chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV, HIBV, HIBV
Symptoms: Device issue, Poor quality product administered
Clinical narrative: bubbles in the Prefilled Syringes/terrible time drawing the vaccines back out of the reconstituted vial; Product Complaint; Administration of defective vaccine 14 May; Administration of defective vaccine 13MAY; This non-serious case was reported by a other health professional via sales rep and described the occurrence of product administration error in a patient who received Hib (Hiberix) (batch number 5C934, expiry date 14-MAR-2026) and (batch number 73FP5, expiry date 12-JUN-2027) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included Hib (Hiberix) (batch number 5C934, expiry date 14-MAR-2026) and (batch number 73FP5, expiry date 12-JUN-2027) for prophylaxis and Hib (Hiberix) (batch number 5C934, expiry date 14-MAR-2026) and (batch number 73FP5, expiry date 12-JUN-2027) for prophylaxis.   On 14-MAY-2024, the patient received Hiberix. On 13-MAY-2024, the patient received Hiberix. On 13-MAY-2024, the patient received Hiberix. On 13-MAY-2024, not applicable after receiving Hiberix and an unknown time after receiving Hiberix and Hiberix, the patient experienced product administration error (Verbatim: Administration of defective vaccine 13MAY). On 14-MAY-2024, the patient experienced product administration error (Verbatim: Administration of defective vaccine 14 May). On an unknown date, the patient experienced device use error (Verbatim: bubbles in the Prefilled Syringes/terrible time drawing the vaccines back out of the reconstituted vial) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the product administration error, product administration error, device use error and pharmaceutical product complaint were unknown.   Additional Information: GSK receipt date: 15-MAY-2024 The reporter was a medical assistance at a medical facility. Health care professional reported having difficulty withdrawing the vaccine from the reconstituted vial.  The previous three vaccines had a similar issue, the needle was unscrewed off while it was in the reconstitute vial and the product leaked out. The defect was discovered during preparation and/or administration. The mixing/shaking performed after reconstitution with gently, vigorously, laterally and upside-down. The reporter was asked approximately how much vaccine was left in the affected vial, was the stopper pierced in the circular area dedicated to perforation, was air injected into the vial and if so, how much air was injected. Three Hiberix vaccines but they had a terrible time drawing the vaccines back out of the reconstituted vial, they saw only bubbles in the Prefilled Syringes, but they were able to do it, they got it done, and then they were about to administer a fourth one, they could not even draw it up, so they needed to unscrew the needle which means that the liquid diluent came out and the vaccine was not administered, but they thought might be they were doing something wrong or the batch has a malfunction.
Age: 20.0
Sex: F
Vaccine: YF
Symptoms: Confusional state, Loss of consciousness, Nausea
Clinical narrative: Patient arrived at clinic to get yellow fever vaccine and typhoid vaccine. Was informed by provider and patient that patient has a history of passing out when receiving vaccines and getting labs done. Was advised by provider if patient has a syncope to lower head of bed and raise legs. Patient was sitting on clinic bed in an upright positing with head rest up and partner holding her hand. Patient was given yellow fever vaccine. Patient reported she did not feel it and continued to talk with her partner. She stated she want to rest before getting the vaccine. About a minute later patient stated she felt nauseous and passed out, partner was still holding her hand. Nurse lowered the head of bed and lifted legs. Nurse then called out for assistance. Provider arrived as patient was waking up and medical assistant brought vital sign machine. Provider assessed patient- patient was confused when waking up and then became alert and oriented. Vitals were taken and were stable. Patient apologized for passing out and clinical staff reassured her that she had nothing to be sorry about. Patient then expressed the want to get the next vaccine-typhoid. Patient was informed by provider that she can come back for typhoid vaccine and did not have to get it that day. Patient insisted on getting the typhoid vaccine. Provider wanted patient to be monitored and vitals taken every 5 minutes for 15 minutes. Patient vitals were stable and relayed to provider. Patient still wanted to get vaccine and provider okayed patient getting the typhoid vaccine. Patient requested to stay in a lying position when getting the next vaccine. Patient received typhoid vaccine with no issues- she did not have a syncope episode and continued to talk with her partner. Patient was monitored for an additional 15 minutes and vital taken after the minutes. Patient expressed that she felt fine and denies any issues of complaints. Patient and partner walked out to checkout.
