chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Pain around injection area starting 4 hours post dose (2nd shot).; Headache starting 8 hours post dose(2nd shot) lasting 2 hours without any medication.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 29Mar2021 (Batch/Lot number: unknown) at the age of 48 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), administration date: 08Mar2021, when the patient was 48 years old, for COVID-19 immunisation.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered", described as "Pain around injection area starting 4 hours post dose (2nd shot)."; HEADACHE (non-serious) with onset Mar2021, outcome "recovered", described as "Headache starting 8 hours post dose(2nd shot) lasting 2 hours without any medication.". Therapeutic measures were taken as a result of vaccination site pain. Therapeutic measures were not taken as a result of headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the site; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administration date 19Feb2021 (Lot number: EN5318) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "psoriasis" (unspecified if ongoing), notes: Verbatim: Psoriasis. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose: EL9262), administration date: 29Jan2021, when the patient was 46 years old, for COVID-19 immunisation, reaction(s): "pain". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at the site".  Additional information: After my second injection on 19Feb2021, I had pain at the site, but my range of motion was not impacted. (same arm).  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Nausea
Clinical narrative: Nausea/abdominal discomfort on Sa 27Mar; Nausea/abdominal discomfort on Sa 27Mar; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 25Mar2021 (Batch/Lot number: unknown) 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), for COVID-19 immunisation.  The following information was reported: HEADACHE (non-serious) with onset 26Mar2021, outcome "recovered" (28Mar2021), described as "Headache"; NAUSEA (non-serious), ABDOMINAL DISCOMFORT (non-serious) all with onset 27Mar2021, outcome "recovered" (28Mar2021) and all described as "Nausea/abdominal discomfort on Sa 27Mar". Therapeutic measures were taken as a result of headache, nausea, abdominal discomfort.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Headache; muscle aches; 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 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches".  Additional information: the events occurred 16 hours after second dose of Pfizer COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: felt dizzy; 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) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "felt dizzy". Additional information: The following day after getting the vaccine, he took multivitamins and felt dizzy. He also wanted to confirm how long he needed to wait before he could drink alcohol after the vaccine.   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: soreness; 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 26Mar2021 (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: MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "soreness". Patient experiencing soreness this evening. Her 2nd dose will be on 15Apr2021.   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: arm pit swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "arm pit swelling". The patient had covid vaccine a week ago and just today has arm pit swelling and would like to talk to someone about delayed side effects.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report received from a non-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 for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), 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: Vaccination site pain
Clinical narrative: Arm pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), 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) with onset 28Mar2021, outcome "not recovered", described as "Arm pain at injection site". 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-2021344405 Same reporter/drug, similar event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness
Clinical narrative: flu-like symptoms; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (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 immunization. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "not recovered", described as "headache"; INFLUENZA LIKE ILLNESS (non-serious) with onset 26Mar2021, outcome "unknown", described as "flu-like symptoms". Additional information: Reporter was asking if wife (patient) can take Advil or Aleve for that. Both drugs are pain relievers.  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
Clinical narrative: pain in the right eye part; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (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: EYE PAIN (non-serious) with onset 27Mar2021, outcome "unknown", described as "pain in the right eye part". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Neck pain
