chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Ear swelling, Musculoskeletal stiffness, Oedema peripheral, Rash, Rash pruritic
Clinical narrative: A day or two after I received the shot I started to get extensive pruritic rashes throughout both arms, my neck, my ears, my legs, and later on my abdomen. The rashes continued to get more severe into the following week. At the height of the adverse reaction, my left arm had significant edema and my ears were so swollen they were stiff and I could not sleep on my side. The rashes on my arms were also oozing fluids, which I had to treat with calomine lotion. After about one week I sought care through urgent care, and the doctor prescribed me doxycycline 100mg BID for 10 days, stating that the rashes looked like a secondary infection (most likely due to the vaccine as I do not have a history of skin conditions, and my daily routine did not change at all that would expose me to anything as I work from home). Symptoms started to resolve after about 2 weeks, and though I am doing much better now the rash scars on my legs, arms, and neck still remain and are still healing. My abdomen still has some lingering rash but it looks like it is resolving.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Scar, Skin weeping, Sleep disorder
Clinical narrative: A day or two after I received the shot I started to get extensive pruritic rashes throughout both arms, my neck, my ears, my legs, and later on my abdomen. The rashes continued to get more severe into the following week. At the height of the adverse reaction, my left arm had significant edema and my ears were so swollen they were stiff and I could not sleep on my side. The rashes on my arms were also oozing fluids, which I had to treat with calomine lotion. After about one week I sought care through urgent care, and the doctor prescribed me doxycycline 100mg BID for 10 days, stating that the rashes looked like a secondary infection (most likely due to the vaccine as I do not have a history of skin conditions, and my daily routine did not change at all that would expose me to anything as I work from home). Symptoms started to resolve after about 2 weeks, and though I am doing much better now the rash scars on my legs, arms, and neck still remain and are still healing. My abdomen still has some lingering rash but it looks like it is resolving.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mobility decreased, Paraesthesia
Clinical narrative: Numbness and tingling in pinky finger/side of hand on vaccinated arm.  Could not close finger all the way.  When spoke to him later in the day he stated also tingly in ring finger.  Strength was better.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Myalgia
Clinical narrative: Experienced in order: Diarrhea, stomach pain, nausea, bodyaches, fatigue, muscle aches, chills. Took antacid for stomach pain and zofran for nausea which helped but did not completely resolve those symptoms. Later took 400mg ibuprofen and 1000mg acetaminophen for muscle ache and chills, which resolved those symptoms for about 5-6 hours before they started to return.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain
Clinical narrative: Experienced in order: Diarrhea, stomach pain, nausea, bodyaches, fatigue, muscle aches, chills. Took antacid for stomach pain and zofran for nausea which helped but did not completely resolve those symptoms. Later took 400mg ibuprofen and 1000mg acetaminophen for muscle ache and chills, which resolved those symptoms for about 5-6 hours before they started to return.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Shot at 1215 pm. By 6 pm, itchy red hives on both arms, particularly forearms,  neck, and chest,
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphonia, Cough, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Sore throat, cough, loss of voice x1 week
Age: 32.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Placental disorder, Premature delivery
Clinical narrative: marginal placenta; This is a spontaneous report and received from Consumer or other non HCPs from Regulatory Authority. Regulatory number: 2749519-1 (VAERS ID).  A 32-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 05Jan2024 at 15:45 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years intramuscular, in right arm for maternal immunisation. The patient's relevant medical history included: "Latex allergy" (unspecified if ongoing). The patient is expected to deliver one baby(s) on 28Feb2024. The patient took concomitant medications. Vaccination history included: Influenza vaccine (Vaccine: 1176 Influenza (seasonal) (Flublok Quadrivalent), Manufacturer: Protein Sciences Corporation, Route: Intramuscular-IM, Site: Left Arm, Dose 1), for Immunization. The following information was reported: PLACENTA PRAEVIA (medically significant) with onset 30Jan2024 at 15:46, outcome "recovered", described as "marginal placenta". The baby was delivered premature. The baby weighed 2380.875 grams. Clinical courses: Pregnancy was uncomplicated, other than marginal placenta. Due date was 28Feb2024 and baby girl was born. Baby was born 5 pounds and 4 ounces. Both mom and baby are doing well. No reason for late premature birth identified. Medications at time of vaccination included Pre-natal vitamins.