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Confusional state, Delirium, Dizziness, Dyskinesia, Headache
Clinical narrative: Reported Symptoms: 10012218:DELIRIUM; 10019211:HEADACHE; 10042772:SYNCOPE; Narrative: Patient reports receiving flu vaccine 10/20/22 at clinic, around 1930 10/20/22 - almost passed out standing up, sat down, lost consciousness for a few seconds, girlfriend states that patient was jerking, eyes stayed open, had confusion and severe headache last night. Denies hitting head. Headache is mild today, has some dizziness. Hx seizures in past, this one was not similar. Other Relevant HX: Other: SYNCOPE; DELIRIUM; HEADACHE
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Loss of consciousness, Presyncope, Syncope
Clinical narrative: Reported Symptoms: 10012218:DELIRIUM; 10019211:HEADACHE; 10042772:SYNCOPE; Narrative: Patient reports receiving flu vaccine 10/20/22 at clinic, around 1930 10/20/22 - almost passed out standing up, sat down, lost consciousness for a few seconds, girlfriend states that patient was jerking, eyes stayed open, had confusion and severe headache last night. Denies hitting head. Headache is mild today, has some dizziness. Hx seizures in past, this one was not similar. Other Relevant HX: Other: SYNCOPE; DELIRIUM; HEADACHE
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash, Skin reaction
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: 43 y/o female s/p significant skin reaction to moderna covid-19 booster which was given 07JAN2022 at 1500. patient developed redness, swelling and itching from shoulder to elbow. patient still having redness and itchness today, however sx are slowly resolving. Other Relevant HX: Other:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Reported Symptoms: 10025197:LYMPHADENOPATHY; Narrative: Other Relevant HX: Other: LYMPHADENOPATHY
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia
Clinical narrative: Reported Symptoms: 10025197:LYMPHADENOPATHY; 10028322:MUSCLE PAIN; 10028411:MYALGIA; Narrative: Other Relevant HX: Other: MUSCLE PAIN; LYMPHADENOPATHY
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Reported Symptoms: 10066434:EXPIRED DRUG ADMINISTERED; Narrative: Patient presented to pcp office for booster vaccine. After administration of vaccine RN noticed that the vaccine was expired. Patient safety was entered and all additional expired medication was removed. Patient alerted and instructed to monitor for any s/s of isssues with the injection site. No reported issues at the time of report. Other Relevant HX: Other: expired med administered
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Reported Symptoms: 10000424:ACHE; 10005911:BODY TEMPERATURE INCREASED; 10016558:FEVER; 10028813:NAUSEA; 10047700:VOMITING; Narrative: Other Relevant HX: Other: INCREASED BODY TEMPERATURE, BODY ACHES, FEVER, NAUSEA, VOMITING
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Reported Symptoms: 10042674:SWELLING; Narrative: Other Relevant HX: Other: R arm swelling to fingers
Age: 30.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Gave pt a pediatric dose of havrix pt contacted to return for an adult dose today 05/30/2023
Age: 29.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event
Clinical narrative: no known adverse reaction
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: None, the dose was given 12 days after expiration date. Contacted Moderna after analysis  dose found to have been effective still in vaccinating for COVID 19.. No harm to patient
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Pain, Ultrasound scan normal
Clinical narrative: Immediately I had a throbbing pain which I was assured would go away quickly.  It did not.  The pain became more of a shooting pain from the injection site.  Over the weeks that followed the injection site was very painful to the mere touch.  As time went on if the site was bumped an intense shooting pain would happen.  This pain, after years, is more of a constant dull ache, but has never gone away.  If it is touched with any pressure - like if someone grabs my arm to say hello or lead my direction - the pain is as intense as the day the injection was given
Age: 16.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine not appropriate for age; no reaction
Age: 5.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site cellulitis, Injection site erythema, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Red, hot, welted cellulitis of thigh
Age: 58.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: right arm injection - pt presented to pharmacy with redness around entire deltoid (redness the most at injection site), swollen at site of injection, and painful and hot to the touch per pt. Pt stated this has been occurring for 6 days with no signs of improvement
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC20, VARCEL
Symptoms: Dyskinesia, Fatigue, Infant irritability, Nasal congestion, Posture abnormal
Clinical narrative: Called PCP office on 05/29 around 4:30pm, expressed to nurse pt had tmax 101.8 earlier in the morning and had been given tylenol.  parents noticed as pt was playing, he would occasionally "hung over and scrunch" multiple times in a 10 minute period.  seemed cranky and tired but still playing and wetting diapers - Doctor consult referred pt to ED.                                                                                                  ED NOTE : Patient is a 12 month old male ex 31 week gestation with no chronic medical conditions who presents with fever and abnormal movements.    Exam reveals a febrile, fussy but consolable, overall hydrated and stable appearing 12 m/o male with no focal neurologic findings on exam. Fever most likely secondary to viral syndrome given presence of nasal congestion - no increased WOB concerning for bronchiolitis and no focal bacterial exam findings I.e. neck supple, TM normal b/l, lungs clear b/l, low UTI calc score    Primary concern at this time is complex febrile seizure given components of focality and repetativeness v benign tics of childhood  Infantile spasms considered however appearance not consistent and patient upper age for diagnosis.  Reassuring that patient is back to baseline making IC processes less likely. No history placing patient at risk of metabolic disturbances . Neuro consulted.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC20, VARCEL
Symptoms: Pyrexia, Viral infection
