chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Expired product administered
Clinical narrative: Initial information received on 03-Jul-2018 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case involves patient who was vaccinated with an expired dose of 0.5 ml PENTACEL lot number: C5384AA, expiry date: 30-Jun-2018 via intramuscular in right thigh on 03-Jul-2018. On 03-Jul-2018, the patient concomitantly received a dose of suspect MMR not produced by Sanofi Pasteur lot number not reported. The patient's medical history were not reported. It was an actual medication error due to expired vaccine used. It was unknown whether any adverse events occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial information received on 03-Jul-2018 regarding an unsolicited valid non-serious case received from a non-other healthcare professional. This case involves 12-year-old female patient who was vaccinated with a dose of suspect vaccine MENACTRA lot number: U5948AB (expiry date, dose details were not reported) in May-2017. The patient's medical history was not reported. Concomitant medications included ADACEL for Immunisation. It was an actual medication error due to inappropriate schedule of drug administration. In May 2017, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site. On 02-Jul-2018 she also received a dose of the same vaccine lot U5948AB via unknown route in unknown administration site. 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 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. List of documents held by sender: none.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves 15 months female patient who received 0.5 ml fourth dose ACTHIB lot number for lyophilized powder UI797 powder and expiry date 06 July 2018 and diluent lot U5858BA, expiry date 28 June 2018 (frequency once and site of administration were not reported) intramuscularly on 02 July 2018. Concomitant vaccines Hep A and Dtap. It was actual medication error due to Expired vaccine used as she administered ACTHIB lyophilized powder with the diluent before recognizing the diluent expired. 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 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. Documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Expired product administered
Clinical narrative: Initial information received on 03-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a two months old male patient who received expired product diluent of ACTHIB VACCINE lot UI803AA via intramuscular route on 02-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation. It was actual medication error due to Expired product used. It was unknown if the patient experienced any adverse event or not. 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 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. Documents held by sender: none.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Burns second degree, Wrong drug administered
Clinical narrative: Initial information received on 03-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 years old male patient who experienced second degree burn to the right leg and patient was injected with DAPTACEL instead of ADACEL, while he received vaccines DAPTACEL instead of ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 27-Jun-2018, the patient received a 0.5 mL dose of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine lot number not reported via intramuscular route in the right deltoid. On an unknown date, the patient developed a non-serious the patient had a 2nd degree burn to the right leg, following the administration of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine. It was also a case of actual medication error due wrong vaccine administered. Relevant tests were not reported. Final diagnosis was the patient had a second degree burn to the right leg. It was not reported if the patient received a corrective treatment. The outcome was not reported for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site discomfort, Injection site erythema
Clinical narrative: Right shoulder deltoid area became red and uncomfortable. Redness was 6" in greatest dimension.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Body temperature increased, Chills, Dizziness, Nausea, Vomiting
Clinical narrative: Within 2 hours of receiving BEXSERO pt developed nausea, dizziness, chills temps 100.6. Pt vomited 4x.
Age: 51.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: Local reaction, large erythematous inflammation of skin surrounding injection site. Uniform in color. Minimal induration. Well circumscribed. Approx 11cmx8cm. +tenderness and itching reported. Tx with hydrocortisone rx cream, ibuprofen 600mg TID PRN and Benadryl 25mg TID PRN. Will continue to monitor. Not anticipating further treatment.
