chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: Nasal congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) at the age of 45 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NASAL CONGESTION (non-serious) with onset 21Apr2021, outcome "recovering", described as "Nasal congestion". Therapeutic measures were taken as a result of nasal congestion.  Additional information: The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Treatment for the event included acetylsalicylic acid [ASPIRIN] on 21Apr2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: Feeling pain in his legs; His back,he felt achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 40 year-old male patient received bnt162b2 (BNT162B2), administration date 11Apr2021 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Apr2021, outcome "not recovered", described as "Feeling pain in his legs"; BACK PAIN (non-serious) with onset 12Apr2021, outcome "not recovered", described as "His back,he felt achy".  Additional Information: The reporter reported that the patient got a Pfizer COVID vaccine on 11Apr2021, the next day he started feeling pain in his legs and his back, he felt achy, and he was still feeling achy, actually he has had them now for a while, the reporter enquired should it last this long. The reporter asked if the patient should get his 2nd dose on Sunday 02May2021, if he was still experiencing the AE.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: shivering on his bottom lip, kind of like muscle spasms; 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 male patient received bnt162b2 (BNT162B2), administration date 24Apr2021 (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: MUSCLE SPASMS (non-serious), outcome "unknown", described as "shivering on his bottom lip, kind of like muscle spasms". Additional information: about 3 days the patient had shivering on his bottom lip, kind of like muscle spasms.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy, Muscle spasms, Nervousness, Paraesthesia
Clinical narrative: I initially had a severe leg cramp and muscle cramping; I have pins and needle in my feet, and they are numb; I have pins and needle in my feet, and they are numb; Swollen lymph nodes; It's nerving a little bit; This is a spontaneous report received from a contactable Consumer from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 25Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Both my feet have been ice cold before and after receiving the vaccine." (ongoing). The patient's concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "I initially had a severe leg cramp and muscle cramping"; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "I have pins and needle in my feet, and they are numb"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes"; NERVOUSNESS (non-serious), outcome "unknown", described as "It's nerving a little bit". Additional information: patient has been experiencing some side effects, initially had a severe leg cramp and muscle cramping, she had pins and needle in my feet, and they are numb. These symptoms come and goes. The patient generally doesn't get flu shots or anything.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: very severe headache; 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 19 year-old female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Lot number: ER8736) at the age of 19 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "seasonal allergy" (unspecified if ongoing); "Allergic to pollens" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN ALLERGIC taken for seasonal allergy. Vaccination history included: Bnt162b2 (Dose 1, LOT# EW0153), administration date: 09Apr2021, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "very severe headache". Therapeutic measures were taken as a result of headache.  Additional information: The patient experienced very severe headache after the second dose of Pfizer COVID-19 vaccine and was wondering which medicine she should take. It was also reported that the patient took Aleve as treatment.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Mild arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 10:45 (Lot number: Er8737) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergy" (unspecified if ongoing), notes: Sometimes; "Wolff-Parkinson-White syndrome" (unspecified if ongoing); "Supraventricular tachycardia" (unspecified if ongoing). Concomitant medication(s) included: BENADRYL taken for seasonal allergy. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "Mild arm pain".  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 vaccination. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac murmur, Pain, Palpitations, SARS-CoV-2 test
Clinical narrative: achy by the third day have been having heart palpitations and feeling of heart murmur.; achy by the third day have been having heart palpitations and feeling of heart murmur.; achy by the third day have been having heart palpitations and feeling of heart murmur.; This is a spontaneous report received from a contactable Consumer (patient).  A 46-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 13Apr2021 11:00 (Lot number: EP6955) at the age of 46 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Pernicious anaemia" (unspecified if ongoing); "Sulfonamide" (unspecified if ongoing). Concomitant medications included: IRON; cyanocobalamin (B12); ZINC; folic acid (FOLATE); ascorbic acid (C); colecalciferol (D). Past drug history included: pethidine hydrochloride (DEMEROL), reaction: "known allergies: Demerol". Vaccination history included: BNT162B2, administration date: 23Mar2021, when the patient was 46 years old, for COVID-19 immunisation, reactions: "Shortness of breath", "Pressure chest". The following information was reported: PAIN (non-serious), PALPITATIONS (non-serious), CARDIAC MURMUR (non-serious) all with onset 16Apr2021 13:15, outcome "recovered with sequelae" and all described as "achy by the third day have been having heart palpitations and feeling of heart murmur.". The event "achy by the third day have been having heart palpitations and feeling of heart murmur.", "achy by the third day have been having heart palpitations and feeling of heart murmur." and "achy by the third day have been having heart palpitations and feeling of heart murmur." was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, palpitations, cardiac murmur. Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Pre-vaccination and post-vaccination COVID tests were not performed.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021509430 Same drug/reporter/patient, different dose
