chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Sore arm; Swollen Glands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Jan2021 12:30 (Lot number: EL3249) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension", start date: 01Jan2000 (ongoing), notes: Verbatim: Hypertension; "COPD", start date: 01Jan2000 (ongoing), notes: Verbatim: COPD. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Jan2021 16:00, outcome "recovered", described as "Sore arm"; LYMPHADENOPATHY (non-serious) with onset 21Jan2021 16:00, outcome "recovered", described as "Swollen Glands". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy.  Additional information: Vaccination facility information was reported. Seriousness criteria reported as not serious. The patient received second dose on 11feb2021 at 12:30 via intramuscularly in left arm with lot number EL9265 and experienced events sore arm, chills, fever, rash on trunk   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Cold sores (herpes simplex 1) in nose and rarely on mouth; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) in the left arm on 09Mar2021 at 14:00 (at the age of 46-year-old) as dose 1, single for COVID-19 immunisation. Medical history included herpes simplex in nose. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 13Mar2021, since the patient received covid vaccine, the patient experienced cold sores (herpes simplex 1) non-stop (till the time of reporting). The patient suffered from cold sores (herpes simplex 1) in nose and rarely on mouth. The outbreaks were once or twice a year. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event cold sores (herpes simplex 1) in nose and rarely on mouth was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: Amended product details (BNT162b2 Dose 2 was removed from suspect drug) and Vaccine Facility Information (details were added).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Pain in extremity
Clinical narrative: sore arm; nausea; feeling off; 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), intramuscular, administered in arm left, administration date 09Mar2021 12:30 (Lot number: EN6200) at the age of 43 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: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm"; NAUSEA (non-serious), outcome "recovered", described as "nausea"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "feeling off".  Additional Information: 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 did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. Facility type vaccine: Public Health Clinic/Veterans Administration facility. After the 1st shot of vaccine patient reported - regular side effects: sore arm, nausea and feeling off. The patient reported after 24 hrs. of 2nd shot of vaccine experienced chills, headaches, tiredness, no fever within 24 hrs. on 07Apr2021 and week after 2nd shot, broke out on a rash on left side. Started on forehead then by Friday, 09Apr, rash was on eyelid. Went to Eye dry sat and urgent care on Sunday for more rashes around eyebrows and corner of mouth and underneath lip. Went to dermatologist on Tuesday, 13Apr2021 and treated as shingles. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On the mend now but it left some scars and pigmentation issue. On PRD 04Oct2021 it was reported that patient did not have anaphylactic reaction. Patient was not hospitalized. Organ involvement Dermatological/mucosal, generalized erythema, Generalized pruritus with skin rash (Herpes zoster), Generalized prickle sensation (Herpes zoster), Red and itchy eyes (Herpes zoster) on an unspecified date and no emergency department/intensive care unit. Patient received treatment as Valtrex 1gm, prednisone 10 mg, bensal ointment. Reporter considered the Pfizer product had a causal effect to the adverse event. Patient's outcome following the potential anaphylactic reaction was recovered  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Product dose omission issue
Clinical narrative: Not feeling well; her appointment for the second dose is today,but is unable to go; 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 16Apr2021 (Lot number: EW0162, Expiration Date: 31Jul2021) 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: MALAISE (non-serious), outcome "unknown", described as "Not feeling well"; PRODUCT DOSE OMISSION ISSUE (non-serious), outcome "unknown", described as "her appointment for the second dose is today,but is unable to go".  Additional information: The patient wanted to know when the latest day was to get her Pfizer COVID-19 second dose. Caller stated she was not feeling well and wants to reschedule her second dose. Caller also stated she received her first dose 04/16/21 and was scheduled this Friday for her second dose. Caller also wanted to know if the batch number or serial number on the vaccination card is the actual vial that of the COVID-19 vaccine.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Arm has not stopped shaking since getting vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious) with onset Apr2021, outcome "unknown", described as "Arm has not stopped shaking since getting vaccine".  Additional information: It was unknown if reporter was a healthcare occupation/specialty professional (HCP). It was reported that . Just received vaccine 4 hours ago and arm has not stopped shaking since getting vaccine. Wants to know if this was a side effect or whats going on.  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, Myalgia, Nausea
