chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: DTAP, HEP, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient was scheduled to receive a dose of MMR, and varicella. Patient was mistakenly given a dose of MMR/V and Varicella on 01/09/2024. The ordered placed by the NP were for MMR and Varicella separately.  The mistake was not noticed until the end of the day around 5:00PM 01/10/2024. The provider called the number on record and spoke to the patient's guardian on 01/10/2024 at around 10:30am.  The Guardian was informed about the dosing error. The guardian stated the patient has no new symptoms at this moment.  The guardian stated she checked the patient for a rash as well and did not find one. The provider gave the patients guardian her direct phone number with instructions to call if there are any changes.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Incomplete course of vaccination, Influenza like illness, Nightmare
Clinical narrative: Pt called clinic to report that she began experiencing adverse reactions to vaccine around 2000 the day she received it. States that she began to feel like she had the flu, and was having very bad dreams while sleeping.  States that she had no vomiting or nausea, just weakness, fatigue, exhaustion, and the dreams were new while sleeping. She states that she is feeling much better today but wanted to report this so someone else doesn't go through the same thing as she has. She reports that she does have end stage kidney disease. She and her doctor discussed this vaccine prior to administration. He advised that he felt it would be fine, but ultimately it was up to her if she wanted to receive it. After discussing this with her today, she was advised not to receive second dose due to her kidney function at this time per nephrologist.  She agreed and voiced understanding.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient received flu shot second time. First time was 10/26/23 at 4:16 pm in left deltoid. Second time 1/1/24 at 11:55 am. System does not alert nurse administering that shot already received as it is a new order. System needs to be changed to alert provider better once order has been written. Talks to change procedure to have either MD or nurse or both look to paper chart to confirm whether vaccine already received recently.
Age: 1.25
Sex: F
Vaccine: COVID19, FLU4, HIBV, PNC20
Symptoms: Seizure, Status epilepticus
Clinical narrative: Seizure with status epilepticus
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Skin discolouration
Clinical narrative: The patient developed a rash on the right arm where the injection was given.  She said the arm was discolored for over a month.  It was a bruised purple color.  She said it lasted for about a month.  She presented today and her arm had no discoloration.
Age: 0.08
Sex: F
Vaccine: UNK
Symptoms: Intercepted product dispensing error
Clinical narrative: Patient to receive Beyfortus 50 mg/0.5 ml syringe IM, Pharmacy dispensed Beyfortus 100 mg/ml, nurse withdrew Beyfortus 50 mg (0.5 ml) from manufacturer syringe into a new sterile syringe and administered the correct dose.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was incorrectly administered 4 year old vaccines (MMRV and KINRIX) instead of PEDIARIX, HIB, PREVNAR AND ROTAVIRUS.  Thus far, no adverse symptoms.
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Chest X-ray normal, Dyspnoea, Pulmonary function test abnormal
Clinical narrative: He got his vaccine sometime about 6 months ago.  A couple of days later he noticed he was having shortness of breath.  He went to the ER and they did a chest x-ray, and they said that it looked normal and they just sent him home.  The shortness of breath continued and he went to his doctor who said that he looked normal as well.  He was sent for a pulmonary function study and it measured his breathing, and it was very low.   He had the test about 4 months and did not get the results or any treatment for it, The nurse took the test back to the doctor and he did not talk to the doctor.  He has an APT tomorrow for those results.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pain, Secretion discharge
Clinical narrative: He got his vaccine and had some soreness and that was about it.  About 5-7 days later he was having cold symptoms and a sore throat and it got worse and then he called the doctor and he called him in some prescriptions on 12/26/23 of Azithromycin 250 mg 6 tablets, and Benzonate 200 mg capsule.  These medicines did  help his symptoms, and he is now OK.  He had a lot of mucous and today is the first day that he has not coughed up any mucous.   He feels it was related to the vaccine as he had never had a reaction like that to any other vaccines.  He may have had the flu or pneumonia vaccine 30 days prior, but he is not sure which one.