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Uncomfortable Swollen lymph nodes; Tiredness; Injection site Pain; very slight throbbing at the top right side of my head.; This is a spontaneous report received from a contactable Consumer. The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 09:30 (Lot number: EN6205) at the age of 59 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: LYMPHADENOPATHY (non-serious) with onset 11Mar2021, outcome "unknown", described as "Uncomfortable Swollen lymph nodes"; FATIGUE (non-serious) with onset 11Mar2021, outcome "unknown", described as "Tiredness"; VACCINATION SITE PAIN (non-serious) with onset 11Mar2021, outcome "unknown", described as "Injection site Pain"; HEADACHE (non-serious) with onset 11Mar2021, outcome "unknown", described as "very slight throbbing at the top right side of my head.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, fatigue, vaccination site pain, headache. 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.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021507350 Same patient  different drug/event
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Disturbance in attention, Malaise, Myalgia, SARS-CoV-2 test
Clinical narrative: Uncomfortable Swollen lymph nodes; Tiredness; Injection site Pain; very slight throbbing at the top right side of my head.; This is a spontaneous report received from a contactable Consumer. The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 09:30 (Lot number: EN6205) at the age of 59 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: LYMPHADENOPATHY (non-serious) with onset 11Mar2021, outcome "unknown", described as "Uncomfortable Swollen lymph nodes"; FATIGUE (non-serious) with onset 11Mar2021, outcome "unknown", described as "Tiredness"; VACCINATION SITE PAIN (non-serious) with onset 11Mar2021, outcome "unknown", described as "Injection site Pain"; HEADACHE (non-serious) with onset 11Mar2021, outcome "unknown", described as "very slight throbbing at the top right side of my head.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, fatigue, vaccination site pain, headache. 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.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021507350 Same patient  different drug/event
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: feelings of anxiety; My concentration seems off at times; feeling unwell for about 6 hours; muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: EP7534) 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 (Dose 1), administration date: 05Mar2021, when the patient was 59 years old, for Covid-19 Immunization, reaction(s): "Uncomfortable Swollen lymph nodes", "Tiredness", "Injection site Pain", "very slight throbbing at the top right side of my head". The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "feelings of anxiety"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "My concentration seems off at times"; MALAISE (non-serious), outcome "unknown", described as "feeling unwell for about 6 hours"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of anxiety, disturbance in attention, malaise, myalgia.  Additional information: Patient had no covid prior to vaccination and tested covid post vaccination. Patient had no other vaccine in four weeks and no other medications in two weeks. Facility type vaccine was pharmacy or drug store.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Disturbance in attention, Malaise, Myalgia, SARS-CoV-2 test
Clinical narrative: feelings of anxiety; My concentration seems off at times; feeling unwell for about 6 hours; muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: EP7534) 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 (Dose 1), administration date: 05Mar2021, when the patient was 59 years old, for Covid-19 Immunization, reaction(s): "Uncomfortable Swollen lymph nodes", "Tiredness", "Injection site Pain", "very slight throbbing at the top right side of my head". The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "feelings of anxiety"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "My concentration seems off at times"; MALAISE (non-serious), outcome "unknown", described as "feeling unwell for about 6 hours"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of anxiety, disturbance in attention, malaise, myalgia.  Additional information: Patient had no covid prior to vaccination and tested covid post vaccination. Patient had no other vaccine in four weeks and no other medications in two weeks. Facility type vaccine was pharmacy or drug store.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Tinnitus
Clinical narrative: headache; some queasiness/nausea; tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 16:30 (Lot number: ER8734) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Alcoholism" (unspecified if ongoing); "tinnitus" (unspecified if ongoing), notes: mild and generally non bothersome tinnitus since high school. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 31Mar2021 19:00, outcome "recovering", described as "headache"; NAUSEA (non-serious) with onset 31Mar2021 19:00, outcome "recovering", described as "some queasiness/nausea"; TINNITUS (non-serious) with onset 31Mar2021 19:00, outcome "recovering", described as "tinnitus". The events "headache", "some queasiness/nausea" and "tinnitus" were evaluated at the physician office visit. Therapeutic measures were taken as a result of headache, nausea, tinnitus.  Additional information: No other vaccine in four weeks. Other medications in two weeks: SSRI (Selective Serotonin Reuptake Inhibitor). Clinical course: After getting first dose, a few hours later, patient got a headache and some queasiness, the typical side effects. Ears began loudly ringing, which he attributed to the headache and immune response. The headache and nausea quickly faded, but tinnitus remained highly elevated for weeks. GP cleaned out my ears, which were heavily impacted with earwax, and that definitely helped. However, the vaccine does appear to have HIGHLY elevated the ringing. No COVID prior vaccination. No COVID tested post vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021510075 same patient, different vaccine doses/events
