chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; my wife had the shingles vaccines and still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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: my wife had the shingles vaccines and still got it). 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.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-MAY-2025 This case was reported by a patient's husband via interactive digital media. The patient had the shingles vaccines and still had them. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: on my third round of shingles since February.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine (received 2 dose in 2020).   On an unknown date, the patient received the 3rd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced extra dose administered (Verbatim: on my third round of shingles since February.). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 23-MAY-2025 The patient paid 100 dollars each for a shot in the 90's before our insurance would pay for it.  Then in 2020 took the two shot series because it was supposed to be better.  Well, the patient on third round of shingles since February, which led to extra dose administered.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I got them a few months after my first shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced shingles (Verbatim: I got them a few months after my first shot). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-MAY-2025 This case was reported by a patient via interactive digital media. The patient got shingles a few months after my first shot of Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, 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. In DEC-2024, 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.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-MAY-2025 This case was reported by a patient via interactive digital media. The patient had a mild case of shingles at the end of December. The patient reported that initially he/she thought it was just a rash, as there was not much pain. Fortunately, he/she had received the vaccine years earlier. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of 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 clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I received my 1st dose of Shingrix vaccine almost 7 months ago; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine almost 7 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: I received my 1st dose of Shingrix vaccine almost 7 months ago). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 21-MAY-2025 The patient had received their first dose of the Shingrix vaccine almost seven months ago, just beyond the six-month limit.  They had inquired whether they could receive the second dose or if they needed to start over. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Illness, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had both vaccinations now I have shingles real bad, broke out now; Sickness; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 64-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I had both vaccinations now I have shingles real bad, broke out now) and sickness (Verbatim: Sickness). The outcome of the vaccination failure and sickness were not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and sickness to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 25-MAY-2025 This case was reported by a patient via interactive digital media. The patient had both vaccinations and now have shingles real bad, broke out now and have them on left arm covered, left leg two just came up, and two on left side of chest.  The patient said that did not took the vaccination.  The patient super sick with these, this had been 100 percent worse since the shots.  This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of 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 clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine( Dose 1 & 2).
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: am allergic to everything in the vaccine/allergic reaction to the vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: am allergic to everything in the vaccine/allergic reaction to the vaccine). The outcome of the allergic reaction was not reported.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.     It was unknown if the company considered the allergic reaction to be related to Shingrix.   Additional Information: GSK receipt date: 24-MAY-2025 The reporter reported that she had them recently and was allergic to everything in the vaccine and it was awful she was 77. After her close friend developed shingles, she saw how painful it could really be.  She lives a full life, and she did not want shingles to get in the way.  Here was her story on why she started a conversation with her doctor about her shingles risk.
Vaccine: RSV, VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: blustery rash on hands and feet with severe pain; blustery rash on hands and feet with severe pain; This non-serious case was reported by a consumer via sales rep and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Shingrix and Arexvy. On an unknown date, an unknown time after receiving Shingrix and Arexvy, the patient experienced rash (Verbatim: blustery rash on hands and feet with severe pain) and pain (Verbatim: blustery rash on hands and feet with severe pain). The outcome of the rash was unknown and the outcome of the pain was not reported.   It was unknown if the reporter considered the rash and pain to be related to Shingrix and Arexvy.     It was unknown if the company considered the rash and pain to be related to Shingrix and Arexvy.   Additional Information: GSK Receipt Date: 21-MAY-2025 The patient was vaccinated with Shingrix and Arexvy at the pharmacy in the same day. The patient later developed a blustery rash on hands and feet with severe pain.; Sender's Comments:  US-GSK-US2025063431:same reporter
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Three year gap between two doses (Inappropriate schedule of vaccine); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on 11-OCT-2021).   On 04-MAR-2025, the patient received the 2nd dose of Shingrix. On 11-OCT-2021, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Three year gap between two doses (Inappropriate schedule of vaccine)). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK receipt date: 23-MAY-2025 The reporter reported that a patient received the two doses of Shingrix with a three-year gap, did have to revaccinate. 1st vaccination was on October 11th 2021 and 2nd was on March 04th 2025. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: SHINGRIX in immunocompetent people less than 50 years; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: SHINGRIX in immunocompetent people less than 50 years). The outcome of the inappropriate age at vaccine administration was not applicable.   Additional Information: GSK Receipt Date: 25-MAY-2025 The reporter inadvertently gave a 19 year old healthy patient a Shingrix vaccine.  The reporter knew it could be given to immunocompromised situations. The reporter asked any information on response in healthy individuals. The patient received Shingrix below the recommended age schedule, which led to inappropriate age at vaccine administration.
