chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RSV, RSV
Symptoms: Arthralgia, Asthenia, Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: pain in her shoulders; pain in the back of her legs; inhibited her from sitting down properly and from getting up out of bed at night; It was very painful to sit down on the stool; She has weakness; If she's not using a certain muscle for 30 minutes or so this pain and weakness sets in.; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 10Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "knee injury" (unspecified if ongoing), notes: She had a previous knee injury from gardening a few years back. The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset Nov2023, outcome "unknown", described as "If she's not using a certain muscle for 30 minutes or so this pain and weakness sets in."; PAIN (non-serious) with onset Nov2023, outcome "not recovered", described as "It was very painful to sit down on the stool"; ASTHENIA (non-serious) with onset Nov2023, outcome "unknown", described as "She has weakness"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Nov2023, outcome "unknown", described as "inhibited her from sitting down properly and from getting up out of bed at night"; ARTHRALGIA (non-serious) with onset Nov2023, outcome "not recovered", described as "pain in her shoulders"; PAIN IN EXTREMITY (non-serious) with onset Nov2023, outcome "not recovered", described as "pain in the back of her legs". Additional information: patient stated that she received the Abrysvo vaccine on 10Nov2023 and 3-4 days later developed a lot of pain in her shoulders and the back of her legs that inhibited her from sitting down properly and from getting up out of bed at night to use the bathroom.  It was very painful to sit down on the stool. The pain is continuing and she wanted to know if this was something associated with the vaccine weeks later and if this would resolve on it's own.  She has weakness that makes it hard to get up and to bend down to pick things up. She had a previous knee injury from gardening a few years back. If she's not using a certain muscle for 30 minutes or so this pain and weakness sets in.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.
Sex: F
Vaccine: RSV, RSV
Symptoms: Pain, Pain in extremity
Clinical narrative: pain in her shoulders; pain in the back of her legs; inhibited her from sitting down properly and from getting up out of bed at night; It was very painful to sit down on the stool; She has weakness; If she's not using a certain muscle for 30 minutes or so this pain and weakness sets in.; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 10Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "knee injury" (unspecified if ongoing), notes: She had a previous knee injury from gardening a few years back. The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset Nov2023, outcome "unknown", described as "If she's not using a certain muscle for 30 minutes or so this pain and weakness sets in."; PAIN (non-serious) with onset Nov2023, outcome "not recovered", described as "It was very painful to sit down on the stool"; ASTHENIA (non-serious) with onset Nov2023, outcome "unknown", described as "She has weakness"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Nov2023, outcome "unknown", described as "inhibited her from sitting down properly and from getting up out of bed at night"; ARTHRALGIA (non-serious) with onset Nov2023, outcome "not recovered", described as "pain in her shoulders"; PAIN IN EXTREMITY (non-serious) with onset Nov2023, outcome "not recovered", described as "pain in the back of her legs". Additional information: patient stated that she received the Abrysvo vaccine on 10Nov2023 and 3-4 days later developed a lot of pain in her shoulders and the back of her legs that inhibited her from sitting down properly and from getting up out of bed at night to use the bathroom.  It was very painful to sit down on the stool. The pain is continuing and she wanted to know if this was something associated with the vaccine weeks later and if this would resolve on it's own.  She has weakness that makes it hard to get up and to bend down to pick things up. She had a previous knee injury from gardening a few years back. If she's not using a certain muscle for 30 minutes or so this pain and weakness sets in.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19, FLUC4, COVID19, FLUC4
Symptoms: Ear inflammation, Headache, Tinnitus
Clinical narrative: ringing in both ears; Both inner ears feel inflamed and pounding; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Dec2023 at 12:00 as dose 1, single (Lot number: HG4671) at the age of 37 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUAD), on 09Dec2023 as dose 1, single (Lot number: 944461), in left arm. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: pfizer 12yr+ COVID-19 bivalent bivalent (Dose 3, Batch/Lot No: GJ3277, Location of injection: Arm Right, Vaccine Administration Time: 05:00 PM), administration date: 19Oct2022, when the patient was 36-year-old, for COVID-19 immunisation; COVID-19, monovalent, mrna, pfizer, 12+ yrs (Dose 2, Batch/Lot No: EW0177, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 12Jun2021, when the patient was 35-year-old, for COVID-19 immunisation; COVID-19, monovalent, mrna, pfizer, 12+ yrs (Dose 1, Batch/Lot No: EW0185, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 22May2021, when the patient was 35-year-old, for COVID-19 immunisation. The following information was reported: INNER EAR INFLAMMATION (non-serious) with onset 10Dec2023 at 17:00, outcome "not recovered", described as "Both inner ears feel inflamed and pounding"; TINNITUS (non-serious) with onset 10Dec2023 at 17:00, outcome "not recovered", described as "ringing in both ears". It was unknown if therapeutic measures were taken as a result of tinnitus, inner ear inflammation.  