chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise
Clinical narrative: Felt under the weather after first dose, second dose , first booster dose; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Felt under the weather after first dose, second dose , first booster dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 007B21A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included Metastatic melanoma (On immunotherapy between OCT 2020 - DEC2021 to treat Metastatic Melanoma. Otherwise patient has been totally Healthy and Cancer was gone.).   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MALAISE (Felt under the weather after first dose, second dose , first booster dose). In 2021, MALAISE (Felt under the weather after first dose, second dose , first booster dose) had resolved.            No concomitant medications were reported, and Patient was not on any medications at the time of vaccinations.  It was reported that patient felt under the weather for 1 day after the first dose on 21-Feb-2021 and resolved on 22-Feb-2021. On 22-Mar-2021, the patient felt under the weather after second dose and resolved on 23-Mar-2021. On 08-Nov-2021, the patient felt under the weather after first booster dose and resolved on 09-Nov-2021.  No treatment details were reported. .   This case was linked to MOD-2022-610541 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Asthenia, Chills, Fall, Fatigue
Clinical narrative: Felt under the weather after first dose, second dose , first booster dose; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Felt under the weather after first dose, second dose , first booster dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 007B21A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included Metastatic melanoma (On immunotherapy between OCT 2020 - DEC2021 to treat Metastatic Melanoma. Otherwise patient has been totally Healthy and Cancer was gone.).   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MALAISE (Felt under the weather after first dose, second dose , first booster dose). In 2021, MALAISE (Felt under the weather after first dose, second dose , first booster dose) had resolved.            No concomitant medications were reported, and Patient was not on any medications at the time of vaccinations.  It was reported that patient felt under the weather for 1 day after the first dose on 21-Feb-2021 and resolved on 22-Feb-2021. On 22-Mar-2021, the patient felt under the weather after second dose and resolved on 23-Mar-2021. On 08-Nov-2021, the patient felt under the weather after first booster dose and resolved on 09-Nov-2021.  No treatment details were reported. .   This case was linked to MOD-2022-610541 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Nasopharyngitis, Pollakiuria, SARS-CoV-2 test, Somnolence
Clinical narrative: Felt under the weather after first dose, second dose , first booster dose; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Felt under the weather after first dose, second dose , first booster dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 007B21A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included Metastatic melanoma (On immunotherapy between OCT 2020 - DEC2021 to treat Metastatic Melanoma. Otherwise patient has been totally Healthy and Cancer was gone.).   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MALAISE (Felt under the weather after first dose, second dose , first booster dose). In 2021, MALAISE (Felt under the weather after first dose, second dose , first booster dose) had resolved.            No concomitant medications were reported, and Patient was not on any medications at the time of vaccinations.  It was reported that patient felt under the weather for 1 day after the first dose on 21-Feb-2021 and resolved on 22-Feb-2021. On 22-Mar-2021, the patient felt under the weather after second dose and resolved on 23-Mar-2021. On 08-Nov-2021, the patient felt under the weather after first booster dose and resolved on 09-Nov-2021.  No treatment details were reported. .   This case was linked to MOD-2022-610541 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Felt under the weather after first dose, second dose , first booster dose; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Felt under the weather after first dose, second dose , first booster dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 007B21A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included Metastatic melanoma (On immunotherapy between OCT 2020 - DEC2021 to treat Metastatic Melanoma. Otherwise patient has been totally Healthy and Cancer was gone.).   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MALAISE (Felt under the weather after first dose, second dose , first booster dose). In 2021, MALAISE (Felt under the weather after first dose, second dose , first booster dose) had resolved.            No concomitant medications were reported, and Patient was not on any medications at the time of vaccinations.  It was reported that patient felt under the weather for 1 day after the first dose on 21-Feb-2021 and resolved on 22-Feb-2021. On 22-Mar-2021, the patient felt under the weather after second dose and resolved on 23-Mar-2021. On 08-Nov-2021, the patient felt under the weather after first booster dose and resolved on 09-Nov-2021.  No treatment details were reported. .   This case was linked to MOD-2022-610541 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Eye movement disorder, Impaired work ability, Memory impairment
