chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Foetal hypokinesia, Wrong product administered
Clinical narrative: Patient's aunt reported that the patient is currently 29 weeks pregnant, and the patient mistakenly received the GARDASIL 9 vaccine as opposed to receiving the RHOGAM vaccine; The patient mistakenly received the GARDASIL 9 vaccine as opposed to receiving the RHOGAM vaccine; hyperventilating; very worried; This spontaneous prospective pregnancy report was received from the patient's aunt and refers to a 29-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included diabetes. Concomitant therapies were not reported.  The patient became pregnant with LMP of 13-MAY-2024 and EDD of 17-FEB-2025.  On 04-DEC-2024, the patient was mistakenly vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter (strength, lot #, expiry date, and route of administration were not provided) for prophylaxis, instead of receiving anti-d immunoglobulin (RHOGAM) (Wrong product administered).  Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was at 29 week(s).   On an unspecified date in December 2024 (reported as: the past week or so), the patient had not felt the baby moving around as much in her stomach (Captured in MARRS Case 2412USA007152). On 18-DEC-2024, the health care professional contacted the patient and informed her that she had received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  instead of receiving anti-d immunoglobulin (RHOGAM) vaccine. Since that day, the patient had been hyperventilating and very worried.  The pregnancy outcome was pending, but it was reported that the delivery was going to be induced on 26-JAN-025, since she had high risk (unspecified).  The outcome of hyperventilation, and anxiety were not reported. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not applicable.  The causal relationship between the events of hyperventilation, and anxiety and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.; Sender's Comments:  US-009507513-2412USA007152:
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Anxiety, Exposure during pregnancy, Foetal hypokinesia, Hyperventilation, Wrong product administered
Clinical narrative: Patient's aunt reported that the patient is currently 29 weeks pregnant, and the patient mistakenly received the GARDASIL 9 vaccine as opposed to receiving the RHOGAM vaccine; the baby was not moving around as much.; This spontaneous report was received from a Consumer and refers to a fetus of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The patient's mother concurrent condition included diabetes.   On 04-DEC-2024, the patient's mother was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, the patient was exposed to the vaccine transplacentally (strength, dose, lot #, expiry date, and indication were not provided).  On an unknown date in December 2024 (reported as: the past week or so), the patient's mother had not felt the baby moving around as much in her stomach (Foetal hypokinesia).   At the time of reporting, the outcome of the event Foetal hypokinesia was not known.  The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not applicable.   The causal relationship between Foetal hypokinesia and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported. Upon internal review, the event Foetal hypokinesia was determined to be medically significant.; Sender's Comments:  US-009507513-2412USA007145:
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Foetal hypokinesia, Wrong product administered
Clinical narrative: Patient's aunt reported that the patient is currently 29 weeks pregnant, and the patient mistakenly received the GARDASIL 9 vaccine as opposed to receiving the RHOGAM vaccine; the baby was not moving around as much.; This spontaneous report was received from a Consumer and refers to a fetus of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The patient's mother concurrent condition included diabetes.   On 04-DEC-2024, the patient's mother was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, the patient was exposed to the vaccine transplacentally (strength, dose, lot #, expiry date, and indication were not provided).  On an unknown date in December 2024 (reported as: the past week or so), the patient's mother had not felt the baby moving around as much in her stomach (Foetal hypokinesia).   At the time of reporting, the outcome of the event Foetal hypokinesia was not known.  The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not applicable.   The causal relationship between Foetal hypokinesia and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported. Upon internal review, the event Foetal hypokinesia was determined to be medically significant.; Sender's Comments:  US-009507513-2412USA007145:
