chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RSV
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome; This serious case was reported by a consumer via regulatory authority and described the occurrence of guillain barre syndrome in a elderly patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported.   It was unknown if the reporter considered the guillain barre syndrome to be related to Arexvy.     It was unknown if the company considered the guillain barre syndrome to be related to Arexvy.   Additional Information: GSK Receipt Date:04-DEC-2023 The patient self-reported this case. The patient age was in between 65-79 years old. VAERS accepted reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public could submit reports to VAERS. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports might contain information that was incomplete, inaccurate, coincidental, or unverifiable. Most reports to VAERS were voluntary, which mean they were subject to biases. This created specific limitations on how the data can be used scientifically. These systems did not have the same limitations as VAERS and could better assess health risks and possible connections between adverse events and a vaccine. VAERS data were limited to vaccine adverse event reports received between 1990 and the most recent date for which data were available. Follow-up would not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Still got shingles/Suspected vaccination failure; Still got shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Still got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 04-DEC-2023 The reporter was patient's sister who stated that her sister (patient) had the vaccine and still got shingles.  The reporter stated commercial was misleading and shingrix does not prevent shingles. The reporter stated the commercial should say it lessens the outbreak, but may not prevent it. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: COVID19, FLUX, RSV
Symptoms: Nasopharyngitis, Nausea, Pain in extremity, Tremor
Clinical narrative: Sore arms; Was so cold; nauseous; had the shakes; Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis, INFLUENZA VACCINE for prophylaxis and COVID-19 VACCINE for prophylaxis.     On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: Sore arms), tremor (Verbatim: had the shakes), cold (Verbatim: Was so cold) and nausea (Verbatim: nauseous). The patient was treated with paracetamol (Tylenol), ibuprofen sodium (Ibuprofen) and menthol (Ice). The outcome of the pain in arm, cold and nausea were not reported and the outcome of the tremor was resolved (duration 5 hrs).   It was unknown if the reporter considered the pain in arm, tremor, cold and nausea to be related to Arexvy.     It was unknown if the company considered the pain in arm, tremor, cold and nausea to be related to Arexvy. Additional Information: RA Receipt Date: 30-NOV-2023 The patient reported that he/she did get the RSV vaccine along with flu and Covid injections. The patient stated that he/she never had problems with the flu or Covid vaccinations. But having the RSV vaccine the patient had sore arms.  The patient stated that he/she did ice them day before reporting at night and did not feel bad day before reporting after receiving them. The patient had the shakes and was so cold. The patient stated that he/she did take some Tylenol with ibuprofen mixed. The patient stated that the shakes had gone away after 5 hours. The patient was feeling a bit nauseous also. The reporter considered the pain in arm, tremor, cold and nausea unrelated to Influenza vaccine and Covid 19 vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Joint range of motion decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Right arm swollen; arm become red; Arm painful; Pain in right shoulder; Restricted range of motion; This non-serious case was reported by a other health professional via sales rep and described the occurrence of swelling arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-SEP-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced swelling arm (Verbatim: Right arm swollen), erythema of extremities (Verbatim: arm become red), pain in arm (Verbatim: Arm painful), shoulder pain (Verbatim: Pain in right shoulder) and joint range of motion decreased (Verbatim: Restricted range of motion). The outcome of the swelling arm, erythema of extremities, pain in arm, shoulder pain and joint range of motion decreased were not reported.   It was unknown if the reporter considered the swelling arm, erythema of extremities, pain in arm, shoulder pain and joint range of motion decreased to be related to Shingrix.     It was unknown if the company considered the swelling arm, erythema of extremities, pain in arm, shoulder pain and joint range of motion decreased to be related to Shingrix.   Additional Information: GSK receipt date: 01-DEC-2023 The reporter stated that the patient received second Shingrix vaccination in office and said her right arm became swollen, red and painful.  Initially had pain in right shoulder with restricted range of motion. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Disability, Herpes zoster, Neuralgia, Post herpetic neuralgia