Vaccine: COVID19
Symptoms: Migraine, Photophobia
Clinical narrative: photophobia; migraines; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (photophobia) and MIGRAINE (migraines) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PHOTOPHOBIA (photophobia) and MIGRAINE (migraines). At the time of the report, PHOTOPHOBIA (photophobia) and MIGRAINE (migraines) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported. The reporter stated that the physician only knew one other person that had was going through the same condition. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-187590 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-187590:Same reporter, different patient
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain
Clinical narrative: experienced ongoing pain, fatigue, and weakness; experienced ongoing pain, fatigue, and weakness; experienced ongoing pain, fatigue, and weakness; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (experienced ongoing pain, fatigue, and weakness), PAIN (experienced ongoing pain, fatigue, and weakness) and FATIGUE (experienced ongoing pain, fatigue, and weakness) in a 73-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine; for Product used for unknown indication: Pfizer vaccine and Pfizer vaccine. Past adverse reactions to the above products included Fatigue with Pfizer vaccine; Feeling unwell with Pfizer vaccine; and No adverse effect with Moderna COVID-19 vaccine.    On 21-May-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In May 2025, the patient experienced ASTHENIA (experienced ongoing pain, fatigue, and weakness), PAIN (experienced ongoing pain, fatigue, and weakness) and FATIGUE (experienced ongoing pain, fatigue, and weakness). At the time of the report, ASTHENIA (experienced ongoing pain, fatigue, and weakness), PAIN (experienced ongoing pain, fatigue, and weakness) and FATIGUE (experienced ongoing pain, fatigue, and weakness) had not resolved.            No concomitant medication was reported. The patient started getting COVID-19 vaccinations in early 2021.  At first, chose Pfizer and stuck with it, even though it usually made unwell for about half a day and often needing to leave work early due to fatigue. Later, during a busy holiday period, she received a Moderna shot by accident because forgot to ask which brand was being administered. To their surprise, she had no side effects at all with Moderna. Since then, she chose to continue with Moderna, as it seemed to work better for them. Most recently, she received the 2024/2025 Moderna vaccine late on a 21-May-2025 evening, around 6 PM. She experienced ongoing pain, fatigue, and weakness and much stronger symptoms than any she had with Moderna before. She was asking what the difference was between the 2023 and the new 2024/2025 Moderna vaccines. She was concerned because she never had this kind of reaction to Moderna before. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported.  No treatment medication was reported.   Reporter did not allow further contact
Age: 20.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Patient refers that on the date of the vaccination, during the afternoon, a red point appeared on the arm and the next day the whole shoulder turned red, itched and was hot to the touch.  The mother of the patient gave her Panadol and  Benadryl but she has not seen improvement.  The clinic's physician evaluated the patient and told her to monitor the area, keep taking Benadryl and if it is need it also Panadol and if she still don't see improvement to go to e the ER.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: BLOOD IN URINE FOR 3 DAYS
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site rash, Injection site scab, Injection site warmth, Pain
Clinical narrative: Received vaccine on 5/20/25 at 8:06 and on next day employee reported fever, body aches, increase pain to right deltoid, swelling radiating to mid upper arm, and hot to touch.  Reported red rash radiating to shoulder area lasting until 5/24/25 and on 5/25/25 she c/o severe itching began.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Pyrexia, Rash erythematous
Clinical narrative: Received vaccine on 5/20/25 at 8:06 and on next day employee reported fever, body aches, increase pain to right deltoid, swelling radiating to mid upper arm, and hot to touch.  Reported red rash radiating to shoulder area lasting until 5/24/25 and on 5/25/25 she c/o severe itching began.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: Patient started with heavy vaginal bleeding and intermittent moderate cramping approximately 4-5 hrs after vaccine admin. Symptoms reported to office on 5/27/25- 5 days later and she continues to have heavy bleeding. Patient is mid cycle in mestrual schedule and does not typically have breakthrough bleeding..
