chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: sweats; the patient had chills and fever; the patient had chills and fever/teeth were chattering; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), PYREXIA (the patient had chills and fever) and CHILLS (the patient had chills and fever/teeth were chattering) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HYPERHIDROSIS (sweats), PYREXIA (the patient had chills and fever) and CHILLS (the patient had chills and fever/teeth were chattering). At the time of the report, HYPERHIDROSIS (sweats), PYREXIA (the patient had chills and fever) and CHILLS (the patient had chills and fever/teeth were chattering) outcome was unknown.            It was unknown If the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  The patient received his first Moderna Covid-19 vaccine in 2021 probably March or April. The patient received his second Moderna Covid-19 vaccine at an unknown date in 2021. Suspect vaccine dosage text was reported as unknown.  It was reported that after the first dose she was fine however 48 hours later the patient woke up at 2 A.M, the patient had chills and fever. The patient teeth were chattering. She had sweats so bad that I sweated through the bed linens.  After the second dose patient had chills and the fever the same night that he had the vaccine.  Treatment information was not provided.   This case was linked to MOD-2023-753714, MOD-2023-753719 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy; This spontaneous case was reported by a nurse and describes the occurrence of LYMPHADENOPATHY (Lymphadenopathy) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 015H22A and AS7184B) for COVID-19 prophylaxis.     Concurrent medical conditions included Metastatic breast cancer. Concomitant products included ATEZOLIZUMAB (TECENTRIQ) for Metastatic breast cancer, ATORVASTATIN CALCIUM (LIPITOR) and PARACETAMOL (TYLENOL) for an unknown indication.   On 16-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Jun-2023, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymphadenopathy). At the time of the report, LYMPHADENOPATHY (Lymphadenopathy) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that in the past when she got the Moderna she had Lymphadenopathy, so she wanted to get computed tomography (CT) out of the way to prevent everybody getting concerned about Lymphadenopathy associated with the vaccines. in axillary on site of injection. The Lymphadenopathy was axillary primarily on the side the injection. So On 11-Nov-2023 a computed tomography (CT) was requested.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-754625 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-754625:Same patient Monovalent dose
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Headache, Injection site discomfort, Pain
Clinical narrative: general discomfort; soreness in arm; Splitting headache; body aches; chills; fever; discomfort at injection site; This spontaneous case was reported by a patient and describes the occurrence of DISCOMFORT (general discomfort), PAIN IN EXTREMITY (soreness in arm), HEADACHE (Splitting headache), PAIN (body aches) and CHILLS (chills) in a 36-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccine; for COVID-19 prophylaxis: Moderna covid-19 vaccine. Past adverse reactions to the above products included No adverse event with Moderna covid-19 vaccine and Pfizer vaccine.    On 14-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (general discomfort), PAIN IN EXTREMITY (soreness in arm), HEADACHE (Splitting headache), PAIN (body aches), CHILLS (chills), PYREXIA (fever) and INJECTION SITE DISCOMFORT (discomfort at injection site). At the time of the report, DISCOMFORT (general discomfort), PAIN IN EXTREMITY (soreness in arm), HEADACHE (Splitting headache), PAIN (body aches), CHILLS (chills), PYREXIA (fever) and INJECTION SITE DISCOMFORT (discomfort at injection site) had not resolved.            It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: general discomfort; soreness in arm; Splitting headache; body aches; chills; fever; discomfort at injection site; This spontaneous case was reported by a patient and describes the occurrence of DISCOMFORT (general discomfort), PAIN IN EXTREMITY (soreness in arm), HEADACHE (Splitting headache), PAIN (body aches) and CHILLS (chills) in a 36-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccine; for COVID-19 prophylaxis: Moderna covid-19 vaccine. Past adverse reactions to the above products included No adverse event with Moderna covid-19 vaccine and Pfizer vaccine.    