Age: 51.0
Sex: F
Vaccine: MNQ
Symptoms: Local reaction
Clinical narrative: Local reaction, large erythematous inflammation of skin surrounding injection site. Uniform in color. Minimal induration. Well circumscribed. Approx 11cmx8cm. +tenderness and itching reported. Tx with hydrocortisone rx cream, ibuprofen 600mg TID PRN and Benadryl 25mg TID PRN. Will continue to monitor. Not anticipating further treatment.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Hyperhidrosis, Influenza like illness
Clinical narrative: This was my 2nd dose of SHINGRIX. I waited the required minimum of 2 months for the second dosage. Woke up in the middle of the night sweating & nausea. I was super fatigued for the next 2 days. I had what I would describe as flu like symptoms. Saturday afternoon I felt extreme fatigue & got the worst case of chilis I have ever had. I felt more weakness all the way through Tuesday July 10th. I still feel somewhat washed out where normally I have super high energy.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Middle insomnia, Nausea
Clinical narrative: This was my 2nd dose of SHINGRIX. I waited the required minimum of 2 months for the second dosage. Woke up in the middle of the night sweating & nausea. I was super fatigued for the next 2 days. I had what I would describe as flu like symptoms. Saturday afternoon I felt extreme fatigue & got the worst case of chilis I have ever had. I felt more weakness all the way through Tuesday July 10th. I still feel somewhat washed out where normally I have super high energy.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Tremor
Clinical narrative: Full body shaking, feeling very cold, headache.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema
Clinical narrative: An area of redness affecting Rt Deltoid reaction about 6". Non tender and there is no induration. Less than 24 hrs after the injection.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PPV, RV5, PPV
Symptoms: Wrong drug administered
Clinical narrative: Patient was mistakenly given PNEUMOVAX 23 instead of a PREVNAR.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PPV, RV5, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was mistakenly given PNEUMOVAX 23 instead of a PREVNAR.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Rash vesicular
Clinical narrative: 2 weeks post WCC with vaccines (listed above)  patient developed "pox style" rash on arm/leg/torso.  Spreading # for 2 days. Total # of lesions 6. Of note - 1 week post vaccines patient seen for 103 temp in urgent care at Hospital.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Patient described the day after receiving the vaccine having nausea and had to stay home all day. Patient reported taking ginger root candies to help with the nausea, which she explained did not relieve the nausea but may have stopped any vomiting. Patient denied any vomiting, just nausea all day. Explained it started the day after receiving the vaccine and lasted "all day".
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth, Malaise, Pain
Clinical narrative: Patient states there was a dull pain that never fully went away. Patient became ill in February and the injection site became swollen and hot. At the time of reporting 7/11/18 the patient presents with a swollen area approximately the size of a quarter and states it feels like someone is pinching her when she tries to raise her arm. We instructed her to have it checked by a Doctor.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle contractions involuntary, Muscle twitching
Clinical narrative: Provider diagnosed as Fasciculation bilaterally. Twitching in knees both bent and at rest. Pt requested and given Neurology referral based on sibling history of ALS. No medications given and asked to monitor and follow up if worsened.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Dizziness, Nausea, Pain in extremity
Clinical narrative: Patient reported having chills for 4 hours, 3 days after vaccine. She was nauseous. Her right arm was sore (even though she got the vaccine in her left arm...) Arm was better the next day, but then developed severe pain in her lower back. Her MD gave her a Rx for a nausea medication. She now reports getting dizzy.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Chills, Headache, Hyperhidrosis
Clinical narrative: Mom called stating that pt had just returned home from our office after receiving several immunization (Hep A, HPV #1, Meningococcal and Meningococcal B). Mom said he was lying on the bathroom floor complaining of a headache and was shivering and sweating. Patient improved and symptoms were gone after a few minutes.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Pain in extremity, Pyrexia, Rash erythematous
Clinical narrative: Patient came into the pharmacy on 07/11/2018 and said her arm was hurting bad and tender to touch, in addition her arm was hot with a red rash where the injection site was. The patient also has a low grade fever. She said she took ALEVE the night of the vaccine and the day after.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Patient came into the pharmacy on 07/11/2018 and said her arm was hurting bad and tender to touch, in addition her arm was hot with a red rash where the injection site was. The patient also has a low grade fever. She said she took ALEVE the night of the vaccine and the day after.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non valid report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with improperly stored dose of (Oka-Merck) PROQUAD lot # reported as N019282, expiration date 09-JAN-2019 and (Oka/Merck) VARIVAX lot # N021581, expiration date 09-AUG-2019 (for both strength, dose number, route and anatomical location were not provided). The vaccines were reconstituted with properly stored sterile diluent (MERCK). Administered dose of (Oka-Merck) PROQUAD and (Oka/Merck) VARIVAX experienced the temperature excursion of -9 Celsius degrees to 8 Celsius degrees (also reported as 7.3 Celsius degrees) for 1 hour and 9 minutes. There were no previous excursions reported. The digital data logger was involved. No adverse effects were reported. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier was received. Follow up information has been received from a nurse on 12-JUN-2018 and refers to a 4-year-old patient on an unknown gender. On 30-JAN-2018, the patient was vaccinated with improperly stored dose of (Oka-Merck) PROQUAD lot # N019828 with expiration date: 09-JAN-2019 (previously reported as N019282) and (Oka/Merck) VARIVAX lot # N021581, expiration date: 09-AUG-2019. This is one of six reports received from the same reporter. Albumin status for (Oka-Merck) PROQUAD for lot # N019828 has been verified as recombinant human albumin (rHA). Sender's Comments: US-009507513-1801USA006139: US-009507513-1806USA007939: US-009507513-1806USA007940: US-009507513-1806USA007936: US-009507513-1806USA007937.
