chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Papule, Scab
Clinical narrative: Raised area of redness to left thigh, at initial visit for reaction, redness localized, no vesicles. On second visit lesions had spread somewhat, no fevers, erythematous papules with crust formation . Dx varicella infection
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Varicella zoster virus infection
Clinical narrative: Raised area of redness to left thigh, at initial visit for reaction, redness localized, no vesicles. On second visit lesions had spread somewhat, no fevers, erythematous papules with crust formation . Dx varicella infection
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Chills, Pyrexia
Clinical narrative: Fever of 103 and chills. Chills was not listed on the vaccine information sheets for the shots my son received. Treated at home with tylenol. Chills were on and off between 0200 and 0700.
Age: 30.0
Sex: M
Vaccine: HEPA, TDAP, TYP, YF
Symptoms: Injection site pain, Pain
Clinical narrative: Client states he experienced pain in left deltoid  several hours after injection site near the Tdap site and for several weeks following vaccine injection. Pain reportedly occurred mostly during flexion and exertion of left deltoid. During the first month after  vaccines were given he reported pain I left deltoid when performing moderate to heavy lifting . Pain has gradually decreased since returning from trip abroad  at the beginning of June but continues with activities such as heavy weight lifting. Dr.'s  assessment today was noted and decision was made to monitor symptoms for 1 month then consider plan of action if pain continues.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: pt received the second dosage of the shingrix on 07/09/19.  pt started having a severe rash all over her body on 07/12/19,  Pt was advised to visit with her primary doc.  Pt went into her primary doc on 07/12 and she was given kenalog /decadron shot along with benadryl oral q 4 h .  On 07/14/19 pt called, staff rph at store, and consulted with her as the symptoms still persisted without much relief.  Upon consulting with dr's nurse, pt's primary care, they concluded that the rash was caused by a secondary reaction to the shingrix vaccine.  Currenly 07/16/19 pt has a follow up appointment at 3:30 pm .
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site urticaria, Injection site warmth
Clinical narrative: Area around injection site is once inch in diameter, red, hot, hard, and with six  hives.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient reports low grade fever and flu-like symptoms starting Saturday 07/13/19 the day after vaccine administration. Rash developed on the back of the neck at hairline going up behind ear and across forehead late Sunday night into Monday morning, unsure of exact time. Rash was red and itchy (patient provided pictures). Called the pharmacy Monday evening 07/15/19 after no relief and was advised by on duty pharmacist  to take Benadryl which did relieve itchiness and redness. When patient presented on 07/16/19, rash was no longer visible and patient reports no itching of area.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Condition aggravated, Cough, Infection, Malaise, Pyrexia
Clinical narrative: Coughing increased to point of infection along with malaise and fever and antibiotics were prescribed. Patient was ill for 2-3 weeks.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Discharge, Eyelid rash, Herpes zoster, Pain
Clinical narrative: I started with sores on my left foot. I thought it was athlete  feet . My eye started with white bumps at the lash line in both eyes. My right eye was worse. Lower inside right eye had a red pimple. Treated with warm soaks and Ciprofloxacin according to the prescription. It seem to help with the pain and pustules and they started to drain. I would soak my foot in Epsom salt bath  and used Keteonazole cream 2% as prescribed. It made it worse. I stopped using it and used Clotrimazole and that seemed to work well enough to dry the sores out and bring back a dark pink color to the skin on  my large toe and under my foot. It stopped working the week of July 8th 2019. I called Podiatrist  to set up an appointment. I went to this office  July 15th for a visit. He looked at my foot and I informed him of everything. He stated I had shingles cause by the Shingrix SDV/INJ. I should only use Clotrimazole if I still had itching after my shower. He advised me not to receive the second vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash pustular, Skin ulcer
