chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Neck pain, Neuralgia, Pain in extremity, Paraesthesia, Sensory loss
Clinical narrative: Initially, the day after injections, I was unable to stand up; I couldn't grasp with my hands to pull myself up. Eventually, I was able to stand up and walk unsteadily with the use of a cane. Severe aches and pains in neck, shoulders, and legs. Lack of sensation in both feet. Numbness and tingling in both lower legs, including knees.  Nerve pain in both hands.  By the 4th day, my ability to stand had improved. The remaining symptoms have lasted up to and including today, 12/18/23.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Walking aid user
Clinical narrative: Initially, the day after injections, I was unable to stand up; I couldn't grasp with my hands to pull myself up. Eventually, I was able to stand up and walk unsteadily with the use of a cane. Severe aches and pains in neck, shoulders, and legs. Lack of sensation in both feet. Numbness and tingling in both lower legs, including knees.  Nerve pain in both hands.  By the 4th day, my ability to stand had improved. The remaining symptoms have lasted up to and including today, 12/18/23.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Aphasia, Asthenia, CSF test normal, Electroencephalogram abnormal, Encephalitis
Clinical narrative: Altered mental status and transient weakness with MRI findings of encephalitis. She was brought to the ER on 12/2/23 and subsequently hospitalized. She had presented with altered mental status and word finding difficulties for several weeks. On the day of her presentation  to the ER, she was very weak and noted to have a right sided gaze deviation and right sided weakness..
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Enterovirus test negative, Gaze palsy, Hemiparesis, Herpes simplex test negative, Magnetic resonance imaging head abnormal
Clinical narrative: Altered mental status and transient weakness with MRI findings of encephalitis. She was brought to the ER on 12/2/23 and subsequently hospitalized. She had presented with altered mental status and word finding difficulties for several weeks. On the day of her presentation  to the ER, she was very weak and noted to have a right sided gaze deviation and right sided weakness..
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Mental status changes, Scan with contrast abnormal, West Nile virus test negative
Clinical narrative: Altered mental status and transient weakness with MRI findings of encephalitis. She was brought to the ER on 12/2/23 and subsequently hospitalized. She had presented with altered mental status and word finding difficulties for several weeks. On the day of her presentation  to the ER, she was very weak and noted to have a right sided gaze deviation and right sided weakness..
Age: 49.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Computerised tomogram abdomen abnormal, Haemangioma of spleen, Laboratory test, Renal cyst, Tinnitus
Clinical narrative: Ears started ringing within a minute. No testing no treatment. Ongoing and sporadic. Nov 2 2021 had ct scan 2 spleen hemangioma 32x27 mm and 16x7 mm. Right kidney cyst 1.2 mm. Vaccinated 11/23/2021. Had abdomen ultrasound 12-6-2021 spleen hemangioma 29x24x22 mm and 2nd hemangioma not seen. Right kidney 1.2 mm spot and new .8mm x .8mm spot? Was told no concerns, will not increase in number or size. Have had numerous problems. 5-31-2022 ct scan 4 total spleen spots, 3 new
Age: 49.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: Ears started ringing within a minute. No testing no treatment. Ongoing and sporadic. Nov 2 2021 had ct scan 2 spleen hemangioma 32x27 mm and 16x7 mm. Right kidney cyst 1.2 mm. Vaccinated 11/23/2021. Had abdomen ultrasound 12-6-2021 spleen hemangioma 29x24x22 mm and 2nd hemangioma not seen. Right kidney 1.2 mm spot and new .8mm x .8mm spot? Was told no concerns, will not increase in number or size. Have had numerous problems. 5-31-2022 ct scan 4 total spleen spots, 3 new
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Cough, SARS-CoV-2 test
Clinical narrative: Cough
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: nothing happened with her, just gave wrong vaccination
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Hypoaesthesia, Immediate post-injection reaction, Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: 12/18/23: call from pt. to report pain to left shoulder immediately after injection and has since gotten better; also experienced numbness and tingling from injection site to forearm (left arm). No symptoms to right arm.  Numbness/tingling continue intermittently since the vaccine administration.  "Feels like my arm is waking up from being asleep." "different sensation".  She hasn't seen a medical provider for this but has an appt on 1/3/24 where she will mention it if it continues.   Has not tried anything to help the sensation (ibuprofen, etc). She is a nurse and feels like the shot was given a little high in the deltoid.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: 12/18/23: call from pt. to report pain to left shoulder immediately after injection and has since gotten better; also experienced numbness and tingling from injection site to forearm (left arm). No symptoms to right arm.  Numbness/tingling continue intermittently since the vaccine administration.  "Feels like my arm is waking up from being asleep." "different sensation".  She hasn't seen a medical provider for this but has an appt on 1/3/24 where she will mention it if it continues.   Has not tried anything to help the sensation (ibuprofen, etc). She is a nurse and feels like the shot was given a little high in the deltoid.