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: the events "Exposure during pregnancy" and "Premature delivery" were removed.  Follow-up (23Sep2024): This is a spontaneous follow-up report received from a consumer via FDA (2749519-1). Updated information: new reporter (patient), patient details (race and ethnicity, and Age at Vaccination), historical vaccine, product dosage start and stop time, physician (Best Doctor) and vaccine facility information. Follow-up (02Oct2024): Follow-up attempts are completed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400082962 baby case;
Age: 32.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Foetal exposure during pregnancy, Premature baby
Clinical narrative: marginal placenta; This is a spontaneous report and received from Consumer or other non HCPs from Regulatory Authority. Regulatory number: 2749519-1 (VAERS ID).  A 32-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 05Jan2024 at 15:45 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years intramuscular, in right arm for maternal immunisation. The patient's relevant medical history included: "Latex allergy" (unspecified if ongoing). The patient is expected to deliver one baby(s) on 28Feb2024. The patient took concomitant medications. Vaccination history included: Influenza vaccine (Vaccine: 1176 Influenza (seasonal) (Flublok Quadrivalent), Manufacturer: Protein Sciences Corporation, Route: Intramuscular-IM, Site: Left Arm, Dose 1), for Immunization. The following information was reported: PLACENTA PRAEVIA (medically significant) with onset 30Jan2024 at 15:46, outcome "recovered", described as "marginal placenta". The baby was delivered premature. The baby weighed 2380.875 grams. Clinical courses: Pregnancy was uncomplicated, other than marginal placenta. Due date was 28Feb2024 and baby girl was born. Baby was born 5 pounds and 4 ounces. Both mom and baby are doing well. No reason for late premature birth identified. Medications at time of vaccination included Pre-natal vitamins.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: the events "Exposure during pregnancy" and "Premature delivery" were removed.  Follow-up (23Sep2024): This is a spontaneous follow-up report received from a consumer via FDA (2749519-1). Updated information: new reporter (patient), patient details (race and ethnicity, and Age at Vaccination), historical vaccine, product dosage start and stop time, physician (Best Doctor) and vaccine facility information. Follow-up (02Oct2024): Follow-up attempts are completed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400082962 baby case;
Age: 32.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Placenta praevia, Premature delivery
Clinical narrative: marginal placenta; This is a spontaneous report and received from Consumer or other non HCPs from Regulatory Authority. Regulatory number: 2749519-1 (VAERS ID).  A 32-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 05Jan2024 at 15:45 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years intramuscular, in right arm for maternal immunisation. The patient's relevant medical history included: "Latex allergy" (unspecified if ongoing). The patient is expected to deliver one baby(s) on 28Feb2024. The patient took concomitant medications. Vaccination history included: Influenza vaccine (Vaccine: 1176 Influenza (seasonal) (Flublok Quadrivalent), Manufacturer: Protein Sciences Corporation, Route: Intramuscular-IM, Site: Left Arm, Dose 1), for Immunization. The following information was reported: PLACENTA PRAEVIA (medically significant) with onset 30Jan2024 at 15:46, outcome "recovered", described as "marginal placenta". The baby was delivered premature. The baby weighed 2380.875 grams. Clinical courses: Pregnancy was uncomplicated, other than marginal placenta. Due date was 28Feb2024 and baby girl was born. Baby was born 5 pounds and 4 ounces. Both mom and baby are doing well. No reason for late premature birth identified. Medications at time of vaccination included Pre-natal vitamins.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: the events "Exposure during pregnancy" and "Premature delivery" were removed.  Follow-up (23Sep2024): This is a spontaneous follow-up report received from a consumer via FDA (2749519-1). Updated information: new reporter (patient), patient details (race and ethnicity, and Age at Vaccination), historical vaccine, product dosage start and stop time, physician (Best Doctor) and vaccine facility information. Follow-up (02Oct2024): Follow-up attempts are completed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400082962 baby case;
