administration date: 04Mar2021, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Mar2021, outcome "not recovered", described as "arm was sore / her arm was killing her out of nowhere / her arm hurt out of nowhere"; CHILLS (non-serious) with onset 25Mar2021, outcome "unknown", described as "Chills"; FEELING COLD (non-serious) with onset 25Mar2021, outcome "not recovered", described as "So cold"; RENAL PAIN (non-serious) with onset 25Mar2021, outcome "not recovered", described as "kidneys were in so much pain / Her kidneys were killing her"; PAIN (non-serious) with onset 25Mar2021, outcome "not recovered", described as "she was hurting really bad / body was hurting"; FEELING HOT (non-serious) with onset 25Mar2021, outcome "not recovered", described as "body was on fire / patient got hot"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "tired". Therapeutic measures were taken as a result of pain in extremity, chills, feeling cold, renal pain, pain, feeling hot, fatigue. Additional information: The patient's age was reported as 42 (unit was unknown). Clinical course: On 25Mar2021 (reported as yesterday), a couple hours (reported as at 2:30) after receiving her second dose (reported as booster shot), the patient experienced arm was sore / her arm was killing her out of nowhere / her arm hurt out of nowhere and got chills right away, she was so cold, her kidneys were in so much pain, she was hurting really bad, and her body was on fire and her body was hurting. Her kidneys were killing her. Patient hoped it will resolve. It was reported that the patient was drinking lots of water. It was also reported that the patient was fine and was just really tired. Patient was reported to be having a really hard time right now. The patient used blankets and a heating pad as a treatment for the events and with applying this, the patient got hot.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021336057 Same reporter and drug; similar events; different patient.;US-PFIZER INC-2021336059 Same reporter and drug; similar events; different patient.
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: two red spots on her arm, one about the size of a quarter; 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 female patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (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: RASH MACULAR (non-serious), outcome "not recovered", described as "two red spots on her arm, one about the size of a quarter".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Headache
Clinical narrative: 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 (159558). The reporter is the patient. A 80 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Mar2021 (Lot number: ER2613) at the age of 80 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ELIQUIS taken for atrial fibrillation; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "On a blood thinner and got the vaccine"; HEADACHE (non-serious), outcome "unknown", described as "headache". The patient currently on blood thinners and failed to mention that on the HCP who administered her 1st vaccine shot on 21Mar2021. Now, the patient wants to know if this had any interactions and complications with the vaccine and on her upcoming 2nd dose schedule. No follow-up attempts are possible. No further information is expected.