Age: 10.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Front desk staff member wrote the wrong age for child. Child received Pfizer covid vaccine for age 12+ and child is only 10 years 3 months. Error was noticed at the end of day.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Constipation, Diarrhoea, Eye movement disorder, Flatulence, Loss of consciousness
Clinical narrative: Within 30 min after vaccine My eyes rolled around in my head I passed out a couple hours and after that had chronic explosive diarrhea for nearly a month and a half. My primary said to try immodium which stopped it but now has created a further painful situation of endless accidents and painful constipation and gas. I have never experienced anything as horrible as this ever and uts not going away and no one knows why this is happening. The only thing I did that day was get this rsv vaccine and the Moderna covid shot and it was a very dramatic reaction in less than 30 minutes from getting the vaccines   The covid was from Moderna Lot 205e23a  Rsv from Pfizer Lot hf5018  Please help me is there an antidote Have there been other complaints like this from seniors I'm 72
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Stool analysis
Clinical narrative: Within 30 min after vaccine My eyes rolled around in my head I passed out a couple hours and after that had chronic explosive diarrhea for nearly a month and a half. My primary said to try immodium which stopped it but now has created a further painful situation of endless accidents and painful constipation and gas. I have never experienced anything as horrible as this ever and uts not going away and no one knows why this is happening. The only thing I did that day was get this rsv vaccine and the Moderna covid shot and it was a very dramatic reaction in less than 30 minutes from getting the vaccines   The covid was from Moderna Lot 205e23a  Rsv from Pfizer Lot hf5018  Please help me is there an antidote Have there been other complaints like this from seniors I'm 72
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Nasal congestion, SARS-CoV-2 test, Sinus congestion
Clinical narrative: Cough, sinus and  nasal congestion
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Injection site haemorrhage
Clinical narrative: Patient experienced bleeding at the injection site. Pressure was applied, and bleeding stopped. Bandage was applied.
Age: 13.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Fall, Head injury, Hypotonia, Unresponsive to stimuli
Clinical narrative: Patient received flu and covid shot and seemed to be fine. Approximately 30 minutes later, they were present during immunizations administered to 12 y.o. sister. She was standing behind mother against the wall in the clinic. She fell backwards hitting head on wall and fell to floor with limited responsiveness and limp.  Eyes open but not following commands, limp extremities. Lying on floor with head supported.
Age: 84.0
Sex: M
Vaccine: RSV
Symptoms: Joint stiffness, Musculoskeletal stiffness, Polymyalgia rheumatica
Clinical narrative: Symptoms classic for Polymyalgia Rheumatic, (acute sever shoulder and hip girdle/muscle joint stiffness and pain on movement) developed less than 48 hours after receiving the RSV vaccine.  Symptoms were partially relieved by naproxen over the next 2-3 days.   Note that I am a retired MD (neurologist), and a rheumatologist has been consulted.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Cough, SARS-CoV-2 test
Clinical narrative: Cough
Age: 31.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Head injury, Syncope
Clinical narrative: PATIENT AFTER GIVING HER VACCINES ASK FOR PROOF/DOCUMENTATION NEEDED FOR HER WORK. GAVE HER CDC CARD INSIDE THE VACCINATION AREA. THIS TAKES ABOUT APPROX MORE THAN 5 MINUTES. THEN I ASK HER TO STAND RIGHT IN FRONT OF THE CONSULTATION AREA WHERE I WILL GIVE HER PROOF FOR THE FLU SHOT. SHE SUDDENLY LEANED OVER THE SHELVES AND HIT HER FOREHEAD THUS MAKING HER FAINT AND FALL HEADFIRST. EMS WAS CALLED AND WAS GIVEN FIRST AID BEFORE THEY ARRIVED, SHE REFUSED HOSPITALIZATION.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Administration site rash, Chills
Clinical narrative: Patient was fine while in office, later that evening the patient got the chills while at home and a rash around the vaccine administration site.  Patient did not call the office to inform us, but came in on 12/18/2023 and informed me that she had an adverse reaction to the covid shot. Informed provider of reaction and documented in patient's chart.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: gave pt vaccine that was 14 days beyond use date
Age: 49.0
Sex: F
Vaccine: JEV1
Symptoms: Chest pain, Discomfort, Headache, Incorrect dose administered, Vomiting
Clinical narrative: Inadvertently given Ixiaro, 1/2 dose. As soon as the nurse realized she was injecting the incorrect vaccine she withdrew and only given a partial dose. She reported the event to patient. That evening patient reported she had a HA and vomiting and developed CP. She reported she went to the ER and did not provide any notes or details from the visit. She called to report all that had transpired and wanted compensation for her discomfort. The issue was resolved and no other adverse reactions reported.
