chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nervousness
Clinical narrative: Nervous; chills little bit for about half of day/chills and all but I did not have a fever; felt really tired and I felt really tired the day this two days feeling very tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 20Mar2021 (Lot number: ER8729) at the age of 63 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Anxiety disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NERVOUSNESS (non-serious) with onset 22Mar2021, outcome "unknown", described as "Nervous"; CHILLS (non-serious) with onset 21Mar2021, outcome "recovered" (Mar2021), described as "chills little bit for about half of day/chills and all but I did not have a fever"; FATIGUE (non-serious) with onset 21Mar2021, outcome "not recovered", described as "felt really tired and I felt really tired the day this two days feeling very tired". Therapeutic measures were taken as a result of chills.  Additional information: The patient received Tylenol for chills.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: lightheaded feelings; hurtful arms; This is a spontaneous report from a Pfizer-sponsored program. A contactable female Other HCP(Patient). A female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) as 1st dose single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "lightheaded feelings"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "hurtful arms".  Additional information: The Caller, called to confirm her second dose of the Covid-19 vaccine schedule since the Facility was not calling or confirming her schedule up until now. provided the date of her first dose of the vaccine given on 01Mar2021. After a while, started sharing her adverse event 3 or 4 days after the vaccine which caused lightheaded feelings and hurtful arms. Cold transferred due to a long queue. Created and submitted an AE form. Were any unaddressed medical questions referred or forwarded to Medical Information? No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: The next morning when she woke up, she had a headache; Four hours later, she had chills; 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 female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 18Mar2021 07:00 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHILLS (non-serious) with onset 18Mar2021 11:00, outcome "unknown", described as "Four hours later, she had chills"; HEADACHE (non-serious) with onset 19Mar2021, outcome "recovered" (21Mar2021), described as "The next morning when she woke up, she had a headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: not feeling well; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "not feeling well".  Additional information: HCP, (name) (a Pharmacist) is reporting that her patient got 1st dose of the Covid-19 vaccine last 23Feb2021. The patient cannot attend her 2nd dose schedule on time. The patient can take the 2nd dose after 6 weeks for the reason that the patient will be having surgery and not feeling well. Cannot provide the name of the patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Mar 18, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had pain/experienced pain more in that area, with outcome of unknown. Additional information: Verbatim/Event description: 1st dose vaccine yesterday (Mar 18, 2021). When questioned if she had any shots for the last 3 weeks and she said "no." She remembered she had an Epidural shot and now experiences pain more in that area. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (002591). A 70-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient felt abnormal/patient felt icky after the COVID-19 vaccine, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: next morning after receiving the vaccine all the severe pain was gone; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "lupus" (unspecified if ongoing); "severe pain from Fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "next morning after receiving the vaccine all the severe pain was gone". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance, Muscle spasms
Clinical narrative: Back pain; muscle spasms; barely walked; 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 female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), 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: BACK PAIN (non-serious) with onset 20Mar2021, outcome "unknown", described as "Back pain"; MUSCLE SPASMS (non-serious) with onset 20Mar2021, outcome "unknown", described as "muscle spasms"; GAIT DISTURBANCE (non-serious) with onset 20Mar2021, outcome "unknown", described as "barely walked".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Some pain in the injection area; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 26Feb2021 06:15 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Some pain in the injection area". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient reported that, had no issues with the first injection except some pain in the injection area. No therapeutic measure was taken for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event pain in the injection area was resolved on an unspecified date in 2021 at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Mobility decreased, Pain
