chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Covid vaccine was administered at a nursing home facility by Pharmacy. The administering professional asked the patient which vaccines she wanted and she stated "everything".  On the form the requested vaccines were "Influenza, Pneumonia and Shingles" The pharmacist let the patient know that Shingles was a two dose series so we would not be giving it to her because we would not be visiting the site till the next year and it would be in her best interest to get the shingles vaccine within the 2 to 6 month time frame. Hence, the patient was given the Influenza, Pneumonia and Covid vaccine instead since the patient stated "everything". After the Covid vaccine was administered, the patient stated that she did not want to receive the Covid vaccine.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Product preparation error
Clinical narrative: Vaccine was reconstituted with normal saline instead of provided dilutant.
Age: 15.0
Sex: M
Vaccine: FLU3, HPV9, MMR, MNQ, TDAP, VARCEL
Symptoms: Dizziness
Clinical narrative: Vaccine administration began at 1140AM. Vaccine admin completed at 11:45AM. Patient reported dizziness when starting to stand up from exam table. Patient instructed to lay down on exam table. Patient reported feeling faint.  Vitals taken at 11:46AM: BP: 79/38, Pulse: 54, O2: 100%. Vitals immediately repeated with legs elevated above the heart, BP: 78/36, Pulse: 57, O2: 99%. Patient instructed to take deep breaths, provided cup of water, Supervisor notified. Vitals reassessed at 11:48AM: BP: 98/57, Pulse: 57, O2: 100%. Vitals reassessed 1153AM: BP: 101/58, Pulse: 55, O2: 99%. Patient tolerated sitting up, no complaint of dizziness. Patient assisted in standing, no complaint of dizziness. Patient escorted to waiting room. Patient rested in waiting room until comfortable to leave with family.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: just painful and decrease range in motion, no swelling, no lumps, no fever
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Patient is 14 years old, received additional HPV vaccine on 12/02/2024.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse reaction. Just the wrong dosage given.   The dose given was for a 6 month to 4 year old and the correct dose that should have been given is 5 to 11 years old
Age: 34.0
Sex: M
Vaccine: COVID19, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient accidentally given Moderna 6 months - 11 year old vaccine instead of adult dose (Spikevax).
Age: 3.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events reported. No treatments given. Age inappropriate dose was given.
Age: 1.25
Sex: M
Vaccine: PNC20
Symptoms: Computerised tomogram head, Electrocardiogram abnormal, Electroencephalogram, Full blood count, Influenza virus test
Clinical narrative: within 24 hours of vaccine, patient had 2 seizures, admitted to Neurology, testing done, awaiting follow up with pediatric neurology and cardiology (WPW on EKG)
Age: 1.25
Sex: M
Vaccine: PNC20
Symptoms: Metabolic function test, Respiratory syncytial virus test, SARS-CoV-2 test, Seizure, Wolff-Parkinson-White syndrome
Clinical narrative: within 24 hours of vaccine, patient had 2 seizures, admitted to Neurology, testing done, awaiting follow up with pediatric neurology and cardiology (WPW on EKG)
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Ear discomfort, Headache, Influenza like illness, Throat irritation
Clinical narrative: flu like symptoms - scratch y throat ears clogged to the point of not hearing headache
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombectomy
Clinical narrative: Acute stroke requiring a thrombectomy
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Pt developed hives 2 days after receiving the vaccine at Pharmacy.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Blood lactic acid, Cardiac monitoring, Electrocardiogram, Eye pruritus, Full blood count
Clinical narrative: itching of eyes, throat and body, HA
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Metabolic function test, Pruritus, Throat irritation
Clinical narrative: itching of eyes, throat and body, HA
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Blood test normal, Chills, Computerised tomogram normal, Electrocardiogram normal
Clinical narrative: Patient received influenza (FLUAD) vaccine on 11/14/24. Patient stated she has had a sore/painful arm since then. She stated she got better for a few days, then on 12/2/24, patient started having excruciating pain in the arm, heart palpitations, chills/shaking, increase blood pressure, numbness in legs and arm and headache. She went to the ER and they did an EKG, blood test, MRI and CAT scan. ER doctor proceeded to tell her that nothing was wrong. ER doctor told her that it looks like the placement of the vaccine given was "too high" and hit the bursa. Nurse also confirmed that the same thing happened to her and the patient is adamant that this reaction is due to the placement of the vaccine and not the ingredients of the vaccine. Patient stated no medications was given to her at the ER and to continue Tylenol as needed. Patient stated she takes Aleve to help with the pain.  Patient has started methotrexate a month and half ago and is on other medications as well. Patient is to follow up with PCP in a few days.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia, Magnetic resonance imaging normal, Pain in extremity, Palpitations