Age: 63.0
Sex: M
Vaccine: PNC20
Symptoms: Erythema, Hyperhidrosis, Pruritus, Skin warm
Clinical narrative: 5/20 received pneumonia vaccine, noticed 2 days ago it was red and itchy, woke up warm and sweaty, did not have a fever. Area looks red to this RN with some scratching from patient, ensuring he is not laying on it.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Skin discolouration, Vitiligo
Clinical narrative: We found a white spot on my daughter a few months after second dose, but didn't think anything of it. Then we went on vacation in January and she came back with a huge white spot on her back. She was later diagnosed with vitiligo. It has spread rapidly, and has really affected her mental health.
Age: 57.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Pain is worsening and range of motion is now limited-Medium, Additional Details: Felt immediate pain when shot was given . Said she felt like immunizer just jabbed it in and kept pushing. Has taken tylenol with no improvement. I recommended she see her MD. she is applying ice. Pt said she will give it 2 more days, and if no improvement will see MD. Recommended she go sooner, especially if pain keeps worsening since now going up her neck and range on motion of arm declining. can't fully raise arm
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lethargy
Clinical narrative: Systemic: Exhaustion / Lethargy-Medium, Additional Details: Patient states still gets tired very quickly & belies it started around the same time as rec'd Vaccine
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: rash started as a bump then spreaded on arm-Medium, Other Vaccines:  VaccineTypeBrand: Covid; Manufacturer: Moderna; LotNumber: 8081260; Route: Intramuscular; BodySite: Right Deltoid; Dose: ; VaxDate: 04/13/2025
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: rash started as a bump then spreaded on arm-Medium, Other Vaccines:  VaccineTypeBrand: Covid; Manufacturer: Moderna; LotNumber: 8081260; Route: Intramuscular; BodySite: Right Deltoid; Dose: ; VaxDate: 04/13/2025
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Dizziness, Dyskinesia, Moaning, Nausea
Clinical narrative: Systemic: Abdominal Pain-Severe, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Severe, Additional Details: Within 5 minutes of HEPLISAV-B administration, patient began to complain that she felt dizzy and "like she was going to pass out". She sat down and said she felt like she was going to throw up. She was moaning and throwing her head back and closing her eyes. Pharmacy staff provided a trash can, paper towels, water, and stayed with her while she phoned a family member who picked her up 15 min later. She said she was going to the emergency room but we have not confirmed that she went.
Age: 39.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Patient received the first dose overseas with no issues. After the second dose her arm was very sore. She checked in after a week and her arm was still sore and red at the time. At the 2 week mark, patient called again to report the pain had subsided but was still painful if she pressed on it. She stated "its hurts if I stand still and think about it" No otther symptoms were reported at the time. No redness or bruises. Patient was cousneled to continue monitoring and take advil for the pain.
Age: 39.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Patient received the first dose overseas with no issues. After the second dose her arm was very sore. She checked in after a week and her arm was still sore and red at the time. At the 2 week mark, patient called again to report the pain had subsided but was still painful if she pressed on it. She stated "its hurts if I stand still and think about it" No otther symptoms were reported at the time. No redness or bruises. Patient was cousneled to continue monitoring and take advil for the pain.
Age: 39.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: pt states there is a lump in her arm that is still present and feels as if circulation in her left arm has decreased significantly.-Medium
Age: 39.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: pt states there is a lump in her arm that is still present and feels as if circulation in her left arm has decreased significantly.-Medium
Age: 59.0
Sex: M
Vaccine: PNC21
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Numbness is wrist/hand area, Other Vaccines:  VaccineTypeBrand: Zoster (Shingrix); Manufacturer: Glaxosmithkline; LotNumber: H97H2; Route: Intramuscular; BodySite: Left Arm; Dose: 1; VaxDate: 04/18/2025
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pruritus, Pyrexia, Rash, Rash pruritic
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Fever-Mild, Additional Details: pt developed fever the night of the injection, the next day a itchy rash appeared on neck and chest. it was severe for about 7 days and didnt go aware for about 30 days. it is still itchy under the skin today with no redness. pt took zyrtec with little relief, oral benadryl seemed to help a little, also used hydrocortisone cream and benadryl cream. later pt switched to allegra which seemed to help more than the zyrtec.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain, Dizziness, Nausea, Vomiting
Clinical narrative: Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Additional Details: MMR ( priorix) was administerd and few minutes atfer patient started feeling nauseaus, lightheaded, she rested on her back with feet held up, we cal 911 as well. Patient vomitted and used restroom, paramedics assess patient, placed ice pack on back of her head, took vitals, assess and  determine she was ok. patient left after some time and actually returned next day ( May 16 th) for her last vaccine.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Dysphagia, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Additional Details: Several minutes after getting vaccine patient comes back to pharmacy to state that he felt he was having an allergic rxn from the vaccine. I offered to give benadryl, but patient stated he had "steroids" in the car as this has happened to him and his dad in the past from vaccines. Pt comes back to pharmacy hours later stating he had used epipen in the car from an anaphylaxic rxn.