Clinical narrative: really tired; off-the-chart aches and chills; off-the-chart aches and chills; couldn't move or touch his arm it hurt so much; couldn't move or touch his arm it hurt so much; could tell the exact location of every lymph node in his body; This is a spontaneous report received from non-contactable consumer from a sales representative. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 21Mar2021 (Lot number: EN6203) 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 (non-serious), CHILLS (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "off-the-chart aches and chills"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious) all with onset Mar2021, outcome "unknown" and all described as "couldn't move or touch his arm it hurt so much"; LYMPHADENOPATHY (non-serious) with onset Mar2021, outcome "unknown", described as "could tell the exact location of every lymph node in his body"; FATIGUE (non-serious) with onset 22Mar2021, outcome "unknown", described as "really tired".  Additional information: The patient's age was reported as 62 (unit unspecified). The patient stated that he still a little chilled and moderately achy (although, no fever).  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: really tired; off-the-chart aches and chills; off-the-chart aches and chills; couldn't move or touch his arm it hurt so much; couldn't move or touch his arm it hurt so much; could tell the exact location of every lymph node in his body; This is a spontaneous report received from non-contactable consumer from a sales representative. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 21Mar2021 (Lot number: EN6203) 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 (non-serious), CHILLS (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "off-the-chart aches and chills"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious) all with onset Mar2021, outcome "unknown" and all described as "couldn't move or touch his arm it hurt so much"; LYMPHADENOPATHY (non-serious) with onset Mar2021, outcome "unknown", described as "could tell the exact location of every lymph node in his body"; FATIGUE (non-serious) with onset 22Mar2021, outcome "unknown", described as "really tired".  Additional information: The patient's age was reported as 62 (unit unspecified). The patient stated that he still a little chilled and moderately achy (although, no fever).  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Panic reaction
Clinical narrative: Caller states he was doing fine this morning until he looked at his card and started to panic; 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 male patient received bnt162b2 (BNT162B2), administration date 20Feb2021 (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: PANIC REACTION (non-serious) with onset 23Mar2021, outcome "unknown", described as "Caller states he was doing fine this morning until he looked at his card and started to panic". Additional information: Patient received first dose on 20Feb2021. He was told his second dose was scheduled for 31Mar2021. His card said second dose was due 13Mar2021. He did not receive second dose on 13Mar2021. He checked his vaccine card today, and on the back of his card it said he should have taken his second dose on 13Mar2021. The patient was also asking what should he do about this. He was doing fine this morning until he looked at his card and started to panic. He went for his first dose of the covid vaccine on 20Feb2021. After receiving the first dose of the covid vaccine, the gentlemen that the patient spoke too, who was very professional said to him, he will see him on 31Mar2021. Then patient had to go over and sit for 15-20 minutes to make sure he was okay, before excusing himself to his car. He talked to the nurse, and the nurse also told him she would see him on 31Mar2021. So now he was getting his stuff together because 31Mar2021 was right around the corner. He flipped the card over and the card said 13Mar2021. He was asking if 13Mar2021 was the date that he was supposed to get the second dose of the covid vaccine. He was not sure what to do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Pain
