chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PNC
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: This is a spontaneous report based on information received by Pfizer from Merck & Co., Inc. (manufacturer control number: 00569760) from a contactable consumer, reporting for son. A 47-year-old male patient of an unspecified ethnicity received the PREVNAR, via an unspecified route of administration on an unspecified date at a single dose for immunization. The consumer was completely certain that her son did not receive PNEUMOVAX 23. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced drug ineffective as the patient developed pneumonia. The clinical outcome of the events, drug ineffective and pneumonia, was unknown. No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented with redness, swelling, and warmth at the injection site on 9/1/2017 at 10:15AM. She was seen by an NP who diagnosed cellulitis and prescribed IV ceftriaxone 2 gram. This was given during her visit. Follow up call on 9/7/2017 indicates that cellulitis had resolved.
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Patient, who is an adult, was given a pediatric does of Hep A inadvertently. No S/S of any reaction.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: NO SYMPTOMS OR ADVERSE REACTIONS.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Patient stated he was sore at injection site and then developed a fever. He went to the hospital and they admitted him and he stayed for 3 days.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Musculoskeletal stiffness, Seizure, Slow response to stimuli
Clinical narrative: After patient received this vaccine and BICILLIN, the patient was eating lunch in a chair and stiff with witness convulsions. After placing the patient on the floor he was alert and oriented with slow responses and movement. He stated it was default for him to move. Transfer to hospital for further evaluation.
Sex: F
Vaccine: HEPA
Symptoms: Hepatitis A, Liver function test, Sepsis, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 40-year-old female patient who received HAVRIX. Co-suspect products included HAVRIX. On an unknown date, the patient received the 1st dose of HAVRIX (intramuscular) and the 2nd dose of HAVRIX. On 30th August 2017, unknown after receiving HAVRIX and HAVRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), hepatitis A (serious criteria hospitalization) and sepsis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the hepatitis A and sepsis were recovering/resolving. It was unknown if the reporter considered the vaccination failure, hepatitis A and sepsis to be related to HAVRIX and HAVRIX. Additional details were provided as follows: The concomitant medication was unknown. The age at vaccination was not reported. In 2008, the patient received the HAVRIX vaccine series on her arm. On 30th August 2017, the patient was hospitalized for Hepatitis A and sepsis. The patient had spent 7 days in the hospital and was still recovering. The patient had to have weekly physician visits and twice a week liver function tests. This case considered to be suspected vaccination failure as the details regarding exact time to onset and lab test confirmation for hepatitis A was unknown.
Age: 55.0
Sex: M
Vaccine: PNC13
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Nerve conduction studies
Clinical narrative: Guillain Barre syndrome.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (reported also as administrator) refers to a patient of an unknown age and gender. The patient's concomitant therapies, concurrent conditions and medical history were not reported. On 05-SEP-2017, the patient was vaccinated with ROTATEQ orally, lot # L048854, expiration date 31-AUG-2017 (concentration and dose were not reported). On 05-SEP-2017, the patient was vaccinated with expired product. No adverse effects were reported. The outcome of the event was not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 05-SEP-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N019923 and expiration date of 28-APR-2019 0.5 ml, intramuscularly for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature excursion of  -1°C or colder for a time frame of 1 day 13 hours 30 minutes. There was previous temperature excursion of 9°C to 25°C for 7 hours 20 minutes. A "data logger" was involved. Sender's Comments: US-009507513-1709USA004386.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 07-SEP-2017, the patient was vaccinated with an expired dose of GARDASIL 9 (route of administration and frequency were unspecified) lot # L028083 (expiration date: 03-SEP-2017) for prophylaxis. No adverse effects reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose and route of administration were unspecified) lot # N002913 (expiration date 23-FEB-2019) for prophylaxis. No adverse effects were reported. The vaccines were exposed to a temperature excursion of 32 to 35 Fahrenheit degrees for a timeframe of 72 hours. There was no previous temperature excursion or digital data logger involved. No product quality complaint was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA006453.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to an unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. From 16-AUG-2017 to 12-SEP-2017, the patients were vaccinated improperly stored doses of with ROTATEQ lot # M041768 with expiration date 25-JUN-2018, orally, for prophylaxis. The temperature reported was 35 Fahrenheit degrees with a duration of 30 minutes. No adverse effects were reported. A product quality complaint was not involved.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose and route of administration were unspecified) lot # N013521 (expiration date 23-JAN-2019) for prophylaxis. No adverse effects were reported. The vaccines were exposed to a temperature excursion of 32 to 35 Fahrenheit degrees for a timeframe of 72 hours. There was no previous temperature excursion or digital data logger involved. No product quality complaint was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA005583.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient states her arm has been sore for 2 weeks.