Clinical narrative: I started with sores on my left foot. I thought it was athlete  feet . My eye started with white bumps at the lash line in both eyes. My right eye was worse. Lower inside right eye had a red pimple. Treated with warm soaks and Ciprofloxacin according to the prescription. It seem to help with the pain and pustules and they started to drain. I would soak my foot in Epsom salt bath  and used Keteonazole cream 2% as prescribed. It made it worse. I stopped using it and used Clotrimazole and that seemed to work well enough to dry the sores out and bring back a dark pink color to the skin on  my large toe and under my foot. It stopped working the week of July 8th 2019. I called Podiatrist  to set up an appointment. I went to this office  July 15th for a visit. He looked at my foot and I informed him of everything. He stated I had shingles cause by the Shingrix SDV/INJ. I should only use Clotrimazole if I still had itching after my shower. He advised me not to receive the second vaccine.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Hypersensitivity
Clinical narrative: The patient received the vaccination on 5/8/19 and reported to the pharmacy on 5/12/19 that they experienced a severe allergic reaction that was described as having extreme difficulty with breathing. The patient decided to go to the ER for treatment.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 12-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 13-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Experienced in her words cold sore/fever blister on mouth the next day and lasted for approximately 7 days. Had no other side effects.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling appeared about 30 minutes after vaccine. Still red and swollen 5 days later. No tenderness, not hot to touch.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Dyspnoea
Clinical narrative: Weakness, dizziness with near syncopal episode, headache, blurred vision, nausea, fever, rigors, swelling at the site of injection, arm pain, joint pain, shortness of breath
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Injection site swelling, Nausea, Pain in extremity, Presyncope
Clinical narrative: Weakness, dizziness with near syncopal episode, headache, blurred vision, nausea, fever, rigors, swelling at the site of injection, arm pain, joint pain, shortness of breath
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, Vision blurred
Clinical narrative: Weakness, dizziness with near syncopal episode, headache, blurred vision, nausea, fever, rigors, swelling at the site of injection, arm pain, joint pain, shortness of breath
Age: 47.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was notified of the error the next day.  Patient did not have an allergic reaction.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Face oedema
Clinical narrative: Facial edema which occurred approximately 10 minutes after vaccine administration.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Blood pressure increased, Blood test, Insomnia, Pruritus, Skin discolouration
Clinical narrative: severe itching elevated BP     skin decoloration    insomnia    itching from arms to neck constantly since  last,year.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Blood culture, Body temperature, C-reactive protein, Erythema, Full blood count
Clinical narrative: Left arm swelling, pain, itchy, hot, and redness. Body aches and temperature.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Metabolic function test, Pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Left arm swelling, pain, itchy, hot, and redness. Body aches and temperature.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Left arm swelling, pain, itchy, hot, and redness. Body aches and temperature.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and itching on upper torso and back to just below breast and to where the shot was given. Patient has taken sponge baths using aveno oatmeal which has helped the itching but not the hives. She has also taken benadryl during the day but it did not help.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Right upper arm cellulitis
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Eye movement disorder
Clinical narrative: Parents report that for 24 hours after vaccine, both patient's eyes severely deviated to the side.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Pyrexia
Clinical narrative: Injection site soreness; joint pain; headache;  low grade fever (99.4).   Symptoms slowly  came on and were mostly gone by 36 hours following injection of vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Skin warm, Swelling
Clinical narrative: Patient states arm was sore the day she got the vaccine. the next 2-3 days she experienced swelling, soreness, redness, hot to the touch.  today (6 days later), she states that the soreness went away however the area is still red and warm to the touch. For treatment, pharmacist recommended to apply cold compress and take ibuprofen. Patient may also try to take benadryl as well.
Age: 28.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Malaise, Nausea, Peripheral swelling
Clinical narrative: Patient's mother reported "feeling sick", "arm swollen", "nausea".