Clinical narrative: headache/weird pain in her head; but it continued and got worse after first vaccine; horrible pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 26Feb2021 10:30 (Batch/Lot number: unknown) at the age of 75 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Trigeminal neuralgia" (ongoing); "before the first shot she had a headache because of facial pain but thinks the shot made it worse" (unspecified if ongoing); "before the first shot she had a headache because of facial pain but thinks the shot made it worse" (unspecified if ongoing); "Dry eyes" (ongoing); "High blood pressure" (ongoing); "heart to keep everything calm primarily heart pain due to stress" (ongoing); "heart to keep everything calm primarily heart pain due to stress" (ongoing); "bones" (ongoing); "to keep up my health" (ongoing). Concomitant medication(s) included: ATACAND taken for hypertension (ongoing); TOPROL taken for angina pectoris, stress (ongoing); VITAMIN D NOS taken for bone disorder (ongoing); FLAXSEED OIL [LINUM USITATISSIMUM SEED OIL] taken for dry eye (ongoing); CENTRUM A TO ZINC taken for supplementation therapy (ongoing). The following information was reported: HEADACHE (non-serious) with onset 26Feb2021, outcome "recovering", described as "headache/weird pain in her head"; CONDITION AGGRAVATED (non-serious) with onset 26Feb2021, outcome "recovering", described as "but it continued and got worse after first vaccine"; PAIN (non-serious) with onset 26Feb2021, outcome "recovering", described as "horrible pain".  Additional information: The patient had no prior vaccination (within 4 weeks). The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. Clinical course: Patient stated before the first shot she had a headache because of facial pain but thinks the shot made it worse. Patient stated she was driving home and all of a sudden had a horrible pain and was wondering if the shot caused the pain. Patient stated she had been having a headache but it continued and got worse after first vaccine and immediately after she felt a weird pain in her head. Patient stated it was gradually decreasing between the first and second shot. The patient did not undergo any relevant tests. The adverse events did not require a visit to Emergency Room/Physician Office visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dysphagia, Influenza like illness, Malaise
Clinical narrative: sick; like having the flu; nausea; diarrhea; vomiting; couldn't eat, could only drink very little; dry heaves; dizzy; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in right arm, administration date 07Mar2021 13:00 (Lot number: EN6205) at the age of 76 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney cancer" (not ongoing), notes: Had cryosurgery; cancer free for about 6 years.; "cryosurgery for kidney cancer" (not ongoing); "Breast cancer" (ongoing); "high blood pressure" (ongoing); "hip surgery", start date: 04Jan2021, stop date: 04Jan2021, notes: hip surgery on 04Jan2021 but didn't work so another one on 11Feb2021. Concomitant medication(s) included: FASLODEX taken for breast cancer female (ongoing); HERCEPTIN taken for breast cancer female, start date: 2011 (ongoing); IBRANCE taken for breast cancer female (ongoing); DOXAZOSIN taken for hypertension (ongoing). The following information was reported: MALAISE (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "sick"; INFLUENZA LIKE ILLNESS (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "like having the flu"; NAUSEA (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "nausea"; DIARRHOEA (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "diarrhea"; VOMITING (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "vomiting"; DYSPHAGIA (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "couldn't eat, could only drink very little"; RETCHING (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "dry heaves"; DIZZINESS (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "dizzy".  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Retching, Vomiting
Clinical narrative: sick; like having the flu; nausea; diarrhea; vomiting; couldn't eat, could only drink very little; dry heaves; dizzy; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in right arm, administration date 07Mar2021 13:00 (Lot number: EN6205) at the age of 76 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney cancer" (not ongoing), notes: Had cryosurgery; cancer free for about 6 years.; "cryosurgery for kidney cancer" (not ongoing); "Breast cancer" (ongoing); "high blood pressure" (ongoing); "hip surgery", start date: 04Jan2021, stop date: 04Jan2021, notes: hip surgery on 04Jan2021 but didn't work so another one on 11Feb2021. Concomitant medication(s) included: FASLODEX taken for breast cancer female (ongoing); HERCEPTIN taken for breast cancer female, start date: 2011 (ongoing); IBRANCE taken for breast cancer female (ongoing); DOXAZOSIN taken for hypertension (ongoing). The following information was reported: MALAISE (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "sick"; INFLUENZA LIKE ILLNESS (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "like having the flu"; NAUSEA (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "nausea"; DIARRHOEA (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "diarrhea"; VOMITING (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "vomiting"; DYSPHAGIA (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "couldn't eat, could only drink very little"; RETCHING (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "dry heaves"; DIZZINESS (non-serious) with onset 10Mar2021, outcome "recovered" (14Mar2021), described as "dizzy".  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Poor quality sleep, Vaccination site warmth
