chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Joint lock
Clinical narrative: Approximately 19-20 hours following immunization, the patient was swinging on the playground at school and her shoulders locked up and she couldn't move them for a few minutes. Later that day, she yawned and had her jaw lock up for a few seconds. The jaw locking occurred twice. She has not experienced any other symptoms.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Aphasia, Depression, Intermenstrual bleeding, Memory impairment
Clinical narrative: 3 days later I started bleeding vaginally and it was not time for my period and the bleeding lasted 45 days. I have never had a history of irregular or heavy cycles. I have always been consistent/on time and normal. Once that was over, my periods were extremely irregular for the net 6 months. One it got back to normal, it was only a 25-26 day cycle where I used to have 28-29 day cycles. The next day I was waking up and there was a noise in my head that coinsides with the movement of my eyes. Once I was fully awake it would go away. It was like a high pitched shooting noise that happens in the waking period. It lasted 2 years and its only just now starting to go away. Also experienced pshycological effects. Trouble with sleeping and memory, word finding. Psychological distress, anxiety and depression. Not diagnosed, that is just how I felt.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Mental disorder, Sleep disorder, Tinnitus
Clinical narrative: 3 days later I started bleeding vaginally and it was not time for my period and the bleeding lasted 45 days. I have never had a history of irregular or heavy cycles. I have always been consistent/on time and normal. Once that was over, my periods were extremely irregular for the net 6 months. One it got back to normal, it was only a 25-26 day cycle where I used to have 28-29 day cycles. The next day I was waking up and there was a noise in my head that coinsides with the movement of my eyes. Once I was fully awake it would go away. It was like a high pitched shooting noise that happens in the waking period. It lasted 2 years and its only just now starting to go away. Also experienced pshycological effects. Trouble with sleeping and memory, word finding. Psychological distress, anxiety and depression. Not diagnosed, that is just how I felt.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Morphoea, Ultrasound scan, X-ray
Clinical narrative: morphea on shin  currently under care of dermatologist  waiting on  rheumatology appointment
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Decreased appetite, Dysstasia, Fatigue, Gait disturbance
Clinical narrative: Today she is here for adverse reaction she had to shingles shot on 7/3/2023.  About 2 weeks after that she noticed stiffness in hips and knees. Stood and almost fell. 5 weeks later we talked on 8/10/2023.  She states she is staggering. Unable to walk the way she used to. Loss of appetite, and major fatigue. She is really angry because she had joint pain before, but things are worse now. She has to hold on to things all the way to the bathroom when she first gets up. The longer she sits the stiffer she gets, then she takes minutes to be able to walk smoothly. Denies dizziness or headache. No tremor. Severe fatigue, no energy past 4pm.  Coming off Lyrica for sciatica, did not find it to be helpful.  Going to accupuncture.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint stiffness, Pain
Clinical narrative: Today she is here for adverse reaction she had to shingles shot on 7/3/2023.  About 2 weeks after that she noticed stiffness in hips and knees. Stood and almost fell. 5 weeks later we talked on 8/10/2023.  She states she is staggering. Unable to walk the way she used to. Loss of appetite, and major fatigue. She is really angry because she had joint pain before, but things are worse now. She has to hold on to things all the way to the bathroom when she first gets up. The longer she sits the stiffer she gets, then she takes minutes to be able to walk smoothly. Denies dizziness or headache. No tremor. Severe fatigue, no energy past 4pm.  Coming off Lyrica for sciatica, did not find it to be helpful.  Going to accupuncture.
