chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Blood pressure really high after first dose of COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; cabozantinib (CABOMETYX), first regimen (Batch/Lot number: unknown) at 40 mg 1x/day (40 mg, qd) and second regimen (Batch/Lot number: unknown) at 60 mg 1x/day (60 mg, qd). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "Blood pressure really high after first dose of COVID vaccine". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for cabozantinib was unknown.  Additional information:The patient received the first dose of Cabometyx 60 mg, qd (route of administration is not reported). On an unknown date, the patient started decrease dose at Cabometyx 40 mg, qd (route of administration not provided). The date of the most recent dose of Cabometyx prior to the event was not reported. Initially, during Cabometyx therapy, patient's blood pressure had been maintained to normal level. Further, on an unknown date, the patient experienced blood pressure high (blood pressure increased) after first dose of COVID vaccine. The reporter did not provide causality assessment for blood pressure increased with respect to Cabometyx.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer. This 66-year-old female consumer (patient) reported that COVID-19 Vaccine is a Pfizer product, COVID-19 Vaccine manufacturer Unspecified, Start: Unspecified Stop: Unspecified), Unknown number of COVID-19 Vaccine and Expiry Date of COVID-19 Vaccine: Unknown (the)Reaction(s)/Event(s) as reported by primary source Dates for I was feeling a bit light headed and dizzy: (From: Unspecified To: Unspecified),Dates for I was on the bathroom floor in the pool of blood; I got myself up, I passed out again: (From: Unspecified To: Unspecified), Dates for I am badly bruised: (From: Unspecified To: Unspecified)Dates for My eyes rolled back to my head: (From: Unspecified To: Unspecified),Dates for Sore arm: (From: Unspecified To: Unspecified),Dates for Very very low grade fever: (From: Unspecified To: Unspecified), Dates for Tired: (From: Unspecified To: Unspecified) Dates for I hit my head: (From: Unspecified To: Unspecified), Dates for I am not able to open, not able to eat because in the fall I hit my jaw so badly: (From: Unspecified To: Unspecified).  Additionall information; The patient stated, "The patient  just want to report, I am going to report it to you or the CDC because the place that I got the booster does not seem really that concerned, the patient had a terrible side effect to the Pfizer Booster vaccine that I think should be made aware of, I don't know if other people have reported some of the effects." The patient have stated Pfizer COVID 19 Vaccine it was the COVID 19 Pfizer booster, The patient had the first two shots and this is my booster." Treatment: The patient Stated, "Well Few days after I just took some Advil because I am not able to open, not able to eat because in the fall I hit my jaw so badly, so the only thing I have been taking is some Advil, I took absolutely before my vaccine and took nothing for two or three days after my vaccine." Other Vaccine (Prior to 4 weeks of COVID Vaccine): The patient stated, "No Nothing"    No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101465729 Same patient and drug, different events separated in time;US-PFIZER INC-202101465992 Same patient and drug, different events separated in time
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity
Clinical narrative: headaches; sore arm; muscle aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP, Other HCP and Pharmacist) for a sponsored program. Other Case identifier(s): 20201114988(3).  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) at the age of 67 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 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm"; MYALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "muscle aches"; HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional Information: The patient reported she had her second Covid vaccination on 26Feb2021 and experienced a sore arm and muscle aches after receiving the vaccination which have since resolved. She is unsure if headaches are related to Opsumit or the Covid vaccination.   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: Blood pressure increased, Blood pressure measurement, Diarrhoea, Dizziness, Headache