Clinical narrative: I work telehealth from home as a therapist. I got up per normal for 9am client. I have only vague memory of the 55 minute session and took notes. During my 10 am session, I was aware that my eyes started to close several times as if I were falling asleep. I again, have very little memory and don?t know if I took notes. I had a 60 minute break and fell asleep on the couch in my office (at least I think I did). I saw a 12pm client and barely remember.  I knew something was really not normal then. I stopped work and immediately went to bed, sleeping from 1-4:45 pm. I cooked dinner and think I was more together the rest of the evening.   When I woke up this morning, I went to finish a couple of notes that I had to complete from Thursday and realized that I had clients yesterday as I forgot. Also, I thought I didn?t even contact my 1:30pm appointment to cancel. However, when I looked at my phone, it turned out that I did contact the client. This I had no recollection of however, as the day has gone on, I realize I can see little bits of the morning but nothing clear.   This has NEVER happened to me.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea exertional, Fatigue, Feeling abnormal
Clinical narrative: First dose I had a long standing rash, SOB and allergic reaction needing treatment. Second dose the rash went away, and all my lymphnodes have swollen and all over my body, I have persistant fatique, brain fog, DOE, and occasional chest pain and tightness.   I have had no relief. Being referred to local Infectious Disease.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: First dose I had a long standing rash, SOB and allergic reaction needing treatment. Second dose the rash went away, and all my lymphnodes have swollen and all over my body, I have persistant fatique, brain fog, DOE, and occasional chest pain and tightness.   I have had no relief. Being referred to local Infectious Disease.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Decreased appetite, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain, redness, swelling, itching at site of injections. Patient with other complaints not feeling well, restless, poor appetite, fever.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Malaise, Pyrexia, Restlessness
Clinical narrative: Pain, redness, swelling, itching at site of injections. Patient with other complaints not feeling well, restless, poor appetite, fever.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Administration of vaccine adjuvant suspension component (liquid) without active antigen (powder)/shingrix :adjuvant only; Administration of vaccine adjuvant suspension component (liquid) without active antigen (powder)/shingrix :adjuvant only; This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 539ZT, expiry date 31st August 2023) for prophylaxis.   On 22nd June 2022, the patient received the 1st dose of Shingrix. On 22nd June 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 and 29- JUN-2022 Reporter's Comments: The GlaxoSmithKline sales representative called GlaxoSmithKline response center the morning of 29th June 2022 to report that the previous day late in the day he was at a medical office and was shown a box of Shingrix. The box had 5 vials of the adjuvant missing.  The sales representative asked what happened to the vials.  The response that was given was that they were administered to 5 patients. No further information was gathered by sales representative such as lot number, patient's initials, patients genders, or route of administration. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The patient was administered vaccine adjuvant suspension component (liquid) without active antigen (powder) component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This is 1 of the 5 cases reported by the same reporter.   Follow-up information received on 01-JUL-2022. This follow-up was considered significant.  Reporter's Comments: Health care professional reported that somewhere in beginning of June, 5 patients were administered only adjuvant.  Summary of Changes: Updated start date of suspect vaccine and Event as June 2022.   Follow-up information received on 12-JUL-2022. This follow-up was considered significant. Reporter's Comments: The reporter was a practice manager  The reporter considered this medication error as without harm as adjuvant powder was not mixed and erroneously administered only adjuvant administered to the patient. The reporter considered the outcome of events as recovered and did not considered the events to be related to Shingrix. Summary of Changes: Updated patient's demographic details, Product details and event start date were updated. Narrative was updated.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR100445:Same reporter US-GLAXOSMITHKLINE-US2022099857:Same reporter US-GLAXOSMITHKLINE-US2022AMR100449:Same reporter US-GLAXOSMITHKLINE-US2022AMR100452:Same reporter
Age: 58.0