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea, Loss of personal independence in daily activities
Clinical narrative: patient reports severe shortness of breath. pt was advised by provider to go to the hospital. she states that SOB was severe enough to limit daily activity. further advised patient to follow provider initial advice to be seen
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient presented to off site clinic looking for her second shingles vaccine. After receiving the shot, upon billing to her insurance, we were made aware that she had already had 2 doses of SHINGRIX.  Patient received a 3rd dose of SHINGRIX.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: She said her arm was red and swollen and she was diagnosed with cellulitis.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, HEP, PNC13, RV5
Symptoms: No adverse event
Clinical narrative: pt showed no symptoms . vaccines was given around 9am by mself.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Condition aggravated, Dementia Alzheimer's type, Hemiplegia, Speech disorder
Clinical narrative: 9 days after his first shot he took a massive stroke despite having no prior record of high blood pressure or anything.. he is still alive and paralyzed on his left side with his speech being very poor and it drastically fast tracked his alziemers diagnoses
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Cold sweat, Diarrhoea, Dizziness, Lethargy
Clinical narrative: Patient reported lethargy, dizziness, diarrhea, and a cold clammy feeling the next morning after receiving her vaccine. She reported lying down when symptoms began and sleeping for about 2-3 hours and her symptoms had resolved upon waking.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site nodule, Injection site swelling
Clinical narrative: Patient presented 2 days after receiving vaccination with hard, raised, red  nodule at injection site. Nodule was warm to the touch. Discussed watching perimeter of inflamed tissue and to seek medical care if worsening. Pt will monitor, and treat nodule with cold compress and OTC antihistamine for itching.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Injection site warmth
Clinical narrative: Patient presented 2 days after receiving vaccination with hard, raised, red  nodule at injection site. Nodule was warm to the touch. Discussed watching perimeter of inflamed tissue and to seek medical care if worsening. Pt will monitor, and treat nodule with cold compress and OTC antihistamine for itching.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Headache, Pain, Peripheral swelling, Rash, Skin warm
Clinical narrative: Localized eruption of skin on vaccine sight. Pt c/o c/o rash after IZ  IZs at WCC on 9/12/23 - mcv4, hpv, tdap - all 3 in L arm  states yesterday felt headache and body aches today got home from school and had swelling on L arm with warmth,  no open sores, discharge new izs to here were hpv and mvc4
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Contusion, Nodule
Clinical narrative: KNOT UNDER SKIN AND BRUISING IN THE AREA
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Left arm red and swollen and hot to the touch.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Cough, Injection site erythema
Clinical narrative: Cough developed the next day after vaccination.  A 3 by 5 inches bright red spot also appeared below injection site but not itchy.  Cough and red spot lingered 6 days. Patient did not seek any medical treatment.
Age: 76.0
Sex: M
Vaccine: FLUA4, RSV
Symptoms: Dyspnoea, Pruritus, Swelling face, Urticaria
Clinical narrative: Patient woke early the morning after vaccination feeling very itchy, upon looking in the mirror he realized he was covered in hives - breathing was slightly hindered, but not a lot. His face was also swollen.  He went to the ER where they administered benadryl and pepcid and was sent home with prescriptions for those as well as a medrol dose pack.  Time frame to reaction would have been about 14 hours later.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient had red arm about 4 inches and some itching and swelling,  I referred her to primary care prescriber or urgent care.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Disorientation, Pyrexia
Clinical narrative: Patient reports developing a fever (103 degrees), chills, and feeling disoriented.  Patient spent the night in the hospital. On the next day, patient reports overall improvement.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity, Rash, Rash pruritic, Urticaria
Clinical narrative: Patient said she was fine after receiving the vaccine and only experienced sore arm the night of receiving the vaccine. Patient said the next day (tues. Sept. 12th) was when she developed rashes all around her neck and welts on the side of her back. She said she took an antihistamine and applied cortisone which helped.  Patient says that the rash was extremely itchy. Patient came to the pharmacy on Thursday September 14th and said that her condition was improved.
