chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Vision blurred
Clinical narrative: Blurred vision; Abdominal discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 86-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose number unknown, single (Lot number: H64677) at the age of 86 years for covid-19 immunisation. The patient's relevant medical history included: "heart patient" (unspecified if ongoing), notes: He is a heart patient. The patient's concomitant medications were not reported. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset Sep2023, outcome "unknown"; VISION BLURRED (non-serious) with onset Sep2023, outcome "unknown", described as "Blurred vision". Additional information: Reporter stated, 86-year-old husband had a COVID shot yesterday. He is experiencing abdominal discomfort and some blurred vision. Reporter would like to know if abdominal problems and blurred visions can be a side effect of COVID 19. Indication of the vaccine: Reporter stated, Because the news is saying all over that the new vaccine is available and the people over 65 should take it. Reporter was provided with the number of Pfizer Medical Information as (phone number withheld) and was requested to select option 3, Monday to Friday, timings as 8 AM to 7 PM. Further probing could not be done as the reporter was unwilling to complete the report. Hence, limited information was available over the call.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: With her first dose she had arm pain; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 60-year-old female patient received bnt162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EK5730, Expiration Date: 31Mar2021) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "prevention of cardiovascular disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing); ATORVASTATIN taken for cardiovascular disorder. Past drug history included: Bactrim, reaction(s): "rash". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "With her first dose she had arm pain".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300309742 Same patient, different vaccine dose and different event.;
Age: 15.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: Fever of 104; Muscle ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 at 08:45 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 15 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 24Sep2023 at 08:45 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "congenital heart disease" (ongoing), notes: congenital heart disease open heart surgery when 1 year old; "open heart surgery" (ongoing), notes: congenital heart disease open heart surgery when 1 year old; "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for asthma (ongoing). Vaccination history included: Bnt162b2 (Primary Immunization series complete.), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 24Sep2023, outcome "recovered" (25Sep2023), described as "Fever of 104"; MYALGIA (non-serious) with onset 24Sep2023, outcome "recovering", described as "Muscle ache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, myalgia.  Additional information: Yesterday they had gotten the vaccine and by bedtime around 9:00 PM/9:30 PM her son experienced a fever of 104 and really bad muscle aches. However, this morning when he woke up his temperature was 98 and he was fine. Treatment: Gave 650mg of Tylenol. Muscle Aches-It's milder now. It's to the point where he can go school. It was not debilitating or anything. Confirmed patient received the Pfizer booster shot for covid vaccine and she is speaking with them the pharmacy and informed there would be fewer side effects with the Pfizer brand vs the Moderna.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate abnormal, Hypertension
Clinical narrative: My blood pressure is like 143/80; It is showing on the machine as abnormal heartbeat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose number unknown (booster), single (Lot number: HF9275) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; manufacture unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose number unknown (booster), manufacture unknown), for COVID-19 Immunization. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "My blood pressure is like 143/80"; HEART RATE ABNORMAL (non-serious), outcome "unknown", described as "It is showing on the machine as abnormal heartbeat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient got Covid shot yesterday (23Sep2023). The patient did not have those side effects at all and today (24Sep2023), the patient woke up this morning and took  blood pressure, blood pressure was like 143/80, but it was showing on the machine as abnormal heartbeat. The patient stated 'hope I am not dead by then'. Patient stated that the rest of his/her vaccines had different numbers, all the different boosters the patient got so.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Lot number: GH9693) for covid-19 immunisation; bnt162b2 (BNT162B2), on 19Oct2021 as dose 1, single (Lot number: FF2590), on 09Nov2021 as dose 2, single (Lot number: FIT8028) and on 11Feb2022 as dose 3 (booster), single (Lot number: PK9893) for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing). Concomitant medication(s) included: TOPIRAMATE, start date: Jul2022, stop date: Sep2023. Past drug history included: Ergotamines, reaction(s): "Known allergies: ergotamines"; Triptans, reaction(s): "Known allergies: triptans". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood calcitonin, Blood test, Cough, Influenza, SARS-CoV-2 test