Clinical narrative: Patient received influenza (FLUAD) vaccine on 11/14/24. Patient stated she has had a sore/painful arm since then. She stated she got better for a few days, then on 12/2/24, patient started having excruciating pain in the arm, heart palpitations, chills/shaking, increase blood pressure, numbness in legs and arm and headache. She went to the ER and they did an EKG, blood test, MRI and CAT scan. ER doctor proceeded to tell her that nothing was wrong. ER doctor told her that it looks like the placement of the vaccine given was "too high" and hit the bursa. Nurse also confirmed that the same thing happened to her and the patient is adamant that this reaction is due to the placement of the vaccine and not the ingredients of the vaccine. Patient stated no medications was given to her at the ER and to continue Tylenol as needed. Patient stated she takes Aleve to help with the pain.  Patient has started methotrexate a month and half ago and is on other medications as well. Patient is to follow up with PCP in a few days.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered at inappropriate site, Tremor
Clinical narrative: Patient received influenza (FLUAD) vaccine on 11/14/24. Patient stated she has had a sore/painful arm since then. She stated she got better for a few days, then on 12/2/24, patient started having excruciating pain in the arm, heart palpitations, chills/shaking, increase blood pressure, numbness in legs and arm and headache. She went to the ER and they did an EKG, blood test, MRI and CAT scan. ER doctor proceeded to tell her that nothing was wrong. ER doctor told her that it looks like the placement of the vaccine given was "too high" and hit the bursa. Nurse also confirmed that the same thing happened to her and the patient is adamant that this reaction is due to the placement of the vaccine and not the ingredients of the vaccine. Patient stated no medications was given to her at the ER and to continue Tylenol as needed. Patient stated she takes Aleve to help with the pain.  Patient has started methotrexate a month and half ago and is on other medications as well. Patient is to follow up with PCP in a few days.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Dizziness, Headache, Injection site swelling
Clinical narrative: On 11/29/24, MOC called Nurseline to report that on 11/27/24 pt received 2 vaccines, on 11/28/24, pt started feeling dizzy,  swelling at injection site, small headache when dizzy. Per Nurse line report, pt was advised to see pcp within 3 days, and to call nurse line back with worsening symptoms.  Pt is scheduled to pcp on 12/03/24
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: On 11/29/24, MOC called Nurseline to report that on 11/27/24 pt received 2 vaccines, on 11/28/24, pt started feeling dizzy,  swelling at injection site, small headache when dizzy. Per Nurse line report, pt was advised to see pcp within 3 days, and to call nurse line back with worsening symptoms.  Pt is scheduled to pcp on 12/03/24
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Dizziness, Headache, Injection site swelling
Clinical narrative: dizziness x 6 days
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: dizziness x 6 days
Age: 17.0
Sex: F
Vaccine: COVID19, FLU3, MENB, MNQ
Symptoms: Syncope
Clinical narrative: patient fainted during checkout process after receiving vaccines.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient had never received a COVID vaccine and did not ask for it.  It was given in error.  Patient had wanted a flu shot.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered on 12/02/2024 - expiration date of vaccine 11/30/2024 .                                                                                 Patient has not experienced any adverse symptoms
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Head injury, Syncope
Clinical narrative: Patient fainted shortly after receiving vaccine and hit head with no major injury noted
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Immediate post-injection reaction, Limb discomfort, Paraesthesia
Clinical narrative: Member had popping then tingling sensation in arm immediately after. vaccine. Member states she believes vaccine was given higher than normal. Member seen in clinic for adverse reaction. Member has continued pain. and limited ROM.