Age: 1.08
Sex: M
Vaccine: HIBV, MMR
Symptoms: Rash
Clinical narrative: Mild localized rash.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came in the day after receiving the vaccination. Her left arm was swollen and red and hot to the touch around the injection site.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Large local inflammatory reaction of left upper arm. Erythema, swelling, warmth of arm measuring 25 cm x 15 cm. Treatment - local steroids, ice, monitoring.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness, Muscle twitching, Opisthotonus, Pallor
Clinical narrative: Patient was given immunizations and staff had left the room. Mom called for help within 5 min for help. She stated that patient arched her back, arms and fingers twitching and passed out. Patient O2 sat was 84% on room air, pulse was 44, lips white. We placed patient in recover position, covered her. Her O2 returned to 100%, pulse 68, Blood pressure 92/68. We had her recover for a half hour and watched patient until she was ready to leave. I called to check on patient yesterday, there was no answer at home. Today I was able to reach the mother, she stated that she is doing better today and returned to school on 09/13/2017.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PT REPORTS SWELLING, TENDERNESS AND REDNESS AT INJECTION SITE. SWELLING TO THE SIZE OF A BASEBALL.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling, Injection site urticaria, Local reaction
Clinical narrative: Reports local RXN RUA 2/2 BEXSERO vaccine which was administered 8/31/2017. Area became swollen and then 7 welts or hives appeared. Area was sore and very tender to touch beginning the next day. Welts resolved by Sunday evening. Better now but remains swollen.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Adverse reaction that started Saturday evening with redness and swelling at the injection site. Doxycycline started Sunday morning, two doses taken Sunday. Injection site was red, swollen, itchy and hot to touch. Size of inflammation was 4 centimeters circular area. Monday 9/11/17 MD reevaluation and Doxycycline stopped, started Loratadine and topical Triamcinolone along with BENADRYL at night. Redness and swelling continued to diminish and as of 9/13/2017 there is complete resolution.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Infection, Injection site erythema, Injection site swelling
Clinical narrative: Patient had previous ZOSTAVAX injection in 2016. Patient experienced redness and swelling at the injection site. Patient complained that the redness/swelling/sensitivity progressed for 2 days until he went to physician, who told the patient that he most likely experienced an infection due to the injection.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Hyperhidrosis, Immediate post-injection reaction, Presyncope, Tremor
Clinical narrative: Patient had a presyncopal event immediately following vaccine administration. S/S include diaphoresis, flushing, and full body shaking most notable in the limbs. The symptoms resolved after 3-5 min and did not progress to a full syncopal episode.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site warmth, Neck pain, Peripheral swelling, Pruritus
Clinical narrative: ITCHING AND SWELLING WITH REDNESS ON ARM. SIGHT IS WARM TO THE TOUCH WITH PAIN AND RADIATES TO MY NECK.