Age: 49.0
Sex: F
Vaccine: JEV1
Symptoms: Wrong product administered
Clinical narrative: Inadvertently given Ixiaro, 1/2 dose. As soon as the nurse realized she was injecting the incorrect vaccine she withdrew and only given a partial dose. She reported the event to patient. That evening patient reported she had a HA and vomiting and developed CP. She reported she went to the ER and did not provide any notes or details from the visit. She called to report all that had transpired and wanted compensation for her discomfort. The issue was resolved and no other adverse reactions reported.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received a second dose of Arexvy on 12/18/2023 first dose was administered 9/27/2023
Age: 25.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Abdominal pain upper, Arthralgia, Bone pain, Chills, Diarrhoea
Clinical narrative: I awoke in the middle of the night experiencing nausea, stomach pains, bone and joint pain all over body, chills, feverish, panic, headache, fatigue, diarrhea. As the symptoms increased in severity a panic attack occurred and lasted about 30-40 minutes. I fell back asleep eventually and awoke to all the same symptoms in the morning except panic and chills. Most symptoms dissipated about 12 hours after they began with lingering and more mild fatigue, headache, muscle aches, and nausea for about 24 hours.
Age: 25.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Fatigue, Headache, Myalgia, Nausea, Panic attack
Clinical narrative: I awoke in the middle of the night experiencing nausea, stomach pains, bone and joint pain all over body, chills, feverish, panic, headache, fatigue, diarrhea. As the symptoms increased in severity a panic attack occurred and lasted about 30-40 minutes. I fell back asleep eventually and awoke to all the same symptoms in the morning except panic and chills. Most symptoms dissipated about 12 hours after they began with lingering and more mild fatigue, headache, muscle aches, and nausea for about 24 hours.
Age: 25.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Panic reaction, Pyrexia, Sleep disorder
Clinical narrative: I awoke in the middle of the night experiencing nausea, stomach pains, bone and joint pain all over body, chills, feverish, panic, headache, fatigue, diarrhea. As the symptoms increased in severity a panic attack occurred and lasted about 30-40 minutes. I fell back asleep eventually and awoke to all the same symptoms in the morning except panic and chills. Most symptoms dissipated about 12 hours after they began with lingering and more mild fatigue, headache, muscle aches, and nausea for about 24 hours.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Blood urine present, Computerised tomogram
Clinical narrative: Blood in the urine
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Contusion, Pruritus
Clinical narrative: Patient stated she started having some itching in random spots (palm of hands, crook of neck, chest area) around 3-4 days after receiving the vaccine. She mentioned she did not start new medications (or any increase in dosing , etc) and she did not change anything at home (i.e. no new detergent, etc). She also mentioned a small bruise started developing on her hand when the itching started.
Age: 0.83
Sex: M
Vaccine: DTAPIPV, FLU4, PNC20
Symptoms: Wrong product administered
Clinical narrative: Kinrix was given to patient instead of Pediarix
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given a 12 plus covid vaccine by mistake. He should have received a 5-11 year old covid vaccine instead. Spoke to parent and  Physican  to inform of error. Patient is not having any ill effects after injection and no futher follow up is necessary.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: pain, redness, cellulitis
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received a 12year + vaccine instead of a 6 month - 11 year vaccine. No symptoms at this time.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Condition aggravated, Immediate post-injection reaction
Clinical narrative: After just recovering from a colitis flare my condition began to immediately deteriorate and has progressively worsen to a full flare from which I am still suffering.
