chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Vision blurred
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 year old female patient. The patient had none medical history, none drug reactions nor allergies and none concomitant medications. None of lab diagnostic studies were performed. On 16-04-2015, the patient received the first dose of GARDASIL (Lot number: L001442 and expiration date: 22-JUN-2015) and on 15-JUN-2015, the second dose of GARDASIL (Lot number: L001442 and expiration date: 04-NOV-2016). On 19-NOV-2015, the patient received GARDASIL 9 (Lot number: L028083 and expiration date: 23-SEP-2017) intramuscular as the third dose in the series. On 19-NOV-2015 (five to ten minutes after receiving GARDASIL 9), the patient developed a headache, blurry vision and became nauseous. The patient sought medical attention as she was in the office at the time of the adverse event. The patient was given Ondansetron (manufacturer unspecified) and Ibuprofen (manufacturer unspecified) as a treatment. On 20-NOV-2015, the patient was still groggy and was seen by the physician on the same day. The physician completed a neurological exam and determined the patient was very tremulous in the legs and arms, she had clonus of the ankles, both hands were weak with the left hand being a little weaker than the right hand, the patient's knees were hyper reflexive and the patient had optical neuritis. The outcome of headache, blurry vision, nausea, optic neuritis, hyperreflexia, muscular weakness, clonus and tremor was unknown. The relatedness between the events and GARDASIL, GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional (healthcare worker) refers to an unspecified number of patients of unknown ages and genders. Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (single dose vial) (lot # K019561, expiration date: 20-APR-2016; dose, frequency and route of administration were not reported). No adverse effects were reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a "baby" male patient of unknown age. Patient's medical history and concurrent condition were not provided. On 27-NOV-2015 the patient was vaccinated with RECOMBIVAX HB (lot # L018500) Expiration 13-APR-2017 (route, dose number and anatomical location were not provided) which was incorrectly stored. Concomitant medications were not reported. No adverse events were reported. This is one of five reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse (LVN) refers to unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with a dose of GARDASIL (lot No: K011562 expiration date 08-APR-2017)(dose and route were not provided). The licensed vocational nurse (LVN) stated that on multiple unspecified date, multiple unspecified patients were administered improperly stored Gardasil. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 09-NOV-2015, the patient was vaccinated with a dose of improperly stored PROQUAD lot # L011080, expiry date 01-OCT-2016, (dose, strength, route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown demographics. The patients medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored COMVAX (lot #, dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hyperaesthesia, Pain, Peripheral swelling
Clinical narrative: Information has been received from a healthcare worker referring to a 48 year old female patient. The patient had no pertinent medical history. The patient had no pertinent medical history. The patient had doxycycline and codeine allergy. On 01-DEC-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L033707 with expiration date of 18-MAY-2017, 0.5 ml, intramuscular). Concomitant therapies included albuterol, ESTRACE, amlodipine, omeprazole, levothyroxine sodium, clobetasol propionate and cholecalciferol. 8 hours after receiving PNEUMOVAX 23, the patient developed redness and swelling on the arm. The redness had spread to chest and upper shoulder. The red area was sensitive to touch. Her whole body was also achy. The patient sought medical attention by seeing the physician. No treatment was given for the events. No lab diagnostics study performed. The patient was not recovered from the events. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 04-DEC-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 injection (lot # L014420 with expiration date 23-FEB-2017; dose, route and frequency were not provided). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 0.41