Clinical narrative: Very tired; Arm was killing her; Did not sleep well; hot at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EP6955, Expiration Date: 30Jun2021) in 2021 as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Very tired"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Arm was killing her"; POOR QUALITY SLEEP (non-serious) with onset 2021, outcome "unknown", described as "Did not sleep well"; VACCINATION SITE WARMTH (non-serious) with onset 2021, outcome "unknown", described as "hot at injection site". Additional information: Following the first dose of COVID vaccine, patient was very tired, did not sleep well, tossed and turned, woke up tired. Her arm was killing her and hot at injection site. Tired all next day. Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dry mouth, Headache, Nausea
Clinical narrative: headaches; Chills; nausea and vomiting; nausea and vomiting; arm started to swell; Dry mouth; Weakness; This is a spontaneous report received from a contactable reporter (Consumer).  A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 22Mar2021 09:00 (Lot number: EN6204) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Aneurysm" (ongoing), notes: Diagnosed about a year ago, on right side of brain, 2mm very small; "Lupus" (ongoing), notes: Diagnosed a few years ago. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 22Mar2021, outcome "recovering", described as "headaches"; CHILLS (non-serious) with onset 22Mar2021, outcome "recovering", described as "Chills"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 22Mar2021, outcome "recovering" and all described as "nausea and vomiting"; PERIPHERAL SWELLING (non-serious) with onset 22Mar2021, outcome "recovering", described as "arm started to swell"; DRY MOUTH (non-serious) with onset 22Mar2021, outcome "recovering", described as "Dry mouth"; ASTHENIA (non-serious) with onset 22Mar2021, outcome "recovering", described as "Weakness". The events "headaches", "chills", "nausea and vomiting", "nausea and vomiting", "arm started to swell", "dry mouth" and "weakness" were evaluated at the emergency room visit. Additional Information: The reporter stated that she was told to call about the symptoms her mom was having. The reporter stated her mom got the Pfizer Covid vaccine on Monday, 22Mar2021, and she has had some side effects and the doctor told her to call them in. The patient got the first dose on 22Mar2021 around 9AM. After a few hours later she started having headaches, got chills and extreme nausea, her arm started to swell, had dry mouth and felt weakness. These all occurred on the same day and have improved since then. The patient went to urgent care around 8:30PM on 22Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vomiting
Clinical narrative: headaches; Chills; nausea and vomiting; nausea and vomiting; arm started to swell; Dry mouth; Weakness; This is a spontaneous report received from a contactable reporter (Consumer).  A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 22Mar2021 09:00 (Lot number: EN6204) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Aneurysm" (ongoing), notes: Diagnosed about a year ago, on right side of brain, 2mm very small; "Lupus" (ongoing), notes: Diagnosed a few years ago. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 22Mar2021, outcome "recovering", described as "headaches"; CHILLS (non-serious) with onset 22Mar2021, outcome "recovering", described as "Chills"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 22Mar2021, outcome "recovering" and all described as "nausea and vomiting"; PERIPHERAL SWELLING (non-serious) with onset 22Mar2021, outcome "recovering", described as "arm started to swell"; DRY MOUTH (non-serious) with onset 22Mar2021, outcome "recovering", described as "Dry mouth"; ASTHENIA (non-serious) with onset 22Mar2021, outcome "recovering", described as "Weakness". The events "headaches", "chills", "nausea and vomiting", "nausea and vomiting", "arm started to swell", "dry mouth" and "weakness" were evaluated at the emergency room visit. Additional Information: The reporter stated that she was told to call about the symptoms her mom was having. The reporter stated her mom got the Pfizer Covid vaccine on Monday, 22Mar2021, and she has had some side effects and the doctor told her to call them in. The patient got the first dose on 22Mar2021 around 9AM. After a few hours later she started having headaches, got chills and extreme nausea, her arm started to swell, had dry mouth and felt weakness. These all occurred on the same day and have improved since then. The patient went to urgent care around 8:30PM on 22Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: itchy arm at injection site; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 39-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), administration time 10:30, administered in arm left (lot number EL9621) 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, lot number unknown), for covid-19 immunisation, reactions: "tired", "sore neck", "sore arm". The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 20Feb2021, outcome "recovered" (2021), described as "itchy arm at injection site". Therapeutic measures were not taken as a result of vaccination site pruritus.  Additional information: The event onset date was also reported as 21Feb2021. The vaccine was administered at a military facility.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093141 same patient/drug, different vaccine dose/event
