chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Body temperature abnormal, Headache, Nausea, Pain
Clinical narrative: Headache; Temperature; aches and pains/soreness; the whole the nausea; 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 patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Lot number: EN6200, Expiration Date: 30Jun2021) at the age of 71 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Headache"; BODY TEMPERATURE ABNORMAL (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Temperature"; PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "aches and pains/soreness"; NAUSEA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "the whole the nausea". Relevant laboratory tests and procedures are available in the appropriate section. clinical course: patient had a delayed reaction to the first vaccine. most people (further clarification unknown) they going to had reaction it happens in the first day or two, after had the second vaccine, mine happened on day 13th of 14 days to be fully vaccinated. Patient got all of the symptoms, likevheadache, the temperature, the aches and pains, the whole the nausea and it lasted 4 days, then patient go on and patient get, that all happened in Mar2021. The reaction happened like on 05Apr2021 & then in May2021 patient got tested for MAC lung and then in Jul2021 and then in Jul2021 patient got shingles., these are all related to immune system. Now they are asking to take another booster and patient was scared (Further clarification unknown) because patient did not have no idea what was going to happen? and whether or not patient was going to have other reaction, not just the reaction the soreness and the headache and all that but some other thing that may come up and pop up. The MAC lung, patient am asymptomatic on the MAC lung and the test that they did to sputum, it was corrupted and they could not do anything for it. So, Doctor told not going to take the sputum test again unless patient become symptomatic.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 antibody test
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP. A female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced illness (got super, super sick afterwards), with outcome of unknown. Relevant laboratory tests and procedures available in the appropriate section. Additional information: This reporter's mother-in-law completed the Pfizer COVID-19 vaccine series (she thinks in Jun). She got super, super sick afterwards. She received COVID-19 antibody test; results: negative ("zero" for antibodies a week or two). She wanted to know if this is typical. She is wary of getting the vaccine if it does not work. She provided no demographic information, age, batch/lot number or further information regarding her mother. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Influenza like illness
Clinical narrative: 2nd dose - severe flu like symptoms for two days; headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimotos Disease" (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "2nd dose - severe flu like symptoms for two days"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache". Therapeutic measures were not taken as a result of influenza like illness, headache.  Additional information: No covid prior vaccination. No covid tested post vaccination. No known allergies.Other vaccine in 4weeks was Flu Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2021 (Lot number: EL3249) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LAMICTAL; VIT C; MULTI VIT. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EK5731, Location of injection: Arm Left), administration date: 21Dec2020, when the patient was 40 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "not recovered", described as "Left arm pain". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: After second dose, rashes in addition to itchiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Aug2021 (Batch/Lot number: unknown) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Currently asthmatic" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; ANTIHISTAMINE ALLERGY RELIEF; SYMBICORT. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Right), administration date: 04Aug2021, when the patient was 37 years old, for Covid-19 Immunization, reaction(s): "Itchiness occurred on right side of body for a couple of days after first dose". The following information was reported: RASH PRURITIC (non-serious) with onset 2021, outcome "not recovered", described as "After second dose, rashes in addition to itchiness". Therapeutic measures were not taken as a result of rash pruritic.  Additional information:  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications Vitamins within 2 weeks of vaccination. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; 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 64 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "vertigo".  Additional info: Patient stated, in between her first and second dose of the vaccine she had vertigo. Caller stated after the second vaccine, two and a half weeks later she got vertigo again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (11Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Diarrhoea, Gastrointestinal disorder, Nausea