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) referring to a 13 weeks old male patient. Pertinent medical history and drug reactions/allergies were not reported. On 02-DEC-2015 the patient was vaccinated with his first dose of ROTATEQ (lot # K012432, expiration date 20-MAY-2016, dose was not reported) orally. Concomitant drug was not reported. No adverse effects were reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 12 year old female patient. Medical history was not provided. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 lot # L019287, intramuscular injection (dose and expiration date were not reported). The physician stated that prior to GARDASIL 9 injection, the patient was on an unspecified antibiotic, which she did not take the day before receiving her vaccine injection, and continued the antibiotics, the day after the vaccine injection. It was not known if the unspecified antibiotics had an effect on the vaccine injection. The physician stated that 3 days after injection with GARDASIL 9, the patient removed her bandage and noticed what she thought was hives. The patient's mother also noticed that the "hives" seemed to be spreading. The patient's mother took the patient to the emergency room, where the patient was treated for a possible allergic reaction to GARDASIL 9. The outcome of urticarial and allergy to vaccine was reported as recovered on therapy (unspecified date). Relatedness between the therapy with GARDASIL 9 and the events was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 12 year old female patient. Medical history was not provided. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 lot # L019287, intramuscular injection (dose and expiration date were not reported). The physician stated that prior to GARDASIL 9 injection, the patient was on an unspecified antibiotic, which she did not take the day before receiving her vaccine injection, and continued the antibiotics, the day after the vaccine injection. It was not known if the unspecified antibiotics had an effect on the vaccine injection. The physician stated that 3 days after injection with GARDASIL 9, the patient removed her bandage and noticed what she thought was hives. The patient's mother also noticed that the "hives" seemed to be spreading. The patient's mother took the patient to the emergency room, where the patient was treated for a possible allergic reaction to GARDASIL 9. The outcome of urticarial and allergy to vaccine was reported as recovered on therapy (unspecified date). Relatedness between the therapy with GARDASIL 9 and the events was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Fatigue, Influenza like illness, Influenza virus test negative, Injection site erythema
Clinical narrative: Extreme soreness and redness at injection site, followed by fever (up to 101*) for next 36 hours.  Unusual muscle and joint pain and fatigue. Redness at injection site spread to entire upper arm and lessened somewhat before dissipating around 6 days later.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: Extreme soreness and redness at injection site, followed by fever (up to 101*) for next 36 hours.  Unusual muscle and joint pain and fatigue. Redness at injection site spread to entire upper arm and lessened somewhat before dissipating around 6 days later.
Age: 33.0
Sex: M
Vaccine: HEPAB
Symptoms: Ageusia, Dyspnoea, Injection site bruising, Malaise, Mouth swelling
Clinical narrative: I have a strange bruise on my arm from the vaccines that were administered, I have a terrible sickness, my mouth feels swollen, I can't taste my food since Sunday, I can't breathe during my sleep, and, I'm losing sleep because of it. I never felt this sick until after those shots on Tuesday at my doctors office.
Age: 33.0
Sex: M
Vaccine: HEPAB
Symptoms: Sleep disorder
Clinical narrative: I have a strange bruise on my arm from the vaccines that were administered, I have a terrible sickness, my mouth feels swollen, I can't taste my food since Sunday, I can't breathe during my sleep, and, I'm losing sleep because of it. I never felt this sick until after those shots on Tuesday at my doctors office.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Initially, the injection site was only slightly red and itchy, and no cause for concern. Two days later patient's entire front upper left arm was visibly swollen, very red, and hot to the touch. He experienced no pain or tenderness. His temperature remained normal, he was given a cold compress, no medications and recovered the following day.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Hallucination, visual
Clinical narrative: Weakness initially, then hallucinations of seeing people who were not real, on 11/29/2015.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Herpes zoster, Rash
Clinical narrative: I noticed a very painful rash on upper left buttock approx. 30 hours after taking the Prevnar13 shot in my left arm. I went to the Dr. the next morning on 12/11/15 and it was verified that it was Shingles. Started on Valtrex & Neurontin immediately. I had my Shingles Vac. April 2013 Don't know if it's related to the Prevnar13? I'm retired and not under any stress. It has not spread anymore and starting to dry up as of 12/15/2015.
Age: 0.44
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous
Clinical narrative: Child given vaccine at 2:00pm 12/10/15. Child developed red rash on her body at 7:00pm 12/10/15.  Seen in clinic 12/11/15 with Nurse Practioner.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Diarrhoea, Flatulence, Nausea, Vomiting
Clinical narrative: Diarrhea, nausea, gas, vomiting, chills for 2 days.
Age: 68.0
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Cellulitis
Clinical narrative: Patient developed cellulitis.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Muscular weakness
Clinical narrative: Weakness and limited mobility in right arm (IM injection in right deltoid).
