chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: Patient does have a history of osteoarthritis in bilateral shoulders, left worse than right.  However, she also reports new onset worsening shoulder pain and stiffness since she had her COVID and flu injections in September We did discuss the diagnosis of SIRVA, and she also meets the diagnostic criteria for this diagnosis She does find that at home range of motion exercises offer some benefit, but this is not sustained Will refer to PT, f/u in 10wks
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: PT CAME TO PHARMACY IN PERSON ON 12/9/24 AND STATED THE DAY AFTER HER VACCINES (ON 12/8/24 SHE NOTICED THESE SYMTOMS) SHE EXPERIENCED HIVES AND ITCHINESS ALL OVER HER BODY. SHE STATED SHE TOOK BENADRYL WHICH HELPED SOMEWHAT BUT FELT IT NECESSARY TO GO TO THE URGENT CARE. THE URGENT CARE GAVE HER A CORTISONE SHOT. PT REPORTED TO STILL HAVE HIVES AND ITCHINESS BUT STATED IT WAS GETTING BETTER. WE EDUCATED PT TO KEEP AN EYE ON SYMPTOMS AND TO SEEK MEDICAL ATTENTION IF THEY GET WORSE. PT STATED SHE HAS ALREADY NOTIFIED HER PRIMARY CARE PROVIDER. PHARMACY TEAM VERIFIED THESE WERE THE SAME MANUFACTURES SHE RECEIVED LAST TIME FOR BOTH FLU AND COVID. SHE DID NOT HAVE ANY ADVERSE REACTIONS AFTER THAT ADMINISTRATION IN 2/2024
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under 65 was administered High Dose Influenza
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: PATIENT HAD REDNESS AND PAIN AT INJECTION SITE - PAIN TO TOUCH - HOT AT SITE
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient was given Covid 2023-2024 vaccine after the recommended beyond use date before we had Covid 2024-2025 vaccine available. Patient denied any symptoms and refused to have revaccination with current formulary.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient was given Covid 2023-2024 vaccine after the recommended beyond use date before we had Covid 2024-2025 vaccine available. Patient denied any symptoms and refused to have revaccination with current formulary.
Age: 40.0
Sex: M
Vaccine: COVID19, HEP, IPV, MMR, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient was given Covid 2023-2024 vaccine after the recommended beyond use date before we had Covid 2024-2025 vaccine available. Patient denied any symptoms and refused to have revaccination with current formulary.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event
Clinical narrative: no adverse reaction
Age: 83.0
Sex: M
Vaccine: COVID19, HEP, IPV, MMR, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient was given Covid 2023-2024 vaccine after the recommended beyond use date before we had Covid 2024-2025 vaccine available. Patient denied any symptoms and refused to have revaccination with current formulary.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Injection site pain
Clinical narrative: Stomach pains, diarrhea, fatigue, and administration site is sore to the touch 5 days after
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Asthenia, Blood test, Chest X-ray normal, Chest discomfort
Clinical narrative: pts arm became very sore. He took advil and put ice pack on it. His arm hurt worse than it has ever hurt after any other vaccine in his past.  His throat became sore and then had tightness in his throat and chest. His eyes became very red and watery. He became weak and had to go to the ER. He had an EKG. He was examined for hives and a rash but he did not have one.  He was diagnosed as having a  anaphylaxis reaction. He was given decadron, benadryl, and pepcid. His chest xray was negative and he had blood work. He was released to go home after 5 hours. He was prescibed prednisone and told to take benadryl. He contacted his PCP next day to make FU appt but to return to ER if needed. It took about 5 days to feel about to normal.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram, Lacrimation increased, Ocular hyperaemia, Oropharyngeal pain, Pain in extremity
Clinical narrative: pts arm became very sore. He took advil and put ice pack on it. His arm hurt worse than it has ever hurt after any other vaccine in his past.  His throat became sore and then had tightness in his throat and chest. His eyes became very red and watery. He became weak and had to go to the ER. He had an EKG. He was examined for hives and a rash but he did not have one.  He was diagnosed as having a  anaphylaxis reaction. He was given decadron, benadryl, and pepcid. His chest xray was negative and he had blood work. He was released to go home after 5 hours. He was prescibed prednisone and told to take benadryl. He contacted his PCP next day to make FU appt but to return to ER if needed. It took about 5 days to feel about to normal.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: pts arm became very sore. He took advil and put ice pack on it. His arm hurt worse than it has ever hurt after any other vaccine in his past.  His throat became sore and then had tightness in his throat and chest. His eyes became very red and watery. He became weak and had to go to the ER. He had an EKG. He was examined for hives and a rash but he did not have one.  He was diagnosed as having a  anaphylaxis reaction. He was given decadron, benadryl, and pepcid. His chest xray was negative and he had blood work. He was released to go home after 5 hours. He was prescibed prednisone and told to take benadryl. He contacted his PCP next day to make FU appt but to return to ER if needed. It took about 5 days to feel about to normal.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: site swollen, warm to touch,  Patient states she has applied warm compress but is still tender and painful  to touch
