chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 18.0
Sex: U
Vaccine: HPV4, MNQ
Symptoms: Loss of consciousness, Seizure, Urinary incontinence, Vomiting
Clinical narrative: She passed out and had a seizure for about 15 seconds with urinary incontinence. She vomited 2-3 times when she regained consciousness.
Sex: M
Vaccine: TDAP
Symptoms: Product quality issue, Underdose
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of underdose in a adult male patient who received BOOSTRIX (batch number 949LJ, expiry date 21st February 2017). This case was associated with a product complaint. On an unknown date, the patient received BOOSTRIX .4 ml. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced underdose and product complaint. On an unknown date, the outcome of the underdose and product complaint were unknown. Additional information received: Reporter stated that they pulled a dose from the single-dose BOOSTRIX vial but each time there were only 0.4mL instead of 0.5mL. They administered 0.4mL to 3 patients. Nurse also reported that the vials only gave 0.4 ml rather than 0.5 ml per dose. For 3 vials, a 3cc hash marked syringe, 5/8ths inch 25 gauge needle was used. The other vial had a 1 ml syringe used, and still showed 0.4 ml. The practice is used to using prefilled syringes. There are no leaks or cracks in the vials and the packaging is dry. The reporter did not wish to use the remaining of 6 vials due to low fill. Product return is from reporter. A credit memo was requested as replacement.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Dizziness, Fatigue, Feeling abnormal, Nausea
Clinical narrative: 2 hours after immunization, onset of dizziness and fatigue. Feeling of the floor falling out underneath feet. Nausea and generalized weakness. Symptoms lasted 3 days, worst for first 24 hours post immunization.
Age: 10.0
Sex: M
Vaccine: HPV4
Symptoms: Choking sensation, Eye swelling
Clinical narrative: Pt presented to clinic for 11 y/o well child exam. When 3rd HPV dose offered, Mom stated 2nd dose of HPV on 8/5/14 caused swollen eyes and choking sensation which prompted an ER visit. Mom was advised may be caused by HPV vaccine and to decline further doses.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: At around 11 pm (6/03/15), per mother, patient developed high fever (105 degrees F) which lasted for 10 minutes with administration of TYLENOL and cold sponge bath. After 10 minutes, temperature decreased to (102 degrees F).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and soreness at injection site. Patient instructed to take BENADRYL.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Blood immunoglobulin E decreased, Injection site erythema, Injection site plaque, Injection site swelling
Clinical narrative: 10 x 10 cm very red sl raised plaque (R) upper arm centered over MMR site. No pain, heat, swelling, itching.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema
Clinical narrative: Red area on Left Deltoid.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Developed swelling, itching, pain, locd at site of injection 24-48 hours afterwards.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient developed 7 cm x 5 cm red rash in area around injection site 2 days following administration.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Patient had her arm swell in area of injection. Also she noted that it was red, itched, and had a burning sensation. This continued for at least a week.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Blood creatinine increased, Dehydration, Gastroenteritis, Immunosuppressant drug level increased, International normalised ratio increased
Clinical narrative: I believe this SAE is unrelated to the vaccine, but this happened within 30 days of a study vaccine, so I am reporting it per protocol. I am preparing my FDA annual report and noticed this - I had not known previously. Patient was hospitalized for severe gastroenteritis with dehydration on day 27 after vaccination.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 24-APR-2013, the patient was vaccinated with the first dose of GARDASIL (dose, strength, anatomical location, lot number and expiration date were not reported). On 08-MAY-2013, a second dose of GARDASIL (dose, strength, anatomical location, lot number and expiration date were not reported) was administered. On 19-NOV-2014, a third dose of GARDASIL (dose, strength, anatomical location, lot number and expiration date were not reported) was administered. On 21-JAN-2015, a fourth dose (extra dose administered) of GARDASIL (dose, strength, anatomical location, lot number and expiration date were not reproted) was administered. On 27-MAY-2015, a fifth dose (extra dose administered) of GARDASIL (dose, strength, anatomical location, lot number and expiration date were not reported) was administered. Concomitant medication was not reported. No adverse effect was reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Type III immune complex mediated reaction
Clinical narrative: Arthus phenomenon in the left deltoid and the left subcutaneous tissue (localized to the injection sites). Only had mild erythema, swelling, and warmth at the location of injection.