Clinical narrative: nausea; chills; muscle pain; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 17Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: unknown), administration date: 27Mar2021, for covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset Apr2021, outcome "unknown", described as "nausea"; CHILLS (non-serious) with onset Apr2021, outcome "unknown", described as "chills"; MYALGIA (non-serious) with onset Apr2021, outcome "unknown", described as "muscle pain".  Additional information: Caller was calling on behalf of his wife who got and finished the 2 doses of the vaccine yesterday 17Apr2021. They were aware of the side effects, and he stated that she had this like nausea, chills, and muscle pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Carpal tunnel syndrome
Clinical narrative: Carpal Tunnel; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer-sponsored program. The reporter is the patient.  A 47-year-old female patient received bnt162b2 (BNT162B2), administration date 09Apr2021 (Lot number: ER8734) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Carpal Tunnel" (ongoing), notes: Carpal Tunnel. The patient's concomitant medications were not reported. The following information was reported: CARPAL TUNNEL SYNDROME (non-serious), outcome "unknown", described as "Carpal Tunnel".  Additional information: Patient scheduled on the 27th for the 2nd dose (18 days only) she mentioned that on the 29th, and will be having a surgery and aware of the side effects and wondering if the patient can take it late and like 5 days after the surgery and if it's ok. patient Scheduled for surgery related to this condition Carpel tunnel on 27 Apr 2021. The patient heard that the worst side effects happen after the second dose of the vaccine. The patient was wondering how regimented the time frame between vaccines is. Could the patient reschedule the vaccine.  Would rescheduling it ruin the vaccines. Should the patient need postpone the surgery. Would patient be okay if just got the vaccine and the surgery on the dates they are scheduled for.  Patient states that got first dose of the vaccine on 09Apr2021. The patient Says that was got it at a facility.  patient husband goes to the facility and states that they were offering the vaccine to spouses. Communication: The caller was provided with phone number of option 3, and hours of operation, prior to attempted warm transfer.  The caller provided with report reference. Unable to warm transfer due to high call volume. The caller agreed to cold transfer to facility.Caller states that  has been on hold for a long time.  Patient was under the impression from the person who transferred them to facility that  was being transferred to a different facility.    Follow-up #01(19Apr2021) : This is a Follow-up spontaneous report from a contactable consumer. This female consumer(patient) reported that: The report was not related to a study or programme. Dates for Questioning if patient should postpone second vaccine or possibly postpone carpal tunnel surgery and Reporter seriousness for Questioning if patient should postpone second vaccine or possibly postpone carpal tunnel surgery was unspecified. NDC number of COVID Vaccine was Not Provided. Expiry Date of Covid Vaccine was Not Provided. Other Products was  Not Provided. An investigation assessment was not provided.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Caller stated that she is "freaking out"  and that she does not want to receive the second dose of the vaccine.; 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) (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: As underlying conditions she has high blood pressure; "nose bleeds" (unspecified if ongoing), notes: nose bleeds; "venous insufficiency in both her legs" (unspecified if ongoing), notes: venous insufficiency in both her legs; "an ears disease that cause her to feel vertigo" (unspecified if ongoing), notes: an ears disease that cause her to feel vertigo; "she has 13 allergies to medicines." (unspecified if ongoing), notes: she has 13 allergies to medicines.; "Vertigo" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Caller stated that she is "freaking out"  and that she does not want to receive the second dose of the vaccine.".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Malaise
Clinical narrative: not feeling well; stomach bug and  not feeling well.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: ABDOMINAL DISCOMFORT (non-serious) with onset 19Apr2021, outcome "unknown", described as "stomach bug and  not feeling well."; MALAISE (non-serious), outcome "unknown", described as "not feeling well". Patient stated that these events were not due to the first vaccine as she had no issues. Patient would like to reschedule second dose.   No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache
Clinical narrative: headache; feeling warm; This is a spontaneous report received from a contactable reporter(Consumer) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 29Mar2021 (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) with onset 18Apr2021, outcome "unknown", described as "headache"; FEELING HOT (non-serious) with onset 18Apr2021, outcome "unknown", described as "feeling warm". Additional Information: Patient was asking if she can take the vaccine on another day because tomorrow is her schedule to take the 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: woke up today with a cold; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 17Apr2021 (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), administration date: 27Mar2021, for COVID-19 immunisation. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 18Apr2021, outcome "unknown", described as "woke up today with a cold". Additional Information: Patient wants to know if she can take Sudafed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: but he developed a cold this week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 70 year-old male patient received bnt162b2 (BNT162B2) (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), outcome "unknown", described as "but he developed a cold this week".  Additional information: She said that her father is scheduled to get the 2nd dose on Saturday, but he developed a cold this week. She would like to know if they can reschedule him in getting the 2nd dose. When asked for the date of the 1st dose she said she can't remember the exact date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: feel tingly & kind of numb; feel tingly & kind of numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 11:00 (Lot number: ER8733) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Discoid lupus erythematosus" (unspecified if ongoing), notes: Verbatim: Discoid lupus erythematosus (Skin lupus, NOT systemic lupus); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. The following information was reported: PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 24Mar2021 11:15, outcome "recovering" and all described as "feel tingly & kind of numb". Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia. Additional information: No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: stated that she noticed on her forearm that she red lines like her veins; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2) (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 immunization. The following information was reported: ERYTHEMA (non-serious) with onset 15Apr2021, outcome "not recovered", described as "stated that she noticed on her forearm that she red lines like her veins".  Additional information: The patient got her second dose of vaccine and last night noticed on her forearm that she had red lines like her veins. Stated that she still has them this morning. Stated that they were not raised or anything. The patient wanted to know if she needed to go get checked.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Pain
Clinical narrative: Metallic taste to food; Body aches; Extremely tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 14:00 (Lot number: ER2613) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 24Mar2021 17:00, outcome "recovered" (25Mar2021 17:00), described as "Metallic taste to food"; PAIN (non-serious) with onset 24Mar2021 17:00, outcome "recovered" (2021), described as "Body aches"; FATIGUE (non-serious) with onset 24Mar2021 17:00, outcome "recovered" (2021), described as "Extremely tired". Therapeutic measures were not taken as a result of dysgeusia, pain, fatigue.  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: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache for five days; This is a spontaneous report received from a contactable reporter (Consumer).  A 77 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 06Apr2021 (Lot number: ER8733) at the age of 77 years as dose number unknown, 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) with onset Apr2021, outcome "recovered" (Apr2021), described as "headache for five days". Therapeutic measures were taken as a result of headache. Additional information: Patient has been administered with BNT162b2 by a Nurse at the same time as his wife. Headache was treated with aspirin and Tylenol (Paracetamol).  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021444651 same reporter/drug, different patient, similar event
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen gland under arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (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: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen gland under arm".  Additional information: Her husband's experience with the Covid 19 vaccine, she mentioned that two other guys her husband went with on the same day to get their Covid 19 vaccines, had the same problem with a swollen gland under their arm. She had no further information regarding the guys that received their Covid 19 vaccine with her husband.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Movement disorder, Pain
Clinical narrative: Pain; she cant move; cant sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Lot number: E200162) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Spine surgery" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Pain"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "she cant move"; INSOMNIA (non-serious), outcome "unknown", described as "cant sleep".  Additional information: Patient was told to take Tylenol even before the vaccine but Tylenol did not help nor did any of the other aspirins. She asks if she can start taking the Aleve to help her with the pain the back. Aleve works for her. Patient clarifies that the Spine Surgery was a while ago prior to the first dose, she was actually due to go back to surgeon next week.