chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: Vertigo; Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Jan2021 (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: VERTIGO (non-serious) with onset Jan2021, outcome "unknown", described as "Vertigo"; TINNITUS (non-serious) with onset Jan2021, outcome "unknown", described as "Tinnitus".   Additional information included: As per caller he received his "1st dose at the beginning of Jan2021 and 3 weeks later the 2nd dose and it started since after the 1st dose. Patient had seen the doctor and they said there was no cure for the tinnitus".  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, Feeling abnormal, Lymph node palpable, Pain
Clinical narrative: lymph node that keeps popping up; achy; chills; interesting reaction; 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 57 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "UTI" (unspecified if ongoing); "Swollen lymph nodes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number:1), for COVID-19 immunization; Shingrix vaccine; Flu shot. The following information was reported: LYMPH NODE PALPABLE (non-serious), outcome "unknown", described as "lymph node that keeps popping up"; PAIN (non-serious), outcome "unknown", described as "achy"; CHILLS (non-serious), outcome "unknown", described as "chills"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "interesting reaction".  Additional information: The caller stated her first dose of the vaccine was awesome, she had not one side effect. She had the second shot on Tuesday and was already feeling under the weather when she got it with fluid in her ear but no fever. Wednesday morning she got the chills, was achy, and had all those reactions all day. The next day, yesterday, she was totally good. However, on the left side she has a lymph node that keeps popping up (she got the shot on the left side both times). This happened both times but mainly with the second. It started protruding Wednesday and it is still here, she can feel it move. The caller asked if this is normal and why she would have a swollen lymph node. After the verbal response she asked if a robust immune response was good.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Emotional disorder, Fatigue
Clinical narrative: very emotional; became exhausted after a day or two of this/still tired; very dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 12:00 (Lot number: ER8737) 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: DIZZINESS (non-serious) with onset 07Apr2021 12:00, outcome "not recovered", described as "very dizzy"; EMOTIONAL DISORDER (non-serious), outcome "not recovered", described as "very emotional"; FATIGUE (non-serious), outcome "not recovered", described as "became exhausted after a day or two of this/still tired". Therapeutic measures were not taken as a result of dizziness, emotional disorder, fatigue.  Additional information: The reporter thought that might be they were just a little excited, but it didn't went away for days. The patient did not receive any other vaccine in four weeks nor other medications in two weeks. The patient did not had Covid prior vaccination nor tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Nausea
Clinical narrative: chills; vomiting; nausea; severe dizziness; Weakness; Fatigue /severe fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 21:30 (Lot number: EW0169) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Schizoaffective disorder" (unspecified if ongoing); "POTS" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: RISPERIDONE; PRAZOSIN; FLUDROCORTISONE; RITALIN. Past drug history included: Amoxycillin, reaction(s): "Known allergies: Amoxycillin". The following information was reported: VOMITING (non-serious) with onset 24Apr2021 12:00, outcome "not recovered", described as "vomiting"; NAUSEA (non-serious) with onset 24Apr2021 12:00, outcome "not recovered", described as "nausea"; DIZZINESS (non-serious) with onset 24Apr2021 12:00, outcome "not recovered", described as "severe dizziness"; ASTHENIA (non-serious) with onset 24Apr2021 12:00, outcome "not recovered", described as "Weakness"; FATIGUE (non-serious) with onset 24Apr2021 12:00, outcome "not recovered", described as "Fatigue /severe fatigue"; CHILLS (non-serious) with onset 25Apr2021 13:00, outcome "not recovered", described as "chills". The events "vomiting", "nausea", "fatigue /severe fatigue" and "chills" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vomiting, nausea. Therapeutic measures were not taken as a result of dizziness, asthenia.  Additional Information: The patient did not have any other vaccines 4 weeks prior to vaccination .The patient did not have Covid prior to vaccination. The patient was not tested for Covid post vaccination. vomiting and nausea for 5 out of the following 6 days, severe dizziness, weakness and fatigue. Days 2-13 post-vaccination have been throwing up nearly every day. On Day 7 went to urgent care and received Famotidine 40 mg 2x/day and Promethazine 25 mg 4x/day to treat nausea/vomiting and it works to keep food down sometimes. Also, patient frequently had chills and severe fatigue. No fever.   