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Burning sensation, Haemorrhoids, Laboratory test
Clinical narrative: After receiving the vaccine, I began experiencing a burning sensation in my left leg, which the doctors couldn?t explain. I also developed hemorrhoids. A few years later, in 2024, I had a heart attack diagnosed as an ST elevation (STEMI) myocardial infarction involving the left main coronary artery, and again, none of the doctors could provide an explanation for this.
Age: 74.0
Sex: F
Vaccine: COVID19, HEP, IPV, MMR, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient was given Covid 2023-2024 vaccine after the recommended beyond use date before we had Covid 2024-2025 vaccine available. Patient denied any symptoms and refused to have revaccination with current formulary.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dehydration, Myalgia
Clinical narrative: Extreme muscular pain in legs. Dehydration. Stomach pain. The symptoms lasted 24 hours.
Age: 47.0
Sex: M
Vaccine: COVID19, HEP, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient was given Covid 2023-2024 vaccine after the recommended beyond use date before we had Covid 2024-2025 vaccine available. Patient denied any symptoms and refused to have revaccination with current formulary.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Received flu vaccine in the morning of 12/6/24. On 12/7/24 around 5pm, patient got itchy on her abdomen, and she scratched area, and it became red.  Around 10 or 11pm, she noticed she had bumps on her abdomen, upper chest, and back. She states bumps were itchy and it was red. She put baby location on areas, and it helped and then it became itchy again. She then put on a cream but cannot recall the name, but states it was for rash and burns and it helped. She reports that it is still itching and still has the bumps on her abdomen, upper chest, and back areas.
Age: 1.58
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is 20 months old and was administered Alfuria Influenza vaccine that is intended for individuals that are older than 3 years of age. Patient had no adverse reactions to the vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: firm, swollen area on outer aspect left thigh approximately 5 inches long, 3 inches wide, with 2 inch red area at site of injection
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called regarding T/E for VAXNUEVANCE, and GARDASIL-9. HCP reported that this T/E was previously reported with case number #02649671, however the incorrect time was provided. Outcome for GARDASIL-9 was no longer supported and HCP mentioned that th; This spontaneous report was received from nurse practitioner and refers to a patients of unkown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #X024251, expiration date: 15-MAY-2026, administered for prophylaxis (strength, and route of administration were not provided); and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #1965035, expiration date: 20-SEP-2025, administered for prophylaxis (strength, and route of administration were not provided). Those vaccines underwent temperature excursion from 01-AUG-2024 to 05-AUG-2024, in 60.4 Farenheit for 86 hours 35 minutes (Product storage error). No additional adverse event was reported.  This ia s non-valid case due to lack of patients identifiers.  Follow-up information has been received on 02-DEC-2024:  This spontaneous report was received from a Nurse Practitioner refers to a 12-year-old male patient.      On 20-AUG-2024, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), formulation: injection, lot # 1965035, expiration date 20-SEP-2025, 0.5 milliliter in the left deltoid (route of administration was not provided) for prophylaxis.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse event was reported; A FBE called on behalf of an HCP (not on the line) to report an AE for MMR II (lot: W030848 expiration: 09/27/2024).  The expired dose of MMR II was inadvertently administered by a nurse on 10/03/2024 to a female patient (date of birth: 09/11/2022) w; This spontaneous report was received from physician and refers to a 2-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown), varicella virus vaccine live (oka/merck) (VARIVAX) (manufacturer unknown), hepatitis a vaccine (+) inactivated (VAQTA) (manufacturer unknown) and hepatitis a vaccine (+) inactivated (VAQTA SYRINGE (DEVICE)) (manufacturer unknown).   On 03-OCT-2024, the patient was vaccinated with first dose of expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, lot #W030848, expiration date: 27-SEP-2024, administered for prophylaxis on right leg(strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
Age: 61.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Caller stated no patient symptoms have been reported/ no additional AE; an expired dose of PNEUMOVAX 23 was inadvertently administered to a patient; This spontaneous report was received from HBP and refers to a 61-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 03-DEC-2024, the patient was inadvertently vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (Expired product administered), 1 dose, lot #X018278, expiration date: 24-NOV-2024, administered for prophylaxis (strength, and route of administration were not provided). No patient's symptoms were reported. Caller stated product was never involved in a temperature excursion. No additional adverse events.