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea
Clinical narrative: This spontaneous report was received from a consumer referring to an "over 70 year old" female patient. There was no information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, lot#, dose and route unspecified) for prophylaxis. The consumer reported that, the patient couldn't breathe on an unspecified date, after receiving the "pneumonia shot". It was reported that the reporter could not confirm or deny that the "pneumonia shot" that was given to the patient was a Merck product. The outcome of the event dyspnoea was unknown at the time of this report. No product quality complaint was involved. Causality assessment was not provided. No further information was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies from the patients were not provided. From 29-AUG-2017 to 07-SEP-2017 (specific dates unknown), the patients were vaccinated with improperly stored doses of PROQUAD lot # N016113, expiration date: 21-NOV-2018, and lot N013270, expiration date: 25-OCT-2018, for prophylaxis. Concomitant therapies included sterile diluent. The temperature excursion was reported as: -14°C to 10°C for 8 minutes. Data logger was reported as "Yes". Sender's Comments: US-009507513-1709USA005074.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse concerning a patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 11-JUL-2014, the patient was vaccinated with a first dose of GARDASIL lot # reported as: V014219, expiration date: 05-OCT-2015 for prophylaxis (dose, and route of administration were not reported). On 16-AUG-2014, the patient received the second dose of GARDASIL, expiration date: 19-JUN-2016 for prophylaxis (dose, route of administration and  lot number were not reported). The patient received the third dose of GARDASIL, lot # L018286, expiration date: 13-APR-2017 for prophylaxis (dose, and route of administration were not reported), on 13-JUL-2015. No adverse effects reported. Lot number V014219 is an invalid lot number for GARDASIL. Sender's Comments: US-009507513-1709USA004083.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as a nurse), referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX lot # M027343 and expiration date on 01-JUN-2018, (dose and route of administration were not provided) for prophylaxis. Concomitant therapies included sterile diluent (MRK), used for reconstitution of the vaccine and which was properly stored. The doses of VARIVAX were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (7.5°F), during a time frame of 35 minutes which was detected by the data logger. There was not prior temperature excursion and no adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX lot # M040623 and expiration date on 31-DEC-2017 or with lot # N012492 and expiration date on 17-MAR-2018 (dose and route of administration were not provided) for prophylaxis. Concomitant therapies included sterile diluent (MRK), used for reconstitution of the vaccine and which was properly stored. The doses of ZOSTAVAX were exposed to a temperature excursion of 15 degrees Fahrenheit (°F) to 46°F, during a time frame of 17.5 hours which was detected by the data logger. There was not prior temperature excursion and neither adverse events nor product quality complaints were reported.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Erythema, Fatigue, Pain, Sluggishness
Clinical narrative: ARM RED, SORE, DIZZY, LIGHTHEADED, TIRED, SLUGGISH.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Significant redness, swelling, egg shaped area erythema at injection site. Started on Clindamycin 9/8/17 TID x 7 days. Symptoms persist as of evaluation today (9/13/17).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Blood culture, C-reactive protein, Chest X-ray, Culture urine, Cytomegalovirus test
Clinical narrative: Fever that lasted 10 days; no other symptoms.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Differential white blood cell count, Epstein-Barr virus antibody, Full blood count, Laboratory test, Metabolic function test
Clinical narrative: Fever that lasted 10 days; no other symptoms.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Parvovirus B19 test, Pyrexia, Red blood cell sedimentation rate, Urine analysis
Clinical narrative: Fever that lasted 10 days; no other symptoms.
Age: 68.0
Sex: F
Vaccine: MEN
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot, swollen area several inches in circumference around shot site.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Hyperhidrosis, Tinnitus, Vomiting
Clinical narrative: Approximately one hour after vaccination, the patient reported ringing of ears. Shortly after, she experienced dizziness, vomiting, sweating, and a headache. No treatment was needed.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, redness and pain, started a few hours after vaccine-per patient.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: PATIENT CAME BACK TO PHARMACY ON 9/12/2017 (AROUND 5PM) AND STATED THAT THE AREA WHERE SHE HAD RECEIVED HER PREVNAR INJECTION WAS SWOLLEN AND ITCHY, ESPECIALLY ITCHY THE NIGHT BEFORE (9/11/17). I LOOKED AT HER ARM AND IT DID LOOK SLIGHTLY SWOLLEN AND MAYBE A LITTLE RED. SHE STATE THAT THE INJECTION SITE WAS VERY ITCHY SO I SUGGESTED SHE TAKE DIPHENHYDRAMINE AND CONSULT WITH HER DOCTOR. I ALSO COUNSELED THAT IF HER SYMPTOMS DID NOT GET BETTER OR IF WORSENED, ESPECIALLY IF GENERALIZED SYMPTOMS OCCURED OR DIFFICULTY BREATHING TO GO TO EMERGENCY ROOM RIGHT AWAY. I CALLED HER BACK THE NEXT MORNING AND SHE STATED THAT THE ITCHING WAS GONE, THE SWELLING WAS DOWN, AND THAT EVERYTHING WAS BETTER.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: The day after the shots were administered he was complaining of his leg hurting. At his evening bath is when we noticed his leg. His left thigh was red, firm, warm to touch, swollen the entire size of his thigh with a bruise in the middle the size of a baseball. We called the nurse line and they said to do a cold compress and if it doubled in size or pussed to take him to the ER. No fever was present during this reaction. Since it was the weekend and the doctor office was then closed over the weekend, I awaited doctor contact until Monday morning. I was informed that this kind of reaction was "normal" - but nothing about this reaction was normal in my opinion.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site warmth
Clinical narrative: The day after the shots were administered he was complaining of his leg hurting. At his evening bath is when we noticed his leg. His left thigh was red, firm, warm to touch, swollen the entire size of his thigh with a bruise in the middle the size of a baseball. We called the nurse line and they said to do a cold compress and if it doubled in size or pussed to take him to the ER. No fever was present during this reaction. Since it was the weekend and the doctor office was then closed over the weekend, I awaited doctor contact until Monday morning. I was informed that this kind of reaction was "normal" - but nothing about this reaction was normal in my opinion.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Edema, redness, pain. Took 600mg IBU at 2200 on 9/12/17 with no decrease in pain or swelling.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient over the age of 6 (7 year old) received DTaP=INFANRIX rather than Tdap. Not indicated for patients over age 6.
