chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a pediatric patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) lot # L030587 expiration date 10-FEB-2017 (strength, dose number and route of administration were not provided). The patient's concomitant medications were not reported. The Licensed Practical Nurse also reported the temperature excursion that PROQUAD (Merck) was exposed to: -8.6 degrees C in a time frame of 19 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effects were reported and no product quality issue was involved. Additional information is not expected as no consent to contact the reporter was provided.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Erythema multiforme, Injection site erythema, Injection site reaction
Clinical narrative: Pt received PREVNAR on 2/9 and the next day pt noted redness and swelling on the right arm the next day. per RN note, arm is warm to touch. Spoke with provider in ER who states cellulitis of (R) arm may be due to local site injection reaction. Writer noted that injection site was not particularly more erythematous.  Erythema multiform and edema, warm to touch. Ceftriaxone 1 gm once, sulfamethizole/trimethoprim 1 tab BID, cephalexin 500 mg tid.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Local reaction, Oedema, Peripheral swelling, Skin warm
Clinical narrative: Pt received PREVNAR on 2/9 and the next day pt noted redness and swelling on the right arm the next day. per RN note, arm is warm to touch. Spoke with provider in ER who states cellulitis of (R) arm may be due to local site injection reaction. Writer noted that injection site was not particularly more erythematous.  Erythema multiform and edema, warm to touch. Ceftriaxone 1 gm once, sulfamethizole/trimethoprim 1 tab BID, cephalexin 500 mg tid.
Sex: F
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a female patient of unknown age. There was no pertinent medical history, concurrent condition, concomitant medication or drug allergy described. On an unspecified date in November, 2015, the patient was administered a dose of improperly stored dose of RECOMBIVAX HB lot # K019502, expiration date unspecified (strength, dose and route were not reported). The vaccine was stored under an unspecified temperature for 3 weeks. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist via a company representative to three patients of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On an unknown date the patients were vaccinated with doses of ZOSTAVAX (dose and route unspecified). Other suspect and concomitant therapies were not reported. On an unknown date the patient contracted shingles. The outcome of the event was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swelling, redness, pain and warm to touch that started 6 days after injection. Patient was seen and given antibiotics and steroids.
Sex: M
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a male patient of unknown age. There was no pertinent medical history, concurrent condition, concomitant medication or drug allergy described. On an unspecified date in November, 2015, the patient was administered a dose of improperly stored dose of RECOMBIVAX HB lot # K019502, expiration date unspecified (strength, dose and route were not reported). The vaccine was stored under an unspecified temperature for 3 weeks. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Biopsy skin, Lichen planus, Skin lesion
Clinical narrative: Client developed darkened round lesions on her torso after 2nd dose of MMR and Hep B vaccines. Dermatologist biopsied and diagnosed with Lichen Planus Pigmentosus possibly caused by vaccines.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia
Clinical narrative: Approximately 3-4 days post injection of ZOSTAVAX patient reported severe headache which resolved in 2 days. Patient also reported increased muscle pains, as she usually suffers from muscle and sometimes joint pain. Muscle pains have decreased but are still present.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: RUE with redness, warmth, and tenderness to the area below the deltoid and not at the site of the injection. Area measures approximately 15 cm x 4 cm. No fluctuance at the site or fluid drainage. BENADRYL, MOTRIN, cool/warm compresses at the site for treatment.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Pt started having soreness the next day after vaccine. There was a red spot swollen at the site which continue gets bigger the next couple days. Pt went to see MD and was prescribed KEFLEX for 7 days. 3 days after the KEFLEX, the redness and swollen start going away.
