chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Discomfort, Dyspnoea, Hallucination, Loss of personal independence in daily activities, Mental disorder
Clinical narrative: I recall picking up victim, male 55+ as an ER discharge on the event 2022. He stated he was short of breath.  He stated his oxygen was 94-95%. He was experiencing paranoid hallucinations about his roommates hurting him. As a result he wanted to stay at a friends place. We proceeded to his residence. We then went to his friends apartment. He did not have an address or phone number for the friend. He just knew he lived by store. During the ride he expressed discomfort breathing. He admitted to having 3 doses of Pfizer. We arrived at a large apartment complex with identical buildings. We made contact with the neighbor of his friend. He could not care for himself. During the course of the ride after he hallucinated and expressed difficulty breathing I asked him if he wanted to go back to hospital or seek medical care. He declined. I told him I'd make sure to make contact with someone that could help him and not leave him alone. he was incapable of self-care at the time of discharge from the ER due to the breathing and mental health issues.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paranoia
Clinical narrative: I recall picking up victim, male 55+ as an ER discharge on the event 2022. He stated he was short of breath.  He stated his oxygen was 94-95%. He was experiencing paranoid hallucinations about his roommates hurting him. As a result he wanted to stay at a friends place. We proceeded to his residence. We then went to his friends apartment. He did not have an address or phone number for the friend. He just knew he lived by store. During the ride he expressed discomfort breathing. He admitted to having 3 doses of Pfizer. We arrived at a large apartment complex with identical buildings. We made contact with the neighbor of his friend. He could not care for himself. During the course of the ride after he hallucinated and expressed difficulty breathing I asked him if he wanted to go back to hospital or seek medical care. He declined. I told him I'd make sure to make contact with someone that could help him and not leave him alone. he was incapable of self-care at the time of discharge from the ER due to the breathing and mental health issues.
Sex: U
Vaccine: HEP, HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14 year old Received A Dose of Heplisav-B; Initial report received on 17-Aug-2023 and 30-Aug-2023 (VAERS)  A VAERS report was retrieved from FDA VAERS from the Centers for Disease Control and Prevention website (VAERS ID #2672874-1) on 30-Aug-2023 and was noted as being reported to VAERS on 17-Aug-2023.   A registered nurse reported that a 14-year-old female patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   Medical history included seasonal allergies, anxiety, and attention deficit hyperactivity disorder. The patient had no known allergies or reactions.   Concomitant medications were not reported at the time of vaccination.  Previously, the patient received a 3-dose hepatitis B series on 26-Mar-2009, 19-May-2009, and 20-Jul-2009 (no details were provided).   On 16-Aug-2023, the 14-year-old patient received dose 1 of HEPLISAV-B (Lot # 942761, expiration date 31 Aug-2025, NDC # 43528-003-05) intramuscularly in the left deltoid.  In the chart, the indication for the HEPLISAV-B vaccine was noted as the patient "was due for it." No adverse reactions were reported.  No additional information was provided.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
Sex: U
Vaccine: HEP, HEP
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, No adverse event
Clinical narrative: 14 year old Received A Dose of Heplisav-B; Initial report received on 17-Aug-2023 and 30-Aug-2023 (VAERS)  A VAERS report was retrieved from FDA VAERS from the Centers for Disease Control and Prevention website (VAERS ID #2672874-1) on 30-Aug-2023 and was noted as being reported to VAERS on 17-Aug-2023.   A registered nurse reported that a 14-year-old female patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   Medical history included seasonal allergies, anxiety, and attention deficit hyperactivity disorder. The patient had no known allergies or reactions.   Concomitant medications were not reported at the time of vaccination.  Previously, the patient received a 3-dose hepatitis B series on 26-Mar-2009, 19-May-2009, and 20-Jul-2009 (no details were provided).   On 16-Aug-2023, the 14-year-old patient received dose 1 of HEPLISAV-B (Lot # 942761, expiration date 31 Aug-2025, NDC # 43528-003-05) intramuscularly in the left deltoid.  In the chart, the indication for the HEPLISAV-B vaccine was noted as the patient "was due for it." No adverse reactions were reported.  No additional information was provided.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The medical assistant is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX  (w032370  4/19/2025) Temperature: 37.2F; This spontaneous report was received from a medical assistant referring to an unknown age and gender patient. The patient's concurrent condition, medical history, and concomitant medications were not reported.   