Clinical narrative: pain and weakness in both arms after having the vaccines; I also having a shaking feeling in both upper arms; pain and weakness in both arms after having the vaccines; Blood pressure increased; Diarrhea; Recurring headaches; Slight dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Jul2021 10:00 (Lot number: EW0164) at the age of 65 years as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Administration time: 09:00, Anatomical site of injection:  Left arm, Batch/lot number: Unknown EW0197, Event required visit to: Physician Office, Seriousness: Important medical event, Treatment: no), administration date: 15Jun2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "pain in both arms", "weakness in both arms". The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 2021, outcome "unknown", described as "Blood pressure increased"; DIARRHOEA (medically significant) with onset 2021, outcome "unknown", described as "Diarrhea"; HEADACHE (medically significant) with onset 2021, outcome "unknown", described as "Recurring headaches"; DIZZINESS (medically significant) with onset 2021, outcome "recovered" (Sep2021), described as "Slight dizziness"; MUSCULAR WEAKNESS (medically significant), PAIN IN EXTREMITY (medically significant) all with onset 13Jul2021 10:00, outcome "not recovered" and all described as "pain and weakness in both arms after having the vaccines"; TREMOR (medically significant) with onset 13Jul2021 10:00, outcome "not recovered", described as "I also having a shaking feeling in both upper arms". The patient visited family physician due to continued pain and weakness in both arms after having the vaccines. The patient was also having a shaking feeling in both upper arms and sometimes indicate to his chest. The patient underwent the following laboratory tests and procedures in 2021 included blood pressure measurement: increased.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Tremor
Clinical narrative: pain and weakness in both arms after having the vaccines; I also having a shaking feeling in both upper arms; pain and weakness in both arms after having the vaccines; Blood pressure increased; Diarrhea; Recurring headaches; Slight dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Jul2021 10:00 (Lot number: EW0164) at the age of 65 years as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Administration time: 09:00, Anatomical site of injection:  Left arm, Batch/lot number: Unknown EW0197, Event required visit to: Physician Office, Seriousness: Important medical event, Treatment: no), administration date: 15Jun2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "pain in both arms", "weakness in both arms". The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 2021, outcome "unknown", described as "Blood pressure increased"; DIARRHOEA (medically significant) with onset 2021, outcome "unknown", described as "Diarrhea"; HEADACHE (medically significant) with onset 2021, outcome "unknown", described as "Recurring headaches"; DIZZINESS (medically significant) with onset 2021, outcome "recovered" (Sep2021), described as "Slight dizziness"; MUSCULAR WEAKNESS (medically significant), PAIN IN EXTREMITY (medically significant) all with onset 13Jul2021 10:00, outcome "not recovered" and all described as "pain and weakness in both arms after having the vaccines"; TREMOR (medically significant) with onset 13Jul2021 10:00, outcome "not recovered", described as "I also having a shaking feeling in both upper arms". The patient visited family physician due to continued pain and weakness in both arms after having the vaccines. The patient was also having a shaking feeling in both upper arms and sometimes indicate to his chest. The patient underwent the following laboratory tests and procedures in 2021 included blood pressure measurement: increased.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: My Pigmentation is coming back all over my body and I don't burn in the sun; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as does 2, single for covid-19 immunisation. Relevant medical history included: "I was not able to be in direct sunlight without burning" (unspecified if ongoing), notes: I was not able to be in direct sunlight without burning; "Pigmentation began to return after more than ten years" (unspecified if ongoing), notes: Melanin, which produces my Pigmentation began to return after more than ten years. The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1), for COVID-19 immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "My Pigmentation is coming back all over my body and I don't burn in the sun".  Additional information: it was reported that after the second dose patient Melanin, which produces his Pigmentation began to return after more than ten years. His Pigmentation was completely entirely gone. Patient was not able to be in direct sunlight without burning. Now he could be in direct sunlight without any consequences.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Fever; Chills; Tiredness; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Nov2021 18:45 (Lot number: FK5127) at the age of 11 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Influenza vaccine, administration date: 08Oct2021, for Influenza immunisation; Meningococcal vaccine (Meningococcal MCV4P), administration date: 08Oct2021, for Meningococcal Immunisation; Hpv vaccine, administration date: 08Oct2021, for HPV immunisation; Tdap vaccine, administration date: 08Oct2021, for Teatanus . The following information was reported: PYREXIA (non-serious) with onset 09Nov2021 10:00, outcome "recovered" (Nov2021), described as "Fever"; CHILLS (non-serious) with onset 09Nov2021 10:00, outcome "recovered" (Nov2021), described as "Chills"; FATIGUE (non-serious) with onset 09Nov2021 10:00, outcome "recovered" (Nov2021), described as "Tiredness"; VOMITING (non-serious) with onset 09Nov2021 10:00, outcome "recovered" (Nov2021), described as "Vomiting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, fatigue, vomiting.  Additional information: Patient had no known allergies. Patient was not diagnosed with COVID-19, prior to vaccination. On 09Nov2021 (since the vaccination), patient had been tested for COVID-19 via nasal swab (BinaxNow), result was negative.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Product preparation error, Pyrexia