Age: 62.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Itching, red, and swollen at site of injection. Received shot on 3/25, went to doctor on 3/28 because of pain and other symptoms unresolved. MD said to ice and take TYLENOL. 3/31 same symptoms but swelling and redness worse.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: Initial unsolicited report received from a Healthcare professional via other company (Pfizer) on 04 March 2016. Manufacturer Report Number: 2016114783. This case involves a female patient (age was not reported) who was vaccinated with a dose of Flu Shot (batch number, expiration date, route and site of administration was not reported) on an unspecified date. It was reported that patient had no problem when she received flu shot this year. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had sore arm. Lab data and corrective treatment was not reported. Patient was recovered from event as it was reported that patient had sore arm for a day or two. List of documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Cellulitis according to PCP. Redness on arm adjacent to injection site. 7 days of cephalexin and cotrimoxazole.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Activities of daily living impaired, Computerised tomogram head, Computerised tomogram head normal, Computerised tomogram normal, Dizziness
Clinical narrative: Information has received from a medical assistant referring to a 12 years old female patient. The patient had no medical history or drug reactions/allergies. There was no concomitant medication. On 29-OCT-2014, the patient was vaccinated with the first dose of GARDASIL (lot # K011492, dose and expiration were not reported). The patient was seen in the office on 05-DEC-2014 due to the patient developing migraines on an unspecified date. The patient was prescribed IMITREX as treatment on 05-DEC-2014. The patient then received the 2nd dose of GARDASIL (Lot# was reported as L011846 and exp. 06-JUN-2017, dose was not reported) on 06-JAN-2015. The patient was seen in the office on 22-JAN-2015 due to the patient developing body aches, nausea, dizziness and "the IMITREX wasn't helping" (unspecified date). The medical assistant stated the patient was switched from IMITREX to TOPAMAX on 22-JAN-2015 as treatment for the symptoms that were not reported on 22-JAN-2015. The patient then received the 3rd dose of GARDASIL (Lot# K008931 and unspecified expiration date, dose was not reported) on 04-FEB-2015 (Inappropriate schedule of vaccine administered) and then received a 4th dose of GARDASIL 9 (Lot# L016429 and unspecified expiration date, dose was not reported) on 02-NOV-2015 per patient's mother's request (Extra dose administered). The patient's mother called the office on 03-FEB-2016 stating the patient was experiencing headaches, dizziness, "severe" pain in the head, neck, arms and legs, blurry vision (all which started on an unspecified date) and had missed an unspecified number of days of school (unspecified dates). The patient was referred to an unspecified neurologist and had a CT scan of the head, brain and spine performed (unspecified date) which came back as "normal". The outcome of the events was unknown. Causality was not reported. The reporter considered the event of headaches, dizziness, "severe" pain in the head, neck, arms and legs, blurry vision to be disability as the patient hadn't been able to attend school. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Headache, Migraine, Nausea, Neck pain
Clinical narrative: Information has received from a medical assistant referring to a 12 years old female patient. The patient had no medical history or drug reactions/allergies. There was no concomitant medication. On 29-OCT-2014, the patient was vaccinated with the first dose of GARDASIL (lot # K011492, dose and expiration were not reported). The patient was seen in the office on 05-DEC-2014 due to the patient developing migraines on an unspecified date. The patient was prescribed IMITREX as treatment on 05-DEC-2014. The patient then received the 2nd dose of GARDASIL (Lot# was reported as L011846 and exp. 06-JUN-2017, dose was not reported) on 06-JAN-2015. The patient was seen in the office on 22-JAN-2015 due to the patient developing body aches, nausea, dizziness and "the IMITREX wasn't helping" (unspecified date). The medical assistant stated the patient was switched from IMITREX to TOPAMAX on 22-JAN-2015 as treatment for the symptoms that were not reported on 22-JAN-2015. The patient then received the 3rd dose of GARDASIL (Lot# K008931 and unspecified expiration date, dose was not reported) on 04-FEB-2015 (Inappropriate schedule of vaccine administered) and then received a 4th dose of GARDASIL 9 (Lot# L016429 and unspecified expiration date, dose was not reported) on 02-NOV-2015 per patient's mother's request (Extra dose administered). The patient's mother called the office on 03-FEB-2016 stating the patient was experiencing headaches, dizziness, "severe" pain in the head, neck, arms and legs, blurry vision (all which started on an unspecified date) and had missed an unspecified number of days of school (unspecified dates). The patient was referred to an unspecified neurologist and had a CT scan of the head, brain and spine performed (unspecified date) which came back as "normal". The outcome of the events was unknown. Causality was not reported. The reporter considered the event of headaches, dizziness, "severe" pain in the head, neck, arms and legs, blurry vision to be disability as the patient hadn't been able to attend school. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Pain in extremity, Vision blurred
