chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site swelling
Clinical narrative: Fever 100 Fahrenheit; Swelling on the injection site; She reports that her 15 month old son received 0.5 ml of Moderna COVID-19 vaccine 6M-11Y; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (Fever 100 Fahrenheit), VACCINATION SITE SWELLING (Swelling on the injection site) and OVERDOSE (She reports that her 15 month old son received 0.5 ml of Moderna COVID-19 vaccine 6M-11Y) in a 15-month-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Oct-2023, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 19-Oct-2023, the patient experienced PYREXIA (Fever 100 Fahrenheit), VACCINATION SITE SWELLING (Swelling on the injection site) and OVERDOSE (She reports that her 15 month old son received 0.5 ml of Moderna COVID-19 vaccine 6M-11Y). The patient was treated with PARACETAMOL (TYLENOL) (oral use) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever 100 Fahrenheit) and VACCINATION SITE SWELLING (Swelling on the injection site) had not resolved and OVERDOSE (She reports that her 15 month old son received 0.5 ml of Moderna COVID-19 vaccine 6M-11Y) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was provided.  It was mentioned that mother gave oral Tylenol and it was working. The fever was still going on. The patient has normal swelling on the injection site.   No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: He thinks it might be worse than a UTI; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (He thinks it might be worse than a UTI) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced IMMUNISATION REACTION (He thinks it might be worse than a UTI). At the time of the report, IMMUNISATION REACTION (He thinks it might be worse than a UTI) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient got the Spikevax 12+. The patient states he thinks he has to go to the hospital. He is supposed to get a UTI test tomorrow. He thinks it's getting worse.
Sex: F
Vaccine: UNK
Symptoms: Oropharyngeal pain
Clinical narrative: has a sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (has a sore throat) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Moderna Covid-19 vaccine (Dose 1 on 26-Feb-2021, lot number: 025M20A and expiration date was not known.), Moderna Covid-19 vaccine (Dose 2 on second 26-Mar-2021 and lot number and expiry date were not provided.). Past adverse reactions to the above products included No adverse event with Moderna Covid-19 vaccine; and Pain in arm with Moderna Covid-19 vaccine.    On 19-Oct-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (has a sore throat). At the time of the report, OROPHARYNGEAL PAIN (has a sore throat) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. The patient was driving and cannot provide more information on her previous doses.   This case was linked to US-MODERNATX, INC.-MOD-2023-746605 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746605:Same Reporter different Product (Moderna covid-19 vaccine )
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Injection site erythema, Interchange of vaccine products, Pain in extremity
Clinical narrative: The patient reports a very sore arm immediately; Red at the injection site; The patients first Covid-19 vaccine is a Pfizer vaccine/The patient received her first Moderna Covid-19 vaccine on July 13, 2021; Interchange of vaccine products; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (The patient reports a very sore arm immediately), INJECTION SITE ERYTHEMA (Red at the injection site), COVID-19 IMMUNISATION (The patients first Covid-19 vaccine is a Pfizer vaccine/The patient received her first Moderna Covid-19 vaccine on July 13, 2021) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in an elderly female patient who received mRNA-1273 (Spikevax) (batch nos. 092D21A and 085D21A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Pfizer (First COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Pfizer.   On 13-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Dec-2021, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (The patient reports a very sore arm immediately), INJECTION SITE ERYTHEMA (Red at the injection site), COVID-19 IMMUNISATION (The patients first Covid-19 vaccine is a Pfizer vaccine/The patient received her first Moderna Covid-19 vaccine on July 13, 2021) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, PAIN IN EXTREMITY (The patient reports a very sore arm immediately), INJECTION SITE ERYTHEMA (Red at the injection site), COVID-19 IMMUNISATION (The patients first Covid-19 vaccine is a Pfizer vaccine/The patient received her first Moderna Covid-19 vaccine on July 13, 2021) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant or treatment medications were provided.  The patients first Covid-19 vaccine is a Pfizer vaccine. After first Moderna Covid-19 vaccine, the patient reported a very sore arm immediately and red at the injection site. After second Moderna Covid-19 vaccine, the patient reported a sore arm and redness at the injection site.   This case was linked to US-MODERNATX, INC.-MOD-2023-746609 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746609:Master case (bivalent dose)
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus
Clinical narrative: Itchiness on the ankle and a day later she started to have itchiness on the groin area; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itchiness on the ankle and a day later she started to have itchiness on the groin area) in a 62-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Hashimoto's disease (in treatment with Levothyroxine), Penicillin allergy, Allergy to antibiotic (Amoxicillin allergy) and Allergy to plants (Poison Ivy allergy).    On 12-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 19-Oct-2023,  after starting , the patient experienced PRURITUS (Itchiness on the ankle and a day later she started to have itchiness on the groin area). At the time of the report, PRURITUS (Itchiness on the ankle and a day later she started to have itchiness on the groin area) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  On 19 OCT 2023 patient was having itchiness on the ankle and a day later she started to have itchiness on the groin area, the patient complained that the itching was getting worse at night.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscle tightness, Musculoskeletal stiffness, Myalgia
Clinical narrative: feeling muscle pain and it just flared up; Really bad back, muscles in back froze up and back is killing; Really bad back, muscles in back froze up and back is killing; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (feeling muscle pain and it just flared up), BACK PAIN (Really bad back, muscles in back froze up and back is killing) and MUSCULOSKELETAL STIFFNESS (Really bad back, muscles in back froze up and back is killing) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 19-Oct-2023, the patient experienced BACK PAIN (Really bad back, muscles in back froze up and back is killing) and MUSCULOSKELETAL STIFFNESS (Really bad back, muscles in back froze up and back is killing). On 20-Oct-2023, the patient experienced MYALGIA (feeling muscle pain and it just flared up). The patient was treated with IBUPROFEN (ANADVIL) at an unspecified dose and frequency. At the time of the report, MYALGIA (feeling muscle pain and it just flared up) had not resolved and BACK PAIN (Really bad back, muscles in back froze up and back is killing) and MUSCULOSKELETAL STIFFNESS (Really bad back, muscles in back froze up and back is killing) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered BACK PAIN (Really bad back, muscles in back froze up and back is killing) and MUSCULOSKELETAL STIFFNESS (Really bad back, muscles in back froze up and back is killing) to be not related. No further causality assessment was provided for MYALGIA (feeling muscle pain and it just flared up).    No concomitant medications were provided.  The patient felt arm sore for maybe a few days with previous Moderna doses, but with this new one, didn't feel anything at all, absolutely nothing and patient was also wanted to know, if it is possible that maybe the vaccination provider administered the vaccine wrong and maybe then the vaccine was not working.  The patient started having really bad back, muscles in back froze up and back is killing since yesterday but as per the patient it was not due to the vaccine, but mentioned the patient was feeling muscle pain and it just flared up and needed to leave the call to take Advil and cannot stay in the call too long and decided to finish the call.   This case was linked to US-MODERNATX, INC.-MOD-2023-746637 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746637:Same patient, different dose
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; Revaccination with different COVID-19 vaccine; she started feeling numbness in the arm that was injected; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (she started feeling numbness in the arm that was injected), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     It was unknown if the patient had any relevant medical history/conditions, allergy, concomitant diseases and risk factor.  Previously administered products included for COVID-19 prophylaxis: Pfizer (All previous COVID-19 and received were all Pfizer). Past adverse reactions to the above products included No adverse event with Pfizer.    On 19-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced HYPOAESTHESIA (she started feeling numbness in the arm that was injected). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, HYPOAESTHESIA (she started feeling numbness in the arm that was injected) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant or treatment medications were provided.  Caller wanted to know that, is it normal to have the adverse event and since all previous doses were Pfizer, does that make a difference if the patient received Moderna for the last dose.   Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Injection site pain, Malaise, Pain