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Loss of consciousness, Vomiting
Clinical narrative: Possible momentary loss of consciousness; Diarrhoea; vomiting; dizziness, needed to lie on floor; This is a spontaneous report received from a Consumer or other non HCP.  An 80-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 27Sep2024 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "chronic constipation" (unspecified if ongoing); "history of occasional episodes of situational Vaso-vagal syncope." (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation as dose number unknown, single; LINZESS; ACICLOVIR; HYDROCHLOROTHIAZIDE; SIMVASTATIN; DENOSUMAB. The following information was reported: DIARRHOEA (non-serious) with onset 28Sep2024 at 18:45, outcome "recovering"; LOSS OF CONSCIOUSNESS (medically significant) with onset 28Sep2024 at 18:45, outcome "recovering", described as "Possible momentary loss of consciousness"; DIZZINESS (non-serious) with onset 28Sep2024 at 18:45, outcome "recovering", described as "dizziness, needed to lie on floor"; VOMITING (non-serious) with onset 28Sep2024 at 18:45, outcome "recovering". Therapeutic measures were not taken as a result of loss of consciousness, diarrhoea, vomiting, dizziness.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: Note from patient delivered to us: "Had usual soreness at site in left am, fever and tiredness 9/26, but on 9/27 had a mild headache and short episode of being unable to speak words I was thinking such as "dryer" became "dremmer" - associative aphasia this lasted for 10 minutes from 1120am until 1130 then again 1240 until 1255. We were going to go to the hospital if it happened again. There was no slurring, no motor changes, no other stroke symptoms. I clearly knew what I wanted to say but for those 10 minutes the words came out incorrectly although pronounced clearly. There has been no reoccurence. I believe this should be reported as a VAERs for the vaccine. Thank you."
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Dyspraxia, Fatigue, Headache, Injection site pain
Clinical narrative: Note from patient delivered to us: "Had usual soreness at site in left am, fever and tiredness 9/26, but on 9/27 had a mild headache and short episode of being unable to speak words I was thinking such as "dryer" became "dremmer" - associative aphasia this lasted for 10 minutes from 1120am until 1130 then again 1240 until 1255. We were going to go to the hospital if it happened again. There was no slurring, no motor changes, no other stroke symptoms. I clearly knew what I wanted to say but for those 10 minutes the words came out incorrectly although pronounced clearly. There has been no reoccurence. I believe this should be reported as a VAERs for the vaccine. Thank you."
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Note from patient delivered to us: "Had usual soreness at site in left am, fever and tiredness 9/26, but on 9/27 had a mild headache and short episode of being unable to speak words I was thinking such as "dryer" became "dremmer" - associative aphasia this lasted for 10 minutes from 1120am until 1130 then again 1240 until 1255. We were going to go to the hospital if it happened again. There was no slurring, no motor changes, no other stroke symptoms. I clearly knew what I wanted to say but for those 10 minutes the words came out incorrectly although pronounced clearly. There has been no reoccurence. I believe this should be reported as a VAERs for the vaccine. Thank you."
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to device use error, No adverse event, Underdose
Clinical narrative: No additional adverse event was reported; 12 months old patient moved his leg during a routine vaccination appointment today, 9/25/2024, which resulted in less than recommended dose being administered into the patients leg; This spontaneous report was received from a medical assistant and refers to a 12-months-old patient of an unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 25-SEP-2024, the patient was vaccinated with the first dose (of two dose series) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, route of administration and anatomical site of administration were not provided). On that date, the patient moved his leg during the routine vaccination, which resulted in less than recommended dose administered into the patient's leg (Accidental underdose). According to the reporter, the patient did not experience any symptoms or medical concerns due to the moving the legs during the attempted administration. No additional adverse event was reported.