Age: 1.67
Sex: M
Vaccine: DTAPHEPBIP, HEPA, PNC13
Symptoms: Chest X-ray, Computerised tomogram head, Depressed level of consciousness, Electrocardiogram, Electroencephalogram
Clinical narrative: Child was taken to daycare 7/25/17, mother received phone call that child was running around and became very lethargic and collapsed to ground, was very hard to arouse. 911 was activated, EMS reports approximately 5 seizure episodes back to back on transport to Hospital. Tx received in ER, notes include "we reviewed that the immunizations are not related, but may have lowered the threshold in someone who is already risk for having a seizure." referred to Pediatric Neurology at another facility.
Age: 1.67
Sex: M
Vaccine: DTAPHEPBIP, HEPA, PNC13
Symptoms: Lethargy, Seizure, Syncope, Ultrasound abdomen
Clinical narrative: Child was taken to daycare 7/25/17, mother received phone call that child was running around and became very lethargic and collapsed to ground, was very hard to arouse. 911 was activated, EMS reports approximately 5 seizure episodes back to back on transport to Hospital. Tx received in ER, notes include "we reviewed that the immunizations are not related, but may have lowered the threshold in someone who is already risk for having a seizure." referred to Pediatric Neurology at another facility.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen area, warm to touch on upper right arm.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: SWOLLEN ON THE INJECTION SITE. REDNESS AND WARM TO TOUCH. PAINFUL AND SORENESS TO SITE. PLACED COLD COMPRESS.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was inadvertently administered an expired dose of PROQUAD lot # M010478 with expiration date on 01-SEP-2017 for prophylaxis. Concomitant therapies included sterile diluent. There was no adverse event.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies from the patients were not provided. Since 05-SEP-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # N01494, expiration date: 11-NOV-2018, and lot # N012135, expiration date: 14-OCT-2018,  for prophylaxis. Concomitant therapies included sterile diluent. The doses were exposed to 6°F to 14°F for one hour. No previous temperature excursion was reported. Data Logger was reported as "Yes".  No adverse events were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005139.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N), referring to a patient of unknown age and gender. The patient´s medical history, historical drugs, concomitant therapies and current conditions were not reported. It was reported that, between 30-AUG-2017 and 01-SEP-2017, the patient received an improperly stored dose of PEDVAXHIB lot # N001348 with expiration date of 31-OCT-2019 (dosage schedule and route of administration were not reported) for prophylaxis. No adverse effects reported. The temperature excursion was 34.5°F for 14 hours and 42 minutes; however, there was no previous temperature excursion.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis. On an unknown date, the primary reporter heard from other pharmacist that unspecified patient "got shingles", additionally it was stated that the sterile diluent (manufacturer unknown) was missed. At the time of the report, the outcome of herpes zoster was unknown. The reporter did not assess the relatedness between herpes zoster and ZOSTAVAX.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies from the patients were not provided. From 29-AUG-2017 to 07-SEP-2017 (specific dates unknown), the patients were vaccinated with improperly stored doses of VARIVAX lot # M049127, expiration date: 15-DEC-2018, and lot # M045204, expiration date 11-NOV-2018, for prophylaxis. Concomitant therapies included sterile diluent. The temperature excursion was reported as: -14°C to -10°C for 8 minutes. It was also reported that doses experienced a previous temperature excursion: -14°C to -10°C for 17 minutes and -9°C to 8°C for 1hr and 17 minutes. Data logger was reported as "Yes". No adverse events were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004196.