Clinical narrative: reported slight fever x 24hrs only; The dose the patient received however was of an undiluted product; The dose the patient received however was of an undiluted product; This is a spontaneous report from a contactable registered nurse.(Other HCP) from medical information team.  A 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported),  intramuscular, administered in deltoid right, administration  on 11Nov2021 as Dose 2, Single (at the age of 18-year-old) for covid-19 immunization. Relevant medical history included: "Prosthetic valve functioning normally", start date: 24Nov2015 (ongoing), notes: Patient Medical History (including any illness at time of vaccination):, Illness/AE: Prosthetic valve functioning normally, Onset date: placed 24Nov2015 , 18Oct2021, stop date: Ongoing. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Pfizer/BioNtech COVID-19 Vaccine Details:, Dose: 1st, Date: 18Oct2021, Time (24hr): Approx. 16:40 , Anatomical site of Location:  Right deltoid, Batch/Lot number: 30145BA, Route of administration: Intramuscular, Illness/AE: Tetralogy of Fallot, Onset date: 18Oct2021, stop date: Ongoing checked), administration date: 18Oct2021, when the patient was 18 years old, for Covid-19 immunization, reaction(s): "Tetralogy of Fallot", "Prosthetic valve functioning normally". The reported stated that the patient that received his 2nd dose of the Pfizer COVID 19 Vaccine yesterday (11Nov2021) and was of an undiluted dose of the vaccine and they wanted to know what to do next or what guidance Pfizer may have pertaining to this situation. The patient was monitored in clinic for 30 minutes post administration and no adverse reactions were reported that the reporter was aware of at this time. They haven't reached out to the patient yet, but he was fine that they knew of, but they're in the process of reporting this and they need to know what they need to do and when they need to do it if anything should be done differently. She said that she needs to know how much she should freak out right now. No investigation assessment was reported. The events that are reported as OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 11Nov2021 16:42, outcome "unknown" and all described as "The dose the patient received however was of an undiluted product"; PYREXIA (non-serious), outcome "recovered", described as "reported slight fever x 24hrs only".  Follow up(18Nov2021): Additional Information:Patient provided information regarding the adverse event(s) with the use of the product: Yes, There is no causal effect to the adverse effect. Patient did not take any vaccine prior vaccination (within 4 weeks). Patient concomitant drug therapy was none. Patient Family medical history relevant to AE was none. Specific Relevant Test for thromboembolic events with thrombocytopenia was None  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Feeling abnormal, Headache
Clinical narrative: fever (101.8 F); chills; full body aches; joint pain; brain fog; lymph node swelling (armpit of injection site arm); injection site pain; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 10:00 (Lot number: FF 8841) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing), notes: IBS; "PCOS" (unspecified if ongoing), notes: PCOS. Concomitant medication(s) included: INFLUENZA, administration date 27Oct2021; KARIVA. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Dose Number: 1, Batch/Lot No: EL 3249, Location of injection: Left Arm), administration date: 26Jan2021, when the patient was 22 years old, for COVID-19 Immunization; Bnt162b2 (Product: COVID 19, Brand: Pfizer, Dose Number: 2, Batch/Lot No: EL 3247, Location of injection: Left Arm), administration date: 16Feb2021, when the patient was 22 years old, for COVID-19 Immunization, reaction(s): "Low-grade fever (100.4 F)", "body aches", "headache", "bruising injection armpit", "injection site pain", "lymph node pain and swelling", "lymph node pain and swelling".  The following information was reported: PYREXIA (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "fever (101.8 F)"; CHILLS (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "full body aches"; ARTHRALGIA (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "joint pain"; FEELING ABNORMAL (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "brain fog"; LYMPHADENOPATHY (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "lymph node swelling (armpit of injection site arm)"; VACCINATION SITE PAIN (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "injection site pain"; HEADACHE (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain, arthralgia, feeling abnormal, lymphadenopathy, vaccination site pain, headache.  Additional information: The facility where the most recent COVID-19 vaccine was administered was at the workplace clinic. The patient did not have any known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia, Vaccination site pain
