chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: the vaccination site arm muscle at first dose hurt; 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.  An 80 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in arm (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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "the vaccination site arm muscle at first dose hurt".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tonsillitis
Clinical narrative: patient received first dose of vaccine today, being treated for acute tonsilitus; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (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: TONSILLITIS (non-serious) with onset 07Apr2021, outcome "unknown", described as "patient received first dose of vaccine today, being treated for acute tonsilitus". Therapeutic measures were taken as a result of tonsillitis.  Additional Information: No patient identifiers were provided but the reporter has first-hand knowledge of the patient and was reporting on a specific patient. Patient received first dose of vaccine on 07Apr2021, being treated for acute tonsillitis, nurse wanted to know if there were any contraindications for steroids.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 10:00 (Lot number: EN6204) at the age of 71 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu shot (last one was 2 years ago, it was the Flu shot and she had no reaction). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Mar2021 16:00, outcome "recovered" (2021), described as "sore arm".   No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: Dizzy; Tired; Weakness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 10:30 (Lot number: ER8732) at the age of 82 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus", start date: 2000 (ongoing), notes: Verbatim: Diabetes; "Hypertension", start date: 2000 (ongoing), notes: Verbatim: Hypertension; "Spinal cord injury", start date: 2018 (unspecified if ongoing), notes: Verbatim: Injury to C6 and C7, Caller states that she had a fall in 2018 and suffered an injury to C6 and C7 on her spinal cord.States that her hands are still weak related to this.; "Arthritis" (ongoing), notes: Verbatim: Arthritis; "Fall", start date: 2018 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 01Apr2021, outcome "recovering", described as "Dizzy"; FATIGUE (non-serious) with onset 01Apr2021, outcome "recovering", described as "Tired"; ASTHENIA (non-serious) with onset 01Apr2021, outcome "recovering", described as "Weakness".  Additional Information:  Prior Vaccinations (within 4 weeks) were none. AE(s) following prior vaccinations was none. Patient's Medical History (Including any illness at time of vaccination) was none. Family Medical History Relevant to AE(s) was none. Relevant Tests were none .The patient had a fall in 2018 and suffered an injury to C6 and C7 on her spinal cord. Stated that her hands are still weak related to this. patient was supposed to return for her second one on 14 Apr 2021.She didn't even felt when she got the shot and that her arm wasn't sore like she's read a lot of people's have been. There was no history of all previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). The patient did not taken Prior Vaccinations within 4 weeks.The patient has not been taken additional Vaccines Administered on Same Date of the Pfizer Suspect.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain
Clinical narrative: neck pain; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious), outcome "unknown", described as "neck pain"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  Additional information: The patient received both doses and started experiencing side effects such as neck pain and nausea. The pain started increasing lately and she wanted to know if that's normal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: There's like pain down my arm and into my pinky; almost like nerve pain, but not; Pain in hand, arm, forearm, like muscle pain; Pain in hand, arm, forearm, like muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (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: PAIN (non-serious), outcome "unknown", described as "There's like pain down my arm and into my pinky; almost like nerve pain, but not"; PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "Pain in hand, arm, forearm, like muscle pain".  Additional information: Reporter was wondering, was just trying to figure out if should just get the second dose of the Pfizer COVID-19 vaccine or not. Reporter got it 3 weeks ago and supposed to get his/her second dose this week. And his/her arm, like ever since got the first dose, there's like pain down his/her arm and into pinky. It's almost like nerve pain, but not. And so, have like pain in my hand, in my arm, in my forearm, like muscle pain and stuff. So reporter wondering, he/she don't know, if should be getting the second dose or not."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: feeling achy; 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 06Apr2021 (Batch/Lot number: unknown) as dose 2, 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), outcome "unknown", described as "feeling achy". Additional Information: Patient had the second dose on 06Apr2021. He is feeling achy.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, SARS-CoV-2 test