Age: 67.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Contusion
Clinical narrative: large expanding bruise on right arm
Age: 0.08
Sex: M
Vaccine: RV5
Symptoms: Faeces discoloured, Haematochezia, Mucous stools, Occult blood positive
Clinical narrative: Blood streaked,  mucousy green stools started 1 day after vaccine (never present before). Still present 8 days after.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Fatigue, Hallucination, Hyperhidrosis
Clinical narrative: Around 11:00 p.m. on the same day as the shot, I had a very bad reaction. I was extremely dizzy and weak.  I would take a couple of steps forward, then a couple backward or sideways. I was sweating profusely and my whole mattress where I lay was wet. I never shook so severely in all my life and could not control it. That went on for about a half-hour. When back in bed I put two heavy blankets over me and that seemed to help. And I was hallucinating, something I'd never done before----When I looked at my bed, it was covered by hundreds of small, yellow, balls. The whole top of the bed was covered.  I was and am physically exhausted from this event.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Around 11:00 p.m. on the same day as the shot, I had a very bad reaction. I was extremely dizzy and weak.  I would take a couple of steps forward, then a couple backward or sideways. I was sweating profusely and my whole mattress where I lay was wet. I never shook so severely in all my life and could not control it. That went on for about a half-hour. When back in bed I put two heavy blankets over me and that seemed to help. And I was hallucinating, something I'd never done before----When I looked at my bed, it was covered by hundreds of small, yellow, balls. The whole top of the bed was covered.  I was and am physically exhausted from this event.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arteriogram normal, Blood creatinine increased, Cardiac stress test normal, Chest pain, Computerised tomogram normal
Clinical narrative: Back in Sept/ October 2021 chest would hurt when I took a deep breath and it would hurt down my neck to left shoulder & it would come and go and I had test after test after complaining about chest pain and Drs., my primary, an ER Dr. and a cardiologist said all test I had, CT scan, Xray, a breathing test, stress test, echocardiogram, arteriogram, covid test, all  came back normal, I had gone to an RA Dr. October 2021 and one of my blood markers was very high for inflammation, the RA Dr. said I didn't have arthritis & didn't understand why the high inflammation which now is back to normal.  I truly believe this is/was pericarditis the symptoms where too much like what I was going through, pain when taking deep breath, inflammation, never ever in my life had anything like this, which I told every Dr I believed it was pericarditis from the vaccine & of course they didn't agree at that time with me. I had the 2nd Pzifer shot in June 2021. I'm just hope I'm over this.  MY UPDATE Jan 2023,  the pain finally stopped about a year ago Jan 2022 and haven't had it since.  When I was going to the RA Dr back in Oct 2021 my SED  rate which shows inflammation in your body,  was so high back in October 2021 she did start me on methotrexate and I think that must have helped.  Now in 2023 I'm going to a kidney dr. because since 6/2021 right after the vaccine my creatinine marker has increased, and I have to have a kidney biopsy.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram normal, Inflammation, Inflammatory marker increased, Injection site pain, Laboratory test
Clinical narrative: Back in Sept/ October 2021 chest would hurt when I took a deep breath and it would hurt down my neck to left shoulder & it would come and go and I had test after test after complaining about chest pain and Drs., my primary, an ER Dr. and a cardiologist said all test I had, CT scan, Xray, a breathing test, stress test, echocardiogram, arteriogram, covid test, all  came back normal, I had gone to an RA Dr. October 2021 and one of my blood markers was very high for inflammation, the RA Dr. said I didn't have arthritis & didn't understand why the high inflammation which now is back to normal.  I truly believe this is/was pericarditis the symptoms where too much like what I was going through, pain when taking deep breath, inflammation, never ever in my life had anything like this, which I told every Dr I believed it was pericarditis from the vaccine & of course they didn't agree at that time with me. I had the 2nd Pzifer shot in June 2021. I'm just hope I'm over this.  MY UPDATE Jan 2023,  the pain finally stopped about a year ago Jan 2022 and haven't had it since.  When I was going to the RA Dr back in Oct 2021 my SED  rate which shows inflammation in your body,  was so high back in October 2021 she did start me on methotrexate and I think that must have helped.  Now in 2023 I'm going to a kidney dr. because since 6/2021 right after the vaccine my creatinine marker has increased, and I have to have a kidney biopsy.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Painful respiration, Red blood cell sedimentation rate increased, SARS-CoV-2 test negative, X-ray normal
Clinical narrative: Back in Sept/ October 2021 chest would hurt when I took a deep breath and it would hurt down my neck to left shoulder & it would come and go and I had test after test after complaining about chest pain and Drs., my primary, an ER Dr. and a cardiologist said all test I had, CT scan, Xray, a breathing test, stress test, echocardiogram, arteriogram, covid test, all  came back normal, I had gone to an RA Dr. October 2021 and one of my blood markers was very high for inflammation, the RA Dr. said I didn't have arthritis & didn't understand why the high inflammation which now is back to normal.  I truly believe this is/was pericarditis the symptoms where too much like what I was going through, pain when taking deep breath, inflammation, never ever in my life had anything like this, which I told every Dr I believed it was pericarditis from the vaccine & of course they didn't agree at that time with me. I had the 2nd Pzifer shot in June 2021. I'm just hope I'm over this.  MY UPDATE Jan 2023,  the pain finally stopped about a year ago Jan 2022 and haven't had it since.  When I was going to the RA Dr back in Oct 2021 my SED  rate which shows inflammation in your body,  was so high back in October 2021 she did start me on methotrexate and I think that must have helped.  Now in 2023 I'm going to a kidney dr. because since 6/2021 right after the vaccine my creatinine marker has increased, and I have to have a kidney biopsy.
