chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This literature marketed report has been received from the author of a published literature. BACKGROUND The effect of a third dose of the M-M-R II vaccine in stemming a mumps outbreak is unknown. During an outbreak among vaccinated students at the University, health officials implemented a widespread MMR vaccine campaign. The authors evaluated the effectiveness of a third dose for outbreak control and assessed for waning immunity. METHODS Of 20,496 university students who were enrolled during the 20152016 academic year, mumps was diagnosed in 259 students. The authors used Fisher's exact test to compare unadjusted attack rates according to dose status and years since receipt of the second M-M-R II vaccine dose. The authors used multivariable time-dependent Cox regression models to evaluate vaccine effectiveness, according to dose status (three vs. two doses and two vs. no doses) after adjustment for the number of years since the second dose. RESULTS Before the outbreak, 98.1% of the students had received at least two doses of M-M-R II vaccine. During the outbreak, 4783 received a third dose. The attack rate was lower among the students who had received three doses than among those who had received two doses (6.7 vs. 14.5 cases per 1000 population, P<0.001). Students had more than nine times the risk of mumps if they had received the second M-M-R II dose 13 years or more before the outbreak. At 28 days after vaccination, receipt of the third vaccine dose was associated with a 78.1% lower risk of mumps than receipt of a second dose (adjusted hazard ratio, 0.22; 95% confidence interval, 0.12 to 0.39). The vaccine effectiveness of two doses versus no doses was lower among students with more distant receipt of the second vaccine dose. This report concerned 34 patients of unknown age and gender. On unknown dates, the patients received three doses of M-M-R II (dose, route, lot# and expiration date unknown) for prophylaxis. On unknown dates, the patients experienced mumps. The outcome of the events was unknown. The authors considered the events to be related to M-M-R II. This is one of the several reports that received from the same literature article. Sender's Comments: US-009507513-1709USA014639: US-009507513-1709USA012424.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 20-SEP-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # N011867 with expiration date on 08-NOV-2018 (anatomical route of vaccination was not provided) for prophylaxis. It was also reported that, PNEUMOVAX 23, was exposed to a temperature of 70 °F for a 120 hours time frame. The above mentioned vaccine, was not involve in any previous temperature excursion and the call was not made due to a data logger. Furthermore, no adverse effects were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA014897: US-009507513-1709USA014898.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 22-SEP-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # N011867 with expiration date on 08-NOV-2018 (anatomical route of vaccination was not provided) for prophylaxis. It was also reported that, PNEUMOVAX 23, was exposed to a temperature of 70 °F for a 120 hours time frame. The above mentioned vaccine, was not involve in any previous temperature excursion and the call was not made due to a data logger. Furthermore, no adverse effects were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA014851: US-009507513-1709USA014898.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 22-SEP-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # N011867 with expiration date on 08-NOV-2018 (anatomical route of vaccination was not provided) for prophylaxis. It was also reported that, PNEUMOVAX 23, was exposed to a temperature of 70 °F for a 120 hours time frame. The above mentioned vaccine, was not involve in any previous temperature excursion and the call was not made due to a data logger. Furthermore, no adverse effects were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA014897: US-009507513-1709USA014851.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Pneumonia
Clinical narrative: Initial unsolicited report received from consumer on 20-Sep-2017. This case involves a 70-year-old female patient who was vaccinated with 0.5 ml dose of FLUZONE HD (also reported as Fluzone High-Dose) (frequency once, batch number, expiration date, dose and site of administration was not reported) via intramuscular route on an unspecified date in Sep 2016. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced "the flu" which became bronchial pneumonia from Nov 2016, few month following the vaccination. It was reported that, the patient received FLUZONE HD in 1995 (reported as "19952"). Lab data was not reported. The patient received corrective treatment (unspecified). The patient's was recovered from the event on an unspecified date. Upon internal review, the company decided to consider the event serious because of important medical event broncho pneumonia. List of documents held by sender: none.; Sender's Comments: The patient experienced Broncho Pneumonia and flu like symptoms post vaccination with FLUZONE HD. Time to onset seems to be compatible and the event is unlisted with the vaccine. No information regarding patients medical history or concurrent medical condition has been provided. Broncho pneumonia could have n alternate etiolofy that should be investigated and ruled out before assessing the case. BAsed upon reported information the role of the vaccine can not be assessed.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Induration, Nodule
Clinical narrative: Couple of red spots on left arm 1 to 2 inches in diameter in one of the spots has a hard knot. I recommended using ice, TYLENOL/ibuprofen and BENADRYL and to contact dr. Pt went to ER 9/29/17. Pt received cephalexin for cellulitis.