No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: chills; vomiting; nausea; severe dizziness; Weakness; Fatigue /severe fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 21:30 (Lot number: EW0169) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Schizoaffective disorder" (unspecified if ongoing); "POTS" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: RISPERIDONE; PRAZOSIN; FLUDROCORTISONE; RITALIN. Past drug history included: Amoxycillin, reaction(s): "Known allergies: Amoxycillin". The following information was reported: VOMITING (non-serious) with onset 24Apr2021 12:00, outcome "not recovered", described as "vomiting"; NAUSEA (non-serious) with onset 24Apr2021 12:00, outcome "not recovered", described as "nausea"; DIZZINESS (non-serious) with onset 24Apr2021 12:00, outcome "not recovered", described as "severe dizziness"; ASTHENIA (non-serious) with onset 24Apr2021 12:00, outcome "not recovered", described as "Weakness"; FATIGUE (non-serious) with onset 24Apr2021 12:00, outcome "not recovered", described as "Fatigue /severe fatigue"; CHILLS (non-serious) with onset 25Apr2021 13:00, outcome "not recovered", described as "chills". The events "vomiting", "nausea", "fatigue /severe fatigue" and "chills" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vomiting, nausea. Therapeutic measures were not taken as a result of dizziness, asthenia.  Additional Information: The patient did not have any other vaccines 4 weeks prior to vaccination .The patient did not have Covid prior to vaccination. The patient was not tested for Covid post vaccination. vomiting and nausea for 5 out of the following 6 days, severe dizziness, weakness and fatigue. Days 2-13 post-vaccination have been throwing up nearly every day. On Day 7 went to urgent care and received Famotidine 40 mg 2x/day and Promethazine 25 mg 4x/day to treat nausea/vomiting and it works to keep food down sometimes. Also, patient frequently had chills and severe fatigue. No fever.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo attacks every 3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 13Mar2021 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Meniere's disease", start date: Oct2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VERTIGO (non-serious), outcome "recovered", described as "vertigo attacks every 3 days".  Additional information: The patient has no known allergies.  Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Event was experienced for 14 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Balance disorder, Body temperature, Body temperature increased, Dizziness
Clinical narrative: felt off/really bad; Light-headed; Arm is sore; Vomiting; Running a temperature; slept all day/really fatigued/real tired; Off balance; She is worried about if this is how bad the first shot is; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received BNT162B2 (BNT162B2), administration date 20Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: She had Covid before, and it feels like those symptoms all over again. The patient took concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt off/really bad"; DIZZINESS (non-serious), outcome "unknown", described as "Light-headed"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm is sore"; VOMITING (non-serious), outcome "unknown", described as "Vomiting"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "Running a temperature"; FATIGUE (non-serious), outcome "unknown", described as "slept all day/really fatigued/real tired"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Off balance"; ANXIETY (non-serious), outcome "unknown", described as "She is worried about if this is how bad the first shot is". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The patient had her first Covid-19 shot on 20Apr2021 and this is day 3. The first day was really bad. Yesterday, she slept all day. Now, she woke up again this morning and was still not feeling right. She felt off, tired, and light-headed. The patient asked if all of this is normal and or is this something, she should be concerned about it. She mentioned she has heard so many people who took their first shot and had nothing but a sore arm. Her arm is sore. The first day, she had vomiting and was running a temperature. She had Covid before, and it felt like those symptoms all over again. Today was the beginning of day 3 and she was still feeling really fatigued, real tired, and off balance. She took blood thinners and high blood pressure medication daily. She was wondering if it was normal to go this long after the first shot. She was worried about if this is how bad the first shot is, what the second one will do to her. She just needed to know if this is normal. If it was normal she won't panic, she will just ride it out.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain in extremity, Vomiting
Clinical narrative: felt off/really bad; Light-headed; Arm is sore; Vomiting; Running a temperature; slept all day/really fatigued/real tired; Off balance; She is worried about if this is how bad the first shot is; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received BNT162B2 (BNT162B2), administration date 20Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: She had Covid before, and it feels like those symptoms all over again. The patient took concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt off/really bad"; DIZZINESS (non-serious), outcome "unknown", described as "Light-headed"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm is sore"; VOMITING (non-serious), outcome "unknown", described as "Vomiting"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "Running a temperature"; FATIGUE (non-serious), outcome "unknown", described as "slept all day/really fatigued/real tired"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Off balance"; ANXIETY (non-serious), outcome "unknown", described as "She is worried about if this is how bad the first shot is". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The patient had her first Covid-19 shot on 20Apr2021 and this is day 3. The first day was really bad. Yesterday, she slept all day. Now, she woke up again this morning and was still not feeling right. She felt off, tired, and light-headed. The patient asked if all of this is normal and or is this something, she should be concerned about it. She mentioned she has heard so many people who took their first shot and had nothing but a sore arm. Her arm is sore. The first day, she had vomiting and was running a temperature. She had Covid before, and it felt like those symptoms all over again. Today was the beginning of day 3 and she was still feeling really fatigued, real tired, and off balance. She took blood thinners and high blood pressure medication daily. She was wondering if it was normal to go this long after the first shot. She was worried about if this is how bad the first shot is, what the second one will do to her. She just needed to know if this is normal. If it was normal she won't panic, she will just ride it out.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pain, Vaccination site pain, Vomiting