Age: 42.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Blood potassium decreased, Dysarthria, Headache, Hypoaesthesia, Neurological examination normal
Clinical narrative: Headache prior to immunizations. Exercised after shots. Felt numb arm & left side face afterward & complained mild speech slurred. Seen in ER-dx Bell's Palsy but no record of examination. Neuro exam (-) on 5/15 in clinic.
Age: 42.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: VIIth nerve paralysis, White blood cell count increased
Clinical narrative: Headache prior to immunizations. Exercised after shots. Felt numb arm & left side face afterward & complained mild speech slurred. Seen in ER-dx Bell's Palsy but no record of examination. Neuro exam (-) on 5/15 in clinic.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a patient of unknown demographics regarding himself/herself. No pertinent medical history, concurrent conditions or concomitant mediations were reported. On 10-JUN-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (1 time vaccine), dose route and frequency not reported. The outcome of expired product administered was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a Registered Nurse concerning a patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On 18-DEC-2009, the patient was vaccinated with the first dose of VAQTA, intramuscular, (Lot #, exp. date, strength and dose not provided). On 11-JUN-2010, the patient was vaccinated with the second dose of VAQTA, intramuscular, (Lot #, exp. date, strength and dose not provided); it was administered seven days too soon. There was no concomitant medication reported. No adverse effects were reported. Additional information has been requested.
Age: 0.75
Sex: M
Vaccine: HIBV
Symptoms: Crying, Pain, Vaccine positive rechallenge
Clinical narrative: Intense crying, inconsolable until cries self to sleep. Acting like he is in intense pain. This happened all three times he has had the HIB vaccine.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: Nausea, Vomiting, chills and fever, back, rib cage, headache, and diarrhea. Beginning 6/11/2015 through 6/15/2015 - Emergency Room Treatment on 6/11/2015 diagnosed above symptoms. Discharged.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Nausea, Vomiting, chills and fever, back, rib cage, headache, and diarrhea. Beginning 6/11/2015 through 6/15/2015 - Emergency Room Treatment on 6/11/2015 diagnosed above symptoms. Discharged.
Age: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Cerebrovascular accident
Clinical narrative: MCA Stroke.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Itching at vaccine area.  Red spot at vaccine site and five small bumps around site with no blister formation.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Abdominal pain lower, Colonoscopy, Haematochezia, Mucous stools, Proctitis ulcerative
Clinical narrative: Patient seen with blood and mucous in stool x 1 week on 08/29/2014. Referred to GI and had colonoscopy on 09/26/2014. Patient to Apriso 0.375 grams x 6 weeks and Canasa supp. 1000mg x 6 weeks.  Dx with Ulcerative Proctosigmoiditis on 01/20/2015.  Had LLQ pain and rectal bleeding again on 05/25/2015 and seen by GI.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Rectal haemorrhage
Clinical narrative: Patient seen with blood and mucous in stool x 1 week on 08/29/2014. Referred to GI and had colonoscopy on 09/26/2014. Patient to Apriso 0.375 grams x 6 weeks and Canasa supp. 1000mg x 6 weeks.  Dx with Ulcerative Proctosigmoiditis on 01/20/2015.  Had LLQ pain and rectal bleeding again on 05/25/2015 and seen by GI.
Age: 0.8
Sex: F
Vaccine: PNC13
Symptoms: Mechanical urticaria
Clinical narrative: Child developed dermotagraphic urticaria.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site haemorrhage, Injection site mass, Injection site swelling
Clinical narrative: Per orders of Dr., injection of PCV13 given by MA Extern and supervised by CMA. Patient had slight immediate adverse reaction. Shot was given in the right deltoid.  Patient bled more than normal (Pt on blood thinner).  Immediately, the area swelled up and a soft lump formed about 30 mm.  No redness.  Patient stated he felt fine.  Dr. was asked to look at the site.  Doctor cleared the patient to leave and requested the patient to call us if the reaction got any worse, if there was pain, more redness or if it became hot to the touch.  Patient agreed to do so.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: No adverse effect.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Induration, Injection site reaction, Neck pain, Peripheral swelling, Rash macular
Clinical narrative: Left arm swelling, induration, pain radiating up neck on left side, blotchy redness to left upper arm.
Age: 71.0
Sex: F
Vaccine: PNC13, TD
Symptoms: Blood culture, Blood test, Chest X-ray normal, Culture urine, Erythema
Clinical narrative: Fever, vomiting, right arm swelling, pain, redness and lymphangitis.