Age: 57.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: 9/22 patient woke up with right arm being red, swollen, and slightly warm. Patient called pharmacy and was told to take BENADRYL, use an ice pack, and take TYLENOL for pain. 9/23 patient went to the doctor where he was told the same thing. 9/25 events were resolved.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Vaccine given in left shoulder. About 30 minutes later, began feeling slight tingling in the left pinkie finger and numbness in the lower part of the left palm. Within a couple of hours, those feelings subsided. Twenty-four hours later, my left pinkie finger felt slightly sore as if it had been overworked. But otherwise, am fine.
Age: 14.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Exposure during pregnancy
Clinical narrative: 14 year old pregnant patient was given Dtap. I made the mistake trying to remember that the patient is still a child and should not have an adult dose but forgot the DTaP was for kids only up to 6 or 7. Scanner did not work in the patient's room.
Age: 87.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient developed swelling and pain at injection site.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site swelling, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: PT REPORTS REDNESS AND SWELLING ON UPPER RIGHT ARM AROUND SITE OF INJECTION. PT REPORTS "ACHY AND STIFF' FEELING IN ARM. PT ALSO REPORTS HEADACHE FROM PRIOR NIGHT. PT TOOK UNKNOWN DOSE OF IBUPROFEN WHICH CLEARED HEADACHE BUT DID NOT REDUCE REDNESS OR SWELLIN AT INJECTION SITE. PT WAS GIVEN VACCINE INFORMATION SHEET AND REASSURED THAT THE REACTION IS WITHING NORMAL REALMS OF FLU SHOT REACTION AND THAT SYMPTOMS USUALLY RESOLVE IN 1 TO 2 DYAS.. PT INSTRUCTED TO USE IBUPROFEN EVERY 6 HOURS FOR PAIN AND STIFFNESS AND TO USE ICE PACKS ON SITE FOR COMFORT.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test normal, Inflammation, Injection site pain, Oedema peripheral, Urine analysis normal
Clinical narrative: Patient stated that the puncture site where vaccine was applied is really sore. He also stated and show me his right armpit was inflamed or/and swollen. Patient stated that it is really painful.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Swollen, red around injection site. Covers half of the upper arm.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Lip swelling, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vomiting in a 17-year-old female patient who received BEXSERO (batch number 16A201, expiry date 31st January 2019). On 19th September 2017, the patient received BEXSERO .5 ml. On 19th September 2017, 2 hrs after receiving BEXSERO, the patient experienced vomiting, injection site pain and lip swelling. The patient was treated with (NOS) BENADRYL and ZOFRAN. On an unknown date, the outcome of the vomiting, injection site pain and lip swelling were unchanged. It was unknown if the reporter considered the vomiting, injection site pain and lip swelling to be related to BEXSERO. Additional details were reported as follows: The patient was seen in the office for further treatment with BENADRYL and ZOFRAN. No further information was reported regarding the event.