Clinical narrative: she gets a cough every time she gets a Covid shot or vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 3 (booster), single (Lot number: GH9702) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Medullary thyroid cancer" (unspecified if ongoing), notes: Medullary thyroid cancer History of Medullary Thyroid Cancer; had Thyroid Removed; "Ulcer" (unspecified if ongoing), notes: she does have an ulcer and esophageal ulcers history; "esophageal ulcers history" (unspecified if ongoing), notes: she does have an ulcer and esophageal ulcers history; "Blood Pressure" (ongoing); "Migraine" (ongoing); "Covid", start date: Feb2020 (unspecified if ongoing); "bilateral pneumonia" (unspecified if ongoing); "influenza" (unspecified if ongoing); "Flu" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure abnormal (ongoing); SYNTHROID taken for medullary thyroid cancer (ongoing); TOPAMAX taken for migraine (ongoing); BYSTOLIC (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot no.: EW0153), administration date: 05Apr2021, for Covid-19 immunization, reaction(s): "she gets a cough every time she gets a Covid shot or vaccine"; bnt162b2 (DOSE 2, SINGLE, Batch/Lot no.: EW0171), administration date: 26Apr2021, for Covid-19 immunization, reaction(s): "she gets a cough every time she gets a Covid shot or vaccine"; Flu shot, administration date: 2022, for Immunization. The following information was reported: COUGH (non-serious), outcome "unknown", described as "she gets a cough every time she gets a Covid shot or vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the reporter states she also has a weird cough, states she gets a cough every time she gets a Covid shot or vaccine.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Thyroid disorder
Clinical narrative: Thyroid issue; This is a spontaneous report received from a contactable reporter (Other HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received bnt162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) 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 immunisation; Bnt162b2 (dose 2, single), for COVID-19 immunisation. The following information was reported: THYROID DISORDER (non-serious), outcome "unknown", described as "Thyroid issue". Additional information: The patient reported that she got Pfizer COVID vaccines including the booster but not the 4th one. She didn't get the 4th because of a thyroid issue. She has not had COVID. All the COVID she's had are all Pfizer and she didn't have bad reactions to them.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in one toe constantly/terrible pain in one toe/ It is burning pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNISATION SERIES COMPLETE;  UNKNOWN MANUFACTURER), for COVID-19 immunization, reaction(s): "No problems"; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "No problems". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Sep2023, outcome "not recovered", described as "pain in one toe constantly/terrible pain in one toe/ It is burning pain".  Additional information: Caller mentioned she got her shot yesterday, and a pedicure but the pain was nothing she did, but she wanted to know if it was the vaccine as it was pain in one toe constantly. Patient had COVID shots and the booster shots and had no problems. Yesterday she went to get the new COVID vaccine shot that was out. Last night she started getting terrible pain in one toe and it was still going on. It was burning pain.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: arm pain at the injection site; Caller is looking for pain relief on her muscles; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 70-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: Unknown, She had the other Pfizer COVID vaccines up to this point), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "arm pain at the injection site"; MYALGIA (non-serious), outcome "unknown", described as "Caller is looking for pain relief on her muscles". Additional information: Patient experienced arm pain at the injection site. Caller is looking for pain relief on her muscles. She has a homeopathic medication named arnica montana and wants to know if it is okay to use around the injection site. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Scar
Clinical narrative: some scarring going on; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Smallpox vaccine (at the age of 9 years old got the smallpox vaccine which is on the same site), for Immunization, reaction(s): "skin reaction"; Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE, Anatomical site: Deltoid), for COVID-19 immunisation; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Anatomical site: Deltoid), for COVID-19 immunisation. The following information was reported: SCAR (non-serious), outcome "not recovered", described as "some scarring going on".  Additional information: Patient said it looks very much to him like when he was 9 years old when he got the smallpox vaccine which was on the same site. It was also in the same deltoid where he got the previous Pfizer Covid original vaccines as well boosters including the last Bivalent one and he never had a problem with any of them. He had the injection on Sunday, took the bandage off the next morning and it looked about the same as it looks now, doesn't look infected and getting better almost gone but it looks like there's some scarring going on. He was a physician for over 30 years and was curious to see if they have anything reported like that as it happened immediately after the vaccine and definitely has to do with some kind of skin reaction to the vaccine. He said they may want to pass it on to other people maybe it will help somebody else. Then he asked was it possible if this was something more common that's been happening and they start getting reports of this that Pfizer can get to back to him and let him know.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Injection site induration, Injection site mass, Injection site nodule