Age: 71.0
Sex: F
Vaccine: PNC13, TD
Symptoms: Lymphangitis, Pain, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, right arm swelling, pain, redness and lymphangitis.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Client reported redness at the site of injection, warmth to touch with slight itching. Advised to use ice pack to sight and take Benadryl.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Oropharyngeal pain
Clinical narrative: Very sore throat and hoarse voice in the morning for four days.  Took throat lozenge.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Joint range of motion decreased, Pain, Pruritus, Rash
Clinical narrative: Quality: itches. The pain is mild (no pain at rest, but movement can trigger mild pain). Associated symptoms include a limited range of motion (some pain with abduction).
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Headache, Nausea, Rash
Clinical narrative: Was dizzy, nauseated, vomited x 1 and had a syncopal episode during a lab draw after receiving the vaccine, improved after crackers, resting with legs elevated, then reported feeling fatigued and with a headache for 2 days after the vaccine but did not seek care, 2 weeks after vaccinations then developed a rash on her forearms.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: Was dizzy, nauseated, vomited x 1 and had a syncopal episode during a lab draw after receiving the vaccine, improved after crackers, resting with legs elevated, then reported feeling fatigued and with a headache for 2 days after the vaccine but did not seek care, 2 weeks after vaccinations then developed a rash on her forearms.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt is experiencing swelling, redness, warmth and itching at the injection site.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: PATIENT DEVELOPED NON INJECTION SITE RASH ON BACK AND STOMACH, URTICARIA.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash, Skin warm, Swelling face
Clinical narrative: Patient developed rash on face (chin and near eye), warm upon touch, swelling on the face, urticaria. Patient went to PCP for check up and was prescribed Medrol dose pack. Itchiness, redness and swelling has reduced after starting Medrol dose pack.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient developed rash on face (chin and near eye), warm upon touch, swelling on the face, urticaria. Patient went to PCP for check up and was prescribed Medrol dose pack. Itchiness, redness and swelling has reduced after starting Medrol dose pack.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Pyrexia
Clinical narrative: Patient had a fever, redness and cellulitis at the injection site.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site urticaria
Clinical narrative: Patient had a fever, redness and cellulitis at the injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Itching and injection site redness.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient had red, hot, swollen arm at sight of vaccine administration.  I sent her to the urgent care where she was prescribed a course of antibiotics.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Injection site pain, Pyrexia
Clinical narrative: The patient reports that she had pain on the injection site, inflammation, and fever from the day the vaccine was administered.  On the 3rd day, she visited the doctor and he prescribed Prednisone.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Right deltoid induration measuring 43 mm x 75 mm, tender/sore at injection sight, redness at injection site.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Redness, warm, "rash" at site of injection about the size of a finger tip.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site initially itchy. That evening it was red and swollen. Over next 2 days it changed to a bruised look.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness pain, hot, raised injection site in 5" diameter.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, Pain
Clinical narrative: Information has been received from a consumer via Market research referring to her/his friend's daughter, a 13 year old female patient. The patient's concurrent condition included lead poisoning. On an unknown date in 2000 the patient was vaccinated with the first dose of GARDASIL (strength, dose, route, lot # and expiration date were unknown). On an unknown date the patient experienced pain which lasted a week and she was in bed for a week after GARDASIL injection. Therapy with GARDASIL was reported as interrupted and the patient did not get the second dose. The outcome of pain was reported as recovered/resolved on an unknown date in 2000, and did not appeared again. The reporter considered pain to be related to GARDASIL. It was reported none of the other friends chose to take GARDASIL because of these staked events. The reporter considered the event was serious due to the patient was in bed for a week. This is one of two cases received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. The patient had no medical history or drug reactions/allergies. On 11-JUN-2015 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, once, lot# and expire date were not reported) subcutaneously. No concomitant medication was reported. On 12-JUN-2015, the patient experienced redness at the injection site. The patient sought medical attention via seeing in the pharmacy. No treatment was given for the event. No lab diagnostics studies were performed. The outcome of the event was reported as not recovered/not resolved. Causality was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, Pain
Clinical narrative: Information has been received from a consumer via Market Research referring to her/his friend's daughter, a 13 year old female patient. It was reported the patient was healthy. On an unknown date in 2000 the patient was vaccinated with the first dose of GARDASIL (strength, dose, route, lot # and expiration date were unknown). On an unknown date the patient experienced pain which lasted a week and she was in bed for a week after GARDASIL injection. Therapy with GARDASIL was reported as interrupted and the patient did not get the second dose. The outcome of pain was reported as recovered/resolved on an unknown date in 2000, and it did not appear again. The reporter considered pain to be related to GARDASIL. It was reported none of the other friends chose to take GARDASIL because of these stated events. The reporter considered the event was serious due to the patient was in bed for a week. This is one of two cases received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a Licensed Vocation Nurse referring to two unspecified six month old patients of unknown gender. On 12-JUN-2015, the patient were inadvertently vaccinated with a dose of VAQTA (lot number, dose and route were unknown) (Drug administered to patient of inappropriate age). No adverse effects were reported. Additional information is not expected because the reporter did not want to be contacted.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse and a physician referring to a 12 months old patient of unknown gender. Concurrent conditions and medical history were not reported. On 11-FEB-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot# J005693, expire date 07-MAY-2015, dose, route, anatomical location were not reported) (incorrect product storage). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all the follow up has been done.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has bene received from a registered nurse and a physician referring to a 4 years old patient of unknown gender. Concurrent conditions and medical history were not reported. On 19-MAR-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot# J005693, expire date 07-MAY-2015, dose, route, anatomical location were not reported) (incorrect product storage). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all the follow up has been done.
