chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Arthralgia, Bursitis, Pain
Clinical narrative: Subacromial bursitis; This spontaneous case was retrieved on 06-Dec-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2709524-1) reported by other healthcare professional and concerned a 29-year-old, female patient.    The patient's relevant medical history and concomitant medications were not reported.  It was reported that on 27-Sep-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: reported as '1', route of administration: intramuscular (IM), anatomical location: left arm (LA) and indication: not reported). The batch number reported was P100588968. The reported batch number was identified by Seqirus to be linked to the suspect product Afluria Quadrivalent (influenza vaccine inact sag 4v) instead of the reported suspect product Fluad Quadrivalent. Based on the reported batch number, the suspect product was changed to Afluria Quadrivalent.  On the same date, in the evening after receiving Afluria Quadrivalent, the patient began having pain.  On an unspecified date in 2023, (reported after approximately one month), the patient was seen for continued left shoulder pain and was diagnosed with subacromial bursitis.  At the time of the initial reporting, the patient had not recovered from the event.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A 29-year-old, female patient experienced pain on the same evening after being vaccinated with Afluria Quadrivalent. Approximately a month later, the patient visited physician due to shoulder pain that persisted since vaccination and was diagnosed with subacromial bursitis. Causality for reported event is assessed as possibly related, based on plausible temporal relationship.; Sender's Comments: A 29-year-old, female patient experienced pain on the same evening after being vaccinated with Afluria Quadrivalent. Approximately a month later, the patient visited physician due to shoulder pain that persisted since vaccination and was diagnosed with subacromial bursitis. Causality for reported event is assessed as possibly related, based on plausible temporal relationship.
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Balance disorder, Gait disturbance, Pain
Clinical narrative: after administration of the AREXVY vaccine he developed pain in his muscles and bones; after administration of the AREXVY vaccine he developed pain in his muscles and bones; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle pain in a adult male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3B252) for prophylaxis.   On 02-NOV-2023, the patient received Arexvy (left deltoid). In NOV-2023, 2 days after receiving Arexvy, the patient experienced muscle pain (Verbatim: after administration of the AREXVY vaccine he developed pain in his muscles and bones) and bone pain (Verbatim: after administration of the AREXVY vaccine he developed pain in his muscles and bones). The outcome of the muscle pain and bone pain were not resolved.   It was unknown if the reporter considered the muscle pain and bone pain to be related to Arexvy.     It was unknown if the company considered the muscle pain and bone pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-DEC-2023. Reporter was the consumer who received the Arexvy vaccine in his left deltoid. Lot number of adjuvant 3B252 was on reporters vaccination card.    The patient stated a couple of days after administration of the Arexvy vaccine he developed pain in his muscles and bones.  The reporter reported after one week the symptoms subsided and then after another week the symptoms returned.   The patient had seen a neurologist and his primary physician. The reporter consented to follow up.