Sex: F
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-APR-2018, the patient may have received an improperly stored dose of ROTATEQ, orally, lot# N004811 and expiration date: 29-SEP-2018 (dose was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 9 to 25 degrees Fahrenheit for 45 minutes. Data logger was involved. There were no previous excursions reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, and concomitant medication. The ZOSTAVAX was recommended and prescribed to the patient for long-term prevention against shingles. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. Instead the patient contracted a persistent strain of shingles, or severe herpes zoster. On an unknown date in 2016, the patient was treated for the onset of a rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages and required and continues to require extensive medical care and treatment. As a further proximate result of the ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Induration
Clinical narrative: 21 x 23 cm pink indurated area - Lateral upper arm to dorsal and ventral aspect - 250 - 270 degree.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Blood cholesterol, Dizziness, Full blood count, Headache, Metabolic function test
Clinical narrative: Began c/o headache (severe) in the afternoon after receiving vaccine that morning. Photophobia, dizziness, nausea went to ER and admitted overnight.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Nausea, Photophobia
Clinical narrative: Began c/o headache (severe) in the afternoon after receiving vaccine that morning. Photophobia, dizziness, nausea went to ER and admitted overnight.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Pain, Vomiting
Clinical narrative: Vomiting, weak, sore all over body for 24 hours after immunization.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: Red hot swollen arm. Diarrhea. Very painful - even more so compared to first dose. Went to MD and was prescribed steroids 6/29/18.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Nodule, Skin warm
Clinical narrative: Within 24 hours  - redness, heat, knot over next 48 hours - redness and heat spread down the arm and went to urgent care 3 days after vaccine to get antibiotics.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Diarrhea. Red, hot, swollen/pain at injection site. Pain lasted 3 weeks after shot. (This was not reported to us until she came in for her second dose).
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt's arm red and swollen.
Age: 77.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Balance disorder, Dizziness, Dysphagia, Erythema, Fatigue
Clinical narrative: Swallowing - redness - pain - blurred vision, dizziness - fatigue - imbalance in right arm.
Age: 77.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Pain, Vision blurred
Clinical narrative: Swallowing - redness - pain - blurred vision, dizziness - fatigue - imbalance in right arm.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Hives 48 hrs after shots. Shot site red ? which one. Still off and on hives on 7/9/18.
Age: 18.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Head injury, Loss of consciousness, Nausea, Seizure like phenomena, Tremor
Clinical narrative: Pt received Hep A and B vaccines. Was going to walk around store a few minutes before leaving. Pt felt nauseous approximately 3 min after receiving vaccines and sat down in a chair. Passed out, hit head, and started shaking. Witnesses described it as seizure-like. 911 was called and responded. Pt did not leave with them.
Age: 19.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Head injury, Syncope
Clinical narrative: Syncopal episode post vaccination. VS obtained. Reported she felt dizzy and lightheaded and "woke up on the exam room floor". Observation of patient for at least one hour. Pt. struck head on floor - ice to head.
Age: 1.17
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC
Symptoms: Pyrexia, Weight bearing difficulty
Clinical narrative: Pt had a RXN (R) thigh with fever would not bear any weight on his (R) leg.
Age: 18.0
Sex: M
Vaccine: MMR, MNQ
Symptoms: Discomfort, Dizziness, Lethargy, Pyrexia
Clinical narrative: Lethargy and fever 99.7 'F from oral thermometer, started 24 hours after dizziness progressed. Slight trouble breathing and discomfort.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Pt said there was severe, persistent pain in her arm at the injection site that has interfered with her daily activity.
