chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Cheilitis, Ear infection, Infection, Lymphadenitis
Clinical narrative: 4 days after I had my third booster shot, I spiked a fever of 104.4.  Then, after the fever, my lymph nodes became inflamed & I had an infection in my jaw.  It was so swollen.  I had sores all inside my mouth, lip & I couldn?t eat anything for at least 10 days.  It burned so bad & was one of the most painful things I?ve ever experienced. I also had lumps under my arms.  I had an ear infection too. I was given medication for mono.  Lidocaine for the pain & a really powerful mouthwash.   It has weighed on me for some time that I should?ve reported this.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Pyrexia, Stomatitis, Swelling face
Clinical narrative: 4 days after I had my third booster shot, I spiked a fever of 104.4.  Then, after the fever, my lymph nodes became inflamed & I had an infection in my jaw.  It was so swollen.  I had sores all inside my mouth, lip & I couldn?t eat anything for at least 10 days.  It burned so bad & was one of the most painful things I?ve ever experienced. I also had lumps under my arms.  I had an ear infection too. I was given medication for mono.  Lidocaine for the pain & a really powerful mouthwash.   It has weighed on me for some time that I should?ve reported this.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: Patient was found unresponsive in his cell, sitting in a chair. A Lucas machine was applied to patient and continued until EMS arrived and confirmed death of patient.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient was given a duplicate RSV vaccine. Initial dose was administered 11/3/2023
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Cough, Dyspnoea, Fatigue, Pain
Clinical narrative: Fatigue 3pm Friday/slept. Saturday/chills, fatigue, achy. Sunday around 1am woke to horrible dry cough & continued other symptoms. Temperature was 100.2. Continuous coughing throughout the day with upper airway wheezing and some SOB. Went to Urgent Cate around 4:30pm on Sunday. Home COVID test negative.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: SARS-CoV-2 test negative, Wheezing
Clinical narrative: Fatigue 3pm Friday/slept. Saturday/chills, fatigue, achy. Sunday around 1am woke to horrible dry cough & continued other symptoms. Temperature was 100.2. Continuous coughing throughout the day with upper airway wheezing and some SOB. Went to Urgent Cate around 4:30pm on Sunday. Home COVID test negative.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Patient called to say about a week after vaccine started to have bilateral leg pain and weakness. She's seeing doctor for issues and they are unsure of reason for on going leg problems. She was concerned about getting flubok in the future and wanted to know if she had had it in the past.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing began in both ears but stronger in my left ear after getting my first shot. It seems to happen soon after getting the vaccination.
Age: 80.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 15.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect. Patient was given the covid moderna spikevax 12+ a day passed the beyond use date (BUD). Vaccine was given on 1/22/25 and the BUD was 1/21/25.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism, Thromboembolectomy
Clinical narrative: billateral pulmonary embolism
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: patient given expired vaccine. vaccine expired October 2024
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Nausea
Clinical narrative: Patient had his well child visit scheduled with his sibling. While Dr. was assessing the patient's sibling, the nurses brought the patient and his father into another exam room to administer scheduled vaccinations. Patient received MenQuadfi, Adacel, and Fluzone. After administration, patient stood up and returned to original exam room with his sibling. Patient then began feeling nauseous and the nurses prompted him to sit down in the chair. The nurses brought him an emesis bag, water, and a cold wash cloth then Dr. was notified. Patient was prompted to lay on the exam table with feet elevated with a pillow, patient did so. Patient recovered on the table for about 10 minutes and once feeling better they checked out.
Age: 44.0
Sex: M
Vaccine: HEPAB
Symptoms: Unevaluable event
Clinical narrative: none
Age: 63.0
Sex: F
Vaccine: FLU3, PNC20, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient mentioned the injection sites on her left arm was red, swollen, and itchy.