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This is a spontaneous report based on the information reported to Pfizer (Reference ID: NVSC2021US087521). This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (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, Unknown Manufacturer), for covid-19 Immunisation. The following information was reported: MALAISE (non-serious) with onset 29Apr2021, outcome "unknown", described as "not feeling well".  Additional information: Patient stated she got her 2nd COVID vaccine and She was not feeling well today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Single supraclavicular lymphnode (on left side) swollen (> 1.0cm); single Axillary lymphnode (also on left side) slightly enlarged. Cannot palpate but can be felt when arm in certain positions.; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 15:00 (at the age of 27-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 16:00 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history included psoriasis, epstein-barr virus as a teen, two ovarian cysts, chronic fatigue syndrome (recovered) and attention deficit hyperactivity disorder (A.D.D). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), birth control (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN), VIT D [ERGOCALCIFEROL] and ubidecarenone (COQ10), all from an unknown date for unknown indications and unknown if ongoing. On 08Apr2021, the patient had single supraclavicular lymph node (on left side) swollen (> 1.0cm), single axillary lymph node (also on left side) slightly enlarged. Cannot palpate but could be felt when arm was in certain positions. Changes were noticeable after first dose and increased after second dose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events single supraclavicular lymph node (on left side) swollen (> 1.0cm) and single axillary lymph node (also on left side) slightly enlarged, which cannot palpate but can be felt when arm in certain positions that were noticeable after first dose and increased after second dose were Resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Added vaccine Facility Information, Con med Vit D recoded as VIT D [ERGOCALCIFEROL], Outcome of Event captured as Recovering/Resolving.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain, Oropharyngeal discomfort
Clinical narrative: Felt like my ears were clogged within 15 minutes.; I felt a sensation like something was stuck in my throat when I swallowed.; and my right ear has some ear pain and I still have a slight sensation in my throat.; This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 45-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01May2021 09:15 (Lot number: Ew0167) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "pitted fruit such as cherries" (unspecified if ongoing).  Concomitant medication included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN D [VITAMIN D NOS]; ZINC. Past drug history included: Penicillin, reaction(s): "Known allergies: penicillin". The following information was reported: EAR DISCOMFORT (non-serious) with onset 01May2021 10:00, outcome "unknown", described as "Felt like my ears were clogged within 15 minutes."; OROPHARYNGEAL DISCOMFORT (non-serious) with onset 01May2021 10:00, outcome "unknown", described as "I felt a sensation like something was stuck in my throat when I swallowed."; EAR PAIN (non-serious) with onset 01May2021 10:00, outcome "unknown", described as "and my right ear has some ear pain and I still have a slight sensation in my throat.". Therapeutic measures were not taken as a result of ear discomfort, oropharyngeal discomfort, ear pain. The patient felt like his ears were clogged within 15 minutes. He waited at the hospital for a total of 30 minutes and headed home. About 15 minutes after leaving the hospital the patient felt a sensation like something was stuck in my throat when he swallowed. About 2.5 hours since the injection and right ear has some ear pain and he still have a slight sensation in my throat. The throat sensation is not really an itchy one, it feels more like something is in there.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: She's been having pain on her lower back area; 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) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "She's been having pain on her lower back area". Therapeutic measures were taken as a result of back pain.  Clinical course: Caller states she had her 1st Pfizer vaccine dose yesterday. Caller was told at the vaccination site to not take Ibuprofen and she could take acetaminophen in 7 days. She also takes a sleeping aid and Flexeril  for ongoing treatment. Are these ok to take. Patient already got the 1st shot and she was advised that she can only take Tylenol. She's been having pain on her lower back area. She was told to stay away from Ibuprofen and take only Tylenol. Caller wanted to know if she can take Lidocaine instead. She mentioned that she'll just take Tylenol since PMI is already closed.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Heart rate increased, Hyperhidrosis, Hypertension