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Bone pain, Myalgia
Clinical narrative: after administration of the AREXVY vaccine he developed pain in his muscles and bones; after administration of the AREXVY vaccine he developed pain in his muscles and bones; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle pain in a adult male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3B252) for prophylaxis.   On 02-NOV-2023, the patient received Arexvy (left deltoid). In NOV-2023, 2 days after receiving Arexvy, the patient experienced muscle pain (Verbatim: after administration of the AREXVY vaccine he developed pain in his muscles and bones) and bone pain (Verbatim: after administration of the AREXVY vaccine he developed pain in his muscles and bones). The outcome of the muscle pain and bone pain were not resolved.   It was unknown if the reporter considered the muscle pain and bone pain to be related to Arexvy.     It was unknown if the company considered the muscle pain and bone pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-DEC-2023. Reporter was the consumer who received the Arexvy vaccine in his left deltoid. Lot number of adjuvant 3B252 was on reporters vaccination card.    The patient stated a couple of days after administration of the Arexvy vaccine he developed pain in his muscles and bones.  The reporter reported after one week the symptoms subsided and then after another week the symptoms returned.   The patient had seen a neurologist and his primary physician. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Decreased appetite, Diarrhoea, Nausea, Retching, Vomiting
Clinical narrative: intermittent vertigo; arm soreness; headache; nausea; Vomiting; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 08-DEC-2023, the patient received Arexvy (intramuscular, right deltoid). On 08-DEC-2023, 18 hrs after receiving Arexvy, the patient experienced pain in arm (Verbatim: arm soreness), headache (Verbatim: headache), nausea (Verbatim: nausea) and vomiting (Verbatim: Vomiting). On 10-DEC-2023, the patient experienced vertigo (Verbatim: intermittent vertigo). On 09-DEC-2023, the outcome of the vomiting was resolved. The outcome of the pain in arm, headache, nausea and vertigo were not resolved.   It was unknown if the reporter considered the pain in arm, headache, nausea, vomiting and vertigo to be related to Arexvy.     It was unknown if the company considered the pain in arm, headache, nausea, vomiting and vertigo to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-DEC-2023 The reporter was patient. The reporter reported that about 18 hours after receiving her AREXVY vaccination on 12/08/2023, she experienced arm soreness, headache, nausea and vomiting. The reporter also complains of intermittent vertigo, which started about 2 days after the vaccination. The arm soreness, nausea and intermittent vertigo have not recovered. The reporter did not consent to follow-up.  GSK Receipt Date: 13-DEC-2023 This update was considered Non-significant. Case update: In structural field of source document arm soreness, nausea and intermittent vertigo outcome recovered as per structured field mention however in narrative mention that event as not recovered
Age: 72.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Headache, Nausea, Pain in extremity, Vertigo, Vomiting
Clinical narrative: intermittent vertigo; arm soreness; headache; nausea; Vomiting; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 08-DEC-2023, the patient received Arexvy (intramuscular, right deltoid). On 08-DEC-2023, 18 hrs after receiving Arexvy, the patient experienced pain in arm (Verbatim: arm soreness), headache (Verbatim: headache), nausea (Verbatim: nausea) and vomiting (Verbatim: Vomiting). On 10-DEC-2023, the patient experienced vertigo (Verbatim: intermittent vertigo). On 09-DEC-2023, the outcome of the vomiting was resolved. The outcome of the pain in arm, headache, nausea and vertigo were not resolved.   It was unknown if the reporter considered the pain in arm, headache, nausea, vomiting and vertigo to be related to Arexvy.     It was unknown if the company considered the pain in arm, headache, nausea, vomiting and vertigo to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-DEC-2023 The reporter was patient. The reporter reported that about 18 hours after receiving her AREXVY vaccination on 12/08/2023, she experienced arm soreness, headache, nausea and vomiting. The reporter also complains of intermittent vertigo, which started about 2 days after the vaccination. The arm soreness, nausea and intermittent vertigo have not recovered. The reporter did not consent to follow-up.  GSK Receipt Date: 13-DEC-2023 This update was considered Non-significant. Case update: In structural field of source document arm soreness, nausea and intermittent vertigo outcome recovered as per structured field mention however in narrative mention that event as not recovered
Sex: U
Vaccine: RSV, RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Wrong Vaccine Administered; 6 month old that was inadvertantly given Arexvy; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 6-month-old patient who received RSVPreF3 adjuvanted (Arexvy) (batch number L7HN5, expiry date 08-DEC-2024) for prophylaxis.   On 13-DEC-2023, the patient received Arexvy. On 13-DEC-2023, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: Wrong Vaccine Administered) and inappropriate age at vaccine administration (Verbatim: 6 month old that was inadvertantly given Arexvy). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 13-DEC-2023 The vaccine administration facility was the same as primary reporter. The patient was inadvertently given Arexvy, which led to wrong vaccine used and inappropriate age at vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: RSV, RSV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Wrong Vaccine Administered; 6 month old that was inadvertantly given Arexvy; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 6-month-old patient who received RSVPreF3 adjuvanted (Arexvy) (batch number L7HN5, expiry date 08-DEC-2024) for prophylaxis.   On 13-DEC-2023, the patient received Arexvy. On 13-DEC-2023, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: Wrong Vaccine Administered) and inappropriate age at vaccine administration (Verbatim: 6 month old that was inadvertantly given Arexvy). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 13-DEC-2023 The vaccine administration facility was the same as primary reporter. The patient was inadvertently given Arexvy, which led to wrong vaccine used and inappropriate age at vaccine administered. The reporter consented to follow up.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from an Other HCP.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 07Dec2023 to 12Dec2023. Clinical course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: A causal relationship to the suspect drug BNT162b2 cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.