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 82 year-old female patient received bnt162b2 (BNT162B2), administration date 22Feb2021 09:40 (Lot number: EN5318) at the age of 82 years as dose 2, single dose for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL, start date: 23Jan2002, stop date: 21Apr2002. Vaccination history included: Bnt162b2 (Dose: 1st, Time: 9:40 AM, Batch/ Lot number: EN5318), administration date: 01Feb2021, when the patient was 82 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "mild fatigue"; NECK PAIN (non-serious) with onset 26Feb2021, outcome "recovered", described as "Neck pain". Therapeutic measures were not taken as a result of neck pain. No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph gland; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administration date 17Feb2021 10:30 (Lot number: EN9581) at the age of 71 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "lupus  (SLE)", start date: Jun1979 (ongoing), notes: Mild case in remission; "PVC's", start date: Sep2015 (ongoing), notes: Extra heartbeat no effects; "acid reflux" (ongoing); "anxiety" (ongoing); "back pain" (ongoing). Concomitant medication(s) included: NEXIUM taken for gastrooesophageal reflux disease (ongoing); XANAX taken for anxiety (ongoing); TRAMADOL taken for back pain (ongoing); ASPIRIN (E.C.) taken for back pain (ongoing). Vaccination history included: BNT162B2 (Dose:1, time of adminstartion: 10.20 am, Route:intramuscular, Lot no: EL3249), administration date: 27Jan2021, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 18Feb2021 03:00, outcome "recovered" (19Feb2021), described as "Swollen lymph gland". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient's family medical history included: mother, father and 2 sisters had cancer; brother had a Parkinson's. The patient had no prior vaccination (within 4 weeks). The patient did not undergo any relevant tests.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain
Clinical narrative: It hit the bone. She hollered because it hurt so bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), administered in arm left, administration date 25Mar2021 (Lot number: ER8733) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Blood Pressure" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: JANUMET [METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE MONOHYDRATE] taken for diabetes mellitus (ongoing); GLIPIZIDE taken for diabetes mellitus; LOSARTAN taken for blood pressure measurement (ongoing); METHIMAZOLE taken for thyroid disorder (ongoing). Vaccination history included: Bnt162b2 (dose 1), administration date: 03Mar2021, when the patient was 73 years old, for COVID-19 immunisation, reaction(s): "pain in the right shoulder where she got the shot", "pain over her heart area", "toothache", "pain in the right shoulder travels down the right arm. It goes down the shoulder and down the arm", "pain in the right shoulder travels down the right arm. It goes down the shoulder and down the arm". The following information was reported: BONE PAIN (non-serious) with onset 25Mar2021, outcome "recovered" (25Mar2021), described as "It hit the bone. She hollered because it hurt so bad".  Additional information: He said the shot had to be in the other shoulder and he put it in the left shoulder in the bone. It hit the bone. She hollered because it hurt so bad. He said no one ever jumped like that before. She jumped because it hurt. She still has the pain in the right shoulder, but she doesn't feel anything in the left where she got it today. Caller clarified Pfizer shot as COVID19 Vaccine. The pain in the right shoulder travels down the right arm. It goes down the shoulder  and down the arm.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: some minor soreness; 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 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date Mar2021 (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) with onset Mar2021, outcome "unknown", described as "some minor soreness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Influenza, Oropharyngeal pain
Clinical narrative: I am like well may be that can maybe a 24 hours flu or something; Terrible sore throat; Inside of my jaw and the lip on the right side only is just burning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE taken for rheumatoid arthritis; DULOXETINE; FOLIC ACID; TRAZODONE; METHOTREXATE; TRAMADOL. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "Terrible sore throat"; BURNING SENSATION (non-serious) with onset Mar2021, outcome "not recovered", described as "Inside of my jaw and the lip on the right side only is just burning"; INFLUENZA (non-serious), outcome "unknown", described as "I am like well may be that can maybe a 24 hours flu or something". Therapeutic measures were taken as a result of oropharyngeal pain. Additional information: Consumer stated, "I had a shot on Saturday the 20th and I felt pretty good Saturday, Sunday, Monday night I got a terrible sore throat and the inside of my jaw and the lip on the right side only is just burning for some reason, same thing with the sore throat." It stayed pretty much the same that's why I am going to call my doctor this afternoon to see if I in tomorrow. I just forgot to get it a couple of days. "Yeah pretty much, as you keep going you try to pretend it's getting better but it's not getting any better. Like I said I am not getting any better. I don't have any temperature, that's why I was having another weird fact or two, because I am like well may be that can maybe a 24-hour flu or something but that's not going away." "The only thing I am doing is gargle with salt water. That's all they tell you to do when you have sore throat, just gargle with salt water." "I haven't done anything yet, I am going to call my regular physician and if they find anything then I may get in tomorrow."