Age: 33.0
Sex: M
Vaccine: FLUA4
Symptoms: Arthralgia, Blood test normal, Dyspnoea, Facial pain, Fatigue
Clinical narrative: My hands and feet get cold. I feel real tired and short of breath. I can't sleep laying down because I feel pressure on my hands. I have pain when I eat chocolate. Pain of my facial bones and joints
Age: 33.0
Sex: M
Vaccine: FLUA4
Symptoms: Limb discomfort, Pain, Peripheral coldness, Sleep disorder
Clinical narrative: My hands and feet get cold. I feel real tired and short of breath. I can't sleep laying down because I feel pressure on my hands. I have pain when I eat chocolate. Pain of my facial bones and joints
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Dysphonia, Dyspnoea, Exposure during pregnancy, Fatigue
Clinical narrative: I was 31 weeks and 6 days pregnant at the time of my vaccination. My due date is 2/14/24. My pregnancy is considered high risk due to my diagnosis of Leiden Factor V and my baby has been found to have a prominent rectum in utero and an umbilical vein varix. 12/19/23 I received the TDap vaccine. 12/23/23 I began having a minor cough and sore throat. 12/25/23 my coughing had progressed into a hoarse cough, severe sore throat, and I have new fatigue and aches. I began to treat my symptoms with cough drops, humidifiers, tea, Dayquil/Nyquil, and/or Mucinex per the approved list by my OB provider. 12/28/23 my coughing had progressed further into severe coughing fits that often led me to vomit or urinate myself. I often could not catch my breath and my cough resembled whooping cough. OTC medications did not help symptoms. I was seen in the clinic again 12/28/23 where I was prescribed budesonide (nebulizer), codeine-guaifenesin, and albuterol (nebulizer). My cough continued with minimal improvement where I was seen again by the clinic on 1/4/24. I then had prednisone 40mg for 5 days prescribed to me. My symptoms have slowly improved following the Prednisone but I do continue to have coughing fits and breathlessness that I continue to treat with the nebulizers.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Oropharyngeal pain, Pain
Clinical narrative: I was 31 weeks and 6 days pregnant at the time of my vaccination. My due date is 2/14/24. My pregnancy is considered high risk due to my diagnosis of Leiden Factor V and my baby has been found to have a prominent rectum in utero and an umbilical vein varix. 12/19/23 I received the TDap vaccine. 12/23/23 I began having a minor cough and sore throat. 12/25/23 my coughing had progressed into a hoarse cough, severe sore throat, and I have new fatigue and aches. I began to treat my symptoms with cough drops, humidifiers, tea, Dayquil/Nyquil, and/or Mucinex per the approved list by my OB provider. 12/28/23 my coughing had progressed further into severe coughing fits that often led me to vomit or urinate myself. I often could not catch my breath and my cough resembled whooping cough. OTC medications did not help symptoms. I was seen in the clinic again 12/28/23 where I was prescribed budesonide (nebulizer), codeine-guaifenesin, and albuterol (nebulizer). My cough continued with minimal improvement where I was seen again by the clinic on 1/4/24. I then had prednisone 40mg for 5 days prescribed to me. My symptoms have slowly improved following the Prednisone but I do continue to have coughing fits and breathlessness that I continue to treat with the nebulizers.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Streptococcus test negative, Urinary incontinence, Vomiting
Clinical narrative: I was 31 weeks and 6 days pregnant at the time of my vaccination. My due date is 2/14/24. My pregnancy is considered high risk due to my diagnosis of Leiden Factor V and my baby has been found to have a prominent rectum in utero and an umbilical vein varix. 12/19/23 I received the TDap vaccine. 12/23/23 I began having a minor cough and sore throat. 12/25/23 my coughing had progressed into a hoarse cough, severe sore throat, and I have new fatigue and aches. I began to treat my symptoms with cough drops, humidifiers, tea, Dayquil/Nyquil, and/or Mucinex per the approved list by my OB provider. 12/28/23 my coughing had progressed further into severe coughing fits that often led me to vomit or urinate myself. I often could not catch my breath and my cough resembled whooping cough. OTC medications did not help symptoms. I was seen in the clinic again 12/28/23 where I was prescribed budesonide (nebulizer), codeine-guaifenesin, and albuterol (nebulizer). My cough continued with minimal improvement where I was seen again by the clinic on 1/4/24. I then had prednisone 40mg for 5 days prescribed to me. My symptoms have slowly improved following the Prednisone but I do continue to have coughing fits and breathlessness that I continue to treat with the nebulizers.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Vaccine Proquad given had expired October 29, 2023.   The patient will return before 28 days for repeat vaccine.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Blood test, Catheterisation cardiac abnormal, Chest pain, Intracardiac thrombus