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; chills; headache; myalgia; Doctor said my records showed 1 vaccine and never asked if I had already received my second dose so I was given a third dose within 4 months; This non-serious case was reported by a consumer and described the occurrence of fever in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 2 doses on an unknown date). Concurrent medical conditions included atrial fibrillation, blood cholesterol increased and clotting disorder. Concomitant products included diltiazem hydrochloride (Dilt-Xr), atorvastatin, rivaroxaban (Xarelto) and flecainide acetate.   On 21-NOV-2024, the patient received the 3rd dose of Shingrix. On 21-NOV-2024, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: Fever), chills (Verbatim: chills), headache (Verbatim: headache), myalgia (Verbatim: myalgia) and extra dose administered (Verbatim: Doctor said my records showed 1 vaccine and never asked if I had already received my second dose so I was given a third dose within 4 months). The outcome of the fever, chills, headache and myalgia were not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the fever, chills, headache and myalgia to be related to Shingrix.     It was unknown if the company considered the fever, chills, headache and myalgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-NOV-2024 The doctor said records showed 1 vaccine and never asked if he had already received his second dose so he was given a third dose within 4 months, which led to extra dose administered.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Drug dose administration interval too long; 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 HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 29-MAR-2024).   On 22-NOV-2024, the patient received the 2nd dose of Twinrix. On 22-NOV-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). The outcome of the drug dose administration interval too long 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: 22-NOV-2024 The reporter called to ask about a patient schedule and what advise could be given to him to give a third dose of Twinrix, if they had to restart series or what to do. The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 49.0
Sex: F
Vaccine: COVID19, PPV
Symptoms: Erythema, Pyrexia
Clinical narrative: ERYTHEMA; FEVER
Age: 50.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: my right arm ached  24 hours after the injection. The pan originated  on the exterior side of my right bicep. 2 months later the pain  has steadily worsened  making daily tasks  involving my right arm difficult and painful.  An Orthopedic Dr. noted that I have  SIRVA.
Age: 50.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: X-ray limb normal
Clinical narrative: my right arm ached  24 hours after the injection. The pan originated  on the exterior side of my right bicep. 2 months later the pain  has steadily worsened  making daily tasks  involving my right arm difficult and painful.  An Orthopedic Dr. noted that I have  SIRVA.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash, Rash maculo-papular, Rash vesicular
Clinical narrative: Healthy 13 month old received live varicella vaccine 12/18/24 at 1:30 pm. Friday at 2pm patient noted to have maculopapular rash on abdomen/chest with sparse vesicular rash on face/cheek and right thigh where injection was given
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: Patient's arm was very sore the next day and she called the doctor.  She stated that she couldn't move her arm at all.  The doctor told her she had SIRVA due to the vaccination.  The patient didn't state any treatment that was given to her.  When she reported the symptoms to the pharmacy she had recovered from the event but no longer want to get vaccines.
Age: 23.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: 36 weeks pregnant, 3rd pregnancy, estimated delivery date 1/16/2025
Age: 63.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: COVID-19, Culture urine, Headache, Oropharyngeal pain, Pain
Clinical narrative: Sore throat, headache, fever, congestion, body aches, COVID Diagnosis 12/17/2024, UTI 12/16/2024
Age: 63.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test, Urinary tract infection, Urine analysis
Clinical narrative: Sore throat, headache, fever, congestion, body aches, COVID Diagnosis 12/17/2024, UTI 12/16/2024
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient received dose #1 of shingrix & hep B on 12/18/24. Presented to pharmacy today (12/21) with minor swelling and redness in right arm (site of shingrix administration). She complained of some pain yesterday and minor heat in the arm. I felt pt's arm and it felt mildly warm and not swollen but there was redness in about a 3 in squared area. I drew on the pt's arm and told her if the redness exceeds the lines or if her arm gets more swollen or she begins to feel a heartbeat in her arm then she needs to go in and be seen. Pt denied having fever since vaccine was given.
Age: 61.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood electrolytes normal, Computerised tomogram abdomen normal, Illness, International normalised ratio normal, Scan with contrast normal
Clinical narrative: It is not believed the current illness is related to vaccinations.