Clinical narrative: Mild episodes of Migraine; Arm pain where I received the shot; Nauseous; Throwing up several times; This cost me some hours with my work because of this pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 14Apr2021 (Lot number: EW0169) at the age of 24 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "Mild episodes of Migraine"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Arm pain where I received the shot"; NAUSEA (non-serious), outcome "unknown", described as "Nauseous"; VOMITING (non-serious), outcome "unknown", described as "Throwing up several times"; PAIN (non-serious), outcome "unknown", described as "This cost me some hours with my work because of this pain".  Additional information: Other Products and Investigation Assessment are reported as NO  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: sore throat; runny nose.; I feel generally ill; 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 (005570). The reporter is the patient.  A 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 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose."; MALAISE (non-serious), outcome "unknown", described as "I feel generally ill".  Additional information: She had second Covid vaccine. And a few hours later she had a severe sore throat and runny nose. Now it had been a little over 48 hours and she still had the runny nose and she feel generally ill. Is this normal and how long should this last. Most of the information that she read doesn't list a sore throat or runny nose as a side effect. She don't have seasonal allergies etc.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: lymph nodes swollen; lymph nodes were painful; fatigue; pain in collarbone area, aunder arms and from shoulders to elbows; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Apr2021 16:00 (Lot number: ER8735) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Wheat" (unspecified if ongoing); "known allergies: animal dander" (unspecified if ongoing); "anemia" (unspecified if ongoing); "asthma" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "Hypothyroid/hashimotos" (unspecified if ongoing); "Hypothyroid/hashimotos" (unspecified if ongoing); "known allergies: hay fever" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; VENTOLIN [SALBUTAMOL]; SINGULAIR; SUPER B COMPLEX [VITAMIN B COMPLEX]; D3; LORAZEPAM; MAGNESIUM; VENOFER. Past drug history included: Hydrochlorothiazide, reaction(s): "known allergies: hydrochlorothyazide". Vaccination history included: Bnt162b2 (dose 1, Lot number: EN6206, Administration time: 04:00 PM, Vaccine location: Left arm), administration date: 18Mar2021, when the patient was 22 years old, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 20Apr2021 12:00, outcome "not recovered", described as "lymph nodes swollen"; LYMPH NODE PAIN (non-serious) with onset 20Apr2021 12:00, outcome "not recovered", described as "lymph nodes were painful"; FATIGUE (non-serious) with onset 20Apr2021 12:00, outcome "not recovered", described as "fatigue"; PAIN (non-serious) with onset 20Apr2021 12:00, outcome "not recovered", described as "pain in collarbone area, aunder arms and from shoulders to elbows". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, fatigue, pain.  Additional information: If other vaccine in four weeks: No. On 20Apr2021 patient noted all lymph nodes in neck, arms and chest were swollen and painful. Over the next few days lymph nodes continued to grow in size and become more painful. On 30Apr2021 while she had slightly less swelling, lymph nodes were incredibly painful and still enlarged. She also fatigued easily. Patient experienced the most pain in collarbone area, under arms, and from shoulders to elbows. She had to miss several days of work due to this reaction.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature fluctuation, Feeling cold, Influenza, Nasopharyngitis
Clinical narrative: "feels so sick\never felt this way in my life'\ She has flu symptoms; cold symptoms; getting hot and cold; freezing; 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) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunization. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as ""feels so sick\never felt this way in my life'\ She has flu symptoms"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold symptoms"; BODY TEMPERATURE FLUCTUATION (non-serious), outcome "unknown", described as "getting hot and cold"; FEELING COLD (non-serious), outcome "unknown", described as "freezing".  Additional information: reporter received the second dose of the vaccine. She stated she feels so sick, never felt this way in my life. She has flu symptoms, it feels like cold symptoms, she's getting hot and cold, and is freezing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Scan brain