Age: 1.03
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse and a physician referring to a 12 months old patient of unknown gender. Concurrent conditions and medical history were not reported. On 06-FEB-2015, the patient was vaccinated with a dose of improperly stored (Oka/Mrerck) (lot # J005693, expire date 07-MAY-2015, dose, route, anatomical location were not reported). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all the follow up has been done.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse and a physician referring to a 4 years old patient of unknown gender. Concurrent conditions and medical history were not reported. On 20-APR-2015, the patient was vaccinated with a dose of improperly stored (Merck) VARIVAX (lot# J005693, expire date 07-MAY-2015, dose, route, anatomical location were not reported) (incorrect product storage). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all the follow up has been done.
Age: 1.02
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse and a physician referring to a 12 month old patient of unknown gender. Concurrent conditions and medical history were not reported. On 16-APR-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot# J005693, expire date 07-MAY-2015, dose, route, anatomical location were not reported). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all the follow up has been done.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Erythema, Hot flush, Injection site erythema, Injection site pain
Clinical narrative: Painful left arm after Tdap on 6/8/15. Used ice packs over towel. Seen rheumatology on 6/10/15 who prescribed steroid pack for RA pain in finger and other joints. Patient found this helpful for RA pain, but as I understand it the left arm pain continued and she experienced fitful sleep due to this. Today she awoke with a rash on her left arm and hot flashes through out the day. There was some initial itching, but she used essential oil on it and there is not further itching. The pain continues. No breathing difficulties, facial edema, or swallowing difficulties. Afebrile. No lesion, erythema, or edema at injection site-there is tenderness. Anterior to injection site there is a 7 x 2.5 cm erythematous hive. second rash mid medial forearm raised 3.5 x 4.5 cm erythematous wheal appearing lesion with 1-2 mm vesicle x 2 at lower periphery. Continue prednisone, add OTC anti-histamine, tramadol for pain. Tylenol for fever sensation (may take along with Tramadol), CLARITIN or ZYRTEC or ALLEGRA (usually one adult dose daily), ice packs as needed (covered so not directly touching skin. ED for worsening or new symptoms.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site urticaria, Pain in extremity, Pruritus, Rash, Sleep disorder
Clinical narrative: Painful left arm after Tdap on 6/8/15. Used ice packs over towel. Seen rheumatology on 6/10/15 who prescribed steroid pack for RA pain in finger and other joints. Patient found this helpful for RA pain, but as I understand it the left arm pain continued and she experienced fitful sleep due to this. Today she awoke with a rash on her left arm and hot flashes through out the day. There was some initial itching, but she used essential oil on it and there is not further itching. The pain continues. No breathing difficulties, facial edema, or swallowing difficulties. Afebrile. No lesion, erythema, or edema at injection site-there is tenderness. Anterior to injection site there is a 7 x 2.5 cm erythematous hive. second rash mid medial forearm raised 3.5 x 4.5 cm erythematous wheal appearing lesion with 1-2 mm vesicle x 2 at lower periphery. Continue prednisone, add OTC anti-histamine, tramadol for pain. Tylenol for fever sensation (may take along with Tramadol), CLARITIN or ZYRTEC or ALLEGRA (usually one adult dose daily), ice packs as needed (covered so not directly touching skin. ED for worsening or new symptoms.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Painful left arm after Tdap on 6/8/15. Used ice packs over towel. Seen rheumatology on 6/10/15 who prescribed steroid pack for RA pain in finger and other joints. Patient found this helpful for RA pain, but as I understand it the left arm pain continued and she experienced fitful sleep due to this. Today she awoke with a rash on her left arm and hot flashes through out the day. There was some initial itching, but she used essential oil on it and there is not further itching. The pain continues. No breathing difficulties, facial edema, or swallowing difficulties. Afebrile. No lesion, erythema, or edema at injection site-there is tenderness. Anterior to injection site there is a 7 x 2.5 cm erythematous hive. second rash mid medial forearm raised 3.5 x 4.5 cm erythematous wheal appearing lesion with 1-2 mm vesicle x 2 at lower periphery. Continue prednisone, add OTC anti-histamine, tramadol for pain. Tylenol for fever sensation (may take along with Tramadol), CLARITIN or ZYRTEC or ALLEGRA (usually one adult dose daily), ice packs as needed (covered so not directly touching skin. ED for worsening or new symptoms.