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 12:15 (Lot number: EN6208) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis", start date: 1999 (unspecified if ongoing); "Breast cancer", start date: 2012 (unspecified if ongoing); "Blood pressure", start date: 1998 (unspecified if ongoing); "vitamin D low" (unspecified if ongoing); "anemia" (unspecified if ongoing); "Iron low" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "stomach" (unspecified if ongoing); "lymph nodes taken out for examination back when she had breast cancer" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE taken for rheumatoid arthritis, start date: 1999 (ongoing); POTASSIUM CHLORIDE taken for blood cholesterol abnormal, blood pressure abnormal, start date: 1999 (ongoing); CLONIDINE taken for blood pressure measurement, start date: 1999 (ongoing); FOLIC ACID taken for rheumatoid arthritis, start date: 2001 (ongoing); TIAZAC XC taken for blood pressure measurement, start date: 1999 (ongoing); LOSARTAN taken for blood pressure measurement, start date: 2005 (ongoing); METOPROLOL taken for blood pressure measurement, start date: 2006 (ongoing); HYDRALAZINE APS taken for blood pressure measurement, start date: 2008 (ongoing); VITAMIN D2 taken for vitamin d decreased, start date: 2010 (ongoing); IRON taken for blood iron decreased, anaemia (ongoing); DICYCLOMINE taken for gastrointestinal disorder (ongoing); OMEPRAZOLE taken for gastrointestinal disorder (ongoing). Vaccination history included: Bnt162b2 (Dose number:01; Left arm, Lot Number: EN6200, Administration time; 15:00), administration date: 25Feb2021, for Covid-19 Immunization, reaction(s): "swollen lymph nodes". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 21Mar2021, outcome "not recovered", described as "swollen lymph nodes". Additional information: Got the second dose 19Mar2021 at 1215PM in the left arm. She noticed swollen lymph nodes on her shoulder in the collar bone area on the left side; first noticed Sunday 21Mar2021. History of all previous immunization with the Pfizer vaccine considered as suspect: None. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Did any AE(s) require a visit to Emergency Room?  No. Physician Office? No. Prior Vaccinations (within 4 weeks): None. Family History: No. Relevant test: None.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Weight
Clinical narrative: ill for 4 days after the booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), 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, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "ill for 4 days after the booster dose". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: It was a most unpleasant experience, also frightening. It may be relevant that any weight is 94 pounds. I was given the same dose as my partner who weighs 185. He was ill for 4days after the booster shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Feeling abnormal, Pain in extremity, Paraesthesia
Clinical narrative: Painful tingly sensation in left arm from shoulder all the ay to fingers./Pain under armpit and inside of elbow and wrist; Painful tingly sensation in left arm from shoulder all the ay to fingers.; I feel like I might have a panic attack/Feels like arm is asleep/This is terribly frightening and uncomfortable./I'm so scared; Pain under armpit and inside of elbow and wrist; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jan2022 15:15 (Batch/Lot number: unknown) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Known allergies:No. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Jan2022 22:00, outcome "not recovered", described as "Painful tingly sensation in left arm from shoulder all the ay to fingers./Pain under armpit and inside of elbow and wrist"; PARAESTHESIA (non-serious) with onset 08Jan2022 22:00, outcome "not recovered", described as "Painful tingly sensation in left arm from shoulder all the ay to fingers."; FEELING ABNORMAL (non-serious) with onset 08Jan2022 22:00, outcome "not recovered", described as "I feel like I might have a panic attack/Feels like arm is asleep/This is terribly frightening and uncomfortable./I'm so scared"; AXILLARY PAIN (non-serious) with onset 08Jan2022 22:00, outcome "not recovered", described as "Pain under armpit and inside of elbow and wrist". Therapeutic measures were not taken as a result of pain in extremity, paraesthesia, feeling abnormal, axillary pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19. It was reported that, The patient felt like The patient might have a panic attack. The patient took a clonazepam a few minutes ago. Her whole arm has been tingly like he hit a nerve all the way to her fingers. It was horrible like prickly and asleep. The arm that got the shot. Her armpit and inside of elbow and wrist on that arm have actual pain. The patient so scared. It was a painful tingly for maybe 8 hours now. Her whole hand and everything what was wrong with her. But it did not start immediately after the injection it took a couple of hours so the patient don't think he hit a nerve with a needle. Optional Information: Patient may have autoimmune disorder.