Varicella virus vaccine live (Oka/Merck) (VARIVAX) lot# W032370 (reported as w032370), expiry date was reported as 19-APR-2025, but upon internal validation established as 10-OCT-2024, was stored at temperature of 37.2 degree Fahrenheit (F) for 18 hours. There was no previous temperature excursion. On 13-SEP-2023, after temperature excursion, the patient was vaccinated with 1 dose of the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (dose, schedule of vaccination, route of administration, and anatomical site of injection was not provided) as prophylaxis (product storage error). No additional adverse events (AEs) were reported (no adverse event). No further information was provided.  This is one of 4 reports received from the same reporter.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects were reported; an inadvertent administration of a 4th dose of GARDASIL 9 to a 15 yr old female; This spontaneous report was received from a physician referring to a 15-year-old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 05-OCT-2021, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, route of administration, lot number and expiration date were not reported). On 21-FEB-2022, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, route of administration, lot number and expiration date were not reported). On 18-AUG-2022, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, route of administration, lot number and expiration date were not reported).  On 01-NOV-2023, the patient was inadvertently vaccinated with the forth dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot# W026152 has been verified to be a valid lot number, expiration date was reported as 29-JAN-2025), 0.5 ml, administered by a health professional for prophylaxis (strength and route of administration were not reported) (extra dose administered). No adverse effects were reported. The reporter also asked about any future adverse effects to be aware of.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No symptoms reported/No additional AE/PQC; a 38-year-old male patient that received their first dose of GARDASIL 9 in July 2022 and is scheduled to receive their second dose on 10-NOV-2023; This spontaneous report has been received from a pharmacist and refers to a 38-year-old male patient. His pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.  On an unspecified date in July 2022, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection 0.5 milliliter (route of administration, anatomical location of vaccination, lot number and expiration date were not provided) as prophylaxis. The patient is scheduled to receive his second dose on 10-NOV-2023 (inappropriate schedule of product administration). No symptoms or additional adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; Initial Report Received on 14-Apr-2023  A family medicine health care provider reported to the HEPLISAV-B Pregnancy Registry that a pregnant female (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history or concomitant medications were reported.   The last menstrual period date, pregnancy history, and pregnancy risk factors were not reported. The patient's estimated date of delivery is 16-Nov-2023.  On an unspecified date, the pregnant patient received a dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not reported). No additional information was provided.  The Pregnancy Registry made follow-up phone calls to the reporter and left messages but did not receive any responses. Therefore, no further follow-up will be conducted by the Pregnancy Registry. The reporter did not provide permission for Dynavax to follow up.  Company Comment:  The company considers the event as non-serious.; Sender's Comments: The company considers the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Patient Received Heplisav-B June 2023, Came Back and Received Engerix-B A Month and 5 Days Later; Initial Report Received on 04-Oct-2023  An advanced nurse practitioner reported that a patient (age, sex, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization June 2023 and received Engerix-B a month and 5 days later.  Medical history and allergies at the time of vaccination were not reported. Medications at the time of vaccination were not reported.  On an unspecified date in Jun-2023, the patient received HEPLISAV-B (NDC # 43528-002-01, lot #, expiration date, route and site of administration not reported) for hepatitis B immunization.   On an unspecified date, a month and 5 days later, the patient received Engerix-B (Lot #, expiration date, NDC #, route and site of administration not reported) as the second dose for hepatitis B immunization.    No additional information was reported.   Company Comment:  The company considers the event as non-serious.; Sender's Comments: The company considers the event as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032086) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu on 16-Oct-2023. Past adverse reactions to the above products included No adverse reaction with Flu.    On 16-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 microgram. On 16-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced NEUROPATHY PERIPHERAL (neuropathy) (seriousness criterion medically significant). The patient was treated with IBUPROFEN at a dose of 400 milligram twice a day. At the time of the report, NEUROPATHY PERIPHERAL (neuropathy) was resolving.            Concomitant medication was not reported.  Patient experienced neuropathy in her left hand which was in the arm patient received the vaccination. Patient also experiencing left hand weakness at a level of 2/10. The neuropathy comes and goes and was mild but bothersome. The patient did not experience any additional symptoms/events. The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available.  