Age: 62.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site rash, Pain, Pyrexia, Tenderness
Clinical narrative: Fever; pain; tenderness; irregular rash area extending in to mid arm; This is a spontaneous report received from an Other HCP.  A 62-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 20May2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for immunisation. The patient's relevant medical history included: "Allergic rhinitis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 20May2025, outcome "not recovered", described as "Fever"; RASH (non-serious) with onset 20May2025, outcome "not recovered", described as "irregular rash area extending in to mid arm"; PAIN (non-serious) with onset 20May2025, outcome "not recovered"; TENDERNESS (non-serious) with onset 20May2025, outcome "not recovered". Therapeutic measures were not taken as a result of pyrexia, pain, tenderness, rash. Additional information: The patient did not receive any other vaccines on the same date as PREVNAR 20, the patient did not receive any other vaccines within 4 weeks PRIOR to the PREVNAR 20, the patient did not take any other medications within 2 weeks of the event starting. Vaccine location reported as right shoulder area. Patient experienced fever, pain and tenderness in addition to irregular rash area extending in to mid arm.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Dizziness, Headache, Injection site erythema, Injection site pain
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Mild, Systemic: Headache-Medium, Systemic: Joint Pain-Medium, Additional Details: PATIENT IS super tired, Other Vaccines:  VaccineTypeBrand: SHINGRIX; Manufacturer: GLAXCO; LotNumber: 9RC7A; Route: IM; BodySite: LEFT ARM; Dose: ; VaxDate: UNKNOWN
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Mild, Systemic: Headache-Medium, Systemic: Joint Pain-Medium, Additional Details: PATIENT IS super tired, Other Vaccines:  VaccineTypeBrand: SHINGRIX; Manufacturer: GLAXCO; LotNumber: 9RC7A; Route: IM; BodySite: LEFT ARM; Dose: ; VaxDate: UNKNOWN
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Dizziness, Fatigue, Flushing
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pain, Pruritus, Pyrexia, Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product label issue
Clinical narrative: Systemic: no adverse event occurred. Unable to document administration error with detail as none of the administration errors apply and there is no comment section in vaccine administration error so used this option instead. Patient was given varicella correctly  (-Mild, Additional Details: no adverse event occurred. Unable to document administration error with detail as none of the administration errors apply and there is no comment section in vaccine administration error so used this option instead. Patient was given varicella correctly  (with the diluent and the active vial reconstituted correctly). The administration of vaccine was documented correctly however in another part of the chart the diluent had the wrong lot number recorded (active vial lot was recorded, instead) , Other Vaccines:  VaccineTypeBrand: heplisav; Manufacturer: dynavax tech; LotNumber: 944920; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: 04/04/2025
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: patient complaining of arm pain for 2 days, she said she could not move her arm. but she says since this am its a little better and she can move her  arm and not as much pain, she says now her upper arm to her elbow only hurts-Severe, Additional Details: patient complained of pain in her left arm. and said was given badly. will follow up with patient tomorrow
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Aphasia, Confusional state, Flushing, Hyperhidrosis, Loss of consciousness
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient recieved 2 vaccines hep a and b , after second shot , pt fell silent , and after about 30 seconds, his head fell forward , then he passed out on the floor , I tried to catch him ,and then he started to shake a little, seizure like reaction , then his partner screamed and after a few seconds , he became conscious again and looked at us very confused but was able to speak right away , we gave him water and crackers and he sat for 15+min then felt fine and comfortable to leave with partner, Other Vaccines:  VaccineTypeBrand: havrix; Manufacturer: gsk; LotNumber: z27pb; Route: sq; BodySite: left arm; Dose: 1; VaxDate: 05/19/2025