Age: 1.0
Sex: F
Vaccine: RV5
Symptoms: Rotavirus test positive
Clinical narrative: Potentially also experiencing CDIFF infection.; HCP reported that a patient who had been previously vaccinated with ROTATEQ had recently tested positive for ROTAVIRUS; This spontaneous report was received from a nurse practitioner regarding to a 1-year-old female patient.   The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drugs reactions or allergies were not reported.   On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliters (ml), administered orally for prophylaxis (strength, lot #, and expiry date were not provided).  On an unknown date, it was reported that the patient was recently tested positive for rotavirus and was also potentially experiencing a CDIFF (Clostridium difficile) infection. At the time of reporting, the outcome of the events was not reported.   The causal relationship between the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown.   Upon internal review, the event of Clostridium difficile infection was determined to be medically significant.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Received a Frozen Dose; Initial report received on 04-Sep-2024.  A reporter type in the reported that a patient (age, gender, race, and ethnicity not provided) received a frozen dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 03-Sep-2024, the patient received a dose of HEPLISAV-B (lot # 944942, expiration date 13-Jan-2027, and NDC # 43528-003-05). The dose of HEPLISAV-B had been frozen. No side effects were reported.   No other information was available.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: A Couple of Weeks Late For The Second Dose; Initial report received on 09-Sep-2024.  A pharmacist in the reported that a patient (age, gender, race, and ethnicity unknown) was two months late for their appointment for the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and concomitant medications were not reported.   On an unknown date, the patient received the first dose of HEPLISAV-B (Lot number, expiration date, NDC, and injection site not reported) intramuscularly.   At time of report, the patient was two months late for their appointment for the second dose of HEPLISAV-B (Lot number, expiration date, NDC, and injection site unknown) intramuscularly. The patient had no further side effects.  No other information was available.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Received Dose 4 Weeks Ago ,and Has Not Had Second Dose; Initial report received on 11-Sep-2024.  A pharmacist reported that a patient (age, gender, race, and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization more than four weeks ago and has not had the second dose yet.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unknown date, the patient received the first dose of HEPLISAV-B (lot #, expiration date, NDC #, route and site not reported).  The patient received this dose "more than four weeks ago" and has not returned for the second dose.   No other information was available.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received First Dose, and Second Dose Engerix; Initial report received on 12-Sep-2024.  A reporter in the reported that a patient (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) as the first dose for hepatitis B immunization and then received ENGERIX-B as the second dose.  No medical history or concomitant medications were reported.    On an unknown date, the patient received the first dose of HEPLISAV-B (NDC # 43528-002-01; lot #, expiration date, route, and site not reported). On an unknown date, a month after the first dose of HEPLISAV-B, the patient was administered ENGERIX-B as the second dose for hepatitis B immunization.   No other information was available.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate Scheduled of Product Administration; Initial report received on 16-Sep-2024.  A pharmacist reported that a patient (gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and received the second dose three days after receiving the first.   Medical history and concomitant medication were not reported.     On an unknown date, dose 1 of HEPLISAV-B (lot #, expiration date, and NDC #, site not reported) was administered.  On an unknown date, three days after receiving the first dose, dose 2 of HEPLISAV-B (lot #, expiration date, and NDC #, site not reported) was administered.   No other information was available.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain, Rash
Clinical narrative: body rash on my middle torso and lower back; headache; ache all over; This non-serious case was reported by a consumer and described the occurrence of rash in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15-SEP-2024, the patient received the 1st dose of Shingrix. In SEP-2024, less than a week after receiving Shingrix, the patient experienced headache (Verbatim: headache) and generalized aching (Verbatim: ache all over). On 16-SEP-2024, the patient experienced rash (Verbatim: body rash on my middle torso and lower back). The outcome of the rash was not resolved and the outcome of the headache and generalized aching were not reported.   It was unknown if the reporter considered the rash, headache and generalized aching to be related to Shingrix.     It was unknown if the company considered the rash, headache and generalized aching to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-SEP-2024 1 days after received Shingrix vaccine, the patient experienced rash on torso. He also experienced headache, ache all over and no fever. The patient went to physician on 19th September 2024. He still had the body rash on his middle torso and lower back. No other products received by the patient. No symptoms were treated.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenitis
Clinical narrative: lymphadenitis; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of lymphadenitis in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 5R3PB, expiry date 20-SEP-2026) for prophylaxis.   On 14-SEP-2024, the patient received Shingrix. On 16-SEP-2024, 2 days after receiving Shingrix, the patient experienced lymphadenitis (Verbatim: lymphadenitis). The outcome of the lymphadenitis was not resolved.   It was unknown if the reporter considered the lymphadenitis to be related to Shingrix.     It was unknown if the company considered the lymphadenitis to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-SEP-2024 The pharmacist reported that a patient was administered with Shingrix and she reported to pharmacy today (at the time of reporting) that she was experiencing lymphadenitis.  The patient discovered it this (day of reporting) morning when she was putting on deodorant.