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: having a real kind of tinny taste in mouth, funky metal taste in mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 (Lot number: EW0162) at the age of 73 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: DYSGEUSIA (non-serious) with onset 16Apr2021, outcome "recovering", described as "having a real kind of tinny taste in mouth, funky metal taste in mouth".  Additional information included: Caller reported it was about the same, maybe a little less than what it was when the caller first noticed. Kind of like that taste you got in mouth when a person has an MRI and they put that contrast in there, kind of like a funny taste. The patient had no emergency room or Physician office. No prior vaccinations within 4 weeks. No AE(s) following prior vaccinations. No patient's Medical History (including any illness at time of vaccination) and no family medical history.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Tinnitus
Clinical narrative: ears rang so loud it was painful; ears rang so loud it was painful; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 14Apr2021 (Lot number: ER0731) at the age of 46 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: METOPROLOL. Vaccination history included: Bnt162b2 (DOSE 1; Lot number: ER8727; Anatomical location: Arm left), administration date: 24Mar2021, for COVID-19 Immunisation, reaction: "ears rang loudly for 5 days". The following information was reported: TINNITUS (non-serious), EAR PAIN (non-serious) all with onset Apr2021, outcome "not recovered" and all described as "ears rang so loud it was painful". Therapeutic measures were not taken as a result of tinnitus, ear pain. Additional Information: Patient had no other vaccine within four weeks. Patient stated that her ear is still ringing loudly. Patient had no COVID prior to vaccination and had not tested for COVID since the vaccination. Patient has no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021425336 same patient/drug, different dose/event
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza, Pain
Clinical narrative: Felt flu; aching; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2, administration date: 18Jan2021, for COVID-19 Immunization. The following information was reported: INFLUENZA (non-serious) with onset Feb2021, outcome "unknown", described as "Felt flu"; PAIN (non-serious) with onset Feb2021, outcome "unknown", described as "aching"; HEADACHE (non-serious) with onset Feb2021, outcome "unknown", described as "headache". It was unknown if therapeutic measures were taken as a result of influenza, pain, headache.  Additional information: Caller (Name) had her 1st dose (28Jan2021) and 2nd dose (18Feb2021) she didn't have a sticker for her 2nd dose and wanted to get answers for that. Felt flu symptoms after 2nd dose (nothing major) aching and headache.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Body temperature decreased, Feeling abnormal, Headache, Insomnia
Clinical narrative: sore arm; Headache; short-lived drop in body temperature; shaking uncontrollably; hands and feet were like ice; my whole body had tensed up; unable to sleep; experienced sharp, sudden pain in my calf muscles; lower back pain; ringing in my ears; nauseous; pain in my left side; odd sensation in my head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; BODY TEMPERATURE DECREASED (non-serious), outcome "unknown", described as "short-lived drop in body temperature"; TREMOR (non-serious), outcome "unknown", described as "shaking uncontrollably"; PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME (non-serious), outcome "unknown", described as "hands and feet were like ice"; TENSION (non-serious), outcome "unknown", described as "my whole body had tensed up"; INSOMNIA (non-serious), outcome "unknown", described as "unable to sleep"; MYALGIA (non-serious), outcome "unknown", described as "experienced sharp, sudden pain in my calf muscles"; BACK PAIN (non-serious), outcome "unknown", described as "lower back pain"; TINNITUS (non-serious), outcome "unknown", described as "ringing in my ears"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; PAIN (non-serious), outcome "unknown", described as "pain in my left side"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "odd sensation in my head". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: I only know of two other people who have had very similar symptoms to your vaccine. The reactions detailed above were much worse that first week and lessened as time progressed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Palmar-plantar erythrodysaesthesia syndrome
Clinical narrative: sore arm; Headache; short-lived drop in body temperature; shaking uncontrollably; hands and feet were like ice; my whole body had tensed up; unable to sleep; experienced sharp, sudden pain in my calf muscles; lower back pain; ringing in my ears; nauseous; pain in my left side; odd sensation in my head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; BODY TEMPERATURE DECREASED (non-serious), outcome "unknown", described as "short-lived drop in body temperature"; TREMOR (non-serious), outcome "unknown", described as "shaking uncontrollably"; PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME (non-serious), outcome "unknown", described as "hands and feet were like ice"; TENSION (non-serious), outcome "unknown", described as "my whole body had tensed up"; INSOMNIA (non-serious), outcome "unknown", described as "unable to sleep"; MYALGIA (non-serious), outcome "unknown", described as "experienced sharp, sudden pain in my calf muscles"; BACK PAIN (non-serious), outcome "unknown", described as "lower back pain"; TINNITUS (non-serious), outcome "unknown", described as "ringing in my ears"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; PAIN (non-serious), outcome "unknown", described as "pain in my left side"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "odd sensation in my head". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: I only know of two other people who have had very similar symptoms to your vaccine. The reactions detailed above were much worse that first week and lessened as time progressed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tension, Tinnitus, Tremor