Clinical narrative: fever (101.8 F); chills; full body aches; joint pain; brain fog; lymph node swelling (armpit of injection site arm); injection site pain; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 10:00 (Lot number: FF 8841) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing), notes: IBS; "PCOS" (unspecified if ongoing), notes: PCOS. Concomitant medication(s) included: INFLUENZA, administration date 27Oct2021; KARIVA. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Dose Number: 1, Batch/Lot No: EL 3249, Location of injection: Left Arm), administration date: 26Jan2021, when the patient was 22 years old, for COVID-19 Immunization; Bnt162b2 (Product: COVID 19, Brand: Pfizer, Dose Number: 2, Batch/Lot No: EL 3247, Location of injection: Left Arm), administration date: 16Feb2021, when the patient was 22 years old, for COVID-19 Immunization, reaction(s): "Low-grade fever (100.4 F)", "body aches", "headache", "bruising injection armpit", "injection site pain", "lymph node pain and swelling", "lymph node pain and swelling".  The following information was reported: PYREXIA (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "fever (101.8 F)"; CHILLS (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "full body aches"; ARTHRALGIA (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "joint pain"; FEELING ABNORMAL (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "brain fog"; LYMPHADENOPATHY (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "lymph node swelling (armpit of injection site arm)"; VACCINATION SITE PAIN (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "injection site pain"; HEADACHE (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain, arthralgia, feeling abnormal, lymphadenopathy, vaccination site pain, headache.  Additional information: The facility where the most recent COVID-19 vaccine was administered was at the workplace clinic. The patient did not have any known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Eye inflammation, Eye swelling, Swelling face
Clinical narrative: He had like reaction like face is swollen; like inflammation in his eyes; swollen eyes like for the face he has a swollen face especially in the eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 13Nov2021 (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: SWELLING FACE (non-serious) with onset Nov2021, outcome "unknown", described as "He had like reaction like face is swollen"; EYE INFLAMMATION (non-serious) with onset Nov2021, outcome "unknown", described as "like inflammation in his eyes", EYE SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "swollen eyes like for the face he has a swollen face especially in the eyes".   Additional information: The patient mother stated that her son got vaccine yesterday (13Nov2021). When probed for the confirmation vaccine name as Covid-19 Vaccine and she stated that, her son had reaction like face was swollen like inflammation in his eyes and also had a swollen face especially in the eyes.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Fever; chills; body ache; headache; swollen lymph node in under arm of left arm (injection arm); injection site soreness/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 35 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Nov2021 12:45 (Lot number: FF2589) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing); "known allergies: Sea food" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0153, Location of injection: Arm Left, Vaccine Administration Time: 09:45 AM, Route of Administration: Intramuscular), administration date: 10Apr2021, when the patient was 34 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER2613, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM, Route of Administration: Intramuscular), administration date: 20Mar2021, when the patient was 34 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 13Nov2021 11:00, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 13Nov2021 11:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 13Nov2021 11:00, outcome "recovering", described as "body ache"; HEADACHE (non-serious) with onset 13Nov2021 11:00, outcome "recovering", described as "headache"; LYMPHADENOPATHY (non-serious) with onset 13Nov2021 11:00, outcome "recovering", described as "swollen lymph node in under arm of left arm (injection arm)"; VACCINATION SITE PAIN (non-serious) with onset 13Nov2021 11:00, outcome "recovering", described as "injection site soreness/left arm pain". Therapeutic measures were taken as a result of pyrexia, chills, pain, headache, lymphadenopathy, vaccination site pain.  Additional information: Other medications in two weeks: Metformin, Multivitamin.