Age: 23.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Patient came in for up dating immunizations, she is pregnant and due on 02/25/2025. Nurse gave Tdap, Influenza and RSV vaccine. RSV vaccine was given in error. Wrong medication and wrong dose given.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: The patient presents for evaluation of left shoulder pain.   He received an influenza vaccine on 10/31/2024, which initially caused mild soreness. However, the discomfort has progressively worsened, to the point where he struggles to lift his arm. The pain is particularly severe when he attempts to sleep, dress, or apply deodorant. Despite the passage of time, the pain has not subsided and remains constant, described as a throbbing sensation.    He has no prior history of shoulder issues or similar pain. The pain does not radiate and there is no associated numbness or weakness. He occasionally takes ibuprofen, but it provides minimal relief. He is right-handed and reports no visible swelling or bumps. He recalls that the injection was more painful than usual. No previous reaction similar to this with any other vaccine.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Cough, Pyrexia, SARS-CoV-2 test
Clinical narrative: Cough, fever, chills
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: pain at injection site for 4+weeks after the shot, no swelling, bruising or signs of infection  noted, just pain
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Cough, fever, shortness of breath
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered on 12/02/2024 - vaccine expiration date 11/30/2024                                                                                  Patient has not experienced any adverse symptoms                                                                                                                                      Vaccine obtained from clinic
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Malaise, Pruritus, Throat tightness
Clinical narrative: Five to ten minutes after receiving flu vaccine, employee started getting itchy; employee bought benadryl at the pharmacy and took 50mg around 1620. After that, closer to 1635 or 1630, employee's throat started feeling tight and she was slightly short of breath. The employee gave herself her own epi pen around 1640. Medical response and 911 were called. Employee was sent to ED for follow up. Employee still not feeling well the next day.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Pruritus, Throat tightness
Clinical narrative: Five to ten minutes after receiving flu vaccine, employee started getting itchy; employee bought benadryl at the pharmacy and took 50mg around 1620. After that, closer to 1635 or 1630, employee's throat started feeling tight and she was slightly short of breath. The employee gave herself her own epi pen around 1640. Medical response and 911 were called. Employee was sent to ED for follow up. Employee still not feeling well the next day.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Malaise, Pruritus, Throat tightness
Clinical narrative: Patient received the flu shot around 4:00 p.m..  Within about 5 minutes after receiving the vaccine, she started feeling itchy and within 15 minute she felt some tightness in her throat. She took 50 mg of oral Benadryl around 4:20 p.m. and self administered 0.3 mg of IM epinephrine in her right thigh around 4:40 p.m.  I called medical response and the ambulance and she was transported to Hospital.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Pruritus, Throat tightness
Clinical narrative: Patient received the flu shot around 4:00 p.m..  Within about 5 minutes after receiving the vaccine, she started feeling itchy and within 15 minute she felt some tightness in her throat. She took 50 mg of oral Benadryl around 4:20 p.m. and self administered 0.3 mg of IM epinephrine in her right thigh around 4:40 p.m.  I called medical response and the ambulance and she was transported to Hospital.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Left shoulder pain post vaccination. Pain is getting progressively worse.
Age: 10.0
Sex: F
Vaccine: COVID19, HPV9
Symptoms: Dizziness, Pallor, Presyncope
Clinical narrative: Patient had a near syncopal episode. She turned pale and became dizzy.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Burning sensation, Pain
Clinical narrative: Right  forearm burning pain with motion
Age: 84.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient erroneously received a second dose of Fluzone High Dose the day after her first. There were no adverse reactions. Patient called advice nurse, referred to MD, Per MD, no adverse effects with receiving 2 flu shots in 48 hours.