Age: 61.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no side effects have been reported; inadvertently expired PNEUMOVAX 23 (PFS) was administered to a patient on 11/27/2024.; This spontaneous report was received from a medical assistant, who was also the office manager, referring to a 61-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 27-NOV-2024, the patient was inadvertently vaccinated with expired pneumococcal 23v polysaccharide vaccine (PNEUMOVAX 23) injection (one dose, lot#: X018278, expiration date: 24-NOV-2024; strength, exact dose, and route of administration were not reported) for prophylaxis by a healthcare professional (HCP) (expired product administered). No temperature excursion (T/E) occurred. No side effects or additional adverse events (AE) were reported (no adverse event).
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called regarding T/E for VAXNUEVANCE, and GARDASIL-9. HCP reported that this T/E was previously reported with case number #02649671, however the incorrect time was provided. Outcome for GARDASIL-9 was no longer supported and HCP mentioned that th; This spontaneous report was received from a Nurse Practitioner and refers to a 19-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-AUG-2024, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection, lot #1965035, expiration date: 20-SEP-2025, 0.5 milliliter, administered in the left deltoid for prophylaxis (route of administration were not provided).   Administered dose was exposed to temperature excursion from 01-AUG-2024 to 05-AUG-2024, of 60.4 degrees Fahrenheit for 86 hours and 35 minutes (product storage error). No additional adverse event was reported (no adverse event).
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called regarding T/E for VAXNUEVANCE, and GARDASIL-9. HCP reported that this T/E was previously reported with case number, however the incorrect time was provided. Outcome for GARDASIL-9 was no longer supported and HCP mentioned that th; This spontaneous report was received from a Nurse Practitioner and refers to a 14-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-AUG-2024, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection, lot # X024251, expiration date: 15-MAY-2026, 0.5 milliliter, administered in the left deltoid for prophylaxis (route of administration were not provided).   Administered dose was exposed to temperature excursion from 01-AUG-2024 to 05-AUG-2024, of 60.4 degrees Fahrenheit for 86 hours and 35 minutes (product storage error). No additional adverse event was reported (no adverse event).
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: the patient was febrile after the vaccinations and had a fever of 102.7 degrees Fahrenheit; This spontaneous report was received from a physician and refers to a 14-month-old male patient. The reporter provided limited pertinent information and demographic data.  The patient's medical history, concurrent conditions and concomitant therapies were not reported. The physician reported that the patient was afebrile before the vaccines were administered to the patient.  On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection; with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection; and with a dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, all administered for prophylaxis (dose, lot #, expiry date, and route of administration were not provided). After the vaccines were administered to the patient, the patient's temperature was checked before leaving.  On an unknown date, the patient was febrile after the vaccinations and had a fever of 102.7 degrees Fahrenheit (pyrexia). No additional adverse event (AE) and no product quality complaint (PQC) was reported. The outcome of pyrexia was not provided.  The causal relationship between pyrexia and the suspect vaccines was not reported.  Lot # is being requested and will be submitted if received.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported as of now.; reconstituted a PEDVAXHIB Vaccine with the Merck Sterile Diluent and it was administered to a 4 month old patient; This spontaneous report has been received from a medical assistant, referring to a 4-month-old patient of an unknown gender. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not reported.  On 02-DEC-2024, the patient was vaccinated with the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot# X020943, expiry date 06-MAR-2026, administered for prophylaxis (dose, route of administration and anatomical location were not reported), inadvertently reconstituted with sterile diluent (MERCK STERILE DILUENT), lot# 2031282, expiry date 15-JAN-2027 (dose, route of administration and anatomical location were not reported) (product preparation error). Full amount was administered to the patient. No symptoms reported (no adverse event).