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: tiredness; a little headache; soreness at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 14 year-old female patient received bnt162b2 (COMIRNATY), administration date 06Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer: Unknown, Dose number: 1st), for Covid-19 immunization; Covid-19 vaccine (Manufacturer: Unknown, Dose number: 2nd), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 07Jan2022, outcome "unknown", described as "tiredness"; HEADACHE (non-serious) with onset 07Jan2022, outcome "unknown", described as "a little headache"; VACCINATION SITE PAIN (non-serious) with onset 07Jan2022, outcome "unknown", described as "soreness at the injection site".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: Swelling in underarm of left arm where shot was administered; Pain with swelling and has not decrease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Jan2022 15:45 (Batch/Lot number: unknown) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown. Did not receive, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM, Route of Administration: Intramuscular), administration date: 06May2021, when the patient was 43 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown. Did not receive, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM, Route of Administration: Intramuscular), administration date: 15Apr2021, when the patient was 43 years old, for COVID-19 Immunization.  The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 08Jan2022 07:30, outcome "not recovered", described as "Swelling in underarm of left arm where shot was administered"; PAIN (non-serious) with onset 08Jan2022 07:30, outcome "not recovered", described as "Pain with swelling and has not decrease". Therapeutic measures were not taken as a result of peripheral swelling, pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperacusis, Product use issue, SARS-CoV-2 test, Tinnitus
Clinical narrative: Off and on rumbling sound in both ears; Off and on rumbling sound in both ears; Other vaccine same date vaccine date 08Oct2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 88 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Oct2021 14:00 (Lot number: FE3592) at the age of 88 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU taken for immunisation, administration date 08Oct2021. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19, brand:Pfizer, lot number:EL1283, administration time: 12:00 PM, dose number:2, location: Right arm), administration date: 13Feb2021, when the patient was 87 years old, for COVID-19 immunization; Bnt162b2 (Prev dose product: COVID 19, brand: Pfizer, lot number: E10142, administration time: 12:00 PM, dose number:1, location: Right arm), administration date: 23Jan2021, when the patient was 87 years old, for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 08Oct2021, outcome "unknown", described as "Other vaccine same date vaccine date 08Oct2021"; TINNITUS (non-serious), HYPERACUSIS (non-serious) all with onset 10Dec2021 13:00, outcome "not recovered" and all described as "Off and on rumbling sound in both ears". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus, hyperacusis.  Additional information: No other vaccine was administered in four weeks. No allergies. No other medications taken in two weeks. No covid prior to vaccination. Covid tested post vaccination was reported as Yes. It was reported that off and on rumbling sound in both ears, day and night for past month to 6 weeks.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Immunisation, Interchange of vaccine products, Rash, Urticaria
Clinical narrative: I had the Moderna, first 2; Skin reaction; I had my first hive rash on my upper leg and now, I have 4 more; hives and rash; Skin reaction; I had my first hive rash on my upper leg and now, I have 4 more; hives and rash; Pfizer, I had a stomach reaction too; booster; This is a spontaneous report received from a 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 02Dec2021 (Lot number: FJ1620) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Moderna (Dose: 1, I had the Moderna, first 2 and I had a stomach reaction to those; very severe with Moderna), for Covid-19 Immunization, reaction(s): "stomach reaction"; Moderna (Dose: 2), for Covid-19 Immunization, reaction(s): "stomach reaction". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "I had the Moderna, first 2"; IMMUNISATION (non-serious) with onset 02Dec2021, outcome "unknown", described as "booster"; URTICARIA (non-serious), RASH (non-serious) all with onset 09Dec2021, outcome "not recovered" and all described as "Skin reaction; I had my first hive rash on my upper leg and now, I have 4 more; hives and rash"; ABDOMINAL DISCOMFORT (non-serious) with onset 03Dec2021, outcome "unknown", described as "Pfizer, I had a stomach reaction too". Therapeutic measures were taken as a result of urticaria, rash.  Additional information:Investigation Assessment was No.Any prior vaccinations (within 4 weeks) was No. Consumer stated  had the Moderna (Further clarifications unknown hence suspect captured as Unspecified Product), first 2 and had a stomach reaction to those (Further clarifications Unknown) and then Pfizer,  had a stomach reaction too but it was about 3 or 4 hours the next day but that was,could face that kind of, but it was severe with Moderna so I did not report it because it was gone in a day.Consumer stated, Of course, you would. Okay, so not oral but creams. had  tried Cortisone cream and  had tried this lotion but  not doing that really. So, Cortisone cream and basically Tinactin, it a fungus thing. It looked a little bit like ringworm and patient did a little bit of research and guess fungus was part of the COVID thing itself, and Neosporin. That was totally recommended on your, Neosporin was recommended for these rashes that had shown up.   No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; moderate fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 16 years as dose 3 (booster), 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, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; PYREXIA (non-serious), outcome "unknown", described as "moderate fever".  Additional Information: Events took place after the product use.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Dermatitis atopic, Pruritus, Rash, Urticaria