Clinical narrative: Developed a hard knot about 2 inches wide at the site of the injection; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A 73-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 24Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE MASS (non-serious) with onset Sep2023, outcome "recovered", described as "Developed a hard knot about 2 inches wide at the site of the injection". Therapeutic measures were not taken as a result of injection site mass.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: it was reported that she developed a hard knot about 2 inches wide at the site of the injection. The nurse told her if it did not resolve or clear up, then to call the office back. The nurse stated she never called back.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: She said that her girlfriend had blood clots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "She said that her girlfriend had blood clots". Clinical Course: She said that her girlfriend "almost lost her leg" and had "blood clots".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid; covid; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid". Clinical course: Patient received vaccine 8 days ago and now had covid. The caller wanted to know how long did the vaccine becomes effective once is administered and also wanted to know if there could be a drug interaction between the vaccine and an antiviral (molnupiravir) for the treatment of covid 19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I have taken all five of your Pfizer Vaccinations (Pfizer COVID-19 Vaccines); I got COVID; I have taken all five of your Pfizer Vaccinations (Pfizer COVID-19 Vaccines); I got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have taken all five of your Pfizer Vaccinations (Pfizer COVID-19 Vaccines); I got COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid on an unknown date. Clinical course: Patient took all five of Pfizer Vaccinations (Clarified as Pfizer COVID-19 Vaccines) latest being about a year ago and was waiting for the new one to come out and then sure enough, got COVID and now the patient was on Paxlovid.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300311011 same patient/reporter, different product/event.;
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 59 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "former throat cancer" (unspecified if ongoing); "Squamous cell carcinoma (SCC)", start date: 2013 (unspecified if ongoing), notes: 10 years ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had received the treatment of COVID-19 as Paxlovid on 16Sep2023 to 20Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300310711 same patient, different drug/AE;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300310568 same patient, different drug/AE;
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 09Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 07Feb2022 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 17Sep2023, outcome "unknown", COVID-19 (medically significant) with onset 17Sep2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 17Sep2023 to 21Sep2023. 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-202300312383 same patient/drug and different dose and event;
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukaemia" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: oats" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2023, stop date: 13Sep2023; IMBRUVICA, start date: 25Aug2023, stop date: 13Sep2023. Past drug history included: Flagyl, reaction(s): "Known allergies: Flagyl". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. with paxlovid from 13Sep2023 to 17Sep2023.  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-202300311187 Same patient, different drug/event;
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pruritus
Clinical narrative: Right arm ich that has lasted 2 years now; Inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 (BNT162B2), on 29Oct2021 as dose 2, single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "copd" (unspecified if ongoing); "stroke" (unspecified if ongoing). The patient has no known allergies. The patient has no COVID prior to vaccination and was not tested positive for COVID post vaccination. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right), administration date: 15Feb2021, when the patient was 66-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 29Oct2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; PRURITUS (disability) with onset 29Oct2021 at 15:00, outcome "not recovered", described as "Right arm ich that has lasted 2 years now".