Age: 69.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Expired product administered, Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Vaqta that expired on 01-OCT-20224 administered; Extra dose administereed on 05-DEC-2024; VAQTA dose first dose administered on 03-JUN-2024 and 2nd dose on 08-AUG-2024; This spontaneous report was received from a medical assistant referring to a 70-year-old male patient.   No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 03-JUN-2024 and 08-AUG-2024, the patient was respectively vaccinated with the first and second dose of with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of vaccine administered), it was noted that vaccine second dose was administered too early. On 05-DEC-2024, the patient was vaccinated with the third dose (Extra dose administered) of with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #X006702, that expired on 01-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) (Expired vaccine used).  No adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Respiration abnormal
Clinical narrative: Cough resembling asthma; Abnormal breathing; This non-serious case was reported by a consumer and described the occurrence of cough resembling asthma in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included zolpidem tartrate (Ambien), baclofen, gabapentin and ibuprofen (Advil).   On 07-NOV-2024, the patient received Shingrix. On 08-NOV-2024, 1 days after receiving Shingrix, the patient experienced cough resembling asthma (Verbatim: Cough resembling asthma) and abnormal breathing (Verbatim: Abnormal breathing). The outcome of the cough resembling asthma and abnormal breathing were not resolved.   It was unknown if the reporter considered the cough resembling asthma and abnormal breathing to be related to Shingrix.     It was unknown if the company considered the cough resembling asthma and abnormal breathing to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-NOV-2024 The patient had Cough resembling asthma and Abnormal breathing. The patient stated that as the air cooled it seemed to bet worse. The inhaler had helped some will increase Benadryl. The patient stated that she was drinking water all day.  The reporter stated that it felt horrible.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Pain in arm; Fever; fatigue; This non-serious case was reported by a consumer via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Pain in arm), fever (Verbatim: Fever) and fatigue (Verbatim: fatigue). The outcome of the pain in arm, fever and fatigue were resolved.   The reporter considered the pain in arm, fever and fatigue to be related to Shingrix.     The company considered the pain in arm, fever and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-NOV-2024 Patient had fatigue, pain in arm, fever. Patient said she did not consider an adverse event, but following guidelines by reporting after she stated the side effects were terrible.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache
Clinical narrative: extreme headache/headache was sever/headache as almost like meningitis or enchphalitis type of headache; feeling badly from 1 day after the vaccination; This non-serious case was reported by a physician via sales rep and described the occurrence of headache in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: extreme headache/headache was sever/headache as almost like meningitis or enchphalitis type of headache) and feeling bad (Verbatim: feeling badly from 1 day after the vaccination). The outcome of the headache and feeling bad were not reported.   It was unknown if the reporter considered the headache and feeling bad to be related to Shingrix.     It was unknown if the company considered the headache and feeling bad to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-NOV-2024 The physician himself was the patient. He explained that after receiving his own first dose of Shingrix vaccination, he experienced extreme headache and feeling badly from 1 day after the vaccination until 6 days later. He indicated the headache was sever. He described the headache as almost like meningitis or encephalitis type of headache. He did not experience either of those diagnosis. He used those words to emphasize the severity of the headache.