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Food allergy, Pharyngeal oedema
Clinical narrative: The patient is a 74-year-old female with a history of diabetes, CAD who presents to clinic for evaluation and recommendations on receipt of an influenza vaccine due to a history of any allergy. She reports she developed an egg allergy in 1990. She states she believes she can eat eggs in small amounts, but generally avoids them including in baked goods and is not sure what will happen if she eats them. She reports she's had throat swelling and shortness of breath making it hard to swallow. It has not been treated or evaluated. She denies urticaria lesions, pruritus, oral, facial, tongue swelling, conjunctivitis, rhinorrhea, tachycardia, chest pain, nausea or emesis. She reports she had an event after receipt influenza vaccine in the 1990s consisting of throat swelling and difficulty swallowing, which occurred approximately 15 minutes after vaccine recently and was 20-25 minutes in duration. It was not treated and resolved spontaneously. She denies urticaria lesions, pruritus, oral, facial, tongue swelling, conjunctivitis, rhinorrhea, tachycardia, chest pain, nausea or emesis with this episode. She may have had anxiety. She states she received influenza vaccine last year and that it was "egg free" and given at clinic. No reaction to this vaccine.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 67 year old patient of unknown gender. On 03-DEC-2015, the patient was vaccinated with a dose of improperly stored ZOSTAVAX lot # L023118, expiration date: 24-SEP-2016 (dose, route and site of administration were not reported). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified "18 or 19 year old" patient of unknown gender. Information about patients' concurrent conditions and medical history was not reported. On unknown dates the patients were vaccinated with an adult dose of RECOMBIVAX HB (lot#, dose and route not reported) which was outside the recommendations per the RECOMBIVAX HB prescribing information. No adverse effects were reported. Additional information is not expected because the physician did not want to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with unspecified number of doses of improperly stored ROTATEQ (lot# K016261, expiration date 23-JUN-2016; lot# K016311, expiration date 26-MAY-2016; lot# reported as K016260, expiration date 05-MAY-2016; dose not reported) orally. No adverse event was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medications, drug reactions or allergies reported. On an unknown dates, the patients were vaccinated with improperly stored PROQUAD (Merck) injection (lot# K009470, expiration date 03-JAN-2016, dose, anatomical location and route administration were not reported). Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Extra dose administered
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a 65 year old male patient who has chronic obstructive pulmonary disease and smoker as current conditions. No medical history was reported. On unspecified dates, less than 5 years apart, the patient received "several doses" of PNEUMOVAX 23 (dose, route, lot number and expiration date were not provided). No concomitant medication reported. Since an unspecified date, the patient had chronic obstructive pulmonary disease (COPD). The COPD was not recovered at the moment of this report. Additional information is not expected, because the reporter did not allow to contact him.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 11-DEC-2015 the patient was vaccinated with an expired dose of VAQTA 25/0.5 (lot# K008984, expiry date 21-OCT-2015, does and route were unspecified). No adverse effect was reported. No product quality complaint (PQC). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On 10-DEC-2015 the patient was vaccinated with an expired dose of VAQTA (lot # K000578 with expired date 21-SEP-2015, intramuscular, dose unknown) inadvertently. No concomitant therapy was provided. No adverse effects were reported. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: PNC13
Symptoms: Chest X-ray, Chills, Fatigue, Full blood count, Influenza A virus test
Clinical narrative: Patient reporting at doctors office chills, body aches, slight respiratory discomfort, fatigue. Pt was instructed to take TYLENOL.
Age: 48.0
Sex: M
Vaccine: PNC13
Symptoms: Influenza B virus test, Pain, Respiratory disorder
Clinical narrative: Patient reporting at doctors office chills, body aches, slight respiratory discomfort, fatigue. Pt was instructed to take TYLENOL.