Age: 13.0
Sex: M
Vaccine: COVID19, FLU3, HPV9
Symptoms: Underdose
Clinical narrative: Covid vaccine- was administered a smaller dose than required for age
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Asthenia, Fall, Head injury, Headache, Hyperhidrosis
Clinical narrative: 1053 - Patient was given vaccinations and stated she was okay. 1056 - Patient fell off of the bed (3 ft) and hit right side of head on to concrete floor. Patient tensed up, as if she was going to seize, and EMS was called by APRN and school nurse was called to bring emergency bag by RN. Vital signs were started as patient arose to sitting position. She stated she did not know what happened that caused her to be on the floor but had a headache, weakness, and was sweating. Stated last thing she remembered was her vision going fuzzy, having a headache, and feeling weak following the Gardasil vaccination. She said this started after medication was put in to arm. Patient was alert and orientated x3, eyes equal and reactive with no tunneling, felt like she was weak with headache and sweating, paleness noted on assessment. 1059-1101- AP RN attempted to call guardian. 1103 - Guardian called back on patient's sister's cell phone. APRN spoke with guardian over situation. Guardian stated she would be on her way to the school now, estimated to arrive in 10 minutes.  1105 - Patient was moved on to bed with the standby assist x3. Wet towel was placed on head and legs were raised. Patient will remain NPO at this time. Stated she last ate at 0730, chicken biscuit and 2 apple juices.  1110 - EMS arrived, report given. 1112 - Orthostatic vital signs and blood glucose check was started by EMS.  1118 - Cardiac monitor was placed on patient by EMS. HR 96, normal sinus rhythm per EMS.  1132 - Guardian arrived and given explanation of what happened from staff, then spoke with EMS workers.  1143 - Patients guardian spoke with EMS and staff, chose to sign EMS paperwork to refuse transportation. Stated that she would take her to Urgent Care for head evaluation after leaving. She was still complaining of headache but weakness and vision had improved. Patient was walking but APRN walked her to car as standby assist.  1150 - Report was given to Urgent Care (RN). 1157 - Supervisor, RN, made aware of the situation.  1221 - Added report given to Urgent Care (RN). 1243 - Spoke with RN, about appropriate reporting.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Musculoskeletal stiffness, Pallor, Sinus rhythm, Vision blurred
Clinical narrative: 1053 - Patient was given vaccinations and stated she was okay. 1056 - Patient fell off of the bed (3 ft) and hit right side of head on to concrete floor. Patient tensed up, as if she was going to seize, and EMS was called by APRN and school nurse was called to bring emergency bag by RN. Vital signs were started as patient arose to sitting position. She stated she did not know what happened that caused her to be on the floor but had a headache, weakness, and was sweating. Stated last thing she remembered was her vision going fuzzy, having a headache, and feeling weak following the Gardasil vaccination. She said this started after medication was put in to arm. Patient was alert and orientated x3, eyes equal and reactive with no tunneling, felt like she was weak with headache and sweating, paleness noted on assessment. 1059-1101- AP RN attempted to call guardian. 1103 - Guardian called back on patient's sister's cell phone. APRN spoke with guardian over situation. Guardian stated she would be on her way to the school now, estimated to arrive in 10 minutes.  1105 - Patient was moved on to bed with the standby assist x3. Wet towel was placed on head and legs were raised. Patient will remain NPO at this time. Stated she last ate at 0730, chicken biscuit and 2 apple juices.  1110 - EMS arrived, report given. 1112 - Orthostatic vital signs and blood glucose check was started by EMS.  1118 - Cardiac monitor was placed on patient by EMS. HR 96, normal sinus rhythm per EMS.  1132 - Guardian arrived and given explanation of what happened from staff, then spoke with EMS workers.  1143 - Patients guardian spoke with EMS and staff, chose to sign EMS paperwork to refuse transportation. Stated that she would take her to Urgent Care for head evaluation after leaving. She was still complaining of headache but weakness and vision had improved. Patient was walking but APRN walked her to car as standby assist.  1150 - Report was given to Urgent Care (RN). 1157 - Supervisor, RN, made aware of the situation.  1221 - Added report given to Urgent Care (RN). 1243 - Spoke with RN, about appropriate reporting.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Patient is presenting to our office on 1/27/2025 for left arm soreness that has been present since receiving the Tdap booster on 4/22/24. Patient states that she began having left deltoid muscle soreness 2 days after receiving the vaccine and the pain has not gone away or improved. Pain is described as a 7/10, non-radiating, constant pain that makes it difficult to carry any objects with her left arm. Patient has not been to the hospital or seen a doctor previously for this complaint. She has not tried any medications for pain.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Loss of personal independence in daily activities, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Patient reports she developed severe pain of left shoulder within hours of administration.  She reports her immunization was given in an improper location and was given too high.  She is still experiencing pain from top of shoulder into neck muscles, and down elbow.  She is currently in Physical Therapy.  Motrin and heat are not improving pain.  Range of motion has been affected. She has difficulty sleeping and dressing.  She has been instructed to avoid laying on left side.  She is a left side sleeper previous to this event.  She has been instructed to ice it daily.  She is being evaluated by one of her primary care physicians tomorrow.  She will continue with Physical Therapy.  She will also be scheduled acute follow up with the clinic who administered her flu vaccine when an appointment is available.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered at inappropriate site, Sleep disorder