Age: 4.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hepatitis B administered on 04-FEB-1998; Hepatitis B administered on 10-FEB-1997; This spontaneous report has been received from a lawyer, via a Memo, Plaintiff Fact Sheet and Medical Records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (2311USA000042), concerning a currently 31-year-old female patient. Her historical vaccines included: DTP (Diphtheria, Tetanus, Pertussis), HIB PRP-OMP (Haemophilus influenzae b), MMR (Measles, Mumps, Rubella) and POL-OPV (Polio, live virus). Her concomitant vaccinations included: diphtheria vaccine toxoid, pertussis vaccine, tetanus vaccine toxoid (DTP), measles vaccine, mumps vaccine, rubella vaccine (MMR), polio vaccine live oral (reported as POL-OPV (Polio, live virus) and varicella zoster vaccine (reported as VAR (Varicella, chickenpox).  On 19-OCT-1996, the patient was vaccinated with hepatitis b vaccine (recombinant) vaccine (manufacturer unknown) (reported as HBV ped/adol, 3 dose sch (Hepatitis B)) (formulation, dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis.  On 10-FEB-1997, she was vaccinated with the next dose of hepatitis b vaccine (recombinant) vaccine (manufacturer unknown) (reported as HBV ped/adol, 3 dose sch (Hepatitis B)) (formulation, dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). On 04-FEB-1998, she was vaccinated with the next dose of hepatitis b vaccine (recombinant) vaccine (manufacturer unknown) (reported as HBV ped/adol, 3 dose sch (Hepatitis B)) (formulation, dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). Other vaccinations included: HAV ped (Hepatitis A), HAV ped/adol 2 dose sch (Hepatitis A), HPV4 (Human papillomavrisu, quadrivalent), influenza vaccine inact split 4v (FLULAVAL QUADRIVALENT), INFs (Influenza split virus), INFs pres free 3yrs-adult (Influenza), influenza vaccine inact split 3v (AFLURIA), MENcn-ACYW (Meningococcal conjugate, groups ACYW-135), Tdap (ADACEL) (Tetanus, diphtheria, acellular pertussis), VAR (Varicella, chickenpox) and td 7yrs-adult (tetanus, diphtheria), adsorber.  This is one of the few reports concerning the same patient.; Sender's Comments:  US-009507513-2312USA003370: US-009507513-2312USA003368: US-009507513-2312USA003369:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Var adminstered on 03-OCT-2006; Var adminstered on 19-OCT-1996; This spontaneous report has been received from a lawyer, via a Memo, Plaintiff Fact Sheet and Medical Records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (2311USA000042), concerning a currently 31-year-old female patient. Her historical vaccines included: DTP (Diphtheria, Tetanus, Pertussis), HIB PRP-OMP (Haemophilus influenzae b), MMR (Measles, Mumps, Rubella) and POL-OPV (Polio, live virus). Her concomitant therapies included: diphtheria vaccine toxoid, pertussis vaccine, tetanus vaccine toxoid (DTP), hepatitis b vaccine (reported as HBV ped/adol, 3 dose sch (Hepatitis B)), measles vaccine, mumps vaccine, rubella vaccine (MMR), and polio vaccine live oral (reported as POL-OPV (Polio, live virus).  On 19-OCT-1996, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) (reported as VAR (Varicella, chickenpox)) (formulation, dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age).  On 03-OCT-2006, she was vaccinated with the next dose of varicella virus vaccine live (Oka/Merck) (manufacturer unknown) (reported as VAR (Varicella, chickenpox)) (formulation, dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). Other vaccinations included: HAV ped (Hepatitis A), HAV ped/adol 2 dose sch (Hepatitis A), HBV ped/adol, 3 dose sch (Hepatitis B), HPV4 (Human papillomavrisu, quadrivalent), influenza vaccine inact split 4v (FLULAVAL QUADRIVALENT), INFs (Influenza split virus), INFs pres free 3yrs-adult (Influenza), influenza vaccine inact split 3v (AFLURIA), MENcn-ACYW (Meningococcal conjugate, groups ACYW-135), Tdap (ADACEL) (Tetanus, diphtheria, acellular pertussis), and td 7yrs-adult (tetanus, diphtheria), adsorber.  This is one of the few reports concerning the same patient.; Sender's Comments:  US-009507513-2312USA003367: US-009507513-2312USA003368: US-009507513-2312USA003369:
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No reported signs/symptoms of adverse effects; PROQUAD was accidentally administered to a 14 yo patient; This spontaneous report was received from a medical assistant, referring to a 14-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 05-DEC-2023, the patient was accidentally vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) injection, lot # X018570, expiration date: 05-JAN-2025, administered for prophylaxis (strength, anatomical site of administration and route of administration were not provided) (product administered to patient of inappropriate age). No reported signs/symptoms of adverse effects. No additional adverse event (AE).