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to a female patient of unknown age. Patient's current conditions and medical history was not provided. On an unknown date, the patient was vaccinated with a first dose of GARDASIL (Lot# and expiration date was not known). On 08-DEC-2015, the patient visited the reporter's office to receive the second dose of GARDASIL 9. No adverse effects was reported. There were no product quality complaints. The outcome of Interchange of vaccine products was unknown. The causality for Interchange of vaccine products was not reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 23 year old female patient. The patient's pertinent medical history and drug allergies were not reported. On an unknown date in the past the patient received the first dose of GARDASIL (lot#, dose, strength and route unknown) at an unspecified location. On 25-MAR-2013 the patient was vaccinated with the second dose of GARDASIL (lot# H021608 with expiration date of 13-AUG-2015, dose, strength and route unknown) in Dr.'s office. On 07-DEC-2015, the patient received the third dose of GARDASIL (lot#, dose, strength and route unknown) (inappropriate schedule of drug administration). No adverse effects had been reported for any doses. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 04-DEC-2015 the patient was vaccinated with a dose of expired M-M-R II lot # J014876, expiration date: 21-NOV-2015, (dose, dose #, route and application site were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On 07-DEC-2015 the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot# K026803 with expired date 05-DEC-2015, route and dose were unknown). No concomitant therapy was provided. No adverse effect was reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Interchange of vaccine products
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to an 18 year old female patient. Patient's concurrent condition, concomitant medications and medical history was not provided. On an unknown date, the patient was vaccinated with first dose of GARDASIL 9. On 08-DEC-2015, the patient was vaccinated with second dose of GARDASIL instead of GARDASIL 9. There was no product quality complaint reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 09-DEC-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (dose was not reported) lot # J014812, expiration date 20-FEB-2015, subcutaneous. No adverse effect has been reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unspecified. On 11-DEC-2015 the patient was inadvertently vaccinated with PNEUMOVAX 23 (lot # K007262 with expiration dated of 25-NOV-2015; strength, dosage, frequency and route unspecified) (expired product administered). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 09-NOV-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # L011080, expiry date 01-OCT-2016, (dose, strength, route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 19-OCT-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # L002213, expiry date 21-JUL-2016, (dose, strength, route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: FLU3, HEPA, PPV
Symptoms: Wrong drug administered
Clinical narrative: Patient was given Pneumococcal 23 and should have received a Prevnar 13.
Age: 0.24
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal pain, Aggression, Crying, Developmental delay, Listless
Clinical narrative: We noticed something was not quite right with our child at home immediately following birth. He was crying a lot. Once home he was screaming and we contacted the pediatrician and weye told it was colic. We continued with vaccinations on schedule. By around 1 year our child was having seizures when he would cry and it seemed like he was passing out. We contacted the pediatrician and we're told he was spoiled and was throwing temper tantrums. We continued with vaccines on schedule. His seizures became more severe and I asked my doctor if it could be the shots and he told me absolutely not that my child was trying to get attention. We continued with vaccinations. On 04/27/2012 after his last set of shots he was very listless and his seizures were terrible. We decided to stop vaccines altogether. He still has seizures. He has some neurological issues and development issues.
Age: 0.24
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Loss of consciousness, Nervous system disorder, Screaming, Seizure
Clinical narrative: We noticed something was not quite right with our child at home immediately following birth. He was crying a lot. Once home he was screaming and we contacted the pediatrician and weye told it was colic. We continued with vaccinations on schedule. By around 1 year our child was having seizures when he would cry and it seemed like he was passing out. We contacted the pediatrician and we're told he was spoiled and was throwing temper tantrums. We continued with vaccines on schedule. His seizures became more severe and I asked my doctor if it could be the shots and he told me absolutely not that my child was trying to get attention. We continued with vaccinations. On 04/27/2012 after his last set of shots he was very listless and his seizures were terrible. We decided to stop vaccines altogether. He still has seizures. He has some neurological issues and development issues.
Age: 13.0
Sex: M
Vaccine: HEP, HPV4, VARCEL
Symptoms: Dizziness, Nausea, Pruritus, Throat irritation
Clinical narrative: 15 mins after vaccine administration he c/o itchy throat, itching around his neck and feeling dizzy. Initially felt mildly nauseous but it subsided, no vomiting. He denies dyspnea. O: BP: 115/60, HR 88, SaO2 100%, RR 16, T: 98.6.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Injection site pain, Pain in extremity, Tendon pain
Clinical narrative: Severe pain at left arm, just below injection site, with radiation to left shoulder and left elbow.
Age: 10.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Abdominal pain upper, Back pain, Balance disorder, Dizziness, Headache
Clinical narrative: Fever 102-104 started on 12/12/15, 12/13/15 mom noticed red, splotchy area on right arm, complaints of dizziness, and off balance, back, neck, and stomach pain, headache.
Age: 10.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Neck pain, Pyrexia, Rash, Rash macular
Clinical narrative: Fever 102-104 started on 12/12/15, 12/13/15 mom noticed red, splotchy area on right arm, complaints of dizziness, and off balance, back, neck, and stomach pain, headache.
Age: 0.36
Sex: F
Vaccine: RV1
Symptoms: Urticaria
Clinical narrative: Patient broke out in hives, lasted 45 minutes then went away. Patient was seen at local emergency room, the symptoms weren't visible. Upon discharge the patient broke out again, then was treated with Benadryl and monitored then discharged. Later that even the patient broke out again in hives.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Fatigue, Headache, Injection site pain, Neck pain
Clinical narrative: Painful (R) arm to shoulder, neck. Sore throat. Shaking fits. Fatigue. Vomiting. Diarrhea. Headache.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Oropharyngeal pain, Tremor, Vomiting
Clinical narrative: Painful (R) arm to shoulder, neck. Sore throat. Shaking fits. Fatigue. Vomiting. Diarrhea. Headache.