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 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 at 15:00 as dose 4 (booster), single (Lot number: fk9895) at the age of 58 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: other medical history: Hypertension. The patient took concomitant medications. 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical course: If vaccine received: Yes. Other medication in 2weeks: Yes. Known allergies: no. Other medical history: Hypertension.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive; Positive; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Aug2021 at 12:00 as dose 1, single (Lot number: EW0167), in left leg and on 01Sep2021 at 10:00 as dose 2, single (Lot number: FC3183) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing), notes: Known allergies: Latex; "Known allergies: Milk" (unspecified if ongoing), notes: Known allergies: Milk; "Known allergies: covid 19 vaccine" (unspecified if ongoing), notes: Known allergies: covid 19 vaccine. The patient took concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 16Jan2022, outcome "not recovered", VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jan2022) Positive, notes: Nasal Swab; (unspecified date) Unknown result.  Clinical Information: It was reported that anatomical site of administration of Dose-2 was Left buttock.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the Vaccination failure and Covid-19 for the suspect vaccines cannot be excluded. However, the efficacy of a drug varies from patient to patient and can be affected by different factors.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Audiogram, Blood test, Ear infection, Otorrhoea, Pyrexia
Clinical narrative: I had fever; my BP was up and down; head is terrible from the ringing and it starts in her left ear and moves into her head; head is terrible from the ringing and it starts in her left ear and moves into her head; 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 66-year-old female patient received BNT162b2 (BNT162B2), on 21Oct2021 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: BNT162b2 (Dose 1, Single; Batch/Lot number: ENW9581; Administration Time: evening don't know the time), administration date: 29Jan2021, when the patient was 66-year-old, for Covid-19 immunization, reaction(s): "arm sore", "little fever"; BNT162b2 (Dose 2, Single; Batch/Lot number: EN6201; Administration Time: Evening 6 - 7 pm), administration date: 23Feb2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "she look it up as tinnitus", "I had a buzzing noise in my head", "she maybe had an infection inside her ear since the right ear sometimes has drainage", "she maybe had an infection inside her ear since the right ear sometimes has drainage", "I had a fever", "dehydrated", "pain", "fainted", "high BP"; BNT162b2 (Dose 3 (booster), single; Batch/Lot number: FE3592; Administration Time: 10:00 AM), administration date: 05Oct2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "I had a buzzing noise in my head/the buzzing got worse", "I had a buzzing noise in my head/the buzzing got worse/ It is getting worse", "body aches/body pain", "A lot of fever", "Sore arm", "Low energy", "BP was up and down". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "I had fever"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "my BP was up and down"; HEADACHE (non-serious), TINNITUS (non-serious), outcome "unknown" and all described as "head is terrible from the ringing and it starts in her left ear and moves into her head". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that booster dose was rough on the patient. The patient was more worried about getting Covid. Caller stated was small and maybe needed a smaller dose, which was known that cannot do at that time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: I had fever; my BP was up and down; head is terrible from the ringing and it starts in her left ear and moves into her head; head is terrible from the ringing and it starts in her left ear and moves into her head; 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 66-year-old female patient received BNT162b2 (BNT162B2), on 21Oct2021 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: BNT162b2 (Dose 1, Single; Batch/Lot number: ENW9581; Administration Time: evening don't know the time), administration date: 29Jan2021, when the patient was 66-year-old, for Covid-19 immunization, reaction(s): "arm sore", "little fever"; BNT162b2 (Dose 2, Single; Batch/Lot number: EN6201; Administration Time: Evening 6 - 7 pm), administration date: 23Feb2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "she look it up as tinnitus", "I had a buzzing noise in my head", "she maybe had an infection inside her ear since the right ear sometimes has drainage", "she maybe had an infection inside her ear since the right ear sometimes has drainage", "I had a fever", "dehydrated", "pain", "fainted", "high BP"; BNT162b2 (Dose 3 (booster), single; Batch/Lot number: FE3592; Administration Time: 10:00 AM), administration date: 05Oct2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "I had a buzzing noise in my head/the buzzing got worse", "I had a buzzing noise in my head/the buzzing got worse/ It is getting worse", "body aches/body pain", "A lot of fever", "Sore arm", "Low energy", "BP was up and down". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "I had fever"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "my BP was up and down"; HEADACHE (non-serious), TINNITUS (non-serious), outcome "unknown" and all described as "head is terrible from the ringing and it starts in her left ear and moves into her head". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that booster dose was rough on the patient. The patient was more worried about getting Covid. Caller stated was small and maybe needed a smaller dose, which was known that cannot do at that time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Audiogram, Dehydration, Ear discomfort, Fatigue, Feeling abnormal