Clinical narrative: He had gotten his J&J vaccine on 3/26/21 and started with a fever, and then he started having violent vomiting for 2 days.  Then he had to get IV fluids the 2nd night.  They told them that it was just his body reacting to it.  Later when it came time to do the booster they told him to get a different brand.    He then got this vaccine, on the day he got it he was OK, and on 1/3/24 he had a heart attack with a blood clot in his heart diagnosed as a non-ST segment myocardial infarction.  He was having chest pain, was taken to the ER and they did a cardiac catheterization and found the non-ST segment myocardial infarction and transferred to another hospital.  They treated him with medications, and he was discharged home on 1/5/24 towards the evening.  He has restrictions for 20 days ,and is to FU with cardiology to see what has happened.  They put him on 81 mg of aspirin, Lipitor, Lopressor/metoprolol and Pradaxa.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Pyrexia, Vomiting
Clinical narrative: He had gotten his J&J vaccine on 3/26/21 and started with a fever, and then he started having violent vomiting for 2 days.  Then he had to get IV fluids the 2nd night.  They told them that it was just his body reacting to it.  Later when it came time to do the booster they told him to get a different brand.    He then got this vaccine, on the day he got it he was OK, and on 1/3/24 he had a heart attack with a blood clot in his heart diagnosed as a non-ST segment myocardial infarction.  He was having chest pain, was taken to the ER and they did a cardiac catheterization and found the non-ST segment myocardial infarction and transferred to another hospital.  They treated him with medications, and he was discharged home on 1/5/24 towards the evening.  He has restrictions for 20 days ,and is to FU with cardiology to see what has happened.  They put him on 81 mg of aspirin, Lipitor, Lopressor/metoprolol and Pradaxa.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Medical assistant in clinic administered 0.25ml of wrong formulation of Moderna Covid vaccine.  Drew up and administered formulation for 12 years and older to patient that was 9 months old.  Prepared correct AMOUNT of vaccine but from wrong vial.  No harm to patient.  Physician checked on patient and no signs/symptoms.  Will recheck on patient the following day.
Age: 69.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received vaccine on October 19, 2023, but this was not documented in the chart in a timely manner. In the interim, patient was seen on November 22, 2023 and was given the Flu vaccine again. This duplication was found when nurse from the first vaccination documented the Flu vaccines given on October 19, 2023 on December 5, 2023. Patient was contacted regarding the duplication with no adverse events reported to nurse.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, PNC20, RV5
Symptoms: Rash
Clinical narrative: Immunizations received on 01/08/2024. Rash all over body on 01/09/2024 - Note from provider: Mother reports they noticed the rash on her legs and back, this morning. It has since spread to her neck and back of her hair. The patient recently finished a course of amoxicillin. Mother reports she had a diaper rash from the amoxicillin and was using anti-itch cream on it. The patient is otherwise eating and drinking well. The patient is playful and not uncomfortable. No cough or itching. The mother denies any change of detergents or different food. She was uncomfortable prior to her appointment. Parents mentioned that she received a vaccine yesterday. Has not had fever in last 48 hours. She experienced a runny nose previously. The mother sates during her last visit about a week ago, she was found to have some redness in her ear. She was given ibuprofen this morning. Mother states her elder sibling used to get rash around the mouth during teething and also the patient has significant teething at present.
Age: 1.25
Sex: M
Vaccine: HIBV, PNC15
Symptoms: Febrile convulsion, Influenza, Influenza A virus test positive, Pyrexia
Clinical narrative: Received HiB and PCV 15 1/8 in the morning. Developed fever 1/8 at night on same day that vaccines were administered. Was asymptomatic prior to vaccine administration per report. Noted to have febrile seizure that night 1/8 and again 1/9 in AM per report, admitted to hospital for observation. Found to have flu A and became symptomatic with recurrent fevers. Febrile seizure thought more likely related to flu vaccine vs multifactorial (flu and vaccines).
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Syncope
Clinical narrative: Fainting hours later 3 times.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Computerised tomogram, Diarrhoea, Laboratory test
Clinical narrative: Severe stomach cramps and diarrhea from 12/07/23 3am to 12/15/23.