Sex: F
Vaccine: MENB
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a adolescent female patient who received BEXSERO. On in unknown date, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced influenza-like symptoms. BEXSERO was discontinued (Dechallenge was positive). On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. The reporter considered the influenza-like symptoms to be almost certainly related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient was high school aged. The patient received unknown concomitant medication. The patient experienced severe flu like symptoms after receiving BEXSERO. The patient was taken to the emergency room but was not hospitalized. After a couple of days the symptoms resolved.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Diarrhoea haemorrhagic, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 9/19/17-Swollen site. 9/20/17-bloody diarrhea, fever, chills. 9/21/17 Site swollen, red and hot (size of baseball) large hive on knee and extended to bottom of legs. BENADRYL-no help. 9/22/17-Went to family Dr. steroid dose pak, ATERAX, CLARITIN, and PEPCID. Felt better by evening. Came to Emp. Health 9/29/17. Vaccine site soft no redness. No hives.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Urticaria
Clinical narrative: 9/19/17-Swollen site. 9/20/17-bloody diarrhea, fever, chills. 9/21/17 Site swollen, red and hot (size of baseball) large hive on knee and extended to bottom of legs. BENADRYL-no help. 9/22/17-Went to family Dr. steroid dose pak, ATERAX, CLARITIN, and PEPCID. Felt better by evening. Came to Emp. Health 9/29/17. Vaccine site soft no redness. No hives.
Sex: F
Vaccine: MENB
Symptoms: Induration
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of induration in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced induration. On an unknown date, the outcome of the induration was unknown. It was unknown if reporter considered the induration to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. As per the physician, he had a patient who got BEXSERO and experienced induration, larger than what was described in the package insert. The physician refused to provide more information.
Sex: M
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of swelling of legs in a adult male patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced swelling of legs. On an unknown date, the outcome of the swelling of legs was unknown. It was unknown if the reporter considered the swelling of legs to be related to BOOSTRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received BOOSTRIX about 10 years ago before reporting and experienced leg swelling to the product due to ingredient of horse by products. The healthcare professional reported that the patient received the vaccine at another facility when the adverse reaction occurred. The healthcare professional verified if indeed horse by products were currently used in the manufacturing process. No further information was available regarding the event.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Pt. phoned clinic stating she has warmth to site, itching, redness, H/A, swelling from site to elbow. Symptoms lessening daily. Symptoms began 9/22/2017 and still present.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Loss of consciousness, Nausea, Spinal column injury
Clinical narrative: I am a 52 year old female in great health. I am not taking any medication. I was administered the FLUARIX Quad flu vaccine in the P.M. on 09/23/17. 12 hours later, early Sunday A.M. I got up to use the restroom. While returning to bed I started feeling nauseous and hot. In a matter of seconds I blacked out an my body hit a console table breaking everything sitting on it. I ended up seriously injuring my tailbone from landing on the ceramic tile floor. I am fortunate I didn't crack my head open as well. I've had flu vaccines for the past 5 years and never had side effects. This is the first time I passed out in my lifetime. The flu shot was the only usual event experienced that day. I originally blacked out at 4A.M. 09/25/17 and continued to have symptoms of blacking out through 10A.M. This will be the last time  I get a flu shot. I will risk the flu rather than suffer through a tailbone injury for weeks or months.
Age: 0.17
Sex: U
Vaccine: DTAP
Symptoms: Syringe issue
Clinical narrative: RN was giving patient INFANRIX pre-filled 0.5 ml injection. The pre-filled vaccine was being injected and shot back at the nurse. Per RN, the syringe appears to be defective.