Clinical narrative: tingling on the tongue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (Batch/Lot number: unknown) at the age of 81 years as single dose for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN; METOPROLOL [METOPROLOL TARTRATE]; LIPITOR [ATORVASTATIN CALCIUM]. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 24Jan2021, when the patient was 81 years old, for Covid-19 immunization, reaction(s): "Dry mouth", "tingling tongue", "For the past 3 days tingling was worse", "Dry tongue". The following information was reported: PARAESTHESIA ORAL (non-serious), outcome "not recovered", described as "tingling on the tongue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The day of first vaccine experienced dry tongue, dry mouth from days later experienced tingling on the tongue, for the past 3 days the tingling was worse, she reported to Pfizer and her doctor. Dr advised a brain scan, results were negative. 18Feb2021 received second vaccination. The patient still had tingling on tongue on an unknown date. No other ill effects. Saw Neurologist, saw Ent- no known reason as yet. She was still experiencing the tingling on her tongue would be happy to hear from you and add to any finding as she find then.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 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 (Dose: 1), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache". The event "headache" was evaluated at the physician office visit. Additional information: The patient has had headache for the last month after the vaccine. The patient went to the doctor about this and the doctor wants the patient to go through all of this testing and the patient can't afford it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Laboratory test, Pain in extremity, Tongue discomfort
Clinical narrative: felt very tired; Headache; "weird tongue"; sore arm; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (060820).  A 38 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). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "felt very tired"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Headache"; TONGUE DISCOMFORT (non-serious) with onset 2021, outcome "recovered" (2021), described as ""weird tongue""; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient was taking Ibrance 100 mg oral once a day for the treatment of breast cancer since 05Jan2021 and ongoing.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Did not feel well after shot; This is a spontaneous report received from a non-contactable reporter (Consumer).  A female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date after shot, the patient did not feel well. The clinical outcome of the event did not feel well was unknown at the time of this report.   Amendment: This follow-up report is being submitted to amend previously reported information: Country for patient and Vaccination Facility Country added.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Blepharospasm
Clinical narrative: eye started twitching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 23 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 11:50 (Batch/Lot number: unknown) at the age of 23 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: BLEPHAROSPASM (non-serious) with onset 08Apr2021, outcome "not recovered", described as "eye started twitching".  Additional information: Reported she was calling on the behalf of her boyfriend, who had his first COVID-19 Vaccine on 08Apr2021. She said a couple minutes after her boyfriend received his first COVID-19 Vaccine, he had eye twitching right away and it lasts a couple of seconds and it happens every couple of hours. Reporter states his received the injection in his left arm. She stated her boyfriend's eye twitching was like if a person was tired or had too much caffeine From: 8 Apr 2021 To: Ongoing). She said the eye twitching stopped at the time, but her boyfriend still had eye twitching that happened a couple times during the day since then. The caller asked since her boyfriend was still experiencing the eye twitching, was he at risk if he got the second COVID-19 Vaccine. She said her boyfriend wanted to know if he should still get the second COVID-19 Vaccine, because he wanted to be fully vaccinated. Had this type of side effect been reported before?.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Fatigue, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: Slept drank a lot of fluids and just felt fatigued on Monday; Flu like symptoms; Sore arm; Hurts all over; She thought she was dying and she could not function; She thought she was dying and she could not function; Chills; 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 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 23Apr2021 (Lot number: ER8737) at the age of 62 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: PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Hurts all over"; ANXIETY (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset Apr2021, outcome "unknown" and all described as "She thought she was dying and she could not function"; INFLUENZA LIKE ILLNESS (non-serious) with onset 23Apr2021, outcome "unknown", described as "Flu like symptoms"; PAIN IN EXTREMITY (non-serious) with onset 23Apr2021, outcome "unknown", described as "Sore arm"; FATIGUE (non-serious) with onset 26Apr2021, outcome "unknown", described as "Slept drank a lot of fluids and just felt fatigued on Monday"; CHILLS (non-serious) with onset Apr2021, outcome "unknown", described as "Chills".  Additional information included: The patient had her first dose on last Friday. The patient's arm was sore the same night where she received the vaccine and then through the weekend she had flu like symptoms. She thought she was dying and she could not function. The patient was supposed to have the next dose on 10May2021 and was scared to get the second dose if the symptoms were going to be worse. The patient had flu like symptoms including chills, hurting all over. The patient didn't have headache. The patient took Pfizer covid shot because she doesn't want covid. The patient stated that she was fat. Her sore arm was the least of it. It was more sore than a flu shot, but she anticipated that. That was the least of her problems. It was not like she couldn't live with it.