Sex: F
Vaccine: VARZOS
Symptoms: Nasal congestion, Rhinorrhoea
Clinical narrative: Stuffy nose after having shingle vaccine; Had a runny nose since shingles shot; This spontaneous report was received from a consumer (also reported as "report source health professional") via pharmacy regarding a a 71-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included secondary pulmonary arterial hypertension. Her concomitant medications included sitagliptin phosphate (JANUVIA), simvastatin (manufacturer unknown), paracetamol (TYLENOL), mirtazapine, sodium chloride (SALINE NASAL SPRAY), carbohydrates nos (+) fats nos (+) fibre (+) dietary (+) minerals nos (+) proteins nos (+) vitamins nos (ENSURE ACTIVE HIGH PROTEIN), umeclidinium bromide (INCRUSE ELLIPTA), salbutamol sulfate (ALBUTEROL SULFATE HFA), sildenafil citrate, allopurinol, doxazosin mesilate, famotidine, colchicine, dapagliflozin propanediol monohydrate (FARXIGA), digoxin, furosemide, loratadine, and spironolactone.   On 15-AUG-2022, the patient started therapy with treprostinil sodium (TYVASO) powder, 64 microgram, four times a day (qid), administered as inhalation use for secondary pulmonary arterial hypertension (strength, lot #, and expiry date were not provided). On an unknown date in November 2023, the patient was vaccinated with zoster vaccine live (manufacturer unknown) (reported as "Varicella zoster vaccine") subcutaneous injection, administered as shingle immunization (dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided).  On an unknown date in November 2023 (reported as "about a week ago from the day of reporting"), the patient experienced stuffy nose (Nasal congestion) after having zoster vaccine live (manufacturer unknown) (reported as "shingle vaccine"). On an unknown date in 2023, the patient had a runny nose (Rhinorrhoea) since zoster vaccine live (manufacturer unknown) (reported as "shingles shot") and was treated with cetirizine hydrochloride (ZYRTEC). At the time of reporting, the patient had not recovered from the event of nasal congestion. The outcome of the event rhinorrhoea was not provided. The action taken with treprostinil sodium (TYVASO) regarding the events was not reported. The action taken with zoster vaccine live (manufacturer unknown) regarding the events was not applicable.   The reporter considered nasal congestion and rhinorrhoea to be related to zoster vaccine live (ZOSTAVAX). However, the causal relationship between nasal congestion, rhinorrhoea, and treprostinil sodium (TYVASO) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Neuroendocrine carcinoma of the skin
Clinical narrative: Wife has Merkel cell carcinoma and is on Keytruda; This spontaneous case was reported by a non-health professional and describes the occurrence of NEUROENDOCRINE CARCINOMA OF THE SKIN (Wife has Merkel cell carcinoma and is on Keytruda) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna (Dose 1), Moderna (Dose 4), Moderna (Dose 3) and Moderna (Dose 2). Past adverse reactions to the above products included No adverse event with Moderna, Moderna, Moderna and Moderna.    On an unknown date, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROENDOCRINE CARCINOMA OF THE SKIN (Wife has Merkel cell carcinoma and is on Keytruda) (seriousness criterion medically significant). The patient was treated with PEMBROLIZUMAB (KEYTRUDA) ongoing since an unknown date for Merkel cell carcinoma, at an unspecified dose and frequency. At the time of the report, NEUROENDOCRINE CARCINOMA OF THE SKIN (Wife has Merkel cell carcinoma and is on Keytruda) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Company Comment This spontaneous case concerns a female patient of an unknown age with medical history of Previously administered products included for COVID-19 prophylaxis with Moderna vaccine (4 doses) without adverse events who experienced the unexpected medically significant event of Neuroendocrine carcinoma of the skin unknown days of 5th. dose of mRNA-1273.815 vaccine. At the time of the report, the outcome of the event was unknown. As per data available to date, there is no evidence that mRNA-1273 vaccine can cause cancer or relapses and vaccine does not modify DNA. On the other hand, COVID-19 mRNA vaccines are recommended in cancer patients as protection from a possible SARS-COV-2 infection. The event was considered as "not related. The benefit-risk relationship of mRNA-1273.815  vaccine is not affected by this report.   Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After receiving Spikevax, all his Osteoarthritis pain went away until today, 18DEC2023.; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (After receiving Spikevax, all his Osteoarthritis pain went away until today, 18DEC2023.) in a 71-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Osteoarthritis (Horrible Osteoarthritis prior to Pandemic). Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included Osteoarthritis with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 28-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (After receiving Spikevax, all his Osteoarthritis pain went away until today, 18DEC2023.). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (After receiving Spikevax, all his Osteoarthritis pain went away until today, 18DEC2023.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient reports that he had 5 previous Pfizer COVID-19 vaccines. After each Pfizer vaccine his horrible Osteoarthritis pain went away for 3 days. He had a little arthritis pain at the time of reporting with the same intensity as prior to Spikevax vaccination. He stated that he never had other vaccines with his COVID-19 shots. The treatment medication was not reported by reporter.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Injection site pain, Pain, Pyrexia
Clinical narrative: The 14th he had general aches like he was having the flu; The 14th he had a little fever; He has also had shoulder pain,; He has also had hip pain; He has also had back pain; Following the Spikevax vaccine he had some soreness at the injection site the first day; This spontaneous case was reported by a patient and describes the occurrence of PAIN (The 14th he had general aches like he was having the flu), BACK PAIN (He has also had back pain), INJECTION SITE PAIN (Following the Spikevax vaccine he had some soreness at the injection site the first day), PYREXIA (The 14th he had a little fever) and ARTHRALGIA (He has also had shoulder pain,) in a 73-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030540) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1, lot number ENB201) on 27-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 2, lot number FP7533) on 29-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 3, lot number FJ8762) on 30-Nov-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 4, lot number GJ3277) on 12-Dec-2022 and Flu shot on 28-Nov-2023. Past adverse reactions to the above products included No adverse event with Flu shot, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 13-Dec-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 13-Dec-2023, the patient experienced BACK PAIN (He has also had back pain), INJECTION SITE PAIN (Following the Spikevax vaccine he had some soreness at the injection site the first day), ARTHRALGIA (He has also had shoulder pain,) and ARTHRALGIA (He has also had hip pain). On 14-Dec-2023, the patient experienced PAIN (The 14th he had general aches like he was having the flu) and PYREXIA (The 14th he had a little fever). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 2 capsules. At the time of the report, PAIN (The 14th he had general aches like he was having the flu), BACK PAIN (He has also had back pain), INJECTION SITE PAIN (Following the Spikevax vaccine he had some soreness at the injection site the first day), PYREXIA (The 14th he had a little fever), ARTHRALGIA (He has also had shoulder pain,) and ARTHRALGIA (He has also had hip pain) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. It was reported that injection site soreness seemed to drift into his right elbow. He took 2 capsules of tylenol yesterday, which helped with his pain. He also believes his thermoregulation seems a little off. Patient was having a bowl of oatmeal and a cup of coffee, makes him get very sweaty right after.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: She has long COVID now; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (She has long COVID now) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: covid-19 vaccine (dose 1 batch no-0272723) on 13-Feb-2021, covid-19 vaccine (dose 2 batch no-030M20A) on 13-Mar-2021, covid-19 vaccine (dose 3 batch no-031H21A) on 03-Dec-2021 and covid-19 vaccine (dose 4 batch no-066K21A) on 12-May-2022. Past adverse reactions to the above products included No adverse event with covid-19 vaccine, covid-19 vaccine, covid-19 vaccine and covid-19 vaccine. Concurrent medical conditions included Seasonal allergy and Sleep apnea.    On 16-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Sep-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POST-ACUTE COVID-19 SYNDROME (She has long COVID now). At the time of the report, POST-ACUTE COVID-19 SYNDROME (She has long COVID now) had not resolved.            The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. The patient had long COVID. The patient was already not feeling well. The patient was fatigue and had crashing fatigue. The patient stated she had some good days and some bad days. She also stated she had a bad headache. No treatment medication was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Pyrexia, Vaccination site pain, Vaccination site rash