Age: 44.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Pt noticed a large lump on her arm that was painful at the injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Injection site pain, Myalgia
Clinical narrative: Within two hours after vaccine- muscle pain at injection site (left arm), within 20 hours fever (highest 101.1 F), chills, all over muscle/body aches, slight stomach upset, headache. Bed rest, ibuprofen and acetaminophen alternating- for about 36 hours.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Within two hours after vaccine- muscle pain at injection site (left arm), within 20 hours fever (highest 101.1 F), chills, all over muscle/body aches, slight stomach upset, headache. Bed rest, ibuprofen and acetaminophen alternating- for about 36 hours.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Tremor
Clinical narrative: Fever Tmax 101 x 2 days. Shaking (L) leg 30 sec to 1 minute associated with not being interactive x 1 days but leg shaking lasted x 1 month per mother. Seen at ER.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Loss of consciousness
Clinical narrative: Patient was sitting on bench with boyfriend after recieving injection and passed out. Boyfriend lowered her to the floor. She was awake and alert. E-squad was called, they came and evaluated her. Vitals were normal and Patient refused further treatment. Went home.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Erythema multiforme
Clinical narrative: EM minor.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: Severe headache, body aches, fever (possibly even delirium)-which lasted 12 hours. Some slight nausea during the first week as well as lack of energy/tiredness. Extreme pain, heat, redness, swelling at injection site which spread about 2 inches either side and lasted 7 days. I slept a lot during the first 7 days e.g. having to go to bed mid afternoon and sleeping right through till the following morning. Wasn't able to do much gardening and couldn't go to gym classes. After 10 days there is still some redness and swelling and a red circle at injection site about the size of a pencil eraser. Went to gym class and felt slightly nauseous and shivery, lay down in the afternoon and didn't feel well enough to attend an evening event. Slept 12 hours. Today is day 12 and still not feeling great.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Severe headache, body aches, fever (possibly even delirium)-which lasted 12 hours. Some slight nausea during the first week as well as lack of energy/tiredness. Extreme pain, heat, redness, swelling at injection site which spread about 2 inches either side and lasted 7 days. I slept a lot during the first 7 days e.g. having to go to bed mid afternoon and sleeping right through till the following morning. Wasn't able to do much gardening and couldn't go to gym classes. After 10 days there is still some redness and swelling and a red circle at injection site about the size of a pencil eraser. Went to gym class and felt slightly nauseous and shivery, lay down in the afternoon and didn't feel well enough to attend an evening event. Slept 12 hours. Today is day 12 and still not feeling great.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Nausea, Pain, Pyrexia
Clinical narrative: Severe headache, body aches, fever (possibly even delirium)-which lasted 12 hours. Some slight nausea during the first week as well as lack of energy/tiredness. Extreme pain, heat, redness, swelling at injection site which spread about 2 inches either side and lasted 7 days. I slept a lot during the first 7 days e.g. having to go to bed mid afternoon and sleeping right through till the following morning. Wasn't able to do much gardening and couldn't go to gym classes. After 10 days there is still some redness and swelling and a red circle at injection site about the size of a pencil eraser. Went to gym class and felt slightly nauseous and shivery, lay down in the afternoon and didn't feel well enough to attend an evening event. Slept 12 hours. Today is day 12 and still not feeling great.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Swelling
Clinical narrative: Swelling with redness.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Abdominal pain, Nausea
Clinical narrative: Abdominal pain and nausea, onset 2 days after receiving vaccines at check-up. Symptoms resolved the following day with supportive care.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Middle insomnia, Pain in extremity, Pyrexia
Clinical narrative: Upon receiving two doses of SHINGRIX, experienced nighttime awakening, fever, chills, and sore arm.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site oedema, Injection site swelling, Malaise
Clinical narrative: Developed flu-like symptoms and significant swelling/erythema at site of injection with both shots. Felt perfect prior to injections. I did think the F/U like Sx were significant and the site of injection erythema/edema was also significant. It was an identical reaction with both injections. I feel GSK should tell people about this reaction. It was self-limited but I did not feel well for several days with both injections.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Oropharyngeal pain, Pain, Pyrexia, Rash generalised
Clinical narrative: Patient received the 1st dose on 5/10/18 and experienced aches, pains, and a low grade fever. Patient returned for the 2nd dose on 7/6/18 and developed aches, pains, sore throat, headache, fever of 100.5 F, and an all over body rash within 3 hours of administration. Patient saw his physician on 7/11/18 and later called our pharmacy to explain what happened.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting, Wrong drug administered
Clinical narrative: Patient received SHINGRIX in error instead of HAVRIX. Patient complain about fever and throwing up. She took TYLENOL and she is feeling better.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Cold sweat, Fall, Pallor, Syncope