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fever for 24 hours; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Sep2023, outcome "recovered" (Sep2023), described as "Low grade fever for 24 hours". Therapeutic measures were not taken as a result of pyrexia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: That evening started with chills, and mild headache. Upon waking headache was worse and had bodyaches along with continuing chills; That evening started with chills, and mild headache. Upon waking headache was worse and had bodyaches along with continuing chills; That evening started with chills, and mild headache. Upon waking headache was worse and had bodyaches along with continuing chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 11Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for influenza immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious), HEADACHE (non-serious), PAIN (non-serious) all with onset 25Sep2023 at 23:00, outcome "not recovered" and all described as "That evening started with chills, and mild headache. Upon waking headache was worse and had bodyaches along with continuing chills". Therapeutic measures were not taken as a result of chills, headache, pain.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021307812 Same patient/drug and different doses;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid 19 treatment; Covid 19 treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), in Sep2022 as dose number unknown, single (batch/lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history included: "penicillin allergies" (unspecified if ongoing); "acacia allergies" (unspecified if ongoing); "breast cancer" (unspecified if ongoing), notes: 20 years breast cancer survivor. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 17Sep2023 to 21Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Vomiting
Clinical narrative: She was exhausted; Felt awful for a few days in a row; She threw up in the middle of the night; She got a killer headache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received bnt162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6202, Expiration Date: 30Jun2021) at the age of 60 years for COVID-19 immunisation. The patient's relevant medical history included: "GERD" (ongoing); "Had gall bladder removed" (unspecified if ongoing). Concomitant medication included: ESOMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing). The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "She was exhausted"; MALAISE (non-serious), outcome "unknown", described as "Felt awful for a few days in a row"; VOMITING (non-serious), outcome "unknown", described as "She threw up in the middle of the night"; HEADACHE (non-serious), outcome "recovered", described as "She got a killer headache". Therapeutic measures were taken as a result of headache. Additional information: The patient reported that for her reactions with her prior COVID shots, states one time she threw up in the middle of the night and the first two laid her low like she was exhausted and felt awful for a few days in a row and another one she got a killer headache with that Tylenol could not get rid of and had that a day or two and then after the immunization, she would feel better the next day after 2-3 days of misery, she would wake up feeling perfectly normal the next day. She and her friends would say that the previous symptoms they all had for throwing up and feeling and bad headaches and all that was just due to the immunization as was widely reported with a lot of people. She states she does not know which dose of her COVID vaccines the headache and throwing up were associated with. For the other patients or friends she spoke with that had symptoms after having the COVID vaccinations, she has no patient specific information to provide, no names or manufacturers of their vaccines, no lots.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300311396 same patient and vaccine; different dose and event;US-PFIZER INC-202300311393 same patient, vaccine, and event; different dose;US-PFIZER INC-202300311394 same patient and vaccine; different dose and event;US-PFIZER INC-202300310950 same patient and vaccine; different dose and event;US-PFIZER INC-202300311395 same patient and vaccine; different dose and event;
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Vomiting
Clinical narrative: She was exhausted; Felt awful for a few days in a row; She threw up in the middle of the night; She got a killer headache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received bnt162b2 (BNT162B2), on 26Mar2021 as dose 2, single (Lot number: EP6955, Expiration Date: 30Jun2021) at the age of 60 years for COVID-19 immunisation. The patient's relevant medical history included: "GERD" (ongoing); "Had gall bladder removed" (unspecified if ongoing). Concomitant medications included: ESOMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: bnt162b2 (dose 1, single; lot number: EN6202; expiration date: 30Jun2021), administration date: 05Mar2021, when the patient was 60-year-old, for COVID-19 immunisation, reactions: "Felt awful for a few days in a row", "She was exhausted", "She threw up in the middle of the night", "She got a killer headache". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "She was exhausted"; MALAISE (non-serious), outcome "unknown", described as "Felt awful for a few days in a row"; VOMITING (non-serious), outcome "unknown", described as "She threw up in the middle of the night"; HEADACHE (non-serious), outcome "recovered", described as "She got a killer headache". Therapeutic measures were taken as a result of headache. Additional information: The patient reported that for her reactions with her prior COVID shots, states one time she threw up in the middle of the night and the first two laid her low like she was exhausted and felt awful for a few days in a row and another one she got a killer headache with that Tylenol could not get rid of and had that a day or two and then after the immunization, she would feel better the next day after 2-3 days of misery, she would wake up feeling perfectly normal the next day. She and her friends would say that the previous symptoms they all had for throwing up and feeling and bad headaches and all that was just due to the immunization as was widely reported with a lot of people. She states she does not know which dose of her COVID vaccines the headache and throwing up were associated with. For the other patients or friends she spoke with that had symptoms after having the COVID vaccinations, she has no patient specific information to provide, no names or manufacturers of their vaccines, no lots.