Age: 81.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Cough, Diarrhoea, Headache, SARS-CoV-2 test negative
Clinical narrative: Patient reports diarrhea starting the morning following vaccination and continuing now for 5 days. She has been on a BRAT diet and her PCP offer testing a stool sample. Her insurance will not pay for stool sample test unless diarrhea lasts 7+ days and she plans to follow up if needed. She also reports a headache and cough starting today.
Age: 78.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Contusion, Dizziness, Eye contusion, Fall, Nausea
Clinical narrative: Patient reported upon awakening Saturday morning (day after vaccines were received 9/9/23) she was very dizzy and nausea. These symptoms went on into the next day, Sunday at which the patient had a fall that resulted in the ER. When she came to the pharmacy today she had black eyes and bruises on her face from the fall. Said she was still having symptoms and had just seen her PCP for the symptoms. Was given zofran and scopolamine patches to help with signs and symptoms.
Age: 81.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Dyspnoea, Gait disturbance
Clinical narrative: Patient reported that she experienced extrem shortness of breath around 9pm the evening she received the RSV vaccine. She said it was so severe she could not walk up the stairs and she almost called EMS. The incident resolved completely after about 30 minutes and she reported no residual effects.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID vaccine breakthrough case. Pfizer 1/25/21 EL9261, 2/15/21 EM9810, 11/29/21 FJ8762
Age: 0.5
Sex: F
Vaccine: PNC15, PNC15, PNC15, PNC15
Symptoms: Syringe issue
Clinical narrative: No symptoms reported.; IBC from an HCP calling with a PQC on 1 VAXENUEVANCE syringe that was not part of the recalled lots. When asked for the details of the product quality complaint, the HCP stated transferred the call to the nurse who administered the vaccine. Spoke wit; IBC from an HCP calling with a PQC on 1 VAXENUEVANCE syringe that was not part of the recalled lots. When asked for the details of the product quality complaint, the HCP stated transferred the call to the nurse who administered the vaccine. Spoke wit; the plastic part by the plunger of the VAXNEUVANCE syringe was broken off on the circular ring while administering the vaccine; This spontaneous report was received from other health professional and referred to a 6-month-old female patient. The patient's medical history, concurrent condition, and concomitant therapy were not reported.  On 08-SEP-2023, the patient received the third dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringe, 0.5 milliliter injection, quantity: 1 (valid lot #X019197 with reported expiration date: 30-AUG-2025), administered intramuscularly as immunization.  When asked for the details of the product quality complaint, it was reported that the plastic part by the plunger of the vaccine was broken off on the circular ring while administering the vaccine (Syringe issue). The nurse (HCP) who administered the vaccine got a "little scratch" on her right hand due to the breakage of the syringe while administering the injection (information was entered into MARRS# 2309USA003698). The vaccine with the product quality issue was administered to the patient (Poor quality product used and poor quality device used). There were no symptoms reported and no missed doses (no adverse event).   This is two report from a same reporter. ; Sender's Comments:  US-009507513-2309USA003698:MSD
Age: 0.5
Sex: F
Vaccine: PNC15, PNC15, PNC15, PNC15
Symptoms: No adverse event, Poor quality product administered, Syringe issue
Clinical narrative: No symptoms reported.; IBC from an HCP calling with a PQC on 1 VAXENUEVANCE syringe that was not part of the recalled lots. When asked for the details of the product quality complaint, the HCP stated transferred the call to the nurse who administered the vaccine. Spoke wit; IBC from an HCP calling with a PQC on 1 VAXENUEVANCE syringe that was not part of the recalled lots. When asked for the details of the product quality complaint, the HCP stated transferred the call to the nurse who administered the vaccine. Spoke wit; the plastic part by the plunger of the VAXNEUVANCE syringe was broken off on the circular ring while administering the vaccine; This spontaneous report was received from other health professional and referred to a 6-month-old female patient. The patient's medical history, concurrent condition, and concomitant therapy were not reported.  On 08-SEP-2023, the patient received the third dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringe, 0.5 milliliter injection, quantity: 1 (valid lot #X019197 with reported expiration date: 30-AUG-2025), administered intramuscularly as immunization.  When asked for the details of the product quality complaint, it was reported that the plastic part by the plunger of the vaccine was broken off on the circular ring while administering the vaccine (Syringe issue). The nurse (HCP) who administered the vaccine got a "little scratch" on her right hand due to the breakage of the syringe while administering the injection (information was entered into MARRS# 2309USA003698). The vaccine with the product quality issue was administered to the patient (Poor quality product used and poor quality device used). There were no symptoms reported and no missed doses (no adverse event).   This is two report from a same reporter. ; Sender's Comments:  US-009507513-2309USA003698:MSD