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: psoriasis on the hands basically cleared up, legs stopped itching and looked 70 percent better; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Psoriasis", start date: 1981 (ongoing), notes: for over 40 years. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "psoriasis on the hands basically cleared up, legs stopped itching and looked 70 percent better". Additional information: The patient was not on any immune suppression drugs. The vaccine stopped the scales on the patient's skin and rerouted the immune system. The patient has never seen anything like this in the past (as reported).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer) 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: HEADACHE (non-serious), outcome "unknown", described as "Headache". Additional information: The patient reported that the only symptom she had after her first dose was a headache.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Burning sensation, Dizziness
Clinical narrative: Feeling unsteady; Burning sensation; Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): AE-2021-4752.  A 46 year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (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: BALANCE DISORDER (non-serious), outcome "unknown", described as "Feeling unsteady"; BURNING SENSATION (non-serious), outcome "unknown", described as "Burning sensation"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: Very fatigued; Nausea; woke up with rapid heartbeat and continued for several hours; headache; Could not sleep much due to rapid heartbeat; Woke up at 3AM. Finally fell asleep at 7AM, awoke at 2PM then slept again from 5-7PM; Arm was very sore; Slight chills; 99.5 temp that went away quickly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Feb2021 12:00 (Lot number: EN9809, Expiration Date: Jun2021) at the age of 57 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, Lot no: EL-1283, EXP: Apr2021, Vaccination time: 12:00), administration date: 29Jan2021, when the patient was 57 years old, for COVID-19 immunisation, reaction(s): "About 3 am woke up with chills", "headache", "Arm was very sore", "Saturday, was very tired/lethargic/Felt blah all day, tired", "out of breath". The following information was reported: CHILLS (non-serious) with onset 20Feb2021, outcome "recovered", described as "Slight chills"; BODY TEMPERATURE INCREASED (non-serious) with onset 20Feb2021, outcome "recovered", described as "99.5 temp that went away quickly"; HEART RATE INCREASED (non-serious) with onset 20Feb2021 03:00, outcome "recovered", described as "woke up with rapid heartbeat and continued for several hours"; HEADACHE (non-serious) with onset 20Feb2021 03:00, outcome "recovered", described as "headache"; INSOMNIA (non-serious) with onset 20Feb2021 03:00, outcome "recovered", described as "Could not sleep much due to rapid heartbeat"; SLEEP DISORDER (non-serious) with onset 20Feb2021 03:00, outcome "recovered", described as "Woke up at 3AM. Finally fell asleep at 7AM, awoke at 2PM then slept again from 5-7PM"; FATIGUE (non-serious) with onset 20Feb2021 14:00, outcome "recovered", described as "Very fatigued"; NAUSEA (non-serious) with onset 20Feb2021 14:00, outcome "recovered", described as "Nausea"; PAIN IN EXTREMITY (non-serious) with onset 20Feb2021, outcome "recovered", described as "Arm was very sore". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, body temperature increased, heart rate increased, headache, insomnia, sleep disorder, fatigue, nausea, pain in extremity.  Additional Information: The vaccine was given at a workplace clinic. It was reported that the patient generally have a very good immune system and rarely get sick and when she did, it usually only last a few days. It was further reported that after about a total of 16-17 hours, the patient suddenly felt fine. The patient was still experiencing some fatigue up to 2 weeks after each shot. Events did not result to emergency room nor physician office visit.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Insomnia, Nausea, Pain in extremity