Additional information: No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. 24 hours after the vaccine (as reported), patient started experiencing ringing in both ears but especially acute in the right ear. It's been more than 72 hours by now and the ringing is still continuing. Both inner ears feel inflamed and pounding when walking or hearing loud noises.  The information on the batch/lot number for BNT162b2 omi xbb.1.5  will be requested and submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19, FLUC4, COVID19, FLUC4
Symptoms: Inner ear inflammation, Tinnitus
Clinical narrative: ringing in both ears; Both inner ears feel inflamed and pounding; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Dec2023 at 12:00 as dose 1, single (Lot number: HG4671) at the age of 37 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUAD), on 09Dec2023 as dose 1, single (Lot number: 944461), in left arm. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: pfizer 12yr+ COVID-19 bivalent bivalent (Dose 3, Batch/Lot No: GJ3277, Location of injection: Arm Right, Vaccine Administration Time: 05:00 PM), administration date: 19Oct2022, when the patient was 36-year-old, for COVID-19 immunisation; COVID-19, monovalent, mrna, pfizer, 12+ yrs (Dose 2, Batch/Lot No: EW0177, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 12Jun2021, when the patient was 35-year-old, for COVID-19 immunisation; COVID-19, monovalent, mrna, pfizer, 12+ yrs (Dose 1, Batch/Lot No: EW0185, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 22May2021, when the patient was 35-year-old, for COVID-19 immunisation. The following information was reported: INNER EAR INFLAMMATION (non-serious) with onset 10Dec2023 at 17:00, outcome "not recovered", described as "Both inner ears feel inflamed and pounding"; TINNITUS (non-serious) with onset 10Dec2023 at 17:00, outcome "not recovered", described as "ringing in both ears". It was unknown if therapeutic measures were taken as a result of tinnitus, inner ear inflammation.  Additional information: No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. 24 hours after the vaccine (as reported), patient started experiencing ringing in both ears but especially acute in the right ear. It's been more than 72 hours by now and the ringing is still continuing. Both inner ears feel inflamed and pounding when walking or hearing loud noises.  The information on the batch/lot number for BNT162b2 omi xbb.1.5  will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19-2, COVID19
Symptoms: Biopsy skin abnormal, Drug eruption, Pruritus, Rash, Superficial inflammatory dermatosis
Clinical narrative: Perivascular Dermatitis; This is a spontaneous report received from a Consumer or other non HCP.  An adult patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUPERFICIAL INFLAMMATORY DERMATOSIS (medically significant) with onset Nov2023, outcome "unknown", described as "Perivascular Dermatitis". The event "perivascular dermatitis" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: (Nov2023) Perivascular Dermatitis. Therapeutic measures were taken as a result of superficial inflammatory dermatosis.  Clinical course: The patient had the Covid booster on 01Nov2023 and developed an itchy rash a day and a half later. After three weeks, two doctor visits and a steroid shot, patient was seen by a dermatologist. The area was biopsied and result was "Perivascular Dermatitis". Patient asked if Pfizer had anyone with this reaction. If so, it was asked what is recommended patient care. No one can give patient the answer, so was doing their job and reaching out to Pfizer.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19-2, COVID19
Symptoms: Biopsy, Superficial inflammatory dermatosis
Clinical narrative: Perivascular Dermatitis; This is a spontaneous report received from a Consumer or other non HCP.  An adult patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUPERFICIAL INFLAMMATORY DERMATOSIS (medically significant) with onset Nov2023, outcome "unknown", described as "Perivascular Dermatitis". The event "perivascular dermatitis" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: (Nov2023) Perivascular Dermatitis. Therapeutic measures were taken as a result of superficial inflammatory dermatosis.  Clinical course: The patient had the Covid booster on 01Nov2023 and developed an itchy rash a day and a half later. After three weeks, two doctor visits and a steroid shot, patient was seen by a dermatologist. The area was biopsied and result was "Perivascular Dermatitis". Patient asked if Pfizer had anyone with this reaction. If so, it was asked what is recommended patient care. No one can give patient the answer, so was doing their job and reaching out to Pfizer.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pruritus, Injection site rash, Pruritus, Rash