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Dizziness, Eye movement disorder, Hyperhidrosis, Loss of consciousness, Muscle rigidity
Clinical narrative: Patient lost consciousness within minutes of receiving both vaccines. Hep A given first followed by HPV.  Patient felt lightheaded and dizzy. While being lied down on exam table he lost consciousness for less than 30 seconds. Concern for seizure activity (witnesses - father and medical assistant - saw rigid extremities). Head also flexed up and to left while eyes rolled back into head. Patient regained consciousness without apparent post-ictal state. Was diaphoretic and pale. Vitals normal. After one hour unable to sit up without vomiting. Also complained of shooting pain in bilateral hands. Given benadryl and monitored until color return and feeling well enough to leave. Feeling in usual state of health within 24 hours.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Nuclear magnetic resonance imaging brain, Pain in extremity, Pallor, Posture abnormal, Seizure
Clinical narrative: Patient lost consciousness within minutes of receiving both vaccines. Hep A given first followed by HPV.  Patient felt lightheaded and dizzy. While being lied down on exam table he lost consciousness for less than 30 seconds. Concern for seizure activity (witnesses - father and medical assistant - saw rigid extremities). Head also flexed up and to left while eyes rolled back into head. Patient regained consciousness without apparent post-ictal state. Was diaphoretic and pale. Vitals normal. After one hour unable to sit up without vomiting. Also complained of shooting pain in bilateral hands. Given benadryl and monitored until color return and feeling well enough to leave. Feeling in usual state of health within 24 hours.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Vomiting
Clinical narrative: Patient lost consciousness within minutes of receiving both vaccines. Hep A given first followed by HPV.  Patient felt lightheaded and dizzy. While being lied down on exam table he lost consciousness for less than 30 seconds. Concern for seizure activity (witnesses - father and medical assistant - saw rigid extremities). Head also flexed up and to left while eyes rolled back into head. Patient regained consciousness without apparent post-ictal state. Was diaphoretic and pale. Vitals normal. After one hour unable to sit up without vomiting. Also complained of shooting pain in bilateral hands. Given benadryl and monitored until color return and feeling well enough to leave. Feeling in usual state of health within 24 hours.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Abdominal pain, Arthralgia, Culture, Full blood count, Gait disturbance
Clinical narrative: It started from an extensive rash on the tummy, around ears, neck and face and significant facial swelling especially in between eyes. It all happened in a matter of a few hours. The patient was taken immediately to the pediatrician. Doctor ordered to do a Strep Throat test and immediately decided that it's a common viral infection that presents with hives. She didn't want to even consider the possibility of the adverse vaccine reaction even though the patient's mother clearly stated that she is sure that it's from that. She didn't perform any viral test, nor checked the patient's blood. Prescribed steroids for hives, asked to get topical Benadryl and liquid Zyrtec. Next day the child was feeling worse. The rash started going to the limbs and he started complaining of the pain in his joints, especially knees. Patient started limping and his fever spiked to 102 Fahrenheit. The mother took the patient to the Hospital Pediatric ER after calling Doctor's office to confirm that it's what they recommend.  Doctor, after long battling the mother's opinion regarding the post-vaccine reaction admitted that the patient is having the actual measles following the vaccination 10 days. The patient started feeling nauseous and turned all yellow while in the ER and complained of the tummy ache. The doctor checked his belly and held off releasing the patient for an hour. Nurses performed a strep throat test, ran CBC Blood Test and performed nasal virus test. Told the patient to take Benadryl and Motrin at home The patient continues to be very sick and the sickness seems to be consistent with the symptoms of measles. His upper and lower limbs are all swollen, his whole body is covered in a rash, he has a high fever and feels nauseous.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Lip swelling, Measles post vaccine, Nausea, Pyrexia, Rash generalised