Clinical narrative: Information has received from a medical assistant referring to a 12 years old female patient. The patient had no medical history or drug reactions/allergies. There was no concomitant medication. On 29-OCT-2014, the patient was vaccinated with the first dose of GARDASIL (lot # K011492, dose and expiration were not reported). The patient was seen in the office on 05-DEC-2014 due to the patient developing migraines on an unspecified date. The patient was prescribed IMITREX as treatment on 05-DEC-2014. The patient then received the 2nd dose of GARDASIL (Lot# was reported as L011846 and exp. 06-JUN-2017, dose was not reported) on 06-JAN-2015. The patient was seen in the office on 22-JAN-2015 due to the patient developing body aches, nausea, dizziness and "the IMITREX wasn't helping" (unspecified date). The medical assistant stated the patient was switched from IMITREX to TOPAMAX on 22-JAN-2015 as treatment for the symptoms that were not reported on 22-JAN-2015. The patient then received the 3rd dose of GARDASIL (Lot# K008931 and unspecified expiration date, dose was not reported) on 04-FEB-2015 (Inappropriate schedule of vaccine administered) and then received a 4th dose of GARDASIL 9 (Lot# L016429 and unspecified expiration date, dose was not reported) on 02-NOV-2015 per patient's mother's request (Extra dose administered). The patient's mother called the office on 03-FEB-2016 stating the patient was experiencing headaches, dizziness, "severe" pain in the head, neck, arms and legs, blurry vision (all which started on an unspecified date) and had missed an unspecified number of days of school (unspecified dates). The patient was referred to an unspecified neurologist and had a CT scan of the head, brain and spine performed (unspecified date) which came back as "normal". The outcome of the events was unknown. Causality was not reported. The reporter considered the event of headaches, dizziness, "severe" pain in the head, neck, arms and legs, blurry vision to be disability as the patient hadn't been able to attend school. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: DPP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen tender lymph node above collar bone on side of injection.
Age: 6.0
Sex: F
Vaccine: FLUX, FLUX(H1N1), PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a registered nurse referring to a 6 year old female patient with sickle cell anaemia. The patient did not have known drug allergies. On 16-MAR-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K020215 with expiration date of 15-MAY-2016, 0.5 ml once, subcutaneous in the right thigh). Concomitant vaccines included a flu shot and a H1N1 shot which were given at different sites. On 19-MAR-2016, the patient was admitted to hospital with a cellulitis at the right thigh and treated with intravenous clindamycin, and was discharged on an unspecified date in March 2016. The patient was sent home from the hospital on oral clindamycin, prescribed for 9 day. On 22-MAR-2016, she came to the office for a follow up visit and the right thigh was completely clear with no evidence of infection at all. The outcome of cellulitis at the right thigh was reported as recovered on that day. The causal relationship between cellulitis at the right thigh and PNEUMOVAX 23 was not provided. The reporter requested for a lot check for PNEUMOVAX 23 (lot # K020215 with expiration date of 15-MAY-2016). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Hodgkin's disease
Clinical narrative: This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's medical history included Hodgkin's lymphoma in approximately 1996 (reported as about 20 years ago), that the physician thought it was cured. No information about the patient's concurrent conditions was provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (route, strength, dose, frequency and lot number were not reported). Concomitant medications were not reported. On an unspecified date a year and a half after vaccination, the patient developed Hodgkin's lymphoma. At the time of the report, the outcome of the event and the action taken with the therapy were unknown. The relatedness between the event and the therapy was not provided. No product quality complaint was involved. Upon internal review, Hodgkin's lymphoma was determined to be medically significant. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Upper extremity mass
Clinical narrative: Patient reported to Employee Health on 4/1/2016 for other reasons and described having a reaction after received and influenza vaccine in October. She developed what sounds like a large red line and lump as well as soreness in her left arm. She states she was encouraged by a provide to have Physical Therapy work with her.  The situation has improved since physical therapy involvement.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 11.2 x 7 cm area of swelling, erythema, heat, and tenderness at site of injection. Pt noticed redness and swelling at injection site 5 days after injection was given; however, admits that the onset may have been sooner and she may not have noticed as she had been wearing long sleeves.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site cellulitis
Clinical narrative: PT had abrupt onset of cellulitis surrounding area of vaccine admin site 2 days after injection.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic shock, Blood pressure increased, Heart rate increased, Pharyngeal oedema, Pharyngeal paraesthesia
Clinical narrative: Anaphylactic shock - elevated pulse and blood pressure; tingling / swollen throat.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Erythema, Peripheral swelling, Tenderness
Clinical narrative: Left arm swelling, redness, painful to touch, spreading down arm.
Age: 1.63
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Provided Pentacel IZ which was given sooner than the recommended interval. Last IZ was at 15 months. Components of the combination drug require 6 months between and was given at 4.