Clinical narrative: I had fever; my BP was up and down; head is terrible from the ringing and it starts in her left ear and moves into her head; head is terrible from the ringing and it starts in her left ear and moves into her head; 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 66-year-old female patient received BNT162b2 (BNT162B2), on 21Oct2021 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: BNT162b2 (Dose 1, Single; Batch/Lot number: ENW9581; Administration Time: evening don't know the time), administration date: 29Jan2021, when the patient was 66-year-old, for Covid-19 immunization, reaction(s): "arm sore", "little fever"; BNT162b2 (Dose 2, Single; Batch/Lot number: EN6201; Administration Time: Evening 6 - 7 pm), administration date: 23Feb2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "she look it up as tinnitus", "I had a buzzing noise in my head", "she maybe had an infection inside her ear since the right ear sometimes has drainage", "she maybe had an infection inside her ear since the right ear sometimes has drainage", "I had a fever", "dehydrated", "pain", "fainted", "high BP"; BNT162b2 (Dose 3 (booster), single; Batch/Lot number: FE3592; Administration Time: 10:00 AM), administration date: 05Oct2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "I had a buzzing noise in my head/the buzzing got worse", "I had a buzzing noise in my head/the buzzing got worse/ It is getting worse", "body aches/body pain", "A lot of fever", "Sore arm", "Low energy", "BP was up and down". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "I had fever"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "my BP was up and down"; HEADACHE (non-serious), TINNITUS (non-serious), outcome "unknown" and all described as "head is terrible from the ringing and it starts in her left ear and moves into her head". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that booster dose was rough on the patient. The patient was more worried about getting Covid. Caller stated was small and maybe needed a smaller dose, which was known that cannot do at that time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Illness, Pain, Pain in extremity, Pyrexia, Syncope
Clinical narrative: I had fever; my BP was up and down; head is terrible from the ringing and it starts in her left ear and moves into her head; head is terrible from the ringing and it starts in her left ear and moves into her head; 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 66-year-old female patient received BNT162b2 (BNT162B2), on 21Oct2021 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: BNT162b2 (Dose 1, Single; Batch/Lot number: ENW9581; Administration Time: evening don't know the time), administration date: 29Jan2021, when the patient was 66-year-old, for Covid-19 immunization, reaction(s): "arm sore", "little fever"; BNT162b2 (Dose 2, Single; Batch/Lot number: EN6201; Administration Time: Evening 6 - 7 pm), administration date: 23Feb2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "she look it up as tinnitus", "I had a buzzing noise in my head", "she maybe had an infection inside her ear since the right ear sometimes has drainage", "she maybe had an infection inside her ear since the right ear sometimes has drainage", "I had a fever", "dehydrated", "pain", "fainted", "high BP"; BNT162b2 (Dose 3 (booster), single; Batch/Lot number: FE3592; Administration Time: 10:00 AM), administration date: 05Oct2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "I had a buzzing noise in my head/the buzzing got worse", "I had a buzzing noise in my head/the buzzing got worse/ It is getting worse", "body aches/body pain", "A lot of fever", "Sore arm", "Low energy", "BP was up and down". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "I had fever"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "my BP was up and down"; HEADACHE (non-serious), TINNITUS (non-serious), outcome "unknown" and all described as "head is terrible from the ringing and it starts in her left ear and moves into her head". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that booster dose was rough on the patient. The patient was more worried about getting Covid. Caller stated was small and maybe needed a smaller dose, which was known that cannot do at that time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Audiogram, Blood pressure measurement, Blood test, Condition aggravated, Immunisation