Clinical narrative: He got his vaccine, had some mild sensation at the point of the vaccine, a little bit of sensitivity for a day or two and it went away.  He then started having itching on his back and got his wooden back scratcher and scratched it.  It did not go away and felt that he may have had a bed bug and it was very localized.  It stayed itchy for the better part of a week.  It seemed to grow on a larger part of his back.  Then he started getting itching on his chest and upper abdomen.  Then his arms started breaking out, left arm worse than the right.  Since about 2 2 1/2 weeks ago and 3 days it was deep red in color, swelling from the back of his left hand, all the way to about 4 1/2" in chest above his elbow, around his arm, skin was started to flake off and very heavy.  Then he had some on the lower part of his left arm from the blow to his wrist and not as bad as the right arm did.    His brother who is a dermatologist told him that it must be from the vaccine.  The area from his shoulder to his chest is clear, which is above where he got the shot.  He read some stuff about the Moderna shot that there was a new variant on the COVID and that they had made an adaptation for on this vaccine, and maybe that change was why he was reacting to it.  He had had the other vaccines and no reactions to them.   He put some creams that made it worse, and was reading about what people were using and read that Vaseline and Benadryl to use, so he used them and the Benadryl is helping keep the itching some, and has been putting hot water on the spots and has reduced the inflammation.  He did stop in to a dermatologist office and talked to them, but he has not seen a dermatologist other than speaking to his brother who is a dermatologist.    His brother thinks that things are related to candida and that if that's treated then that will resolve his problems.    The itching has gone down, has not had any today, and has taken less Benadryl today.  He still has some areas on his chest, and has scabs from scratching them, but they are almost gone.  He has also had rashes in his groin which have also almost gone as well.  His back is not itching anymore, and his arms get itchy some, but it is rare and they are improving as well.  When he woke up this morning and they felt pretty good, and then about an hour and half later they started itching again, and he took 25 mg of Benadryl and about 15 minutes later the itching disappeared and they have been fine since then.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Injection site reaction, Peripheral swelling, Pruritus, Rash
Clinical narrative: He got his vaccine, had some mild sensation at the point of the vaccine, a little bit of sensitivity for a day or two and it went away.  He then started having itching on his back and got his wooden back scratcher and scratched it.  It did not go away and felt that he may have had a bed bug and it was very localized.  It stayed itchy for the better part of a week.  It seemed to grow on a larger part of his back.  Then he started getting itching on his chest and upper abdomen.  Then his arms started breaking out, left arm worse than the right.  Since about 2 2 1/2 weeks ago and 3 days it was deep red in color, swelling from the back of his left hand, all the way to about 4 1/2" in chest above his elbow, around his arm, skin was started to flake off and very heavy.  Then he had some on the lower part of his left arm from the blow to his wrist and not as bad as the right arm did.    His brother who is a dermatologist told him that it must be from the vaccine.  The area from his shoulder to his chest is clear, which is above where he got the shot.  He read some stuff about the Moderna shot that there was a new variant on the COVID and that they had made an adaptation for on this vaccine, and maybe that change was why he was reacting to it.  He had had the other vaccines and no reactions to them.   He put some creams that made it worse, and was reading about what people were using and read that Vaseline and Benadryl to use, so he used them and the Benadryl is helping keep the itching some, and has been putting hot water on the spots and has reduced the inflammation.  He did stop in to a dermatologist office and talked to them, but he has not seen a dermatologist other than speaking to his brother who is a dermatologist.    His brother thinks that things are related to candida and that if that's treated then that will resolve his problems.    The itching has gone down, has not had any today, and has taken less Benadryl today.  He still has some areas on his chest, and has scabs from scratching them, but they are almost gone.  He has also had rashes in his groin which have also almost gone as well.  His back is not itching anymore, and his arms get itchy some, but it is rare and they are improving as well.  When he woke up this morning and they felt pretty good, and then about an hour and half later they started itching again, and he took 25 mg of Benadryl and about 15 minutes later the itching disappeared and they have been fine since then.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Scab, Skin exfoliation