Sex: U
Vaccine: FLUX, HEP
Symptoms: Bite, Pruritus, Swelling face, Urticaria
Clinical narrative: face swelling; developed hives. Up and down my legs, my back, abdomen, arms; bite marks on my legs; began having itchy skin, palms, feet, back; This non-serious case was reported by a consumer and described the occurrence of hives in a patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   On 17-SEP-2024, the patient received the 3rd dose of Hepatitis B vaccine. On an unknown date, the patient received Influenza vaccine. On 19-SEP-2024, 2 days after receiving Hepatitis B vaccine, the patient experienced itchy skin (Verbatim: began having itchy skin, palms, feet, back). On 21-SEP-2024, the patient experienced bite (Verbatim: bite marks on my legs). On 28-SEP-2024, the patient experienced hives (Verbatim: developed hives. Up and down my legs, my back, abdomen, arms). On an unknown date, the patient experienced facial swelling (Verbatim: face swelling). The patient was treated with prednisone, epinephrine and omalizumab (Xolair). The outcome of the hives, itchy skin, bite and facial swelling were resolved.   It was unknown if the reporter considered the hives, itchy skin, bite and facial swelling to be related to Hepatitis B vaccine.     It was unknown if the company considered the hives, itchy skin, bite and facial swelling to be related to Hepatitis B vaccine.   Additional Information: GSK Receipt Date-09-NOV-2024 The consumer reported that he/she received third Hep B booster shot on 17th September 2024. By the 19th of September the patient began having itchy skin, palms, feet, back. By the 21st, the patient developed what appeared to be bite marks on my legs. This had the patient washing everything, from bedding to clothing. By the 28th, the patient had developed hives, up and down his/her legs, her back, abdomen, arms. Fast forward another week, as some hives would ease while more replaced them. The patient have had 2 trips to the emergency department for hives, the latter had the patient face swelled and the patient was given a second dose of prednisone and steroid cream. The hives finally resolved after two days of a swollen face, 7 weeks of uncontrollable itches, and new prescription of epinephrine. The patient also have begun receiving a monthly dose of Xolair, courtesy of an unknown reaction to his/her Hep B and Flu vaccines. The patient would be happy to find out what the Hep B inoculation was cultured in. If the patient were given a guess, the patient would had to say that it may have been albumin. Please, the patient would like to know what could have been fatal. The patient did know that the patient may be the 1 in 1 million, but the patient believe that the risk of Xolair was also anaphylactic shock as well. It was unknown if the reporter considered the hives, itchy skin, bite and facial swelling to be related to Influenza vaccine.
Sex: U
Vaccine: RSV
Symptoms: Malaise
Clinical narrative: I am still sick today; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced sickness (Verbatim: I am still sick today). The outcome of the sickness was not resolved.   It was unknown if the reporter considered the sickness to be related to Arexvy.     It was unknown if the company considered the sickness to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-NOV-2024  The case was received from the patient via (Open field AE monitoring) interactive digital media. The patient self reported this case for himself/herself. The patient reported that he/she was still sick on the day of reporting for the third time after the shot.
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a elderly male patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included renal failure, cholelithiasis, dialysis, pneumonia, gallbladder removal and gallstones. Previously administered products included Ultomiris.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced pain in arm (Verbatim: Pain in arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 09-NOV-2024 The patient reported that after his Bexsero vaccine he felt like he was shot in his left arm and had pain in extremity) for three weeks.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; I had my vaccinations and still got it in my arm; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had my vaccinations and still got it in my arm). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-DEC-2024 This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available. Patient had vaccinations and experienced Shingles in arm. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not get 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received first dose in 2019).   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: did not get 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-DEC-2024 Patient had 1st Shingrix dose in 2019, but did not get 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: rash near the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-JUN-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: rash near the injection site). The outcome of the rash was not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-NOV-2024 The pharmacist reported that a patient received Shingrix vaccine and got the rash near to the injection site that had not resolved. Later in the call the patient could be heard in the background of the pharmacy stating the rash from the first dose did improve, but did not completely resolve.  