Age: 70.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pruritic erythematous swelling at COVID vaccine site beginning about 48 hours after dose; diameter about 6 cm.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Depression, Feeling abnormal, Myalgia
Clinical narrative: I felt off that day, normal expected side effects; intense muscle aches and shivering that went away in 2 days or so. But I also felt an intensity to my mental wellbeing. Before, my medication was working great and I had no complaints. After this booster, and the one before, and when I got covid, I felt the medications for my depression become--almost less effective. My psychiatrist agreed to up lexipro. I felt better. But never as content as I used to.   TLDR: Neuro issues with meds
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient presented to the pharmacy 2 days post vaccination with redness extending the length of both arms from what could be visualized from elbow to hands on the underside. When asked if the rash was localized to the arms the patient stated that it was on most of her body including torso and legs down to the knees. She said it was not at all irritating and had no symptoms other than the redness/rash. At that point I advised the patient to seek medical care without any further delay and she proceeded to the ER. Patient returned to the pharmacy a few hours later to pick up a steroid pack prescribed by the hospital and her presentation and complaints were unchanged. Upon following up with patient the next day (10/1) she stated the steroid had already reduced most of the redness and saw good clinical improvement.
Age: 32.0
Sex: F
Vaccine: COVID19, FLU3, HEP
Symptoms: Chills, Dysphonia, Headache, Pain in extremity, Pruritus
Clinical narrative: Arm pain within hours, fever/chills/headache  for 2 days, horse voice within 24 hours, itchiness all over for 2 days, sneezing for 2 days
Age: 32.0
Sex: F
Vaccine: COVID19, FLU3, HEP
Symptoms: Pyrexia, Sneezing
Clinical narrative: Arm pain within hours, fever/chills/headache  for 2 days, horse voice within 24 hours, itchiness all over for 2 days, sneezing for 2 days
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Frequent bowel movements, Headache, Pain
Clinical narrative: 9/27/2024 Headache, body ache. 9/28/2024 Evening; loose stool. 9/29/2024-10/1/2024 Diarrhea, frequent bowel movement at frequency of once every 60-90 minutes
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Tinnitus
Clinical narrative: Tinnitus(ringing in my ear) right ear
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: Debilitating chronic fatigue, continuing and worsening over the past year
Age: 37.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction at the Covid vaccine site, not the flu vaccine site (though the flu site was an inch above the Covid site). Swelling in a bandaid sized patch around injection site. Area is warm, red, raised, and tender. I noticed it a few hours after the vaccination. It has persisted a day later.
Age: 34.0
Sex: M
Vaccine: UNK
Symptoms: Computerised tomogram head, Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Myelitis transverse
Clinical narrative: I work at Auto Finance, and it seemed like everyone around me was getting sick. I decided to get a flu shot and asked the nurse administering the shot if it was okay to do so even though I had a sore throat. She assured me that it was. The shot was administered by her at Auto department in temp at the break room during lunch at September 17th at 12 :40.  Unfortunately, five days later, I began experiencing severe pain that I initially attributed to sciatica. However, the pain escalated, and I eventually became paralyzed from the waist down. After multiple misdiagnoses, I was finally diagnosed with Transverse myelitis.
Age: 34.0
Sex: M
Vaccine: UNK
Symptoms: Pain, Paraplegia
Clinical narrative: I work at Auto Finance, and it seemed like everyone around me was getting sick. I decided to get a flu shot and asked the nurse administering the shot if it was okay to do so even though I had a sore throat. She assured me that it was. The shot was administered by her at Auto department in temp at the break room during lunch at September 17th at 12 :40.  Unfortunately, five days later, I began experiencing severe pain that I initially attributed to sciatica. However, the pain escalated, and I eventually became paralyzed from the waist down. After multiple misdiagnoses, I was finally diagnosed with Transverse myelitis.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Injection site hypoaesthesia, Injection site pain, Injection site warmth
Clinical narrative: Injection site sore but also numb in the center. Upper arm hot to the touch. Fatigue that is manageable but worsening over the course of last 6 hours. Chills and skin prickles. Fingers hurt.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Injection site sore but also numb in the center. Upper arm hot to the touch. Fatigue that is manageable but worsening over the course of last 6 hours. Chills and skin prickles. Fingers hurt.