Clinical narrative: Postherpetic neuralgia; shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In APR-2023, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: Postherpetic neuralgia). The patient was treated with gabapentin, paracetamol (Tylenol) and codeine phosphate (Codeine). The outcome of the shingles was not reported and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the shingles and post herpetic neuralgia to be related to Shingrix.     It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingrix.   Additional Information: GSK receipt date: 01-DEC-2023 The reporter reported that she developed shingles in April and now she suffered with post herpetic neuralgia. The reporter stated that it was a condition that some people get following the initial outbreak of shingles. The reporter stated that it was a cool disease and caused constant extreme nerve pain which was debilitating. The reporter stated that before shingles, she was active at the gym and working.  The reporter reported that now (at the time of reporting) she wake up and prayed that the nerve pain would be tolerable.  The reporter reported that Gabapentin and Tylenol helped but sometimes it took codeine. The reporter stated that she had took the first vaccine but not the second one.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Feeding disorder, Headache, Insomnia, Nausea
Clinical narrative: soreness in arm; headache; nausea; diarrhea; couldn't eat; could not sleep; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 25-NOV-2023, the patient received Arexvy (intramuscular, left arm). On 26-NOV-2023, 1 days after receiving Arexvy, the patient experienced pain in arm (Verbatim: soreness in arm), headache (Verbatim: headache), nausea (Verbatim: nausea), diarrhea (Verbatim: diarrhea), unable to eat (Verbatim: couldn't eat) and insomnia (Verbatim: could not sleep). The outcome of the pain in arm, headache, nausea, diarrhea, unable to eat and insomnia were unknown.   It was unknown if the reporter considered the pain in arm, headache, nausea, diarrhea, unable to eat and insomnia to be related to Arexvy.     It was unknown if the company considered the pain in arm, headache, nausea, diarrhea, unable to eat and insomnia to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-DEC-2023 24 hours after injection, the patient had soreness in arm, headache, nausea, diarrhea, couldn't eat and could not sleep. The caller stated that the patient never had a reaction to any vaccine but experienced the above symptoms. The reporter did not consent to follow-up. Took adverse event information and transferred to an healthcare professional.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: soreness in arm; headache; nausea; diarrhea; couldn't eat; could not sleep; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 25-NOV-2023, the patient received Arexvy (intramuscular, left arm). On 26-NOV-2023, 1 days after receiving Arexvy, the patient experienced pain in arm (Verbatim: soreness in arm), headache (Verbatim: headache), nausea (Verbatim: nausea), diarrhea (Verbatim: diarrhea), unable to eat (Verbatim: couldn't eat) and insomnia (Verbatim: could not sleep). The outcome of the pain in arm, headache, nausea, diarrhea, unable to eat and insomnia were unknown.   It was unknown if the reporter considered the pain in arm, headache, nausea, diarrhea, unable to eat and insomnia to be related to Arexvy.     It was unknown if the company considered the pain in arm, headache, nausea, diarrhea, unable to eat and insomnia to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-DEC-2023 24 hours after injection, the patient had soreness in arm, headache, nausea, diarrhea, couldn't eat and could not sleep. The caller stated that the patient never had a reaction to any vaccine but experienced the above symptoms. The reporter did not consent to follow-up. Took adverse event information and transferred to an healthcare professional.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: NP reported a patient was inadvertently administered an Expired Engerix(exp:11/23/23) dose today on 12/1/23.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 40-year-old female patient who received HBV (Engerix B) (batch number 9AX5P, expiry date 23-NOV-2023) for prophylaxis.   On 01-DEC-2023, the patient received Engerix B. On 01-DEC-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: NP reported a patient was inadvertently administered an Expired Engerix(exp:11/23/23) dose today on 12/1/23.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 1-Dec-2023 Nurse practitioner called to inquired that how to proceed. The reporter consented to follow up. The patient inadvertently received an expired dose of Engerix-B, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Pharmacist reports a patient may have been given just the adjuvant portion of Shingrix.; Pharmacist reports a patient may have been given just the adjuvant portion of Shingrix.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Pharmacist reports a patient may have been given just the adjuvant portion of Shingrix.) and inappropriate dose of vaccine administered (Verbatim: Pharmacist reports a patient may have been given just the adjuvant portion of Shingrix.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 1-Dec-2023 Pharmacist reported that a patient might had been given just the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not know if this actually occurred they were investigating it, follow up was ok via her email in healthcare professional details. The reporter consented to follow-up.