Age: 0.5
Sex: F
Vaccine: PNC15, PNC15, PNC15, PNC15
Symptoms: Injury, Scratch, Syringe issue
Clinical narrative: No symptoms reported.; IBC from an HCP calling with a PQC on 1 VAXENUEVANCE syringe that was not part of the recalled lots. When asked for the details of the product quality complaint, the HCP stated transferred the call to the nurse who administered the vaccine. Spoke wit; IBC from an HCP calling with a PQC on 1 VAXENUEVANCE syringe that was not part of the recalled lots. When asked for the details of the product quality complaint, the HCP stated transferred the call to the nurse who administered the vaccine. Spoke wit; the plastic part by the plunger of the VAXNEUVANCE syringe was broken off on the circular ring while administering the vaccine; This spontaneous report was received from other health professional and referred to a 6-month-old female patient. The patient's medical history, concurrent condition, and concomitant therapy were not reported.  On 08-SEP-2023, the patient received the third dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringe, 0.5 milliliter injection, quantity: 1 (valid lot #X019197 with reported expiration date: 30-AUG-2025), administered intramuscularly as immunization.  When asked for the details of the product quality complaint, it was reported that the plastic part by the plunger of the vaccine was broken off on the circular ring while administering the vaccine (Syringe issue). The nurse (HCP) who administered the vaccine got a "little scratch" on her right hand due to the breakage of the syringe while administering the injection (information was entered into MARRS# 2309USA003698). The vaccine with the product quality issue was administered to the patient (Poor quality product used and poor quality device used). There were no symptoms reported and no missed doses (no adverse event).   This is two report from a same reporter. ; Sender's Comments:  US-009507513-2309USA003698:MSD
Age: 0.5
Sex: F
Vaccine: PNC15, PNC15, PNC15, PNC15
Symptoms: Injury, Injury associated with device, Poor quality device used, Scratch, Skin laceration
Clinical narrative: No symptoms reported.; IBC from an HCP calling with a PQC on 1 VAXENUEVANCE syringe that was not part of the recalled lots. When asked for the details of the product quality complaint, the HCP stated transferred the call to the nurse who administered the vaccine. Spoke wit; IBC from an HCP calling with a PQC on 1 VAXENUEVANCE syringe that was not part of the recalled lots. When asked for the details of the product quality complaint, the HCP stated transferred the call to the nurse who administered the vaccine. Spoke wit; the plastic part by the plunger of the VAXNEUVANCE syringe was broken off on the circular ring while administering the vaccine; This spontaneous report was received from other health professional and referred to a 6-month-old female patient. The patient's medical history, concurrent condition, and concomitant therapy were not reported.  On 08-SEP-2023, the patient received the third dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringe, 0.5 milliliter injection, quantity: 1 (valid lot #X019197 with reported expiration date: 30-AUG-2025), administered intramuscularly as immunization.  When asked for the details of the product quality complaint, it was reported that the plastic part by the plunger of the vaccine was broken off on the circular ring while administering the vaccine (Syringe issue). The nurse (HCP) who administered the vaccine got a "little scratch" on her right hand due to the breakage of the syringe while administering the injection (information was entered into MARRS# 2309USA003698). The vaccine with the product quality issue was administered to the patient (Poor quality product used and poor quality device used). There were no symptoms reported and no missed doses (no adverse event).   This is two report from a same reporter. ; Sender's Comments:  US-009507513-2309USA003698:MSD
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event, Product preparation issue