Age: 23.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Cardiac disorder, Postural orthostatic tachycardia syndrome
Clinical narrative: POTS and/or unspecified cardiac issues.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-ganglioside antibody positive, Burning sensation, Dizziness, Extra dose administered, Headache
Clinical narrative: I did receive the Covid vaccine with the Flu vaccine together ( I do not have the name of the flu vaccine given) There was an error and I received two flu vaccine on the right arm and one covid vaccine on the left am. I did develop neurologic symptoms about 72 hours after vaccination : severe dizziness, headache, muscle weakness and burning sensation with needling sensation on four extremities.  After several weeks symptoms did not resolve. Antibody tested by Neurologist positive for ganglioside GQ1B 1/400. Hospital admission 10/4/24 but Neurologist in the hospital refused to see me , Outpatient Neurologist has been following and performing diagnostic testing. After two months I still have weakness on lower extremities and burning sensation in hands and feet
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Muscular weakness, Neurological symptom, Paraesthesia
Clinical narrative: I did receive the Covid vaccine with the Flu vaccine together ( I do not have the name of the flu vaccine given) There was an error and I received two flu vaccine on the right arm and one covid vaccine on the left am. I did develop neurologic symptoms about 72 hours after vaccination : severe dizziness, headache, muscle weakness and burning sensation with needling sensation on four extremities.  After several weeks symptoms did not resolve. Antibody tested by Neurologist positive for ganglioside GQ1B 1/400. Hospital admission 10/4/24 but Neurologist in the hospital refused to see me , Outpatient Neurologist has been following and performing diagnostic testing. After two months I still have weakness on lower extremities and burning sensation in hands and feet
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Patient age above the 2-18 valid dose age. No adverse reaction.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Computerised tomogram head normal, Confusional state, Injection site inflammation, Magnetic resonance imaging head normal
Clinical narrative: TIA  approximately 22 hours after vaccination.    Significant inflammation at injection site just like mine prior COVID injection site not this painful or inflamed.   Thus supporting increased inflammatory response.  Symptoms lasted about 30 minutes with RNs noting confusion and difficulty expressing herself.   Taken down to emergency room as she was volunteering at hospital. Symptoms totally resolved in 30 minutes
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: TIA  approximately 22 hours after vaccination.    Significant inflammation at injection site just like mine prior COVID injection site not this painful or inflamed.   Thus supporting increased inflammatory response.  Symptoms lasted about 30 minutes with RNs noting confusion and difficulty expressing herself.   Taken down to emergency room as she was volunteering at hospital. Symptoms totally resolved in 30 minutes
Age: 0.75
Sex: M
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: Nurse notified provider and parent. There were no symptoms at time of visit.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Patient 19 at age of vaccine dose age range 2-18. No adverse reaction; wrong dose given (0.5ml instead of 1.0ml for 19 and older)
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Contracted covid 19 on day 8 after vaccine.  Took Paxlovid to treat the illness
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Swelling and bruising at injection site which grew to a 50-cent piece size over the first few days.  Swelling subsided, but the bruising has continued.
Age: 1.08
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Diarrhoea, Extra dose administered
Clinical narrative: My daughter has not had any symptoms other than diarrhea but i am reporting that she was NOT supposed to receive this shot, she had already completed her 3 doses of this and this is what they accidently gave her. She was supposed to only get a single dose of the Hib shot, instead they gave her a fourth dose of this.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV9, MENB, MNQ
Symptoms: Sensory disturbance, Syncope, Tinnitus
Clinical narrative: Patient experienced syncope soon after vaccines were administered. Patient was alert and oriented within 30 seconds and complained of ringing in the ears and legs feeling "weird" BP 137/74 PULSE 61. Cool pack was applied to patient's back/neck area and legs were elevated. Patient's symptoms improved and patient was observed for 15 minutes before leaving office. Advised patient and mom to follow up with urgent care/ER if symptoms return and/or worsen.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Hypoaesthesia, Immunoglobulin therapy, Mobility decreased, Paraesthesia
Clinical narrative: Numbness and tingling from waist down. I was paralyzed from neck down March 2022 i started having numbness and tingling in my feet and it worked itself up. From March till April 19 i lost my all mobility to walk. I didn?t get some of my mobility back till September 2022. I am now having to get IVIG treatments every two months
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: Numbness and tingling from waist down. I was paralyzed from neck down March 2022 i started having numbness and tingling in my feet and it worked itself up. From March till April 19 i lost my all mobility to walk. I didn?t get some of my mobility back till September 2022. I am now having to get IVIG treatments every two months
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: No adverse event
Clinical narrative: no symptoms at time of visit.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Brain fog, Disorientation, Influenza, Nausea, Vomiting