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Skin warm
Clinical narrative: After receiving FLUVIRIN multidose within two hours severe nausea set in. Within ten minutes of receiving the vaccine my arm felt extremely hot. Both issues have not subsided as of 9/23/17.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Patient was administered vaccine by pharmacist; is unsure if dose was delivered. She says she heard a "popping" sound at the time of administration. She was upset that she might not have gotten the vaccine and is at risk.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal pain, Developmental delay, Grunting, Insomnia, Irritability
Clinical narrative: She stopped sleeping and became fussy - discontent 24/7. She did not develop much or roll until 9 MO - 3 MO after last vaccine. Diagnosed with extreme colic - she screams, grunts, groans all day, still doesn't sleep at night - Told Doc - they don't acknowledge. Took to acupuncturist and she did a muscle sensitivity test to try and help figure out symptoms since her PCP doesn't ever have an answer and the DTaP came back as sensitivity and affecting her.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Laboratory test abnormal, Screaming
Clinical narrative: She stopped sleeping and became fussy - discontent 24/7. She did not develop much or roll until 9 MO - 3 MO after last vaccine. Diagnosed with extreme colic - she screams, grunts, groans all day, still doesn't sleep at night - Told Doc - they don't acknowledge. Took to acupuncturist and she did a muscle sensitivity test to try and help figure out symptoms since her PCP doesn't ever have an answer and the DTaP came back as sensitivity and affecting her.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Chills, Dyspnoea, Feeding disorder, Feeling cold, Feeling hot
Clinical narrative: Got the shots at 10:20am. Then around 1:00 the same day, starting feeling cold and chills and shivering. Then about 6:00 pm starting feeling very hot. Had difficulty sleeping, breathing, felt very nauseated through the night of 10/27. On 10/28 in arm, still felt hot and had trouble breathing. Was unable to eat until 3:00 pm 10/28/17. After eating still felt generally unwell and had occasional chills. Felt normal by 10/29 in he A.M. No injection site swelling or redness. Arm was slightly sore, but not usually so. No medical treatment was sought.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Insomnia, Malaise, Nausea, Pain in extremity
Clinical narrative: Got the shots at 10:20am. Then around 1:00 the same day, starting feeling cold and chills and shivering. Then about 6:00 pm starting feeling very hot. Had difficulty sleeping, breathing, felt very nauseated through the night of 10/27. On 10/28 in arm, still felt hot and had trouble breathing. Was unable to eat until 3:00 pm 10/28/17. After eating still felt generally unwell and had occasional chills. Felt normal by 10/29 in he A.M. No injection site swelling or redness. Arm was slightly sore, but not usually so. No medical treatment was sought.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and mild swelling 3 x 1.5 cm on the Rt deltoid area.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Pallor, Syncope
Clinical narrative: SYNCOPE AND COLLAPSE (ICD-780.2) (ICD10-R55). Approximately 15-20 min after vaccines given, phlebotomy done, patient immediately felt lightheaded, then approx 30 syncopal episode HR 55, BP 80/50, pale, diaphoretic. Also faint w/ blood or painful events. Regained consciousness spontaneously, HR and BP improved  bp; 92/58 p; 68. Given water and monitored for 15 min after episode, color and diaphoresis gradually improved.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Disturbance in attention, Dizziness, Dysstasia, Headache
Clinical narrative: Extreme dizziness, unable to stand, Low blood pressure, Headaches, Blurry vision in left eye, Unsettled stomach, Hard to concentrate, Rapid heart rate.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Heart rate increased, Hypotension, Postural orthostatic tachycardia syndrome, Vision blurred
Clinical narrative: Extreme dizziness, unable to stand, Low blood pressure, Headaches, Blurry vision in left eye, Unsettled stomach, Hard to concentrate, Rapid heart rate.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Redness from site injection in upper left arm down to below elbow. Slight swelling and stiffness. Patient came to pharmacy on 9/29/17 at 1:30pm to show arm which was red. Patient advised to take BENADRYL and to ice area. He confirmed that swelling, redness and stiffness was decreasing.
Age: 42.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Cellulitis, Feeling abnormal, Influenza like illness, Pain in extremity, Streptococcus test negative
Clinical narrative: PATIENT STATED ARM SORE THE NIGHT OF RECEIVING VACCINES & "FELT LIKE HAD FLU". WENT TO WORK ON TUESDAY AND HIS BOSS WAS MESSING WITH ARM AND TEASING HIM ABOUT GETTING OVER THE SORENESS. AS DAY PROGRESSED HE CONTINUED TO FEEL WORSE. HE WENT TO URGENT CARE AND HE STATED HIS WBC WAS 23, SO THEY SENT HIM TO THE ER. HE WENT HOME FIRST TO CHANGE CLOTHES THEN WENT TO ER. HE STATED THEY ASKED QUESTIONS AND RAN TEST. CHECKED HIM FOR STREP THROAT & WAS QUESTIONING HIM ABOUT CAMPING & IF HE HAD TICK BITES. HE STATED THE DR QUESTIONED IF THE IMMUNIZER CLEANED THE SITE & IF EVERYTHING WAS STERILE. HE STATED HE TOLD THEM YES HE WATCHED EVERYTHING. HE STATED ALL TESTS CAME BACK FINE & THE DIAGNOSIS THE DR GAVE HIM WAS CELLULITIS DUE TO ONE OF THE VACCINATIONS. THERE WAS NO DIRECT SWELLING AT INJECTION SITE. PATIENT CAME TO PHARMACY TO REPORT ON 9/29/17 AT ABOUT 1PM. INJECTION SITE WAS LOOKED AT, BUT NO VISIBLE POINT OF ENTRY OR SWELLING. HE STATED HE'S FEELING BETTER AND THE DR PUT HIM ON ANTIBIOTICS.