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fever; chills; body ache; headache; swollen lymph node in under arm of left arm (injection arm); injection site soreness/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 35 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Nov2021 12:45 (Lot number: FF2589) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing); "known allergies: Sea food" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0153, Location of injection: Arm Left, Vaccine Administration Time: 09:45 AM, Route of Administration: Intramuscular), administration date: 10Apr2021, when the patient was 34 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER2613, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM, Route of Administration: Intramuscular), administration date: 20Mar2021, when the patient was 34 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 13Nov2021 11:00, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 13Nov2021 11:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 13Nov2021 11:00, outcome "recovering", described as "body ache"; HEADACHE (non-serious) with onset 13Nov2021 11:00, outcome "recovering", described as "headache"; LYMPHADENOPATHY (non-serious) with onset 13Nov2021 11:00, outcome "recovering", described as "swollen lymph node in under arm of left arm (injection arm)"; VACCINATION SITE PAIN (non-serious) with onset 13Nov2021 11:00, outcome "recovering", described as "injection site soreness/left arm pain". Therapeutic measures were taken as a result of pyrexia, chills, pain, headache, lymphadenopathy, vaccination site pain.  Additional information: Other medications in two weeks: Metformin, Multivitamin.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling cold, Pain
Clinical narrative: Fever; chills; extreme fatigue; ever joint in my body hurt.; was painful just to move my fingers or any joint in my body; I felt like I was freezing but I was wrapped in blankets.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 13:15 (Lot number: 33026130) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: LYRICA. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 20Feb2021, when the patient was 55 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 13Nov2021 20:00, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 13Nov2021 20:00, outcome "recovering", described as "chills"; FATIGUE (non-serious) with onset 13Nov2021 20:00, outcome "recovering", described as "extreme fatigue"; ARTHRALGIA (non-serious) with onset 13Nov2021 20:00, outcome "recovering", described as "ever joint in my body hurt."; PAIN (non-serious) with onset 13Nov2021 20:00, outcome "recovering", described as "was painful just to move my fingers or any joint in my body"; FEELING COLD (non-serious) with onset 13Nov2021 20:00, outcome "recovering", described as "I felt like I was freezing but I was wrapped in blankets.". Therapeutic measures were not taken as a result of pyrexia, chills, fatigue, arthralgia, pain, feeling cold.  Additional Information: Patients had no other vaccines in four weeks, the patient had no covid prior vaccination and have not been tested since the vaccination   No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; chills; extreme fatigue; ever joint in my body hurt.; was painful just to move my fingers or any joint in my body; I felt like I was freezing but I was wrapped in blankets.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 13:15 (Lot number: 33026130) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: LYRICA. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 20Feb2021, when the patient was 55 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 13Nov2021 20:00, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 13Nov2021 20:00, outcome "recovering", described as "chills"; FATIGUE (non-serious) with onset 13Nov2021 20:00, outcome "recovering", described as "extreme fatigue"; ARTHRALGIA (non-serious) with onset 13Nov2021 20:00, outcome "recovering", described as "ever joint in my body hurt."; PAIN (non-serious) with onset 13Nov2021 20:00, outcome "recovering", described as "was painful just to move my fingers or any joint in my body"; FEELING COLD (non-serious) with onset 13Nov2021 20:00, outcome "recovering", described as "I felt like I was freezing but I was wrapped in blankets.". Therapeutic measures were not taken as a result of pyrexia, chills, fatigue, arthralgia, pain, feeling cold.  