Clinical narrative: Flu symptoms, nausea, vomiting, brain fog, disorientation
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Sleep disorder
Clinical narrative: Patient reported waking up in the middle of the night with severe pain (likely inflammatory) in right hip. Patient describes sensation similar to Shingles.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: individual received 6 mos-11 yr old dose of covid vaccine
Age: 47.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient requested a flu shot, the pharmacist did not realize that the patient got one on 08/15/24, now two doses were given this season.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: individual received 6 mos-11 yr old dose of covid vaccine
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Hyperhidrosis, Throat tightness
Clinical narrative: Diaphoretic, erythema, sob and feeling throat closing up.  4 liters of oxygen given nasal cannula , vitals monitored and 0.3 mg epinephrine administered subcutaneously in right arm. patient recovered to baseline pulse ox 100 % room air, denied any sob or difficulty breathing. no complains vitals signs stable, no sob noted. medical doctor completed out patient visit, patient returned home.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: individual received 6 mos-11 yr old dose of covid vaccine
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a second dose of 24/25 Flucelvax in error. No adverse effects noted.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse symptoms, wrong dose of vaccine was given.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 yr old individual received 6 mos-11 yr old dose of covid vaccine
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Hypoaesthesia, Pain in extremity
Clinical narrative: patient got the shot on 11/3/24 after about two weeks later on 11/16/24 patient got a reaction on his arm. He started feeling soreness, numbness, and bruising that has got worse. between 11/3/24 and 11/16/24 when he started feeling the symptoms he had no adverse reactions
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11 year old received spikevax for 12 years and older
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 10 year old received spikevax for 12 years and older
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 10 year old received spikevax for 12 years and older
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: ACCIDENTALLY INJECTED 2 COVID SHOTS BY ACCIDENT. THINKING ONE SHOT WAS A FLU SHOT AND THE OTHER WAS A COVID.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse symptoms noted, wrong dose was given.
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Blood pressure increased, Blood test, Chest pain, Computerised tomogram, Electrocardiogram
Clinical narrative: Just want to give you heads up what happened after I left your office yesterday. At 8 last night I had started to not feel well and then it got worse. I had chest pains, palpitations and my blood pressure was up to 180. My daughter the NP was guiding me as I didn?t want to go to the ER  on holiday - I took extra aspirin amd Motrin amd then finally fell asleep till 5. I wasn?t 100% in the morning so we decided it?s not busy there so went in to do EkG and bloodwork.  I thought if all came back good we would be able to go home. The Er Dr for some reason called Dr. but it was his son and they thought I had a stent which was not true and decided to admit me so I could have a stress test done sometime tomorrow. I was so upset , so finally Dr. came in and I spoke to him and he heard the story about my shot, and agreed to do a cat Scan with contrast and if that was good I could go home amd do stress test next week.
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Malaise, Palpitations, Scan with contrast
Clinical narrative: Just want to give you heads up what happened after I left your office yesterday. At 8 last night I had started to not feel well and then it got worse. I had chest pains, palpitations and my blood pressure was up to 180. My daughter the NP was guiding me as I didn?t want to go to the ER  on holiday - I took extra aspirin amd Motrin amd then finally fell asleep till 5. I wasn?t 100% in the morning so we decided it?s not busy there so went in to do EkG and bloodwork.  I thought if all came back good we would be able to go home. The Er Dr for some reason called Dr. but it was his son and they thought I had a stent which was not true and decided to admit me so I could have a stress test done sometime tomorrow. I was so upset , so finally Dr. came in and I spoke to him and he heard the story about my shot, and agreed to do a cat Scan with contrast and if that was good I could go home amd do stress test next week.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Fluad Sr Dose given in error to 45 year old female.
Age: 24.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Gave a pediatric dose of Hep A to an adult. No signs or symptoms of adverse effect.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia
Clinical narrative: My husband was vaccinated on November 29, at approximately 11 am. The next day late at night he started with diplopia on the right side when turning his gaze. Later, diplopia when turning his gaze to the left side. Symptoms that continue to this day, reducing the problem on the left side. I contacted Dr. and he instructed me to administer eterocoxib 90 mg. one every 24 hours, orally, for three days. Rest of neurological clinical examination normal. It is worth mentioning that the influenza vaccine was also applied to the other arm.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC20, RV5
Symptoms: Diarrhoea
Clinical narrative: Mom states that 12 hours after vaccines were given, patient developed diarrhea.  Diarrhea continued for 3 weeks and occurred around the clock.