Clinical narrative: sore arm; Headache; short-lived drop in body temperature; shaking uncontrollably; hands and feet were like ice; my whole body had tensed up; unable to sleep; experienced sharp, sudden pain in my calf muscles; lower back pain; ringing in my ears; nauseous; pain in my left side; odd sensation in my head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; BODY TEMPERATURE DECREASED (non-serious), outcome "unknown", described as "short-lived drop in body temperature"; TREMOR (non-serious), outcome "unknown", described as "shaking uncontrollably"; PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME (non-serious), outcome "unknown", described as "hands and feet were like ice"; TENSION (non-serious), outcome "unknown", described as "my whole body had tensed up"; INSOMNIA (non-serious), outcome "unknown", described as "unable to sleep"; MYALGIA (non-serious), outcome "unknown", described as "experienced sharp, sudden pain in my calf muscles"; BACK PAIN (non-serious), outcome "unknown", described as "lower back pain"; TINNITUS (non-serious), outcome "unknown", described as "ringing in my ears"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; PAIN (non-serious), outcome "unknown", described as "pain in my left side"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "odd sensation in my head". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: I only know of two other people who have had very similar symptoms to your vaccine. The reactions detailed above were much worse that first week and lessened as time progressed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Body temperature decreased, Feeling abnormal, Headache, Insomnia
Clinical narrative: sore arm; Headache; short-lived drop in body temperature; shaking uncontrollably; hands and feet were like ice; my whole body had tensed up; unable to sleep; experienced sharp, sudden pain in my calf muscles; lower back pain; ringing in my ears; Nauseous; Pain in my left side; Odd sensation in my head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; BODY TEMPERATURE DECREASED (non-serious), outcome "unknown", described as "short-lived drop in body temperature"; TREMOR (non-serious), outcome "unknown", described as "shaking uncontrollably"; PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME (non-serious), outcome "unknown", described as "hands and feet were like ice"; TENSION (non-serious), outcome "unknown", described as "my whole body had tensed up"; INSOMNIA (non-serious), outcome "unknown", described as "unable to sleep"; MYALGIA (non-serious), outcome "unknown", described as "experienced sharp, sudden pain in my calf muscles"; BACK PAIN (non-serious), outcome "unknown", described as "lower back pain"; TINNITUS (non-serious), outcome "unknown", described as "ringing in my ears"; NAUSEA (non-serious), outcome "unknown", described as "Nauseous"; PAIN (non-serious), outcome "unknown", described as "Pain in my left side"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Odd sensation in my head".  Additional information: I only know of two other people who have had very similar symptoms to your vaccine. The reactions detailed above were much worse that first week, and lessened as time progressed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Palmar-plantar erythrodysaesthesia syndrome
Clinical narrative: sore arm; Headache; short-lived drop in body temperature; shaking uncontrollably; hands and feet were like ice; my whole body had tensed up; unable to sleep; experienced sharp, sudden pain in my calf muscles; lower back pain; ringing in my ears; Nauseous; Pain in my left side; Odd sensation in my head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; BODY TEMPERATURE DECREASED (non-serious), outcome "unknown", described as "short-lived drop in body temperature"; TREMOR (non-serious), outcome "unknown", described as "shaking uncontrollably"; PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME (non-serious), outcome "unknown", described as "hands and feet were like ice"; TENSION (non-serious), outcome "unknown", described as "my whole body had tensed up"; INSOMNIA (non-serious), outcome "unknown", described as "unable to sleep"; MYALGIA (non-serious), outcome "unknown", described as "experienced sharp, sudden pain in my calf muscles"; BACK PAIN (non-serious), outcome "unknown", described as "lower back pain"; TINNITUS (non-serious), outcome "unknown", described as "ringing in my ears"; NAUSEA (non-serious), outcome "unknown", described as "Nauseous"; PAIN (non-serious), outcome "unknown", described as "Pain in my left side"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Odd sensation in my head".  Additional information: I only know of two other people who have had very similar symptoms to your vaccine. The reactions detailed above were much worse that first week, and lessened as time progressed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tension, Tinnitus, Tremor