Sex: U
Vaccine: HEPAB
Symptoms: Product preparation error, Underdose
Clinical narrative: Twinrix was not completely re-suspended according to the instructions in the PI; When they were done administering it, they could see that there was white powder left in the vaccine.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in drug usage process in a patient who received HAB (Twinrix) for prophylaxis.   On 30-NOV-2023, the patient received Twinrix. On 30-NOV-2023, an unknown time after receiving Twinrix, the patient experienced wrong technique in drug usage process (Verbatim: Twinrix was not completely re-suspended according to the instructions in the PI) and incomplete dose administered (Verbatim: When they were done administering it, they could see that there was white powder left in the vaccine.). The outcome of the wrong technique in drug usage process and incomplete dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-DEC-2023 The pharmacist reported that, Twinrix was not completely re-suspended according to the instructions in the pi which led to wrong technique in drug usage process. The pharmacist reported, when they were done administering it, they could see that there was white powder left in the vaccine which led to incomplete dose administered. HCP (healthcare professional) did not have any patient or vaccine details as this was administered by a different HCP. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via mail.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received the first shingrix dose 2 years ago; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient received the first shingrix dose 2 years ago). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 01-DEC-2023 The reporter stated that patient received the first shingrix dose 2 years ago. The reporter received information through the chat and that stated did not have information on patient. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. (Drug dose administration interval too long) plus 7 days.
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia
Clinical narrative: Caller mentioned she would never get the Shingrix vaccine because her daughter received it a couple years ago and she could not swallow; This non-serious case was reported by a consumer via call center representative and described the occurrence of unable to swallow in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced unable to swallow (Verbatim: Caller mentioned she would never get the Shingrix vaccine because her daughter received it a couple years ago and she could not swallow). The outcome of the unable to swallow was resolved.   It was unknown if the reporter considered the unable to swallow to be related to Shingrix.     It was unknown if the company considered the unable to swallow to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-DEC-2023 The caller was the mother of the patient.  The reporter mentioned she would never get the Shingrix vaccine because her daughter received it a couple years ago and she could not swallow.   The reporter did not consent to follow-up with HCP.
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: a dose of Kinrix was accidentally administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 09-NOV-2023) for prophylaxis.   On 30-NOV-2023, the patient received the 1st dose of Kinrix. On 30-NOV-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: a dose of Kinrix was accidentally administered to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:01-DEC-2023 A Licensed Vocational Nurse contacted GSK via phone on 12/01/2023 inquiring about Kinrix and what information is available about the recommendations on how to proceed after a dose of Kinrix was accidentally administered to a patient which was already expired on 9th November 2023 which led to expired vaccine used.  They gave information about the event, vaccine and patient. Medical information was read and sent via e-mail. Consented to follow up.  the vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Urticaria
Clinical narrative: Hives all over body; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized urticaria in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced generalized urticaria (Verbatim: Hives all over body). The outcome of the generalized urticaria was unknown.   It was unknown if the reporter considered the generalized urticaria to be related to Shingrix.     It was unknown if the company considered the generalized urticaria to be related to Shingrix.   Additional Information: RA Receipt date: 01-DEC-2023 The reporter was a patient. The patient called to inquire about any information about Arexvy versus Shingrix. Patient received the dose of Shingrix vaccine in 2017 when it first came out. After the vaccine, patient experienced hives all over body. The physician advised not to get the second dose and stated patient that probably had enough protection and did not have to risk the second one reactions. Patient mentioned before attempting the Arexvy vaccine wanted to know the comparison of the Shingrix and RSV serum. Patient asked the question that what the risk was for her since she had an adverse reaction to Shingrix. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: she received an expired Shingrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a female patient who received Herpes zoster (Shingrix) (expiry date 31-OCT-2023) for prophylaxis.   On 29-NOV-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: she received an expired Shingrix vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 01-DEC-2023 & 02-DEC-2023 A patient reported her healthcare professional (HCP) had informed her that she received an expired Shingrix vaccine, which led to expired vaccine used. The patient reported her HCP was going to call GlaxoSmithKline to see if it was okay, but she had not called her back and she was trying to find out by calling herself.  The patient would not provide any information further. She would wait to hear from her HCP. The reporter did not consent to follow up.