Sex: U
Vaccine: RAB
Symptoms: Device issue
Clinical narrative: Describe Event, Problem, or Product Use Error: Our nurses pointed out that the RabAvert Rabies vaccine kit contains an IM needle that lacks a safety device. In order to prevent needlesticks and accidental transmission of blood-borne pathogens, standard of care in hospitals is to utilize safety devices on all needles. By its nature, RabAvert is used in ER settings, which can often be crowded and fast paced, thereby increasing the risk of a needlestick injury. We are hoping to encourage some modification to the needle that comes in the box of RabAvert vaccines so there is a safety feature.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Migraine, Nausea, Visual impairment
Clinical narrative: I received the COVID Comirnaty 30 mcg 0.3 mL injection from Pfizer and within 24 hours I had pain at injection site and a severe migraine with nausea, vision changes, 9/10 pain. This went on for 3 days without help from rescue medications or pain medications.
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Injection site erythema, Injection site mass, Injection site swelling, Lymph node pain
Clinical narrative: Received a Prevnar 20 vaccine. Day 2 tried, but arm swelled and ached most of the day. Day 3 am has a knot in it and is red and swollen at the injection site. Day 4 still swollen and red with the knot at injection site, but swelling and some pain going up neck in lymph system. Tender lymph nodes in shoulder and neck.
Sex: F
Vaccine: PNC20
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Received a Prevnar 20 vaccine. Day 2 tried, but arm swelled and ached most of the day. Day 3 am has a knot in it and is red and swollen at the injection site. Day 4 still swollen and red with the knot at injection site, but swelling and some pain going up neck in lymph system. Tender lymph nodes in shoulder and neck.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Erythema, Injection site swelling, Pruritus, Rash macular, Skin warm
Clinical narrative: Received Moderna covid vaccine and influenza vaccine of unknown brand in pediatric clinic on 9/28 and 36 hours later injection site excessively swollen (injections placed near one another in upper right arm, swelling extended down to elbow), reminiscent of hives but not blotchy, itchy, red, warm to touch, only mildly improved after 1 dose of 12.5mg diphenhydramine. Cannot visibly identify which vaccines causatory.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: I went to pharmacy to get my flu vaccine. I declined the COVID one. The technician took my paperwork, handed me back the 1-sheet about the flu vaccine and gave me a shot. I got a call a few hours later they think they gave me the COVID one and not the flu. There were 2 patients after me and they had an extra flu vile at the end. The said they were pretty sure they gave me COVID not flu but I honestly don't feel confident they even know which one they gave me or if it was me and not one of the other 2 patients that had the mix up. This could be really dangerous and I want to make sure it got reported so that they can fix their process so it doesn't happen again and seriously hurt someone next time.
Sex: M
Vaccine: RSV
Symptoms: Product physical issue
Clinical narrative: Vial adaptor applied to RSV vial and diluent did not reach vial. Vial still had powder in it - no liquid. Discarded and new RSV vaccine prepared and given. Remaining vials in same lot to be returrned to vendor 10/01/2024
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Blood uric acid normal, C-reactive protein increased, Gout, Joint swelling
Clinical narrative: Had a pneumococcal conjugate 20 vaccine. Developed intense pain and swelling in right ankle within 8 hours. Initially thought to be cellulitis. Treated with two antibiotics for seven days with no change. Then treated with idomethacin and prednsone for gout and finally clearing. I have never had gout or a gout flare before. I had Spikevax 2024-25 on 8/27/2024. PCP feels it could have been a combiatinon of the two vaccines close together.
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Red blood cell sedimentation rate normal, White blood cell count normal
Clinical narrative: Had a pneumococcal conjugate 20 vaccine. Developed intense pain and swelling in right ankle within 8 hours. Initially thought to be cellulitis. Treated with two antibiotics for seven days with no change. Then treated with idomethacin and prednsone for gout and finally clearing. I have never had gout or a gout flare before. I had Spikevax 2024-25 on 8/27/2024. PCP feels it could have been a combiatinon of the two vaccines close together.