Clinical narrative: He got his vaccine, had some mild sensation at the point of the vaccine, a little bit of sensitivity for a day or two and it went away.  He then started having itching on his back and got his wooden back scratcher and scratched it.  It did not go away and felt that he may have had a bed bug and it was very localized.  It stayed itchy for the better part of a week.  It seemed to grow on a larger part of his back.  Then he started getting itching on his chest and upper abdomen.  Then his arms started breaking out, left arm worse than the right.  Since about 2 2 1/2 weeks ago and 3 days it was deep red in color, swelling from the back of his left hand, all the way to about 4 1/2" in chest above his elbow, around his arm, skin was started to flake off and very heavy.  Then he had some on the lower part of his left arm from the blow to his wrist and not as bad as the right arm did.    His brother who is a dermatologist told him that it must be from the vaccine.  The area from his shoulder to his chest is clear, which is above where he got the shot.  He read some stuff about the Moderna shot that there was a new variant on the COVID and that they had made an adaptation for on this vaccine, and maybe that change was why he was reacting to it.  He had had the other vaccines and no reactions to them.   He put some creams that made it worse, and was reading about what people were using and read that Vaseline and Benadryl to use, so he used them and the Benadryl is helping keep the itching some, and has been putting hot water on the spots and has reduced the inflammation.  He did stop in to a dermatologist office and talked to them, but he has not seen a dermatologist other than speaking to his brother who is a dermatologist.    His brother thinks that things are related to candida and that if that's treated then that will resolve his problems.    The itching has gone down, has not had any today, and has taken less Benadryl today.  He still has some areas on his chest, and has scabs from scratching them, but they are almost gone.  He has also had rashes in his groin which have also almost gone as well.  His back is not itching anymore, and his arms get itchy some, but it is rare and they are improving as well.  When he woke up this morning and they felt pretty good, and then about an hour and half later they started itching again, and he took 25 mg of Benadryl and about 15 minutes later the itching disappeared and they have been fine since then.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Haemorrhage, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: He got his vaccine, had some mild sensation at the point of the vaccine, a little bit of sensitivity for a day or two and it went away.  He then started having itching on his back and got his wooden back scratcher and scratched it.  It did not go away and felt that he may have had a bed bug and it was very localized.  It stayed itchy for the better part of a week.  It seemed to grow on a larger part of his back.  Then he started getting itching on his chest and upper abdomen.  Then his arms started breaking out, left arm worse than the right.  Since about 2 2 1/2 weeks ago and 3 days it was deep red in color, swelling from the back of his left hand, all the way to about 4 1/2" in chest above his elbow, around his arm, skin was started to flake off and very heavy.  Then he had some on the lower part of his left arm from the blow to his wrist and not as bad as the right arm did.    His brother who is a dermatologist told him that it must be from the vaccine.  The area from his shoulder to his chest is clear, which is above where he got the shot.  He read some stuff about the Moderna shot that there was a new variant on the COVID and that they had made an adaptation for on this vaccine, and maybe that change was why he was reacting to it.  He had had the other vaccines and no reactions to them.   He put some creams that made it worse, and was reading about what people were using and read that Vaseline and Benadryl to use, so he used them and the Benadryl is helping keep the itching some, and has been putting hot water on the spots and has reduced the inflammation.  He did stop in to a dermatologist office and talked to them, but he has not seen a dermatologist other than speaking to his brother who is a dermatologist.    His brother thinks that things are related to candida and that if that's treated then that will resolve his problems.    The itching has gone down, has not had any today, and has taken less Benadryl today.  He still has some areas on his chest, and has scabs from scratching them, but they are almost gone.  He has also had rashes in his groin which have also almost gone as well.  His back is not itching anymore, and his arms get itchy some, but it is rare and they are improving as well.  When he woke up this morning and they felt pretty good, and then about an hour and half later they started itching again, and he took 25 mg of Benadryl and about 15 minutes later the itching disappeared and they have been fine since then.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Psoriasis, Skin exfoliation, Skin fragility
Clinical narrative: He got his vaccine, had some mild sensation at the point of the vaccine, a little bit of sensitivity for a day or two and it went away.  He then started having itching on his back and got his wooden back scratcher and scratched it.  It did not go away and felt that he may have had a bed bug and it was very localized.  It stayed itchy for the better part of a week.  It seemed to grow on a larger part of his back.  Then he started getting itching on his chest and upper abdomen.  Then his arms started breaking out, left arm worse than the right.  Since about 2 2 1/2 weeks ago and 3 days it was deep red in color, swelling from the back of his left hand, all the way to about 4 1/2" in chest above his elbow, around his arm, skin was started to flake off and very heavy.  Then he had some on the lower part of his left arm from the blow to his wrist and not as bad as the right arm did.    His brother who is a dermatologist told him that it must be from the vaccine.  The area from his shoulder to his chest is clear, which is above where he got the shot.  