Clinical narrative: I had fever; my BP was up and down; head is terrible from the ringing and it starts in her left ear and moves into her head; head is terrible from the ringing and it starts in her left ear and moves into her head; 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 66-year-old female patient received BNT162b2 (BNT162B2), on 21Oct2021 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: BNT162b2 (Dose 1, Single; Batch/Lot number: ENW9581; Administration Time: evening don't know the time), administration date: 29Jan2021, when the patient was 66-year-old, for Covid-19 immunization, reaction(s): "arm sore", "little fever"; BNT162b2 (Dose 2, Single; Batch/Lot number: EN6201; Administration Time: Evening 6 - 7 pm), administration date: 23Feb2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "she look it up as tinnitus", "I had a buzzing noise in my head", "she maybe had an infection inside her ear since the right ear sometimes has drainage", "she maybe had an infection inside her ear since the right ear sometimes has drainage", "I had a fever", "dehydrated", "pain", "fainted", "high BP"; BNT162b2 (Dose 3 (booster), single; Batch/Lot number: FE3592; Administration Time: 10:00 AM), administration date: 05Oct2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "I had a buzzing noise in my head/the buzzing got worse", "I had a buzzing noise in my head/the buzzing got worse/ It is getting worse", "body aches/body pain", "A lot of fever", "Sore arm", "Low energy", "BP was up and down". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "I had fever"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "my BP was up and down"; HEADACHE (non-serious), TINNITUS (non-serious), outcome "unknown" and all described as "head is terrible from the ringing and it starts in her left ear and moves into her head". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that booster dose was rough on the patient. The patient was more worried about getting Covid. Caller stated was small and maybe needed a smaller dose, which was known that cannot do at that time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia, Tinnitus
Clinical narrative: I had fever; my BP was up and down; head is terrible from the ringing and it starts in her left ear and moves into her head; head is terrible from the ringing and it starts in her left ear and moves into her head; 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 66-year-old female patient received BNT162b2 (BNT162B2), on 21Oct2021 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: BNT162b2 (Dose 1, Single; Batch/Lot number: ENW9581; Administration Time: evening don't know the time), administration date: 29Jan2021, when the patient was 66-year-old, for Covid-19 immunization, reaction(s): "arm sore", "little fever"; BNT162b2 (Dose 2, Single; Batch/Lot number: EN6201; Administration Time: Evening 6 - 7 pm), administration date: 23Feb2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "she look it up as tinnitus", "I had a buzzing noise in my head", "she maybe had an infection inside her ear since the right ear sometimes has drainage", "she maybe had an infection inside her ear since the right ear sometimes has drainage", "I had a fever", "dehydrated", "pain", "fainted", "high BP"; BNT162b2 (Dose 3 (booster), single; Batch/Lot number: FE3592; Administration Time: 10:00 AM), administration date: 05Oct2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "I had a buzzing noise in my head/the buzzing got worse", "I had a buzzing noise in my head/the buzzing got worse/ It is getting worse", "body aches/body pain", "A lot of fever", "Sore arm", "Low energy", "BP was up and down". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "I had fever"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "my BP was up and down"; HEADACHE (non-serious), TINNITUS (non-serious), outcome "unknown" and all described as "head is terrible from the ringing and it starts in her left ear and moves into her head". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that booster dose was rough on the patient. The patient was more worried about getting Covid. Caller stated was small and maybe needed a smaller dose, which was known that cannot do at that time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Headache, Pyrexia, Tinnitus
Clinical narrative: I had fever; my BP was up and down; head is terrible from the ringing and it starts in her left ear and moves into her head; head is terrible from the ringing and it starts in her left ear and moves into her head; 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 66-year-old female patient received BNT162b2 (BNT162B2), on 21Oct2021 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: BNT162b2 (Dose 1, Single; Batch/Lot number: ENW9581; Administration Time: evening don't know the time), administration date: 29Jan2021, when the patient was 66-year-old, for Covid-19 immunization, reaction(s): "arm sore", "little fever"; BNT162b2 (Dose 2, Single; Batch/Lot number: EN6201; Administration Time: Evening 6 - 7 pm), administration date: 23Feb2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "she look it up as tinnitus", "I had a buzzing noise in my head", "she maybe had an infection inside her ear since the right ear sometimes has drainage", "she maybe had an infection inside her ear since the right ear sometimes has drainage", "I had a fever", "dehydrated", "pain", "fainted", "high BP"; BNT162b2 (Dose 3 (booster), single; Batch/Lot number: FE3592; Administration Time: 10:00 AM), administration date: 05Oct2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "I had a buzzing noise in my head/the buzzing got worse", "I had a buzzing noise in my head/the buzzing got worse/ It is getting worse", "body aches/body pain", "A lot of fever", "Sore arm", "Low energy", "BP was up and down". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "I had fever"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "my BP was up and down"; HEADACHE (non-serious), TINNITUS (non-serious), outcome "unknown" and all described as "head is terrible from the ringing and it starts in her left ear and moves into her head". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that booster dose was rough on the patient. The patient was more worried about getting Covid. Caller stated was small and maybe needed a smaller dose, which was known that cannot do at that time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest discomfort, Dyspnoea, Headache, Heart rate
Clinical narrative: breakthrough case of Covid after taking three doses of Pfizer BioNTech Covid vaccine; breakthrough case of Covid after taking three doses of Pfizer BioNTech Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 04Aug2021 as dose 1, single (Lot number: EW0177), in arm, on 25Aug2021 as dose 2, single (Lot number: FC3184), in arm and on 15Feb2022 as dose 3 (booster), single (Lot number: FJ6369) at the age of 52 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder; ALLEGRA-D 12 HOUR taken for hypersensitivity. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jul2022 at 05:00, outcome "not recovered" and all described as "breakthrough case of Covid after taking three doses of Pfizer BioNTech Covid vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Positive; (18Jul2022) Positive, notes: She took two positive test today. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: She had breakthrough case of Covid after taking three doses of Pfizer BioNTech Covid vaccine. She filled a report because she worked for Pfizer and needed to report Covid when she had vaccines, so that was what she was doing. She can't find the protocol of what to do if she had Covid, how many days she should stay at home and what she found was outdated. She reported an adverse with vaccine and Pfizer should have all this information. Adverse event was from the booster dose. Pfizer had all the where and time and all that stuff. The initial report was filed end of Feb2022 for the AE on the booster dose. Patient took two at home covid tests on 18JUL2022, that were positive. Time the Vaccination was Given as they were all PM, in the afternoon or early evening. Vaccines were administered at pharmacy. No family medical history relevant to adverse events. No additional vaccines were administered on same date of the Pfizer suspect. Adverse event did not require a visit to emergency room or physician office. Time of onset of events was reported as 05:00 CT. The primary infection site was reported as unknown and did not cause any secondary site. No predisposing factors and no culture performed. No serotyping was done. Patient did not receive any treatment for events. Patient received antipyretic Use (around the date(s) of Vaccination) was possible she took Ibuprofen or Tylenol.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Lethargy, Muscle tightness, Musculoskeletal stiffness, Nausea
Clinical narrative: breakthrough case of Covid after taking three doses of Pfizer BioNTech Covid vaccine; breakthrough case of Covid after taking three doses of Pfizer BioNTech Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 04Aug2021 as dose 1, single (Lot number: EW0177), in arm, on 25Aug2021 as dose 2, single (Lot number: FC3184), in arm and on 15Feb2022 as dose 3 (booster), single (Lot number: FJ6369) at the age of 52 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder; ALLEGRA-D 12 HOUR taken for hypersensitivity. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jul2022 at 05:00, outcome "not recovered" and all described as "breakthrough case of Covid after taking three doses of Pfizer BioNTech Covid vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Positive; (18Jul2022) Positive, notes: She took two positive test today. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: She had breakthrough case of Covid after taking three doses of Pfizer BioNTech Covid vaccine. She filled a report because she worked for Pfizer and needed to report Covid when she had vaccines, so that was what she was doing. She can't find the protocol of what to do if she had Covid, how many days she should stay at home and what she found was outdated. She reported an adverse with vaccine and Pfizer should have all this information. Adverse event was from the booster dose. Pfizer had all the where and time and all that stuff. The initial report was filed end of Feb2022 for the AE on the booster dose. Patient took two at home covid tests on 18JUL2022, that were positive. Time the Vaccination was Given as they were all PM, in the afternoon or early evening. Vaccines were administered at pharmacy. No family medical history relevant to adverse events. No additional vaccines were administered on same date of the Pfizer suspect. Adverse event did not require a visit to emergency room or physician office. Time of onset of events was reported as 05:00 CT. The primary infection site was reported as unknown and did not cause any secondary site. No predisposing factors and no culture performed. No serotyping was done. Patient did not receive any treatment for events. Patient received antipyretic Use (around the date(s) of Vaccination) was possible she took Ibuprofen or Tylenol.