Clinical narrative: Called PCP office on 05/29 around 4:30pm, expressed to nurse pt had tmax 101.8 earlier in the morning and had been given tylenol.  parents noticed as pt was playing, he would occasionally "hung over and scrunch" multiple times in a 10 minute period.  seemed cranky and tired but still playing and wetting diapers - Doctor consult referred pt to ED.                                                                                                  ED NOTE : Patient is a 12 month old male ex 31 week gestation with no chronic medical conditions who presents with fever and abnormal movements.    Exam reveals a febrile, fussy but consolable, overall hydrated and stable appearing 12 m/o male with no focal neurologic findings on exam. Fever most likely secondary to viral syndrome given presence of nasal congestion - no increased WOB concerning for bronchiolitis and no focal bacterial exam findings I.e. neck supple, TM normal b/l, lungs clear b/l, low UTI calc score    Primary concern at this time is complex febrile seizure given components of focality and repetativeness v benign tics of childhood  Infantile spasms considered however appearance not consistent and patient upper age for diagnosis.  Reassuring that patient is back to baseline making IC processes less likely. No history placing patient at risk of metabolic disturbances . Neuro consulted.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Blood glucose, Crying, Full blood count, Haematochezia, Infant irritability
Clinical narrative: Mild fussiness beginning within first 24 hours, some spitting.  Evaluation in clinic on 3/21/24 with blood in stool, poor color and weight loss of 9 oz.  Phone consult with GI and observation at home with clinic f/u 3/22/24.  Continued fussiness, some spitting and crying out like cramping pain and weight loss of additional 2 oz.   Refer to ER.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Infantile spitting up, Intussusception, Muscle spasms, Ultrasound scan abnormal, Weight decreased
Clinical narrative: Mild fussiness beginning within first 24 hours, some spitting.  Evaluation in clinic on 3/21/24 with blood in stool, poor color and weight loss of 9 oz.  Phone consult with GI and observation at home with clinic f/u 3/22/24.  Continued fussiness, some spitting and crying out like cramping pain and weight loss of additional 2 oz.   Refer to ER.
Age: 8.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Lymphadenopathy, Peripheral swelling
Clinical narrative: Lymphadenopathy and arm swelling/redness
Age: 1.33
Sex: M
Vaccine: PNC20
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever, red swollen injection site, fatigue
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, tenderness, increased warmth and swelling to right deltoid. Treatment : tylenol, keflex 500 mg qid x 10 days, ice pack, rest
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Pt started with an injection site reaction. She used cool compresses, then went to the MD and is now on triamcinolone 0.1%cream, prednisone 20mg, loratidine, and benadryl
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Hyperhidrosis, Hypertonia
Clinical narrative: At the time of injection, the patient was trembling, and after vaccination, she was diaphoretic, zoned out but responsive to questions.  She then started leaning to her left and was assisted to lean back in the chair.   She remained responsive and after 2 minutes was observed to be more alert.  She was advised to remain seated for monitoring.  After approximately 5 minutes, she stated that she was fine and wanted to leave.  She was advised to rise slowly and remain still for at least 30 seconds to ensure that she did not fall.  She then reported that she was fine and ready to leave, and her sister stated that she would help her out.  After leaving the clinic, they walked approximately 30 feet down the hallway, and they were observed to stop with the patient leaning heavily on her sister.  A wheelchair was obtained, and she was seated in the chair.  Additional medical intervention was declined, and her sister reported that this reaction had happened before when she received vaccines.  The patient got up from the wheelchair unassisted and got into the vehicle.  She was advised to seek medical intervention if her condition fails to improve.  She left with her sister driving.
Age: 32.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired covid pfizer vaccine.  no adverse reactions/effects noted.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: patient has returned to the office with complaint of vaccine reaction. She is complaining of left side of face tingling, left side of tongue, left arm, left leg. She denies any trouble breathing or leg swelling.  Her vital signs are normal.  She was ordered and given Benadryl 25 mg po given in office. She stated this happened after the COVID vaccine, and after an influenza vaccine in the past.  After 30 minutes she states her symptoms are resolving. She called her spouse to come and get her. She calm, cooperative. No distress noted. Patient was taken from the exam room to the front lobby. Provider waited with her. She states her symptoms have resolved to slight tingling to the left side of her tongue and left face area. Discussed taking another benadryl 25 mg tablet in 4 hours if her symptoms have not resolved.  Go to ER for any throat swelling, difficulty breathing, chest pain or worsening condition. She is agreeable. She left at approximately 6:30 pm. With her spouse.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Child was mistakenly given two doses of Pediatric Hep A at the same time. One in the right arm, one in the left arm. One of the doses was suppose to be HPV. The child tolerated the doses fine and did not have any issues or adverse reactions within 30 minutes after receiving the extra vaccine while he waited in our office.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Burning Numbness tingling injection site pain rash
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Burning Numbness tingling injection site pain rash
Age: 15.0
Sex: M
Vaccine: HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Pallor, Vomiting
Clinical narrative: After receiving the 6 vaccines, pt showed signs of weakness and pale color at 1100.  Pt had emesis twice after symptoms were discovered.   Pt reported he did not eat breakfast this morning before coming.  VS were taken after event and WNL.   Pt given refreshments to help in recovery.  After 15 min, pt reported that he felt better.