Clinical narrative: It started from an extensive rash on the tummy, around ears, neck and face and significant facial swelling especially in between eyes. It all happened in a matter of a few hours. The patient was taken immediately to the pediatrician. Doctor ordered to do a Strep Throat test and immediately decided that it's a common viral infection that presents with hives. She didn't want to even consider the possibility of the adverse vaccine reaction even though the patient's mother clearly stated that she is sure that it's from that. She didn't perform any viral test, nor checked the patient's blood. Prescribed steroids for hives, asked to get topical Benadryl and liquid Zyrtec. Next day the child was feeling worse. The rash started going to the limbs and he started complaining of the pain in his joints, especially knees. Patient started limping and his fever spiked to 102 Fahrenheit. The mother took the patient to the Hospital Pediatric ER after calling Doctor's office to confirm that it's what they recommend.  Doctor, after long battling the mother's opinion regarding the post-vaccine reaction admitted that the patient is having the actual measles following the vaccination 10 days. The patient started feeling nauseous and turned all yellow while in the ER and complained of the tummy ache. The doctor checked his belly and held off releasing the patient for an hour. Nurses performed a strep throat test, ran CBC Blood Test and performed nasal virus test. Told the patient to take Benadryl and Motrin at home The patient continues to be very sick and the sickness seems to be consistent with the symptoms of measles. His upper and lower limbs are all swollen, his whole body is covered in a rash, he has a high fever and feels nauseous.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Streptococcus test, Swelling face, Urticaria, Viral infection, Viral test
Clinical narrative: It started from an extensive rash on the tummy, around ears, neck and face and significant facial swelling especially in between eyes. It all happened in a matter of a few hours. The patient was taken immediately to the pediatrician. Doctor ordered to do a Strep Throat test and immediately decided that it's a common viral infection that presents with hives. She didn't want to even consider the possibility of the adverse vaccine reaction even though the patient's mother clearly stated that she is sure that it's from that. She didn't perform any viral test, nor checked the patient's blood. Prescribed steroids for hives, asked to get topical Benadryl and liquid Zyrtec. Next day the child was feeling worse. The rash started going to the limbs and he started complaining of the pain in his joints, especially knees. Patient started limping and his fever spiked to 102 Fahrenheit. The mother took the patient to the Hospital Pediatric ER after calling Doctor's office to confirm that it's what they recommend.  Doctor, after long battling the mother's opinion regarding the post-vaccine reaction admitted that the patient is having the actual measles following the vaccination 10 days. The patient started feeling nauseous and turned all yellow while in the ER and complained of the tummy ache. The doctor checked his belly and held off releasing the patient for an hour. Nurses performed a strep throat test, ran CBC Blood Test and performed nasal virus test. Told the patient to take Benadryl and Motrin at home The patient continues to be very sick and the sickness seems to be consistent with the symptoms of measles. His upper and lower limbs are all swollen, his whole body is covered in a rash, he has a high fever and feels nauseous.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Yellow skin
Clinical narrative: It started from an extensive rash on the tummy, around ears, neck and face and significant facial swelling especially in between eyes. It all happened in a matter of a few hours. The patient was taken immediately to the pediatrician. Doctor ordered to do a Strep Throat test and immediately decided that it's a common viral infection that presents with hives. She didn't want to even consider the possibility of the adverse vaccine reaction even though the patient's mother clearly stated that she is sure that it's from that. She didn't perform any viral test, nor checked the patient's blood. Prescribed steroids for hives, asked to get topical Benadryl and liquid Zyrtec. Next day the child was feeling worse. The rash started going to the limbs and he started complaining of the pain in his joints, especially knees. Patient started limping and his fever spiked to 102 Fahrenheit. The mother took the patient to the Hospital Pediatric ER after calling Doctor's office to confirm that it's what they recommend.  Doctor, after long battling the mother's opinion regarding the post-vaccine reaction admitted that the patient is having the actual measles following the vaccination 10 days. The patient started feeling nauseous and turned all yellow while in the ER and complained of the tummy ache. The doctor checked his belly and held off releasing the patient for an hour. Nurses performed a strep throat test, ran CBC Blood Test and performed nasal virus test. Told the patient to take Benadryl and Motrin at home The patient continues to be very sick and the sickness seems to be consistent with the symptoms of measles. His upper and lower limbs are all swollen, his whole body is covered in a rash, he has a high fever and feels nauseous.
Age: 71.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt reported pain, redness and swelling at injection site for 6 days. Redness of arm was from injection site to 2 inches above the elbow. Pt was seen by a doctor on 7-16-19 and prescribed Keflex
Age: 70.0
Sex: M
Vaccine: VARCEL
Symptoms: Alcohol test, Blood lactic acid, Chest X-ray, Chills, Computerised tomogram head
Clinical narrative: Chills, Fever 101.9 & Delirium. Fever reduced with Tylenol, & delirium started clearing 5-7 hours later while at the ER.  Patient was back to normal after sleeping several hours.  Doctor advises not to get 2nd shot.