Clinical narrative: minor GI issues; diarrhea; nausea; constipation; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program. A 57 year-old female 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: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization.  The following information was reported: GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "minor GI issues"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; CONSTIPATION (non-serious), outcome "unknown", described as "constipation".  Additional information: Patient took an extra 4 days off of her week break of Ibrance (Tab 100mg, start date: 15May2020) due to getting Covid booster shot. Patient reports having minor GI issues (diarrhea, nausea, constipation).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Grade 1 severity tenderness at the injection site; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 12:15 (Lot number: FF2589) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation, administration date 15Sep2021; CHLORTHALIDONE; ATORVASTATIN; KCL. Past drug history included: Mucinex, reaction(s): "known allergies: mucinex". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 15Mar2021, when the patient was 65 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM), administration date: 22Feb2021, when the patient was 65 years old, for COVID-19 Immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 01Oct2021 22:00, outcome "recovered" (Oct2021), described as "Grade 1 severity tenderness at the injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: If other vaccine in 4 weeks: Flu on 15Sep2021, vaccine location: Left arm. If covid prior vaccination: No. If covid tested post vaccination: No. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. Did the event required the initiation of new medication/other treatment/procedure: No.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Intermenstrual bleeding
Clinical narrative: Spotting every other day; BNT162B2 dose 1 administration date 20Jan2021 and dose 2 administration date 05Mar2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Lot number: EN6202) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1; Batch/Lot number EL3249; vaccine location: Left arm), administration date: 20Jan2021, when the patient was 56 years old, for Covid-19 immunization. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious) with onset 29Apr2021, outcome "not recovered", described as "Spotting every other day"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Mar2021, outcome "unknown", described as "BNT162B2 dose 1 administration date 20Jan2021 and dose 2 administration date 05Mar2021". The event "spotting every other day" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of intermenstrual bleeding.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Facility type vaccine:  Health Clinic/ Administration facility. No other vaccine received in four weeks. The event resulted in doctor or other healthcare professional office/clinic visit.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: his only complaint has been pain in the injection site.; 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 1, single, (Batch/Lot number: unknown) as dose 2, single and (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. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "his only complaint has been pain in the 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-202101302225 same reporter/product, different patient / event.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, SARS-CoV-2 test
Clinical narrative: having problems with both my feet, both big toes are numb top and underneath my big toes.; 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 right, administration date 24Mar2021 09:30 (Lot number: EP6955) as dose 2, single and administered in arm right, administration date 05Mar2021 09:00 (Lot number: EN6198) as dose 1, single for COVID-19 immunization. Relevant medical history included: "high blood pressure" (ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder; OLMESARTAN taken for hypertension. Past drug history included: Iodine, reaction(s): "known allergies: iodine". The following information was reported: HYPOAESTHESIA (non-serious) with onset Jun2021, outcome "not recovered", described as "having problems with both my feet, both big toes are numb top and underneath my big toes.". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of hypoaesthesia.  Additional Information: Patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient had no COVID prior vaccination. It was reported that patient had numbing on top right foot and around toes. Noticed numbing around Jun/ Jul2021. Especial big toe area. Numbing on left foot, mainly on top front around high toe area. Numbing was continued as of current date. Specific relevant test for thromboembolic events with thrombocytopenia was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder, Vaccination site pain
Clinical narrative: I had a minimal sore spot from the shot; sore arm; sleep impacted; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (167798).  A 69 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "I had a minimal sore spot from the shot"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; SLEEP DISORDER (non-serious), outcome "unknown", described as "sleep impacted". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Supraclavicular lymph node pain and swelling and axillary lymphadenopathy; Supraclavicular lymph node pain and swelling and axillary lymphadenopathy; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Sep2021 09:30 (Lot number: FC3184) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Autoimmune" (unspecified if ongoing); "Thyroiditis" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; WELLBUTRIN; GABAPENTIN; SILENOR. Past drug history included: Sulfonamide for Sulfonamide:Allergy. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3246, Location of injection: Arm Right), administration date: 13Jan2021, when the patient was 36 years old, for Covid-19 Immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EH9899, Location of injection: Arm Right), administration date: 22Dec2020, when the patient was 36 years old, for Covid-19 Immunisation. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 01Oct2021 23:00, outcome "not recovered" and all described as "Supraclavicular lymph node pain and swelling and axillary lymphadenopathy". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I ultimately only had a little soreness on my arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 38 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I ultimately only had a little soreness on my arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: My daughter and I got sick with our 2nd dose; 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 37 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "My daughter and I got sick with our 2nd dose". 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-202101303684 same drug/event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: My daughter and I got sick with our 2nd dose; 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 parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "My daughter and I got sick with our 2nd dose". No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101303668 same drug/event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I only had a sore arm at the injection site for a couple of days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-healthcare professional) for a Pfizer sponsored program (167798). The reporter is the patient. A 52-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: Unknown) as dose 1, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "I only had a sore arm at the injection site for a couple of days".  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Within 24 hours of all three Covid vaccines, a lymph node just above my left collarbone swelled up to the size of a nickel; The area was painful; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2020 (Lot number: EK5730) at the age of 44 years as dose 1, single and administered in arm left, administration date 18Jan2021 (Lot number: EK5730) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing), notes: Other medical history: Seasonal allergies; "Allergy: Latex" (unspecified if ongoing), notes: Known allergies: Latex. The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Within 24 hours of all three Covid vaccines, a lymph node just above my left collarbone swelled up to the size of a nickel"; PAIN (non-serious), outcome "unknown", described as "The area was painful". Therapeutic measures were not taken as a result of lymphadenopathy, pain. Additional information: The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen decreased, Therapeutic response unexpected
Clinical narrative: PSA level went down(per graph of PSA); but after getting the vaccines his levels went down at least 40%. PSA went down for no other reason of why it happened twice and it was weird to him since he had the vaccine; A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 30Dec2020 (Lot number: Pfizer 1284) as dose 1, single and intramuscular, administered in arm, administration date 20Jan2021 (Lot number: EL8982) as dose 2, single for covid-19 immunisation. Relevant medical history included: "HBP" (ongoing); "prostate cancer", start date: Dec2018 (ongoing); "Hypercholesterolemia", start date: Dec2018 (ongoing); "Weakened immune system" (unspecified if ongoing); "chemotherapy" (unspecified if ongoing). Concomitant medication(s) included: ABIRATERONE taken for prostate cancer (ongoing); LIPITOR taken for blood cholesterol (ongoing); DEXAMETHASONE taken for prostate cancer (ongoing); LOSARTAN taken for hypertension (ongoing). The following information was reported: PROSTATIC SPECIFIC ANTIGEN DECREASED (non-serious), outcome "unknown", described as "PSA level went down(per graph of PSA)"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "but after getting the vaccines his levels went down at least 40%. PSA went down for no other reason of why it happened twice and it was weird to him since he had the vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller states he has had prostate cancer and has been on treatment on that. Wants to report an unusual thing the Pfizer covid shot. His PSA was going up when on treatment and he stopped that because it kept going up. He was on a chemotherapy treatment and had stopped it because it wasnt working, not for a period of time, but after he got the vaccines his levels went down at least 40%. He noticed the levels going down twice when he got the initial Covid dose and the booster dose, his PSA level went down substantially for no other reason. Clarifies he had prostate cancer prior, way before getting the vaccine. This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: The only side effect I had with my arm was sore at the injection site; This is a spontaneous report from a non-contactable consumer via Pfizer sponsored program US COVID-19 Vaccine Online Consumer Community. An 53 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "The only side effect I had with my arm was sore at the injection site".  Additional information: The only side effect I had with my arm was sore at the injection site.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: a slightly sore arm and a general malaise; a slightly sore arm and a general malaise; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (167798). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), MALAISE (non-serious), outcome "recovered" (2021) and all described as "a slightly sore arm and a general malaise".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, White blood cell disorder
Clinical narrative: full body inflammation; affecting her white blood cells; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (148871). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization; Bnt162b2 (2nd dose), for COVID-19 Immunization. The following information was reported: INFLAMMATION (non-serious), outcome "unknown", described as "full body inflammation"; WHITE BLOOD CELL DISORDER (non-serious), outcome "unknown", described as "affecting her white blood cells". Additional information: Patient took Ibrance experienced full body inflammation, stated it started about 1 month ago after getting her COVID booster shot. Also felt like it affected her white blood cells similar to what she felt on Ibrance in the past. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Fatigue, Headache, Myalgia