This is a Spontaneous case concerning a female patient of unknown age, previously vaccinated with a flu vaccine and no other medical history reported, who experienced the unexpected serious (medically significant) event of Neuropathy peripheral which began on the same day after the administration of SPIKEVAX 2023-2024 PFS vaccine. The patient experienced an intermittent neuropathy in the left hand (vaccination arm) and a left-hand weakness at a level of 2/10. Patient is being treated with ibuprofen. No further information was available in the report. The benefit-risk relationship of SPIKEVAX 2023-2024 PFS Vaccine is not affected by this report.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site erythema, Injection site haematoma, Injection site pruritus, Injection site reaction
Clinical narrative: I reported to my PCP at 11/16/2023 11:00 AM ongoing vaccine side effect from RSV vaccine Got RSV shot 11/8/2023  Arm swelling like the size of the grapefruit Edge of redness, itching like crazy  Treatment MD 11/17/2023 4:21 PM I am a physician helping your provider respond to incoming messages and results today.  I would massage it and put a warm compress on it. If it gets worse, please go to the UC to be evaluated.  Still an issue over the weekend and got appointment to see PA-C on Monday.   Employee at 11/20/2023  9:00 AM  1. Hematoma -Its likely that when you received your vaccination, a blood vessel was hit, and it caused bleeding under the skin, we call it a "hematoma". With your history of Von Willebrand disease, this is the most likely cause of your symptoms. -I recommend applying ice to the area to minimize the itching sensation and the swelling. BUT if it feels better with heat, to minimize soreness, that is okay too. -Follow up as needed, otherwise your symptoms appear self limiting and should not cause more problems.   I went today 11/22/2023 for monthly allergy shots but was turned away because of the bruising and itching at the RSV shot site. Injection nurse wrote: Employee at 11/22/2023  9:10 AM -Two patient identifiers were confirmed -The patient chart and order were reviewed -The patient reports receiving an LDL RSV injection on 11/08/23 that caused redness, swelling and itchiness -A review of the chart shows the patient was seen for this area of concern on 11/20/23 -The patient reports ongoing itchiness and slight redness at the site; the Injection Room RN observed the patient continuing to scratch at the site. The patient states that her symptoms are better but have not resolved. -The team RN spoke with Dr, the 11/22/23 doctor of the day, who recommends the patient not receive her allergy injection today -The Injection Room RN recommended the patient follow up with Dr to review this area of concern who can plan, advise, and follow the patient care -The patient indicates understanding of these issues and agrees with the plan. -This patient update will be sent to Dr. The patient is requesting a call back from the Allergy team with next steps.  -The Allergy team members can close the TE following patient outreach / contact. the Allergy doctor office nurse wrote:  RN 11/22/2023 1:05PM The injection room nurse let us know that they were not able to give your allergy shot today since you still had some swelling and itching from the RSV vaccine. Dr said that you can resume your allergy shots once the swelling and itching has resolved and you are feeling better. No need to see him for a visit/evaluation. I sent the injection room nurses a message as well so they know the plan. Please let me know if you have any other questions.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Vascular injury
Clinical narrative: I reported to my PCP at 11/16/2023 11:00 AM ongoing vaccine side effect from RSV vaccine Got RSV shot 11/8/2023  Arm swelling like the size of the grapefruit Edge of redness, itching like crazy  Treatment MD 11/17/2023 4:21 PM I am a physician helping your provider respond to incoming messages and results today.  I would massage it and put a warm compress on it. If it gets worse, please go to the UC to be evaluated.  Still an issue over the weekend and got appointment to see PA-C on Monday.   Employee at 11/20/2023  9:00 AM  1. Hematoma -Its likely that when you received your vaccination, a blood vessel was hit, and it caused bleeding under the skin, we call it a "hematoma". With your history of Von Willebrand disease, this is the most likely cause of your symptoms. -I recommend applying ice to the area to minimize the itching sensation and the swelling. BUT if it feels better with heat, to minimize soreness, that is okay too. -Follow up as needed, otherwise your symptoms appear self limiting and should not cause more problems.   I went today 11/22/2023 for monthly allergy shots but was turned away because of the bruising and itching at the RSV shot site. Injection nurse wrote: Employee at 11/22/2023  9:10 AM -Two patient identifiers were confirmed -The patient chart and order were reviewed -The patient reports receiving an LDL RSV injection on 11/08/23 that caused redness, swelling and itchiness -A review of the chart shows the patient was seen for this area of concern on 11/20/23 -The patient reports ongoing itchiness and slight redness at the site; the Injection Room RN observed the patient continuing to scratch at the site. The patient states that her symptoms are better but have not resolved. -The team RN spoke with Dr, the 11/22/23 doctor of the day, who recommends the patient not receive her allergy injection today -The Injection Room RN recommended the patient follow up with Dr to review this area of concern who can plan, advise, and follow the patient care -The patient indicates understanding of these issues and agrees with the plan. -This patient update will be sent to Dr. The patient is requesting a call back from the Allergy team with next steps.  -The Allergy team members can close the TE following patient outreach / contact. the Allergy doctor office nurse wrote:  RN 11/22/2023 1:05PM The injection room nurse let us know that they were not able to give your allergy shot today since you still had some swelling and itching from the RSV vaccine. Dr said that you can resume your allergy shots once the swelling and itching has resolved and you are feeling better. No need to see him for a visit/evaluation. I sent the injection room nurses a message as well so they know the plan. Please let me know if you have any other questions.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Cutaneous vasculitis, Petechiae, Vasculitis
Clinical narrative: Petechiae, small vessel vasculitis on lower extremities. Started about 3 days after the vaccine administration
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Autopsy, Sudden death
Clinical narrative: Sudden death. Autopsy reports body unharmed, asymptomatic, and healthy, other than being dead.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Condition aggravated, Electrocardiogram, Full blood count, Lethargy
Clinical narrative: Pt had 5th vaccination yesterday (first 4 were Pfizer), this was Moderna (unsure if it's bivalent). Pt had arm soreness & lethargy with others. After Moderna booster yesterday, today had onset of atrial fibrillation. Given PO Cardizem 240 mg ER in  ED, labs taken. Briefly in sinus rhythm after arrival then back to AF.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Metabolic function test, Pain in extremity, Sinus rhythm
Clinical narrative: Pt had 5th vaccination yesterday (first 4 were Pfizer), this was Moderna (unsure if it's bivalent). Pt had arm soreness & lethargy with others. After Moderna booster yesterday, today had onset of atrial fibrillation. Given PO Cardizem 240 mg ER in  ED, labs taken. Briefly in sinus rhythm after arrival then back to AF.
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lymphadenopathy, Oedema peripheral, Pain
Clinical narrative: 4 inch diameter Axillary swelling/lymphadenopathy and pain.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Red rash reaction at the injection site. Itchy and raised skin.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Pain, Rash
Clinical narrative: shingles/Shingles rash up from right arm all the way to neck and hairline right side; pain all over/pain generalized; chills but no fever; rash goes up right arm to neck and hairline on right side only; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number YG4SK, expiry date 15-SEP-2025) for prophylaxis.   On 07-NOV-2023, the patient received the 1st dose of Shingrix (right arm). On 10-NOV-2023, 3 days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles/Shingles rash up from right arm all the way to neck and hairline right side). In NOV-2023, the patient experienced general body pain (Verbatim: pain all over/pain generalized), chills (Verbatim: chills but no fever) and rash (Verbatim: rash goes up right arm to neck and hairline on right side only). The outcome of the shingles, general body pain and chills were not resolved and the outcome of the rash was not reported.   It was unknown if the reporter considered the shingles, general body pain, chills and rash to be related to Shingrix.     It was unknown if the company considered the shingles, general body pain, chills and rash to be related to Shingrix.   Additional Information: GSK Receipt date: 13-NOV-2023  The registered pharmacist reported that a patient was given dose 1 Shingrix. She stated he went to healthcare professional on 10th November 2023 and was diagnosed with shingles.  The rash goes up right arm to neck and hairline on right side only. She also stated he mentioned he had pain (generalized) and chills but no fever.  The reporter did not consent to follow-up.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: The patient experienced severe arm pain in left arm after dosing,; This non-serious case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number 4M24Z, expiry date 31-JUL-2026) for prophylaxis.   Previously administered products included Bexsero (received 1st dose of Bexsero on 25th January 2023 of batch no 4L274 and expiry date 30th September 2024).   On 03-NOV-2023, the patient received the 2nd dose of Bexsero (intramuscular, left deltoid). On an unknown date, an unknown time after receiving Bexsero, the patient experienced pain in arm (Verbatim: The patient experienced severe arm pain in left arm after dosing,). The patient was treated with ibuprofen. The outcome of the pain in arm was resolving.   It was unknown if the reporter considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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:13-NOV-2023 The medical assistant reported that patient received Bexsero vaccine and experienced severe arm pain in left arm after dosing, which is still ongoing but had improved a little bit. The reporter was not sure of the onset of the pain. The patient was using ibuprofen for the pain.  The Vaccine Administration Facility was the same as Primary Reporter. This case was linked with US2023157074, US2023157077 reported by same reporter for different patients. The reporter consent to follow up.; Sender's Comments:  US-GSK-US2023157074:Diff. patient US-GSK-US2023157077:Diff. patient