Age: 1.77
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC13
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: After administering vaccines, PT's right leg immediately began to swell and redness spread up the leg. Notified Dr of the reaction. Dr ordered 12.5 mg/5ml of Benadryl. Medication given and within 30 minutes, the swelling and redness diminished.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Crying, Decreased appetite, Insomnia, Staring, Unresponsive to stimuli
Clinical narrative: He would not sleep, would not eat, every time he layed down he would let out a high pitched squill and cry for hours. He would stare of into space and be non responsive.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 01-MAR-2016, the patient was vaccinated with ZOSTAVAX (lot # L039095, expiry date: 08-JAN-2017). The patient experienced shingles on 03-MAR-2016. Patient reported that she noticed a rash on her body on 29-FEB-2016, day before vaccination with ZOSTAVAX. She contacted the pharmacist on 03-MAR-2016, for a prescription regarding VALTREX. She informed the pharmacist that she thought that ZOSTAVAX would treat her rash. Patient required medical attention and consulted her physician on the same day, to seek treatment for the rash. The physician diagnosed her with shingles. It was unknown if the patient had shingles before receiving ZOSTAVAX. At the time of this report, the patient has not taken any doses of VALTREX. Outcome of the event, shingles was unknown. Reporting pharmacist did not assessed the causality of the event with respect to therapy with ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 01-MAR-2016, the patient was vaccinated with ZOSTAVAX (lot # L039095, expiry date: 08-JAN-2017). The patient experienced shingles on 03-MAR-2016. Patient reported that she noticed a rash on her body on 29-FEB-2016, day before vaccination with ZOSTAVAX. She contacted the pharmacist on 03-MAR-2016, for a prescription regarding VALTREX. She informed the pharmacist that she thought that ZOSTAVAX would treat her rash. Patient required medical attention and consulted her physician on the same day, to seek treatment for the rash. The physician diagnosed her with shingles. It was unknown if the patient had shingles before receiving ZOSTAVAX. At the time of this report, the patient has not taken any doses of VALTREX. Outcome of the event, shingles was unknown. Reporting pharmacist did not assessed the causality of the event with respect to therapy with ZOSTAVAX. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling at the site of injection 3x5 cm in diameter, warm to touch.
Sex: F
Vaccine: FLUX, TTOX
Symptoms: Antipsychotic drug level decreased, Appetite disorder, Depressed mood, Psychotic disorder, Therapeutic response changed
Clinical narrative: Initial unsolicited case received from a consumer on 24-Mar-2016. Manufacturer report number-2015_014613. This case involves a female patient (age was not reported) who was vaccinated with a dose of TETANUS TOXOID (Tetanus Vaccine) and a dose of INFLUENZA VACCINE (Influenza Vaccine) (batch number, expiration date, dose, route and site of administration were not reported) both on an unspecified date in 2015. Patient also received 400 mg dose of Abilify Maintena (Aripiprazole) (manufacturer:Otsuka, as a suspension for injection via intramuscular route) for schizophrenia on unspecified date in 2014 and on an unknown date in 2015, patient started to take 30 mg daily dose of oral Abilify for unknown indication. The patient's relevant medical history was unknown. The patient's past drug history includes Haldol and Prolixin which lead to alopecia, hair growing slowly and thinning hair both for unknown indications. Patient's ongoing current conditions involved schizophrenia. The patient's concomitant medications were unknown. On an unknown date in 2015, the patient received influenza shot and a tetanus shot which diluted the Abilify Maintena out of her system which was also described as the shots lessened the Abilify Maintena in her blood. When Abilify Maintena was diluted her hair had gotten healthier. On an unknown date in late Oct-2015 or early Nov-2015, the patient had psychotic episode because Abilify Maintena was diluted out of her system and she was subsequently admitted to hospital on unspecified date in 2015, where she was started on Abilify 30 mg daily and Abilify Maintena was not given in the hospital. On an unknown date the patient reported that Abilify made her extremely hungry and made her feel depressed. At the time of this report, the patient continued to take Abilify and is not taking Abilify Maintena, Influenza shot, or the Tetanus shot. It was unknown if there was relevant lab data. Corrective treatments were not reported. It was reported that outcome of the event psychotic episode was resolved and the outcome of the event: influenza shot and tetanus shot diluting Abilify Maintena out her system were unknown. This case was considered as serious due to hospitalization and the reporter did not provide causality between the events and suspect drugs. List of document held by sender: none. Sender's Comments: This is a non-medically confirmed case. Time to onset is unknown. The patient had a significant medical history of Schizophrenia and was on Abilify Maintena for treating the same. The patient's past drug history also included Haldol and Prolixin for unspecified indication. Further information on medical confirmation of the case, time to onset, data confirming the decrease of the antipsychotic drug level in the body, etc. will be needed for further assessment. Based on the information available, role of the vaccines cannot be assessed.