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 65-year-old male patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 65, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunization. The patient had fatigue (became very tired), myalgia (muscle and joint aches), arthralgia, headache, photophobia (light sensitivity) and decreased appetite (no appetite), with outcome of unknown. This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 65-year-old male patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 65, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunization. The patient had fatigue (became very tired), myalgia (muscle and joint aches), arthralgia, headache, photophobia (light sensitivity) and decreased appetite (no appetite), with outcome of unknown. This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Insomnia, Nausea, Vomiting
Clinical narrative: vomiting; insomnia; nausea; headache; dizziness; This is a spontaneous report received from a non-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 03Sep2021 17:30 (Batch/Lot number: unknown) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fact V Leiden heterogeneous type" (unspecified if ongoing), notes: Fact V Leiden heterogeneous type; "migraine" (unspecified if ongoing), notes: history of migraine. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known Allergy: Codeine". The following information was reported: VOMITING (non-serious) with onset 03Sep2021 18:00, outcome "not recovered", described as "vomiting"; INSOMNIA (non-serious) with onset 03Sep2021 18:00, outcome "not recovered", described as "insomnia"; NAUSEA (non-serious) with onset 03Sep2021 18:00, outcome "not recovered", described as "nausea"; HEADACHE (non-serious) with onset 03Sep2021 18:00, outcome "not recovered", described as "headache"; DIZZINESS (non-serious) with onset 03Sep2021 18:00, outcome "not recovered", described as "dizziness". It was unknown if therapeutic measures were taken as a result of vomiting, insomnia, nausea, headache, dizziness. Additional information: Patient had vomiting, nausea, headache, dizziness and insomnia lasting 10 nights. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. The patient did not have covid prior to vaccination and was not covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen left armpit lymph node; 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 female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Oct2021 11:30 (Lot number: 30135BA) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (ongoing); "Allergies/ Mostly pollen allergies" (ongoing), notes: Allergies/ Mostly pollen allergies. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for seasonal allergy, start date: 2000 (ongoing); FLONASE [FLUTICASONE PROPIONATE] taken for seasonal allergy, start date: 2000 (ongoing); PRILOSEC [OMEPRAZOLE MAGNESIUM]; VITAMIN D 2000; L-5HPT; YAZ. Past drug history included: Pistachios, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose 2; Batch/Lot No: ER8732; Location of injection: Arm Right; Vaccine Administration Time: 11:00 AM; Route of administration: Intramuscular), administration date: 07Apr2021, when the patient was 33 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1; Batch/Lot No: EN6202; Location of injection: Arm Right; Vaccine Administration Time: 11:30 AM; Route of administration: Intramuscular), administration date: 09Mar2021, when the patient was 33 years old, for Covid-19 Immunization; Flu vaccine (Dose 1; Batch/Lot number: Unknown; Location of injection: Left arm; Vaccine Administration Time: 11:30 AM; Route of administration: Muscular), administration date: 29Sep2021, when the patient was 33 years old, for Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 03Oct2021 10:00, outcome "recovered" (2021), described as "Swollen left armpit lymph node". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information: Relevant Tests: None. Vaccination facility type: Pharmacy or drug store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device Date: 04Oct2021. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Tinnitus, Vaccination site pain
Clinical narrative: I do have the ringing in my ears that's not going away, It's like a little bee stuck between my brain and all; My left arm shoulder which never hurt before is achy when I sleep at night, it aches at certain position; it just 'hurt in' the joint area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Atrial fibrillation" (unspecified if ongoing); "Neuropathy peripheral" (unspecified if ongoing); "Pacemaker", start date: 2001 (ongoing), notes: I have a pacemaker installed and that thing is going on for 20 years. The patient took concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "I do have the ringing in my ears that's not going away, It's like a little bee stuck between my brain and all"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "My left arm shoulder which never hurt before is achy when I sleep at night, it aches at certain position"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "it just 'hurt in' the joint area".  Additional information: Patient stated that ringing in my ears that's not going away, it's like a little bee stuck between my brain and all (Clarification unknown), that I do notice and then my left arm shoulder which never hurt before is achy when I sleep at night, it aches at certain position then it eventually goes away and then I fall sleep, so that's my two complaints, it's in my left shoulder and I am right handed. So strange I 'didn't use' and my left hand that much or left arm that's a little strange that thing is all of a sudden aching right where the shot was, it just 'hurt in' the joint area but not where the shot was put in.  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: Myalgia, SARS-CoV-2 test