Additional Information: Patients had no other vaccines in four weeks, the patient had no covid prior vaccination and have not been tested since the vaccination   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: large hives broke out on buttocks and have persisted for 10+ days traveling to flanks; Fever for 2 days after booster; Vomiting for 2 days after booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 15:30 (Lot number: FH8028) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0170, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 23Apr2021, when the patient was 35 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 02Apr2021, when the patient was 35 years old, for COVID-19 immunization; Flu vaccine vii, administration date: Oct2021, for Immunisation. The following information was reported: PYREXIA (non-serious) with onset 06Nov2021 02:00, outcome "not recovered", described as "Fever for 2 days after booster"; VOMITING (non-serious) with onset 06Nov2021 02:00, outcome "not recovered", described as "Vomiting for 2 days after booster"; URTICARIA (non-serious) with onset 07Nov2021, outcome "not recovered", described as "large hives broke out on buttocks and have persisted for 10+ days traveling to flanks". The events "fever for 2 days after booster", "vomiting for 2 days after booster" and "large hives broke out on buttocks and have persisted for 10+ days traveling to flanks" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pyrexia, vomiting, urticaria. Included Anti itch cream, pill. Waiting on steroids.  Additional Information: Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Decreased activity, Fatigue
Clinical narrative: chills; fatigue; has an increase in blood pressure; has difficulty with physically strenuous activities; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): EC-2021-097823 (Eisai).  A female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 25Oct2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; lenvatinib mesilate (LENVIMA), oral since 08Nov2021 (ongoing) (Batch/Lot number: unknown) at 14 mg for endometrial cancer. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "recovering", described as "chills"; FATIGUE (non-serious), outcome "not recovered", described as "fatigue"; BLOOD PRESSURE INCREASED (non-serious), outcome "not recovered", described as "has an increase in blood pressure"; DECREASED ACTIVITY (non-serious), outcome "not recovered", described as "has difficulty with physically strenuous activities". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for lenvatinib mesilate was unknown.  Additional information: Patient reports ongoing fatigue after start of therapy has difficulty with physically strenuous activities but can do light house work. Unknown if MD is aware. Patient states she had second covid vaccine on 10/25/2021 and has chills but states it is improving. unknown if MD aware. Patient reports after start of therapy she has an increase in blood pressure. Patient will notify MD.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Before he got his 2nd dose, he got in contact with someone with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65 year-old male patient received bnt162b2 (COMIRNATY), administration date 27Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing), notes: has diabetes, HTN, and CLL (Chronic lymphocytic leukemia).; "HTN" (unspecified if ongoing), notes: has diabetes, HTN, and CLL (Chronic lymphocytic leukemia).; "CLL (Chronic lymphocytic leukemia)" (unspecified if ongoing), notes: has diabetes, HTN, and CLL (Chronic lymphocytic leukemia). The patient's concomitant medications were not reported. The following information was reported: EXPOSURE TO SARS-COV-2 (non-serious) with onset 2021, outcome "unknown", described as "Before he got his 2nd dose, he got in contact with someone with COVID".  Follow-up (17Nov2021): 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: Ageusia, Anosmia
Clinical narrative: lost taste; lost smell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Feb2021 16:00 (Lot number: EL9266) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Multiple myeloma" (unspecified if ongoing); "Reaction: Allergy" (unspecified if ongoing). Concomitant medication(s) included: ZOMETA. The following information was reported: AGEUSIA (non-serious) with onset 31Aug2021 02:45, outcome "recovering", described as "lost taste"; ANOSMIA (non-serious) with onset 31Aug2021 02:45, outcome "recovering", described as "lost smell". It was unknown if therapeutic measures were taken as a result of ageusia, anosmia.  Additional information: The events did not result in doctor or other healthcare professional office/clinic visit; The most recent COVID-19 vaccine was administered in Workplace clinic administration facility.The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. No Known allergies. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Inappropriate schedule of product administration, Off label use, Osteoarthritis
Clinical narrative: First Dose 29Apr2021, second dose 02May2021; First Dose 29Apr2021, second dose 02May2021; felt tired; Cough; Runny nose; Osteoarthritis getting bad in knuckles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4155792-00 (Company).  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 02May2021 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Drug: Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Tozinameran), Unknown, Daily Dose: First Dose (1 in 1 Once) , Route of Administration: Intra-muscular, Therapy Dates(From/To): 29Apr2021-29Apr2021), administration date: 29Apr2021, when the patient was 65 years old, for COVID-19 Immunization, reaction(s): "Osteoarthritis aggravated".  