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Patient received 0.5 ml Jynneos vaccine intradermally; Case reference number US-BN-2023-001812 is a spontaneous case report initially received on 20-Nov-2023 from nurse via Regulatory Authority (reference number: USBAV23-1931) and concerns an adult male patient.  The patient's relevant medical history and concomitant medications were not provided.  On 17-Nov-2023, the patient was vaccinated with the first dose of Jynneos vaccine (batch number: FDP0020), at a dose of 0.5 ml, administered intradermally at unknown site of administration for indication reported as protection in patient with high risk of monkeypox (explicitly coded as 'intradermal injection'). As reported, the patient received 0.5 ml instead of 0.1 ml and the reporter asked if there was anything outside of the usual side effects that the patient should be notified of.  As reported, the patient did not report any side effects related to the Jynneos administration.  No further information provided.; Reporter's Comments: An adult male patient was vaccinated with the first dose of Jynneos vaccine, administered intradermally at unknown site of administration for protection in patient with high risk of monkeypox. Intradermal injection is listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Intradermal injection is not related to Jynneos vaccine, but to a human factor. The case is non-serious.; Sender's Comments: An adult male patient was vaccinated with the first dose of Jynneos vaccine, administered intradermally at unknown site of administration for protection in patient with high risk of monkeypox. Intradermal injection is listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Intradermal injection is not related to Jynneos vaccine, but to a human factor. The case is non-serious.
Sex: U
Vaccine: RSV
Symptoms: Atrial fibrillation
Clinical narrative: Atrial fibrillation; This serious case was reported by a consumer via regulatory authority and described the occurrence of atrial fibrillation 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 atrial fibrillation (Verbatim: Atrial fibrillation) (serious criteria GSK medically significant). The outcome of the atrial fibrillation was not reported.   It was unknown if the reporter considered the atrial fibrillation to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation to be related to Arexvy.   Additional Information: GSK receipt Date:07-DEC-2023 The patient had atrial fibrillation after Arexvy vaccination. The follow up would not possible as no contact details were available.
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Headache, Nausea, Vomiting
Clinical narrative: headache; Vomiting; nausea; Shoulder pain (due joint disorder); This non-serious case was reported by a consumer and described the occurrence of shoulder pain (due joint disorder) in a 62-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Concurrent medical conditions included depression, anxiety, stomach irritated feeling of and neurological disorder nos. Additional patient notes included the patient thought she was going to die and she knew she had been diagnosed with a neurological disorder.   On 24-APR-2023, the patient received Hepatitis B vaccine. On 26-APR-2023, 2 days after receiving Hepatitis B vaccine, the patient experienced shoulder pain (due joint disorder) (Verbatim: Shoulder pain (due joint disorder)). On an unknown date, the patient experienced headache (Verbatim: headache), vomiting (Verbatim: Vomiting) and nausea (Verbatim: nausea). The outcome of the shoulder pain (due joint disorder), headache, vomiting and nausea were not resolved.   It was unknown if the reporter considered the shoulder pain (due joint disorder), headache, vomiting and nausea to be related to Hepatitis B vaccine.     It was unknown if the company considered the shoulder pain (due joint disorder), headache, vomiting and nausea to be related to Hepatitis B vaccine.   Additional Information: GSK Receipt Date: 11-DEC-2023 The patient reported this case for herself. The patient had vomiting, nausea, headache and shoulder pain (due joint disorder) for which intervention required. The reporter consented to follow-up.