Age: 60.0
Sex: F
Vaccine: COVID19-2, HEPAB, VARZOS, VARZOS
Symptoms: Axillary pain, Oedema peripheral, Skin lesion, Soft tissue disorder, Soft tissue swelling
Clinical narrative: When the Shingrix vaccine was administered, a painful lesion with edema presented on the L axilla on the 2nd day. I put hydrocortisone and cleansed it with (head and shoulder) for the zinc. On the 3rd day the tissue was big and rotten, it was porous and spongy. I went to the pharmacy, and I talked to the one in charge and she told me she would report it to the CDC for a reaction. She didn't tell me what to use and it lasted since October. The lesion became big and expelled a stinky odor. I came back this week and talked to the nurse in charge. She evaluated me and told me it was a reaction, but she was leaving. She took me to the products section, (drinkable soap and talk) and today the 10th of January its worse, and I am very concerned.
Age: 60.0
Sex: F
Vaccine: COVID19-2, HEPAB, VARZOS, VARZOS
Symptoms: Wound complication
Clinical narrative: When the Shingrix vaccine was administered, a painful lesion with edema presented on the L axilla on the 2nd day. I put hydrocortisone and cleansed it with (head and shoulder) for the zinc. On the 3rd day the tissue was big and rotten, it was porous and spongy. I went to the pharmacy, and I talked to the one in charge and she told me she would report it to the CDC for a reaction. She didn't tell me what to use and it lasted since October. The lesion became big and expelled a stinky odor. I came back this week and talked to the nurse in charge. She evaluated me and told me it was a reaction, but she was leaving. She took me to the products section, (drinkable soap and talk) and today the 10th of January its worse, and I am very concerned.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Death
Clinical narrative: Patient passed away the following morning.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: Received a notice on/after January 05, 2023 that the expiry date had been updated by AstraZeneca from 01-Jan-2024, to 25-Dec-2023.
Age: 86.0
Sex: F
Vaccine: UNK
Symptoms: Wrong product administered
Clinical narrative: Gave wrong vaccine
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: Received a notice on/after January 05, 2023 that the expiry date had been updated by AstraZeneca from 01-Jan-2024, to 25-Dec-2023.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: Received a notice on/after January 05, 2023 that the expiry date had been updated by AstraZeneca from 01-Jan-2024, to 25-Dec-2023.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: Received a notice on/after January 05, 2023 that the expiry date had been updated by AstraZeneca from 01-Jan-2024, to 25-Dec-2023.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: Expired vaccine. Received a notice on/after January 05, 2023 that the expiry date had been updated by AstraZeneca from 01-Jan-2024, to 25-Dec-2023.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: Expired vaccine. Received a notice on/after January 05, 2023 that the expiry date had been updated by AstraZeneca from 01-Jan-2024, to 25-Dec-2023.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse events reported to date, but the vaccine was given too soon in regards to the last covid 19 moderna spikevax vaccine which was given 12/22/23.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain in extremity, Rash, Rash erythematous
Clinical narrative: On November 15, I had terrible pain in my left leg.  A red rash appeared on my left thigh the next day, and I was informed I had shingles.  I contracted Shingles within 2 months after I got the Covid shot after getting ALL  the vaccines against Shingles: the first shot and then the series of 2 shots that was supposed to be much more effective.
Age: 14.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: Expired vaccine. Received notice from AstraZeneza on/after 01/05/2024 that FluMist with an expiration date of 01-Jan-2024 had an updated expiry date of 25-Dec-2023.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling Pain Redness at the sight of injection .
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Cough, Feeling abnormal
Clinical narrative: On 1/10/24, patient reports cough that began shortly after getting the vaccine. She also reports "not feeling like herself" since the vaccine.