The following information was reported: OFF LABEL USE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 02May2021, outcome "unknown" and all described as "First Dose 29Apr2021, second dose 02May2021"; FATIGUE (non-serious) with onset 02May2021, outcome "recovered" (May2021), described as "felt tired"; COUGH (non-serious) with onset 2021, outcome "recovered" (2021), described as "Cough"; RHINORRHOEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Runny nose"; OSTEOARTHRITIS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Osteoarthritis getting bad in knuckles". The action taken for adalimumab was unknown.  Additional information: Drug: Pfizer BioNTech covid-19 vaccine (tozinameran) (tozinameran),unknown, unknown, unknown Daily dose: 1) first Dose (1 in 1 once) 2) Second Dose (1 in 1 Once) 3)-Third Dose (1 in 1 Once) Route of Admin:  1) Intra-muscular 2) Intra-muscular 3) Intra-muscular Therapy Dates/Duration 1)09Apr2021- 09Apr2021 2) 09May2021-09May2021 3) 23Dec2021- 23Dec2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: First Dose 29Apr2021, second dose 02May2021; First Dose 29Apr2021, second dose 02May2021; felt tired; Cough; Runny nose; Osteoarthritis getting bad in knuckles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4155792-00 (Company).  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 02May2021 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Drug: Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Tozinameran), Unknown, Daily Dose: First Dose (1 in 1 Once) , Route of Administration: Intra-muscular, Therapy Dates(From/To): 29Apr2021-29Apr2021), administration date: 29Apr2021, when the patient was 65 years old, for COVID-19 Immunization, reaction(s): "Osteoarthritis aggravated".  The following information was reported: OFF LABEL USE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 02May2021, outcome "unknown" and all described as "First Dose 29Apr2021, second dose 02May2021"; FATIGUE (non-serious) with onset 02May2021, outcome "recovered" (May2021), described as "felt tired"; COUGH (non-serious) with onset 2021, outcome "recovered" (2021), described as "Cough"; RHINORRHOEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Runny nose"; OSTEOARTHRITIS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Osteoarthritis getting bad in knuckles". The action taken for adalimumab was unknown.  Additional information: Drug: Pfizer BioNTech covid-19 vaccine (tozinameran) (tozinameran),unknown, unknown, unknown Daily dose: 1) first Dose (1 in 1 once) 2) Second Dose (1 in 1 Once) 3)-Third Dose (1 in 1 Once) Route of Admin:  1) Intra-muscular 2) Intra-muscular 3) Intra-muscular Therapy Dates/Duration 1)09Apr2021- 09Apr2021 2) 09May2021-09May2021 3) 23Dec2021- 23Dec2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Exposure to SARS-CoV-2, SARS-CoV-1 test, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: has been exposed to the virus multiple times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Lot number: EN6206) as dose 1, single and administration date 07Apr2021 (Lot number: ER8729) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications.  The following information was reported: EXPOSURE TO SARS-COV-2 (non-serious) with onset 2021, outcome "unknown", described as "has been exposed to the virus multiple times". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was stated that the caller worked in the airport. The caller didn't have any symptoms with the first 2 doses of the vaccine and had been exposed to the virus multiple times but never had the virus. The caller's daughter had the virus last year for Christmas and the caller took care of her daughter and monitored her temperature and oxygen level. The caller's daughter had a bad reaction to the virus and the caller never got the virus while she was taking care of her.The caller notes that she had the rapid covid test on 21Nov2021 at the clinic in the airport which was negative. The caller seen her doctor on 17Nov2021and they did her blood work and checked her covid antibodies. The caller's antibodies were positive this time but they were negative in the past. The caller is unsure when her antibodies were checked previously, she is unsure if she had her covid vaccines yet at this point. The caller will have to ask her doctor about this. First Dose: NDC, and expiration date unknown.Second Dose: NDC, and expiration date unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Pain in extremity, Pyrexia
Clinical narrative: arm pain at the injection site; arm pain at the injection site; headache; feeling cold; extremely tired; Low grade fever; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the parent.  A 7 year-old male 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: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "arm pain at the injection site"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FEELING COLD (non-serious), outcome "unknown", described as "feeling cold"; FATIGUE (non-serious), outcome "unknown", described as "extremely tired"; PYREXIA (non-serious), outcome "unknown", described as "Low grade fever".  Additional information: Low grade fever was also present on day 2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.