Age: 26.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.) referring to a 26 year old patient of unknown gender. No relevant medical history or concurrent conditions were reported. On 12-JUN-2015 the patient was vaccinated with an expired dose of MMR II (lot # J006185, expiration date 24-MAY-2015; dose and route not reported). No adverse effects were reported. Additional information is not expected as the reporter did not want to be contacted.
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Information has been received from a physician via a company representative referring to a male patient of unknown age. The patient's concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 (strength, lot#, expiration date, dose and route were unknown). On an unknown date the patient's arm swelled up and the patient went to an unknown emergency room and received unspecified treatment. It was not known which hospital, if the patient was admitted or discharged to home, or the dates. The outcome of the event was unknown. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse and a physician referring to a 12 months old patient of unknown gender. Concurrent conditions and medical history were not reported. On 02-MAR-2015, the patient was vaccinated with a dose of improperly stored (Merck) VARIVAX (lot# J013728, expire date 30-OCT-2015, dose, route, anatomical location were not reported) (incorrect product storage). No adverse effects were reported and no product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all the follow up has been done.
Age: 1.02
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse and a physician referring to a 12 months old patient of unknown gender. Concurrent conditions and medical history were not reported. On 12-MAR-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot# J005693, expire date 07-MAY-2015, dose, route, anatomical location were not reported) (incorrect product storage). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all the follow up has been done.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Hypotension, Pallor
Clinical narrative: Had a pallor, hypotensive episode after first set of shots. Provider elected to leave out pertussis in future vaccinations.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain lower, Blood test abnormal, Disturbance in attention, Dizziness, Fatigue
Clinical narrative: Information has been received from Sanofi Pasteur (manufacturer control # E2015-06471) on 12-JUN-2015 as a part of business agreement. Case received from an other health care professional via the Heath Authorities on 08-Jun-2015 under the reference number DK-DKMA-ADR 22988484 and DK-DKMA-EFO012034. Case is medically confirmed. Primary source was a physician. A 14-year-old female patient (weight 60 kg, height 167 cm), with no medical history reported, had received three injections of GARDASIL (batch number not reported) via intramuscular route into not reported site of administration on 22-Sep -2011 (D1), on 03-Nov-2011 (D2) and on 15-Mar-2012 (D3). on 09-Nov-2014, the patient developed visual disturbance, tiredness, headache, nauseas, dizziness, yellow eyes, red eyes, cramps in throat, legs, feet and arms, concentration impaired, severe pain in lower abdomen. In Feb-2015, the patient got stuck with thoughts, action activities. On an unspecified date, the patient developed increased liver enzymes. The patient was treated with morphine ibumetin, paracetamol, physiotherapist, psychologist and cranio sacral therapy. The following test and examinations had been performed: MRI cerebrum, lumbar puncture and blood test. The blood test showed increased liver function. At the time of reporting the outcome for increased liver function was unknown and the patient had not recovered from all the other events.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Liver function test increased, Lumbar puncture, Muscle spasms, Nausea
Clinical narrative: Information has been received from Sanofi Pasteur (manufacturer control # E2015-06471) on 12-JUN-2015 as a part of business agreement. Case received from an other health care professional via the Heath Authorities on 08-Jun-2015 under the reference number DK-DKMA-ADR 22988484 and DK-DKMA-EFO012034. Case is medically confirmed. Primary source was a physician. A 14-year-old female patient (weight 60 kg, height 167 cm), with no medical history reported, had received three injections of GARDASIL (batch number not reported) via intramuscular route into not reported site of administration on 22-Sep -2011 (D1), on 03-Nov-2011 (D2) and on 15-Mar-2012 (D3). on 09-Nov-2014, the patient developed visual disturbance, tiredness, headache, nauseas, dizziness, yellow eyes, red eyes, cramps in throat, legs, feet and arms, concentration impaired, severe pain in lower abdomen. In Feb-2015, the patient got stuck with thoughts, action activities. On an unspecified date, the patient developed increased liver enzymes. The patient was treated with morphine ibumetin, paracetamol, physiotherapist, psychologist and cranio sacral therapy. The following test and examinations had been performed: MRI cerebrum, lumbar puncture and blood test. The blood test showed increased liver function. At the time of reporting the outcome for increased liver function was unknown and the patient had not recovered from all the other events.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging brain, Obsessive-compulsive disorder, Ocular hyperaemia, Ocular icterus, Visual impairment