Age: 24.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: No adverse reactions to date, patient advised to watch for any reactions.
Age: 1.67
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd MMR and varicella was accidentally given to child on 5/29/2024.    The first initial MMR and varicella was given on 11/29/2023 so vaccines were given 6 months apart and at the incorrect age for the booster which should have been at age 4-6yrs.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Gave HPV to early, contact patient and patient talked to provider.
Age: 60.0
Sex: M
Vaccine: PNC20
Symptoms: Asthenia, Axillary mass, Axillary pain, Blood glucose decreased, Injection site erythema
Clinical narrative: Pt c/o received pneumonia 20 vaccine one week ago shortly after Pt reports he felt "weak" checked BS 69, rechecked 61, Pt ate apple. Pt states one episode of low BS has not had this before or since will monitor. Pt is taking a higher dose of Metformin Pt received pneumonia 20 vaccine noticed right arm erythema wear he received injection same day. The following day arm swollen in the area and painful with movement. Pt states he developed pain in right axillary, and can feel two lumps described sunflower seeds (possible lymph nodes). Pt states improving still has some pain right axillary to the touch and feels two lumps.  Pt offered an apt tomorrow for further evaluation. Pt declined. Pt wants to monitor and if any worsening or not going away will come in to be seen. Pt given ER/EMS precautions if any change or worsening condition.  Pt verbalized understanding
Age: 60.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site swelling, Pain, Tenderness
Clinical narrative: Pt c/o received pneumonia 20 vaccine one week ago shortly after Pt reports he felt "weak" checked BS 69, rechecked 61, Pt ate apple. Pt states one episode of low BS has not had this before or since will monitor. Pt is taking a higher dose of Metformin Pt received pneumonia 20 vaccine noticed right arm erythema wear he received injection same day. The following day arm swollen in the area and painful with movement. Pt states he developed pain in right axillary, and can feel two lumps described sunflower seeds (possible lymph nodes). Pt states improving still has some pain right axillary to the touch and feels two lumps.  Pt offered an apt tomorrow for further evaluation. Pt declined. Pt wants to monitor and if any worsening or not going away will come in to be seen. Pt given ER/EMS precautions if any change or worsening condition.  Pt verbalized understanding
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired vaccination
Age: 88.0
Sex: M
Vaccine: PNC20, RSV
Symptoms: Myalgia
Clinical narrative: Patiet reports 3 days after getting the shot he started getting a golf ball sized area of muscle pain in his left leg. The pain has moved to different muscle groups of both legs, arms, and shoulders and is sometimes in all of them at once. He has been taking tylenol to help with the pain.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 6 month vaccines 8 days before due date. No reaction as of now, but wanted to report to VAERS. Parent aware of vaccine error and was provided signs and symptoms of adverse reaction to reach out to PCP/VAERS.  Vaccine were administered to patient 5/29/2024 and they were not due for vaccines until 6/6/2024.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Asthma, COVID-19, Condition aggravated, Detoxification
Clinical narrative: MODERNA #1 4/9/2021 MODERNA #2 5/7/2021 VACCINE FAILED MULTIPLE EPISODES OF COVID THEN DEVELOPED MRNA COVID VACCINE INDUCED ASTHMA, WORSENED FOOD ALLERGIES, POST-EXERTIONAL FATIGUE AND COVID-19 VACCINE INDUCED IMMUNE DEFICIENCY MANIFESTED BY RECURRENT URI  TREATED WITH MULTIPLE ROUNDS OF STEROIDS, ANTIHISTAMINES, ALBUTERAL INHALER, TEZSPIRE INJECTIONS, ALL WITH NO IMPROVEMENT.  STARTED PROTOCOL.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Fatigue, Hypersensitivity, Immunisation reaction
Clinical narrative: MODERNA #1 4/9/2021 MODERNA #2 5/7/2021 VACCINE FAILED MULTIPLE EPISODES OF COVID THEN DEVELOPED MRNA COVID VACCINE INDUCED ASTHMA, WORSENED FOOD ALLERGIES, POST-EXERTIONAL FATIGUE AND COVID-19 VACCINE INDUCED IMMUNE DEFICIENCY MANIFESTED BY RECURRENT URI  TREATED WITH MULTIPLE ROUNDS OF STEROIDS, ANTIHISTAMINES, ALBUTERAL INHALER, TEZSPIRE INJECTIONS, ALL WITH NO IMPROVEMENT.  STARTED PROTOCOL.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunodeficiency, Infection, Laboratory test, Pulmonary function test, Upper respiratory tract infection