Sex: U
Vaccine: RVX
Symptoms: Asthma, Condition aggravated, Wheezing
Clinical narrative: asthma exacerbations; wheezing; This non-serious case was reported by a physician via sales rep and described the occurrence of asthma aggravated in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included asthma.   On an unknown date, the patient received RSV vaccine. On an unknown date, 2 days after receiving RSV vaccine, the patient experienced asthma aggravated (Verbatim: asthma exacerbations) and wheezing (Verbatim: wheezing). The outcome of the asthma aggravated and wheezing were not reported.   It was unknown if the reporter considered the asthma aggravated and wheezing to be related to RSV vaccine.     It was unknown if the company considered the asthma aggravated and wheezing to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 08-DEC-2023 Doctor of medicine reported that the stable asthma patient received the RSV vaccine and 2 days later patient had asthma exacerbations resulting in sever wheezing. The doctor of medicine was unsure which RSV vaccine patient received. The reporter consented to follow-up. This case had been linked with US2023AMR172869, by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR172869:Different patient, same reporter
Sex: U
Vaccine: RVX
Symptoms: Asthma, Condition aggravated, Wheezing
Clinical narrative: asthma exacerbations; severe wheezing; This non-serious case was reported by a physician via sales rep and described the occurrence of asthma aggravated in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included asthma (stable asthma).   On an unknown date, the patient received RSV vaccine. On an unknown date, 2 days after receiving RSV vaccine, the patient experienced asthma aggravated (Verbatim: asthma exacerbations) and wheezing (Verbatim: severe wheezing). The outcome of the asthma aggravated and wheezing were not reported.   It was unknown if the reporter considered the asthma aggravated and wheezing to be related to RSV vaccine.     It was unknown if the company considered the asthma aggravated and wheezing to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 08-DEC-2023 The physician was unsure which RSV vaccine (unknown if this is from Arexvy or Abrysvo) did the patient received. The physician reported that the stable asthma patient received the RSV vaccine and 2 days later had asthma exacerbations resulting in severe wheezing. The reporter consented to follow-up. This case had been linked with US2023AMR172828, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR172828:Different patient, same reporter
Sex: U
Vaccine: RSV
Symptoms: Intercepted product preparation error
Clinical narrative: mixing two adjuvants together instead of mixing an adjuvant and a powder; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted product preparation error in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient did not receive Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted product preparation error (Verbatim: mixing two adjuvants together instead of mixing an adjuvant and a powder). The outcome of the intercepted product preparation error was unknown.   Additional Information: GSK Receipt Date: 8-DEC-2023 A pharmacist reported about mixing two adjuvants together instead of mixing an adjuvant and a powder, the dose was not administered, which led to intercepted product preparation error. Lot number and expiration date were not provided. No additional information provided. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: potential side effects after an expired dose of Engerix-B was given.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 55-year-old female patient who received HBV (Engerix B) (expiry date 31-MAY-2023) for prophylaxis.   On 07-DEC-2023, the patient received the 1st dose of Engerix B. On 07-DEC-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: potential side effects after an expired dose of Engerix-B was given.). The outcome of the expired vaccine used 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: 08-DEC-2023 A Pharmacist contacted GSK via phone inquiring about Engerix-B and what information was available about the information available for the potential side effects after an expired dose of Engerix-B was given. The partial information about patient, event and vaccine was given. The reporter consented to follow up. The patient received the of Engerix B which was already expired on 31st May 2023 which led to expired vaccine used. The vaccine administration facility is the same as primary reporter.
Sex: F
Vaccine: TDAP
Symptoms: Product storage error, Wrong product administered
Clinical narrative: MA requests stability data for Bexsero, Menveo (2-vial), Havrix, Shingirx, Boostrix, Twinrix, Engerix-B stored at 23F x 75hrs 45mins on 02DEC2023. Twinrix was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received DTPa (Reduced antigen) (Boostrix) (batch number DD7F7, expiry date 06-DEC-2025) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: MA requests stability data for Bexsero, Menveo (2-vial), Havrix, Shingirx, Boostrix, Twinrix, Engerix-B stored at 23F x 75hrs 45mins on 02DEC2023. Twinrix was administered). The outcome of the incorrect storage of drug 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:08-DEC-2023 The MA requests stability data for Bexsero, Menveo (2-vial), Havrix, Shingirx, Boostrix, Twinrix, Engerix-B stored at 23F x 75hrs 45mins on 2nd December 2023. There is no prior excursions. The Twinrix was administered to the patient. Are this vaccine stable?  What they need to do with the patient who have been administered the vaccine? The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023172439:Twinrix case for second patient
Sex: M
Vaccine: HEPAB
Symptoms: Product storage error