Clinical narrative: Information has been received from Sanofi Pasteur (manufacturer control # E2015-06471) on 12-JUN-2015 as a part of business agreement. Case received from an other health care professional via the Heath Authorities on 08-Jun-2015 under the reference number DK-DKMA-ADR 22988484 and DK-DKMA-EFO012034. Case is medically confirmed. Primary source was a physician. A 14-year-old female patient (weight 60 kg, height 167 cm), with no medical history reported, had received three injections of GARDASIL (batch number not reported) via intramuscular route into not reported site of administration on 22-Sep -2011 (D1), on 03-Nov-2011 (D2) and on 15-Mar-2012 (D3). on 09-Nov-2014, the patient developed visual disturbance, tiredness, headache, nauseas, dizziness, yellow eyes, red eyes, cramps in throat, legs, feet and arms, concentration impaired, severe pain in lower abdomen. In Feb-2015, the patient got stuck with thoughts, action activities. On an unspecified date, the patient developed increased liver enzymes. The patient was treated with morphine ibumetin, paracetamol, physiotherapist, psychologist and cranio sacral therapy. The following test and examinations had been performed: MRI cerebrum, lumbar puncture and blood test. The blood test showed increased liver function. At the time of reporting the outcome for increased liver function was unknown and the patient had not recovered from all the other events.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse and a physician referring to a 4 years old patient of unknown gender. Concurrent conditions and medical history were not reported. ON 27-MAR-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot# J005693, expire date 07-MAY-2015, dose, route, anatomical location were not reported) (incorrect product storage). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all the follow up has been done.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Erythema multiforme, Extra dose administered, Musculoskeletal stiffness, Myalgia
Clinical narrative: Pt inadvertently received 5 doses instead of 1 on 8-29-13. On 8-30-13 she reports her arm is 1 and 3/4 inch swollen, it is red, warm and stiff in the upper arm but she does not feel bad or sick. Denies trouble breathing, no facial swelling, no heart palpitation, no behavior changes, denies numbness or tingling, or fever. Myalgia, erythema multiforme and purpura.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Purpura, Skin warm
Clinical narrative: Pt inadvertently received 5 doses instead of 1 on 8-29-13. On 8-30-13 she reports her arm is 1 and 3/4 inch swollen, it is red, warm and stiff in the upper arm but she does not feel bad or sick. Denies trouble breathing, no facial swelling, no heart palpitation, no behavior changes, denies numbness or tingling, or fever. Myalgia, erythema multiforme and purpura.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4, HPV4
Symptoms: Balance disorder, Blood test, Chest pain, Computerised tomogram, Dizziness
Clinical narrative: Shaking, repeating herself, c/o being hot, gait difficulty, headaches, not remembering things, chest discomfort, chattering her teeth, stuttering, did not recognize family members. Admitted to hospital.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4, HPV4
Symptoms: Electroencephalogram, Headache, Muscular weakness, Tremor, Urine analysis
Clinical narrative: Shaking, repeating herself, c/o being hot, gait difficulty, headaches, not remembering things, chest discomfort, chattering her teeth, stuttering, did not recognize family members. Admitted to hospital.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4, HPV4
Symptoms: Blood test, Chest discomfort, Chills, Computerised tomogram, Drug screen
Clinical narrative: Shaking, repeating herself, c/o being hot, gait difficulty, headaches, not remembering things, chest discomfort, chattering her teeth, stuttering, did not recognize family members. Admitted to hospital.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4, HPV4
Symptoms: Dysphemia, Feeling hot, Gait disturbance, Headache, Memory impairment
Clinical narrative: Shaking, repeating herself, c/o being hot, gait difficulty, headaches, not remembering things, chest discomfort, chattering her teeth, stuttering, did not recognize family members. Admitted to hospital.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4, HPV4
Symptoms: Repetitive speech, Tremor, Urine analysis
Clinical narrative: Shaking, repeating herself, c/o being hot, gait difficulty, headaches, not remembering things, chest discomfort, chattering her teeth, stuttering, did not recognize family members. Admitted to hospital.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4, HPV4
Symptoms: Blood test, Chest discomfort, Computerised tomogram, Drug screen, Feeling hot
Clinical narrative: Shaking, repeating herself, c/o being hot, gait difficulty, headaches, not remembering things, chest discomfort, chattering her teeth, stuttering, did not recognize family members. Admitted to hospital.