On 14-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (general discomfort), PAIN IN EXTREMITY (soreness in arm), HEADACHE (Splitting headache), PAIN (body aches), CHILLS (chills), PYREXIA (fever) and INJECTION SITE DISCOMFORT (discomfort at injection site). At the time of the report, DISCOMFORT (general discomfort), PAIN IN EXTREMITY (soreness in arm), HEADACHE (Splitting headache), PAIN (body aches), CHILLS (chills), PYREXIA (fever) and INJECTION SITE DISCOMFORT (discomfort at injection site) had not resolved.            It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharitis, Conjunctival oedema, Drainage, Eye infection, Headache
Clinical narrative: sinus pain; drainage; eye infection; eyelid inflammation; conjunctival edema; headache; swollen lymph glands; Very sore at injection site; This spontaneous case was reported by a patient and describes the occurrence of SINUS PAIN (sinus pain), DRAINAGE (drainage), EYE INFECTION (eye infection), BLEPHARITIS (eyelid inflammation) and CONJUNCTIVAL OEDEMA (conjunctival edema) in a 58-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 09-Dec-2023, the patient experienced SINUS PAIN (sinus pain), DRAINAGE (drainage), EYE INFECTION (eye infection), BLEPHARITIS (eyelid inflammation), CONJUNCTIVAL OEDEMA (conjunctival edema), HEADACHE (headache), LYMPHADENOPATHY (swollen lymph glands) and VACCINATION SITE PAIN (Very sore at injection site). At the time of the report, SINUS PAIN (sinus pain), DRAINAGE (drainage), EYE INFECTION (eye infection), BLEPHARITIS (eyelid inflammation), CONJUNCTIVAL OEDEMA (conjunctival edema), HEADACHE (headache), LYMPHADENOPATHY (swollen lymph glands) and VACCINATION SITE PAIN (Very sore at injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blepharitis: eye/headache that turned into massive eye infection in both eyes..     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Patient had oral antibiotics and two others which were administered directly into eye.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Sinus pain, Vaccination site pain
Clinical narrative: sinus pain; drainage; eye infection; eyelid inflammation; conjunctival edema; headache; swollen lymph glands; Very sore at injection site; This spontaneous case was reported by a patient and describes the occurrence of SINUS PAIN (sinus pain), DRAINAGE (drainage), EYE INFECTION (eye infection), BLEPHARITIS (eyelid inflammation) and CONJUNCTIVAL OEDEMA (conjunctival edema) in a 58-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 09-Dec-2023, the patient experienced SINUS PAIN (sinus pain), DRAINAGE (drainage), EYE INFECTION (eye infection), BLEPHARITIS (eyelid inflammation), CONJUNCTIVAL OEDEMA (conjunctival edema), HEADACHE (headache), LYMPHADENOPATHY (swollen lymph glands) and VACCINATION SITE PAIN (Very sore at injection site). At the time of the report, SINUS PAIN (sinus pain), DRAINAGE (drainage), EYE INFECTION (eye infection), BLEPHARITIS (eyelid inflammation), CONJUNCTIVAL OEDEMA (conjunctival edema), HEADACHE (headache), LYMPHADENOPATHY (swollen lymph glands) and VACCINATION SITE PAIN (Very sore at injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blepharitis: eye/headache that turned into massive eye infection in both eyes..     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Patient had oral antibiotics and two others which were administered directly into eye.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymphadenopathy; This spontaneous case was reported by a nurse and describes the occurrence of LYMPHADENOPATHY (lymphadenopathy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902, 002B21A and 011MZ0A) for COVID-19 prophylaxis.     Concurrent medical conditions included Metastatic breast cancer (Immunotherapy). Concomitant products included ATEZOLIZUMAB (TECENTRIQ) for Metastatic breast cancer, ATORVASTATIN CALCIUM (LIPITOR) and PARACETAMOL (TYLENOL) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (lymphadenopathy). At the time of the report, LYMPHADENOPATHY (lymphadenopathy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported   This case was linked to US-MODERNATX, INC.-MOD-2023-754644, MOD-2023-755176 (Patient Link).