Age: 61.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: White blood cell count normal
Clinical narrative: It is not believed the current illness is related to vaccinations.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Bacterial vulvovaginitis, Device placement issue, Injection site pain, Injection site rash
Clinical narrative: red hot  tender rash at vaccine site on arm appearing 24 hours after lasting about 3 days. no treatment needed.  my period started 11/20/2024 and vaginal itching and odor within a week or so. Itching odor and period continued until last week accompanied by some abdominal and back cramping. appt made last Wednesday 12/18 to see Dr at clinic, got pelvic US and IUD was misplaced in cervix, took out IUD and replaced with new one. Vaginal swab showed rare bacteria, treated with flagyl. Current light spotting.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Intermenstrual bleeding, Intra-uterine contraceptive device removal, Muscle spasms, Rash erythematous
Clinical narrative: red hot  tender rash at vaccine site on arm appearing 24 hours after lasting about 3 days. no treatment needed.  my period started 11/20/2024 and vaginal itching and odor within a week or so. Itching odor and period continued until last week accompanied by some abdominal and back cramping. appt made last Wednesday 12/18 to see Dr at clinic, got pelvic US and IUD was misplaced in cervix, took out IUD and replaced with new one. Vaginal swab showed rare bacteria, treated with flagyl. Current light spotting.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Smear vagina, Ultrasound pelvis abnormal, Vaginal odour, Vulvovaginal pruritus
Clinical narrative: red hot  tender rash at vaccine site on arm appearing 24 hours after lasting about 3 days. no treatment needed.  my period started 11/20/2024 and vaginal itching and odor within a week or so. Itching odor and period continued until last week accompanied by some abdominal and back cramping. appt made last Wednesday 12/18 to see Dr at clinic, got pelvic US and IUD was misplaced in cervix, took out IUD and replaced with new one. Vaginal swab showed rare bacteria, treated with flagyl. Current light spotting.
Age: 28.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Exposure during pregnancy, Pain, Product use issue
Clinical narrative: Patient's spouse, called our pharmacy around 11:00 am MST and reported his wife was having diarrhea and aches starting around 9:00 pm MST. He reported that they did some looking online concerning the Arexvy vaccine and found that it wasn't FDA approved in pregnancy.  I instructed him to contact her OBGYN. I followed up with the patient approximately 20 minutes later and the patient's spouse said that they had contacted her provider.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient did not have any adverse side effects. Patient had already received Prevnar 20 vaccine on 12/05/2022.  She had requested a flushot, RSV and pneumonia shot on 12/20/2024 and it was not caught that she had already had the Prevnar 20 vaccine due to the time elapsed.
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Gait inability, Guillain-Barre syndrome, Headache, Immunoglobulin therapy, Intensive care
Clinical narrative: Patient started feeling ill 2 days later after receiving the Arexvy vaccine, patient was having a headache as well. Patient was diagnose with GBS? He then had to go into critical care for 5 days while receiving a spinal tap, MRI, IG drip and also had to relearn how to walk
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Lumbar puncture, Magnetic resonance imaging, Malaise
Clinical narrative: Patient started feeling ill 2 days later after receiving the Arexvy vaccine, patient was having a headache as well. Patient was diagnose with GBS? He then had to go into critical care for 5 days while receiving a spinal tap, MRI, IG drip and also had to relearn how to walk
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Full blood count, Injected limb mobility decreased, Injection site bruising, Injection site mass
Clinical narrative: Patient's daughter reports that about three hours post-vaccination, patient began experiencing "severe, tearful pain" at the injection site. This impeded her range of motion in her left arm and lasted for several hours. The patient's daughter noticed 2 days after vaccination that a bruise roughly 3 inches wide was forming a ring midway between the injection site and the elbow on the patients arm that is still present 2 weeks later. A secondary lump also appeared at the injection site 5 days after receiving the vaccine and remains 2 weeks after vaccination. Patient utilized OTC Tylenol to manage the initial pain until it subsided and was instructed to hold her Xarelto for 1 day.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Patient's daughter reports that about three hours post-vaccination, patient began experiencing "severe, tearful pain" at the injection site. This impeded her range of motion in her left arm and lasted for several hours. The patient's daughter noticed 2 days after vaccination that a bruise roughly 3 inches wide was forming a ring midway between the injection site and the elbow on the patients arm that is still present 2 weeks later. A secondary lump also appeared at the injection site 5 days after receiving the vaccine and remains 2 weeks after vaccination. Patient utilized OTC Tylenol to manage the initial pain until it subsided and was instructed to hold her Xarelto for 1 day.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Dyspnoea exertional, Electrocardiogram normal, Fibrin D dimer normal, Full blood count normal
Clinical narrative: Woke up on December 15 and became short of breath with exertion such as climbing stairs or carrying objects such as a recycling can. My pulse would rise but my oxygen saturation was between 97-99%
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Metabolic function test normal, Troponin normal
Clinical narrative: Woke up on December 15 and became short of breath with exertion such as climbing stairs or carrying objects such as a recycling can. My pulse would rise but my oxygen saturation was between 97-99%
Age: 67.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Peripheral swelling
Clinical narrative: Patient called and stated that the arm he received his vaccines in is swollen down to his knuckles.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus
Clinical narrative: patient called stating her injection got red and itchy on the day she got the shot. She itched it and got cellulitis from it and needed to be started on antibiotics.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower
Clinical narrative: Pt explained he is experiencing lower left abdominal pain 1 day after receiving vaccination. Advised pt to reach out to primary care physician regarding this pain.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Donor reports he had pain to his right arm for 4 days starting the day after the immunization. Donor also reports he had a red spot and his right arm was swollen for about one week per donor. Donor denied going to a treating facility and states pain, swelling and red spot went away on its own without treatment. Upon assessment of the right arm, no swelling or redness noted. Donor also denied pain to the right arm.