Clinical narrative: MODERNA #1 4/9/2021 MODERNA #2 5/7/2021 VACCINE FAILED MULTIPLE EPISODES OF COVID THEN DEVELOPED MRNA COVID VACCINE INDUCED ASTHMA, WORSENED FOOD ALLERGIES, POST-EXERTIONAL FATIGUE AND COVID-19 VACCINE INDUCED IMMUNE DEFICIENCY MANIFESTED BY RECURRENT URI  TREATED WITH MULTIPLE ROUNDS OF STEROIDS, ANTIHISTAMINES, ALBUTERAL INHALER, TEZSPIRE INJECTIONS, ALL WITH NO IMPROVEMENT.  STARTED PROTOCOL.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: MODERNA #1 4/9/2021 MODERNA #2 5/7/2021 VACCINE FAILED MULTIPLE EPISODES OF COVID THEN DEVELOPED MRNA COVID VACCINE INDUCED ASTHMA, WORSENED FOOD ALLERGIES, POST-EXERTIONAL FATIGUE AND COVID-19 VACCINE INDUCED IMMUNE DEFICIENCY MANIFESTED BY RECURRENT URI  TREATED WITH MULTIPLE ROUNDS OF STEROIDS, ANTIHISTAMINES, ALBUTERAL INHALER, TEZSPIRE INJECTIONS, ALL WITH NO IMPROVEMENT.  STARTED PROTOCOL.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, COVID-19, Chills, Diarrhoea, Disturbance in attention
Clinical narrative: 2 weeks after the vaccine i got very sickly. I threw up for 8 hours straight. I had a fever and chills.  Then I kept getting worse. I started to get dizzy, fatigue, severe panic attacks, convultions, hestamine reactions, shortness of breath, muscle tears, muscle weakness, insomnia, hot and cold intolerance, head aches, sleep walking, night terrors, diahrea, inability to focus, brain fog, inability to walk more than 100 feet.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Epstein-Barr virus infection, Fatigue, Gait disturbance
Clinical narrative: 2 weeks after the vaccine i got very sickly. I threw up for 8 hours straight. I had a fever and chills.  Then I kept getting worse. I started to get dizzy, fatigue, severe panic attacks, convultions, hestamine reactions, shortness of breath, muscle tears, muscle weakness, insomnia, hot and cold intolerance, head aches, sleep walking, night terrors, diahrea, inability to focus, brain fog, inability to walk more than 100 feet.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Histamine intolerance, Insomnia, Laboratory test, Magnetic resonance imaging
Clinical narrative: 2 weeks after the vaccine i got very sickly. I threw up for 8 hours straight. I had a fever and chills.  Then I kept getting worse. I started to get dizzy, fatigue, severe panic attacks, convultions, hestamine reactions, shortness of breath, muscle tears, muscle weakness, insomnia, hot and cold intolerance, head aches, sleep walking, night terrors, diahrea, inability to focus, brain fog, inability to walk more than 100 feet.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging pelvic, Malaise, Muscle injury, Muscular weakness
Clinical narrative: 2 weeks after the vaccine i got very sickly. I threw up for 8 hours straight. I had a fever and chills.  Then I kept getting worse. I started to get dizzy, fatigue, severe panic attacks, convultions, hestamine reactions, shortness of breath, muscle tears, muscle weakness, insomnia, hot and cold intolerance, head aches, sleep walking, night terrors, diahrea, inability to focus, brain fog, inability to walk more than 100 feet.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve conduction studies, Panic attack, Post vaccination syndrome, Post-acute COVID-19 syndrome, Pyrexia
Clinical narrative: 2 weeks after the vaccine i got very sickly. I threw up for 8 hours straight. I had a fever and chills.  Then I kept getting worse. I started to get dizzy, fatigue, severe panic attacks, convultions, hestamine reactions, shortness of breath, muscle tears, muscle weakness, insomnia, hot and cold intolerance, head aches, sleep walking, night terrors, diahrea, inability to focus, brain fog, inability to walk more than 100 feet.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Sleep terror, Somnambulism, Temperature intolerance, Vomiting
Clinical narrative: 2 weeks after the vaccine i got very sickly. I threw up for 8 hours straight. I had a fever and chills.  Then I kept getting worse. I started to get dizzy, fatigue, severe panic attacks, convultions, hestamine reactions, shortness of breath, muscle tears, muscle weakness, insomnia, hot and cold intolerance, head aches, sleep walking, night terrors, diahrea, inability to focus, brain fog, inability to walk more than 100 feet.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: 2 weeks after the vaccine i got very sickly. I threw up for 8 hours straight. I had a fever and chills.  Then I kept getting worse. I started to get dizzy, fatigue, severe panic attacks, convultions, hestamine reactions, shortness of breath, muscle tears, muscle weakness, insomnia, hot and cold intolerance, head aches, sleep walking, night terrors, diahrea, inability to focus, brain fog, inability to walk more than 100 feet.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site rash, Injection site urticaria, Pain in extremity, Peripheral swelling
Clinical narrative: Pt with prolonged pain in arm at site of injection (1 week) and then after 1 week developed urticarial rash - 4-5 cm diam, around site of injection and extending distally to elbow. Rash improved with benadryl. After rash, pt then developed swelling and pain of 4th and 5th fingers that has persisted (now 6 weeks post vaccination and seen in office for different reason). On exam, fullness of MCP, and PIP joints of 4th and 5th fingers, no redness, no warmth. No other joint pain or swelling. No fevers.