Clinical narrative: the rash all over my body totally went berserk; extremely itchy; atopic dermatitis; Hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 14Oct2021 (Lot number: FE3592) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D3 (ongoing); VITAMIN C [ASCORBIC ACID] (ongoing); MAGNESIUM MALATE (ongoing). Vaccination history included: Bnt162b2 (Dose: 01, Lot: EN5318, Dose: Unknown strength/volume/dose injection to left arm during day time between 10:00 and 14:00-not positive of exact time.), administration date: 30Jan2021, when the patient was 67 years old, for Covid-19 immunization; Bnt162b2 (Dose: 02, Lot: EN6203, Dose: Unknown strength/volume/dose injection to left arm during day time between 10:00 and 14:00-not positive of exact time. Second dose completed her prescribed therapy for 2 doses of Pfizer Covid Shot because that's what the CDC told them to do. These 2 doses were not administered at # Clinic.), administration date: 21Feb2021, when the patient was 67 years old, for Covid-19 immunization, reaction(s): "skin is so thin, I scratch it bleeds", "skin is so thin, I scratch it bleeds". The following information was reported: RASH (non-serious) with onset 2021, outcome "not recovered", described as "the rash all over my body totally went berserk"; PRURITUS (non-serious) with onset 2021, outcome "not recovered", described as "extremely itchy"; DERMATITIS ATOPIC (non-serious) with onset 2021, outcome "unknown", described as "atopic dermatitis"; URTICARIA (non-serious) with onset 2021, outcome "not recovered", described as "Hives". The event "extremely itchy" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, pruritus, dermatitis atopic, urticaria.  Additional information: The patient reported that as the treatment for these adverse events she takes Zyrtec in the morning with a Pepcid, Allegra in the afternoon with a Pepcid, She takes about 100mg of Benadryl at night to sleep. She explained that treatment also included her concomitant products which she has continued therapy with: Vitamin D3, Vitamin C and Magnesium malate and also she has been on cortisone cream and prednisone for 9 months as treatment for pruritus.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate decreased
Clinical narrative: heart rate slowing down; 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 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: HEART RATE DECREASED (non-serious), outcome "unknown", described as "heart rate slowing down". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Consumer stated, Patient don't know exactly, he took his booster shot. When he took his first two shots, he had a problem with heart rate slowing down. Patient just wanted to know if anybody if has something have or not.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: After 2 days of recieving the 2nd shot, I have noticed tingling sensation all around my body. The sensation was  constant for the first week then it became sporadic occurrance for couple months. The tingling sensation dminished over time but as of today, 1/28/22, I sometime get tingling sensation on my face
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Electrocardiogram abnormal, Palpitations, Tachycardia
Clinical narrative: Palpitations, tachycardia, PVCs and chest pain (less severe after 10 days).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Palpitations, tachycardia, PVCs and chest pain (less severe after 10 days).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Back pain, Balance disorder, Blood test abnormal, Dysuria
Clinical narrative: Beginning around 11/12-11/15/21 developed increasing Leg and back pain, leg weakness, loss of balance, loss of deep tendon reflexes, right foot drop, saddle numbness and difficulty urinating . Seen at local clinic 11/29 /21 then ER 12/1/21. Admitted to hospital on 12/1/21. Scans , LP, and blood work done. IV steroids and pain meds given. Discharged 12/4/21.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hyporeflexia, Lumbar puncture abnormal, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal
Clinical narrative: Beginning around 11/12-11/15/21 developed increasing Leg and back pain, leg weakness, loss of balance, loss of deep tendon reflexes, right foot drop, saddle numbness and difficulty urinating . Seen at local clinic 11/29 /21 then ER 12/1/21. Admitted to hospital on 12/1/21. Scans , LP, and blood work done. IV steroids and pain meds given. Discharged 12/4/21.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Peroneal nerve palsy, Protein total increased