Age: 68.0
Sex: M
Vaccine: COVID19, FLU3, VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient experienced some soreness in arm with first Shingrix shot. When second Shingrix was administered patient experienced greater soreness in his left arm. At times he had difficulty lifting his arm. He left for trip shortly after receiving 2nd Shingrix shot. He states he took tylenol or motrin for the pain. Patient reported this  December 13 after returning from trip. Recommended he continue with ibuprofen and consult his physician.  Spoke to patient December 20, he stated he was applying ice which has help a lot. He still has not seen his physician
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Ependymoma
Clinical narrative: Brain  tumor, located between  the cerebellum and brain stem ependymona, grade 2
Age: 18.0
Sex: F
Vaccine: IPV, MMR, TYP, VARCEL
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: PATIENT RECEIVED FOUR VACCINATIONS.  IMMEDIATELY AFTER THE FOURTH VACCINE (M-M-R) WAS COMPLETED THE PATIENT FAINTED.  SHE WAS OUT FOR ABOUT 30 SECONDS THEN CAME TO.  HER MOTHER SAID THIS HAPPENS TO HER SOMETIMES.  THE PATIENT  WAITED AT THE PHARMACY ABOUT 30 MINUTES AND DRANK SOME WATER.
Age: 13.0
Sex: M
Vaccine: TYP
Symptoms: Crying, Muscle spasms, Pain
Clinical narrative: vivotif taken at 7:40. Cramping started around noon. Cramping pains in waves. Lying on floor, squirming and crying.  Treatments tried: Gas X, Tums, Epsom salt bath, yogurt, broth
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: baseball size swelling on arm that is hot to touch appeared 24 hours after injection and is very painful. tried Tylenol and Benadryl to treat. patient feels as though it above the standard local reaction that she has had with other vaccines.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: DUPLICATION  ;The event that occured is that the patient received an additional flu vaccine when she already received one in 10/2024.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: PATIENT STATED SHE DEVELOPED A SMALL RASH ON HER STOMACH/NAVAL AREA. PATIENT STATED IT DOES NOT HURT, NO SWELLING OF LIPS/TONGUE, NO ANAPHYLACTIC TYPE SYMPTOMS. COUNSELED PATIENT ON SIGNS/SYMPTOMS OF WHAT TO LOOK OUT FOR AND WHEN TO SEE MEDICAL ATTENTION
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a vaccine she already received previously. Patient stated she had not had it but that turned out to be incorrect. No adverse effects were experienced
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient experienced no adverse event. They were just accidentally given a 3rd dose of the vaccine due to reporting discrepancies.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Lymphadenopathy, Rash
Clinical narrative: Rash over chest, arms, stomach, legs. Ankle swelling. Lymph node swelling on left side of head/neck. Had an office visit on 10/16/24.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: chills, weakness, nausea, headache, dizzy, and fatigue
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Nausea
Clinical narrative: chills, weakness, nausea, headache, dizzy, and fatigue
Age: 33.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Asthenia, Cough, Fatigue, Headache, Pyrexia
Clinical narrative: Fever weaknes, fatigue, cough, headache, vomiting,, sinus congestion
Age: 33.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Sinus congestion, Vomiting
Clinical narrative: Fever weaknes, fatigue, cough, headache, vomiting,, sinus congestion
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood thyroid stimulating hormone normal, Cardiac monitoring, Full blood count normal, Tachycardia
Clinical narrative: Tachycardia noted, one episode of afib lasting a few minutes 12/14/24. Called PCP 12/16 and was seen 12/17.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Oral discomfort, Tenderness
Clinical narrative: ~48 hours after vaccination developed multiple tongue sores (painful to touch) but nothing visible felt like aphthous stomatitis. improved over 4 days, then recurred and has since been waxing/waning with sores (not visible) but with point tenderness that come and change location over 12-24hours and anterior tongue and upper palate "burning" like after drinking something scalding. has persisted with variable intensity over the last 3+ weeks
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: pt got one dose on 10/01/2023 and got duplicate on 12/19/2024 as pt thought this is a yearly vaccine