Clinical narrative: Patient reports she developed severe pain of left shoulder within hours of administration.  She reports her immunization was given in an improper location and was given too high.  She is still experiencing pain from top of shoulder into neck muscles, and down elbow.  She is currently in Physical Therapy.  Motrin and heat are not improving pain.  Range of motion has been affected. She has difficulty sleeping and dressing.  She has been instructed to avoid laying on left side.  She is a left side sleeper previous to this event.  She has been instructed to ice it daily.  She is being evaluated by one of her primary care physicians tomorrow.  She will continue with Physical Therapy.  She will also be scheduled acute follow up with the clinic who administered her flu vaccine when an appointment is available.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: red and some swelling in the right arm
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, MMRV, PNC20
Symptoms: Crying, Product administered to patient of inappropriate age
Clinical narrative: nothing on site, MD did research on administration at this age and then spoke with parents and educated on S/s that they should look for.   The Proquad was administered 1in below the Pediarix on the Rt thigh. Pt was alert and crying and observed for 20-30 min after administration before leaving the clinic with mother.
Age: 52.0
Sex: F
Vaccine: COVID19, FLU3, HEP, MMR, PNC20, TDAP, VARCEL, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient was inappropriately given varicella and shingrix vaccines. Patient should not have received both. Patient was informed of the error, given information on what to do in the case of increased symptoms, and provided the clinic number if she had any additional questions or concerns. The patient required a translator and was contacted by a translatory assisted and expressed understanding.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: The next morning after Shingrix injection, the patient stated that four blisters appeared at injection site, left arm. Patient stated that 5 days later the blisters resolved.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no additional AEs/No other information provided; Caller reports adult formulation of RECOMBIVAX HB was administered to a 18 year old female.  No other information provided.  No additional AEs/PQC reported.  Caller declined AE follow up letter.; This spontaneous report was received from a pharmacist and referred to an 18-year-old female patient. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 15-JAN-2025, the patient was vaccinated adult formulation with hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 10 Microgram/1.0 ml intramuscular injection, 1.0 ml, administered intramuscularly for prophylaxis (lot #, anatomical site of administration and expiry date were not provided) (overdose) by Health Professional. No other information provided. No additional adverse events (AEs).  Additional Information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: No additional AE; initiated the series with GARDASIL approximately 10 years ago. Patient never received the subsequent doses in the series and would like to complete the series with GARDASIL 9; This spontaneous report was received from a nurse practitioner and refers to a currently 24-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date in 2015 (reported as approximately 10 years ago), the patient started therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, (0.5 milliliter, exact dose, lot #, expiration date, route of administration and anatomical location were not provided) administered for prophylaxis. Patient never received the subsequent doses in the series and would like to complete the series with GARDASIL 9 (Inappropriate schedule of vaccine administered). No additional AE/No PQC (No adverse event).  Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Device leakage, Syringe issue, Underdose
Clinical narrative: Merck Sterile Diluent syringe experienced suction when twisting the needle onto the hub of syringe; causing cap of syringe to pop off; MMRII was administered to a patient that was reconstituted using the defective sterile diluent syringe; caller unsure if patient received full amount of dose as some of the diluent leaked out due to the suction.; unsure if patient received full amount of dose; No additional AE; This spontaneous report was received from a nurse, concerning to a 15-month-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the syringe device of the sterile diluent (BAXTER STERILE DILUENT) solution for injection/infusion (lot # 1973242 has been verified for that product, expiration date reported and confirmed as 17-FEB-2026) experienced suction when twisting the needle into the hub of the syringe  (Device malfunction), causing the cap to pop off (Syringe issue). Also, on an unknown date, using that defective syringe device to reconstituted, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA] (M-M-R II) injection, 0.5 milliliter, administered for prophylaxis (strength and route of administration were not provided;  lot # Y010046 has been verified to be valid for this vaccine, expiration date reported and confirmed as 29-MAY-2026). (Poor quality device used). The reporter was unsure if the patient received the full dose as some diluent leaked out due to the suction (Device leakage) (Accidental underdose). No symptoms were reporter. No additional adverse event (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; The HCP reports that VARIVAX was inadvertently administered after suffering from a Temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions were not provided. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 22-NOV-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter/series, lot #Y006522, expiration date: 25-MAR-2026, administered for prophylaxis (strength and route of administration was not provided) inadvertently after suffering from a temperature excursion (Product storage error). Varicella virus vaccine live (oka/merck) (VARIVAX) reached -11.6 degree Celsius but previous excursions for 3 hours 5 minutes. But previous excursions could not be confirmed. No symptomatic adverse events were reported. Lot# and expiration date of the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) were unknown. No additional AE (No adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles again in 2020; I have been diagnosed with Shingles yesterday; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On 01-JAN-2025, more than 2 years after receiving Shingrix, the patient experienced shingles (Verbatim: I have been diagnosed with Shingles yesterday). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles again in 2020). The outcome of the vaccination failure and shingles were not reported and the outcome of the shingles was resolving.   It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JAN-2025 The patient had received Shingrix vaccine in 2017. She had been diagnosed with Shingles the day before reporting. She had Shingles again in 2020 as well.  The patient enquired if the drug was not effective for some people. The patient wonder if there is a booster that would be effective. The patient symptoms were treated.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Nodule
Clinical narrative: large knot on my arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of local swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced local swelling (Verbatim: large knot on my arm). The outcome of the local swelling was not reported.   It was unknown if the reporter considered the local swelling to be related to Shingles vaccine.     It was unknown if the company considered the local swelling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-JAN-2025 The reporter self-reported this case for himself/herself. The reporter need to know after getting a shingle shot it has left a large knot on my arm.  The reporter asked was this normal
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JAN-2025 This case was reported by a patient via interactive digital media. The patient never had shingles until got the shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the completion of primary vaccination schedule, time to onset of shingles and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: given a PRIORIX dose intramuscularly instead of subcutaneously; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 39-year-old female patient who received MMR (Priorix) (batch number 43G92, expiry date 01-MAY-2025) for prophylaxis.   On 03-JAN-2025, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: given a PRIORIX dose intramuscularly instead of subcutaneously). The outcome of the subcutaneous injection formulation administered by other route 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: 03-JAN-2025 The Healthcare professional reported that a female patient was given a Priorix dose intramuscularly instead of subcutaneously, which led to Subcutaneous injection formulation administered by other route.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired Havrix vaccine was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 8-year-old female patient who received HAV (Havrix) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis.   On 14-JAN-2025, the patient received Havrix. On 14-JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: expired Havrix vaccine was administered). 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: 14-JAN-2025 The office manager reported that an expired Havrix vaccine was administered to a patient which led to, expired vaccine used. At the time of reporting, a repeat dose had not been administered. The vaccine administration facility was the same as primary reporter. This case had been link with US2025004475, reported by the same reporter.; Sender's Comments:  US-GSK-US2025004475:Same reporter/Different patient
Age: 46.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Allergy to vaccine, Bronchitis
Clinical narrative: new allergies to influenza vaccine and moderna covid MRNA (messenger RiboNucleic Acid) vaccine,; Patient reports had bronchitis 2 weeks ago that was resolved with an antibiotic; This spontaneous case was reported by a patient and describes the occurrence of BRONCHITIS (Patient reports had bronchitis 2 weeks ago that was resolved with an antibiotic) and ALLERGY TO VACCINE (new allergies to influenza vaccine and moderna covid MRNA (messenger RiboNucleic Acid) vaccine,) in a 46-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for Immunisation.    Co-suspect products included non-company products Influenza vaccine for Immunisation and Dupilumab (Dupixent) solution for injection for Asthma and Eczema.    Concurrent medical conditions included Eczema and Asthma.   On 26-Sep-2023, the patient started Dupilumab (Dupixent) (Subcutaneous use) 600 milligram once a day. On 10-Oct-2023, Dupilumab (Dupixent) (Subcutaneous use) dosage was changed to 300 milligram. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. In October 2023, the patient experienced BRONCHITIS (Patient reports had bronchitis 2 weeks ago that was resolved with an antibiotic). On an unknown date, the patient experienced ALLERGY TO VACCINE (new allergies to influenza vaccine and moderna covid MRNA (messenger RiboNucleic Acid) vaccine,). In 2023, BRONCHITIS (Patient reports had bronchitis 2 weeks ago that was resolved with an antibiotic) had resolved. At the time of the report, ALLERGY TO VACCINE (new allergies to influenza vaccine and moderna covid MRNA (messenger RiboNucleic Acid) vaccine,) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that eczema related symptoms were as severe over the past week just as they were prior to therapy. Physician was aware of it. These severe symptoms continued to be the same since the start of therapy with no reported adverse event. It was unknown if physician was aware of it. The bronchitis was resolved with taking antibiotics. Physician was aware of it.