Clinical narrative: Patient had vasovagal syncope within 5 minutes of receiving immunization. She was sitting when it was administered, but then got up after a few minutes, was leaning against the wall, then slumped to the ground. Pale in face and clammy. No seizure activity. No injuries. Recovered fully and  walked out after lying down and drinking water and juice.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Redness, soreness, & swelling on left arm at site of injection; headache, nausea, elevated temperature, shivering, exhaustion. Symptoms peaked in 18 hours, then gradually diminished and were gone by 72 hours.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Nausea
Clinical narrative: Redness, soreness, & swelling on left arm at site of injection; headache, nausea, elevated temperature, shivering, exhaustion. Symptoms peaked in 18 hours, then gradually diminished and were gone by 72 hours.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Adverse food reaction, Anxiety, Depersonalisation/derealisation disorder, Depression, Electrocardiogram
Clinical narrative: One of the first reactions I experienced after the flu vaccine was depersonalization/derealization. I have now had this neurological issue for 7 months and I have changed my diet and avoided putting any other chemicals in my body. This symptom has been getting better since then. I also experienced extreme anxiety, panic attacks, and depression, which I have never had before. Through my detox I have also noticed these symptoms have lessened. About 3 months after the vaccine I began having gut issues and food reactions. I changed my diet and that began to help. I am almost cured of these symptoms after 7 months, and I chose to heal from this reaction naturally since I believe my body does not metabolize chemicals as well as others.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Electrocardiogram ambulatory, Gastrointestinal disorder, Nervous system disorder, Panic attack
Clinical narrative: One of the first reactions I experienced after the flu vaccine was depersonalization/derealization. I have now had this neurological issue for 7 months and I have changed my diet and avoided putting any other chemicals in my body. This symptom has been getting better since then. I also experienced extreme anxiety, panic attacks, and depression, which I have never had before. Through my detox I have also noticed these symptoms have lessened. About 3 months after the vaccine I began having gut issues and food reactions. I changed my diet and that began to help. I am almost cured of these symptoms after 7 months, and I chose to heal from this reaction naturally since I believe my body does not metabolize chemicals as well as others.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Prolonged pain and restricted active ROM right arm.
Age: 1.0
Sex: M
Vaccine: DTAP, MMR, PNC13, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Maculopapular rash that started behind one of his ears 3 days ago, then spread to his face yesterday, then his  neck, trunk, & extremities, today. No pain or pruritis. No fever, diarrhea, cough, congestion, sore throat. No findings on exam besides the rash. No involvement of palms or soles. No vesicles or pustules.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Malaise, Pyrexia, Tenderness
Clinical narrative: G1P0 28 y/o female, EDD 9/26/18, received Tdap vaccine on right deltoid on 7/6/18. Pt reports fever and malaise on 7/6/18 and 7/7/18 that was treated and resolved w/ TYLENOL. On 7/8/18 developed a hard area of redness below site of injection. Pt was seen on 7/9/18 for acute appt. On exam, pt had a 7x5 cm area of erythema and induration approx 5 cm below area of injection on right deltoid. Mild tenderness on palpation. Vitals were normal. No fetal distress reported.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The patient was mistakenly given the adult dose of the Hepatitis A HAVRIX vaccine instead of the pediatric dose. No adverse reactions noted at time of vaccine. The mistake was noted after the patient had already gone home. Immunization Program was immediately notified of the event for further instruction. The case was then discussed with public health nurse, who reassured the author that no adverse reactions would be expected giving the adult dose of HAVRIX to a 5 y.o. patient. She stated that the dose does not need to be repeated and that he will be due for the pediatric HAVRIX in 6 months. Outgoing call made to his step-mother, but there was no answer. Left message on her voicemail to call back. I plan to discuss the mistake with her and reassure her that no adverse reactions are expected and that he will be due for his 2nd dose (the pediatric HAVRIX) in 6 months.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient has had pain in left arm since the vaccination on 7/9/18. She reports that she cannot use her left arm and it hurts to move the upper arm. She can use her wrist as long as she keep the upper arm still. She has not had fever or any other symptoms. She has redness over the left deltoid and has tenderness with touch. She has restricted range of motion of the left shoulder.  Distally, her sensation and strength are preserved. Her bicep DTR is 2+ bilaterally.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody abnormal