Clinical narrative: My muscle was sore; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 08Jan2021 (Batch/Lot number: unknown) at the age of 61 years as dose 2, single and administration date 19Dec2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension; "Chronic obstructive pulmonary disease" (unspecified if ongoing), notes: Verbatim: COPD; "Hyperlipidaemia" (unspecified if ongoing), notes: Verbatim: Hyperlipidemia; "iliac artery" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "blood pressure" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT taken for major depression; PLAVIX taken for iliac artery occlusion; LOSARTAN taken for blood pressure measurement; ROSUVASTATIN taken for hyperlipidaemia. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "My muscle was sore". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The consumer stated regarding Plavix that she has 100% blockage in her iliac artery, so she was taking it to continue to walk (not further clarified). The patient has clinical depression since she was 15-year-old. The patient did not receive any other vaccines prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: Vaccine affecting her immune system; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Head cold" (unspecified if ongoing), notes: Before the first shot she had a head cold. The patient's concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Vaccine affecting her immune system".  Additional information: Reporter asks can the vaccine affect immune systems? Reporter states before the first shot she had a head cold, then she went and took the vaccine and thought it might be covid, she only took the first shot and never the second. Reporter states her head cold was not clearing up. Reporter states she talked to friends who never had allergies, but they had Covid so it wasn't clearing up either. Reporter states she was reading a little about that it might enter an immune cell. Reporter states she usually gets over a cold in 2 or 3 days, but it is still lasting. Reporter asks if she would have the same problem if she did not get the vaccine? Caller states as soon as she got a head cold she got the vaccine, and would it have cleared up if she had not gotten the vaccine and did it affect her immune system; is it related?   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Reporting an adverse event with the Covd-19 Vaccine; received the Covd-19 Vaccine and leukemia is gone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Leukemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no: 1), for COVID-19 immunization; Bnt162b2 (Dose no: 2), for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Reporting an adverse event with the Covd-19 Vaccine; received the Covd-19 Vaccine and leukemia is gone". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: she still isn't feeling too well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 22Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset Sep2021, outcome "not recovered", described as "she still isn't feeling too well".  Additional information: This is the second case of the two cases. This case is for the reporter sister. Reporter stated that they had Covid vaccine first one on 22Sep. Her sister had the very same day she called up and she had a same reaction (further not clarified), other than that I think she has something little bit extra but she still was not felling too well (hence, split made) and both of us are very concern about it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore arm; aches and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (Lot number: ER8735) at the age of 60 years as dose 1, single and administration date 07May2021 (Lot number: ER8735) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart transplant recipient" (unspecified if ongoing), notes: Verbatim: Heart transplant recipient; "Covid Pneumonia" (unspecified if ongoing), notes: he did have Covid Pneumonia, he was in the Hospital on Jan due to Covid Pneumonia (history).; "Covid" (unspecified if ongoing), notes: He had Covid before the shot (vaccination) and he spent 5 days in ICU.". The patient took concomitant medications. The following information was reported: Pain in Extremity(non-serious) with onset 2021, outcome "unknown", described as "Sore arm"; Pain(non-serious) with onset 2021, outcome "unknown", described as "aches and pains".  Follow-Up (11Oct2021): Follow-up attempts are completed. No further information is expected.  Additional Information:Reporter stated, "My husband is still having the side effects from the Booster shot and they said, now he has to go to see a Neurologist because of the side effects from the Booster shot. They said he may never get rid of the pain in his chest. One thing I want to know it was only 3 months in between shots he got the Booster shot but it says it should be received in between 6 months, I don't understand."Reporter was informed about Pfizer Medical Information Department and provided contact#.Reporter was provided with the number of Pfizer Medical Information # and was requested to select option 3 and timings as 8 am to 8 pm from Monday to Friday as per (EST).Reporter stated, "We almost "lost" (not clarified) him and now he is having this side effect this lasting forever. It is not like he did have Covid Pneumonia, he was in the Hospital on Jan due to Covid Pneumonia (history). He had Covid before the shot (vaccination) and he spent 5 days in ICU."  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This is a spontaneous report received from a contactable other HCP, from a Pfizer-sponsored program (159558). A 15-year-old patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Oct 1, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Expired product administered to patient (patient administered expired vaccine), onset Oct 1, 2021, with outcome of unknown. Additional information: HCP inquired about recommendations for 15-year-old patient administered an expired vaccine Oct 1, 2021. Follow-up attempts completed. No further information expected.