Clinical narrative: No additional AE; Caller reported AE on behalf of a patient who received a vaccination of PROQUAD with expired STERILE DILUENT (no prior TEs). No symptoms reported. Obtained consent to contact HCP. AE Filed (Case #02463502). No additional AE/PQC.; Caller reported AE on behalf of a patient who received a vaccination of PROQUAD with expired STERILE DILUENT (no prior TEs).; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information on patient's medical history,current conditions and concomitant medications were not reported.  On 30-AUG-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #W024972, expiration date: 05-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). and expired sterile diluent (STERILE DILUENT), lot # U012698 and expiration date 25-AUG-2023 for prophylaxis (exact dose, dose number, route and site of administration were not provided) was used during vaccination with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (expired product administered, product preparation issue and no adverse event).
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Wrong product administered
Clinical narrative: no symptomatic adverse events were reported/ no additional AE; PROQUAD and VARIVAX concomitantly instead of MMR-II and VARIVAX; accidently administered PROQUAD and VARIVAX; This spontaneous report was received from a nurse referring to a 12-month-old patient of unspecified age. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was unknown.   On 01-SEP-2023, the patient was administered varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (ml) (route of administration was not reported; lot number W021740 has been verified to be valid, expiration date reported and established as 10-JUL-2024) as prophylaxis. On the same date, the patient accidentally received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) 0.5 ml (route of administration was not reported; lot number W036929 has been verified to be valid, expiration date reported and established as 19-MAY-2024) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as prophylaxis (wrong product administered, accidental overdose).  No symptomatic adverse events were reported (no adverse event).
Age: 12.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No side effects; Patient given PROQUAD and VARIVAX at the same time; This spontaneous report was received from a registered nurse, referring to a 12-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 23-AUG-2023, the patient was given at the same time measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (strength, dose, route, anatomical location, lot #, and expiry date were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, lot #, expiry date, and route of administration were not provided); both administered one time for prophylaxis (overdose). No side effects were reported.
Age: 80.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient said extremely swollen and red arm. Never followed up with the pharmacy and didnt say how long after the shot. She was still in viscinity of pharmacy for 10 minutes after the immunization and did not mention any reaction to pharmacy.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Haematology test, Skin discolouration, Thalamic infarction
Clinical narrative: thrombocytopenia,  bruising and skin changes (brown) eventually
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 2nd dose yet; 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 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 12 months ago with batch number 4CN95 and expiry date 15 September 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: not received 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 05-SEP-2023 The reporter reported that he/she had a patient in office who received the first Shingrex dose 12 months ago.  The reporter wanted to know if he still eligible for a booster or he need to restart series. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: dose of MENQUADFI after the second excursion the temperature reach 0.5 C for 32 minutes/ vaccines were given after the first 3 excursion, with no reported adverse event; Initial information received on 08-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2023SA276685.  This case involves a 11-years-old female patient who was administered dose of meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] after the second excursion (the temperature reached 0.5 c for 32 minutes) and after the first 3 excursion, with no reported adverse event while receiving vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Aug-2023, the patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (T conj) vaccine, solution for injection (batch number: U7673AB; expiry date: 29-Jun-2025) via intramuscular route in the left deltoid for Immunization after the second excursion the temperature reach 0.5 c for 32 minutes and after the first 3 excursion, with no reported adverse event (poor quality product administered) (same day latency).   Reportedly, Temperature excursion details were on 28Aug2023 for 3 hours 31 minutes at 2.1 C to 10.7 C; On 29Aug2023 for 32 minutes at 0.5 C to 6.5 C On 30Aug2023 for 2 hours 1 minutes at 1.0 C to 5.3 C On 31Aug2023 for 3 hours 32 minutes at -0.4 C to 6.0 C; Reason: the refrigerator malfunctioned; Human error: No.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Autoimmune disorder, Dermatitis atopic, Headache, Multiple allergies