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On the following below listed dates multiple unspecified patients were vaccinated with improperly stored GARDASIL 9 lot # L020015 expiry date 16-AUG-2017. On 09-FEB-2016 and 13-FEB-2016 the GARDASIL 9, was exposed to a lowest temperature of + 1.0U C for 29 minutes and 30 minutes respectively. On 10-FEB-2016, 11-FEB-2016, 14-FEB-2016 and 16-FEB-2016, GARDASIL 9, was exposed to a lowest temperature of + 1.2 U C for 25 minutes, 22 minutes, 24 minutes and 34 minutes respectively. On 12-FEB-2016, GARDASIL 9, was exposed temperature of + 1.3U C for 21 minutes. On 15-FEB-2016, GARDASIL 9, was exposed to a lowest temperature of + 1.1U C for 25 minutes. On 17-FEB-2016, GARDASIL 9, was exposed temperature of + 0.0U C duration not reported. On 18-FEB-2016, GARDASIL 9, was exposed to a lowest temperature of - 1.0U C for 12 hours 29 minutes. On 19-FEB-2016, GARDASIL 9, was exposed to a lowest temperature of - 1.1U C for 12 hours 1 minute. Also reported that the vaccine was administered on an unspecified date from 20-FEB-2016 to 29-FEB-2016. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9, lot # L043213 with an expiry date of 28-AUG-2017, (incorrect product storage). Dosing details were not provided. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to her daughter, a 12 month old female patient. On 21-MAR-2016, the patient was inadvertently administered her first dose of VARIVAX (Merck) and PROQUAD (Merck) concomitantly in the same (left) leg (route, dose, lot# and expiration date were unknown). No adverse effects were reported. Additional information has been requested.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Culture stool, Diarrhoea, Febrile convulsion, Influenza virus test negative, Pyrexia
Clinical narrative: Child began with fever, child went to ER was tested for influenza, influenza test negative. Child fever caused a febrile seizure, child was monitored and released home. No admission. Child also began with diarrhea.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Hyperhidrosis, Pallor, Wheezing
Clinical narrative: Became pale, diaphoretic, wheezing after KINRIX in (L) deltoid, PROQUAD in (R) SQ arm. P 104, BP 115/78 EMS called. O2 Sat 100%. Patient stabilized. No medicine given. Mother refused trip to ER. Stated she would call family doctor.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Localized redness distal to injection site -> with appearance of initial stage of cellulitis.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Dental caries
Clinical narrative: Bad rotting teeth.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Blood test, Pyrexia, Rash, Rubella
Clinical narrative: Possible Rubella infection after receiving 2nd dose of MMR. 2nd vaccine received 2/22/16. Began to have skin rash and fever on 3/24/16. Diagnosed by PCP with Rubella infection. Blood work done by PCP. MEDROL Dose Pack stated 3/26/16. Continues to have rash.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Cough, Dyspnoea, Glossodynia, Rhinorrhoea, Wheezing
Clinical narrative: Tongue pain, runny nose. Cough - staccato, difficulty breathing, wheezing. BENADRYL, steroid, Albuterol, EPIPEN. Observation hospital.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Cough, Hypersensitivity, Rales, Rhinorrhoea, Throat tightness
Clinical narrative: Tongue pain, runny nose. Cough - staccato, difficulty breathing, wheezing. BENADRYL, steroid, Albuterol, EPIPEN. Observation hospital.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Tongue pruritus
Clinical narrative: Tongue pain, runny nose. Cough - staccato, difficulty breathing, wheezing. BENADRYL, steroid, Albuterol, EPIPEN. Observation hospital.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Swelling, redness, tenderness, warmth to touch. Antibiotics given for cellulitis. Warm compresses.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: 2 hrs after TDAP got hives. This lasted 4 days per patient.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Vision blurred
Clinical narrative: Patient became lightheaded after receiving vaccine. She said vision was a little blurred. No signs of anaphylaxis or trouble breathing. We kept patient seated and gave water. Patient was coherent and carrying on conversation. Denied our offer to contact PCP or call an ambulance.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Hypoaesthesia, Myalgia, Paraesthesia, X-ray
Clinical narrative: Joint/muscle pain, numbness/tingling in wrist which started on the same day of getting vaccinated.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Pain in extremity, Paraesthesia, Rash papular
Clinical narrative: On 3/21/16 developed pain and tingling down L arm. On 3/24 developed papulovesicular lesions on upper L arm and was seen by me diagnosed with zoster and treated with valacyclovir.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: 2 days after pt developed swelling and redness over the whole bicep area of upper arm, warm to touch and pain. Redness is spreading to elbow on inner aspect of arm. She will contact MD. Already improving, getting better.