Clinical narrative: feeling sick; aches and pains; low grade fever; aches and pains, soreness at the injection site; headache; exhausted; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feeling sick), MYALGIA (aches and pains), PYREXIA (low grade fever), INJECTION SITE PAIN (aches and pains, soreness at the injection site) and HEADACHE (headache) in a 50-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032472) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Pfizer (1st dose) on 07-Apr-2021, Pfizer (2nd dose) on 28-Apr-2021, Pfizer (Booster) on 01-Jan-2022 and Moderna bivalent on 09-Nov-2022. Past adverse reactions to the above products included No adverse event with Moderna bivalent, Pfizer, Pfizer and Pfizer.    On 18-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling sick), MYALGIA (aches and pains), PYREXIA (low grade fever), INJECTION SITE PAIN (aches and pains, soreness at the injection site), HEADACHE (headache) and FATIGUE (exhausted). At the time of the report, MALAISE (feeling sick), PYREXIA (low grade fever), INJECTION SITE PAIN (aches and pains, soreness at the injection site), HEADACHE (headache) and FATIGUE (exhausted) had not resolved and MYALGIA (aches and pains) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant or treatment medications were provided.  The patient was still feeling sick. Patient stated the reactions were not severe. The patient was very achy and exhausted all the time. The reactions got started about 12 hours after the shot on Wednesday night.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: feeling sick; aches and pains; low grade fever; aches and pains, soreness at the injection site; headache; exhausted; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feeling sick), MYALGIA (aches and pains), PYREXIA (low grade fever), INJECTION SITE PAIN (aches and pains, soreness at the injection site) and HEADACHE (headache) in a 50-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032472) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Pfizer (1st dose) on 07-Apr-2021, Pfizer (2nd dose) on 28-Apr-2021, Pfizer (Booster) on 01-Jan-2022 and Moderna bivalent on 09-Nov-2022. Past adverse reactions to the above products included No adverse event with Moderna bivalent, Pfizer, Pfizer and Pfizer.    On 18-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling sick), MYALGIA (aches and pains), PYREXIA (low grade fever), INJECTION SITE PAIN (aches and pains, soreness at the injection site), HEADACHE (headache) and FATIGUE (exhausted). At the time of the report, MALAISE (feeling sick), PYREXIA (low grade fever), INJECTION SITE PAIN (aches and pains, soreness at the injection site), HEADACHE (headache) and FATIGUE (exhausted) had not resolved and MYALGIA (aches and pains) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant or treatment medications were provided.  The patient was still feeling sick. Patient stated the reactions were not severe. The patient was very achy and exhausted all the time. The reactions got started about 12 hours after the shot on Wednesday night.
Age: 97.0
Sex: F
Vaccine: UNK
Symptoms: Malaise
Clinical narrative: caller was concerned because with previous Moderna doses his mother and other old people felt really sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (caller was concerned because with previous Moderna doses his mother and other old people felt really sick) in a 97-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (caller was concerned because with previous Moderna doses his mother and other old people felt really sick). At the time of the report, MALAISE (caller was concerned because with previous Moderna doses his mother and other old people felt really sick) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was provided.  Reporter stated that his brother was forcing his mother to get the Moderna COVID-19 Vaccine, but reporter was concerned because with previous Moderna doses his mother felt really sick.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-746711 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746711:other old people
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blindness, Blood glucose increased, Chills, Diplopia
Clinical narrative: Initially had severe fatigue, chills, headache, fever, then on December 3, I suffered bell's palsy right side, eye stroke (per ophthalmologist surgeon) on left side of face, tachycardia, shortness of breath, high glucose level, A1C went from 5.8 to 6.6, tinnitus, 2 sounds on left side and 4 on right side. All these events started on December 3, 2021 and worsened over the next several days.  It has been difficult dealing with this events as they still continue to this day.  I was unable to report sooner due to vision issues and lightheadness.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Glycosylated haemoglobin increased, Headache
Clinical narrative: Initially had severe fatigue, chills, headache, fever, then on December 3, I suffered bell's palsy right side, eye stroke (per ophthalmologist surgeon) on left side of face, tachycardia, shortness of breath, high glucose level, A1C went from 5.8 to 6.6, tinnitus, 2 sounds on left side and 4 on right side. All these events started on December 3, 2021 and worsened over the next several days.  It has been difficult dealing with this events as they still continue to this day.  I was unable to report sooner due to vision issues and lightheadness.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Retinal artery occlusion, Tachycardia, Tinnitus, Vision blurred
Clinical narrative: Initially had severe fatigue, chills, headache, fever, then on December 3, I suffered bell's palsy right side, eye stroke (per ophthalmologist surgeon) on left side of face, tachycardia, shortness of breath, high glucose level, A1C went from 5.8 to 6.6, tinnitus, 2 sounds on left side and 4 on right side. All these events started on December 3, 2021 and worsened over the next several days.  It has been difficult dealing with this events as they still continue to this day.  I was unable to report sooner due to vision issues and lightheadness.