Age: 70.0
Sex: M
Vaccine: VARCEL
Symptoms: Delirium, Differential white blood cell count, Drug screen, Electrocardiogram, Full blood count
Clinical narrative: Chills, Fever 101.9 & Delirium. Fever reduced with Tylenol, & delirium started clearing 5-7 hours later while at the ER.  Patient was back to normal after sleeping several hours.  Doctor advises not to get 2nd shot.
Age: 70.0
Sex: M
Vaccine: VARCEL
Symptoms: Laboratory test normal, Lymphocyte count decreased, Lymphocyte percentage decreased, Metabolic function test, Neutrophil count increased
Clinical narrative: Chills, Fever 101.9 & Delirium. Fever reduced with Tylenol, & delirium started clearing 5-7 hours later while at the ER.  Patient was back to normal after sleeping several hours.  Doctor advises not to get 2nd shot.
Age: 70.0
Sex: M
Vaccine: VARCEL
Symptoms: Neutrophil percentage increased, Platelet count decreased, Pyrexia, Urine analysis, White blood cell count increased
Clinical narrative: Chills, Fever 101.9 & Delirium. Fever reduced with Tylenol, & delirium started clearing 5-7 hours later while at the ER.  Patient was back to normal after sleeping several hours.  Doctor advises not to get 2nd shot.
Age: 62.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site rash, Rash, Rash vesicular
Clinical narrative: AFTER THE DAY OF AN INJECTION SHE STARTED HAVING RASH LIKE SYMPTOMS ALL OVER HER LEFT SHOULDER, CHEST, ABDOMEN, LOWER BACK. PATIENT STATES RASH LOOKS LIKE CHICKEN POX SYMPTOMS.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain upper, Axillary pain, Fatigue, Feeling hot
Clinical narrative: 5hr: inject site red, swollen,painfull, fatigue 15 hr: hot, ache all over 36 hr: left arm pit painful & swollen 48 hr: severe stomach cramps for a moment 55 hr: nausea, more stomach cramps, feeling over heated 60 hr: feeling bloated & still stomach ache 72 hr: stomach cramps after eating, pain in arm pit not as bad but still swollen 96 hr: injection site and arm pit still little aches, still little nausea, little stomach aches, still fatigued  120 hr: generally feeling okay
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Pain
Clinical narrative: 5hr: inject site red, swollen,painfull, fatigue 15 hr: hot, ache all over 36 hr: left arm pit painful & swollen 48 hr: severe stomach cramps for a moment 55 hr: nausea, more stomach cramps, feeling over heated 60 hr: feeling bloated & still stomach ache 72 hr: stomach cramps after eating, pain in arm pit not as bad but still swollen 96 hr: injection site and arm pit still little aches, still little nausea, little stomach aches, still fatigued  120 hr: generally feeling okay
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: 5hr: inject site red, swollen,painfull, fatigue 15 hr: hot, ache all over 36 hr: left arm pit painful & swollen 48 hr: severe stomach cramps for a moment 55 hr: nausea, more stomach cramps, feeling over heated 60 hr: feeling bloated & still stomach ache 72 hr: stomach cramps after eating, pain in arm pit not as bad but still swollen 96 hr: injection site and arm pit still little aches, still little nausea, little stomach aches, still fatigued  120 hr: generally feeling okay
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Sciatica
Clinical narrative: severe Sciatica pain which resulted in difficultly walking
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pyrexia, Vaccination site pain
Clinical narrative: Patient called 3 days after receiving Shingrix.  She stated she had extreme pain at vaccine site immediately afterwards and for next 2 days.  She also stated that the day after receiving vaccine she had a fever of 102 degrees.  Pain had gone away by third day.  No treatment was given and she did not request medical attention.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Influenza like illness, Nausea
Clinical narrative: Pt was dizzy and sweating immediately after vaccine. On Monday 07/15/2019, patient was in pain, flu -like symptoms, nausea, low grade fever .
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Pt was dizzy and sweating immediately after vaccine. On Monday 07/15/2019, patient was in pain, flu -like symptoms, nausea, low grade fever .