Clinical narrative: he experienced arm pain at the injection site, chills, extra bowel movements, elevated blood pressure and elevated pulse.; he experienced arm pain at the injection site, chills, extra bowel movements, elevated blood pressure and elevated pulse.; he experienced arm pain at the injection site, chills, extra bowel movements, elevated blood pressure and elevated pulse.; he experienced arm pain at the injection site, chills, extra bowel movements, elevated blood pressure and elevated pulse.; he experienced arm pain at the injection site, chills, extra bowel movements, elevated blood pressure and elevated pulse.; he woke up this morning with sweats; 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) (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), CHILLS (non-serious), ABDOMINAL DISCOMFORT (non-serious), HYPERTENSION (non-serious), HEART RATE INCREASED (non-serious), outcome "unknown" and all described as "he experienced arm pain at the injection site, chills, extra bowel movements, elevated blood pressure and elevated pulse."; HYPERHIDROSIS (non-serious), outcome "unknown", described as "he woke up this morning with sweats". Additional information: the patient received the first dose of the Pfizer COVID-19 vaccine 12 days before. During the first week he experienced arm pain at the injection site, chills, extra bowel movements, elevated blood pressure and elevated pulse. He also woke up with sweats.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: he experienced arm pain at the injection site, chills, extra bowel movements, elevated blood pressure and elevated pulse.; he experienced arm pain at the injection site, chills, extra bowel movements, elevated blood pressure and elevated pulse.; he experienced arm pain at the injection site, chills, extra bowel movements, elevated blood pressure and elevated pulse.; he experienced arm pain at the injection site, chills, extra bowel movements, elevated blood pressure and elevated pulse.; he experienced arm pain at the injection site, chills, extra bowel movements, elevated blood pressure and elevated pulse.; he woke up this morning with sweats; 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) (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), CHILLS (non-serious), ABDOMINAL DISCOMFORT (non-serious), HYPERTENSION (non-serious), HEART RATE INCREASED (non-serious), outcome "unknown" and all described as "he experienced arm pain at the injection site, chills, extra bowel movements, elevated blood pressure and elevated pulse."; HYPERHIDROSIS (non-serious), outcome "unknown", described as "he woke up this morning with sweats". Additional information: the patient received the first dose of the Pfizer COVID-19 vaccine 12 days before. During the first week he experienced arm pain at the injection site, chills, extra bowel movements, elevated blood pressure and elevated pulse. He also woke up with sweats.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: she had tingling in her hands and legs; This is a spontaneous report from a contactable Nurse from medical information team.  A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "she had tingling in her hands and legs". Additional information: this nurse referred the patient to a chiropractor thinking it was unrelated to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event paresthesia which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Flushing, Muscle strain
Clinical narrative: Caller states she has also had a pulling in her right leg.; Caller would like to know if the vaccine will cause you to have hot and cold flashes?; hot and cold flashes; 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 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, 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: MUSCLE STRAIN (non-serious), outcome "unknown", described as "Caller states she has also had a pulling in her right leg."; FEELING OF BODY TEMPERATURE CHANGE (non-serious), outcome "unknown", described as "Caller would like to know if the vaccine will cause you to have hot and cold flashes?"; FLUSHING (non-serious), outcome "unknown", described as "hot and cold flashes".  Additional information: patient received the first dose of the Pfizer COVID vaccine a week or two ago. She would like to know if the vaccine will cause to have hot and cold flashes. Patient has also had a pulling in her right leg, it is hard to describe the feeling in her leg but it happens on the right side where the shot was given.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discharge
Clinical narrative: after the shot and there was some clear liquid running down his arm.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 13Apr2021 (Lot number: EW0171, Expiration Date: Aug2021) at the age of 29 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), when the patient was 29 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE DISCHARGE (non-serious) with onset 13Apr2021, described as "after the shot and there was some clear liquid running down his arm.".  Additional Information: HCP states patient called today regarding his 2nd Pfizer vaccine dose he received yesterday. The patient stated he removed his band aid a few hours after the shot and there was some clear liquid running down his arm. The HCP is asking if he is sufficiently vaccinated, what should they do. RA number of Covid-19 Vaccine: 59267100001. When probed for the concern, Pharmacist stated "I am calling regard to one of our patient (consumer). I work for Pharmacy (further clarified reporter type as Pharmacist) and we gave a Pfizer vaccine the Covid vaccination to a patient yesterday (April 13th 2021), a couple of hours after getting the vaccination he called vaccine there was some clear liquid coming out or like that was Drug side effect, so fold down his arm and then he was wondering or were not sure at this point, so was the vaccination that came out or it was like fluid from his body, so we are wondering at this point. Do we vaccinate the patient or we hold off, I am not sure what to do.". When probed for the causality, Pharmacist stated, Yes it came out of the injection site. When probed for any treatment for event, Pharmacist stated, No. When probed for consumer's height and weight, Pharmacist stated, That I don't know. When probed for any other medication condition concomitant medication, Pharmacist stated, I believe he is not. (Further not sure). When probed for any laboratory test, Pharmacist stated, I am not sure either.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: forgetfulness; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 45 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "forgetfulness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Headache, Nausea