Clinical narrative: This spontaneous report as received from a office manager refers to a currently 52-year-old female patient. The patient medical history included administration of TWINRIX vaccine, in 2013, after that she did not "seroconvert". The patient concurrent condition, concomitant medication and drug reactions or allergies were not reported. On an unknown date in February 2014, the patient was vaccinated with two combined doses of pediatric RECOMBIVAX HB, intramuscular for prevention of hepatitis b. She was administered 2 combined doses of pediatric RECOMBIVAX HB in order to receive an adult dose of RECOMBIVAX HB as a booster. The patient did not seek medical attention. On 06-JUN-2018, an unspecified test was performed with a result of "hepatitis B borderline titres". No treatment was given for the adverse events. The outcome of the event of hepatitis B borderline titres was reported as not recovered. The relatedness between the event and vaccination with RECOMBIVAX HB was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 11-FEB-2016, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. Later in February "2015" (considered an error and supposed to be 2016), the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. Later in 2015, the patient was treated by a physician for symptoms of a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-OCT-2011, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 18-FEB-2015, the patient was treated by a physician for symptoms of a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster and severe complications. In 2013, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2007, the patient was inoculated with ZOSTAVAX at a medical practice for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. In 2014, the patient was treated at the same practice for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. A physician recommended and prescribed the ZOSTAVAX vaccine to the patient for long-term prevention against shingles. On an unknown date in 2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. Instead, the patient contracted a persistent strain of shingles, or severe herpes zoster. On or about 29-AUG-2016, the patient was treated by a physician for the onset of a rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injury
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case and litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date, the patient was inoculated with ZOSTAVAX for the long-term prevention of shingles. The patient brings to action for personal injuries and damages suffered as a result of being inoculated with the ZOSTAVAX vaccine. No further information was provided. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Immediate post-injection reaction, Nausea, Vomiting
Clinical narrative: This spontaneous report was received from a nurse referring to a 13 year old male patient. The patient had not pertinent medical history, drug reactions/allergies, concurrent conditions or concomitant medications. On 10-JUL-2018, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, lot # N023828 with expiration date 25-JUN-2020, for prophylaxis. It was stated that immediately following vaccination, the patient experienced abdominal pain and nausea. Additionally, the patient vomited (vomiting). No treatment was given for the events and no laboratory diagnostic test was performed. It was reported that later on the same date, the patient recovered from the events. The causality assessment between the events and GARDASIL 9 was not provided.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 67-year-old female patient who received SHINGRIX (batch number 759E9, expiry date 25th April 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose administered on 15th March 2018, refer case US2018GSK116018) and Shingles vaccine. Concomitant products included paroxetine hydrochloride (Paroxetine), atorvastatin calcium (Atorvastatin), acetylsalicylic acid (Aspirin), ezetimibe and calcium + ergocalciferol (Calcium Plus D). In June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In June 2018, 1 day after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site itching, injection site inflammation and fatigue. In June 2018, the outcome of the injection site swelling, injection site erythema, injection site itching, injection site inflammation and fatigue were recovered/resolved. The reporter considered the injection site swelling, injection site erythema, injection site itching, injection site inflammation and fatigue to be related to SHINGRIX. Additional information was reported as follows: The patient took multi vitamins as a concomitant medication. The patient was vaccinated with the 2nd dose of SHINGRIX on 15th June 2018 or 16th June 2018. The patient reported that she received the SHINGRIX vaccine and the following day experienced swelling, redness, and itching at the injection site, although the events occured at the injection site but did extend out to the deltoid. She also experienced fatigue which started a day after the injection, however her fatigue had resolved. The patient believed that the vaccine given by subcutaneous route instead of intramuscular, because of the events experienced by the patient but healthcare professional stated that he administered the vaccine by intramuscular route.  At the time of reporting, it had been a week since the patient received her 2nd dose and she was almost back to normal. This case was linked to case US2018GSK116018 (1st dose), reporter by the same reporter for the same patient. The case US2018GSK112091, was identified as a duplicate case for case US2018111419, so all the information from case US2018GSK112091 was retained in case US2018111419.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Malaise
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and general malaise. On an unknown date, the outcome of the injection site erythema, injection site pain and general malaise were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site pain and general malaise to be related to SHINGRIX. Additional details were provided as follows: This case was received via webform email. The age at vaccination was not reported. But, it could be 65 or 66 years old. The healthcare professional stated that, the patient did not report any abnormal side effects, but only injection site redness, soreness and general malaise for a duration of 2 days post-injection. No further information was provided.