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: while pushing the plunger down - the syringe began leaking around the edge of the syringe and needle connection site
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Fatigue, Full blood count, Headache, Hot flush
Clinical narrative: Shingles vaccine #1 caused low platelet and white blood cell count, in addition to many symptoms similar to leukemia. I was awakened with a severe headache, had hot flashes and night sweats, developed a petechia patch on my tongue and petechiae rash on my arms, small bruise on my upper left arm, fatigue, etc.
Sex: M
Vaccine: VARZOS
Symptoms: Night sweats, Petechiae, Platelet count decreased, Rash, White blood cell count decreased
Clinical narrative: Shingles vaccine #1 caused low platelet and white blood cell count, in addition to many symptoms similar to leukemia. I was awakened with a severe headache, had hot flashes and night sweats, developed a petechia patch on my tongue and petechiae rash on my arms, small bruise on my upper left arm, fatigue, etc.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Medical Assistant called to report MMRII was given to a 15 month year old male yesterday 9/16/2024, that expired on 9/15/2024.; This spontaneous report was received from medical assistant and refers to a 15-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-SEP-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, expiration date: 15-SEP-2024, administered for prophylaxis (dose, strength, lot #, and route of administration were not provided) (expired product administered). No side effects or symptoms reported. No additional adverse event (AE) was reported.  Lot # has been requested and will be submitted if received.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant confirmed the patient involved has not reported any medical concerns or symptoms after the administration; Medical Assistant stated that a dose of PROQUAD was inadvertently administered to a patient today, 9/25/2024, while their freezer was exposed to a temperature excursion.; This spontaneous report has been received from a medical assistant and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 25-SEP-2024, the patient was inadvertently vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (product storage error), 0.5 milliliter (ml), as a two-dose series, administered as prophylaxis (lot number reported as X027627, which has been verified as valid with expiration date reported and established as 28-MAY-2025) (strength, route of administration, and anatomical site of injection were not reported). The freezer was exposed to a temperature excursion. No additional adverse events were reported in the patient.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Maladministration of expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received MMR (Priorix) (expiry date 01-AUG-2024) for prophylaxis.   On 05-AUG-2024, the patient received Priorix. On 05-AUG-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Maladministration of expired dose). The outcome of the expired vaccine used was not applicable.   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: 19-SEP-2024 Clinical Coordinator asked about the maladministration of three expired doses in three different patients. Vaccination date of patient two of three is August fifth twenty-twenty four. Did not consent to follow-up. The case is linked with US2024116631, US2024116644, by same reporter.; Sender's Comments:  US-GSK-US2024116631:Same reporter/Diffrent patient US-GSK-US2024116644:Same reporter/Diffrent patient
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: inadvertently given a patient a second dose Arexvy vaccination; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 89-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number G22GH, expiry date 01-JUL-2025) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on 02-OCT-2023).   On 13-SEP-2024, the patient received the 2nd dose of Arexvy. On 13-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: inadvertently given a patient a second dose Arexvy vaccination). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2024 The pharmacist reported that they had inadvertently given a patient a second dose of Arexvy vaccination about a year after the first one, which led to extra dose administered. So the reporter was calling to see if there was any information if it was that bad or anything that could help.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on April 9th 2022 and their second dose on January 10th 2024; 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 53-year-old female patient who received Herpes zoster (Shingrix) (batch number K72R2, expiry date 24-JAN-2026) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 09-APR-2022, batch number N354S, expiry date 27-MAY-2023).   On 10-JAN-2024, the patient received the 2nd dose of Shingrix. On 10-JAN-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose on April 9th 2022 and their second dose on January 10th 2024). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 23-SEP-2024 A pharmacist reported that the patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter requested for the information about the need to restart a series of Shingrix They wanted to know if it was necessary to restart the entire vaccination series because the vaccines were two years apart. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: COVID19
Symptoms: Spinal stenosis