Age: 81.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Slight red rash and itching at injection site, right arm.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient has pain in right shoulder and has trouble lifting arm 2 months after injection. Patient claims to have had adverse reaction 12/28/15 but did not report until 2/18/16.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Drooling, Hypertonia, Syncope
Clinical narrative: Hyper tonic, prolonged syncope, drooling referred to Emergency room.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Condition aggravated, Fatigue, Oral disorder, Systemic lupus erythematosus
Clinical narrative: Oral lesions and extreme fatigue developed per pt 2 days after vaccination. Patient reports these symptoms are consistent with a lupus flare. Unknown if vaccination triggered flare. Also usually gets SLE flares at this time of year "change of season flare" s/s significantly resolved after 3 days of prednisone.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Urticaria
Clinical narrative: Warm, red, raised itchy welt.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Nodule, Rash erythematous
Clinical narrative: Red rash 4 cm x 1 1/2 cm on left upper arm. 2nd small nodule palpable.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Injection site pain, Nuclear magnetic resonance imaging abnormal, Periarthritis, Tendonitis
Clinical narrative: I received a flu vaccine on Oct 20, 2015, and have been suffering severe pain on my shoulder where the vaccine was administered. I have bursitis, bicep tendonitis, and frozen shoulder, and will have to go through a surgery.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Occasional stabbing pain at the site of injection. Has continued to recur for over 2 years.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Woke up next morning with hard, swollen, round, red lump at the injection site.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Pain, Sleep disorder
Clinical narrative: I have had constant discomfort, sometimes pain, since receiving this vaccine. I am awakened by this every night unless I take ibuprofen before bed. Any motion requiring lifting of the arm is painful. This has continued for 14 months.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Arthralgia, Influenza like illness, Nasopharyngitis, Platelet count increased
Clinical narrative: Red raised rash over trunk of body.  High fever (102.5) in early September for almost a week, followed by joint pain moving throughout body. Rash has continued to present and itches daily. Hair loss, skin flaking, flu-like symptoms w/ high fever in March followed by a 2 weeks of a cold.  Rash and itching, and joint pain continues to present.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash erythematous, Rash pruritic, Skin exfoliation
Clinical narrative: Red raised rash over trunk of body.  High fever (102.5) in early September for almost a week, followed by joint pain moving throughout body. Rash has continued to present and itches daily. Hair loss, skin flaking, flu-like symptoms w/ high fever in March followed by a 2 weeks of a cold.  Rash and itching, and joint pain continues to present.
Age: 0.53
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Abnormal behaviour, Decreased eye contact, Developmental regression, Listless, Petit mal epilepsy
Clinical narrative: AFTER WAKING UP FOLLOWING MORNING- LISTLESS, NO EYE CONTACT, NO EMOTION, NO BABBLING, NO LAUGHING, WOULD NOT RESPOND TO NAME, DEVELOPMENTAL REGRESSION & STARING SPELLS. CONTINUES TO HAVE STARING SPELLS (ABSENCE SEIZURES).
Age: 0.53
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Staring, Unresponsive to stimuli
Clinical narrative: AFTER WAKING UP FOLLOWING MORNING- LISTLESS, NO EYE CONTACT, NO EMOTION, NO BABBLING, NO LAUGHING, WOULD NOT RESPOND TO NAME, DEVELOPMENTAL REGRESSION & STARING SPELLS. CONTINUES TO HAVE STARING SPELLS (ABSENCE SEIZURES).