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Ear pain, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: adverse event- fever of 101, pain and soreness on right arm radiating to right side of neck and right ear, severe achiness, ha and intermittent dizziness. treatment- alternate between Tylenol and Aleve. use cold compress as needed. to call if sx persist.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: starting the day after vaccination, red swollen area about 3 inches tall and 2 inches wide. hurt to touch and swollen. advised pt to take pain medicine (aleve) and let us know if things get worse & contact dr office
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Monoplegia
Clinical narrative: Patient stated that immunization made her arm feel paralyzed for 3 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: All began 6 hours after vaccine injected: Fatigue Joint pain Muscle soreness Much more scatter-brained than usual No appetite
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pain in extremity, Radiculopathy
Clinical narrative: Left arm pain -myalgia -worse with arm lift /activity Gradually got better and finally resolved after 6 weeks with no treatment Past hx of arm radiclupathy but on Right arm
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: patient received shingrix vaccination on 7/9 and developed the side effects the next day.  Patient came back to pharmacy on 7/12 to show us the area.  It was red and swelling about 2-2.5inches in diameter
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The pharmacist administered the Bexsero with no Health Authority protocol or prescription from the physician.  No adverse effects were reported after the administration but patient should have received Menactra instead.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: SWELLING IN LOWER LEFT LEG , RED , INFLAMMATION
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Headache, Injection site erythema, Injection site pain
Clinical narrative: Both shot one and two gave me the same symptoms, low grade fever, muscle aching. slight headache, upset stomach and low energy. It has only been  24 hours since the second shot so I do not know how long these symptoms will last  After the first shot I felt sick for 3-4 days. The site of shot becomes red within six hours and the next day there is blotchy redness in an area about three inches circle below the original shot. That area is hot and sore feels tight. This red and blotchy area lasted a long time after the first shot, maybe two weeks and would get red again when I took a bath.  The first time I did show my pharmacist otherwise I did not seek treatment.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Myalgia, Pyrexia, Rash macular
Clinical narrative: Both shot one and two gave me the same symptoms, low grade fever, muscle aching. slight headache, upset stomach and low energy. It has only been  24 hours since the second shot so I do not know how long these symptoms will last  After the first shot I felt sick for 3-4 days. The site of shot becomes red within six hours and the next day there is blotchy redness in an area about three inches circle below the original shot. That area is hot and sore feels tight. This red and blotchy area lasted a long time after the first shot, maybe two weeks and would get red again when I took a bath.  The first time I did show my pharmacist otherwise I did not seek treatment.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Crying, Erythema, Injection site erythema, Rash macular
Clinical narrative: Almost immediately after 2nd injection Left thigh area redness above knee anteriorly which spread down 3/4 of lower leg. No heat noted to touch. Crying. Within minutes scattered light reddish noted to right side of face (cheek, forehead area) Received first Hep B on 04-09-19 at Hospital. 7-10-19 was his first Pediarix injection consisting of Dtap, IPV, Hep B.  approximate times, but fairly correct. Consoled infant (father/mother), opened closed door to room, ice pack applied to left thigh, within 5 minutes improvement noted, redness & blotching fading Primary Care Provider, notified by phone message 7-10-19 at 1710 on office voice mail and emergency number; 07-11-19 at 0930 another message left on voice mail of office number.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (R) upper arm swelling, pain, redness Treatment with cold, Tylenol, elevation
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: My arm turned red & sore from elbow to top of shoulder Sore-red top of arm
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Skin warm, Swelling
Clinical narrative: redness swelling rash like warm beginnings day after injection (~8 hours) reaction still not resolved on day 6 after injection
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blood test, Decreased appetite, Headache, Nausea
Clinical narrative: Nausea, very low energy, no appetite especially morning & noon, gagging and periodically I have headaches.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Retching
Clinical narrative: Nausea, very low energy, no appetite especially morning & noon, gagging and periodically I have headaches.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient complained of rash, redness, warm, hard, swelling and painful at injection site. The rash is is 3 & 1/2 inch diameter big.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Patient complained of rash, redness, warm, hard, swelling and painful at injection site. The rash is is 3 & 1/2 inch diameter big.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: After a couple days, patient noticed redness, swelling, warmness to touch, bruising at site. Roughly .50 cent piece size.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Feeling abnormal, Injection site rash, Nausea, Pain in extremity