Sex: U
Vaccine: DTPPVHBHPB, PNC15
Symptoms: Product storage error
Clinical narrative: patient who received VAXELIS PFS and VAXNEUVANCE. Improperly stored vaccines were administered to patient. Temperature 12.1 C FOR 13 MINUTES, 13.1 C FOR 13 MINUTES, previous TE; This non-serious spontaneous safety report, with MSD Case ID number:02478849, was received by a partner on 25-SEP-2023 and forwarded to Company on 26-SEP-2023, from a HCP.   Due to the nature of the event, the causality between the event "patient who received VAXELIS PFS and VAXNEUVANCE. Improperly stored vaccines were administered to patient. Temperature 12.1 C FOR 13 MINUTES, 13.1 C FOR 13 MINUTES, previous TE" and Vaxelis was assessed as not applicable.   Companion case: MCM-005302. Same reporter, same event, different patient.   Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, HEP
Symptoms: Extra dose administered
Clinical narrative: Pt initiated series with unknown Hepatitis B vaccine at 0 months.Patient then received VAXELIS at 2,4 &6 months. AE filed for misuse as Pt initiated series with Hepatitis B vaccine and recd 3 doses of VAXELIS which also counts as Hep B immunization; AE filed for misuse as Pt initiated series with Hepatitis B vaccine and recd 3 doses of VAXELIS which also counts as Hep B immunization.AE is being filed out of precaution for additional dose; This spontaneous safety report, with reference number 02498366, was received by a partner on 27-OCT-2023 and forwarded to Company on the same day, from a HCP.  The causal relationship between Vaxelis and the reported events "Pt initiated series with unknown Hepatitis B vaccine at 0 months. Patient then received VAXELIS at 2,4 &6 months. AE filed for misuse as Pt initiated series with Hepatitis B vaccine and recd 3 doses of VAXELIS which also counts as Hep B immunization" and " AE filed for misuse as Pt initiated series with Hepatitis B vaccine and recd 3 doses of VAXELIS which also counts as Hep B immunization.AE is being filed out of precaution for additional dose" was assessed as not applicable due to the nature of the event.  No further information is expected.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Immunodeficiency, Immunosuppressant drug therapy, Injury associated with device, Renal transplant
Clinical narrative: The patient is immunocompromised; Kidney transplant patient; Received the "Hep B" vaccine in the past and had not seroconverted/has had antibody levels drawn but the vaccine antibodies were not present after vaccination/had not seroconverted with prior "Hep B" vaccinations; Needle stick; This spontaneous report has been received from a pharmacist, regarding a female patient of unknown age. The patient's pertinent medical history, previous drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) intramuscular injection (reported as Hepatitis B vaccine), as prophylaxis (strength, dose, scheme, route and anatomical location of administration, lot number and expiration date were not reported).  She has had antibody levels drawn but the vaccine antibodies were not present after vaccination, she has not seroconverted (Hepatitis B antibody negative).  The patient reportedly, on an unspecified date, underwent a kidney transplant, which led her to take immunosuppressant and therefore being immunocompromised (immunodeficiency).   Then on 19-DEC-2023, the patient, who was a health care worker, got a needle stick (Injury associated with device).   The facility was going to vaccinate her with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) for the needle stick and wanted to determine if this patient needed the 40mcg because of her medical history.   The reported was inquiring if this was going to affect the dose of the vaccination, and if the dose needs to be increased since they haven't converted when she's received a Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) the past.  The outcome of the events was not provided.  The causal relationship between the aforementioned events and Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) was not reported.  Upon internal review, the event immunodeficiency and renal transplant were determined to be medically significant.
Sex: F
Vaccine: HEP
Symptoms: Seroconversion test negative
Clinical narrative: The patient is immunocompromised; Kidney transplant patient; Received the "Hep B" vaccine in the past and had not seroconverted/has had antibody levels drawn but the vaccine antibodies were not present after vaccination/had not seroconverted with prior "Hep B" vaccinations; Needle stick; This spontaneous report has been received from a pharmacist, regarding a female patient of unknown age. The patient's pertinent medical history, previous drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) intramuscular injection (reported as Hepatitis B vaccine), as prophylaxis (strength, dose, scheme, route and anatomical location of administration, lot number and expiration date were not reported).  She has had antibody levels drawn but the vaccine antibodies were not present after vaccination, she has not seroconverted (Hepatitis B antibody negative).  The patient reportedly, on an unspecified date, underwent a kidney transplant, which led her to take immunosuppressant and therefore being immunocompromised (immunodeficiency).   Then on 19-DEC-2023, the patient, who was a health care worker, got a needle stick (Injury associated with device).   The facility was going to vaccinate her with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) for the needle stick and wanted to determine if this patient needed the 40mcg because of her medical history.   The reported was inquiring if this was going to affect the dose of the vaccination, and if the dose needs to be increased since they haven't converted when she's received a Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) the past.  The outcome of the events was not provided.  The causal relationship between the aforementioned events and Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) was not reported.  Upon internal review, the event immunodeficiency and renal transplant were determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: she experienced outbreaks of shingles on her lower right back; This non-serious case was reported by a nurse via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several months after receiving Shingrix, the patient experienced shingles (Verbatim: she experienced outbreaks of shingles on her lower right back). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date:20-DEC-2023 The reporter was GlaxoSmithKline representative on behalf of health care professional (nurse). The heath care professional was the patient. The patient received first dose of Shingrix last year. A few months after the first dose she experienced outbreaks of shingles on her lower right back. The patient was currently experiencing outbreaks (at the time of reporting). The patient never received her second dose. The reporter consented to follow up.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: TE for VAXELIS that had been administered to a patient on 11/20/2023. The TE details were a low temp of 33.15F for 1 hour 8 minutes and 0 seconds on 11/18/2023 with zero previous excursions; This non-serious spontaneous safety report, with the reference number: 02513058 (interaction number: 02513010), was received by a partner on 27-NOV-2023 and forwarded on 28-NOV-2023, from a HCP.  Due to the nature of the event, the causality between the event "TE for VAXELIS (Lot #U7535AA expiration: 09/23/2025) that had been administered to a patient on 11/20/2023. The TE details were a low temp of 33.15F for 1 hour 8 minutes and 0 seconds on 11/18/2023 with zero previous excursions" and Vaxelis was assessed as not applicable.   This case shares the same event with the following companion cases: MCM-005551, MCM-005552, MCM-005554, MCM-005555, MCM-005556, MCM-005557, MCM-005558, MCM-005559, MCM-005560, and MCM-005563.   Further information is expected
Sex: U
Vaccine: PNC20
Symptoms: Pyrexia
Clinical narrative: experienced a fever within 30 hours of administration of Prevnar 20; This is a spontaneous report received from a Physician from a sales representative.  A 70-year-old patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), 30 hrs after the suspect product(s) administration, outcome "unknown", described as "experienced a fever within 30 hours of administration of Prevnar 20". It was unknown if therapeutic measures were taken as a result of pyrexia.  Additional information: Patient 70 years old experienced a fever within 30 hours of administration of Prevnar 20.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein), pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: PNC20
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: pneumonia; mention receiving the vaccine last year with his wife but recently both experiencing a mild case of pneumonia 3 weeks ago; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown", described as "mention receiving the vaccine last year with his wife but recently both experiencing a mild case of pneumonia 3 weeks ago"; PNEUMONIA (medically significant) with onset 2023, outcome "unknown". Clinical course was reported as follows: patient received the vaccine last year with his wife but both experienced a mild case of pneumonia 3 weeks before the report. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein), pneumococcal 20-val conj vac (dipht CRM197 protein)  will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300453529 Same product and event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Rest regimen, Swelling
Clinical narrative: Staying in bed for days; my body swelled up; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 3, single (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 (Dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunization. The following information was reported: REST REGIMEN (non-serious), outcome "unknown", described as "Staying in bed for days"; SWELLING (non-serious), outcome "unknown", described as "my body swelled up". Additional information: Patient received the 4th shot of Pfizer COVID-19 Vaccine). Patient got the 2 first ones a long time ago when the broke out came, patient got the 1st and 2nd. Then when the 3rd one came up patient did not get it, patient got the 4th one because the pharmacist said the COVID flu was worse then it was so patient got this, this would be the 4th one for everyone if they got it but the side effects are really bad on this one, patient was staying in bed for days, the body swelled up. This is really bad for the patient. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Headache, Pain in extremity
Clinical narrative: got Covid; got Covid; severe headache; her right arm hurts that feels like it was going to fall off; This is a spontaneous report received from a Nurse.  A 60-year-old female patient received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown), in 2020 as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2020, outcome "recovered", described as "her right arm hurts that feels like it was going to fall off"; HEADACHE (non-serious) with onset 2020, outcome "recovered", described as "severe headache"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "got Covid". It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19, headache, pain in extremity. Clinical course: After taking Pfizer Covid-19 vaccines (2 Doses and a booster) in 2020 (at the age Of 57 year old), she had a severe headache, and her right arm hurts that feels like it was going to fall off. She also stated that She got Covid anyway even after having these Pfizer vaccines. She was currently 60 year old. Patient did not had covid prior to the vaccination.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a relation with bnt162b2 vaccine in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: PNC20
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: mention receiving the vaccine last year with his wife but recently both experiencing a mild case of pneumonia 3 weeks ago; pneumonia; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown", described as "mention receiving the vaccine last year with his wife but recently both experiencing a mild case of pneumonia 3 weeks ago"; PNEUMONIA (medically significant) with onset 2023, outcome "unknown". Clinical course: the patient received the vaccine last year and got pneumonia this year but it was very mild.     The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein), pneumococcal 20-val conj vac (dipht CRM197 protein)  will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300452803 Same product and event, different patient;
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral atrophy