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: she administered the Covid shot to. 3 of her patients died; This spontaneous case was reported by a physician and describes the occurrence of DEATH (she administered the Covid shot to. 3 of her patients died) 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   This case refers to the patient 1 out of 3 patients died as per the reporter.  Concomitant medication was not reported. The vaccine lot number was not reported.  Treatment medication was not reported.  Company Comment: This spontaneous case concerns an unknown age and gender patient, with no medical history reported, who experienced the unexpected, medically significant and death seriousness criteria event of death unknown days after a dose of mRNA-1273.815 vaccine.  Concomitant medication nor Treatment details were reported. The benefit-risk relationship of mRNA-1273.815 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-750271, US-MODERNATX, INC.-MOD-2023-750269, US-MODERNATX, INC.-MOD-2023-750261, US-MODERNATX, INC.-MOD-2023-750261, US-MODERNATX, INC.-MOD-2023-750264 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750271:Invalid Case US-MODERNATX, INC.-MOD-2023-750269:4th Stroke case US-MODERNATX, INC.-MOD-2023-750261:2nd Death case US-MODERNATX, INC.-MOD-2023-750264:Master Case US-MODERNATX, INC.-MOD-2023-750261:Master case; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Pruritus, Rash
Clinical narrative: Burning; Itchy; Very painful; Developed a rash similar to my flare on his arms; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BURNING SENSATION (Burning), PRURITUS (Itchy), PAIN (Very painful) and RASH (Developed a rash similar to my flare on his arms) in a male patient of an unknown age who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Burning), PRURITUS (Itchy), PAIN (Very painful) and RASH (Developed a rash similar to my flare on his arms). At the time of the report, BURNING SENSATION (Burning), PRURITUS (Itchy), PAIN (Very painful) and RASH (Developed a rash similar to my flare on his arms) outcome was unknown.            Concomitant medication was not provided. It was reported by reporter that her husband had experienced rash on arms similar to her flare. It was itchy, burning and very painful. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-750334 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750334:Wife case
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Hypersomnia, Influenza like illness, Pain
Clinical narrative: flu like symptoms; throat is swollen; feels achy; tired; sleeping a lot; His chest feels restricted while breathing; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PHARYNGEAL SWELLING (throat is swollen), PAIN (feels achy), FATIGUE (tired) and HYPERSOMNIA (sleeping a lot) in a 71-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 11-Nov-2023, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PHARYNGEAL SWELLING (throat is swollen), PAIN (feels achy), FATIGUE (tired), HYPERSOMNIA (sleeping a lot) and CHEST DISCOMFORT (His chest feels restricted while breathing). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had not resolved and PHARYNGEAL SWELLING (throat is swollen), PAIN (feels achy), FATIGUE (tired), HYPERSOMNIA (sleeping a lot) and CHEST DISCOMFORT (His chest feels restricted while breathing) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Contact has received 3 prior doses of the Moderna COVID-19 vaccines without any symptoms. He received his most recent Moderna COVID-19 vaccine on 25 OCT 2023. On 11 NOV 2023 he started feeling flu like symptoms, throat swollen, feels achy, tired, and sleeping a lot. His chest feels restricted while breathing. Went on to my provider website which said that symptoms may be related to the COVID-19 vaccines for 3 weeks after receipt of the vaccines. Has taken there flu once a day for the past couple of days. Got a shingles shot the same day. 2 weeks prior got a flu vaccine.  Company Comment: This is a spontaneous case concerning 71-year-old male patient with no reported medical history, who experienced the non-serious unexpected, AESI event of hypersomnia, together with other non-serious events, which occurred approximately 15 days after a dose mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine, received as the fourth dose of COVID-19 vaccination schedule. It was reported that patient got a shingles shot the same day, and that 2 weeks prior he got a flu vaccine. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: flu like symptoms; throat is swollen; feels achy; tired; sleeping a lot; His chest feels restricted while breathing; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PHARYNGEAL SWELLING (throat is swollen), PAIN (feels achy), FATIGUE (tired) and HYPERSOMNIA (sleeping a lot) in a 71-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 11-Nov-2023, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PHARYNGEAL SWELLING (throat is swollen), PAIN (feels achy), FATIGUE (tired), HYPERSOMNIA (sleeping a lot) and CHEST DISCOMFORT (His chest feels restricted while breathing). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had not resolved and PHARYNGEAL SWELLING (throat is swollen), PAIN (feels achy), FATIGUE (tired), HYPERSOMNIA (sleeping a lot) and CHEST DISCOMFORT (His chest feels restricted while breathing) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Contact has received 3 prior doses of the Moderna COVID-19 vaccines without any symptoms. He received his most recent Moderna COVID-19 vaccine on 25 OCT 2023. On 11 NOV 2023 he started feeling flu like symptoms, throat swollen, feels achy, tired, and sleeping a lot. His chest feels restricted while breathing. Went on to my provider website which said that symptoms may be related to the COVID-19 vaccines for 3 weeks after receipt of the vaccines. Has taken there flu once a day for the past couple of days. Got a shingles shot the same day. 2 weeks prior got a flu vaccine.  Company Comment: This is a spontaneous case concerning 71-year-old male patient with no reported medical history, who experienced the non-serious unexpected, AESI event of hypersomnia, together with other non-serious events, which occurred approximately 15 days after a dose mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine, received as the fourth dose of COVID-19 vaccination schedule. It was reported that patient got a shingles shot the same day, and that 2 weeks prior he got a flu vaccine. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: it causes me to itch; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (it causes me to itch) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 17-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PRURITUS (it causes me to itch). At the time of the report, PRURITUS (it causes me to itch) 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.   The concomitant medication was not reported by reporter. Dosage text for suspect drug was reported as unknown. Patient took the mRNA LNPS B series on the 17th of November. The treatment medication was not reported by reporter.   This case was linked to MOD-2021-077905 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Musculoskeletal stiffness, Pyrexia, Vaccination site pain
Clinical narrative: Body malaise; muscle stiffness; low grade fever; Pain on injection site; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Body malaise), MUSCULOSKELETAL STIFFNESS (muscle stiffness), PYREXIA (low grade fever) and VACCINATION SITE PAIN (Pain on injection site) in a 34-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 19-Nov-2023, the patient experienced MALAISE (Body malaise), MUSCULOSKELETAL STIFFNESS (muscle stiffness), PYREXIA (low grade fever) and VACCINATION SITE PAIN (Pain on injection site). At the time of the report, MALAISE (Body malaise), MUSCULOSKELETAL STIFFNESS (muscle stiffness), PYREXIA (low grade fever) and VACCINATION SITE PAIN (Pain on injection site) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Motion sickness, Nausea, Vomiting
Clinical narrative: Motion sickness started 2 hrs post vaccination; nausea; Vomiting started 1 hr post vaccination; This spontaneous case was reported by a consumer and describes the occurrence of MOTION SICKNESS (Motion sickness started 2 hrs post vaccination), NAUSEA (nausea) and VOMITING (Vomiting started 1 hr post vaccination) in a 42-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 19-Nov-2023, the patient experienced MOTION SICKNESS (Motion sickness started 2 hrs post vaccination). 19-Nov-2023, the patient experienced NAUSEA (nausea) and VOMITING (Vomiting started 1 hr post vaccination). At the time of the report, MOTION SICKNESS (Motion sickness started 2 hrs post vaccination), NAUSEA (nausea) and VOMITING (Vomiting started 1 hr post vaccination) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Muscle spasms
Clinical narrative: cramping; diarrhea; fatigue; chills; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (cramping), DIARRHOEA (diarrhea), FATIGUE (fatigue) and CHILLS (chills) in a 57-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 18-Nov-2023, the patient experienced MUSCLE SPASMS (cramping), DIARRHOEA (diarrhea), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, MUSCLE SPASMS (cramping), DIARRHOEA (diarrhea), FATIGUE (fatigue) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No Concomitant medication was reported.  Events occurred within 6 hours of receipt of vaccination. It was unknown if the patient experienced any additional symptoms/events.  No treatment information was reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Malaise, Pyrexia
Clinical narrative: malaise; fever; headache; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), PYREXIA (fever), HEADACHE (headache) and ARTHRALGIA (joint pain) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 21-Nov-2023, the patient experienced MALAISE (malaise), PYREXIA (fever), HEADACHE (headache) and ARTHRALGIA (joint pain). At the time of the report, MALAISE (malaise), PYREXIA (fever), HEADACHE (headache) and ARTHRALGIA (joint pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2023, Body temperature: 101.8 Farad.         Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: I am itching after a day of receiving the shot; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (I am itching after a day of receiving the shot) in a female patient of an unknown age 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,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PRURITUS (I am itching after a day of receiving the shot). At the time of the report, PRURITUS (I am itching after a day of receiving the shot) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. The patient experienced itching after a day of receiving the shot. There was no swelling, and it didn't happen right away. It was also reported that the patient might call back if nothing comes out of the test scheduled (unspecified). Treatment medication was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Nov-2023: Live non-significant follow up received included reference IDs and reporter details. On 21-Nov-2023: Live significant follow-up received and updated patient details, reporter details and reference IDs.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia, Pruritus