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: patient was administered two doses of Twinrix on 04Oct2023 and 14 Nov2023; Given to adolescent; Given to adolescent; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of product administration in a 14-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   On 14-NOV-2023, the patient received Twinrix. On 04-OCT-2023, the patient received Twinrix. On 04-OCT-2023, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Given to adolescent). On 14-NOV-2023, the patient experienced inappropriate schedule of product administration (Verbatim: patient was administered two doses of Twinrix on 04Oct2023 and 14 Nov2023) and inappropriate age at vaccine administration (Verbatim: Given to adolescent). The outcome of the inappropriate schedule of product administration, inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-DEC-2023 Nurse manager stated a 14-year-old patient was administered two doses of Twinrix, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. Nurse manager noted the nurses who administered the medication stated they were aware it was not indicated for adolescents. She was still investigating the medication error. The patient received the 2 doses of Twinrix not as per schedule, which led to inappropriate schedule of product administration. The reporter consented to follow up from safety. No further details provided on the call.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Extra dose given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 2GG34) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12-JAN-2021 and batch number:53X42) and Shingrix (received 2nd dose on an unknown date and batch number:97Y5D).   On 28-SEP-2023, the patient received the 3rd dose of Shingrix. On 28-SEP-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Extra dose given). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 01-DEC-2023 The reporter was contacted via phone to answer their question about Shingrix and what information was available about the recommendations that were available for the administration of a third dose of Shingrix and more at the petition of patients. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The patient received 3rd dose of Shingrix, which led to extra dose administered.
Sex: F
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: HCP called to report the administration of the diluent of Arexvy to a patient..; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number PR7R5, expiry date 05-MAR-2025) for prophylaxis.   On 01-DEC-2023, the patient received Arexvy. On 01-DEC-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: HCP called to report the administration of the diluent of Arexvy to a patient..) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date:01-DEC-2023 The health care professional called to report the administration of the diluent of Arexvy to a patient which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The health care professional asked for guidance on this situation. The reporter consented to follow up.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 56-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy to wool. Concomitant products included MULTI VITAMIN [ASCORBIC ACID;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;VITAMIN B1 NOS;VITAMIN B12 NOS;VITAMIN D NOS;VITAMIN E NOS] and SIMVASTATIN for an unknown indication.   In 2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient did not have an acute illness at the time of vaccination and up to one month before.  it was reported that, Patient did not have chronic or long-standing health conditions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-750172 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750172:Same patient different product
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis/out of breath; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDITIS (myocarditis/out of breath) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis/out of breath) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis/out of breath) outcome was unknown.        SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) dosing remained unchanged.       The concomitant medication was not reported by reporter. It was reported that patient had that myocarditis and was just completely out of breath for, like, two months and so everything worked out Ok. Since then, patient had done four additional ones. Patient had no problems and so wanted to get Moderna again. The treatment medication was not reported by reporter.  Company Comment: This is a Spontaneous case reported by a patient, concerning a patient of unknown age and gender, with no medical history reported, who experienced the expected and serious (due to medically significant) event of Myocarditis, which occurred on an unknown date after the first dose of SPIKEVAX NOS vaccine. As reported, patient had myocarditis, and was completely out of breath for approximately 2 months. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.   Reporter did not allow further contact
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Plasma cell myeloma