Age: 66.0
Sex: F
Vaccine: HEPAB, PNC20, VARZOS
Symptoms: Skin exfoliation
Clinical narrative: Inside of hands peeling next day
Age: 35.0
Sex: M
Vaccine: DTAP
Symptoms: Underdose, Wrong product administered
Clinical narrative: DTaP vaccine was given to this adult rather than a TDaP vaccine.
Age: 43.0
Sex: F
Vaccine: DTAP
Symptoms: Underdose, Wrong product administered
Clinical narrative: DTaP vaccine was given to this adult rather than a TDaP.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Crying, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: The patient reported pain in LUE; the parent stated that the area is swollen, the upper arm appears swollen, and it is warm to the touch.   Per the parent, there are no neuro, respiratory, heart rate, or GI symptoms.   The parent stated that the patient has been crying and said,  "She never cries," and indicated this is HPV dose 2 and no previous reaction.  Treatment use of OTC analgesic,  Tylenol/Ibuprofen: read package instructions for age or weight-appropriate dose/freq.    Reviewed use of ice/heat: always wrap in a towel and use 20 min on/20 min off.
Age: 44.0
Sex: M
Vaccine: DTAP
Symptoms: Underdose, Wrong product administered
Clinical narrative: DTaP vaccine was given to an adult rather than a TDaP
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: Underdose, Wrong product administered
Clinical narrative: DTaP vaccine was given to this adult rather than a TDaP
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Migraine
Clinical narrative: migraine headache
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I developed shingles
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Chest discomfort, Chills, Cough, Fatigue, Nasal congestion
Clinical narrative: Cough, chills, fatigue, nasal congestion, runny nose, chest tightness
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Cough, chills, fatigue, nasal congestion, runny nose, chest tightness
Age: 65.0
Sex: M
Vaccine: HEP, HEPA, MMRV
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient is needing several vaccines due to being on liver transplant list and not having a list of vaccines he had in the past. After reviewing his listhe would ne we both decided to give the vaccines that he needed in a series. We decided to give Hep A/Hep B/MMR/Varicella. We gave Proquad since it was MMR/Varicella combined and he would only need 1, but was told it was not authorized for that age. With the Hep A and Hep B didn't realize that he was given the pediatric dose. Employee spoke with patient to let him know what had happened. He was ok and understood with what had happened. I spoke with someone and she said that he would need to restart Hep A/Hep B with adult dose and to follow their schedule, but was ok with getting the Proquad. This information was given to patient and he understood.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Feeling hot
Clinical narrative: fatigued,feeling hot with headache and chills         -breathing was "erratic", "I couldn't take a deep breath"         -lightheaded, shaking
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tremor
Clinical narrative: fatigued,feeling hot with headache and chills         -breathing was "erratic", "I couldn't take a deep breath"         -lightheaded, shaking
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Cough, Malaise, Pyrexia, Respiratory tract congestion
Clinical narrative: General malaise, subjective fevers/chills, congestion, rhinorrhea, cough
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: General malaise, subjective fevers/chills, congestion, rhinorrhea, cough
Age: 57.0
Sex: F
Vaccine: CHIK
Symptoms: Antiphospholipid antibodies negative, Rheumatoid factor negative, Unevaluable event
Clinical narrative: Chikungunya like symptoms that have not resolved from 5/22 until today
Age: 15.0
Sex: F
Vaccine: MMR, MNQ, TDAP, VARCEL
Symptoms: Pain, Product storage error
Clinical narrative: On January 9, 2024 the vaccines in the clinic were moved to County Health Department due to a power outage. The power came back on around 9:30a.m. when I arrived to work but I was advised by my supervisor to move the vaccine still in case it took a while for the refrigerator to return to the proper temperature. Vaccines were packed with ice packs and bubble wrap and transported by, CRNP. The vaccine was transported back to County Health Department that afternoon. A temperature excursion was noted on the digital data logger. Once returned to clinic the data logger was found to be beside the ice packs instead of by the vaccine. The vaccine manufacturers of the affected vaccine were notified and made aware of the temperature excursion. I notified the companies that the vaccine reached a temperature of 1.8 degrees Celsius. The max temperature that the vaccine reached during transport was 12.0 degrees Celsius. Per the vaccine companies, the only vaccine that was not recommended to use was the opened vial of IPOL and the opened MDV of Fluzone. They were discarded per the vaccine companies? recommendations.  