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Aspiration joint, Joint effusion
Clinical narrative: Extreme right hip pain and effusion; inflammatory related and not infectious. Hip fluid was aspirated and steroids and pain medication were administered.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient approached our pharmacy 12/21/24 and requested the RSV vaccine.  We processed the claim through her insurance and administered it.  The patient did not remember that she had the RSV vaccine already in November 2023.  The pharmacy did not realize previous dose was given, which resulted in an additional dose outside the current CDC guideline for RSV.  The pharmacist discussed the additional dose with the patient, and she has reported no adverse signs or symptoms.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discharge
Clinical narrative: Nurse gave influenza vaccine into my son's right thigh.  Upon removal of needle, fluid (vaccine) came back out.  In fact, a lot came back out.  Nurse did not address this or even say something about it.  Nurse.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Pain of skin, Sensitive skin, Skin erosion, Skin haemorrhage
Clinical narrative: Following the shot, the skin around my groin probably a 3 3-4 inch diameter turned raw and any friction would leave it sensitive to the touch. Often bleeding. In the pits of my legs to my groin (where my legs met my groin), it was more raw and bleeding often from friction. I tried using ointment for healing because of the pain but it persisted. This happened for a couple of weeks maybe a month or two. Then, the skin stayed red-pink and still has a noticeably different color than the surrounding skin. Even 9 years later the skin has not returned to normal color.
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received second dose of arexvy but she had already received her one dose last December 2023.
Age: 23.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dysmenorrhoea, Full blood count, Polymenorrhoea
Clinical narrative: 12/10/2024- menstruation resumed (after 5 days of no bleeding); 12/16/2024- bleeding consistently light, brown; 12/19/2024- bleeding picked up, bright red, heavy cramping; 12/22/2024- today, bleeding and cramps continue
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a second dose during the same year. First dose was given on 3/22/2024. No adverse reactions noted.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Patient stated arm was red and itchy and remained red and itchy 5 days past injection, it is unknown if and when the redness went away. Patient stated it was not painful and not warm to the touch.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a dose of Arexvy on 12/20/24 after receiving  a dose of Arexvy on 12/29/23 at a different location. Patient has not reported any side effects.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Oedema peripheral, Pruritus
Clinical narrative: My left underarm swollen and itching and severe pain in my lymph nodes. I wash area. Used ice and warm compresses to stop the pain. I took Benadryl and Ibuprofen.  I am still taking Ibuprofen for pain in left underarm .
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Colitis ulcerative, Colonoscopy
Clinical narrative: After the 4th shot of the booster shot of Pfizer, my daughter developed sever stomach pain and ultimately ulcerative collitis.
Age: 70.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received first dose of shingles vaccine and comirnarty covid vaccine in left arm, she woke up a couple days later noticing a red raised area where the vaccines were administered, raised area is painful to the touch. Patient was instructed to apply ice as needed to the area and seek follow up medical care if raised area does not disappear within the next 3 days.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Nausea
Clinical narrative: Donor received the Hep B vaccine at 10:05 and asked to wait for 15 minutes. Donor started feeling nauseated at 10:15 and it lasted for about 45 minutes.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient received Arexvy vaccination in her left arm. She has some swelling, itching, and warmth in the upper arm.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient had previously received the rsv vaccine on 12-15-2023 and then received a dose on 12-21-24. I called pt and asked her if she received the vaccine last year and she said she didn't remember.