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registred nurse referring to an unknown number of unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies from the patients were not provided. Since 05-SEP-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # N014369, expiration date: 09-MAY-2019, and lot # N001527, expiration date 13-JAN-2019, for prophylaxis. Concomitant therapies included sterile diluent. The doses were exposed to 6°F to 14°F for one hour. No previous temperature excursion was reported. Data Logger was reported as "Yes". No adverse events were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004164.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Headache, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: RED, SWOLLEN, HOT TO TOUCH, ITCHY, PAIN IN ARM, AND HEADACHE.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: RED, SWOLLEN, HOT TO TOUCH, ITCHY, PAIN IN ARM, AND HEADACHE.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Pruritus, Swelling
Clinical narrative: REDNESS AT INJECTION SITE, SWELLING, ITCHING.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Patient said she was fine 9-12 but woke up 9-13 with severe pain in the back of both of her lower legs.  No other pain or discomfort except for slight discomfort when she raises her arm in the arm injected.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash macular
Clinical narrative: 2 year old presented for follow up 24 hours after influenza vaccine administered right deltoid. Noted to have scattered erythematous macular blanchable rash approximately 8-10 hours after vaccine. No recent changes in soap/detergent/shampoo nor foods. No known recent illness. No lip/tongue swelling, vomiting nor breathing difficulties. Family treated with benadryl at home for itching. When seen in office rash erythematous blanchable and raised suggestive of potential type III hypersentivity reaction most prominent on abdomen with areas of confluence.  Plan for symptomatic treatment with oral antihistamine for itching (Benadryl/Zyrtec) and taper of oral steroid.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Discomfort, Dizziness, Hyperhidrosis, Injection site pruritus
Clinical narrative: DIZZINESS, AND ITCHING IN THE INJECTION SITE, ABOUT 10 MIN AFTER GETTING THE FLU VACCINE. AROUND 4:30 PM WHICH WAS 2 HOURS LATER I STARTED GETTING SEVERE PAIN IN THE ARM FOLLOWED BY ITCHING BURNING ALL OVER THE BODY, SORE THROAT AND ITCHING AND SWELLING IN THE ARM. BY 6 PM I WAS UNCOMFORTABLE WITH STABBING PAIN IN THE ARM. AND 7:45 I BEGAN TO VOMIT WITH SWEATING AND DIZZINESS. TOOK 800MG MOTRIN AND WENT TO BED. SYMPTOMS WERE PRESENT THOUGHOUT THE NIGHT.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pain in extremity, Pruritus, Pruritus generalised, Vomiting
Clinical narrative: DIZZINESS, AND ITCHING IN THE INJECTION SITE, ABOUT 10 MIN AFTER GETTING THE FLU VACCINE. AROUND 4:30 PM WHICH WAS 2 HOURS LATER I STARTED GETTING SEVERE PAIN IN THE ARM FOLLOWED BY ITCHING BURNING ALL OVER THE BODY, SORE THROAT AND ITCHING AND SWELLING IN THE ARM. BY 6 PM I WAS UNCOMFORTABLE WITH STABBING PAIN IN THE ARM. AND 7:45 I BEGAN TO VOMIT WITH SWEATING AND DIZZINESS. TOOK 800MG MOTRIN AND WENT TO BED. SYMPTOMS WERE PRESENT THOUGHOUT THE NIGHT.
Age: 29.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Headache
Clinical narrative: Adverse event: severe very painful and dizzying headache. Treatment: ibuprofen (1 dose). Outcome: most of headache gone, but faint lingering headache (untreated) until past 50 hours from time of vaccination.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Balance disorder, Dizziness, Fall, Hyperhidrosis, Pallor
Clinical narrative: Upon glancing over at injection, patient reported feeling lightheaded. I went to get him a glass of water and when I got back he was sweating and appeared a little pale and looked unsteady. I got him a granola bar and said he needed to lie down. I went next door to get a nurses help and our technician called 911. He fell off the chair and was lying on his right side when I got back. The nurses took his pulse and checked his blood oxygen level and elevated his feet. EMS arrived a couple minutes later and put him on a stretcher and took patient to the hospital.