Age: 42.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: White blood cell count increased
Clinical narrative: PATIENT STATED ARM SORE THE NIGHT OF RECEIVING VACCINES & "FELT LIKE HAD FLU". WENT TO WORK ON TUESDAY AND HIS BOSS WAS MESSING WITH ARM AND TEASING HIM ABOUT GETTING OVER THE SORENESS. AS DAY PROGRESSED HE CONTINUED TO FEEL WORSE. HE WENT TO URGENT CARE AND HE STATED HIS WBC WAS 23, SO THEY SENT HIM TO THE ER. HE WENT HOME FIRST TO CHANGE CLOTHES THEN WENT TO ER. HE STATED THEY ASKED QUESTIONS AND RAN TEST. CHECKED HIM FOR STREP THROAT & WAS QUESTIONING HIM ABOUT CAMPING & IF HE HAD TICK BITES. HE STATED THE DR QUESTIONED IF THE IMMUNIZER CLEANED THE SITE & IF EVERYTHING WAS STERILE. HE STATED HE TOLD THEM YES HE WATCHED EVERYTHING. HE STATED ALL TESTS CAME BACK FINE & THE DIAGNOSIS THE DR GAVE HIM WAS CELLULITIS DUE TO ONE OF THE VACCINATIONS. THERE WAS NO DIRECT SWELLING AT INJECTION SITE. PATIENT CAME TO PHARMACY TO REPORT ON 9/29/17 AT ABOUT 1PM. INJECTION SITE WAS LOOKED AT, BUT NO VISIBLE POINT OF ENTRY OR SWELLING. HE STATED HE'S FEELING BETTER AND THE DR PUT HIM ON ANTIBIOTICS.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Feeling abnormal
Clinical narrative: Unsteady since last night this morning, feeling "spacey".
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chills, Dyspnoea, Immediate post-injection reaction, Myalgia
Clinical narrative: Immediate (within 15 seconds) tracheal/ chest heaviness and tightness with dyspnea. Mostly resolved within 30 minutes although lingering chest tightness over the next few hours. No wheezing. Approximately 9 hours later, severe myalgias and rigors. Abated with ALEVE. Back to baseline by the next morning.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Tracheal disorder
Clinical narrative: Immediate (within 15 seconds) tracheal/ chest heaviness and tightness with dyspnea. Mostly resolved within 30 minutes although lingering chest tightness over the next few hours. No wheezing. Approximately 9 hours later, severe myalgias and rigors. Abated with ALEVE. Back to baseline by the next morning.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Skin exfoliation
Clinical narrative: Facial desquamation.