Clinical narrative: Fever for 30 hrs; Arm pain at site; Red rash; Loss of taste; This spontaneous case was reported by a patient and describes the occurrence of AGEUSIA (Loss of taste), PYREXIA (Fever for 30 hrs), VACCINATION SITE PAIN (Arm pain at site) and VACCINATION SITE RASH (Red rash) in a 63-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 80777-0102-96) for COVID-19 prophylaxis.     Concurrent medical conditions included Lupus syndrome (Autoimmune - Lupus).    On 14-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 14-Dec-2023, the patient experienced AGEUSIA (Loss of taste) and VACCINATION SITE RASH (Red rash). On an unknown date, the patient experienced PYREXIA (Fever for 30 hrs) and VACCINATION SITE PAIN (Arm pain at site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [GUAIFENESIN;PSEUDOEPHEDRINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, AGEUSIA (Loss of taste) and VACCINATION SITE RASH (Red rash) was resolving and PYREXIA (Fever for 30 hrs) and VACCINATION SITE PAIN (Arm pain at site) outcome was unknown.            Concomitant medication was not provided. Patient had arm pain, red rash at vaccination site started at 1 inch by evening then grew to 6 inches long 3 inches wide, fever for 30 hrs, and loss of taste for several hours. She never had reaction to previous Moderna vaccines or Moderns booster vaccines.  Patient took Benadryl and it did nothing for two days. She followed directions on package. On third day, she tried Sudafed for rash, and this stopped progression of rash. Patient took 6 pills in two days. She took nothing for fever just sweat it out. Arm pain was moving arm to be able to use arm.  Company Comment This spontaneous case concerns a 63-year-old female patient with medical history of Concurrent medical conditions included Lupus syndrome who experienced the unexpected AESI of ageusia and other expected events the same day after a dose of mRNA-1273.815 vaccine. Concomitant medication was not provided. The medical history is a contributor for the events. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immune-mediated neurological disorder
Clinical narrative: autoimmune mediated inflammatory syndrome, neurological; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE-MEDIATED NEUROLOGICAL DISORDER (autoimmune mediated inflammatory syndrome, neurological) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In November 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced IMMUNE-MEDIATED NEUROLOGICAL DISORDER (autoimmune mediated inflammatory syndrome, neurological) (seriousness criterion medically significant). At the time of the report, IMMUNE-MEDIATED NEUROLOGICAL DISORDER (autoimmune mediated inflammatory syndrome, neurological) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient was diagnosed with an autoimmune mediated inflammatory syndrome, neurological, 12 days after getting the Moderna bivalent vaccine in November 2022. Patient had all four Moderna vaccines before that with no side effects or adverse reactions.  Treatment information was not reported. Company comment: This spontaneous case concerns an 82-year-old female patient, with no medical history reported, who experienced the expected and serious (medically significant) event of IMMUNE-MEDIATED NEUROLOGICAL DISORDER, 12 days after the bivalent dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) vaccine. She had all four Moderna vaccines before no adverse reactions. Treatment information was not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) vaccine is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Transient global amnesia
Clinical narrative: transient global amnesia; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TRANSIENT GLOBAL AMNESIA (transient global amnesia) in a 67-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Allergic to latex and corticosteroids.  Concurrent medical conditions included Latex allergy and Drug allergy (corticosteroids).    On an unknown date, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced TRANSIENT GLOBAL AMNESIA (transient global amnesia). At the time of the report, TRANSIENT GLOBAL AMNESIA (transient global amnesia) outcome was unknown.            The patient received at least 3 Moderna vaccines, at least the 2 primary series doses + 1 booster. No concomitant medication was reported. Reporter stated that his wife had transient global amnesia about a month ago and the patient didnot enjoy it, this happened after receiving the Moderna vaccines. No one thinks it was related. No treatment medication was reported.