Clinical narrative: afib; stroke; brain aneurysms; multiple myeloma; He had heart issue, inflammation of the heart; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (afib), CEREBROVASCULAR ACCIDENT (stroke), INTRACRANIAL ANEURYSM (brain aneurysms), PLASMA CELL MYELOMA (multiple myeloma) and CARDITIS (He had heart issue, inflammation of the heart) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 019B21A) for COVID-19 prophylaxis.     Patient reported they did not any medical history or condition before receiving the vaccine. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (afib) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), INTRACRANIAL ANEURYSM (brain aneurysms) (seriousness criterion medically significant), PLASMA CELL MYELOMA (multiple myeloma) (seriousness criterion medically significant) and CARDITIS (He had heart issue, inflammation of the heart) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (afib), CEREBROVASCULAR ACCIDENT (stroke), INTRACRANIAL ANEURYSM (brain aneurysms), PLASMA CELL MYELOMA (multiple myeloma) and CARDITIS (He had heart issue, inflammation of the heart) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac function test: 30 percent of heart pumping.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  He stated he was getting treatment for multiple myeloma, which was not curable. He had heart issue, inflammation of the heart. He was taking 5 different medications to help regulate his heart pumping. He only has 30 % of his heart pumping. He stated he did not have this problem before taking the Moderna virus shot.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 60-year-old male patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) events of Atrial fibrillation (AESI), Cerebrovascular accident (AESI), Carditis (AESI), Intracranial aneurysm and Plasma cell myeloma, which occurred on an unknown date after the second dose of mRNA-1273 vaccine. As reported, patient is getting treatment for multiple myeloma, which is not curable. He is also taking 5 different medications to help regulate his heart pumping. He only has 30% of his heart pumping. At the time of the report, the events had not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypertension, Pain in extremity
Clinical narrative: He has high blood pressure; He has sore arm in down the left arm and up his chest; He also has headaches, and he is fatigue.; He also has headaches, and he is fatigue.; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (He has high blood pressure), PAIN IN EXTREMITY (He has sore arm in down the left arm and up his chest), HEADACHE (He also has headaches, and he is fatigue.) and FATIGUE (He also has headaches, and he is fatigue.) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Patient did not report any medical history or condition.  The patient's past medical history included COVID-19 in October 2022. Previously administered products included for Product used for unknown indication: Pfizer Vaccine. Past adverse reactions to the above products included No adverse event with Pfizer Vaccine.    On 05-Dec-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (He has high blood pressure), PAIN IN EXTREMITY (He has sore arm in down the left arm and up his chest), HEADACHE (He also has headaches, and he is fatigue.) and FATIGUE (He also has headaches, and he is fatigue.). At the time of the report, HYPERTENSION (He has high blood pressure), PAIN IN EXTREMITY (He has sore arm in down the left arm and up his chest), HEADACHE (He also has headaches, and he is fatigue.) and FATIGUE (He also has headaches, and he is fatigue.) had not resolved.            Patient did not have information about previous COVID-19 vaccination records.  Concomitant medication not reported.   Treatment medication not reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Syncope
Clinical narrative: Fainting; muscle ache; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. NDC 80777-0102-96) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 microgram. On 14-Oct-2023, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), MYALGIA (muscle ache), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, SYNCOPE (Fainting), MYALGIA (muscle ache), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was not reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was reported.  Company comment:  This spontaneous case concerns a 69  year  old female patient, with no medical history reported, who experienced the unexpected (according to CCDS data sheet), serious (medically significant) event of syncope. The event occurred the day after a dose of Spikevax 2023 - 2024 vaccine (Andusomeran); no information about previous immunisation schedule was provided. The report stated that the patient experienced muscle ache, fatigue, nausea, and fainting. The outcome was recovered. No further clinical details were provided for medical reviewing. The benefit-risk relationship of Spikevax 2023 - 2024 vaccine (Andusomeran) is not affected by this report.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: arm got sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm got sore) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   In 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In 2023, the patient experienced PAIN IN EXTREMITY (arm got sore). At the time of the report, PAIN IN EXTREMITY (arm got sore) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown. Patient received a flu vaccine before the COVID-19 vaccine.  It was reported that His most recent dose was sometime this year, he thinks a couple months ago. A few days after receiving the most recent dose his arm got sore. When he moves his arm a certain way he still feels it.  Patient had no medications or treatments.   This case was linked to US-MODERNATX, INC.-MOD-2023-752704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-752704:Girlfriend case
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm got sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm got sore) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine.    In 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced PAIN IN EXTREMITY (arm got sore). At the time of the report, PAIN IN EXTREMITY (arm got sore) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that when he moves his arm a certain way, he still feels it. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-752749 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-752749:Girlfriend case