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Paraesthesia, Seizure like phenomena, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient recieved 2 vaccines hep a and b , after second shot , pt fell silent , and after about 30 seconds, his head fell forward , then he passed out on the floor , I tried to catch him ,and then he started to shake a little, seizure like reaction , then his partner screamed and after a few seconds , he became conscious again and looked at us very confused but was able to speak right away , we gave him water and crackers and he sat for 15+min then felt fine and comfortable to leave with partner, Other Vaccines:  VaccineTypeBrand: havrix; Manufacturer: gsk; LotNumber: z27pb; Route: sq; BodySite: left arm; Dose: 1; VaxDate: 05/19/2025
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood disorder, Platelet count decreased
Clinical narrative: Systemic: Blood Disorder  (diagnosed by MD)-Severe, Additional Details: Platelets below 40, ambulance transport to hospital pt. mentioned another person had a similar adverse reaction when they had COVID and flu shots at same time), Other Vaccines:  VaccineTypeBrand: Flu (Fluad Trivalent); Manufacturer: Seqirus; LotNumber: ; Route: ; BodySite: ; Dose: 1; VaxDate: 10/01/2024
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Limb injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Other Vaccines:  VaccineTypeBrand: fluad Trivakebt 2024-25 syr; Manufacturer: sequris; LotNumber: 388498; Route: im; BodySite: right deltoid; Dose: 388498; VaxDate: 12/16/2024
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Fibromyalgia, Headache, Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Body Aches Generalized-Severe, Systemic: triggered fibromialgia flare-Severe, Systemic: Headache-Severe, Other Vaccines:  VaccineTypeBrand: capvaxive; Manufacturer: merck sharp; LotNumber: z002626; Route: im; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Body Aches Generalized-Severe, Systemic: triggered fibromialgia flare-Severe, Systemic: Headache-Severe, Other Vaccines:  VaccineTypeBrand: capvaxive; Manufacturer: merck sharp; LotNumber: z002626; Route: im; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Swelling, Throat irritation
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: states has itching of throat and feeling of swelling, asked what she could possibly take for itching, pharmacist suggested benadryl for itch and to seek medical attention if feeling swelling of throad, patient states is going to visit an urgent care for evaluation
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Injection site pain, Lethargy
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sleep disorder
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Fever-Mild, Systemic: Unable to Sleep-Medium
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Headache, Injection site erythema, Injection site rash, Pyrexia, Rash
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Additional Details: injection site displayed localized rash, also experienced fever and head ache for 2 days
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: states arm hurts, hard to raise-Medium, Additional Details: see above, Other Vaccines:  VaccineTypeBrand: vaqta; Manufacturer: merk; LotNumber: y017625; Route: im; BodySite: left arm; Dose: ; VaxDate: 03/13/2025, VaccineTypeBrand: boostrix; Manufacturer: glaxo smith; LotNumber: 9n4e7; Route: im; BodySite: left arm; Dose: ; VaxDate: 03/13/2025
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Systemic: Headache-Mild
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Systemic: Chills-Medium, Other Vaccines:  VaccineTypeBrand: Shingrix; Manufacturer: GSK; LotNumber: KJ3N3; Route: Intramuscular; BodySite: Left Arm; Dose: 1; VaxDate: 09/27/2024
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: PT FAINTED AFTER GETTING THE VACCINATION. PT TOLD IMMUNIZER THAT SHE FAINTS DURING BLOOD DRAWN AFTER SHE WOKE UP. THE PARA MEDICS WAS CALLED AND SHE FAINTED AGAIN WHEN PARA MEDICS WERE TRYING TO TEST BLOOD GLUCOSE. SHE WAS OK AFTERWARDS AND SHE DID NOT GO WITH THE PARA MEDICS
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Systemic: Nausea-Mild, Systemic: Vomiting-Medium
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site erythema, Tongue eruption
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: rash of the tongue-Mild, Additional Details: Patient states that one week after receiving 2nd immunization in series, she began with experiencing rashes, particularly of the tongue.  She is experienceing significant discomfort to this time.  Main concern is tongue rash. (Redness at injection site inputed in order to proceed to submit form)