Clinical narrative: Very fatigued; Nausea; woke up with rapid heartbeat and continued for several hours; headache; Could not sleep much due to rapid heartbeat; Woke up at 3AM. Finally fell asleep at 7AM, awoke at 2PM then slept again from 5-7PM; Arm was very sore; Slight chills; 99.5 temp that went away quickly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Feb2021 12:00 (Lot number: EN9809, Expiration Date: Jun2021) at the age of 57 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, Lot no: EL-1283, EXP: Apr2021, Vaccination time: 12:00), administration date: 29Jan2021, when the patient was 57 years old, for COVID-19 immunisation, reaction(s): "About 3 am woke up with chills", "headache", "Arm was very sore", "Saturday, was very tired/lethargic/Felt blah all day, tired", "out of breath". The following information was reported: CHILLS (non-serious) with onset 20Feb2021, outcome "recovered", described as "Slight chills"; BODY TEMPERATURE INCREASED (non-serious) with onset 20Feb2021, outcome "recovered", described as "99.5 temp that went away quickly"; HEART RATE INCREASED (non-serious) with onset 20Feb2021 03:00, outcome "recovered", described as "woke up with rapid heartbeat and continued for several hours"; HEADACHE (non-serious) with onset 20Feb2021 03:00, outcome "recovered", described as "headache"; INSOMNIA (non-serious) with onset 20Feb2021 03:00, outcome "recovered", described as "Could not sleep much due to rapid heartbeat"; SLEEP DISORDER (non-serious) with onset 20Feb2021 03:00, outcome "recovered", described as "Woke up at 3AM. Finally fell asleep at 7AM, awoke at 2PM then slept again from 5-7PM"; FATIGUE (non-serious) with onset 20Feb2021 14:00, outcome "recovered", described as "Very fatigued"; NAUSEA (non-serious) with onset 20Feb2021 14:00, outcome "recovered", described as "Nausea"; PAIN IN EXTREMITY (non-serious) with onset 20Feb2021, outcome "recovered", described as "Arm was very sore". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, body temperature increased, heart rate increased, headache, insomnia, sleep disorder, fatigue, nausea, pain in extremity.  Additional Information: The vaccine was given at a workplace clinic. It was reported that the patient generally have a very good immune system and rarely get sick and when she did, it usually only last a few days. It was further reported that after about a total of 16-17 hours, the patient suddenly felt fine. The patient was still experiencing some fatigue up to 2 weeks after each shot. Events did not result to emergency room nor physician office visit.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Very fatigued; Nausea; woke up with rapid heartbeat and continued for several hours; headache; Could not sleep much due to rapid heartbeat; Woke up at 3AM. Finally fell asleep at 7AM, awoke at 2PM then slept again from 5-7PM; Arm was very sore; Slight chills; 99.5 temp that went away quickly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Feb2021 12:00 (Lot number: EN9809, Expiration Date: Jun2021) at the age of 57 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, Lot no: EL-1283, EXP: Apr2021, Vaccination time: 12:00), administration date: 29Jan2021, when the patient was 57 years old, for COVID-19 immunisation, reaction(s): "About 3 am woke up with chills", "headache", "Arm was very sore", "Saturday, was very tired/lethargic/Felt blah all day, tired", "out of breath". The following information was reported: CHILLS (non-serious) with onset 20Feb2021, outcome "recovered", described as "Slight chills"; BODY TEMPERATURE INCREASED (non-serious) with onset 20Feb2021, outcome "recovered", described as "99.5 temp that went away quickly"; HEART RATE INCREASED (non-serious) with onset 20Feb2021 03:00, outcome "recovered", described as "woke up with rapid heartbeat and continued for several hours"; HEADACHE (non-serious) with onset 20Feb2021 03:00, outcome "recovered", described as "headache"; INSOMNIA (non-serious) with onset 20Feb2021 03:00, outcome "recovered", described as "Could not sleep much due to rapid heartbeat"; SLEEP DISORDER (non-serious) with onset 20Feb2021 03:00, outcome "recovered", described as "Woke up at 3AM. Finally fell asleep at 7AM, awoke at 2PM then slept again from 5-7PM"; FATIGUE (non-serious) with onset 20Feb2021 14:00, outcome "recovered", described as "Very fatigued"; NAUSEA (non-serious) with onset 20Feb2021 14:00, outcome "recovered", described as "Nausea"; PAIN IN EXTREMITY (non-serious) with onset 20Feb2021, outcome "recovered", described as "Arm was very sore". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, body temperature increased, heart rate increased, headache, insomnia, sleep disorder, fatigue, nausea, pain in extremity.  Additional Information: The vaccine was given at a workplace clinic. It was reported that the patient generally have a very good immune system and rarely get sick and when she did, it usually only last a few days. It was further reported that after about a total of 16-17 hours, the patient suddenly felt fine. The patient was still experiencing some fatigue up to 2 weeks after each shot. Events did not result to emergency room nor physician office visit.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram, Constipation, Decreased appetite, Fatigue