Age: 53.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Fatigue, Headache, Influenza like illness, Pain, Pain in jaw
Clinical narrative: COVID Vaccination Sequence 1st Dose COVID vaccination: 24-Mar-2021 (Moderna Lot 008B21A) 2nd Dose COVID vaccination: 21-Apr-2021 (Moderna Lot 001C21A) Booster COVID vaccination: 24-Nov-2021 (Moderna Lot 058H21A) Booster COVID vaccination: 21-Oct-2023 (Spikevax 12+ Moderna Lot 3032169) This was the first time I had the shot combined with the flu shot. Same as with the first 3 COVID vaccinations I felt very tired and "flu-ish", had a slight headache and couldn't sleep well, but the first time I did not get nauseous like I did with the first three shots. On the evening of Tu, 24-Oct-2023 (all other symptoms had resided),  I had a sudden onset of pain in my left jaw joint, which still persists today at the time of this report. Chewing still causes significant pain. I am reporting this based on some medical reports I found online earlier today that it could potentially relate to the COVID vaccine.
Age: 53.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Poor quality sleep
Clinical narrative: COVID Vaccination Sequence 1st Dose COVID vaccination: 24-Mar-2021 (Moderna Lot 008B21A) 2nd Dose COVID vaccination: 21-Apr-2021 (Moderna Lot 001C21A) Booster COVID vaccination: 24-Nov-2021 (Moderna Lot 058H21A) Booster COVID vaccination: 21-Oct-2023 (Spikevax 12+ Moderna Lot 3032169) This was the first time I had the shot combined with the flu shot. Same as with the first 3 COVID vaccinations I felt very tired and "flu-ish", had a slight headache and couldn't sleep well, but the first time I did not get nauseous like I did with the first three shots. On the evening of Tu, 24-Oct-2023 (all other symptoms had resided),  I had a sudden onset of pain in my left jaw joint, which still persists today at the time of this report. Chewing still causes significant pain. I am reporting this based on some medical reports I found online earlier today that it could potentially relate to the COVID vaccine.
Sex: F
Vaccine: PNC20
Symptoms: Antibody test abnormal
Clinical narrative: antibody deficiency; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (10Oct2023), this case now contains all required information to be considered valid. 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 21-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GT0538) for immunisation, Device Lot Number: GT0538. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANTIBODY TEST ABNORMAL (non-serious), outcome "unknown", described as "antibody deficiency". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After receiving the vaccine, a blood test was performed to identify what antibodies she developed after receiving the vaccine. The blood work indicated that she only developed antibodies for serotype 19F. Patient stated that she developed a response to most but are low. Patient added that she also developed a response for serotype 33F. As of 10Oct2023, patient was tested for 14 serotypes on the blood work as she's being evaluated for antibody deficiency.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Age: 53.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 53-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 17:30 as dose 1, single (Lot number: 4d9835) at the age of 53 years, in left arm for covid- 19 immunisation; bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster ), single (Lot number: GJ5342), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9263), in left arm, on 14Feb2021 as dose 2, single (Lot number: EL9269), in left arm, on 11Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 10Apr2022 as dose 4 (booster), single (Lot number: Fj4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Disease" (unspecified if ongoing); "depression" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: THYROID, start date: 15Oct2019; PROGESTERONE, start date: 07Dec2020; ESTRADIOL, start date: 07Dec2020; TESTOSTERONE, start date: 15Apr2021; LEXAPRO, start date: 30May2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19, patient took Paxlovid from 30Sep2023 to 05Oct2023.