Age: 62.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Corneal abrasion, Herpes zoster, Ophthalmic herpes zoster, Optic nerve disorder, Pain
Clinical narrative: Information has been received from an approximately 62 year old patient via company reprehensible referring to himself/herself. Patient's concurrent conditions, concomitant medication and medical history were not provided. In approximately June 2011, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route and frequency were not provided). Six months later, in early December 2011, the patient suffered an outbreak of the herpes zoster virus. The rash started at the top of his/her head at the hairline and extended into his/her left eye. The pain could only be described as if a knife were driven into the eye, easily the worse pain the patient had ever experienced in his/her life. The patient's doctor told him/her that the outbreak would have been worse if he/she didn't have the vaccine. At the time of the report, the patient still took Gabapentin 400 mg three times a day for the post Shingles neuralgia (onset date unspecified) and four types of eye drops. Because of the affect to his/her eye the patient suffered corneal abrasions and was on a course of heavy steroids for a year. His/her optic nerve had deteriorated (onset date unspecified) in the affected eye but his/her vision was still intact. At 66 years old (at reporting time) the patient expect his/her treatment would continue for life, with no guarantee he/she wouldn't suffer another outbreak. No product quality complaint (PQC) was reported. The patient also provided feedback on the ZOSTAVAX commercials, and suggested they should contain information regarding the potential dangers of the shingles virus to the eye. The outcome of the events was considered as not recovered. Additional information has been requested. Case 1506USA004975 was deleted from our files and this case was created to correct initial receipt date from 08-JUN-2015 to 01-JUN-2015.
Age: 62.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: Information has been received from an approximately 62 year old patient via company reprehensible referring to himself/herself. Patient's concurrent conditions, concomitant medication and medical history were not provided. In approximately June 2011, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route and frequency were not provided). Six months later, in early December 2011, the patient suffered an outbreak of the herpes zoster virus. The rash started at the top of his/her head at the hairline and extended into his/her left eye. The pain could only be described as if a knife were driven into the eye, easily the worse pain the patient had ever experienced in his/her life. The patient's doctor told him/her that the outbreak would have been worse if he/she didn't have the vaccine. At the time of the report, the patient still took Gabapentin 400 mg three times a day for the post Shingles neuralgia (onset date unspecified) and four types of eye drops. Because of the affect to his/her eye the patient suffered corneal abrasions and was on a course of heavy steroids for a year. His/her optic nerve had deteriorated (onset date unspecified) in the affected eye but his/her vision was still intact. At 66 years old (at reporting time) the patient expect his/her treatment would continue for life, with no guarantee he/she wouldn't suffer another outbreak. No product quality complaint (PQC) was reported. The patient also provided feedback on the ZOSTAVAX commercials, and suggested they should contain information regarding the potential dangers of the shingles virus to the eye. The outcome of the events was considered as not recovered. Additional information has been requested. Case 1506USA004975 was deleted from our files and this case was created to correct initial receipt date from 08-JUN-2015 to 01-JUN-2015.