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Pt received a prevnar dose in 2022 and received another in 2024 in error
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event. Only a one-time single dose vaccine. Pt. received another dose of RSV on 12/20/24. Previous vaccine was given 12/18/2023.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt requested appointment for Pneumonia (prevnar 20) and RSV (arexvy) vaccine.  Went thru our system and insurance with no issues. We gave vaccine, then got email from corporate that pt recieved vaccine last year. Pt did not tell us they have had this vaccine. We are reporting according to store policy, pt made aware RSV is a one and done shot and reports no issues.
Age: 76.0
Sex: M
Vaccine: PNC20, RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received a prevnar dose on 12/12/2012 and 12/19/2024 in error
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Vaccination was given last year and this year for the patient after patient made an appointment, spoke to patient the next day to let know not recommended for her to get again and that we would properly report.  She currently had no issues to note
Age: 50.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Vertigo
Clinical narrative: Vertigo for 3 weeks and still going on
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Blood creatinine, Blood electrolytes, Blood glucose
Clinical narrative: GENERALIZED MYASTHENIA GRAVIS BEGAN 11/23 ON WAKING WITH WEAKNESS IN WHOLE BODY, DIFFICULTY WALKING OR STANDING WITHOUT HOLDING ON TO SOMETHING; LOSING BALANCE. THIS CONTINUED UNTIL I WAS ABLE TO BE REFERRED (11/28 by Dr.) TO A NEUROLOGIST AND SEVERAL TESTS WERE DONE. 11/26 EMERGENCY ROOM VISIT FOR NUMBNESS AND TINGLING IN ARMS AND LEGS. USE OF REGULAR WALKER ADVISED. 3/2/2023 ROLLING WALKER ORDERED.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urea, Brain natriuretic peptide, Differential white blood cell count, Dysstasia, Full blood count
Clinical narrative: GENERALIZED MYASTHENIA GRAVIS BEGAN 11/23 ON WAKING WITH WEAKNESS IN WHOLE BODY, DIFFICULTY WALKING OR STANDING WITHOUT HOLDING ON TO SOMETHING; LOSING BALANCE. THIS CONTINUED UNTIL I WAS ABLE TO BE REFERRED (11/28 by Dr.) TO A NEUROLOGIST AND SEVERAL TESTS WERE DONE. 11/26 EMERGENCY ROOM VISIT FOR NUMBNESS AND TINGLING IN ARMS AND LEGS. USE OF REGULAR WALKER ADVISED. 3/2/2023 ROLLING WALKER ORDERED.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Myasthenia gravis, Paraesthesia, Troponin I
Clinical narrative: GENERALIZED MYASTHENIA GRAVIS BEGAN 11/23 ON WAKING WITH WEAKNESS IN WHOLE BODY, DIFFICULTY WALKING OR STANDING WITHOUT HOLDING ON TO SOMETHING; LOSING BALANCE. THIS CONTINUED UNTIL I WAS ABLE TO BE REFERRED (11/28 by Dr.) TO A NEUROLOGIST AND SEVERAL TESTS WERE DONE. 11/26 EMERGENCY ROOM VISIT FOR NUMBNESS AND TINGLING IN ARMS AND LEGS. USE OF REGULAR WALKER ADVISED. 3/2/2023 ROLLING WALKER ORDERED.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Walking aid user
Clinical narrative: GENERALIZED MYASTHENIA GRAVIS BEGAN 11/23 ON WAKING WITH WEAKNESS IN WHOLE BODY, DIFFICULTY WALKING OR STANDING WITHOUT HOLDING ON TO SOMETHING; LOSING BALANCE. THIS CONTINUED UNTIL I WAS ABLE TO BE REFERRED (11/28 by Dr.) TO A NEUROLOGIST AND SEVERAL TESTS WERE DONE. 11/26 EMERGENCY ROOM VISIT FOR NUMBNESS AND TINGLING IN ARMS AND LEGS. USE OF REGULAR WALKER ADVISED. 3/2/2023 ROLLING WALKER ORDERED.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: pt came in and asked to get rsv vaccine.  unkown at the time but she had already received one dose in december 12/06/2023.  Discovered after the fact when I was filling out her covid-19 vaccine card which had other vaccines on it.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Oral herpes, Pyrexia
Clinical narrative: Fever lasting 24 hours, severe headache lasting 2 weeks, cold sores on lips and in nasal passages bilaterally lasting 2 weeks
Age: 26.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Possible allergic reaction - 2? diameter red area at injection site, itchy, painful, swollen, hot to the touch. Noticed upon waking in the morning and persisted all day. Also had recurrent diarrhea multiple times over the course of the afternoon. Treated arm with Benadryl and ice, no change or improvement.