Clinical narrative: LOT OF ALLERGIES; HEADACHES; SHILREN'S DISEASE; SEVERE ATOPIC DERMATITIS (ECZEMA); PHOTOSENSITIVITY TO THE SUN ON ENTIRE BODY; AUTOIMMUNE DISEASE; This spontaneous report received from a patient via a company representative concerned a 45 year old female of unspecified ethnicity. The patient's weight was 140 pounds, and height was 62 inches. The patient's concurrent conditions included: penicillin allergy, and graves disease (in remission for 12 years), and other pre-existing medical conditions included: Patient was healthy before. The patient experienced drug allergy when treated with amoxicillin, topical steroid, atenolol, ciclosporin, erythromycin, and hydroxyzine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered at deltoid (unspecified) on 09-AUG-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 45 years old. No concomitant medications were reported. In 2021 (since vaccination), the patient had been sick for two years, and still sick from it. The physicians tried to figure out what happened for the past two years, and they were now saying it was from the Janssen COVID-19 Vaccine. The patient had contacted allergies to 12 different things (allergies to medication). The patient had a lot of allergies and lot of things were wonky. Laboratory data (dates unspecified) included: Graves antibodies were through the roof. In 2021, the patient got autoimmune disease which no one knew where it came from. On AUG-2021 (within two week of vaccination), the patient had photosensitivity to the sun on entire body, eczema, severe atopic dermatitis, and diagnosed with Shilren's disease. Since the vaccination patient had photosensitivity to the sun which patient never had before to the point the COVID vaccine caused all this. The patient went to phototherapy twice a week now to make sure she can go outside. The patient wanted to get better because patient was sick of the vaccine. The patient did not use topical steroid anymore since had an adverse event to the vaccine. On an unspecified date, the patient experienced headaches and had a lot of allergies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, severe atopic dermatitis (eczema), photosensitivity to the sun on entire body, lot of allergies, autoimmune disease, and shilren's disease.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230911709-Autoimmune disease. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Photosensitivity reaction, Unevaluable event
Clinical narrative: LOT OF ALLERGIES; HEADACHES; SHILREN'S DISEASE; SEVERE ATOPIC DERMATITIS (ECZEMA); PHOTOSENSITIVITY TO THE SUN ON ENTIRE BODY; AUTOIMMUNE DISEASE; This spontaneous report received from a patient via a company representative concerned a 45 year old female of unspecified ethnicity. The patient's weight was 140 pounds, and height was 62 inches. The patient's concurrent conditions included: penicillin allergy, and graves disease (in remission for 12 years), and other pre-existing medical conditions included: Patient was healthy before. The patient experienced drug allergy when treated with amoxicillin, topical steroid, atenolol, ciclosporin, erythromycin, and hydroxyzine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered at deltoid (unspecified) on 09-AUG-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 45 years old. No concomitant medications were reported. In 2021 (since vaccination), the patient had been sick for two years, and still sick from it. The physicians tried to figure out what happened for the past two years, and they were now saying it was from the Janssen COVID-19 Vaccine. The patient had contacted allergies to 12 different things (allergies to medication). The patient had a lot of allergies and lot of things were wonky. Laboratory data (dates unspecified) included: Graves antibodies were through the roof. In 2021, the patient got autoimmune disease which no one knew where it came from. On AUG-2021 (within two week of vaccination), the patient had photosensitivity to the sun on entire body, eczema, severe atopic dermatitis, and diagnosed with Shilren's disease. Since the vaccination patient had photosensitivity to the sun which patient never had before to the point the COVID vaccine caused all this. The patient went to phototherapy twice a week now to make sure she can go outside. The patient wanted to get better because patient was sick of the vaccine. The patient did not use topical steroid anymore since had an adverse event to the vaccine. On an unspecified date, the patient experienced headaches and had a lot of allergies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, severe atopic dermatitis (eczema), photosensitivity to the sun on entire body, lot of allergies, autoimmune disease, and shilren's disease.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230911709-Autoimmune disease. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 0.58