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Slept drank a lot of fluids and just felt fatigued on Monday; Flu like symptoms; Sore arm; Hurts all over; She thought she was dying and she could not function; She thought she was dying and she could not function; Chills; 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 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 23Apr2021 (Lot number: ER8737) at the age of 62 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: PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Hurts all over"; ANXIETY (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset Apr2021, outcome "unknown" and all described as "She thought she was dying and she could not function"; INFLUENZA LIKE ILLNESS (non-serious) with onset 23Apr2021, outcome "unknown", described as "Flu like symptoms"; PAIN IN EXTREMITY (non-serious) with onset 23Apr2021, outcome "unknown", described as "Sore arm"; FATIGUE (non-serious) with onset 26Apr2021, outcome "unknown", described as "Slept drank a lot of fluids and just felt fatigued on Monday"; CHILLS (non-serious) with onset Apr2021, outcome "unknown", described as "Chills".  Additional information included: The patient had her first dose on last Friday. The patient's arm was sore the same night where she received the vaccine and then through the weekend she had flu like symptoms. She thought she was dying and she could not function. The patient was supposed to have the next dose on 10May2021 and was scared to get the second dose if the symptoms were going to be worse. The patient had flu like symptoms including chills, hurting all over. The patient didn't have headache. The patient took Pfizer covid shot because she doesn't want covid. The patient stated that she was fat. Her sore arm was the least of it. It was more sore than a flu shot, but she anticipated that. That was the least of her problems. It was not like she couldn't live with it.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Drug taken beyond expiry date; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single dose 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: EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Drug taken beyond expiry date".  Additional information: Medical Information Inquiry received from AE. Reporting via database. It has reviewed report. Per Database report dated 27Apr2021 verbatim: "No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Below is the verbatim report. Pharmacy Manager with Pharmacy said their Pharmacy Technician gave a patient the 2nd dose of Pfizer-BioNTech Covid-19 Vaccine after it has expired. HCP wants to know what the next step is for patient. She also wants to know if they should revaccinate the patient. Callback was placed on 30Apr2021 at 3:50 PM. Outbound call disclaimer was provided.  E-transmitting; Possible AE duplicate. Response: Provided disclaimer, and responded from the attached SRD, "Revaccination after Administration of Invalid Dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Caller states he is an allergist and seeing "arms swell up" looking for more specific information; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Caller states he is an allergist and seeing "arms swell up" looking for more specific information".  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chest discomfort, Discomfort, Pain, Pain in extremity
Clinical narrative: right side under arm (arm pit) and down from there very sore and hurts; right side under arm (arm pit) and down from there very sore and hurts; hurts to lift arm or move it; very uncomfortable; feels tight towards the front breast; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28Apr2021 08:00 (Lot number: EW0161) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: unspecified known allergy to medication, food or other products; "Blood pressure high" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1; Lot number: ER8729; Administration time: 08:30), administration date: 07Apr2021, when the patient was 60 years old, for COVID-19 immunisation. The following information was reported: AXILLARY PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 29Apr2021 17:00, outcome "not recovered" and all described as "right side under arm (arm pit) and down from there very sore and hurts"; PAIN (non-serious) with onset 29Apr2021 17:00, outcome "not recovered", described as "hurts to lift arm or move it"; DISCOMFORT (non-serious) with onset 29Apr2021 17:00, outcome "not recovered", described as "very uncomfortable"; CHEST DISCOMFORT (non-serious) with onset 29Apr2021 17:00, outcome "not recovered", described as "feels tight towards the front breast". Therapeutic measures were taken as a result of axillary pain, pain in extremity, pain, feeling abnormal, breast pain. Additional information: The patient took unspecified medications in two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.On 29Apr2021 at 17:00, the patient experienced right side under arm (arm pit) and down from there very sore, and hurts. Felt swollen but was not. It hurt to lift arm or move it. Very uncomfortable. Felt tight towards the front breast. Therapeutic measures were taken as a result of the events and included acetaminophen (TYLENOL); acetaminophen worked just for a while for right side under arm (arm pit) and down from there very sore and hurts, hurts to lift arm or move it.No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia
Clinical narrative: intermittent dizzy spells; tingling in his head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Lot number: ER8732) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, lot/Batch : ER8732, vaccine site : Right arm), administration date: 25Feb2021, for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 25Apr2021, outcome "not recovered", described as "intermittent dizzy spells"; PARAESTHESIA (non-serious) with onset 25Apr2021, outcome "not recovered", described as "tingling in his head".  Additional information: Caller received his second Pfizer Covid vaccine dose on 25Mar2021 (Lot#ER8732). On 25Apr2021 he started to experience intermittent dizzy spells and tingling in his head. Reports it happens "when I lay down, when I get up from laying down, I got dizzy and tried to steady myself and my right side gave away." Response: Referred caller to HCP for treatment recommendations. Spoke from attached document VR-Consumer Inquiry Management (Off-Label or No Info) (v15.0) and FACT SHEET FOR HCPs ADMINISTERING VACCINE; FULL EUA PI (v1.0) (LAB-1457-7.0 Revised: 06 April 2021) section 6.1. Caller says that he has read the flyer that they gave to them after the inoculation and he is having symptoms of something and he didn't know if they are related to the COVID vaccine or not. The flyer didn't touch on what he is having happen to him so it made him wonder if there are other side effects that could occur with the COVID vaccine. He has dizzy spells and from time to time if he lays on his back and puts his head on the pillow he notices tingling. They started about 5 days ago, confirmed to 25Apr2021. Caller is 71 y/o male. Unsuccessful attempt to warm transfer caller to due to long hold time. Will e-transmit to RA as AE. Caller consents to follow-up contact. The caller was provided with phone number of, option 3, and hours of operation of Monday through Friday 8AM to 8PM, EST and Saturday to Sunday 9AM to 3PM EST prior to a cold transfer due to a high call volume.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Impaired work ability, Peripheral coldness, Pyrexia
Clinical narrative: chills; her hands and feet were cold; her body felt hot; felt like she had fever; she did not and she could barely do anything; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (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: CHILLS (non-serious), outcome "unknown", described as "chills"; PERIPHERAL COLDNESS (non-serious), PERIPHERAL COLDNESS (non-serious), outcome "unknown" and all described as "her hands and feet were cold"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "her body felt hot"; PYREXIA (non-serious), outcome "unknown", described as "felt like she had fever"; IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "she did not and she could barely do anything".  Additional Information: Patient that she spoke to a nurse and doctor before about side effects she experienced after receiving the first dose of the Pfizer COVID-19 vaccine. Stated that she had a severe reaction for 3 or 4 days. She had chills, her hands and feet were cold, her body felt hot and felt like she had fever, but she did not, and she could barely do anything. She would like to know if this has been reported.  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, Diarrhoea, Headache, Platelet count
Clinical narrative: headache; Diarrhea; Chills; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 73 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: HEADACHE (non-serious), outcome "unknown", described as "headache"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; CHILLS (non-serious), outcome "unknown", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Discomfort, Hypoaesthesia, Memory impairment, Neuralgia
Clinical narrative: uncomfortable; Prickling feeling along my right face and forehead; numbess in my nose, eye and face; I got up this morning and was disoriented and very confused; forgetful; Neuralgia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 (Lot number: EW0171) 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: CONFUSIONAL STATE (non-serious) with onset 30Apr2021, outcome "recovered" (2021), described as "I got up this morning and was disoriented and very confused"; MEMORY IMPAIRMENT (non-serious) with onset 30Apr2021, outcome "recovered" (2021), described as "forgetful"; NEURALGIA (non-serious) with onset 30Apr2021, outcome "unknown", described as "Neuralgia"; DISCOMFORT (non-serious), outcome "unknown", described as "uncomfortable"; PARAESTHESIA (non-serious) with onset 30Apr2021 15:00, outcome "unknown", described as "Prickling feeling along my right face and forehead"; HYPOAESTHESIA (non-serious) with onset 30Apr2021 15:00, outcome "unknown", described as "numbess in my nose, eye and face". Therapeutic measures were taken as a result of neuralgia.  Additional Information: After the first dose, she got up that morning and was disoriented and very confused and forgetful, this lasted 2 hours. Around 3pm that afternoon she developed a neuralgia, prickling feeling along her right face and forehead, numbness in her nose, eye and face. The patient called HCP and stated that she was not having stroke. The patient took a couple of aspirin for the neuralgia to see if that would ease that up. The patient wanted to get over to medical information at that time. The patient had a reaction one time to an injection from her orthopaedic doctor for her knee. She had a knee that needed replacement. Her pharmacist told her she would be okay to get it. That the ingredient she had the reaction too was rooster comb. It was stated that second dose was scheduled in 3 weeks. The patient was concerned about getting the 2nd dose.  No follow-up attempts are possible. No further information is expected.