Clinical narrative: sore arm; Headache; short-lived drop in body temperature; shaking uncontrollably; hands and feet were like ice; my whole body had tensed up; unable to sleep; experienced sharp, sudden pain in my calf muscles; lower back pain; ringing in my ears; Nauseous; Pain in my left side; Odd sensation in my head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; BODY TEMPERATURE DECREASED (non-serious), outcome "unknown", described as "short-lived drop in body temperature"; TREMOR (non-serious), outcome "unknown", described as "shaking uncontrollably"; PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME (non-serious), outcome "unknown", described as "hands and feet were like ice"; TENSION (non-serious), outcome "unknown", described as "my whole body had tensed up"; INSOMNIA (non-serious), outcome "unknown", described as "unable to sleep"; MYALGIA (non-serious), outcome "unknown", described as "experienced sharp, sudden pain in my calf muscles"; BACK PAIN (non-serious), outcome "unknown", described as "lower back pain"; TINNITUS (non-serious), outcome "unknown", described as "ringing in my ears"; NAUSEA (non-serious), outcome "unknown", described as "Nauseous"; PAIN (non-serious), outcome "unknown", described as "Pain in my left side"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Odd sensation in my head".  Additional information: I only know of two other people who have had very similar symptoms to your vaccine. The reactions detailed above were much worse that first week, and lessened as time progressed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Computerised tomogram, Musculoskeletal chest pain
Clinical narrative: the pain traveled from beneath my rib, up my left side to my armpit; the pain traveled from beneath my rib, up my left side to my armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Crohn's Disease" (unspecified if ongoing); "ileostomy" (unspecified if ongoing); "pain was similar to shingles pain" (unspecified if ongoing), notes: 24 years ago, doctor put me on Acyclovir and a muscle  relaxant; "Food allergy" (unspecified if ongoing); "Levaquin allergy" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3; MULTIVITAMINUM. Vaccination history included: Bnt162b2 (1st dose, EN6203, vaccine location:Left arm, Administration time:08:45Am), administration date: 06Mar2021, for Covid-19 Immunization, reaction(s): "sharp pain under my left lower rib". The following information was reported: MUSCULOSKELETAL CHEST PAIN (non-serious), outcome "not recovered", AXILLARY PAIN (non-serious), outcome "unknown" and all described as "the pain traveled from beneath my rib, up my left side to my armpit". The event "the pain traveled from beneath my rib, up my left side to my armpit" and "the pain traveled from beneath my rib, up my left side to my armpit" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Oropharyngeal pain
Clinical narrative: trouble swallowing; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 61 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: DYSPHAGIA (non-serious), outcome "unknown", described as "trouble swallowing"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Tremor
Clinical narrative: shaking does not last as long and as vigorous/feel that my insides are trembling; shaking does not last as long and as vigorous/feel that my insides are trembling; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 55 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 24Feb2021 (Lot number: EN6198) as dose 2, single for covid-19 immunization. Relevant medical history included: "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "CRPS in Rt. Leg" (unspecified if ongoing), notes: in right leg; "Migraines" (unspecified if ongoing). Concomitant medications included: PROPRANOLOL; LEXAPRO; SIMVASTATIN; COQ10 [UBIDECARENONE]; BABY ASPIRIN. Past drug history included: Clindamycin; Flagell; Amoxicillin. Vaccination history included: BNT162B2 (Dose 1, Lot number: EM9810, Anatomical location: Left arm, Administration time: 11:30 AM), administration date: 06Feb2021, for covid-19 immunization, reactions: "Light sleep" and "shaking vigorously". The following information was reported: TREMOR (non-serious), DISEASE RECURRENCE (non-serious), outcome "unknown" and all described as "shaking does not last as long and as vigorous/feel that my insides are trembling". Therapeutic measures were not taken as a result of tremor and disease recurrence.  Additional information: Patient reported that after the first shot, as she turned in the night and was in light sleep, she was awoken because her head, shoulders and arms were shaking vigorously (lasted maybe 10-15 sec). When fully awoke, it stopped. It happened only once. It happened again the next night. After the second shot, it happened again. This time however, it happened several times during the night and has been increasing in the number of times it happens each week. However, the shaking did not last as long and it was not as vigorous, more of a shake-shake- shake. She had begun to feel that her insides were trembling when she woke up. This did pass the more active she become. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021425435 Same patient and drug; Different dose and events