Clinical narrative: I was completely normal and physically active before the first dose, I have not felt normal since; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: EP7534) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's autoimmune" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing), notes: Allergies: Penicillin. Concomitant medication(s) included: LIOTHYRONINE; LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose:01, Batch/lot number : EN6199, Anatomical Location : Arm Right, Time:19:30 pm), administration date: 03Mar2021, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "Almost fainted once"; Bnt162b2 (Dose:01, Batch/lot number : EN6199, Anatomical Location : Arm Right, Time:19:30 pm), administration date: 03Mar2021, for COVID-19 immunization, reaction(s): "Dizziness/ extreme dizziness/ Some degree of dizziness every day/ Varies from daily light headedness to extreme dizziness". The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "I was completely normal and physically active before the first dose, I have not felt normal since". The event "i was completely normal and physically active before the first dose, i have not felt normal since" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal.  Additional Information: Facility where the most recent COVID-19 vaccine was administered was withheld. The patient receive other vaccines within 4 weeks prior to the COVID vaccine. Reported Event: Dizziness began 10Mar2021 and has not ceased. Varies from daily light headedness to extreme dizziness. Almost fainted once. Some degree of dizziness every day. Have also had extreme fatigue since 09Mar2021. I was completely normal and physically active before the first dose, I have not felt normal since. Date of start of reaction/event was 10Mar2021. Outcome of reaction/event at the time of last observation was Not Recovered/Not Resolved. The adverse event result in any of the following was doctor or other healthcare professional office/clinic visit. Patient did not received treatment received for the adverse event. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Product dose omission issue
Clinical narrative: I wasn't feeling good so I did not go and I did not get a second appointment since then; I still did not get the second shot; I did not get a second appointment since then and I did not get an appointment, they have new waiting for appointment, so this is almost 2 months since I got it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Feb2021 (Lot number: EN6200) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D 2000. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I wasn't feeling good so I did not go and I did not get a second appointment since then; I still did not get the second shot"; PRODUCT DOSE OMISSION ISSUE (non-serious), outcome "unknown", described as "I did not get a second appointment since then and I did not get an appointment, they have new waiting for appointment, so this is almost 2 months since I got it".  Additional Information: She was just trying to ask a question, she got the Pfizer on February 18 and she was supposed to get it back on March 11, the second one and she wasn't feeling good so she did not go and she did not get a second appointment since then and she did not get an appointment, they have new waiting for appointment, so this was almost 2 months since she got it, she was going to have to take the Pfizer all over again or she still can get the second shot (Unspecified Medication). She reschedule for her second shot and she still cannot get an appointment to go, so she still did not get the second shot.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Muscle twitching, Skin warm, Vaccination site inflammation
Clinical narrative: injection site inflammation; inflammation of right lower lip; leg twitching; hot skin; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 (Lot number: EN6206) as dose 2, single for covid-19 immunisation. Relevant medical history included: "DIABETES" (ongoing); "HYPERTENSION" (ongoing). Concomitant medication(s) included: JANUMET LONG; FARXIGA; GLIPIZIDE; RAMIPRIL; LIPITOR [ATORVASTATIN]; VIT D; BENADRYL; ADVIL 12 HOUR. Vaccination history included: Bnt162b2 (Dose 1; lot number EN6205; administration time 08:00 AM,, Anatomical location : Left arm,), administration date: 01Mar2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE INFLAMMATION (non-serious) with onset 22Mar2021 10:00, outcome "recovered" (2021), described as "injection site inflammation"; CHEILITIS (non-serious) with onset 22Mar2021 10:00, outcome "recovered" (2021), described as "inflammation of right lower lip"; MUSCLE TWITCHING (non-serious) with onset 22Mar2021 10:00, outcome "recovered" (2021), described as "leg twitching"; SKIN WARM (non-serious) with onset 22Mar2021 10:00, outcome "recovered" (2021), described as "hot skin". Therapeutic measures were taken as a result of vaccination site inflammation, cheilitis, muscle twitching, skin warm.  Additional information: The patient was administered COVID-19 vaccine at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was treated with BENADRYL, ADVIL for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Taste disorder
Clinical narrative: feel lightheaded; tasted something in her mouth right after she got the vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Apr2021 10:30 (Lot number: EP6955) at the age of 54 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 (1st dose, lot number: EP6955, administrator route: intramuscular, vaccine location: left arm), administration date: 17Mar2021, when the patient was 53 years old, for Covid-19 immunisation. The following information was reported: TASTE DISORDER (non-serious) with onset 07Apr2021, outcome "unknown", described as "tasted something in her mouth right after she got the vaccine"; DIZZINESS (non-serious) with onset 07Apr2021 10:45, outcome "recovered" (Apr2021), described as "feel lightheaded". Therapeutic measures were not taken as a result of dizziness.  Additional information: The patient had no known allergies. It was unknown if the patient had other vaccine in four weeks prior vaccination, if diagnosed with COVID-19 prior vaccination and if tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the injection site; This is a spontaneous report received from a non-contactable reporter (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Mar2021 (Lot number: EN6204)  at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "tree nut allergy" (unspecified if ongoing). The patient has not had COVID prior to vaccination. Concomitant medications included: VITAMIN C [ASCORBIC ACID]; MELATONIN; IBUPROFEN; TYLENOL; VITAMIN D [COLECALCIFEROL]. The patient did not receive any other vaccine in four weeks. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "soreness at the injection site". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: The patient was not tested for COVID post vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a mild symptom which is sore arm; 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 12Mar2021 (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: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "a mild symptom which is sore arm".  Additional information: The second dose is scheduled on 02Apr2021 but patient did not get the second dose on 02Apr2021 because he experienced a mild symptom which is sore arm after getting the first dose. and at the time of report, wanted to know how to get an appointment for the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: Vomiting; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) via COVID-19 Reporting portal. The reporter is the patient.  A 34 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm left, administration date 19Mar2021 10:15 (Lot number: En6207) at the age of 34 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "Obsessive-compulsive disorder (Ocd)" (unspecified if ongoing); "complex post-traumatic stress disorder (ptsd)" (unspecified if ongoing); "known allergies to Nickel" (unspecified if ongoing). Concomitant medications included: citalopram hydrobromide (CELEXA); lorazepam. The following information was reported: VOMITING (non-serious), outcome "unknown," described as "Vomiting." Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue
Clinical narrative: felt a little tired after the first dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (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: FATIGUE (non-serious), outcome "unknown", described as "felt a little tired after the first dose of the vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that her other son who is 16 only felt a little tired after the first dose of the vaccine and he tested negative for Covid. She asked if the vaccines given to 16 year olds is the same as the ones given to adults. She called in for her two sons. Both sons had their first dose of the vaccine last 02Apr2021 and scheduled to have the second dose on 25Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392131 same reporter/drug, different patient/AE
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm hurt; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREDNISONE (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm hurt".  Additional information: This patient had a short hospital stay, but also came on a high dose of prednisone. Patient has been  taking over a month. Patient was still on 5mg Prednisone, at which patient said her pulmonologist allowed her to get the vaccine if she was taking 5mg or less. States that none of these patients reported any side effects from the vaccine, except their arm hurt  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain, Pain in extremity
Clinical narrative: I felt a crippling pain along the left side of my spine to my left leg; I was in a lot of pain and felt my left leg was useless until this morning; I was in a lot of pain and felt my left leg was useless until this morning; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Apr2021 11:15 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Polio" (unspecified if ongoing); "Scoliosis" (unspecified if ongoing); "Seizures" (unspecified if ongoing), notes: History of seizures but no medication currently; "Rheumatic fever" (unspecified if ongoing), notes: 8 yrs of Penicillin for rheumatic fever. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Apr2021 12:30, outcome "recovering", described as "I felt a crippling pain along the left side of my spine to my left leg"; PAIN (non-serious), LIMB DISCOMFORT (non-serious) all with onset 09Apr2021 12:30, outcome "recovering" and all described as "I was in a lot of pain and felt my left leg was useless until this morning". Therapeutic measures were not taken as a result of pain in extremity, pain, limb discomfort.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. About an hour after the shot, she felt a crippling pain along the left side of her spine to left leg. Being a polio survivor whose left side was affected, she was in a lot of pain and felt her left leg was useless until this morning. She was worried about the effects the second shot might have on her body.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia
Clinical narrative: Dizziness still to this day; Tingling in body /pins and needles; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date Mar2021 (Lot number: Er2613) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D [ERGOCALCIFEROL]. Vaccination history included: BNT162B2 (Dose 1, Single, Batch/lot number : EN6202, Anatomical Location:Arm Left, Time: 04:00 PM), administration date: Feb2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 17Mar2021, outcome "not recovered", described as "Dizziness still to this day"; PARAESTHESIA (non-serious) with onset 17Mar2021, outcome "not recovered", described as "Tingling in body /pins and needles". The events "dizziness still to this day" and "tingling in body /pins and needles" were evaluated at the physician office visit and emergency room visit. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Diarrhoea, Irritability, Mood altered, Restlessness