Clinical narrative: SPINAL CANAL COLLAPSING CAUSING STENOSIS; This spontaneous report received from a patient via a company representative concerned a 40 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s 9 (Dose in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced spinal canal collapsing causing stenosis (Dose in series 1). The patient reported received J&J Covid vaccine in 2021 as a healthy 40 year old mom of 3. She had a reaction to the vaccine that has left her no longer capable of work. She had to quit her dream job, sell her dream home, and her children were taken by their father because she was financially ravaged by medical bills and appointments. The patient requested to compensate her for the pain and suffering she had experienced as a result of the vaccine. She could no longer walk without pain. Her spinal canal was collapsing causing stenosis in several areas. She could no longer work or do the things she love. She was forced to file for disability at age of 45. She used to run races and truck her girls around. Now she had nothing left. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of spinal canal collapsing causing stenosis was not reported. This report was serious (Disability Or Permanent Damage).; Sender's Comments: V0-Spinal stenosis. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: daughter was 29 years old, she had died and she had gotten Moderna; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of DEATH (daughter was 29 years old, she had died and she had gotten Moderna) in a 29-year-old female patient 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported. Treatment medications were not provided.  Company Comment: This is a spontaneous case concerning a 29-year-old, female patient with no reported medical history, who experienced the serious (due to medically significant and Fatal), unexpected event of Death. The event occurred on an unknown date, after a dose of SPIKEVAX COVID-19 VACCINE NOS.  The patient died on an unknown date, due to an unknown reason, and it is also unknown if an autopsy was performed or not. The outcome of the event was reported as fatal. Circumstances leading to death, current conditions, medical history, habits, concomitant medications, diagnostic procedures and treatment, were not provided. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-774519, US-MODERNATX, INC.-MOD-2024-774526, US-MODERNATX, INC.-MOD-2024-774527 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774519:Patient 2 of 4 US-MODERNATX, INC.-MOD-2024-774527:Patient 4 of 4 US-MODERNATX, INC.-MOD-2024-774526:Patient 3 of 4; Reported Cause(s) of Death: Unknown cause of death
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, DTPPVHBHPB
Symptoms: Extra dose administered
Clinical narrative: the inadvertent administration of VAXELIS to a patient who was prescribed to be administered with PENTACEL; the inadvertent administration of VAXELIS to a patient who was prescribed to be administered with PENTACEL on 13Jun2024, patient has received an extra dose of Hepatitis B vaccine dose because of the incident; This spontaneous safety report, with reference number 2024SA185693 (Inquiry# 02098792), was received by the partner on 18-JUN-2024 and forwarded on 24-JUN-2024, from an other health professional.   This case was considered non-valid due to no patient identifiers provided.  Due to the nature of the event, the causality between the event "the inadvertent administration of VAXELIS to a patient who was prescribed to be administered with PENTACEL on 13Jun2024, patient has received an extra dose of Hepatitis B vaccine dose because of the incident" and Vaxelis was not applicable.   Further information is expected  Significant Follow-up information was received by the partner on 25-JUN-2024 and forwarded on same day, from a HCP. The case is maintained as non-serious.  This case is now considered valid due to patient identifiers being provided.  Due to the nature of the event, the causality between the event "the inadvertent administration of VAXELIS to a patient who was prescribed to be administered with PENTACEL on 13Jun2024, patient has received an extra dose of Hepatitis B vaccine dose because of the incident" and Vaxelis was not applicable.  No further information is expected.
Age: 1.08
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Circumstance or information capable of leading to medication error, Syringe issue, Underdose
Clinical narrative: Administered VAXELIS to a patient but the patient had swatted out the medication and it sprayed out of the bottle. Caller wanted to know if the dose should be repeated; Administered VAXELIS to a patient but the patient had swatted out the medication and it sprayed out of the bottle. Caller wanted to know if the dose should be repeated; This non-serious spontaneous safety report was received by partner on 23-JUL-2024 and forwarded on 24-JUL-2024 from a other health care professional.  Due to the nature of the event, the causality assessment between Vaxelis and the Vaccine Underdose and Product leakage is assessed as not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HCP called to report TE where a product was administered to a patient.; This non-serious spontaneous safety report, with reference number 02651971 (interaction number: 02651952), was received by partner on 08-AUG-2024 and forwarded on 08-AUG-2024 from other health professional.  Due to the nature of the event, the causality between the event "HCP called to report TE where a product was administered to a patient" and Vaxelis was not applicable.    No further information is expected.