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Headache
Clinical narrative: headaches; brain fog; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headaches) and BRAIN FOG (brain fog) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In 2021, the patient experienced HEADACHE (headaches) (seriousness criterion medically significant) and BRAIN FOG (brain fog) (seriousness criterion medically significant). At the time of the report, HEADACHE (headaches) and BRAIN FOG (brain fog) had not resolved.            No concomitant medications were reported.  It was reported that patient had received the covid vaccine when it came out, the first dose was fine then a month later, received the 2nd shot. It was from a different batch. Patient developed headaches, a terrible brain fog. Patient stated that mid-April will be the 4th year that have suffered with this. Patient would like to know if Moderna would be able to help, or if something to reverse the shot. It also stated that patient was permanently disabled from the Moderna shot and would like to get this head out that Moderna and that vaccine did a job to the patient.  It was unknown if the patient experienced any additional symptoms/events.  No treatment medications were reported.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID19) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 07-Jan-2025, the patient experienced COVID-19 (COVID19). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) at an unspecified dose and frequency. In January 2025, COVID-19 (COVID19) had resolved.            No concomitant medication was reported. He had received five doses of the Moderna covid-19 vaccine since 2021 and was recently diagnosed with covid-19 this month, with detection on 7-Jan-2025. He reports having taken Paxlovid for five days and currently felt well, stating, no problem right now, no coughed, nothing right now. He was feeling very well right now. He believes he was fully recovered right now and had not received a covid-19 vaccine for the 2024-2025 season. No treatment medication was reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: While eating with chopsticks, she suddenly felt stiff in her hands and the chopsticks dropped down right out of her hand; Occasionally experienced numbness of her arms; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MUSCULOSKELETAL STIFFNESS (While eating with chopsticks, she suddenly felt stiff in her hands and the chopsticks dropped down right out of her hand) and HYPOAESTHESIA (Occasionally experienced numbness of her arms) in a 78-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Patient had been receiving Spikevax vaccine, and there had been no problem previously.    In October 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In 2024, the patient experienced MUSCULOSKELETAL STIFFNESS (While eating with chopsticks, she suddenly felt stiff in her hands and the chopsticks dropped down right out of her hand) and HYPOAESTHESIA (Occasionally experienced numbness of her arms). At the time of the report, MUSCULOSKELETAL STIFFNESS (While eating with chopsticks, she suddenly felt stiff in her hands and the chopsticks dropped down right out of her hand) and HYPOAESTHESIA (Occasionally experienced numbness of her arms) had not resolved.            Concomitant medication use information was not provided by reporter.  The reaction had been going on for months.   It was unknown if the patient experienced any additional symptoms/events.   Treatment medication use information was not provided by reporter.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: severe back pain (middle to upper); This spontaneous case was reported by a patient family member or friend and describes the occurrence of BACK PAIN (severe back pain (middle to upper)) in a 90-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In January 2025, the patient experienced BACK PAIN (severe back pain (middle to upper)). The patient was treated with Diclofenac sodium (Voltaren) at an unspecified dose and frequency. At the time of the report, BACK PAIN (severe back pain (middle to upper)) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.       Patient did not receive vaccines within the past 4 weeks. No concomitant medication was reported. The patient did not experience any additional symptoms or events.   This case was linked to US-MODERNATX, INC.-MOD-2025-781607 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-781607:Invalid case
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: she had COVID attack last year; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (she had COVID attack last year) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. In June 2024, the patient experienced COVID-19 (she had COVID attack last year). At the time of the report, COVID-19 (she had COVID attack last year) had resolved.            No concomitant medication was reported.  The patient also mentioned that she had to take the vaccination before travelling to avoid getting sick or COVID. She mentioned that she had COVID attack last year in late June as she did not take the Booster shot. No treatment information was reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: I started losing hair; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (I started losing hair) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043501) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In November 2024, the patient experienced ALOPECIA (I started losing hair). At the time of the report, ALOPECIA (I started losing hair) outcome was unknown.            No concomitant medication was reported. Within 2 weeks after receiving vaccine patient started losing hair and it didn't seem to be letting up. There was no change in his medicine, diet, or water intake. He did read that this was a rare side effect, and it should be improved in 3 to 6 months. No treatment medication was reported.   Reporter did not allow further contact