Age: 1.83
Sex: F
Vaccine: DTAP, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Reddened area to most of right thigh. Had fever over weekend, was seen in the ER. Given instructions to apply ice and rotate Ibuprofen and TYLENOL for fever.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated orally with unknown doses of oral, ROTATEQ (lot # L008057, expiry date: 01-DEC-2016), which were improperly stored. There was no adverse effect reported after improperly stored vaccine was given to the patients. This is one of two reports received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare student refers to a patient of unknown age. On an unknown date in OCT-2014, the patient was vaccinated with first dose of ZOSTAVAX, L032403, 26-NOV-2016 subcutaneous. On 11-DEC-2015, the patient was inadvertently received a second dose with ZOSTAVAX. No adverse effects reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Joint injection, Nuclear magnetic resonance imaging, Rash erythematous
Clinical narrative: I don't remember the exact timing. I had a red itchy bumpy rash on my chest for a few weeks. The itch disappeared but it took weeks for the red bumps to go away. I had bumps under my hair line, back of my neck. A red spot on my left pinky. Pain in my right shoulder. The onset was within a week.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Swelling, X-ray
Clinical narrative: I don't remember the exact timing. I had a red itchy bumpy rash on my chest for a few weeks. The itch disappeared but it took weeks for the red bumps to go away. I had bumps under my hair line, back of my neck. A red spot on my left pinky. Pain in my right shoulder. The onset was within a week.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Med asst prepared incorrect vaccine, flu 0.5 ml instead of 0.25 ml and I gave it.
Age: 13.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Abdominal pain, Dizziness, Headache
Clinical narrative: Dizziness and headache for 2 hours, with mild abdominal pain, starting several hours after vaccine administration (HPV4 [Merck] and influenza Fluzone Quad MDV.
Sex: U
Vaccine: VARCEL
Symptoms: Polymerase chain reaction positive, Varicella post vaccine, Varicella virus test positive
Clinical narrative: This spontaneous report was received from a physician regarding a patient of unknown age and unknown gender. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient developed chickenpox via possible secondary transmission of the varicella virus after a household member was recently administered VARIVAX (Merck) lot/batch, dose, route unknown. Concomitant medications were not reported. On an unknown date, Polymerase chain reaction (PCR) analysis revealed that the specimen contained the wild type varicella zoster virus. The outcome of chicken pox and possible secondary transmission was unknown. Causality assessment was not provided. No product quality complaint (PQC) was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker, who was a certified medical assistant referring to multiple unspecified patients. The information of concurrent conditions, medical history and concomitant medications was not provided. On multiple unspecified dates, the patients were administered improperly stored PROQUAD (Merck) (lot number K008579 and expired date 13-DEC-2015, K008870 and expired date 19-DEC-2015, K025764 and expired date 08-JUN-2016, dose, frequency and route were not provided). No known adverse effect was reported. This is one of two reports received from the same source (linked report MARRS# 1512USA0003027). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to a patient of unknown age and gender. The patient concurrent condition and medical history were unknown. On 25-NOV-2015 the patient was vaccinated with an improperly stored dose of PEDVAXHIB (Lot # 1014427, expiration date 09-MAR-2018) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to a patient of unknown age and gender. The patient concurrent condition and medical history were unknown. On 30-NOV-2015 the patient was vaccinated with an improperly stored dose of PEDVAXHIB (Lot # 1014427, expiration date 09-MAR-2018) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L028666, expiry date: 04-NOV-2016; dose and route were not reported). There were no adverse effect reported after improperly stored vaccine was given to the patients. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Impaired work ability, Injection site pain, Injection site reaction, Musculoskeletal pain, Neck pain
Clinical narrative: Severe constant stabbing pain in my left arm, pain originates at injection site and is deep into the bone near my rotator cuff, up into my neck and shoulder blade. Last week I took extra strength Tylenol or aspirin.  No improvement over the weekend. So when I came to work Monday, I went to the Med Unit (since that's where I received the flu shot). The Dr. at Med Unit diagnosed nerve pain at the injection site and recommended combining low-dose Tylenol and aspirin every 4-6 hours for the next several days to address pain. I'm having a lot of difficulty working. Pain is more severe when sitting at my desk and is now extending down my forearm.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Neuralgia
Clinical narrative: Severe constant stabbing pain in my left arm, pain originates at injection site and is deep into the bone near my rotator cuff, up into my neck and shoulder blade. Last week I took extra strength Tylenol or aspirin.  No improvement over the weekend. So when I came to work Monday, I went to the Med Unit (since that's where I received the flu shot). The Dr. at Med Unit diagnosed nerve pain at the injection site and recommended combining low-dose Tylenol and aspirin every 4-6 hours for the next several days to address pain. I'm having a lot of difficulty working. Pain is more severe when sitting at my desk and is now extending down my forearm.