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: HCP calling to report that 45 y/o female patient received her "first dose of GARDASIL 9 about 6 months ago and is coming in today (11/6/2024) for her second dose because she was told she only needed 2 doses of GARDASIL 9, and to get her second shot i; No adverse event; This spontaneous report was received from Pharmacist and refers to a 45-year-old female. 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 in June 2024, also reported as 6 months ago, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, lot #, expiry date, anatomical location of vaccine and route of administration were not provided) administered for prophylaxis.  On 06-NOV-2024, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, lot #, expiry date, anatomical location of vaccine and route of administration were not provided) administered for prophylaxis. she reported  that she was told that she only needed 2 doses of the vaccine (inappropriate schedule of vaccine administered). At the reporting time, not additional Adverse event was reported.
Sex: F
Vaccine: RSV
Symptoms: Hypoaesthesia, Oxygen saturation decreased, Paraesthesia, Pneumonia, Presyncope
Clinical narrative: Patient was do with pneumonia; tingling in lower extremities; Numbness in lower extremities; near syncope; decreased oxygen level; This serious case was reported by a nurse via sales rep and described the occurrence of pneumonia in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2D3gZ) for prophylaxis.   Concurrent medical conditions included chronic obstructive pulmonary disease, diabetes mellitus and hypertension. Concomitant products included fluticasone furoate;umeclidinium bromide;vilanterol trifenatate (Trelegy).   On 15-OCT-2024, the patient received the 1st dose of Arexvy (right arm). On 16-OCT-2024, 1 days after receiving Arexvy, the patient experienced pneumonia (Verbatim: Patient was do with pneumonia) (serious criteria GSK medically significant), tingling of extremity (Verbatim: tingling in lower extremities) (serious criteria other: serious as per reporter), numbness of lower extremities (Verbatim: Numbness in lower extremities) (serious criteria other: serious as per reporter), presyncope (Verbatim: near syncope) (serious criteria other: serious as per reporter) and oxygen saturation decreased (Verbatim: decreased oxygen level) (serious criteria other: serious as per reporter). On 16-OCT-2024, the outcome of the tingling of extremity, numbness of lower extremities, presyncope and oxygen saturation decreased were resolved. The outcome of the pneumonia was not reported.   It was unknown if the reporter considered the pneumonia, tingling of extremity, numbness of lower extremities, presyncope and oxygen saturation decreased to be related to Arexvy.     The company considered the pneumonia, tingling of extremity, numbness of lower extremities, presyncope and oxygen saturation decreased to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 18-NOV-2024 Nurse reported that patient took 1st dose of Arexvy and experienced numbness and tingling in lower extremities, near syncope with decreased oxygen level.  Patient was do with pneumonia.; Sender's Comments: Pneumonia, Paraesthesia, Hypoaesthesia, Presyncope and  Oxygen saturation decreased are unlisted events which are considered unrelated to GSK vaccine Arexvy.