Sex: U
Vaccine: PNC13, RSV
Symptoms: Palpitations
Clinical narrative: intermittent palpitations; This is a spontaneous report received from a Pharmacist.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 14Jan2025 as dose 1, single (Batch/Lot number: unknown) for immunisation; pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 14Jan2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious) with onset 15Jan2025, outcome "unknown", described as "intermittent palpitations".  Additional information: It was reported via email that last Tuesday (14Jan2025), they administered Abrysvo and Prevnar (reporter confirmed the email only listed as Prevnar, unable to clarify which Prevnar) to the patient and the patient came in today, 20Jan2025, to let know the following day after getting the vaccine (15Jan2025), the patient had intermittent palpitations after receiving the vaccine.    The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Physician.  A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Jul2024 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "aortic dissection", start date: 23Dec2015 (unspecified if ongoing), notes: was medical emergency, genetic, probably thirty people in family would have had it, is a disabling feature of patient; "memory issues", start date: Mar2016 (unspecified if ongoing), notes: became more progressive, right now patient is stable; "head scan", start date: Sep2015 (unspecified if ongoing), notes: helped with diagnosis of memory issues. There were no concomitant medications. Vaccination history included: Moderna covid-19 vaccine (DOSE 1), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 2), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 3 (BOOSTER)), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 4 (BOOSTER)), for Covid-19 immunization; Moderna bvln bstr (DOSE 5 (BOOSTER)), for Covid-19 immunization; Spikevax 12 plus (DOSE 6 (BOOSTER)), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "COVID-19". The clinical course was reported as follows: It was reported that the patient had gotten COVID three times, and twice patient had to be hospitalized, confirmed admitted into hospital, either for two nights or for four nights. Third time patient had to be in the emergency room about seven hours, and then patient seemed fine. The reporter could take patient home or leave her there, thought with patient's memory issues, the patient was probably better at home, but he stated should had left her there. Whenever patient got, was more problematic than when other people were getting it, so had gone ahead and given patient next booster. The patient's husband thought patient had had eight doses now (got other dose in either Sep2024 or Oct2024). The patient shifted over to Pfizer because patient's first doses were Moderna. The patient got Comirnaty 12 plus on 03Jul2024, the reporter thought the dose patient got of Comirnaty 12 plus must have been Pfizer, but unable to confirm.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for event vaccination failure. This case will be reassessed upon receipt of additional information.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aldolase, Blood cholesterol, C-reactive protein, Insomnia, Investigation
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Physician.  A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Jul2024 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "aortic dissection", start date: 23Dec2015 (unspecified if ongoing), notes: was medical emergency, genetic, probably thirty people in family would have had it, is a disabling feature of patient; "memory issues", start date: Mar2016 (unspecified if ongoing), notes: became more progressive, right now patient is stable; "head scan", start date: Sep2015 (unspecified if ongoing), notes: helped with diagnosis of memory issues. There were no concomitant medications. Vaccination history included: Moderna covid-19 vaccine (DOSE 1), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 2), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 3 (BOOSTER)), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 4 (BOOSTER)), for Covid-19 immunization; Moderna bvln bstr (DOSE 5 (BOOSTER)), for Covid-19 immunization; Spikevax 12 plus (DOSE 6 (BOOSTER)), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "COVID-19". The clinical course was reported as follows: It was reported that the patient had gotten COVID three times, and twice patient had to be hospitalized, confirmed admitted into hospital, either for two nights or for four nights. Third time patient had to be in the emergency room about seven hours, and then patient seemed fine. The reporter could take patient home or leave her there, thought with patient's memory issues, the patient was probably better at home, but he stated should had left her there. Whenever patient got, was more problematic than when other people were getting it, so had gone ahead and given patient next booster. The patient's husband thought patient had had eight doses now (got other dose in either Sep2024 or Oct2024). The patient shifted over to Pfizer because patient's first doses were Moderna. The patient got Comirnaty 12 plus on 03Jul2024, the reporter thought the dose patient got of Comirnaty 12 plus must have been Pfizer, but unable to confirm.