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: breakthrough case of Covid after taking three doses of Pfizer BioNTech Covid vaccine; breakthrough case of Covid after taking three doses of Pfizer BioNTech Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 04Aug2021 as dose 1, single (Lot number: EW0177), in arm, on 25Aug2021 as dose 2, single (Lot number: FC3184), in arm and on 15Feb2022 as dose 3 (booster), single (Lot number: FJ6369) at the age of 52 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder; ALLEGRA-D 12 HOUR taken for hypersensitivity. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jul2022 at 05:00, outcome "not recovered" and all described as "breakthrough case of Covid after taking three doses of Pfizer BioNTech Covid vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Positive; (18Jul2022) Positive, notes: She took two positive test today. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: She had breakthrough case of Covid after taking three doses of Pfizer BioNTech Covid vaccine. She filled a report because she worked for Pfizer and needed to report Covid when she had vaccines, so that was what she was doing. She can't find the protocol of what to do if she had Covid, how many days she should stay at home and what she found was outdated. She reported an adverse with vaccine and Pfizer should have all this information. Adverse event was from the booster dose. Pfizer had all the where and time and all that stuff. The initial report was filed end of Feb2022 for the AE on the booster dose. Patient took two at home covid tests on 18JUL2022, that were positive. Time the Vaccination was Given as they were all PM, in the afternoon or early evening. Vaccines were administered at pharmacy. No family medical history relevant to adverse events. No additional vaccines were administered on same date of the Pfizer suspect. Adverse event did not require a visit to emergency room or physician office. Time of onset of events was reported as 05:00 CT. The primary infection site was reported as unknown and did not cause any secondary site. No predisposing factors and no culture performed. No serotyping was done. Patient did not receive any treatment for events. Patient received antipyretic Use (around the date(s) of Vaccination) was possible she took Ibuprofen or Tylenol.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: breakthrough case of Covid after taking three doses of Pfizer BioNTech Covid vaccine; breakthrough case of Covid after taking three doses of Pfizer BioNTech Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 04Aug2021 as dose 1, single (Lot number: EW0177), in arm, on 25Aug2021 as dose 2, single (Lot number: FC3184), in arm and on 15Feb2022 as dose 3 (booster), single (Lot number: FJ6369) at the age of 52 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder; ALLEGRA-D 12 HOUR taken for hypersensitivity. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jul2022 at 05:00, outcome "not recovered" and all described as "breakthrough case of Covid after taking three doses of Pfizer BioNTech Covid vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Positive; (18Jul2022) Positive, notes: She took two positive test today. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: She had breakthrough case of Covid after taking three doses of Pfizer BioNTech Covid vaccine. She filled a report because she worked for Pfizer and needed to report Covid when she had vaccines, so that was what she was doing. She can't find the protocol of what to do if she had Covid, how many days she should stay at home and what she found was outdated. She reported an adverse with vaccine and Pfizer should have all this information. Adverse event was from the booster dose. Pfizer had all the where and time and all that stuff. The initial report was filed end of Feb2022 for the AE on the booster dose. Patient took two at home covid tests on 18JUL2022, that were positive. Time the Vaccination was Given as they were all PM, in the afternoon or early evening. Vaccines were administered at pharmacy. No family medical history relevant to adverse events. No additional vaccines were administered on same date of the Pfizer suspect. Adverse event did not require a visit to emergency room or physician office. Time of onset of events was reported as 05:00 CT. The primary infection site was reported as unknown and did not cause any secondary site. No predisposing factors and no culture performed. No serotyping was done. Patient did not receive any treatment for events. Patient received antipyretic Use (around the date(s) of Vaccination) was possible she took Ibuprofen or Tylenol.