Pharmacist then states the first dose was given about two months before the second dose. The pharmacist and patient both mentioned an food drug and administration study, which the patient found online, that showed if a rash occurred there were two types, one where rash occurred and resolved in 5 days, and one where the rash was not immediate, but ultimately within 10 to15 days, and then it spread to other parts of body.  The study indicated for that group that if you got that type of rash, they said it was vaccine failure.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient got covid/ but she was pretty sick for a week or so; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient got covid/ but she was pretty sick for a week or so) in a 68-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 20-Mar-2024, the patient experienced COVID-19 (Patient got covid/ but she was pretty sick for a week or so). In 2024, COVID-19 (Patient got covid/ but she was pretty sick for a week or so) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported.  Patient got COVID and did not require hospitalization, but she was pretty sick for a week or so.  Patient already had the other Moderna vaccinations for that as well, whenever that vaccination took place.  No treatment medication was reported.   This case was linked to MOD-2024-778754 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: very severe pain in my back/it feels like it's on the right side of my back, like my lower back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (very severe pain in my back/it feels like it's on the right side of my back, like my lower back) in an 80-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043152) for COVID-19 prophylaxis.     The patient's past medical history included Back pain and Arthritis. Previously administered products included for Product used for unknown indication: Flu vaccine on 26-Sep-2024; for Back pain: Advil. Past adverse reactions to the above products included No adverse effect with Advil and Flu vaccine.    On 15-Oct-2024, the patient received first dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In October 2024, the patient experienced BACK PAIN (very severe pain in my back/it feels like it's on the right side of my back, like my lower back). The patient was treated with Gabapentin for Back pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (very severe pain in my back/it feels like it's on the right side of my back, like my lower back) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Patient had a Moderna vaccine and since then he had very severe pain in his back. The patient got up out of bed, it was excruciating and could almost scream. Patient went to the doctor and had a CAT scan done and reported that could be sore for two days or so, that's normal, but the back pain started about 2 weeks, maybe at least 2 weeks to 10 days after the vaccine.   The patient did not know if it was on the right side of his back, like his lower back, and something came up to the middle back, he screamed, it was like somebody was squeezing his muscles from the back. The doctor told the pain could be coming from a facet joint. He never had pain like this in his back. If the patient got pain in my back, he knew that it lasted a few days, and it was in the center of the back and sed to put some ice on and took some Advil, and it went away. He reported that he never had epidural injections.   The patient went for a T spine CAT scan and the doctor gave him gabapentin to take, but patient had taken it for a week so far, and had not done anything, he wished to take the stuff, it would alleviate the pain, but the pain was excruciating like somebody took a spear or a knife and stabbed.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Maternal exposure during pregnancy
Clinical narrative: she developed an extremely itchy, large, red, painful rash along with a fever and she was diagnosed with cellulitis; she's 14 weeks pregnant and she received the booster last December 1st 2024; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of CELLULITIS (she developed an extremely itchy, large, red, painful rash along with a fever and she was diagnosed with cellulitis) and MATERNAL EXPOSURE DURING PREGNANCY (she's 14 weeks pregnant and she received the booster last December 1st 2024) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 01-Dec-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (she's 14 weeks pregnant and she received the booster last December 1st 2024). On an unknown date, the patient experienced CELLULITIS (she developed an extremely itchy, large, red, painful rash along with a fever and she was diagnosed with cellulitis). On 01-Dec-2024, MATERNAL EXPOSURE DURING PREGNANCY (she's 14 weeks pregnant and she received the booster last December 1st 2024) had resolved. At the time of the report, CELLULITIS (she developed an extremely itchy, large, red, painful rash along with a fever and she was diagnosed with cellulitis) was resolving.    Company comment: This case spontaneous concerns a 14 weeks pregnant woman of an unknown age who experienced non serious event of cellulitis and maternal exposure during pregnancy. The event of cellulitis is assessed as related to vaccination due to close temporal association. Maternal exposure during pregnancy is assessed as not applicable. The benefit-risk relationship of product is not affected by this report        she was prescribed antibiotics for cellulitis. No concomitant medications were reported.