Age: 19.0
Sex: M
Vaccine: ANTH, TYP, YF
Symptoms: Syncope
Clinical narrative: Patient experienced syncopal episode. No cutaneous or systemic symptoms. Regained consciousness within 5-10 seconds. Patient evaluated with normal examination and vital signs. Observed for 30 minutes. Stable and asymptomatic at discharge to home.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Patient had redness and swelling, enough to visit her doctor. Lasted around 5 days.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, Diarrhoea, Discoloured vomit, Faeces discoloured, Occult blood positive
Clinical narrative: One half hour after the vaccines were administered the infant vomited liquid brown vomitus. The next day after vaccinations (Thursday), infant had a temperature of 103 degrees and again vomited X1-brown vomitus. The following day (Friday), infant had 2 black liquid stools. He was taken to the ER and was admitted.  They did stool testing which was positive for blood in the stool. Infant was discharged home in 1 day.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Muscular weakness
Clinical narrative: MOP reports that pt experienced bilateral leg weakness and general fatigue onset 3 days after vaccine was administered.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Pt woke up 9/12/13 with redness and slightly swollen area on inside of upper arm on the same arm vaccination given in. Pt felt flu-like symptom with no fever and all over body soreness. As of 9/13/17 redness has not spread and the other symptoms have gone away.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperhidrosis, Nausea, Urticaria, Vomiting
Clinical narrative: Patient experienced hives, sweating, extreme nausea, and vomiting on the evening that she received the vaccine. She has had a heart attack in the past. Daughter was afraid that her symptoms resembled a heart attack.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Musculoskeletal chest pain, Musculoskeletal stiffness, Pain, Similar reaction on previous exposure to drug
Clinical narrative: Couple of hours after vaccination while taking a walk had deep aching pain under my rib cage on right side...it did not radiate to back...but was intense and very uncomfortable...could not bend over, cough, sneeze, burp without pain...next day did not take any ZETIA or NEXIUM but pain continued and was worse along with extreme joint pain and stiffness but expected that part. Today is almost 6 days and aching under rib cage has decreased but is still there....experienced no other medical issues so did not report to my physician yet. Only worried about Liver issues? Had similar results when given ZPAK for bronchitis several years ago only pain under right ribcage was intense and radiated to my back...stopped taking my ZETIA and NEXIUM and pain decreased over 12 hours. Happened again next time given ZPAK and again had to stop ZETIA and NEXIUM while taking. I did stop ZETIA and NEXIUM (only take every 2 days now) and I'm afraid to start them while still having aching pain. Unsure whether this is adverse reaction to the vaccine but certainly follows and is similar to the results I had with ZPAK antibiotics previously.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Erythema of eyelid, Eyelid oedema, Muscular weakness, Pruritus
Clinical narrative: Pt reports having a rash and feeling itchy from her arms to her toes, and the next day, reports feeling weakness of the legs and the sensation going up her back. Her eyelids looked swollen and a little pink. She has since been sent to the ER, and was given BENADRYL to take at home.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Pt reports having a rash and feeling itchy from her arms to her toes, and the next day, reports feeling weakness of the legs and the sensation going up her back. Her eyelids looked swollen and a little pink. She has since been sent to the ER, and was given BENADRYL to take at home.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Vertigo
Clinical narrative: Vertigo began at 1:00 am, continuing through the night. Still going on now, 24 hours after vaccine was administered.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired vaccine. MMRV expiration date was 9/1/17 and shot was given 9/8/17. Parents were informed of the expired vaccine. I called parent to have patient get the MMRV in 4weeks for it to be valid. Patient is okay, When talking to parent on Monday 9/11/17 parent stated patient is good.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Pain, Swelling
Clinical narrative: Injection site reaction aforementioned. Received vaccines 9/11/17, endorsed pain and swelling night on injection, returned to pharmacy 9/13/17 to pick up medication for injection site reaction (9/13/17).
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Patient presented on 9/11/17 with a bruise roughly the size of a nickel.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient noticed a red, hot tender ring around the site of injection 5 days following vaccination. Ring has grown slowly, and it is believed the reaction began immediately following vaccination, but was not noticed right away. At 5 days post vaccination the area affected is approximately 7 inches in diameter.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Skin tightness
Clinical narrative: Patient reported itching, swelling, soreness, and tightness of arm around inject site that night and throughout the night. Started to occur late afternoon, swelling started to subside the following morning. Patient self-treated with BENADRYL cream, and I advised patient to take BENADRYL tablet as well. Pt was noticing swelling reduced the next morning.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported red, swollen, warm bump on arm located 1 to 2 inches above inner elbow on left arm.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Area just below the injection site became red, swollen, and warm a few hours after receiving the vaccine. The patient visited the pharmacy again 4 days later and she said it had improved tremendously. Her arm was still slightly red approximately 2-3 inches below the injection site.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Welts on vaccinated arm.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Middle insomnia, Pain in extremity
Clinical narrative: Woke up in middle of night and noticed pain in arm, next AM it was swollen below the injection site, red, paniful, still painful on day she presented with symptoms on 9/13/17 but was improving. Had been using a cool compress but no other treatment.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Patient says about 1 week after shot got pain in shoulder-not sharp pain but ache.