He read some stuff about the Moderna shot that there was a new variant on the COVID and that they had made an adaptation for on this vaccine, and maybe that change was why he was reacting to it.  He had had the other vaccines and no reactions to them.   He put some creams that made it worse, and was reading about what people were using and read that Vaseline and Benadryl to use, so he used them and the Benadryl is helping keep the itching some, and has been putting hot water on the spots and has reduced the inflammation.  He did stop in to a dermatologist office and talked to them, but he has not seen a dermatologist other than speaking to his brother who is a dermatologist.    His brother thinks that things are related to candida and that if that's treated then that will resolve his problems.    The itching has gone down, has not had any today, and has taken less Benadryl today.  He still has some areas on his chest, and has scabs from scratching them, but they are almost gone.  He has also had rashes in his groin which have also almost gone as well.  His back is not itching anymore, and his arms get itchy some, but it is rare and they are improving as well.  When he woke up this morning and they felt pretty good, and then about an hour and half later they started itching again, and he took 25 mg of Benadryl and about 15 minutes later the itching disappeared and they have been fine since then.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 31-AUG-2007 (age wrong); This case was split from a legal case (2311USA004702) regarding an 8-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were in case 2311USA004702.  On 29-AUG-2000 and 31-AUG-2007 (product administered to patient of inappropriate age), the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) injection for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2311USA004702:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Headache, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: I got the new, uh COVID, uh, Moderna booster on the 13th of December. And I, um, was wondering if I test positive, um, because I've had a headache and some swollen glands; I got the new, uh COVID, uh, Moderna booster on the 13th of December. And I, um, was wondering if I test positive, um, because I've had a headache and some swollen glands; I tested myself for COVID and it was positive; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (I got the new, uh COVID, uh, Moderna booster on the 13th of December. And I, um, was wondering if I test positive, um, because I've had a headache and some swollen glands), LYMPHADENOPATHY (I got the new, uh COVID, uh, Moderna booster on the 13th of December. And I, um, was wondering if I test positive, um, because I've had a headache and some swollen glands) and COVID-19 (I tested myself for COVID and it was positive) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna (never had swollen glands with the other actual Moderna shots.). Past adverse reactions to the above products included No adverse event with Moderna.    On 13-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced HEADACHE (I got the new, uh COVID, uh, Moderna booster on the 13th of December. And I, um, was wondering if I test positive, um, because I've had a headache and some swollen glands), LYMPHADENOPATHY (I got the new, uh COVID, uh, Moderna booster on the 13th of December. And I, um, was wondering if I test positive, um, because I've had a headache and some swollen glands) and COVID-19 (I tested myself for COVID and it was positive). At the time of the report, HEADACHE (I got the new, uh COVID, uh, Moderna booster on the 13th of December. And I, um, was wondering if I test positive, um, because I've had a headache and some swollen glands), LYMPHADENOPATHY (I got the new, uh COVID, uh, Moderna booster on the 13th of December. And I, um, was wondering if I test positive, um, because I've had a headache and some swollen glands) and COVID-19 (I tested myself for COVID and it was positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: headache; Fever on and off, too cold and too hot.; Caller says they still can't touch their left arms because it is still painful at the injection site; very very tired; could not even stand up; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (could not even stand up), HEADACHE (headache), PYREXIA (Fever on and off, too cold and too hot.), INJECTION SITE PAIN (Caller says they still can't touch their left arms because it is still painful at the injection site) and FATIGUE (very very tired) in a 12-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058877) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu shot on 10-Nov-2023. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Penicillin allergy.    On 15-Dec-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 15-Dec-2023, the patient experienced HEADACHE (headache), PYREXIA (Fever on and off, too cold and too hot.) and INJECTION SITE PAIN (Caller says they still can't touch their left arms because it is still painful at the injection site). In December 2023, the patient experienced DYSSTASIA (could not even stand up) and FATIGUE (very very tired). At the time of the report, DYSSTASIA (could not even stand up) and FATIGUE (very very tired) outcome was unknown and HEADACHE (headache), PYREXIA (Fever on and off, too cold and too hot.) and INJECTION SITE PAIN (Caller says they still can't touch their left arms because it is still painful at the injection site) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Caller reported about two daughters who received the vaccine on 15-Dec-2023, 6 to 7 pm. In the evening patient was okay, but they were supposed to go to school in the morning, but they could not go. They got sick, headache, fever, very tired, could not even stand up. They had plans to attend some activities and they could not do it. They would wake up and only could drink water and nothing else. Didn't eat anything and could barely drink water.   This case was linked to US-MODERNATX, INC.-MOD-2023-754048 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-754048:Patient 2