Age: 38.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Loss of consciousness
Clinical narrative: ABOUT 5 SECONDS AFTER THE SECOND SHOT (fLU) WAS GIVEN, THE PT SLUMPED FORWARD AND PASSED OUT. HE CAME TO IN 3 - 4 SECONDS. THEN 2 MINUTES LATER HE PASSED OUT AGAIN FOR 3 - 4 SECONDS.  WE CALLED 911 FOR AN AMBULANCE BUT THE PATIENT REFUSED TREATMEANT SO THE OPERATOR CANCELLED THE  EMTs.   PATIENTED STATED THAT THIS HAS HAPPENED IN THE PAST AND NOT JUST WITH VACCINES. WE GAVE HIM A BOTTLE OF WATER AND HAD HIM SIT IN THE WAITING ROOM FOR 20 MINUTES.  HE SAID HE WAS FEELING FINE
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Bradycardia, Dizziness, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: After injection, patient turned pale and started shaking, reported feeling faint. This was followed by a syncopal episode in which patient lost consciousness and turned pale and diaphoretic. Started vomiting once he woke up. This lasted about 2 minutes. When he came to he was alert and oriented and aware of what had just happened.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope, Tremor, Vomiting
Clinical narrative: After injection, patient turned pale and started shaking, reported feeling faint. This was followed by a syncopal episode in which patient lost consciousness and turned pale and diaphoretic. Started vomiting once he woke up. This lasted about 2 minutes. When he came to he was alert and oriented and aware of what had just happened.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: HCP called to report a temperature excursion for VARIVAX. Caller reported administering VARIVAX vaccine to two patients post excursion. Temperature Stability case #02530793. Additional AE case # 02531255. No PQC. Permission to contact is No.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history, and concomitant medications were not provided.  On an unknown date, varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# X017485, expiry date: 25-JUN-2025) had a temperature excursion. On 08-JAN-2024, after temperature excursion, the patient was vaccinated with the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (product quantity: 1; dose, route of administration, and anatomical location not provided) as prophylaxis (product storage error).   This is one of 2 reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received the first dose of GARDASIL 9 on 11/29/2021...now patient needs the 3rd dose; No Additional AE reported; This spontaneous report was received from a pharmacist referring to a 19-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On 29-NOV-2021, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis at a pharmacy (concentration, dose, route of administration, lot number and expiration date were not reported). On 26-JUL-2022, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis at a pharmacy (concentration, dose, route of administration, lot number and expiration date were not reported).  The reporter stated that now the patient needed the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), and inquired about when the third dose could be given (inappropriate schedule of product administration). No additional adverse event (AE) was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Nerve injury, Pain, Pain in extremity
Clinical narrative: Knot in left upper arm; Pain in bilateral arms/ pain down to her wrist; Pain that felt like nerve damage; This serious case was reported by a consumer via call center representative and described the occurrence of induration in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of swelling (received 1st Shingrix vaccine in MAY-2023, for the tolerance of previous dose refer case - US2024000677).   In JUL-2023, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On an unknown date, 1 hr after receiving Shingrix, the patient experienced induration (Verbatim: Knot in left upper arm) (serious criteria clinically significant/intervention required), pain in arm (Verbatim: Pain in bilateral arms/ pain down to her wrist) (serious criteria clinically significant/intervention required) and nerve damage (Verbatim: Pain that felt like nerve damage) (serious criteria clinically significant/intervention required). The patient was treated with prednisone, naproxen sodium (Aleve) and ibuprofen. Rechallenge with Shingrix was positive. The outcome of the induration, pain in arm and nerve damage were not resolved.   It was unknown if the reporter considered the induration, pain in arm and nerve damage to be related to Shingrix.     It was unknown if the company considered the induration, pain in arm and nerve damage to be related to Shingrix.   Linked case(s) involving the same patient:  US2024000677   Additional Information: GSK Receipt Date: 03-JAN-2024 and 05-JAN-2024 The patient self-reported this case. The patient received her 2nd dose of Shingrix in the upper left arm and resulted in the same adverse events which were occurred after 1st dose. The reporter went to see her healthcare professional and was prescribed Prednisone 10 mg for 10 days. The reporter stated this medication did help, however it was not resolved. Healthcare professional put the reporter on another round of Prednisone 10 mg for 10 more days and the patient took Aleve and Ibuprofen every 4 hours to help with the pain in both arms that radiate to the wrists this has not resolved. The reporter was presently at her Winter home. The reporter would be returning home in May 2024 and intended to follow up with her healthcare professional. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024000677:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles / Suspected vaccination failure; shingles three times since then; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: shingles / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles three times since then). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 5-JAN-2024 and 6-JAN-2024 The patient self-reported this case. The reporter stated that he/she has had the vaccine and had shingles three times since then. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received his second dose of Shingrix late; 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 65-year-old male patient who received Herpes zoster (Shingrix) (batch number LC757, expiry date 21-AUG-2024) for prophylaxis.   Previously administered products included Shingrix (received first dose on 22nd October 2020.).   On 06-NOV-2023, the patient received the 2nd dose of Shingrix. On 06-NOV-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: The patient received his second dose of Shingrix late). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 08-JAN-2024 The pharmacist reported that a patient (2nd of 2 patients) received his second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. The patient's doctor of medicine was telling him to ignore the first dose and get another dose. The reporter consented to follow up. This 2 of 2 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR004151:1st patient