Sex: F
Vaccine: HEPAB
Symptoms: Asthenia, Dizziness, Heart rate increased, Insomnia, Muscular weakness
Clinical narrative: Muscle ache; Weakness; sleeplessness; slight dizzy; felt heartbeat; This non-serious case was reported by a consumer and described the occurrence of muscle pain in a 77-year-old female patient who received HAB (Twinrix adult) for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus (from 66 plus years). Concomitant products included insulin lispro (Humalog), rosuvastatin calcium (Crestor), valsartan (Diovan), dapagliflozin propanediol monohydrate (Farxiga), acetylsalicylic acid, dipyridamole (Aggrenox) and levothyroxine sodium (Levothyroxine).   On 18-SEP-2024, the patient received Twinrix adult. On 29-OCT-2024, 41 days after receiving Twinrix adult, the patient experienced muscle pain (Verbatim: Muscle ache), weakness (Verbatim: Weakness), sleeplessness (Verbatim: sleeplessness), dizziness (Verbatim: slight dizzy) and abnormal physical sensation (Verbatim: felt heartbeat). The outcome of the muscle pain, weakness, sleeplessness, dizziness and abnormal physical sensation were not resolved.   It was unknown if the reporter considered the muscle pain, weakness, sleeplessness, dizziness and abnormal physical sensation to be related to Twinrix adult and Twinrix Pre-Filled Syringe Device.     It was unknown if the company considered the muscle pain, weakness, sleeplessness, dizziness and abnormal physical sensation to be related to Twinrix adult and Twinrix 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: 04-NOV-2024 The patient self-reported this case. The patient received Twinrix adult and experienced muscle ache, sleeplessness, slight dizzy, felt heartbeat and weakness. The patient also received Humalog insulin, Crestor, Diovan, Farxiga, Aggrenox and Levothyroxine. The patient had type 1 diabetic for 66 plus years and very healthy and took vaccine for travel and was fine till vaccine.  The patient asked how long would the side effects last.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: transient pain at injection site; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a 41-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix) for prophylaxis.   On 16-OCT-2024, the patient received the 1st dose of Fluarix (left deltoid). On 19-OCT-2024, 3 days after receiving Fluarix, the patient experienced injection site pain (Verbatim: transient pain at injection site). The outcome of the injection site pain was not resolved.   The reporter considered the injection site pain to be related to Fluarix and Fluarix Pre-Filled Syringe Device.     The company considered the injection site pain to be related to Fluarix and Fluarix 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: 04-NOV-2024 The patient self-reported this case for herself. The patient received first dose of Fluarix at in-house event, had transient pain at injection site since a few days post-vaccination. The pain was reported as worsened.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: body aches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15-NOV-2024, the patient received the 1st dose of Shingrix. On 15-NOV-2024, less than a day after receiving Shingrix, the patient experienced general body pain (Verbatim: body aches). The outcome of the general body pain was not reported.   It was unknown if the reporter considered the general body pain to be related to Shingrix.     It was unknown if the company considered the general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date : 16-NOV-2024 This case was reported by a patient via interactive digital media. Patient reported that the he/she was at that age when just everything aches and had the first dose of the Shingrix vaccine on 15th November 2024. He/she had been sore all day long.  The patient was going early to bed, but did enjoy the empanadas he/she made and also made pork chops with gravy, plum sauce and sweet potato puree.  The patient's body aches but the belly was super happy and also happy to have finally gotten the shingles vaccine.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient was administered their third dose 1 month after the second dose; 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 patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received first dose of Twinrix on an unknown date). Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On an unknown date, the patient received the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: The patient was administered their third dose 1 month after the second dose). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-NOV-2024  The pharmacist reported that a patient received incorrect administration timing of their third Twinrix dose.  The patient was administered their third dose 1 month after the second dose.  The pharmacist did not know the exact dates of administration, product lot numbers, or any patient specific details at the time of reporting.  The patient received third dose of Twinrix shorter than the recommended interval which led to shortening of vaccination schedule. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-month-old female patient who received DTPa (Infanrix) (batch number 7HM5J, expiry date 13-SEP-2024) for prophylaxis.   On 04-NOV-2024, the patient received Infanrix. On 04-NOV-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired Product Used). 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: 04-NOV-2024 The nurse reported that a patient administered dose of Infanrix on 04-NOV-2024, which had an expiration date 13-SEP-2024, which led to expired vaccine used. At the time of reporting the dose was not been repeated. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received a first dose on October Twenty twenty three, and needs guidance on this matter; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2023).   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: received a first dose on October Twenty twenty three, and needs guidance on this matter). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-NOV-2024 The health care professional reported that a patient that received a first dose on October Twenty twenty three, and needs guidance on this matter.  Vaccination date (first dose) and patient gender retrieved, no further detail about vaccine detail and patient demographics were provided from the pharmacy technician´s end.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2024136848:Same reporter, different patient