Age: 26.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site warmth
Clinical narrative: Possible allergic reaction - 2? diameter red area at injection site, itchy, painful, swollen, hot to the touch. Noticed upon waking in the morning and persisted all day. Also had recurrent diarrhea multiple times over the course of the afternoon. Treated arm with Benadryl and ice, no change or improvement.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss. Hair falling out, bald spots.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Rhinorrhoea
Clinical narrative: Runny nose constantly all day - watery
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling
Clinical narrative: Pain in and around right eye and swelling and discoloration around eye.
Sex: M
Vaccine: RSV, RSV
Symptoms: Cough
Clinical narrative: Persistent dry cough; This non-serious case was reported by a consumer and described the occurrence of persistent dry cough in a 76-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 23-OCT-2024, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced persistent dry cough (Verbatim: Persistent dry cough). The outcome of the persistent dry cough was not resolved.   It was unknown if the reporter considered the persistent dry cough to be related to Arexvy.     It was unknown if the company considered the persistent dry cough to be related to Arexvy.   Additional Information: GSK receipt Date: 24-NOV-2024 The case was self reported by patient. The patient received Arexvy vaccine and experienced persistent dry cough. The patient scheduled a doctors visit for persistent dry cough on 27th November.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: CSF culture negative, CSF white blood cell count increased, Encephalitis, Pleocytosis
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Wife states patient ended up contracting meningitis a week after shingrix vaccination and is still currently in the hospital.  They are still trying to find out where he could have contracted menigitis from. Wife wanted us to complete a report.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Meningitis
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Wife states patient ended up contracting meningitis a week after shingrix vaccination and is still currently in the hospital.  They are still trying to find out where he could have contracted menigitis from. Wife wanted us to complete a report.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Deafness unilateral, Scan brain, Tinnitus
Clinical narrative: catching COVID this last summer; catching COVID this last summer; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 17Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EN6201, Expiration Date: 30Jun2021) and on 12Mar2021 as dose 2, 0.3 ml single (Lot number: EN6208) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "catching COVID this last summer". The patient underwent the following laboratory tests and procedures: X-ray: Unknown results. Clinical course: Consumer stated, he was retired they were trying to stay away form people because of this COVID he just ended up catching COVID this last summer.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400326172 same reporter/patient/vaccine, different events;
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, X-ray
Clinical narrative: catching COVID this last summer; catching COVID this last summer; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 17Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EN6201, Expiration Date: 30Jun2021) and on 12Mar2021 as dose 2, 0.3 ml single (Lot number: EN6208) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "catching COVID this last summer". The patient underwent the following laboratory tests and procedures: X-ray: Unknown results. Clinical course: Consumer stated, he was retired they were trying to stay away form people because of this COVID he just ended up catching COVID this last summer.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400326172 same reporter/patient/vaccine, different events;
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: catching COVID this last summer; catching COVID this last summer; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 17Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EN6201, Expiration Date: 30Jun2021) and on 12Mar2021 as dose 2, 0.3 ml single (Lot number: EN6208) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "catching COVID this last summer". The patient underwent the following laboratory tests and procedures: X-ray: Unknown results. Clinical course: Consumer stated, he was retired they were trying to stay away form people because of this COVID he just ended up catching COVID this last summer.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400326172 same reporter/patient/vaccine, different events;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Deafness unilateral, Scan brain, Tinnitus
Clinical narrative: catching COVID this last summer; catching COVID this last summer; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient received BNT162b2 (BNT162B2), on 17Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EN6201, Expiration Date: 30Jun2021) and on 12Mar2021 as dose 2, 0.3 ml single (Lot number: EN6208) for covid-19 immunisation. The patient's relevant medical history included: "heart transplant" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "catching COVID this last summer".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, X-ray