Sex: M
Vaccine: MEN
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: reports that a 7-month old patient received menquadfi with no reported adverse event; Initial information received on 08-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 7-months-old male patient who received meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13V (CRM197) (Prevnar 13); and Rotavirus Vaccine for Prophylactic vaccination (immunization).  On 08-Sep-2023 at 09:00 hours, the 7-month old patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (T conj) vaccine, solution for injection (batch number: U7616AB via intramuscular route in the upper thigh NOS for Immunization with no reported adverse event (product administered to patient of inappropriate age) (same day latency).  Reportedly, the MENQUADFI was given in error because the staff mixed up the vaccines.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Injection site reaction pain swelling and redness; Injection site reaction pain swelling and redness; Injection site reaction pain swelling and redness; Fever over 100; Dizziness; Nausea; Severe Headache; Neck pain; Trouble speaking; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a 62-year-old female 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 injection site pain (Verbatim: Injection site reaction pain swelling and redness), injection site swelling (Verbatim: Injection site reaction pain swelling and redness), injection site erythema (Verbatim: Injection site reaction pain swelling and redness), fever (Verbatim: Fever over 100), dizziness (Verbatim: Dizziness), nausea (Verbatim: Nausea), headache (Verbatim: Severe Headache), neck pain (Verbatim: Neck pain) and speech disorder (Verbatim: Trouble speaking). The outcome of the injection site pain, injection site swelling, injection site erythema, fever, dizziness, nausea, headache, neck pain and speech disorder were resolved (duration 96 hrs).   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, fever, dizziness, nausea, headache, neck pain and speech disorder to be related to Arexvy.     It was unknown if the company considered the injection site pain, injection site swelling, injection site erythema, fever, dizziness, nausea, headache, neck pain and speech disorder to be related to Arexvy.   Additional Information: GSK Receipt Date: 07-SEP-2023 Reporter stated after the administration of Arexvy vaccine patient suffered for 96 hours of reported symptoms (injection site pain, injection site swelling, injection site erythema, fever, dizziness, nausea, headache, neck pain and speech disorder). The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Nausea, Neck pain, Speech disorder
Clinical narrative: Injection site reaction pain swelling and redness; Injection site reaction pain swelling and redness; Injection site reaction pain swelling and redness; Fever over 100; Dizziness; Nausea; Severe Headache; Neck pain; Trouble speaking; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a 62-year-old female 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 injection site pain (Verbatim: Injection site reaction pain swelling and redness), injection site swelling (Verbatim: Injection site reaction pain swelling and redness), injection site erythema (Verbatim: Injection site reaction pain swelling and redness), fever (Verbatim: Fever over 100), dizziness (Verbatim: Dizziness), nausea (Verbatim: Nausea), headache (Verbatim: Severe Headache), neck pain (Verbatim: Neck pain) and speech disorder (Verbatim: Trouble speaking). The outcome of the injection site pain, injection site swelling, injection site erythema, fever, dizziness, nausea, headache, neck pain and speech disorder were resolved (duration 96 hrs).   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, fever, dizziness, nausea, headache, neck pain and speech disorder to be related to Arexvy.     It was unknown if the company considered the injection site pain, injection site swelling, injection site erythema, fever, dizziness, nausea, headache, neck pain and speech disorder to be related to Arexvy.   Additional Information: GSK Receipt Date: 07-SEP-2023 Reporter stated after the administration of Arexvy vaccine patient suffered for 96 hours of reported symptoms (injection site pain, injection site swelling, injection site erythema, fever, dizziness, nausea, headache, neck pain and speech disorder). The reporter consented to follow up.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Client had reaction after vaccination- client became light headed and sweaty, water was given, VS were taken, P60, BP110/70, SPO2 97%. Client recovered and left after sitting 15 minute in waiting area.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired
Age: 1.25
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Wrong product administered
Clinical narrative: PROQUAD was given instead of MMR, so patient got 2 doses of varicella vaccine at the same time