Sex: F
Vaccine: HEP, HEP
Symptoms: Interchange of vaccine products
Clinical narrative: An adult female patient received the first dose of Engerix-B on 8/30/2024, and then on 11/2/2024 she received a dose of Heplisav.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 53-year-old female patient who received HBV (Engerix B) (batch number XS27B, expiry date 17-MAR-2025) for prophylaxis.   Co-suspect products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) for prophylaxis.   On 30-AUG-2024, the patient received the 1st dose of Engerix B. On 02-NOV-2024, the patient received Heplisav b. On an unknown date, an unknown time after receiving Engerix B, the patient experienced interchange of vaccine products (Verbatim: An adult female patient received the first dose of Engerix-B on 8/30/2024, and then on 11/2/2024 she received a dose of Heplisav.). The outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-NOV-2024 The pharmacist reported that a patient received first dose of Engerix B on 30-AUG-2024, and then on 02-NOV-2024, she received a dose of Heplisav, which led to interchange of vaccine products. The reporter was ask did the patient need to get second dose or how did they proceed.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received MMR (Priorix) (batch number 53F2A, expiry date 01-NOV-2024) for prophylaxis.   On 04-NOV-2024, the patient received the 1st dose of Priorix. On 04-NOV-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: expired vaccine used). 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: 04-NOV-2024 Medical Assistant reported 12 month old male patient was administered a dose of Priorix on 04th November 2024, which had an expiration date of 01st November 2024 which led to expired vaccine used. This was the patient first dose. At the time of reporting, the dose has not been repeated. The vaccine administration facility is the same as primary reporter.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: soreness at the injection site; Extra dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on 01-NOV-2023).   On 02-NOV-2024, the patient received the 2nd dose of Arexvy. On 02-NOV-2024, less than a day after receiving Arexvy, the patient experienced injection site pain (Verbatim: soreness at the injection site) and extra dose administered (Verbatim: Extra dose). The outcome of the injection site pain was not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the injection site pain to be related to Arexvy.     It was unknown if the company considered the injection site pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 04-NOV-2024 The case was self reported by patient. The patient received Arexvy vaccine on 01-NOV-2023 and another dose on 02-NOV-2024, which led to extra dose administered. The pharmacy did not aware she received the dose the year before by another pharmacy. The patient had only the soreness at the injection site.
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: experienced loose bowels that lasted 4 months; This non-serious case was reported by a consumer via call center representative and described the occurrence of loose bowel in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUN-2024, the patient received the 1st dose of Shingrix. In JUN-2024, 4 hrs after receiving Shingrix, the patient experienced loose bowel (Verbatim: experienced loose bowels that lasted 4 months). The outcome of the loose bowel was resolved (duration 4 months).   It was unknown if the reporter considered the loose bowel to be related to Shingrix.     It was unknown if the company considered the loose bowel to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR151727   Additional Information: GSK Receipt Date: 04-NOV-2024 The patient self-reported this case. The patient received his first Shingrix dose during the first week of June 2024 and soon after receiving the injection he experienced loose bowels that lasted 4 months.  He also stated that it had resolved when his 2nd dose was due 2 months later. This case is linked with US2024AMR151727, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR151727:same patient, 2nd dose case
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; 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 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number JT347, expiry date 30-SEP-2025) for prophylaxis.   On 02-NOV-2024, the patient received Menveo. On 02-NOV-2024, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 04-NOV-2024  The other health professional reported about a temperature excursion. The other health professional came to found out that one of the vaccines that were not viable, was administer to a patient. The Vaccine Administration Facility was the same as Primary Reporter. The other health professional mentioned that it was the Menveo 1 vial, the vaccine faced an excursion with a maximum temperature of 71.6 degree Fahrenheit, for 61 hours which led to incorrect storage of drug.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administration after the maximum interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 744AH) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on 29-DEC-2020 with batch number 744AH).   On 04-NOV-2024, the patient received the 2nd dose of Shingrix. On 04-NOV-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Administration after the maximum interval). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 04-NOV-2024  The pharmacist reported about the administration of the second dose of Shingrix after the maximum interval.  The patient received second dose of Shingrix longer than the recommended interval which led to lengthening of vaccination schedule. The Vaccine Administration Facility was the same as Primary Reporter