Age: 65.0
Sex: F
Vaccine: FLUX, PNC20
Symptoms: Asthenia, Blister, Headache, Injection site erythema, Injection site pain
Clinical narrative: Intense pain at injection/ very tender to touch anywhere where it is red; headache; fever; no energy; redness around the injection site; And blisters are beginning to form on the skin; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 65-year-old female patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20), on 14Oct2023 at 12:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for immunisation; influenza vaccine (FLU VACCINE VII), on 14Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Type 2 diabetic" (unspecified if ongoing), notes: Otherwise good health. Concomitant medication(s) included: JARDIANCE, start date: 01Jan2023. The following information was reported: BLISTER (non-serious) with onset 16Oct2023, outcome "not recovered", described as "And blisters are beginning to form on the skin"; VACCINATION SITE PAIN (non-serious) with onset 16Oct2023, outcome "not recovered", described as "Intense pain at injection/ very tender to touch anywhere where it is red"; PYREXIA (non-serious) with onset 16Oct2023, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 16Oct2023, outcome "not recovered"; ASTHENIA (non-serious) with onset 16Oct2023, outcome "not recovered", described as "no energy"; VACCINATION SITE ERYTHEMA (non-serious) with onset 16Oct2023, outcome "not recovered", described as "redness around the injection site". It was unknown if therapeutic measures were taken as a result of vaccination site pain, headache, pyrexia, asthenia, vaccination site erythema, blister.  Causality for "intense pain at injection/ very tender to touch anywhere where it is red", "headache", "fever", "no energy", "redness around the injection site" and "and blisters are beginning to form on the skin" was determined associated to device constituent of pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (malfunction).  Additional information: Started with severe reaction. Intense pain at injection, headache, fever, no energy. What's concerning is the redness around the injection site has spread and now includes most of the front of the forearm and is now wrapping around to the back. It is not pink it's red. And blisters are beginning to form on the skin. It is very tender to touch anywhere where it is red. Doctor prescribed antibiotics. But it doesn't appear to be an injection site antibiotic. Something to do with the injection medication is spreading through the forearm at present and seems to be intensifying its effect now into day five.  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein), pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: FLUX, PNC20
Symptoms: Pyrexia
Clinical narrative: Intense pain at injection/ very tender to touch anywhere where it is red; headache; fever; no energy; redness around the injection site; And blisters are beginning to form on the skin; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 65-year-old female patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20), on 14Oct2023 at 12:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for immunisation; influenza vaccine (FLU VACCINE VII), on 14Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Type 2 diabetic" (unspecified if ongoing), notes: Otherwise good health. Concomitant medication(s) included: JARDIANCE, start date: 01Jan2023. The following information was reported: BLISTER (non-serious) with onset 16Oct2023, outcome "not recovered", described as "And blisters are beginning to form on the skin"; VACCINATION SITE PAIN (non-serious) with onset 16Oct2023, outcome "not recovered", described as "Intense pain at injection/ very tender to touch anywhere where it is red"; PYREXIA (non-serious) with onset 16Oct2023, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 16Oct2023, outcome "not recovered"; ASTHENIA (non-serious) with onset 16Oct2023, outcome "not recovered", described as "no energy"; VACCINATION SITE ERYTHEMA (non-serious) with onset 16Oct2023, outcome "not recovered", described as "redness around the injection site". It was unknown if therapeutic measures were taken as a result of vaccination site pain, headache, pyrexia, asthenia, vaccination site erythema, blister.  Causality for "intense pain at injection/ very tender to touch anywhere where it is red", "headache", "fever", "no energy", "redness around the injection site" and "and blisters are beginning to form on the skin" was determined associated to device constituent of pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (malfunction).  Additional information: Started with severe reaction. Intense pain at injection, headache, fever, no energy. What's concerning is the redness around the injection site has spread and now includes most of the front of the forearm and is now wrapping around to the back. It is not pink it's red. And blisters are beginning to form on the skin. It is very tender to touch anywhere where it is red. Doctor prescribed antibiotics. But it doesn't appear to be an injection site antibiotic. Something to do with the injection medication is spreading through the forearm at present and seems to be intensifying its effect now into day five.  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein), pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) has been requested and will be submitted if and when received.