Clinical narrative: Product Storage Error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a male patient who received HAB (Twinrix adult) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   In DEC-2023, the patient received Twinrix adult. On 02-DEC-2023, an unknown time after receiving Twinrix adult, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error). The outcome of the incorrect storage of drug 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: 08-DEC-2023 Medical assistant requested stability data for Bexsero, Menveo (2-vial), Havrix, Shingirx, Boostrix, Twinrix, Engerix-B stored at 23 degree F x 75 hours 45 minutes on 2nd December 2023. No prior excursions. Twinrix administered following excursion to patient. The reporter asked were these vaccines stable, what do they need to do with the patients who had been administered the vaccines. The reporter consented to follow up. This case had been linked with US2023172437, reported by same reporter.; Sender's Comments:  US-GSK-US2023172437:Boostrix case for 1st patient
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a pharmacist called to inform that a patient that had received the 1st dose of Shingrix in 8/Nov/2023 received the 2nd dose on 1/Dec/2023.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number 4JP7M) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 01-DEC-2023, the patient received the 2nd dose of Shingrix. On 01-DEC-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: a pharmacist called to inform that a patient that had received the 1st dose of Shingrix in 8/Nov/2023 received the 2nd dose on 1/Dec/2023.). The outcome of the drug dose administration interval too short was unknown.   Additional Information: RA Receipt Date: 08-DEC-2023 The reporter consented to follow up. The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Sex: F
Vaccine: RSV
Symptoms: Delivery, Exposure during pregnancy, Product use issue
Clinical narrative: a pregnant patient received a dose of Arexvy; child has since been born; This non-serious retrospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy (intramuscular). On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: a pregnant patient received a dose of Arexvy) and live birth (Verbatim: child has since been born). The outcome of the vaccine exposure during pregnancy and live birth were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Live neonate with no apparent congenital anomaly   Additional Information: GSK Receipt Date: 08-DEC-2023 The reporter reported that a pregnant patient received a dose of Arexvy, and the child had since been born, which led to vaccine exposure during pregnancy. The reporter consented to follow-up via email.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: joint pain; Muscle Pain; severe body ache; This non-serious case was reported by a consumer via call center representative and described the occurrence of joint pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-SEP-2023, the patient received the 2nd dose of Shingrix (left arm). On 28-SEP-2023, less than a day after receiving Shingrix, the patient experienced general body pain (Verbatim: severe body ache). On an unknown date, the patient experienced joint pain (Verbatim: joint pain) and muscle pain (Verbatim: Muscle Pain). The patient was treated with  (Corticosteroids). The outcome of the joint pain, muscle pain and general body pain were unknown.   It was unknown if the reporter considered the joint pain, muscle pain and general body pain to be related to Shingrix.     It was unknown if the company considered the joint pain, muscle pain and general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date : 08-DEC-2023 The patient experienced a severe reaction that included joint pain, muscle pain and severe body aches.  The patient stated that she had been on several rounds of corticosteroids to help minimize reaction. The reported that she was inquiring about protocol. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: HCP reported, I just found that one of our patients received a Shingrix vaccine on 5/2,6/20 and 11/2.; patients received a Shingrix vaccine on 5/2, 6/20; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 02-NOV-2023, the patient received the 3rd dose of Shingrix. On 20-JUN-2023, the patient received the 2nd dose of Shingrix. On 20-JUN-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patients received a Shingrix vaccine on 5/2, 6/20). On 02-NOV-2023, the patient experienced extra dose administered (Verbatim: HCP reported, I just found that one of our patients received a Shingrix vaccine on 5/2,6/20 and 11/2.). The outcome of the extra dose administered and drug dose administration interval too short were unknown.   Additional Information: GSK receipt date: 08-DEC-2023 The health care professional reported that they just found that one of their patients received 3 doses of Shingrix vaccine, which led to extra dose administered. The patient received 2nd dose of Shingrix earlier than the recommended interval, which led to shortening of vaccine schedule.  The reporter stated that they were unable to capture any vaccine, or the patient details. The reporter did not consented to follow up.
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: 53 year old patient presented with a prescription for Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug prescribing error in a 53-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient did not receive Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced drug prescribing error (Verbatim: 53 year old patient presented with a prescription for Arexvy). The outcome of the drug prescribing error was unknown.   Additional Information: GSK receipt date: 08-DEC-2023 The pharmacist reported a 53-year-old patient presented with a prescription for Arexvy, which led to drug prescribing error. No lot number or expiration date because the product had not yet been prescribed.  No additional information. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Late 2nd dose / the 2nd dose was not administered yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose on November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Late 2nd dose / the 2nd dose was not administered yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: RA Receipt Date: 08-DEC-2023 The vaccine administration facility was the same as primary reporter and the VAERS details were provided for 1st dose of Shingrix. The reporter did not consent to follow-up. Till he time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. This case had been linked with US2023172468, reported by same reporter.; Sender's Comments:  US-GSK-US2023172468:Female patient case