Sex: U
Vaccine: PNC13
Symptoms: Poor quality product administered
Clinical narrative: product quality complaint for Prevnar 13/the product was defective because it had something floating in it; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 06Dec2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Nurse from product quality group.  A patient (age and gender not provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Lot number: EX1980, Expiration Date: 31Jan2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "product quality complaint for Prevnar 13/the product was defective because it had something floating in it". Additional information: a product quality complaint for Prevnar 13 and was filed yesterday and now would like to clarify if the vaccine that was affected should be returned to Pfizer or returned to Health Authority from where they ordered it as the person she spoke with was not clear about that. No patients were administered the affected Prevnar 13. The vaccine lot is EX1980, expiry date Jan2024 and NDC 0005197101 and for the reported event, states she took the syringe out of the refrigerator and noticed like a white matter in the syringe about 4mm long and did show it to another nurse who also observed this in this Prevnar 13 as well and then just by toughing it, it kind of went away and she is looking at it now and can see a little bit of that and does not think they shook it enough and she had never seen anything like that before. Caller states the product was defective because it had something floating in it, they should have shaken it more than they did.   Causality for "product quality complaint for prevnar 13/the product was defective because it had something floating in it" was determined associated to device constituent of pneumococcal 13-val conj vac (dipht CRM197 protein) (malfunction).  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein)  will be requested and submitted if and when received.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Pain at injection site; fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Dec2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Dec2023, outcome "recovering", described as "Pain at injection site"; PYREXIA (non-serious) with onset Dec2023, outcome "unknown", described as "fever". Additional information: the patient had no drug allergy. He did not received any other vaccines within 4 weeks prior to the COVID vaccine. He received atorvastatin within 2 weeks of vaccination. Prior to the vaccination, he was not diagnosed with COVID-19, and since the vaccination, he was not tested for COVID-19. He had pain at the injection site the following day, and fever on the second night.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Rash, Restless legs syndrome
Clinical narrative: Woke up with a rash on my face which is dense moved down all the way down my body; face was very flush; Restless legs; Leg cramps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 82 years, in left arm for covid-19 immunisation; ropinirole (ROPINIROLE), (Lot number: Unknown, Expiration Date: 12Jul2024); quinine (QUININE), (Lot number: Unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (Dose 1, Lot No. EL3302), administration date: 22Jan2021, for COVID-19 immunisation; Bnt162b2 (Dose 2, Lot No. EL9265), administration date: Feb2021, for COVID-19 immunisation; Bnt162b2 (Dose 3, Lot No. FF2590), administration date: Oct2021, for COVID-19 immunisation; Bnt162b2 (Dose 4, Lot No. BGJ3277), administration date: Oct2022, for COVID-19 immunisation; Moderna (Dose 5), for COVID-19 immunisation. The following information was reported: MUSCLE SPASMS (non-serious) with onset 08Dec2023, outcome "unknown", described as "Leg cramps"; RESTLESS LEGS SYNDROME (non-serious) with onset 08Dec2023, outcome "unknown", described as "Restless legs"; RASH (non-serious) with onset 08Dec2023, outcome "unknown", described as "Woke up with a rash on my face which is dense moved down all the way down my body; face was very flush". The action taken for ropinirole and quinine was unknown. Therapeutic measures were taken as a result of rash.  Additional information: Consumer stated, "I had my second COVID shot on Tuesday and had no ill effects at all, not have  with any of the previous, the first one I had on the COVID-19 was Moderna but this one was of Pfizer (Captured Pfizer COVID-19 Vaccine) and this was Tuesday Friday morning I woke up with a rash on my face which is dense moved down all the way down my body you know my face was very flush also, during this time my doctor is taking me off of the Ropinirole and putting me on, they put me on another drug for my leg cramp, so I was having ill effects from being for my Ropinirole legs. The other vaccine was Moderna. Okay, because I was having ill effects from weaning off my drug. I took Quinine which I had previously been allergic to it and the effects were not the rash they were nerve twitching but this time when I had the rash I attributed it to the the fact that I had Tonic water Quinine to relive my symptoms restless legs. So, I do not know if my rash is from that from that the quinine or if it could be from the vaccine four days after I received it. Consumer stated, "I drink Tonic water which contains Quinine which helps with restless legs. Tonic water. Yes, the leg cramps are not resolved of anything, that is the chronic condition I have and have had all my life. Consumer stated, "I used some cortisone cream on my face and neck. Cortisone I think. Cortisone 10.