Age: 79.0
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Feeling hot, Hypoaesthesia, Laboratory test, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Both arms hurting, hot, sore for 1 wk - woke up with arms stabbing in pain and stiff and numb hands. Suffered for 2 1/2 months after seeing 2 doctors with no help. The suffering was horrible. Will never forget this!!!
Age: 79.0
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Rheumatoid factor
Clinical narrative: Both arms hurting, hot, sore for 1 wk - woke up with arms stabbing in pain and stiff and numb hands. Suffered for 2 1/2 months after seeing 2 doctors with no help. The suffering was horrible. Will never forget this!!!
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Patient states since receiving flu vaccine has had pain in Lt shoulder with ROM. Ibuprofen does not help. Now is painful to lay on that side. No recollection of any injury. No swelling or redness. Moderate pain with motion.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Erythema, Injection site discolouration, Injection site erythema, Skin discolouration
Clinical narrative: The right thigh of the baby showed a lot of redness and the left thigh turned a shade of purple and also displayed some redness.  The arms also showed redness and turned a shade of purple.
Age: 1.31
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site reaction
Clinical narrative: Right thigh Kw/inflammation, hardness, erythema slightly tender circumscribed lesion about 2 1/2 inches in diameter.
Age: 1.31
Sex: M
Vaccine: DTAP
Symptoms: Skin lesion
Clinical narrative: Right thigh Kw/inflammation, hardness, erythema slightly tender circumscribed lesion about 2 1/2 inches in diameter.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. Patient history or concomitant medications not reported. On 01-DEC-2015 the patient was vaccinated with ZOSTAVAX. The patient claims to have experienced a reaction to ZOSTAVAX, which resulted in her being admitted to the hospital. No further information was reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: No AE's on date given (today 12/6/15).
Age: 0.94
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, Respiratory rate increased
Clinical narrative: Fever 103.2 degrees - site soreness, swelling, redness vomiting, shaking, rapid respirations.
Age: 0.94
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Tremor, Vomiting
Clinical narrative: Fever 103.2 degrees - site soreness, swelling, redness vomiting, shaking, rapid respirations.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash
Clinical narrative: Allergic reaction on the right arm about 1 inch in diameter spread around, red, itching but no pain and is not going away from a week now, MD told her to take CLARITIN and the rash is gone.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Mother states the patient was vaccinated on Dec-7-2015 at 8:34 AM with KINRIX Rt arm. MMR in the left arm, Varicella Left arm. Today, Dec-8-2015 presents with redness, swelling on Rt arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot to touch, swelling around upper arm, hardened bump on Lt upper arm, very painful, hurts to touch, hurts to move arm, using ice packs. Reaction started the next day 12/3/15.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Red, hot to touch, swelling around upper arm, hardened bump on Lt upper arm, very painful, hurts to touch, hurts to move arm, using ice packs. Reaction started the next day 12/3/15.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Seizure like phenomena
Clinical narrative: About 30 seconds after completing vaccinations, patient experienced a loss of consciousness with seizure-like activity. Episode lasted 20-30 seconds, and patient returned to baseline within 10 seconds.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV9, MNQ, TDAP
Symptoms: Confusional state, Dyskinesia, Eye movement disorder, Gaze palsy, Pallor
Clinical narrative: About 30 seconds after completing vaccinations, patient experienced a loss of consciousness with seizure-like activity. Episode lasted 20-30 seconds, and patient returned to baseline within 10 seconds.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV9, MNQ, TDAP
Symptoms: Seizure like phenomena
Clinical narrative: About 30 seconds after completing vaccinations, patient experienced a loss of consciousness with seizure-like activity. Episode lasted 20-30 seconds, and patient returned to baseline within 10 seconds.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Pt c/o numbness in arm with dizziness.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Oropharyngeal pain, Peripheral swelling, Pruritus generalised
Clinical narrative: Had flu shot 1 day ago, yesterday swelling finger, feet. Itching all over. Had sore throat. Headaches. Dizziness. Flu shot was given at pharmacy on 12/8/15.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: 4 days after vaccine, rash on chest and vague itching on back with rash. Consistent with shingles.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: C-reactive protein normal, Headache, Red blood cell sedimentation rate normal