Sex: F
Vaccine: RSV
Symptoms: Product storage error
Clinical narrative: Administered after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number N57EC, expiry date 27-MAR-2025) for prophylaxis.   On 05-DEC-2023, the patient received the 1st dose of Arexvy. On 05-DEC-2023, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: Administered after temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 08-DEC-2023 A Pharmacy manager inquiring about Arexvy and what information was available about Information available after a dose of Arexvy that had been left at room temperature for 5 hours had been administered to a patient and how to procced if the dose was invalid, which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Bruxism, Cold sweat, Dizziness, Electrocardiogram, Loss of consciousness
Clinical narrative: Patient had appointment for Moderna XBB 12+ today 12/18/2023 at 10am. Patient advised to wait after for 15 minutes in lobby after vaccination by MA. Patient?s son approached nurses at 1020 stating that ?my dad is having a reaction.? RN, LVN and I approached patient who was sitting slouched to the right on the chair in the lobby. Patient stated he felt faint and had sat down. Per patient, no prior history of syncope after vaccines, no allergic reaction to previous Moderna covid vaccine.  Patient was alert and oriented x 4, skin was cool, clammy and pale. No chest pain per patient. 911 called by RN while assessment was performed. At 1021 patient?s body became tense and rigid, jaw clenched, he started breathing through mouth, became unresponsive but conscious for 30 seconds. Patient legs were elevated on chair. Vital signs @ 1021: BP:158/71 P: 65 O2: 99% on room air.  VS @ 1025 BP: 146/74 P: 61  O2: 99% on room air. Patient stated he ?feels better than 5 minutes ago?. Skin no longer pale. EMT arrived at 1026. They hooked him up to an EKG, during his transfer to the gurney he lost consciousness again. Right after the patient was situated on the gurney, he lost consciousness, became tense and vomited on the gurney. EMT placed him on his left side, took patient to the emergency department after that.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Mouth breathing, Muscle rigidity, Pallor, Posture abnormal, Tension
Clinical narrative: Patient had appointment for Moderna XBB 12+ today 12/18/2023 at 10am. Patient advised to wait after for 15 minutes in lobby after vaccination by MA. Patient?s son approached nurses at 1020 stating that ?my dad is having a reaction.? RN, LVN and I approached patient who was sitting slouched to the right on the chair in the lobby. Patient stated he felt faint and had sat down. Per patient, no prior history of syncope after vaccines, no allergic reaction to previous Moderna covid vaccine.  Patient was alert and oriented x 4, skin was cool, clammy and pale. No chest pain per patient. 911 called by RN while assessment was performed. At 1021 patient?s body became tense and rigid, jaw clenched, he started breathing through mouth, became unresponsive but conscious for 30 seconds. Patient legs were elevated on chair. Vital signs @ 1021: BP:158/71 P: 65 O2: 99% on room air.  VS @ 1025 BP: 146/74 P: 61  O2: 99% on room air. Patient stated he ?feels better than 5 minutes ago?. Skin no longer pale. EMT arrived at 1026. They hooked him up to an EKG, during his transfer to the gurney he lost consciousness again. Right after the patient was situated on the gurney, he lost consciousness, became tense and vomited on the gurney. EMT placed him on his left side, took patient to the emergency department after that.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Patient had appointment for Moderna XBB 12+ today 12/18/2023 at 10am. Patient advised to wait after for 15 minutes in lobby after vaccination by MA. Patient?s son approached nurses at 1020 stating that ?my dad is having a reaction.? RN, LVN and I approached patient who was sitting slouched to the right on the chair in the lobby. Patient stated he felt faint and had sat down. Per patient, no prior history of syncope after vaccines, no allergic reaction to previous Moderna covid vaccine.  Patient was alert and oriented x 4, skin was cool, clammy and pale. No chest pain per patient. 911 called by RN while assessment was performed. At 1021 patient?s body became tense and rigid, jaw clenched, he started breathing through mouth, became unresponsive but conscious for 30 seconds. Patient legs were elevated on chair. Vital signs @ 1021: BP:158/71 P: 65 O2: 99% on room air.  VS @ 1025 BP: 146/74 P: 61  O2: 99% on room air. Patient stated he ?feels better than 5 minutes ago?. Skin no longer pale. EMT arrived at 1026. They hooked him up to an EKG, during his transfer to the gurney he lost consciousness again. Right after the patient was situated on the gurney, he lost consciousness, became tense and vomited on the gurney. EMT placed him on his left side, took patient to the emergency department after that.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received a second dose of Arexy
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site rash
Clinical narrative: Patient reported she has  aabout 6 inches long  rash extened from injection site(left arm), and it looked inflamed and she also felt very sore.  She also reported  it felts like  it has 4 inches long nodules under the injection site when touched
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: Pt went to pharmacy for flu shot.
Age: 50.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Fatigue, Headache, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Headache for 5 days Fever for 4 days (up to 102) Fatigue for 7 days
Age: 63.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Injection site pain, Injection site reaction, Skin tightness
Clinical narrative: Pt called 12/18/2023 to report that after a week following her vaccine on 11/27/23, she was experiencing a sensation that she described as "tight/tense skin" around the injection site that she has been experiencing sporadic dull pain at the injection site as well.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Increase in frequency of heart palpitations, occurring 6 days per week, several times per day.