Sex: M
Vaccine: RSV
Symptoms: Erection increased
Clinical narrative: Prolong erectile; This is a spontaneous report received from a nurse.  A 61-year-old male patient received RSV vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FOLIC ACID; GABAPENTIN; HYDROXYZINE; LOSARTAN; OXYCODONE; TAMSULOSIN; TRAMADOL; COLACE. The following information was reported: ERECTION INCREASED (non-serious), outcome "unknown", described as "Prolong erectile".  Additional Information: The patient that called the pharmacy was complaining that he is having a adverse reaction of Abrysvo. The patient was having prolong erectile and the pharmacist told him that the medication is not associated with his reaction, but he still wanted to double check. The medication was prescribed medication that was sent to that patient.  Batch/lot number is not provided, and it cannot be obtained.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hypersomnia, Myoclonus, Pyrexia
Clinical narrative: Myoclonic torso movements x 24-30 hours duration.; then slept off and on for next day; fever; chills; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Nov2023 as dose 1, single (Lot number: HJ7224) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Long Covid. Diabetes. Hypertension. Memory Impairment high" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; HYDROCHLOROTHIAZIDE; JANUVIA; GLIPIZIDE. Past drug history included: Etodolac, reaction(s): "Allergy"; Lisinopril, reaction(s): "Allergy". The following information was reported: CHILLS (non-serious) with onset 30Nov2023, outcome "recovering"; PYREXIA (non-serious) with onset 30Nov2023, outcome "recovering", described as "fever"; HYPERSOMNIA (non-serious) with onset 01Dec2023, outcome "recovering", described as "then slept off and on for next day"; MYOCLONUS (non-serious) with onset 02Dec2023 at 04:00, outcome "recovering", described as "Myoclonic torso movements x 24-30 hours duration.". Therapeutic measures were not taken as a result of myoclonus, pyrexia, chills, hypersomnia.  Additional information: Myoclonic torso movements x 24-30 hours duration. About 12 hours after injection had fever and chills and then slept off and on for next day. Then had the torso invents the following day. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: alopecia; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 3-year-old female patient received BNT162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), 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: ALOPECIA (non-serious), outcome "unknown".  Additional information: The reporter then asked if her daughter is capable of getting Litfulo for alopecia and if there is an age limit.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I have already been sick from this shot so I'll never get it again; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient 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 and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), administration date: 2021, for Covid-19 Immunisation; Bnt162b2 nos (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunisation. The following information was reported: ILLNESS (non-serious) with onset 2023, outcome "unknown", described as "I have already been sick from this shot so I'll never get it again".  Additional information: Consumer asked how long does Covid-19 vaccine stay in the system as he got 2 shots recently, Caller states he had received 2 doses of Pfizer Biontech Covid 19 vaccines in 2021 per his vaccination card. Patient already been sick from this shot so never get it again. Patient kind of forced by his company to get but he will never get it again. Its made patient really sick very bad.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: currently has Covid; Then a year ago from this holiday she got COVID; Then a year ago from this holiday she got COVID; This is a spontaneous report received from a Nurse from medical information team.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pacemaker" (not ongoing); "10 stents" (not ongoing); "she has a bad heart" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Then a year ago from this holiday she got COVID"; DISEASE RECURRENCE (medically significant) with onset 2023, outcome "unknown", described as "currently has Covid". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19. Clinical course: Patient (retired nurse) wanted to know if it is safe to take a second course of Paxlovid if she had taken Paxlovid approximately a year ago. She currently had COVID and was trying to decide if she should take it again, or not. She had the Pfizer COVID vaccine about 4 years ago when it first came out. Then a year ago from this holiday she got COVID. She took Paxlovid then. She remembers this because her son came into town for holiday and had COVID.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on available information, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and all events.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Electrocardiogram, Neurodevelopment test