Age: 78.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: Red area, hot to touch started 5 days after shot MD prescribed MEDROL dospk.
Age: 78.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: Red area, hot to touch started 5 days after shot MD prescribed MEDROL dospk.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: Patient came to pharmacy to state that left arm was swollen and painful to touch. No other symptoms noted.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash, Urticaria
Clinical narrative: Child presents with rash (hives) to face and forehead. Diphenhydramine 12.5 mg oral liquid 3 ml given.
Age: 12.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Pruritus, Rash, Rash vesicular
Clinical narrative: Painful blistered rash to arm and after TRUMENBA vaccine started itching 2 days after vaccine. Rash developed. No fever or other symptoms. Rash measures 100mmX60mm.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Skin. Rash.
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Pain in area of injection site at onset. Felt like a throbbing tooth ache and progressively got worse. Then starting getting lots of pain in the shoulder, with stiffness and limited movement.
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: X-ray
Clinical narrative: Pain in area of injection site at onset. Felt like a throbbing tooth ache and progressively got worse. Then starting getting lots of pain in the shoulder, with stiffness and limited movement.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Pyrexia, Rash
Clinical narrative: Pt. came into clinic with rash on arm and around injection site. FOC states rash onset was with slight fever and rash also on abdomen.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Patient received HPV vaccination 9/01/17 at 2:33 p.m. Patient reports at 4 p.m. on 09/01/17 she noticed an itchy red rash throughout (denied SOB) her body, worsening at 11 p.m. She went to E.D. at 2 a.m., was given rx for prednisone x 4 days and diphenhydramine x 4 days. Both completed yest, 9/05/17 w/complete recovery from rash.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Pain in extremity, Swelling
Clinical narrative: Patient came in and left arm was bruised and red down her arm; she said it does hurt; she said since the shot it got bigger.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Pt had nausea and dizziness approximately 12 hours after administration. Pt took her nausea medication.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Urticaria
Clinical narrative: Pt. rec'd 5yr. shots on 9/08/17 in office at exam. Parent called 9/09/17 and spoke with Dr. to report pt. with (+) hives after immunizations. No office visit for eval. Parent reassured.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Has mild symptoms after injection soreness redness at site redness turned to bruise, still present. Pain increased dramatically over weekend 9/9/2017. Using NSAIDS, ice, rest.
Age: 62.0
Sex: M
Vaccine: TYP
Symptoms: Anxiety, Dizziness, Dry throat, Feeling jittery, Hypersensitivity
Clinical narrative: Telephone call stating pt had severe allergic reaction to Typhoid oral vaccine, went to Emergency Rm. Pt states taking first dose at 11:15 am on an empty stomach with 2 glasses of water. Drove down to city and noticed feeling "jittery" about 30 minutes later, possible lip swelling, dry throat, then lightheaded, and then became very anxious. ED medication administration 9/2/17 1238 NaCl 0.9% IV soln 1000ml, stopped at 1353 (bolus only), 1346 Diphenhydramine 50mg/ml, 25 mg IV, 1346 Famotidine 40mg oral, 1500 NaCl 0.9% IV soln 1000ml, stopped at 1515 (bolus only). In Emergency room, improvement and with monitoring over several hours and agreed to go home and continue using BENADRYL every 6 hours.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Erythema, Feeling abnormal, Feeling cold, Formication
Clinical narrative: When he inject I fill pain "like Bee-sting" hurt so much and not going away "the pain". I went home "I" fill not good, "then fill cold" when I go to bed "I'm so cold like I have a high-fever" in early-morn. Head ache "Too much" dizzy if I get up. 2-days fever and I see my arm "so red" and hot. "I fill aching" in my arm. For my knowing "I" went to pharmacy to get a flu-shot and I ask if it's okay to take the pneumonia vaccine. "I" said it's back more than 10 yr's. This is my second "vaccine" the first one I got like flu "But nothing" happen to my arm "only now!" and it's so different feelings "the pain" like, Bee-sting". And I feel this pain "like something in my arm "crawling feeling" w/pain, itching. And, the red "is like, tomato" and big, spreading "going-down" to my hand. It's pass my elbow I went to emergency hospital twice case "I'm so worried". The redness, is so fast "swollen itchy". First went to ER "the medicine" is cephalexin 500 mg. capsules/4 x daily for 10 days. Second, went to ER "the medicine" is AMOX-CLAV 875 mg. tablets/take 1-tab. by mouth 12 hours for 10 days. I received shots Penicillin injection at E.R. and it "help so much".