Clinical narrative: My brain shriveled up and I voted and watched news/Cerebral atrophy; This is a spontaneous report received from a Consumer or other non HCP.  A 40-year-old female patient (unknown if pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Dec2023 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years, in right gluteus medius for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBRAL ATROPHY (prolonged hospitalization, disability, medically significant, life threatening) with onset 25Dec2023 at 16:45, outcome "not recovered", described as "My brain shriveled up and I voted and watched news/Cerebral atrophy". The events "my brain shriveled up and i voted and watched news/cerebral atrophy" required physician office visit and emergency room visit. Clinical course: Patient also received other vaccine on 25Dec2023 (lot number: 666). It was reported that event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 70-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Lot number: Hg9498) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Sulfa Drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Vaccine lot number: GH9703, Anatomical location: right arm), administration date: 25Sep2022, when the patient was 69-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose 1; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (booster); Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid received from 06Dec2023 to 12Dec2023 for the treatment of covid-19.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 29Jul2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 55 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) 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 Dec2023, outcome "recovered" (Dec2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 10Dec2023 to 14Dec2023.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obese" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 13Dec2023 to 17Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 91-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 91 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "BPH" (unspecified if ongoing); "PAT" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical location: Right arm), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Right arm), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from Dec2023 to Dec2023. Clinical course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 40.0
Sex: M
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 Consumer or other non HCP.  A 40-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 at 15:00 as dose 1, single at the age of 40 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative, notes: After a negative test. Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 16Dec2023 to 20Dec2023.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Showed symptoms 14Dec, took test 15Dec - positive.; Showed symptoms 14Dec, took test 15Dec - positive.; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Dec2023, outcome "not recovered" and all described as "Showed symptoms 14Dec, took test 15Dec - positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Dec2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 15Dec2023 to 20Dec2023. Clinical course: Showed symptoms 14Dec, took test 15Dec - positive. Patient had no Known allergies.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  An 81-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (Booster), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (Booster), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (Booster), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 6 (Booster), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 7 (Booster), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant) with onset Dec2023, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Dec2023, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid treatment from 12Dec2023 treatment to 16Dec2023.  No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 45-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "GERD" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (20Dec2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Dec2023) Negative, notes: Tested negative day of last Paxlovid pill. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from15Dec2023 to 20Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 35-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Dec2023 at 19:00 as dose 1, single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ehlers danlos syndrome" (unspecified if ongoing); "allergies: Some adhesives" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: COVID-19 (non-serious) with onset Dec2023, outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19 with Paxlovid from 14Dec2023 to 19Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 68.0
Sex: F
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 Consumer or other non HCP.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: El9267), in left arm, on 31May2021 as dose 2, single (Lot number: El9253) and on 04Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Sep2022 as dose 4 (booster), single), in left arm and on 21Oct2023 at 14:00 as dose 5 (booster), single (Lot number: 3030371), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "Bronchiectasis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 09Dec2023 to 13Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300454994 Same patient/product, different dose (dose 2)/events.;
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE; UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE; UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: COVID 19 Treatment with Paxlovid; Treatment start date was on14Dec2023, Treatment stop date was on 19Dec2023, No known allergies.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 78-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Lot number: Gh9703) at the age of 77 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EN6201), in right arm, on 10Mar2021 as dose 2, single (Lot number: EN6206), in right arm and on 26Apr2022 as dose 3 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 10Oct2023 at 12:00 as dose 5 (booster), single (Lot number: 3031281), in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypercholesterolemia" (unspecified if ongoing); "hashimoto's thyroiditis with cysts" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing), notes: osteoarthritis; "known allergies: sulfa" (unspecified if ongoing); "cysts" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine"; Ponstel, reaction(s): "known allergies: ponstel"; Erythromycin, reaction(s): "known allergies: erythromycin"; Keflex, reaction(s): "known allergies: keflex"; Ibuprofen, reaction(s): "known allergies: ibuprofen". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Oct2023 at 12:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 from 13Dec2023 to 17Dec2023.