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypoaesthesia, Product administered at inappropriate site
Clinical narrative: localized reaction of numbness at injection site; erythema at the injection site; The dose was given in the hip instead of the deltoid.; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site numbness in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 34MK3, expiry date 08-JUL-2024) for prophylaxis.   Concurrent medical conditions included anxiety.   On 07-DEC-2023, the patient received the 1st dose of Shingrix. On 07-DEC-2023, an unknown time after receiving Shingrix, the patient experienced vaccine administered at inappropriate site (Verbatim: The dose was given in the hip instead of the deltoid.). On an unknown date, the patient experienced injection site numbness (Verbatim: localized reaction of numbness at injection site) and injection site erythema (Verbatim: erythema at the injection site ). The outcome of the injection site numbness, injection site erythema and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site numbness and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site numbness and injection site erythema to be related to Shingrix.   Additional Information: GSK receipt date: 02-JAN-2024 The nurse practitioner reported a patient experienced a localized reaction of numbness and erythema at the injection site of Shingrix.  The reporter described numbness as scattered. Upon examination the patient could felt almost everything done by the HCP.  Due to these events reporter noted the patient was anxious about getting dose two of the series. The dose was given in the hip instead of the deltoid, which led to vaccine administered at inappropriate site. The reporter consented to follow up.
Age: 0.17
Sex: M
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered a Priorix dose to a 2 month old patient back; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received MMR (Priorix) (batch number 4R2PM, expiry date 21-DEC-2025) for prophylaxis.   On 19-DEC-2023, the patient received Priorix (lt. vastus lateralis). On 19-DEC-2023, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: administered a Priorix dose to a 2 month old patient back). The outcome of the inappropriate age at vaccine administration 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: 04-JAN-2024 The medical assistant (MA) reported that they inadvertently administered a Priorix dose to a 2-month-old patient, which led to an inappropriate age at vaccine administration. The reporter called to inquire, what to look for and how to proceed with patient. The reporter consent to follow up.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Pain has moved to left arm as well/ Pain in right arm from injection site down to fingertips; Feels like needles going down right/Feels like pins going down right arm/tingling; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-NOV-2023, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). On 28-NOV-2023, 30 min after receiving Shingrix, the patient experienced pain in arm (Verbatim: Pain has moved to left arm as well/ Pain in right arm from injection site down to fingertips) and paresthesia (Verbatim: Feels like needles going down right/Feels like pins going down right arm/tingling). The outcome of the pain in arm and paresthesia were not resolved.   It was unknown if the reporter considered the pain in arm and paresthesia to be related to Shingrix.     It was unknown if the company considered the pain in arm and paresthesia to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JAN-2024 The patient self-reported this case. The reporter called stating he received 1st dose of Shingrix vaccine and started feeling pain, tingling, like pins sticking his right arm. The adverse events has not resolved. The patient also stated while talking on the phone his left arm was tingling as well. Healthcare professional had been told and wanted the patient to wait a little while to see it goes away. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Extensive swelling of vaccinated limb, Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: swelling became the size of a baseball/left arm was swollen; the injection burned/Pain at injection site/arm sore to touch; redness at injection site/left arm was red; This non-serious case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 64-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 03-JAN-2024, the patient received Arexvy (left arm). On 03-JAN-2024, less than a day after receiving Arexvy, the patient experienced extensive swelling of vaccinated limb (Verbatim: swelling became the size of a baseball/left arm was swollen), pain in arm (Verbatim: the injection burned/Pain at injection site/arm sore to touch) and erythema of extremities (Verbatim: redness at injection site/left arm was red). The outcome of the extensive swelling of vaccinated limb and erythema of extremities were resolving and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, pain in arm and erythema of extremities to be related to Arexvy.     It was unknown if the company considered the extensive swelling of vaccinated limb, pain in arm and erythema of extremities to be related to Arexvy.   