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300311369 same patient, vaccine, and event; different dose;US-PFIZER INC-202300311395 same patient and vaccine; different dose and event;
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: another one she got a killer headache with that Tylenol could not get rid of; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received bnt162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "GERD" (ongoing), notes: GERD; "Had gall bladder removed" (unspecified if ongoing). Concomitant medication(s) included: ESOMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot: EN6202, Expiry: 30Jun2021), administration date: 05Mar2021, when the patient was 60-year-old, for COVID-19 Immunization, reaction(s): "She was exhausted", "felt awful for a few days in a row", "She threw up in the middle of the night", "She got a killer headache"; bnt162b2 (DOSE 2, SINGLE, Lot: EP6955 , Expiry: 30Jun2021), administration date: 26Mar2021, when the patient was 60-year-old, for COVID-19 Immunization, reaction(s): "She was exhausted", "felt awful for a few days in a row", "She threw up in the middle of the night", "She got a killer headache". The following information was reported: HEADACHE (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "another one she got a killer headache with that Tylenol could not get rid of". Therapeutic measures were taken as a result of headache. Additional information: She got a killer headache with that Tylenol could not get rid of and had that a day or two and then after the immunization, she would feel better the next day after 2-3 days of misery, she would wake up feeling perfectly normal the next day.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300311369 same reporter/patient, differnet vaccine dose;
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received bnt162b2 (BNT162B2), on 14Feb2021 at 15:00 as dose 1, single (Lot number: EL9261), in left arm and on 07Oct2021 at 10:15 as dose 2, single (Lot number: EL9261) at the age of 76 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Jun2022 at 14:15 as dose 3 (booster), single (Lot number: 057M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Stage 1 sarcoidosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Simvastatin, reaction(s): "Drug Allergy", notes: Simvastatin minor random muscle pain; Simvastatin, reaction(s): "minor random muscle pain", notes: Simvastatin minor random muscle pain. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Jun2022 at 14:15, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of interchange of vaccine products, drug ineffective, covid-19 which included Paxlovid taken from 15Sep2023 to 20Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300311398 same reporter/patient, different dose/AE;
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162B2, BNT162B2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for COVID-19 immunisation; bnt162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 25May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "Some plants cause skin allergies" (unspecified if ongoing). Concomitant medications included: GLYBURIDE/METFORMIN; LISINOPRIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Sep2023) Positive, notes: First positive test. Therapeutic measures were taken as a result of vaccination failure, COVID-19 which included Paxlovid from 11Sep2023 to 15Sep2023.   The information on the batch/lot number for BNT162B2, BNT162B2 OMI BA.4-5, bnt162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 18:00 as dose 4 (booster), single (Lot number: G55342) at the age of 42 years, in left arm for COVID-19 immunization; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient received PAXLOVID as COVID 19 Treatment from 18Sep2023 to 23Sep2023.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: Diarrhea; GI upset; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 19:00 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 31Aug2023 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "celiac disease" (unspecified if ongoing); "fibromuscular dysplasia" (unspecified if ongoing); "possible ulcerative colitis" (unspecified if ongoing). Concomitant medication(s) included: PREGABALIN. Past drug history included: Gluten (celiac disease), reaction(s): "Known allergies: Gluten (celiac disease)". The following information was reported: DIARRHOEA (non-serious) with onset 26Sep2023 at 04:00, outcome "not recovered", described as "Diarrhea"; ABDOMINAL DISCOMFORT (non-serious) with onset 26Sep2023 at 04:00, outcome "not recovered", described as "GI upset". Therapeutic measures were not taken as a result of diarrhoea, abdominal discomfort.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective; patient was treated with PAXLOVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.