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Discomfort, Injection site pain
Clinical narrative: Severe pain at injection site on deltoid muscle of left arm. Pain became increasingly severe and radiated throughout shoulder joint until approximately 9 PM. Pain subsided gradually the next day and was only mildly uncomfortable by 5 PM.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: PATIENT SAID THAT THE INJECTION SITE WAS SWELLING AND ITCHING (3/31/2016).  I CALLED AND TALKED TO PATIENT TODAY (4/1/2016), AND SHE SAID THAT SHE IS GETTING BETTER.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness, warmth, and itching at injection site. About inch and half in diameter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Induration, Mass, Skin warm, Tenderness
Clinical narrative: Hard lump, painful to touch and somewhat warm, bruising.
Age: 51.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Feeling abnormal, Pain, Pyrexia, Rash
Clinical narrative: Fever 100.7 and ran it constantly all day next day and feeling not good next day and still with low grade fever and now with rash to left upper outer arm, slight and right upper deltoid region with redness/pain/tender and hot to touch measuring approx 19x23 inches.
Age: 51.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Skin warm, Tenderness
Clinical narrative: Fever 100.7 and ran it constantly all day next day and feeling not good next day and still with low grade fever and now with rash to left upper outer arm, slight and right upper deltoid region with redness/pain/tender and hot to touch measuring approx 19x23 inches.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Asthenia, Discomfort, Fatigue, Injected limb mobility decreased
Clinical narrative: Initially it was fatigue, no energy and felt lethargic. Few days later started feeling pain upper left arm and shoulder.  Whenever I reached out for anything with my left arm, severe pain will shoot through from elbow to the shoulder. I could not raise my arm up, to the side or towards back. If I tried, I felt severe pain in my left shoulder. I could not open my car door or put on seat belt with my left hand. Driving was very painful, shoulder would hurt while steering. I saw my Doctor on Dec 9th, 2015. He asked me to get x-ray but the x-ray did not show anything. He suggested try physical therapy and if it does not work than I should see an orthopedic specialist. I had gone through about 15 sessions of physical therapy. Pain in shoulder has gotten little better. But my arm and shoulder still hurt and sleeping at night is still uncomfortable. Sometimes it wakes me up at middle of night. I have an appointment scheduled with an Orthopedic specialists.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Lethargy, Middle insomnia, Musculoskeletal pain, Sleep disorder
Clinical narrative: Initially it was fatigue, no energy and felt lethargic. Few days later started feeling pain upper left arm and shoulder.  Whenever I reached out for anything with my left arm, severe pain will shoot through from elbow to the shoulder. I could not raise my arm up, to the side or towards back. If I tried, I felt severe pain in my left shoulder. I could not open my car door or put on seat belt with my left hand. Driving was very painful, shoulder would hurt while steering. I saw my Doctor on Dec 9th, 2015. He asked me to get x-ray but the x-ray did not show anything. He suggested try physical therapy and if it does not work than I should see an orthopedic specialist. I had gone through about 15 sessions of physical therapy. Pain in shoulder has gotten little better. But my arm and shoulder still hurt and sleeping at night is still uncomfortable. Sometimes it wakes me up at middle of night. I have an appointment scheduled with an Orthopedic specialists.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: X-ray limb normal
Clinical narrative: Initially it was fatigue, no energy and felt lethargic. Few days later started feeling pain upper left arm and shoulder.  Whenever I reached out for anything with my left arm, severe pain will shoot through from elbow to the shoulder. I could not raise my arm up, to the side or towards back. If I tried, I felt severe pain in my left shoulder. I could not open my car door or put on seat belt with my left hand. Driving was very painful, shoulder would hurt while steering. I saw my Doctor on Dec 9th, 2015. He asked me to get x-ray but the x-ray did not show anything. He suggested try physical therapy and if it does not work than I should see an orthopedic specialist. I had gone through about 15 sessions of physical therapy. Pain in shoulder has gotten little better. But my arm and shoulder still hurt and sleeping at night is still uncomfortable. Sometimes it wakes me up at middle of night. I have an appointment scheduled with an Orthopedic specialists.