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore spot on my arm; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An elderly patient received BNT162b2 (BNT162B2 NOS), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore spot on my arm". Additional information: Caller expressed confidence and comfort in Pfizer products and stated, "I have had all the Covid vaccinations made by you.  I had hardly any reaction to the Pfizer Covid 19 vaccines.  The only reaction was slightly sore spot on my arm after each one and that was it.  I think I have had at least 4, maybe 5, Pfizer Covid 19 vaccines."  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 48.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years, in right 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 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.   The following information was reported: VACCINATION FAILURE (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 vaccination failure, covid-19.  Clinical information: Patient received Paxlovid (Lot number: Gk5810) from 02Dec2023 to 06Dec2023 for the treatment of COVID-19. Patient had no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got very sick after each one; This is a spontaneous report received from a Consumer or other non HCP, Program ID: 201253.  A 76-year-old female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, Lot number: unknown), for COVID-19 immunisation, reaction(s): "got very sick after each one". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got very sick after each one".  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-PV202300202397 same patient/suspect drug/similar events, different dose number;US-PFIZER INC-202300444910 same patient/suspect drug/similar events, different dose number;
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: got very sick after each one; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "got very sick after each one".  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-202300444909 same patient/suspect drug/similar events, different dose number;
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 contactable reporter(s) (Physician). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Lot number: HH7595), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mango allergy" (unspecified if ongoing); "obesity" (unspecified if ongoing); "pcos" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Aspirin allergy". Vaccination history included: moderna (DOSE 1, SINGLE, Batch/Lot No: 028L20A), administration date: 09Feb2021, when the patient was 39-year-old, for COVID-19 immunization; moderna (DOSE 2, SINGLE, Batch/Lot No: 016M20), administration date: 10Mar2021, when the patient was 39-year-old, for COVID-19 immunization; moderna (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: 039F21A), administration date: 29Oct2021, when the patient was 40-year-old, for COVID-19 immunization; moderna (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: 051B22A), administration date: 15Jul2022, when the patient was 40-year-old, for COVID-19 immunization; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot No: GH9697, Location of injection: Arm Left), administration date: 28Oct2022, when the patient was 41-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (03Dec2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Dec2023) Negative, notes: also tested negative the following day. (with resolution of symptoms); (03Dec2023) Negative, notes: Tested negative for Covid on day 5 of treatment. Therapeutic measures (Paxlovid therapy start date: 29Nov2023, stop date: 03Dec2023) were taken as a result of vaccination failure, covid-19.; Sender's Comments: A causal relationship to the suspect drug cannot be excluded for event vaccination failure. This case will be reassessed upon receipt of additional information.
Age: 57.0
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 Nurse.  A 57-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (11Dec2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Dec2023) Negative. Therapeutic measures were taken as a result of vaccination failure, Covid-19 with Paxlovid from 04Dec2023 to 11Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Red, Itchy Rash at the injection site that has spread to other places on left arm; Red, Itchy Rash at the injection site that has spread to other places on left arm; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Nov2023 as dose 1, single (Lot number: Comirnaty 12+ Covid 23-24 Sdv) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure, Afib" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE HIGH DOSE QUADRIVALENT, start date: 27Oct2023, stop date: 27Oct2023. Past drug history included: Penicillin, reaction(s): "Allergy". The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 22Nov2023, outcome "not recovered" and all described as "Red, Itchy Rash at the injection site that has spread to other places on left arm". The action taken for BNT162b2 omi xbb.1.5 was unknown. Therapeutic measures were taken as a result of vaccination site rash, vaccination site erythema.