Moving forward to April 10, 2024. The vaccine was transported again to County Health Department due to inclement weather that day. Vaccine was transported by my supervisor and returned on April 12, 2024. Another temperature excursion occurred when the vaccine was transported back to the clinic. The vaccine companies were again contacted for recommendations on viability of the vaccine. When contacting the vaccine companies, I was asked if any of the vaccines had undergone a previous temperature excursion. It was then when I pulled my documentation from the previous excursion that I realized I had read the temperature log incorrectly and that the vaccine had reached a temperature of negative 1.8 degrees Celsius instead of what I reported to the vaccine companies of a +1.8 Degrees Celsius. Therefore, in fact there were two 2 temp excursions one on January 9, 2024 and the other on April 12th, 2024.  A list of all patients that received vaccines between January 9-April 12th was compiled. The list was sorted through as to what patients received the affected vaccine. Patients were notified of questionable viability of vaccines and were offered and recommended to be revaccinated if desired. Notes were added into immprint for outside providers. The process of packing vaccine during transport during emergencies had been reviewed by all staff to include packaging with conditioned water bottles instead of frozen ice packs. 04/30/2024-Phonecall. Unable to reach. Letter mailed. 05/29/2024-Patient returned to clinic after receiving letter. Counseled on need to have Tdap and Meningitis vaccines repeated due to vaccines undergoing a temperature excursion. Mom declined to have vaccine repeated. Child complained of having body aches since January after vaccines were given. Reports body aches come and go and are relieved by Tylenol. Advised patient to see md/pediatrician to have body aches evaluated.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and swelling around injection site that had spread  into surrounding areas. Patient mentioned itching in that area. She got the vaccine on Friday May 24th and she woke up on Sunday and noticed the reaction. Did not have any systemic effects and felt fine otherwise.  She said it has been getting better now and was more red before.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bundle branch block left, Bundle branch block right, Cardiac stress test, Chest pain, Detoxification
Clinical narrative: PFIZER #1 1/25/2022 PFIZER #2 2/15/2022 DEVELOPED CHEST PAIN, EFFORT INTOLERANCE, POST-EXERTIONAL FATIGUE, FOUND TO HAVE NEW RBBB LPFB DIAGNOSED WITH SUBCLINICAL PFIZER MRNA MYOPERICARDITIS.  NL LVEF.  TREATED WITH COLCHICINE AND PROTOCOL.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Exercise tolerance decreased, Fatigue, Laboratory test
Clinical narrative: PFIZER #1 1/25/2022 PFIZER #2 2/15/2022 DEVELOPED CHEST PAIN, EFFORT INTOLERANCE, POST-EXERTIONAL FATIGUE, FOUND TO HAVE NEW RBBB LPFB DIAGNOSED WITH SUBCLINICAL PFIZER MRNA MYOPERICARDITIS.  NL LVEF.  TREATED WITH COLCHICINE AND PROTOCOL.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myopericarditis
Clinical narrative: PFIZER #1 1/25/2022 PFIZER #2 2/15/2022 DEVELOPED CHEST PAIN, EFFORT INTOLERANCE, POST-EXERTIONAL FATIGUE, FOUND TO HAVE NEW RBBB LPFB DIAGNOSED WITH SUBCLINICAL PFIZER MRNA MYOPERICARDITIS.  NL LVEF.  TREATED WITH COLCHICINE AND PROTOCOL.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram, Full blood count, Metabolic function test
Clinical narrative: RECURRENT ATRIAL FIBRILLATION - PERSISTENT FOR OVER ONE WEEK AND SHE MAY REQUIRE CARDIOVERSION
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blood test normal, Chest X-ray normal, Febrile convulsion, Immunisation reaction, Pyrexia
Clinical narrative: My daughter experienced 2 febrile seizures and was given recuse medication because she was not coming out of the second seizure on her own. She was checked out at the hospital. She was given medicine to help lower her fever. She has an EEG follow up visit due to needing rescues meds.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Diarrhoea, Feeling cold, Injection site erythema, Injection site warmth, Pain
Clinical narrative: Patient experienced diarrhea, body aches, and chills yesterday. No fever, but was on advil. Today, patient has area of redness and warmth directly under injection site. Had the same reaction after last dose, was treated for cellulitis and required hospitalization for IV treatment. Given steroids and clindamycin today.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Pain
Clinical narrative: The patient's mother called on 5/30/24 and stated after the patient received the vaccination yesterday, the patient was in a lot of pain, and this morning was the same. The patient's mother stated the patient is feeling better now, and the pain is not as bad. The mother stated the patient has been taking Ibuprofen and Tylenol for the pain and it has been helping.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, MMRV, PNC15
Symptoms: Extra dose administered, Eye movement disorder
Clinical narrative: Patient was inadvertently given both MMR and Proquad vaccines on the same day 04/22/24.  Received 2 doses of MMR.  Developed abnormal eye movements (possible seizures) on 04/30/24.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blindness, Dizziness, Fatigue, Headache