Sex: M
Vaccine: PNC20
Symptoms: Axillary pain, Extra dose administered, Headache, Pain
Clinical narrative: Gave me Prevnar 20 the second time; Slight headache; Under my arm, the site where the injection was, pain like raising my arm, kind of my armpit there is pain in that area; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID. The reporter is the patient.  A 65-year-old male patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 17Oct2023 as dose 2, single (Lot number: GY1934), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 20 (Dose 1), administration date: 2022. The following information was reported: HEADACHE (non-serious) with onset Oct2023, outcome "unknown", described as "Slight headache"; PAIN IN EXTREMITY (non-serious) with onset Oct2023, outcome "unknown", described as "Under my arm, the site where the injection was, pain like raising my arm, kind of my armpit there is pain in that area"; EXTRA DOSE ADMINISTERED (non-serious) with onset 17Oct2023, outcome "unknown", described as "Gave me Prevnar 20 the second time".  Additional information: The patient stated that he was injected with Prevnar 20 and he thought he needed 2 shots in the series. He thought he was going to get something different but they gave him Prevnar 20 the second time yesterday and now he is experiencing slight headache but under his arm, the site where the injection was, pain like raising his arm, kind of his armpit there is pain in that area; under the armpit not near the site but on the same arm that this was injected. Patient does not know if he was supposed to take Prevnar 13. He went to the pharmacist and they told him that he should be getting 2 doses of Prevnar 20 because he was over 65 so his question was, is that accurate, should he be getting 2 doses of Prevnar 20, 1 year apart or should he have been given something different the second time.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein) has been requested and will be submitted if and when received.
Age: 77.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 79-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: En6203), in left arm and on 31Mar2021 as dose 2, single (Lot number: Fp7534) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing), notes: HBP; "History of diverticulitis" (unspecified if ongoing), notes: History of diverticulitis; "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: BENICAR HCT oral, start date: 01Jan2015. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: friend became sick; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non-HCP).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown" described as "friend became sick."  Additional information: Another person mentioned that a friend became sick after taking an unknown COVID vaccine.   The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Sex: F
Vaccine: RSV
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: injection site is itchy; warm to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE PRURITUS (non-serious) with onset 19Oct2023, outcome "unknown", described as "injection site is itchy"; INJECTION SITE WARMTH (non-serious) with onset 19Oct2023, outcome "unknown", described as "warm to touch". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-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: "Glaucoma" (unspecified if ongoing); "pericardial effusion" (unspecified if ongoing). Concomitant medication(s) included: COSOPT PF. 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (Oct2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: Rebound symptoms one week after testing negative.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335758 Same patient, different drug, different event;
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bronchiectasis" (unspecified if ongoing); "mycobacterial colonization of lungs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "Known allergies: clindamycin"; Penicillin, reaction(s): "Known allergies: Penicillin". 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; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19 with Paxlovid from 07Oct2023 to 11Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335759 same reporter/patient, different product/AE;
Sex: M
Vaccine: RSV
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: injection site is itchy; warm to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "injection site is itchy"; VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "warm to touch".  Additional information: the patient received Abrysvo and experienced the injection site was itchy and warm to touch.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335666 same reporter/drug/event; different patient;
Age: 68.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm 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 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 Oct2023, outcome "recovered" (Oct2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Oct2023) Negative, notes: Tested negative on 17Oct and 18Oct; (18Oct2023) Negative, notes: Tested negative on 17Oct and 18Oct. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 11Oct2023 to 15Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335853 same patient, different drug and event;
Age: 78.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Lot number: HF9275) at the age of 78 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE), administration date: 25Jan2021, for COVID-19 immunisation; bnt162b2 (DOSE 2, SINGLE, Batch/Lot Number: EL9266, Anatomical location: Arm Left), administration date: 13Feb2021, for COVID-19 immunisation; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot Number: FF2590, Anatomical location: Arm Left), administration date: 07Oct2021, for COVID-19 immunisation; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot Number: FP4454, Anatomical location: Arm Left), administration date: 02Jun2022, for COVID-19 immunisation; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot Number: GH9702, Anatomical location: Arm Left), administration date: 20Oct2022, for COVID-19 immunisation; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 6 (BOOSTER), SINGLE, Anatomical location: Arm Left), administration date: 27Apr2023, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Oct2023 at 00:30, outcome "recovered" (19Oct2023) and all described as "Treatment of COVID-19". The event "treatment of covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Oct2023) Positive, notes: I developed symptoms the night of 14Oct. I took a home test which was positive; (19Oct2023) Negative, notes: I had no symptoms and tested negative with a home test on thursday, 19Oct. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 14Oct2023 to 19Oct2023. Clinical Course: Patient developed symptoms the night of 14Oct2023. He took a home test which was positive. He then went to urgent care where the diagnosis was confirmed and a prescription for Paxlovid issued. He started it the evening of the 14 and finished it on the morning of 19Oct2023. Known allergies none that he knew of, but he haven't tried them all.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335899 same patient, different drug and event;