Age: 62.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Corneal abrasion, Eye pain, Herpes zoster, Ophthalmic herpes zoster, Optic nerve disorder
Clinical narrative: Information has been received from an approximately 62 year old patient via company reprehensible referring to himself/herself. Patient's concurrent conditions, concomitant medication and medical history were not provided. In approximately June 2011, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route and frequency were not provided). Six months later, in early December 2011, the patient suffered an outbreak of the herpes zoster virus. The rash started at the top of his/her head at the hairline and extended into his/her left eye. The pain could only be described as if a knife were driven into the eye, easily the worse pain the patient had ever experienced in his/her life. The patient's doctor told him/her that the outbreak would have been worse if he/she didn't have the vaccine. At the time of the report, the patient still took Gabapentin 400 mg three times a day for the post Shingles neuralgia (onset date unspecified) and four types of eye drops. Because of the affect to his/her eye the patient suffered corneal abrasions and was on a course of heavy steroids for a year. His/her optic nerve had deteriorated (onset date unspecified) in the affected eye but his/her vision was still intact. At 66 years old (at reporting time) the patient expect his/her treatment would continue for life, with no guarantee he/she wouldn't suffer another outbreak. No product quality complaint (PQC) was reported. The patient also provided feedback on the ZOSTAVAX commercials, and suggested they should contain information regarding the potential dangers of the shingles virus to the eye. The outcome of the events was considered as not recovered. Additional information has been requested. Case 1506USA004975 was deleted from our files and this case was created to correct initial receipt date from 08-JUN-2015 to 01-JUN-2015.
Age: 54.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Impaired work ability, Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from an office manager/healthcare worker and refers to a 54 years old female patient with BACTRIM, amoxicillin and LEVAQUIN allergy. The patient's medical history included breast cancer. On 02-JUN-2015, the patient was vaccinated with PNEUMOVAX23 (0.5ml, intramuscularly, left arm, lot number: K022886, expiry date: 09-JUN-2016). Concomitant therapies included tramadol hydrochloride, FLONASE and PROZAC. In approximately June 2015, after receiving PNEUMOVAX23, the patient experienced pain in her left arm, itching (unspecified area) (PT: pruritus), nausea, swelling (unspecified area) and a spotty rash on her torso, right arm and both legs (PT: rash). No lab test diagnostic was performed. The patient was seen by a physician in the office on an unspecified date and the physician prescribed BENADRYL, ZYRTEC and MEDROL DOSEPAK. At the time of the report, the patient was a little better (recovering). The relatedness between the therapy with PNEUMOVAX23 and the adverse event was not reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Peripheral swelling, Rash generalised
Clinical narrative: This spontaneous report was received from an office manager/healthcare worker and refers to a 54 years old female patient with BACTRIM, amoxicillin and LEVAQUIN allergy. The patient's medical history included breast cancer. On 02-JUN-2015, the patient was vaccinated with PNEUMOVAX23 (0.5ml, intramuscularly, left arm, lot number: K022886, expiry date: 09-JUN-2016). Concomitant therapies included tramadol hydrochloride, FLONASE and PROZAC. In approximately June 2015, after receiving PNEUMOVAX23, the patient experienced pain in her left arm, itching (unspecified area) (PT: pruritus), nausea, swelling (unspecified area) and a spotty rash on her torso, right arm and both legs (PT: rash). No lab test diagnostic was performed. The patient was seen by a physician in the office on an unspecified date and the physician prescribed BENADRYL, ZYRTEC and MEDROL DOSEPAK. At the time of the report, the patient was a little better (recovering). The relatedness between the therapy with PNEUMOVAX23 and the adverse event was not reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Nausea, Pain in extremity, Pruritus, Rash, Swelling
Clinical narrative: This spontaneous report was received from an office manager/healthcare worker and refers to a 54 years old female patient with BACTRIM, amoxicillin and LEVAQUIN allergy. The patient's medical history included breast cancer. On 02-JUN-2015, the patient was vaccinated with PNEUMOVAX23 (0.5ml, intramuscularly, left arm, lot number: K022886, expiry date: 09-JUN-2016). Concomitant therapies included tramadol hydrochloride, FLONASE and PROZAC. In approximately June 2015, after receiving PNEUMOVAX23, the patient experienced pain in her left arm, itching (unspecified area) (PT: pruritus), nausea, swelling (unspecified area) and a spotty rash on her torso, right arm and both legs (PT: rash). No lab test diagnostic was performed. The patient was seen by a physician in the office on an unspecified date and the physician prescribed BENADRYL, ZYRTEC and MEDROL DOSEPAK. At the time of the report, the patient was a little better (recovering). The relatedness between the therapy with PNEUMOVAX23 and the adverse event was not reported. Additional information has been requested.