Clinical narrative: headache; Nausea; temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 24Apr2021 12:45 (Lot number: EW0150, Expiration Date: 31Jul2021) at the age of 61 years as dose 1 ,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 25Apr2021, outcome "unknown", described as "headache"; NAUSEA (non-serious) with onset 25Apr2021, outcome "unknown", described as "Nausea"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 25Apr2021, outcome "unknown", described as "temperature". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 31Mar2021 at 16:00 (Lot number: ER8733) at the age of 37 years, as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Hashimoto" (ongoing); "High blood pressure" (ongoing), notes: Controlled; "Chronic herpes" (ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Celebrex, reaction(s): "Allergy". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in arm".  Additional information: The patient stated that after the first vaccine she just had a terrible pain in her arm and could barely lift it. The patient had not had COVID prior to vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021508997 Same drug/reporter/patient, different dose
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Tiredness; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 26Apr2021 (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: 1st), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; HEADACHE (non-serious), outcome "unknown", described as "Headache".   Additional Context:  This consumer Confirmed that this report was regarding her older son. After reviewing the call recording, this report was in regards to the caller's older son, who caller mentions experienced tiredness and headache. Caller declined to complete a report for her older son, but mentions he went to get his vaccine the same time as his other brothers (who caller completed a full report on, and it was confirmed the suspect product in their reports was the Pfizer COVID vaccine). The caller mentioned herself, her husband, and older son all experienced tiredness and headache. This report is in regards to caller's older son.  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-2021506701 same reporter/drug/AE, different patient
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Endoscopy, Vaccination site erythema, Vaccination site hypersensitivity, Vaccination site swelling
Clinical narrative: redness with a small bump, now I have a bigger bump; redness with a small bump, now I have a bigger bump; allergy around the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Apr2021 15:00 (Batch/Lot number: unknown) at the age of 65 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: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 01May2021, outcome "not recovered" and all described as "redness with a small bump, now I have a bigger bump"; VACCINATION SITE HYPERSENSITIVITY (non-serious) with onset 01May2021, outcome "not recovered", described as "allergy around the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site swelling, vaccination site hypersensitivity.  Additional information: Reported as, patient received the vaccine on 23Apr but still have redness with a small bump, now patient have a bigger bump and allergy around the injection site that started 01May. On 30Apr patient had endoscopy and colonoscopy with sedation and sedation was administered in the hand right below where she received the vaccine, but she thought it was not due to sedation but for the vaccine. Patient did not had covid prior to vaccination, patient did not tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Investigation, Taste disorder
Clinical narrative: Metallic taste with all 3 shots.; Taste like I have a dirty penny in my mouth. Comes in through the cheeks and sits on tongue. Hit 15 minutes after injection. Lasts almost 48 hours after 1st dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Apr2021 12:00 (Lot number: EW0153) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing), notes: ADHD/Depression/Anxiety combo; "Depression" (unspecified if ongoing), notes: ADHD/Depression/Anxiety combo; "ADHD" (unspecified if ongoing), notes: ADHD/Depression/Anxiety combo; "Obesity" (unspecified if ongoing); "Chronic Inflammation" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: VYVANSE; TRINTELLIX; MAGNESIUM; PROPRANOLOL; SLEEP [DIPHENHYDRAMINE HYDROCHLORIDE]. Past drug history included: Bactrim, reaction(s): "allergic to Bactrim", notes: patient drug name: Sulfa / Bactrim; Wellbutrin, reaction(s): "known allergies: Wellbutrin", notes: known allergies: Wellbutrin. The following information was reported: TASTE DISORDER (non-serious) with onset 11Apr2021 12:30, outcome "recovered" (Apr2021), described as "Taste like I have a dirty penny in my mouth. Comes in through the cheeks and sits on tongue. Hit 15 minutes after injection. Lasts almost 48 hours after 1st dose."; DYSGEUSIA (non-serious) with onset 13Nov2021 10:45, outcome "not recovered", described as "Metallic taste with all 3 shots.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of taste disorder, dysgeusia.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Malaise
Clinical narrative: he wasn't feeling good; Over slept; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: MALAISE (non-serious), outcome "unknown", described as "he wasn't feeling good"; HYPERSOMNIA (non-serious), outcome "unknown", described as "Over slept".  Additional information: Caller wanted to schedule appointment. He wasn't able to make his second dose appointment because he wasn't feeling good and over slept.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.