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a Consumer or other non HCP.  A 13-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 13 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Dec2024, outcome "recovered" (Dec2024), described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient did not receive any other vaccines on the same date as the vaccine(s) for which you are reporting. The patient was taking any other medications within 2 weeks of the event starting. Sore arm. Reporter was a Pfizer employee and awareness date was yesterday 02Dec2024. Reporter couldn't get the Pfizer AE report to work so reporting it here. Patient received Flu as a concomitant drug.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: an increased pain at the injection site; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "an increased pain at the injection site".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: RSV
Symptoms: Aortic valve disease, Cardiac failure congestive, Cardiac murmur, Coronary artery disease, Tachyarrhythmia
Clinical narrative: congestive heart failure; aortic valve disease; coronary artery disease; central tactica rythmia; murmur; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male (age: 77, unknown unit) patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CAVERTA (ongoing). The following information was reported: CARDIAC FAILURE CONGESTIVE (medically significant), outcome "unknown", described as "congestive heart failure"; AORTIC VALVE DISEASE (non-serious), outcome "unknown"; CORONARY ARTERY DISEASE (non-serious), outcome "unknown"; TACHYARRHYTHMIA (non-serious), outcome "unknown", described as "central tactica rythmia"; CARDIAC MURMUR (non-serious), outcome "unknown", described as "murmur".  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV
Symptoms: Hypoaesthesia
Clinical narrative: she has numbness in different areas, all of the same side where she got the vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1; single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "she has numbness in different areas, all of the same side where she got the vaccine". Additional information: Caller's mom got her RSV vaccine and she has numbness in different areas, all of the same side where she got the vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 1.5
Sex: M
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: vaccine was not mixed with the provided diluent but mixed in error with sterile water with no reported adverse event; Initial information received on 04-Dec-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 18 months old male patient received HIB (PRP/T) VACCINE [ACT-HIB] vaccine, was not mixed with the provided diluent but mixed in error with sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Nov-2024, the patient received 0.5 ml of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot UJ996AA expiry 31-Mar-2025) (strength: unknown) was not mixed with the provided diluent but mixed in error with sterile water with no reported adverse event (product preparation error) (latency same day) via unknown route in the left thigh for immunization.  Reporter wants to know: if the dose needs to be repeated then how soon can the correct dose be given   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Chills, Malaise, Nausea, Overdose, Pyrexia
Clinical narrative: Overdose/pediatric patient receiving an adult dose (0.5 mL dose) instead of pediatric (0.25 mL dose); WRONG PRODUCT ADMINISTERED (pediatric patient receiving an adult dose); Chills; Low-grade fever; MALAISE; NAUSEA; This spontaneous case from United States, initially received on 21-Nov-2024, was reported by a health professional and concerns a patient of unknown age/gender.  Medical history information and concomitant medication was reported as unknown. No allergy information was reported.  No Associated Product Quality Complaint and/or Device Issue.  Administration of company suspect drug: On 02-Nov-2024, the patient received Afluria (TIV) for Not reported., Dos regimen: Not reported, Route of administration: Intramuscular, Lot number: AW1671A (batch number reported as AW1671A, CSL Seqirus Batch number unable to be matched)  Non-company suspect drugs: Spikevax (Elasomeran), Indication: covid-19 prophylaxis. Dose regimen: 0.5 milliliter, Lot number: 3043501.  Adverse reactions/events and outcomes: On 02-Nov-2024, the patient experienced Chills (outcome: Recovered / Resolved, stop date: 04-Nov-2024), Low-grade fever (outcome: Recovered / Resolved, stop date: 04-Nov-2024), MALAISE (outcome: Recovered / Resolved, stop date: 04-Nov-2024), NAUSEA (outcome: Recovered / Resolved, stop date: 04-Nov-2024). On 02-Nov-2024 05:00, the patient experienced Overdose/pediatric patient receiving an adult dose (0.5 mL dose) instead of pediatric (0.25 mL dose) (outcome: Recovered / Resolved, stop date: 20-Nov-2024), WRONG PRODUCT ADMINISTERED (pediatric patient receiving an adult dose) (outcome: Recovered / Resolved, stop date: 20-Nov-2024).  Afluria (TIV) action taken: Not Applicable  Reporter Assessment: The reporter considered all the events as non serious and causality was not reported.; Reporter's Comments: All the events considered related to the administration of Afluria (TIV) except Company causality not related for the events Wrong product administered and overdose.