Age: 24.0
Sex: M
Vaccine: HEPAB
Symptoms: Fatigue, Syncope, Tonic clonic movements, Visual impairment
Clinical narrative: Syncope with tonic-clonic arm movement, visual disturbance, fatigue. Patient was braced and came to after about 5-10 seconds. Was given water and cold compress and observed for 15 minutes. Patient reported feeling better sitting for the period of time.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying, Screaming, Sleep disorder
Clinical narrative: After patient had his vaccines, I nursed him and he fell asleep. We left the office and he stayed asleep in his car seat for 4 or 5 hours. He never slept that long. After he woke up, he cried all night long. Screamed. We gave him tylenol and he just kept screaming. We comforted him the best we could and eventually he fell asleep and had very disturbed sleep. We believe he suffered from encephalitis.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARZOS
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report was received from a physician and refers to his 5 year old daughter. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 18-MAR-2016, the patient was vaccinated with a dose of ZOSTAVAX, intramuscularly, at an unspecified location in the thigh (dose, dosage number, lot # and expiration date were not reported), instead of being vaccinated with VARIVAX (Merck). It was also reported that she received a couple of other unspecified vaccines on the same day. The reporter stated that, on 18-MAR-2016, the patient developed a local reaction which was quite significant and aggressive for 4 or 5 days. The reporter stated that the area of injection had become the "size of a softball with a red wheal area that was warm to touch and tender" (injection site swelling) (injection site erythema) (injection site warmth) (injection site pain). The area itched quite a bit, but the patient did not break out with any type of rash (injection site pruritus). Subsequently, it was reported that, on 19-MAR-2016, she developed a fever of 101.5 F (pyrexia) and was administered ibuprofen for treatment. By 20-MAR-2016, her temperature had decreased back to normal. Following this, the reporter had contacted the patient's physician and sent a picture of the affected injection site area. The physician instructed the reporter to give the patient BENADRYL in order to alleviate the redness and swelling. It was reported that the patient received two doses of BENADRYL on 21-MAR-2016 and within 24 hours, the injection site reaction had drastically improved. Furthermore, the reporter stated that the patient had also experienced a headache (headache) for 5 days and at the time of reporting, she was still complaining of "aching in her feet and ankles" (arthralgia) (pain in extremity) and itching at the injection site. It was also reported that no laboratory diagnostic studies were performed. The patient recovered from pyrexia on 20-MAR-2016 and, at the time of reporting, was recovering from the events of injection site erythema, injection site swelling, injection site warmth and injection site pain. Additionally, she recovered from the headache on an unspecified date in March 2016. However, at the time of reporting, the patient had still not recovered from the pain in extremity, arthralgia and injection site pruritus. The reporter, also, provided no causal relationship between the events and vaccination with ZOSTAVAX. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARZOS
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth, Local reaction, Pain in extremity
Clinical narrative: This spontaneous report was received from a physician and refers to his 5 year old daughter. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 18-MAR-2016, the patient was vaccinated with a dose of ZOSTAVAX, intramuscularly, at an unspecified location in the thigh (dose, dosage number, lot # and expiration date were not reported), instead of being vaccinated with VARIVAX (Merck). It was also reported that she received a couple of other unspecified vaccines on the same day. The reporter stated that, on 18-MAR-2016, the patient developed a local reaction which was quite significant and aggressive for 4 or 5 days. The reporter stated that the area of injection had become the "size of a softball with a red wheal area that was warm to touch and tender" (injection site swelling) (injection site erythema) (injection site warmth) (injection site pain). The area itched quite a bit, but the patient did not break out with any type of rash (injection site pruritus). Subsequently, it was reported that, on 19-MAR-2016, she developed a fever of 101.5 F (pyrexia) and was administered ibuprofen for treatment. By 20-MAR-2016, her temperature had decreased back to normal. Following this, the reporter had contacted the patient's physician and sent a picture of the affected injection site area. The physician instructed the reporter to give the patient BENADRYL in order to alleviate the redness and swelling. It was reported that the patient received two doses of BENADRYL on 21-MAR-2016 and within 24 hours, the injection site reaction had drastically improved. Furthermore, the reporter stated that the patient had also experienced a headache (headache) for 5 days and at the time of reporting, she was still complaining of "aching in her feet and ankles" (arthralgia) (pain in extremity) and itching at the injection site. It was also reported that no laboratory diagnostic studies were performed. The patient recovered from pyrexia on 20-MAR-2016 and, at the time of reporting, was recovering from the events of injection site erythema, injection site swelling, injection site warmth and injection site pain. Additionally, she recovered from the headache on an unspecified date in March 2016. However, at the time of reporting, the patient had still not recovered from the pain in extremity, arthralgia and injection site pruritus. The reporter, also, provided no causal relationship between the events and vaccination with ZOSTAVAX. Additional information has been requested.