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Nausea, Tremor, Vaginal haemorrhage
Clinical narrative: Vaginal bleeding; Shaking; Sweating; Chills; Nausea; This spontaneous case was reported by a patient and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding), TREMOR (Shaking), HYPERHIDROSIS (Sweating), CHILLS (Chills) and NAUSEA (Nausea) in a 31-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 06-Dec-2023, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding), TREMOR (Shaking), HYPERHIDROSIS (Sweating), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding), TREMOR (Shaking), HYPERHIDROSIS (Sweating), CHILLS (Chills) and NAUSEA (Nausea) was resolving.            Concomitant medication was not provided. Patient had no reaction till 6 hours later. She had violent shaking from chills, sweating and nausea for next 6 hours but in the morning, she had breakthrough vaginal bleeding. Treatment information was not reported.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (013M20A. 1 st dose) on 21-Feb-2021, Moderna COVID-19 vaccine (026A21A, 2nd dose) on 21-Mar-2021, Moderna COVID-19 vaccine (012F21A, 3rd dose) on 25-Oct-2021, Moderna COVID-19 vaccine (048L21A, 4th dose) on 30-Mar-2022, Moderna COVID-19 vaccine (AS71453B and 5th dose) on 12-Sep-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.    On 21-Apr-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In August 2023, the patient experienced COVID-19 (covid-19). At the time of the report, COVID-19 (covid-19) had resolved.        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.   No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that patient had another bout in Sep2023, around 23-Aug-2023.  No treatment medication was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Brain fog
Clinical narrative: One friend said that she was very foggy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BRAIN FOG (One friend said that she was very foggy) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced BRAIN FOG (One friend said that she was very foggy). At the time of the report, BRAIN FOG (One friend said that she was very foggy) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Suspect product dosage text was reported as unknown. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-752852 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-752852:Friend case
Age: 32.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Caesarean section, Exposure during pregnancy, Premature baby, Premature delivery, Premature separation of placenta
Clinical narrative: Partial placental abruption resulting in preterm birth. Delivered at 36 weeks via emergency c-section
Age: 57.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Arthralgia, Shoulder injury related to vaccine administration
Clinical narrative: patient is complaining of shoulder pain and suspects SIRVA
Age: 16.0
Sex: F
Vaccine: YF
Symptoms: Blood glucose normal, Dizziness, Headache, Laboratory test normal, Paraesthesia
Clinical narrative: Pt started having a headache 10 minutes after receiving vaccine.  She got up to tell her mom and fainted in her mom's arms.  Pt was then positioned in a chair with legs elevated and came through shortly after.  Her fingers were tingly and she felt extremely dizzy. paramedics came and took her vitals  which  were normal, blood sugar was alsonormal.  Pt was taken to ER for monitoring.  Every tests came back normal.
Age: 16.0
Sex: F
Vaccine: YF
Symptoms: Syncope
Clinical narrative: Pt started having a headache 10 minutes after receiving vaccine.  She got up to tell her mom and fainted in her mom's arms.  Pt was then positioned in a chair with legs elevated and came through shortly after.  Her fingers were tingly and she felt extremely dizzy. paramedics came and took her vitals  which  were normal, blood sugar was alsonormal.  Pt was taken to ER for monitoring.  Every tests came back normal.
Age: 10.0
Sex: M
Vaccine: FLU4, HEPA, HPV9
Symptoms: No adverse event
Clinical narrative: No adverse event.
Age: 10.0
Sex: M
Vaccine: COVID19-2, FLU4, HEPA, HPV9
Symptoms: No adverse event
Clinical narrative: No adverse event
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin, Erythema, Infection
Clinical narrative: PATIENT REPORTED REDNESS FROM INJECTION FEW DAYS AFTER VACCINE TO INTERN PHARMACIST, WAS  SEEN BY PRESCRIBER ON 11/22 WHO TREATED SKIN REACTION AS FUNGAL INFECTION WHICH DID NOT IMPROVE SO PATIENT SAW URGENT CARE PROVIDER WHO TREATED WITH KEFLEX WITH NO IMPROVMENT. PATIENT PRESENTED TO PHARMACIST ON DUTY ON 12/11 WITH PSORIASIS LIKE INFECTION IN ARM STATING FROM SHINGRIX VACCINE PATIENT WAS EVALUATED BY DERMATOLOGIST AND STATED BIOPSY WAS TAKEN
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Over 24 hours  after the injection, my injection site became red, itchy, burning, and resulted in a large rock, solid, swollen lump on my arm.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, Skin warm
Clinical narrative: Patient reports rash on left arm that warm to the touch. Rash started on 12/09, the day after vaccination was given. Recommended treatment with benadryl and ibuprofen or tylenol for the pain.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was receiving a flu vaccine at a nursing home. Patient wrote on his consent form that he is 65 YO, but his DOB is 12/XX/19XX. Judging from the 65 YO mark, he was administered the High-Dose Fluzone vaccine when he was actually only 64 YO. He will be 65 YO on XX/XX/20XX.