Clinical narrative: Stroke; This is a spontaneous report received from a Physician.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 15Feb2021 as dose 2, 0.3 ml single (Lot number: EL9261, Expiration Date: 31May2021) at the age of 81 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "weakness in limbs" (unspecified if ongoing); "dysarthria" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot/batch: EL8982, Expiration date: 31May2021), administration date: 25Jan2021, when the patient was 81-year-old, for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 28Feb2021, outcome "recovering", described as "Stroke". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 1 day(s)). The event "stroke" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Electrocardiogram: nothing was found, notes: they were extensive; Neurodevelopment test: nothing was found, notes: they were extensive. It was unknown if therapeutic measures were taken as a result of cerebrovascular accident. Clinical course: Reporter was calling on behalf of the patient which was his mother. She got her first Pfizer covid vaccine on 25Jan2021. Reports on 25Mar2021 she had loop recorder implanted in her chest which records like a continuous EKG. She had no Atrial fibrillation or anything like that. The second Pfizer covid vaccine was on 15Feb2021. On 28Feb2021 she had a stroke. She was admitted to the hospital and overnighted and then that ensued a full on neurological work up and cardiac work up. She had some residual disability, dysarthria, and weakness in limbs but had improved since stroke occur.  Causality assessment: Relatedness of drug to reaction, source of assessment: primary source reporter method of assessment: global introspection, result of assessment: yes.; Sender's Comments: The possible contribution of suspect drug BNT162b2 cannot be totally excluded for reported event given the compatible time association. Case will be reassessed should additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 65.0
Sex: F
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 Consumer or other non HCP.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 27Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa, neosporin, Voltaren" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Neosporin, reaction(s): "known allergies: neosporin"; Voltaren, reaction(s): "known allergies: Voltaren". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 04Dec2023 to 09Dec2023.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Physician from product quality group.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), in Sep2022 as dose 4 (booster), single (Lot number: GJ534R) at the age of 44 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Positive, notes: Treatment of COVID-19. Paxlovid as taken as therapeutic measures as a result of drug ineffective, covid-19 from 06Dec2023 to 11Dec2023. Clinical course: Patient denied for any known allergies.; Sender's Comments: A causal relationship to the suspect drug BNT162b2 cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "Known Allergies: Egg whites" (unspecified if ongoing); "Known Allergies: Melon" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: codeine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (Dec2023) and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of Covid-19; (Dec2023) Negative, notes: After testing negative twice; (Dec2023) Negative, notes: After testing negative twice. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 06Dec2023 to 10Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Neuroendocrine lung cancer" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies: Iodinated contrast dye" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid treatment from 03Dec2023 to 08Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from an Other HCP.  A 73-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 12:30 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes type 2" (unspecified if ongoing); "HTN" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "CAD" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "psoriasis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Allergies: Bactrim"; Allopurinol, reaction(s): "Allergies: allopurinol". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included treatment with PAXLOVID from 04Dec2023 to 08Dec2023.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event Drug ineffective and COVID 19 cannot be ruled out.