Clinical narrative: Beginning around 11/12-11/15/21 developed increasing Leg and back pain, leg weakness, loss of balance, loss of deep tendon reflexes, right foot drop, saddle numbness and difficulty urinating . Seen at local clinic 11/29 /21 then ER 12/1/21. Admitted to hospital on 12/1/21. Scans , LP, and blood work done. IV steroids and pain meds given. Discharged 12/4/21.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Feeling cold, Nasopharyngitis, Pain
Clinical narrative: felt tired; felt cold; felt achy (whole body); felt like he had a cold; pain (soreness) in left armpit; thickness of his left arm; pain in his left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administration date 07Jan2022 (Batch/Lot number: unknown) at the age of 56 years as dose 3 (booster), 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 Immunization; Bnt162b2 (Dose 2), administration date: Mar2021, for Covid-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 08Jan2022, outcome "recovering", described as "thickness of his left arm"; PAIN IN EXTREMITY (non-serious) with onset 07Jan2022, outcome "recovering", described as "pain in his left arm"; FATIGUE (non-serious) with onset 08Jan2022, outcome "recovered" (09Jan2022), described as "felt tired"; FEELING COLD (non-serious) with onset 08Jan2022, outcome "recovered" (09Jan2022), described as "felt cold"; PAIN (non-serious) with onset 08Jan2022, outcome "recovered" (09Jan2022), described as "felt achy (whole body)"; NASOPHARYNGITIS (non-serious) with onset 08Jan2022, outcome "recovered" (08Jan2022), described as "felt like he had a cold"; AXILLARY PAIN (non-serious) with onset 08Jan2022, outcome "recovering", described as "pain (soreness) in left armpit". Therapeutic measures were taken as a result of peripheral swelling, pain in extremity, fatigue, feeling cold, pain, nasopharyngitis, axillary pain.  Additional information: The patient stated that he got the booster shot on Friday morning. The patient stated that on Saturday he felt heavy. On Saturday afternoon that he found thickness and pain in his left arm. The patient stated that there was no lump and when he moves that he has pain. The patient stated that it is a little better today and when that when he press under the armpit that it is thick. Clarified that he felt heavy meant like when you have a cold and one stays on the feet and walk a little bit longer and felt like he had a cold and tired. Later clarified that he felt like he had a cold on Friday afternoon.  The patient stated that on Saturday that he felt achy and tired.  The patient stated that he felt cold. The patient stated that he had his second dose at the end of March of last year. The patient stated that this is 9 months apart. Clarified that he felt achy on his whole body. Clarified that it was the COVID booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: felt tired; felt cold; felt achy (whole body); felt like he had a cold; pain (soreness) in left armpit; thickness of his left arm; pain in his left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administration date 07Jan2022 (Batch/Lot number: unknown) at the age of 56 years as dose 3 (booster), 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 Immunization; Bnt162b2 (Dose 2), administration date: Mar2021, for Covid-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 08Jan2022, outcome "recovering", described as "thickness of his left arm"; PAIN IN EXTREMITY (non-serious) with onset 07Jan2022, outcome "recovering", described as "pain in his left arm"; FATIGUE (non-serious) with onset 08Jan2022, outcome "recovered" (09Jan2022), described as "felt tired"; FEELING COLD (non-serious) with onset 08Jan2022, outcome "recovered" (09Jan2022), described as "felt cold"; PAIN (non-serious) with onset 08Jan2022, outcome "recovered" (09Jan2022), described as "felt achy (whole body)"; NASOPHARYNGITIS (non-serious) with onset 08Jan2022, outcome "recovered" (08Jan2022), described as "felt like he had a cold"; AXILLARY PAIN (non-serious) with onset 08Jan2022, outcome "recovering", described as "pain (soreness) in left armpit". Therapeutic measures were taken as a result of peripheral swelling, pain in extremity, fatigue, feeling cold, pain, nasopharyngitis, axillary pain.  Additional information: The patient stated that he got the booster shot on Friday morning. The patient stated that on Saturday he felt heavy. On Saturday afternoon that he found thickness and pain in his left arm. The patient stated that there was no lump and when he moves that he has pain. The patient stated that it is a little better today and when that when he press under the armpit that it is thick. Clarified that he felt heavy meant like when you have a cold and one stays on the feet and walk a little bit longer and felt like he had a cold and tired. Later clarified that he felt like he had a cold on Friday afternoon.  The patient stated that on Saturday that he felt achy and tired.  The patient stated that he felt cold. The patient stated that he had his second dose at the end of March of last year. The patient stated that this is 9 months apart. Clarified that he felt achy on his whole body. Clarified that it was the COVID booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Experienced moderate fever and chills post vaccination; Experienced moderate fever and chills post vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 14 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "Experienced moderate fever and chills post vaccination". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.