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site pain, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: When he inject I fill pain "like Bee-sting" hurt so much and not going away "the pain". I went home "I" fill not good, "then fill cold" when I go to bed "I'm so cold like I have a high-fever" in early-morn. Head ache "Too much" dizzy if I get up. 2-days fever and I see my arm "so red" and hot. "I fill aching" in my arm. For my knowing "I" went to pharmacy to get a flu-shot and I ask if it's okay to take the pneumonia vaccine. "I" said it's back more than 10 yr's. This is my second "vaccine" the first one I got like flu "But nothing" happen to my arm "only now!" and it's so different feelings "the pain" like, Bee-sting". And I feel this pain "like something in my arm "crawling feeling" w/pain, itching. And, the red "is like, tomato" and big, spreading "going-down" to my hand. It's pass my elbow I went to emergency hospital twice case "I'm so worried". The redness, is so fast "swollen itchy". First went to ER "the medicine" is cephalexin 500 mg. capsules/4 x daily for 10 days. Second, went to ER "the medicine" is AMOX-CLAV 875 mg. tablets/take 1-tab. by mouth 12 hours for 10 days. I received shots Penicillin injection at E.R. and it "help so much".
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Sciatica, Skin bacterial infection, Skin warm, Swelling
Clinical narrative: When he inject I fill pain "like Bee-sting" hurt so much and not going away "the pain". I went home "I" fill not good, "then fill cold" when I go to bed "I'm so cold like I have a high-fever" in early-morn. Head ache "Too much" dizzy if I get up. 2-days fever and I see my arm "so red" and hot. "I fill aching" in my arm. For my knowing "I" went to pharmacy to get a flu-shot and I ask if it's okay to take the pneumonia vaccine. "I" said it's back more than 10 yr's. This is my second "vaccine" the first one I got like flu "But nothing" happen to my arm "only now!" and it's so different feelings "the pain" like, Bee-sting". And I feel this pain "like something in my arm "crawling feeling" w/pain, itching. And, the red "is like, tomato" and big, spreading "going-down" to my hand. It's pass my elbow I went to emergency hospital twice case "I'm so worried". The redness, is so fast "swollen itchy". First went to ER "the medicine" is cephalexin 500 mg. capsules/4 x daily for 10 days. Second, went to ER "the medicine" is AMOX-CLAV 875 mg. tablets/take 1-tab. by mouth 12 hours for 10 days. I received shots Penicillin injection at E.R. and it "help so much".
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Headache, Loss of personal independence in daily activities, Muscle spasms, Pain
Clinical narrative: Mom called 8/26 AM the day after patient received her 3rd HPV #9. Reported fever of 101 at 9 pm she also had leg aches, body aches and muscle cramps. She had a bad headache and extreme exhaustion. 8/28 - headache and fever better. Patient is a runner and unable to run more than 10 mins over next 3-4 days. Pain in arms. Experiencing pain in arm and legs, unable to run, extreme fatigue. Later pt reported that she felt like she was getting a cold for 24 hours after first two shots. She did not report this until after 3rd shot.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Mom called 8/26 AM the day after patient received her 3rd HPV #9. Reported fever of 101 at 9 pm she also had leg aches, body aches and muscle cramps. She had a bad headache and extreme exhaustion. 8/28 - headache and fever better. Patient is a runner and unable to run more than 10 mins over next 3-4 days. Pain in arms. Experiencing pain in arm and legs, unable to run, extreme fatigue. Later pt reported that she felt like she was getting a cold for 24 hours after first two shots. She did not report this until after 3rd shot.
Age: 72.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Pt describes great pain in shoulder after receiving PNEUMOVAX. Pain has decreased in severity since immunisation.