Clinical narrative: Had classic symptoms post vaccine the evening after receiving the injection -- slightly elevated temperature (37.5C), headache, sore arm, and fatigue. Also was experiencing joint pain in the left hand, but it went away without any issues. Woke up in the middle of the night with very sore hips and muscle aches down my legs, to the point where it hurt to move. Again, by the time of waking up in the morning, pain had subsided. When I tried to sit up out of bed, I was hit with incredibly intense nausea and feeling of lightheadedness. Laid back down, and subsided. Got up again and had the same symptoms but slightly less severe, so I went to go and try to eat something to see if that would help. Ate some food and started to black out at the kitchen table -- ears started ringing, losing vision, etc. Made it to the couch and measured my BP after a few minutes, which came out to 80/50. Stayed on the couch for an hour with elevated legs and BP went back to a 100/70.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Sleep disorder, Tinnitus
Clinical narrative: Had classic symptoms post vaccine the evening after receiving the injection -- slightly elevated temperature (37.5C), headache, sore arm, and fatigue. Also was experiencing joint pain in the left hand, but it went away without any issues. Woke up in the middle of the night with very sore hips and muscle aches down my legs, to the point where it hurt to move. Again, by the time of waking up in the morning, pain had subsided. When I tried to sit up out of bed, I was hit with incredibly intense nausea and feeling of lightheadedness. Laid back down, and subsided. Got up again and had the same symptoms but slightly less severe, so I went to go and try to eat something to see if that would help. Ate some food and started to black out at the kitchen table -- ears started ringing, losing vision, etc. Made it to the couch and measured my BP after a few minutes, which came out to 80/50. Stayed on the couch for an hour with elevated legs and BP went back to a 100/70.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chest pain, Headache, Pain in extremity, Syncope
Clinical narrative: Syncope, headache, chest and arm pain.   Immediately requested an ambulance to transport the patient to the nearest hospital.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache, sore arm. Took Tylenol and Sudafed. Pain continued, but became less severe.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Syncope
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Continue to monitor redness,  alternate ibuprofen and tylenol for pain,  hydrocortisone cream for itching
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Patient developed itching and a rash.
Age: 18.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Blood pressure decreased, Injection site pain, Loss of consciousness, Musculoskeletal stiffness, Nausea
Clinical narrative: Minute following immunization administration the patient complained of pain from injection site, then started to appear pale, body stiffened up then passed out. came to with in 10 seconds. The patient went from sitting to laying  on the exam table with feet elevated. He felt nauseous but no vomiting . The patient  drank water and nursing staff applied cool compress on back of neck. The patient's BP dropped from his normal BP at first.  After about 30 min the patient was able to sit up without lightheadedness BP was back to normal. After 45min the patient was stable and left with his parent.
Age: 18.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Pallor
Clinical narrative: Minute following immunization administration the patient complained of pain from injection site, then started to appear pale, body stiffened up then passed out. came to with in 10 seconds. The patient went from sitting to laying  on the exam table with feet elevated. He felt nauseous but no vomiting . The patient  drank water and nursing staff applied cool compress on back of neck. The patient's BP dropped from his normal BP at first.  After about 30 min the patient was able to sit up without lightheadedness BP was back to normal. After 45min the patient was stable and left with his parent.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse event; Accidental overdose; This spontaneous report was received from nurse and refers to a unspecified age and gender patient. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided.  On 22-MAY-2024, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (accidental overdose). No additional adverse event.  Lot number is being requested and will be submitted if received.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received Hiberix diluent alone; received Hiberix diluent alone; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 2-month-old patient who received Hib (Hiberix) (batch number KF25B, expiry date 30-SEP-2025) for prophylaxis.   On 16-APR-2024, the patient received the 1st dose of Hiberix. On 16-APR-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: received Hiberix diluent alone) and inappropriate dose of vaccine administered (Verbatim: received Hiberix diluent alone). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-MAY-2024. The patient received only diluent of Hiberix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of the 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR063487:Same reporter US-GSK-US2024AMR063489:Same reporter US-GSK-US2024AMR063485:Same reporter / different patient US-GSK-US2024AMR063486:Same reporter US-GSK-US2024AMR063484:Same reporter US-GSK-US2024AMR063488:Same reporter