Clinical narrative: Anxiety; Irritability; high or low mood; feeling restless; changes in sleep habits; loose stools; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient 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: ANXIETY (non-serious), outcome "unknown", described as "Anxiety"; IRRITABILITY (non-serious), outcome "unknown", described as "Irritability"; MOOD ALTERED (non-serious), outcome "unknown", described as "high or low mood"; RESTLESSNESS (non-serious), outcome "unknown", described as "feeling restless"; SLEEP DISORDER (non-serious), outcome "unknown", described as "changes in sleep habits"; DIARRHOEA (non-serious), outcome "unknown", described as "loose stools".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Anxiety; Irritability; high or low mood; feeling restless; changes in sleep habits; loose stools; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient 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: ANXIETY (non-serious), outcome "unknown", described as "Anxiety"; IRRITABILITY (non-serious), outcome "unknown", described as "Irritability"; MOOD ALTERED (non-serious), outcome "unknown", described as "high or low mood"; RESTLESSNESS (non-serious), outcome "unknown", described as "feeling restless"; SLEEP DISORDER (non-serious), outcome "unknown", described as "changes in sleep habits"; DIARRHOEA (non-serious), outcome "unknown", described as "loose stools".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: having mild headache each day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 16:30 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (lot number: EN6208, administration time:16:30, administered in left arm, dose 1, no headache in between first and second dose), administration date: 08Mar2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 01Apr2021, outcome "recovered" (Apr2021), described as "having mild headache each day". Therapeutic measures were taken as a result of headache. Additional information: It was also reported that the Lot/Batch number of the vaccine was SR8733 / ER8733. The event was reported as abnormal for patient to have a daily headache. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient been has not tested for COVID-19. Patient had no allergies to medications, food, or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomited; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administration date 10Apr2021 (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: VOMITING (non-serious), outcome "unknown", described as "vomited".  Additional Information: Patient reported that afterward vomited once, and that only saw 'nausea' in the listed AEs so called to ask us if this had been reported before. Confirmed that this was a commonly reported AE.  Spoke from Fact Sheet, Table 2 which lists the frequency of vomiting after the second dose as 1.9 percentage.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Photopsia
Clinical narrative: flashing of vision; rapid heart rate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 37-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 09:00 (Lot number: EP7534) at the age of 36 years as dose 1, single for covid-19 immunization.  Relevant medical history included: "Q Fever" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PHOTOPSIA (non-serious) with onset 08Apr2021 01:00, outcome "recovered" (2021), described as "flashing of vision"; HEART RATE INCREASED (non-serious) with onset 08Apr2021 01:00, outcome "recovered" (2021), described as "rapid heart rate". Therapeutic measures were taken as a result of photopsia, heart rate increased.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was recommended to refer with cardiologist. The patient was not diagnosed with covid-19 prior to vaccination. He was not tested for covid-19 since the vaccination. The patient did not have allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Vomiting
Clinical narrative: not feeling well; vomiting; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (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: Covid-19 vaccine (DOSE 1, SINGLE; manufacture unknown), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 05Apr2021, outcome "unknown", described as "not feeling well"; VOMITING (non-serious) with onset 05Apr2021, outcome "unknown", described as "vomiting"; DIARRHOEA (non-serious) with onset 05Apr2021, outcome "unknown", described as "diarrhea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Feeling abnormal, Hordeolum
Clinical narrative: I woke up with a stye this morning/Her eyes were swollen and gooey; Her eyes were hurting; I feel uncomfortable getting the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Stye" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HORDEOLUM (non-serious) with onset 12Apr2021, outcome "unknown", described as "I woke up with a stye this morning/Her eyes were swollen and gooey"; EYE PAIN (non-serious) with onset 12Apr2021, outcome "unknown", described as "Her eyes were hurting"; FEELING ABNORMAL (non-serious) with onset 12Apr2021, outcome "unknown", described as "I feel uncomfortable getting the second dose". Therapeutic measures were taken as a result of hordeolum, eye pain.  Additional information: Caller called due to take her 2nd dose tomorrow 13Apr2021 but she was uncomfortable taking the 2nd shot of the vaccine. Woke up this morning and her eyes were hurting. Her eyes were swollen and gooey and she had a stye in her eyes. She has been prescribed by her doctor an antibiotic drops for her eyes and she was told that it was an eye infection. She had this before. She wanted to know if she can wait a few more days to get her 2nd shot because she didn't want to get the covid vaccine with an eye infection. Couldn't remember when was her 1st dose. They usually go away within 4 to 5 days. Her doctor usually prescribes antibiotics and suggest putting hot compress on her eye. She feel uncomfortable getting the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling great; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  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. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling great".  The patient (a teacher) sent a group communication to parents stating that she would not be in class today because she received her 2nd dose of Pfizer vaccine and was "not feeling great this morning.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain
Clinical narrative: diarrhea; slight body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 12:30 (Lot number: EN6207) at the age of 63 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; Lot # EN6201; Time of administration 12:30), administration date: 24Feb2021, for Covid-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 26Mar2021, outcome "not recovered", described as "diarrhea"; PAIN (non-serious) with onset 25Mar2021, outcome "recovered" (25Mar2021), described as "slight body aches". Therapeutic measures were taken as a result of pain.  Additional information: Patient had her second dose of vaccine on 24Mar2021 and ever since then, every morning she had diarrhea. There were no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. Not require a visit to emergency room and physician office due to any adverse event. No reported prior vaccinations (within 4 weeks). Patient mentioned that she had a sore arm  after getting a flu shot every season, patient said it was not bad, it was tender in area where they gave it. Patient that the first day after the second dose she had slight body aches. They went away after she took some Motrin. She states that the Motrin, knock it right out. The body aches lasted maybe not even an hour. No further information provided. No relevant Tests were reported.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site inflammation
Clinical narrative: Slight fatigue; Soreness at the injection site after a couple hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 17:00 (Lot number: EP6955) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (lot number: EP6955,, administration time: 05:00 PM,, vaccine location: Left arm,, dose number: 1), administration date: 18Mar2021, when the patient was 39 years old, for COVID-19 immunization, reaction(s): "Soreness at the injection site". The following information was reported: INJECTION SITE INFLAMMATION (non-serious) with onset 08Apr2021 19:00, outcome "recovered" (09Apr2021 07:00), described as "Soreness at the injection site after a couple hours"; FATIGUE (non-serious) with onset 09Apr2021, outcome "recovered" (2021), described as "Slight fatigue". Therapeutic measures were not taken as a result of injection site inflammation, fatigue.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Infection
Clinical narrative: Infection; She went to the pharmacy to get some antibiotics but the pharmacist told her that she would either take the vaccine or the antibiotic but not both; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFECTION (non-serious), outcome "unknown", described as "Infection"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "She went to the pharmacy to get some antibiotics but the pharmacist told her that she would either take the vaccine or the antibiotic but not both".  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: Swelling under my arm area, it's real puffy; under the armpit area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunisation. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Swelling under my arm area, it's real puffy; under the armpit area".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: experienced injection site swelling and redness; experienced injection site swelling and redness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of covid vaccine), for Covid-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset Apr2021, outcome "unknown" and all described as "experienced injection site swelling and redness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: experiencing muscle pain after taking the 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Batch/Lot number: unknown) as dose 2,  single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: MYALGIA (non-serious) with onset Apr2021, outcome "unknown", described as "experiencing muscle pain after taking the 2nd dose". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (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: MALAISE (non-serious) with onset 07Apr2021, outcome "unknown", described as "not feeling well".  Additional information: The reporter stated that his wife was supposed to be scheduled today, 07Apr2021 for her second dose of the vaccine but could not make it because she was not feeling well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise
Clinical narrative: patient was scheduled for second dose on 07Apr2021 but can not make it since she was not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (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: MALAISE (non-serious), outcome "unknown", described as "patient was scheduled for second dose on 07Apr2021 but can not make it since she was not feeling well".  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, Nasal congestion, Oropharyngeal pain
Clinical narrative: sore throat; stuffy nose; felt like chewing on glass; 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), administration date 20Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 26Mar2021, outcome "unknown", described as "sore throat"; NASAL CONGESTION (non-serious) with onset 26Mar2021, outcome "unknown", described as "stuffy nose"; FEELING ABNORMAL (non-serious) with onset 26Mar2021, outcome "unknown", described as "felt like chewing on glass". Therapeutic measures were taken as a result of oropharyngeal pain, nasal congestion, feeling abnormal.    Additional information: Patient was prescribed Azithromyacin and is seeking medical advice whether to proceed with second dose on 10Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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: INSOMNIA (non-serious), outcome "unknown", described as "Insomnia".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.