Clinical narrative: nauseated; vomited; chills; constipation; flu like symptoms; lymph nodes really swollen in armpit and left chest area; muscles tense in armpit; decreased appetite; Tired; Achy; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 77-year-old female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast Cancer" (unspecified if ongoing). Concomitant medications included: IBRANCE taken for breast cancer female, start date: 17Dec2020 (ongoing); AROMASIN taken for breast cancer female (ongoing). Vaccination history included: COVID-19 vaccine (Dose 1, Manufacturer Unknown (Lot Number: Not Provided)), for COVID-19 Immunisation. The following information was reported: NAUSEA (non-serious), outcome "recovered" (22Mar2021), described as "nauseated"; VOMITING (non-serious), outcome "recovered" (22Mar2021), described as "vomited"; CHILLS (non-serious), outcome "recovered" (22Mar2021), described as "chills"; CONSTIPATION (non-serious), outcome "recovered" (22Mar2021), described as "constipation"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered" (22Mar2021), described as "flu like symptoms"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph nodes really swollen in armpit and left chest area"; MUSCLE TIGHTNESS (non-serious), outcome "unknown", described as "muscles tense in armpit"; DECREASED APPETITE (non-serious), outcome "unknown", described as "decreased appetite"; FATIGUE (non-serious), outcome "unknown", described as "Tired"; PAIN (non-serious), outcome "unknown", described as "Achy". The events "lymph nodes really swollen in armpit and left chest area" and "muscles tense in armpit" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient  reported that she had issues lately. She got both COVID vaccines and since then she was feeling nauseated, vomited horribly this last weekend, had chills, constipation, and flu like symptoms which seemed like these side effects had resolved since 22Mar2021. Lymph nodes were really swollen in armpit and left chest area 2 weeks after COVID vaccines and she also experienced muscle tense in armpit so she saw her my primary care professional on 12Mar2021 for this. She had decreased appetite, energy level is ok, tired and achy. She would have appointment with primary care professional on 26Mar2021 and next oncologist appointment on 12Apr2021 with shot to strengthen her bones. She would have lab work, computerized tomography and bone scans before oncology visit. Her last scan showed 2 fractured ribs, last lab work showed white blood cell count 2.5 and tumor markers was down from 595 to 262.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy, Muscle tightness, Nausea, Pain
Clinical narrative: nauseated; vomited; chills; constipation; flu like symptoms; lymph nodes really swollen in armpit and left chest area; muscles tense in armpit; decreased appetite; Tired; Achy; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 77-year-old female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast Cancer" (unspecified if ongoing). Concomitant medications included: IBRANCE taken for breast cancer female, start date: 17Dec2020 (ongoing); AROMASIN taken for breast cancer female (ongoing). Vaccination history included: COVID-19 vaccine (Dose 1, Manufacturer Unknown (Lot Number: Not Provided)), for COVID-19 Immunisation. The following information was reported: NAUSEA (non-serious), outcome "recovered" (22Mar2021), described as "nauseated"; VOMITING (non-serious), outcome "recovered" (22Mar2021), described as "vomited"; CHILLS (non-serious), outcome "recovered" (22Mar2021), described as "chills"; CONSTIPATION (non-serious), outcome "recovered" (22Mar2021), described as "constipation"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered" (22Mar2021), described as "flu like symptoms"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph nodes really swollen in armpit and left chest area"; MUSCLE TIGHTNESS (non-serious), outcome "unknown", described as "muscles tense in armpit"; DECREASED APPETITE (non-serious), outcome "unknown", described as "decreased appetite"; FATIGUE (non-serious), outcome "unknown", described as "Tired"; PAIN (non-serious), outcome "unknown", described as "Achy". The events "lymph nodes really swollen in armpit and left chest area" and "muscles tense in armpit" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient  reported that she had issues lately. She got both COVID vaccines and since then she was feeling nauseated, vomited horribly this last weekend, had chills, constipation, and flu like symptoms which seemed like these side effects had resolved since 22Mar2021. Lymph nodes were really swollen in armpit and left chest area 2 weeks after COVID vaccines and she also experienced muscle tense in armpit so she saw her my primary care professional on 12Mar2021 for this. She had decreased appetite, energy level is ok, tired and achy. She would have appointment with primary care professional on 26Mar2021 and next oncologist appointment on 12Apr2021 with shot to strengthen her bones. She would have lab work, computerized tomography and bone scans before oncology visit. Her last scan showed 2 fractured ribs, last lab work showed white blood cell count 2.5 and tumor markers was down from 595 to 262.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.