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient said he sometimes faints when giving blood or seeing blood and not when getting vaccines. Patient fainted in the vaccination chair and returned in less than a minute. Patient laid down for about ten minutes to recover. Water was given. Patient was able to walk away from the pharmacy under own power., Other Vaccines:  VaccineTypeBrand: prevnar 20; Manufacturer: pfizer; LotNumber: LX44483; Route: IM; BodySite: Left arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: boostrix; Manufacturer: gsk; LotNumber: 793pt; Route: IM; BodySite: Left arm; Dose: ; VaxDate: UNKNOWN
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Severe
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Sleep disorder
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Unable to Sleep-Severe, Additional Details: started 2 days after administration, reports on 5/21 pain kept pt awake, rec pt to take ibuprofen and ice pack and will see dr friday if no improvement. will follow up with pt monday
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Other Vaccines:  VaccineTypeBrand: Flu Vaccine (Fluzone High-Dose Trivalent); Manufacturer: Sanofi; LotNumber: U8524CA; Route: IM; BodySite: Left Arm; Dose: 1; VaxDate: 10/23/2024, VaccineTypeBrand: Boostrix TDAP; Manufacturer: GSK; LotNumber: 235D2; Route: IM; BodySite: Left Arm; Dose: 1; VaxDate: 10/23/2024
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Systemic: Headache-Mild
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain
Clinical narrative: Systemic: body aches as if she had COVID-Mild, Additional Details: Patient reports having body aches after all vaccines. She stated that the aches start on the day the vaccines is given, by that night, and last about 1.5 days.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Systemic: Nausea-Mild
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Headache, Injection site pain, Loss of consciousness, Syncope
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: passed out for couple miutes-Medium, Systemic: Headache-Medium, Systemic: Shakiness-Medium, Additional Details: Patient received both Menveo and Trumenba same time. Advised to stay 15 minutes before leaving. Couple minutes later, Patient passed out and laid on the floor with his sister's assistance. 911 was called and patient gained conscious after 15 minutes. No epipen given.Patient was taken care by paramedic team after. , Other Vaccines:  VaccineTypeBrand: TRUMENBA; Manufacturer: PFIZER; LotNumber: gf4142; Route: IM; BodySite: Left Arm; Dose: ; VaxDate: 05/22/2025
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: passed out for couple miutes-Medium, Systemic: Headache-Medium, Systemic: Shakiness-Medium, Additional Details: Patient received both Menveo and Trumenba same time. Advised to stay 15 minutes before leaving. Couple minutes later, Patient passed out and laid on the floor with his sister's assistance. 911 was called and patient gained conscious after 15 minutes. No epipen given.Patient was taken care by paramedic team after. , Other Vaccines:  VaccineTypeBrand: TRUMENBA; Manufacturer: PFIZER; LotNumber: gf4142; Route: IM; BodySite: Left Arm; Dose: ; VaxDate: 05/22/2025
Age: 62.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Injection site pruritus, Lethargy
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Additional Details: pt felt light headed.  he said he didnt eat breakfast.  he drank some water and orange juice and a cracker, Other Vaccines:  VaccineTypeBrand: twinrx; Manufacturer: ; LotNumber: p2443; Route: im; BodySite: right deltoid; Dose: 1; VaxDate: 05/23/2025, VaccineTypeBrand: priorix; Manufacturer: ; LotNumber: 49m2f; Route: sq; BodySite: left upper arm; Dose: 1; VaxDate: 05/23/2025, VaccineTypeBrand: capvaxive; Manufacturer: ; LotNumber: yo19158; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: 05/23/2025
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Mouth ulceration, Oral herpes
Clinical narrative: Systemic: Shingles; fever blisters; and mouth ulcers.-Medium, Additional Details: Patient has been experiencing Shingles, fever blisters, and mouth ulcers ever since she received the 2 aforementioned vaccines. The symptoms come and go, but haven't completely cleared. Note that patient has received 1 dose of Shingrix vaccine back on 11/09/2022, but hasn't completed the series yet., Other Vaccines:  VaccineTypeBrand: Pneumonia (Prevnar 20); Manufacturer: Wyeth/Pfizer; LotNumber: LG5575; Route: IM; BodySite: Left Arm; Dose: 1; VaxDate: 10/23/2024
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Systemic: Patient got COVID-Severe, Additional Details: Patient says she was hospitalized due to getting COVID-19 in February 2025.