Clinical narrative: Temporal, periorbital HA, constant w/ varying degrees of intensity. ALEVE and TYLENOL taken w/o improvement. 12/08/15: MD appointment.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Induration, Local reaction, Skin warm, Type III immune complex mediated reaction
Clinical narrative: Parent reports arthus type local reaction - large, red, hot, indurated response beginning app. 2 hours after administration and last 4 days.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling, Throat tightness
Clinical narrative: Pt received his Flu shot and shortly after he went home he started to swell up and throat closed. He went to the ER for tx. Received steroids etc. and was released. Pt had a F/u with his PCP and called us to report.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Extreme soreness after administration on 10.17.15 went to MD 11/12 - given meloxicam. As of 12.1.15 no improvement. Patient concerned portion of needle remains in her arm.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Local swelling, Lymphadenopathy, Oedema peripheral, Swelling face
Clinical narrative: Day after shot notice large swollen lymph nodes on my (R) collar bone area, swelling continued up the (R) side of my neck and jawline and under my (R) armpit. Headache at (R) temporal area.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching reported on 11/2/15 at site of PREVNAR injection (right arm). Administered 10/26.
Age: 9.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Injection site nodule, Injection site reaction, Skin lesion, Ultrasound scan
Clinical narrative: Vaccines administered on 11-9-15. Received the flu vaccine in the (R) arm and the HPV in the (L) arm. Each vaccine given in deltoid. Lesion appeared in (L) deltoid. Flesh colored but increasing in size to form quarter size hard knot (2 1/2 cm x 4 cm).
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Blood test, Injected limb mobility decreased, Injection site swelling, Malaise
Clinical narrative: This serious spontaneous report was received from a 44 year old non-pregnant female patient who was a pharmacist and refers to herself. The patient had "sulfa allergy" and no other pertinent medical history. On an unspecified date in 1994, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscular in the left arm (strength, dose, lot # and expiration date were not provided) as "school required". Concomitant therapies included MIRCETTE 28. On an unspecified date, after receiving PNEUMOVAX 23, the patient's left arm "swelled up 3 to 4 times the normal size, from her left shoulder to elbow as well as the skin over her rib cage to her breast line right below her armpit was black and purple, she had a fever, she was vomiting, she had malaise and was achy all over and physically unable to lift her left arm. She stated that she took TYLENOL and BENADRYL as the treatment after seeking medical attention with an unspecified physician on an unspecified date. The reporter stated that "unspecified blood work was drawn due to the adverse event" by an unspecified physician on an unspecified date. The reporter stated that the adverse events caused her a significant disability or incapacity (she was temporarily unable to function with daily tasks). The patient recovered from the adverse events on an unspecified date. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Skin discolouration, Skin swelling, Vomiting
Clinical narrative: This serious spontaneous report was received from a 44 year old non-pregnant female patient who was a pharmacist and refers to herself. The patient had "sulfa allergy" and no other pertinent medical history. On an unspecified date in 1994, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscular in the left arm (strength, dose, lot # and expiration date were not provided) as "school required". Concomitant therapies included MIRCETTE 28. On an unspecified date, after receiving PNEUMOVAX 23, the patient's left arm "swelled up 3 to 4 times the normal size, from her left shoulder to elbow as well as the skin over her rib cage to her breast line right below her armpit was black and purple, she had a fever, she was vomiting, she had malaise and was achy all over and physically unable to lift her left arm. She stated that she took TYLENOL and BENADRYL as the treatment after seeking medical attention with an unspecified physician on an unspecified date. The reporter stated that "unspecified blood work was drawn due to the adverse event" by an unspecified physician on an unspecified date. The reporter stated that the adverse events caused her a significant disability or incapacity (she was temporarily unable to function with daily tasks). The patient recovered from the adverse events on an unspecified date. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.