Clinical narrative: catching COVID this last summer; catching COVID this last summer; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient received BNT162b2 (BNT162B2), on 17Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EN6201, Expiration Date: 30Jun2021) and on 12Mar2021 as dose 2, 0.3 ml single (Lot number: EN6208) for covid-19 immunisation. The patient's relevant medical history included: "heart transplant" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "catching COVID this last summer".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: catching COVID this last summer; catching COVID this last summer; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient received BNT162b2 (BNT162B2), on 17Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EN6201, Expiration Date: 30Jun2021) and on 12Mar2021 as dose 2, 0.3 ml single (Lot number: EN6208) for covid-19 immunisation. The patient's relevant medical history included: "heart transplant" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "catching COVID this last summer".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: HIBV, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; a dose of PEDVAXHIB was administered a patient during a temperature excursion; This spontaneous report was received from a registered nurse, concerning   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the vaccine haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) suffered a temperature excursion (TE) of 24 hours at -20.5 C. The product was inadvertently stored in the freezer. There were no previous temperature excursion reported.   On 12-DEC-2024, the patient was vaccinated with a dose of the vaccine involved in the TE: haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, administered for prophylaxis (strength, dose, and route of administration were not provided;  lot #Y006391, expiration date 09-JUL-2026). (Product storage error). No additional adverse event (No adverse event).
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Gait disturbance, Muscle spasms, Myalgia
Clinical narrative: Pfizer COMIRNATY Covid Booster Shot received on 15 Oct 2024 - Side effects: Uncontrolled painful muscle spasms on both ham[INVALID] and quadriceps muscles. Tender and sensitive hips joints, making it very uncomfortable to walk. Spasms and sensitivity in gluteus maximums muscles, making it uncomfortable to stand. The symptoms started one day after the covid booster shot and have remained since and I still suffer with it today. The symptoms come and go, and are mildly but not completely controlled with 1000mg of acetaminophen. If I try to exercise or stretch, my muscles become very sore the day after and take several days before the soreness goes away. I can tell the difference between the sensitivity associated with adverse effect and muscle soreness from the exercise. The booster shot was administered by a licensed medical professional, Family Practice, within their office. I have no requested treatment, I was managing the symptoms hoping that my body would combat it, but so far, the symptoms remain.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysstasia, Gait disturbance, Muscle spasms, Myalgia, Tenderness
Clinical narrative: Pfizer COMIRNATY Covid Booster Shot received on 15 Oct 2024 - Side effects: Uncontrolled painful muscle spasms on both ham[INVALID] and quadriceps muscles. Tender and sensitive hips joints, making it very uncomfortable to walk. Spasms and sensitivity in gluteus maximums muscles, making it uncomfortable to stand. The symptoms started one day after the covid booster shot and have remained since and I still suffer with it today. The symptoms come and go, and are mildly but not completely controlled with 1000mg of acetaminophen. If I try to exercise or stretch, my muscles become very sore the day after and take several days before the soreness goes away. I can tell the difference between the sensitivity associated with adverse effect and muscle soreness from the exercise. The booster shot was administered by a licensed medical professional, Family Practice, within their office. I have no requested treatment, I was managing the symptoms hoping that my body would combat it, but so far, the symptoms remain.
Age: 35.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Underdose
Clinical narrative: No symptoms reported; their intent was to administer the HAVRIX; This spontaneous report was received from a medical assistant and referred to a 35-year-old patient of unknown gender. The patient's concurrent condition included immunocompromised and any prior vaccination history was uncertain. Concomitant therapies, historical drugs and historical conditions were not reported.  On 25-NOV-2024, the patient was inadvertently vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, pediatric dose (0.5 ml), lot #Y006122, expiration date: 17-MAY-2025, administered for prophylaxis (strength, anatomical site of administration and route of administration were not provided). Their intent was to administer the  hepatitis a vaccine inact (HAVRIX) vaccine (Wrong product administered). No symptoms reported and no additional details provided (no adverse event).