Clinical narrative: SORE ARM, RASH 4" in length-3" below site of shot, NAUSEUS, PUNKY FEELING, NO APPETITE ALL DAY WEDNESDAY (day after shot)
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Nasal congestion, Productive cough, Rash vesicular, Wheezing
Clinical narrative: shortness of breath, wheezing, phlegm, nasal congestion  Rash (vesicular) right groin
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Developed cellulitis (R) arm redness, swelling, warmth, tender
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Tremor
Clinical narrative: 3 days after receiving HPV vaccine, patient developed tremors in both hands that lasted 2-3 hours, she had fever for 24 hours.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Injection site cellulitis, Mass, Pain
Clinical narrative: Injection site cellulitis / cellulitis; This case was reported by a consumer via call center representative and described the occurrence of injection site cellulitis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site cellulitis. The patient was treated with antibiotics nos. On an unknown date, the outcome of the injection site cellulitis was recovered/resolved.   It was unknown if the reporter considered the injection site cellulitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient developed cellulitis at the injection site. The patient was treated with antibiotics for 10 days which cleared up the infection. The reporter wanted to know, was it safe for the patient to get the second dose. The patient asked, both of patient's physician and the pharmacist but, they both defer to the GSK.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm
Clinical narrative: Injection site cellulitis / cellulitis; This case was reported by a consumer via call center representative and described the occurrence of injection site cellulitis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site cellulitis. The patient was treated with antibiotics nos. On an unknown date, the outcome of the injection site cellulitis was recovered/resolved.   It was unknown if the reporter considered the injection site cellulitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient developed cellulitis at the injection site. The patient was treated with antibiotics for 10 days which cleared up the infection. The reporter wanted to know, was it safe for the patient to get the second dose. The patient asked, both of patient's physician and the pharmacist but, they both defer to the GSK.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Injection site cellulitis / cellulitis; This case was reported by a consumer via call center representative and described the occurrence of injection site cellulitis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site cellulitis. The patient was treated with antibiotics nos. On an unknown date, the outcome of the injection site cellulitis was recovered/resolved.   It was unknown if the reporter considered the injection site cellulitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient developed cellulitis at the injection site. The patient was treated with antibiotics for 10 days which cleared up the infection. The reporter wanted to know, was it safe for the patient to get the second dose. The patient asked, both of patient's physician and the pharmacist but, they both defer to the GSK.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives within 24 hours of receiving the shots; hives clustered together in large mass all over body within 72 hours post injection
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Musculoskeletal pain, Nausea, Pain in extremity
Clinical narrative: Arm and shoulder aches, quesy, chills/shivers, headache lasted 3 hours, but is getting better
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 11-OCT-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # N010495 with expiration date 31-MAR-2019 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373: US-009507513-1907USA000067: US-009507513-1906USA011434: US-009507513-1907USA000121:
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; Nurse reports a third dose of MMR II (R03160, 11/1/2020) was administered to a patient 14 years after second dose; Information has been received from a nurse, referring to a patient of unknown age or gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On an unknown date in 2005, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, strength, route, lot# and expiration date were unknown) for prophylaxis. On 24-JUN-2019 (also reported as 14 years after second dose), the patient was vaccinated with the third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, strength and route were unknown; lot# was reported as R03160 and expiration date 01-NOV-2020) for prophylaxis (inappropriate schedule of product administration). No adverse effects reported.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 76 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 15-MAR-2011, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, concentration, lot# and expiration date were not provided) for the long term prevention of shingles and zoster-related conditions by a healthcare provider in a clinic. On an unknown date, the patient suffered following injuries resulting from zoster vaccine live (ZOSTAVAX) use: Herpes Zoster. Pt was treated by a healthcare provider. Outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 01-FEB-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions by healthcare provider in a clinic. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).