Additional Information: GSK receipt date: 08-JAN-2024 The patient received AREXVY and stated that the injection burned as it went in.  When she got home she stated her left arm was swollen, red and painful.  The next day the swelling became the size of a baseball.  She stated that the swelling and redness had mostly came down and her arm was still sore to the touch.  Spoke per PI, mailing PI.  Referred to health care professional (HCP), phone number provided. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: that a few patients may have had one dose of Shingrix without receiving a second dose 2-6 months later; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had received one dose of Shingrix).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: that a few patients may have had one dose of Shingrix without receiving a second dose 2-6 months later). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 08-JAN-2024 Pharmacist chatted in to request medical information on behalf of a nurse in a long term care facility who had several elderly patients that thought they might had a zoster vaccine in the past. The nurse was trying to obtain histories, but the thought was the vaccine was Zostavax, however it was a possibility that a few patients might had one dose of Shingrix without receiving a second dose 2 to 6 months later. This had not yet been confirmed, the nurse was still in the process of trying to obtain the correct vaccine history. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch); Mild injection site redness; Mild fatigue and no interference with activity; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness) and FATIGUE (Mild fatigue and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness) and FATIGUE (Mild fatigue and no interference with activity). At the time of the report, VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness) and FATIGUE (Mild fatigue and no interference with activity) outcome was unknown.            RTI-HS Subject ID was reported as 92851-55682 and AutoCruitment Subject ID was reported as 5472683.  Concomitant medications were not reported.   It was reported that worst pain, tenderness, redness and worst intensity of fatigue experienced anytime during the 2 days after the COVID-19 vaccination, which occurred on Wednesday, Dec 20, 2023 and Thursday, Dec 21, 2023 was recorded.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-756004 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756004:same reporter
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain Barre) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031283) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .25 milliliter. On 31-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 13-Nov-2023 to sometime in December 2023 due to GUILLAIN-BARRE SYNDROME. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain Barre) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication and treatment information was not reported.  Patient had weakness and paralysis in Calf muscle and quads. She was unable to walk without aid (use AFO braces). Her legs are weak and she unable to climb stairs. Also have short amount of time that she can walk. Her hands have also been affected. They are weak and uncoordinated. She was hospitalized for 3 weeks beginning 13 Nov 2023 at Hospital. She received IViG treatment. PT and OT continue. It is unknown if the patient experienced any additional symptoms/events.  Company Comment This is an spontaneous case concerning a 73-years-old female patient with no medical history reported who experienced the seriousness criteria medically significant and hospitalization unexpected AESI of Guillain-Barre syndrome 14 days after a dose of mRNA-1273.815 vaccine. Concomitant medication nor Treatment details were reported. Patient had weakness and paralysis in Calf muscle and quads. She was unable to walk without aid.  At the time of the report, the event had not resolved. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that patient and his wife had Moderna's COVID vaccine since it was first introduced. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-755956 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-755956:Wife Case
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: chills; joint pain; muscle pain; fever; tiredness; headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), PYREXIA (fever) and FATIGUE (tiredness) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jan-2024, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On an unknown date, the patient experienced CHILLS (chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), PYREXIA (fever), FATIGUE (tiredness) and HEADACHE (headaches). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), PYREXIA (fever), FATIGUE (tiredness) and HEADACHE (headaches) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.   She had received an initial dose of the Moderna Vaccine in JAN 2021, a second dose in MAY 2021, an additional dose the next year (2022).  She had not received any other vaccines in the 4 weeks prior to the most recent covid-19 vaccine.   This case was linked to MOD-2024-756116 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; joint pain; muscle pain; fever; tiredness; headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), PYREXIA (fever) and FATIGUE (tiredness) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jan-2024, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On an unknown date, the patient experienced CHILLS (chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), PYREXIA (fever), FATIGUE (tiredness) and HEADACHE (headaches). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), PYREXIA (fever), FATIGUE (tiredness) and HEADACHE (headaches) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.   She had received an initial dose of the Moderna Vaccine in JAN 2021, a second dose in MAY 2021, an additional dose the next year (2022).  She had not received any other vaccines in the 4 weeks prior to the most recent covid-19 vaccine.   This case was linked to MOD-2024-756116 (Patient Link).