Clinical narrative: bad taste in my mouth; itchiness on my left breast; Initial information received on 14-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 47 years old female patient who experienced bad taste in mouth and itchiness on  left breast after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.    On 20-Oct-2023, the patient received unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Suspension for injection) (lot U8201FA) via intramuscular route in the left deltoid for Annual vaccine to prevent flu (Influenza).  On 23-Oct-2023, the patient developed bad taste in my mouth (taste disorder) and itchiness on my left breast (pruritus) 3 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Patient did not experience any additional symptoms/events.   There were no lab data/results available.   Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for all the events.   At time of reporting, the outcome was Not Recovered / Not Resolved for both the events.
Age: 47.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No side effects reported.; HCP calling to report AE for patient who received MMRII intramuscularly on 02-NOV-2023. Patient was a 47 year old.; This spontaneous report was received from a physician referring to a 47-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On 02-NOV-2023, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (dose, lot number and expiration date were unknown), administered intramuscularly by a healthcare professional for prophylaxis (product administered to patient of inappropriate age). No side effects were reported. There was no other known medical information.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no further AE.; Pharmacist calls to report GARDASIL 9 u032676 exp 10/26/2023 was given to a patient 11/7/2023.  See case 02505029.  No further AE.  No PQC.; This spontaneous report was received from a pharmacist and referred to a patient with unknown age and gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 07-NOV-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, one time, lot #u032676, expiration date: 26-OCT-2023, administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided) (Expired vaccine used). No further adverse event (AE).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further AE; MGARDASIL 9 u028825 exp 11/02/2023 given to a 19 years old on 11/13/2023; This spontaneous report was received from a pharmacist and referred to a 19-year-old patient with unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 13-NOV-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, one time, lot #u028825, expiration date: 02-NOV-2023, administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided) (Expired vaccine used). No further adverse event (AE).
Sex: U
Vaccine: COVID19
Symptoms: Cough, Pyrexia
Clinical narrative: Symptomatic cough; got really sick with fever; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (Symptomatic cough) and PYREXIA (got really sick with fever) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032230) 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 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Symptomatic cough) and PYREXIA (got really sick with fever). At the time of the report, COUGH (Symptomatic cough) and PYREXIA (got really sick with fever) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  There was a total of 97 doses consisting of 9 half boxes of vaccines in the vial.  it was reported that one resident that got really sick with fever, symptomatic cough. This was started 48hrs after adiministration.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-750249, US-MODERNATX, INC.-MOD-2023-750488, US-MODERNATX, INC.-MOD-2023-750486, US-MODERNATX, INC.-MOD-2023-750485 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750249:Same Report US-MODERNATX, INC.-MOD-2023-750488:Same Report US-MODERNATX, INC.-MOD-2023-750486:Same Report US-MODERNATX, INC.-MOD-2023-750485:Same Report
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Pain
Clinical narrative: she was miserable for 24 hours; body ache; she felt tired; had a headache; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (she was miserable for 24 hours), PAIN (body ache), FATIGUE (she felt tired) and HEADACHE (had a headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (she was miserable for 24 hours), PAIN (body ache), FATIGUE (she felt tired) and HEADACHE (had a headache). At the time of the report, FEELING ABNORMAL (she was miserable for 24 hours), PAIN (body ache), FATIGUE (she felt tired) and HEADACHE (had a headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  After dose 2, patient felt tired and had a headache and after dose 3 patient was miserable for 24 hours with a headache and body ache.  Treatment medications were not reported.   Reporter did not allow further contact