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for event vaccination failure. This case will be reassessed upon receipt of additional information.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle enzyme, Pain, Pain assessment, Pelvic girdle pain
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Physician.  A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Jul2024 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "aortic dissection", start date: 23Dec2015 (unspecified if ongoing), notes: was medical emergency, genetic, probably thirty people in family would have had it, is a disabling feature of patient; "memory issues", start date: Mar2016 (unspecified if ongoing), notes: became more progressive, right now patient is stable; "head scan", start date: Sep2015 (unspecified if ongoing), notes: helped with diagnosis of memory issues. There were no concomitant medications. Vaccination history included: Moderna covid-19 vaccine (DOSE 1), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 2), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 3 (BOOSTER)), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 4 (BOOSTER)), for Covid-19 immunization; Moderna bvln bstr (DOSE 5 (BOOSTER)), for Covid-19 immunization; Spikevax 12 plus (DOSE 6 (BOOSTER)), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "COVID-19". The clinical course was reported as follows: It was reported that the patient had gotten COVID three times, and twice patient had to be hospitalized, confirmed admitted into hospital, either for two nights or for four nights. Third time patient had to be in the emergency room about seven hours, and then patient seemed fine. The reporter could take patient home or leave her there, thought with patient's memory issues, the patient was probably better at home, but he stated should had left her there. Whenever patient got, was more problematic than when other people were getting it, so had gone ahead and given patient next booster. The patient's husband thought patient had had eight doses now (got other dose in either Sep2024 or Oct2024). The patient shifted over to Pfizer because patient's first doses were Moderna. The patient got Comirnaty 12 plus on 03Jul2024, the reporter thought the dose patient got of Comirnaty 12 plus must have been Pfizer, but unable to confirm.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for event vaccination failure. This case will be reassessed upon receipt of additional information.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dizziness, Gait disturbance, Investigation, Vertigo
Clinical narrative: severe vertigo; dizzy; couldn't walk; couldn't see, vision was really blurry; Rear occipital stroke; This is a spontaneous report received from an Other HCP.  A 33-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (disability, medically significant) with onset 25Mar2023, outcome "recovering", described as "Rear occipital stroke"; VISION BLURRED (non-serious) with onset Jun2023, outcome "recovering", described as "couldn't see, vision was really blurry"; GAIT DISTURBANCE (non-serious) with onset Jun2023, outcome "recovering", described as "couldn't walk"; DIZZINESS (non-serious) with onset Jun2023, outcome "recovering", described as "dizzy"; VERTIGO (non-serious) with onset Jun2023, outcome "recovering", described as "severe vertigo". The patient underwent the following laboratory tests and procedures: numerous tests and studies: Unknown results.  Clinical course: Patient initially suffered two cryptogenic strokes back in April, caller then checked and clarified and confirmed the two strokes were rear occipital strokes. First stroke occurred 25Mar2023, second stroke occurred 05Jun2023. Called to report, has gone through numerous tests and studies, doctors cannot figure out what caused. With first stroke, fainted, lost consciousness, was out for over a minute. With second stroke had severe vertigo, became dizzy, was dizzy for about three weeks nonstop, couldn't walk, was in bed two and a half weeks, couldn't see, vision was really blurry, wasn't stable, couldn't focus on anything for about a month. Would say disabling as well, hard to say whether life threatening, hard to say if life threatening, any time you have a stroke is life threatening.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: The association between the event rear occipital stroke with BNT162b2 NOS can not be fully excluded based on the limited information.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.