Age: 86.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was accidentally given a MENACTRA vaccine instead of a PNEUMOVAX vaccine, patient denies any adverse reactions.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Red rash, warm to touch, soreness on lower part of upper arm approx. 4 inches below area of injection.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site warmth, Neck pain
Clinical narrative: AT 1130, THE FLU VACCINE WAS GIVEN. PATIENT C/O PAIN AT INJECTION SITE. 1230-1300, PATIENT REPORTS PAIN RADIATING UP TO SHOULDER AND NECK AND DOWN RIGHT ARM TO HAND, WITH SWELLING NOTED IN RIGHT HAND 3RD AND 4TH KNUCKLES. REDNESS AND WARMTH AT INJECTION SITE. DEXAMETHASONE 10MG/1ML GIVEN IM TO R DELTOID. DEPO-MEDROL 40MG/1ML IM GIVEN R DELTOID. NO IMPROVEMENT. PATIENT C/O SOB AT 1320. 20 GAUGE IV TO LEFT AC. DEXAMETHASONE 10MG/1ML IVPD AND BENADRYL 50MG IVPB ADMINISTERED. SYMPTOMS SUBSIDED.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: AT 1130, THE FLU VACCINE WAS GIVEN. PATIENT C/O PAIN AT INJECTION SITE. 1230-1300, PATIENT REPORTS PAIN RADIATING UP TO SHOULDER AND NECK AND DOWN RIGHT ARM TO HAND, WITH SWELLING NOTED IN RIGHT HAND 3RD AND 4TH KNUCKLES. REDNESS AND WARMTH AT INJECTION SITE. DEXAMETHASONE 10MG/1ML GIVEN IM TO R DELTOID. DEPO-MEDROL 40MG/1ML IM GIVEN R DELTOID. NO IMPROVEMENT. PATIENT C/O SOB AT 1320. 20 GAUGE IV TO LEFT AC. DEXAMETHASONE 10MG/1ML IVPD AND BENADRYL 50MG IVPB ADMINISTERED. SYMPTOMS SUBSIDED.
Age: 44.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Chills, Influenza like illness, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a 52 years old male patient, positive to human inmunodeficiency virus. The patient's medical history and concomitant medications were not provided. On 08-AUG-2017, the patient was vaccinated with the second dose of PNEUMOVAX 23, lot number M042324, expiration date 10-JUN-2018, for prophylaxis (route of administration was not reported); 8 years after receipt of his first dose, in approximately August 2009. The patient also received MENACTRA (route of administration, indication, lot number and expiration date were not provided) concomitantly with the second dose of PNEUMOVAX 23. On 09-AUG-2017, the patient experienced flu-like symptoms of myalgia, fever and chills. He also reported arm pain which impaired its movement. The events resolved within 24 hours without treatment. . Assessment of the relationship of the aforementioned events to PNEUMOVAX 23 and MENACTRA was not provided. This is one of two cases received from the same source.; Sender's Comments: US-009507513-1708USA004684:
Age: 44.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a 52 years old male patient, positive to human inmunodeficiency virus. The patient's medical history and concomitant medications were not provided. On 08-AUG-2017, the patient was vaccinated with the second dose of PNEUMOVAX 23, lot number M042324, expiration date 10-JUN-2018, for prophylaxis (route of administration was not reported); 8 years after receipt of his first dose, in approximately August 2009. The patient also received MENACTRA (route of administration, indication, lot number and expiration date were not provided) concomitantly with the second dose of PNEUMOVAX 23. On 09-AUG-2017, the patient experienced flu-like symptoms of myalgia, fever and chills. He also reported arm pain which impaired its movement. The events resolved within 24 hours without treatment. . Assessment of the relationship of the aforementioned events to PNEUMOVAX 23 and MENACTRA was not provided. This is one of two cases received from the same source.; Sender's Comments: US-009507513-1708USA004684:
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a consumer regarding a currently 23 year old female patient (also reported as daughter of the patient). Patient's prior vaccinations included DTP, HAVRIX or VAQTA, HIB (unknown type), GARDASIL, influenza, influenza (unknown type), MENACTRA or MENVEO, MMR, Polio OPV, TD, DTAP, AFLURIA and VARIVAX. The patient's concomitant medication and medical history were not reported. On 10-FEB-1994, patient was vaccinated (age at vaccination was 1 day old, infant) with hepatitis b vaccine (recombinant) (Manufacturer unknown) dose 1 (strength, route of administration, lot#, expiry date was not reported) for prophylaxis. On 18-APR1994 and 08-FEB-1995 the patient was vaccinated with dose 2 and dose 3 of hepatitis b vaccine (recombinant) ( Manufacturer unknown) (Inappropriate drug schedule). On 12-JUL-2017, Hepatitis B surface antibody assay been done and found to be Non-Reactive and value was less than 3.10 IU/L, (also reported as Hepatitis B antibodies (protection) were not detected). On an unknown date in September 2017 an additional booster dose of hepatitis b vaccine (recombinant) (Manufacturer unknown) was administered to the patient. It was also reported an additional titre will be drawn. The action taken and outcome of the events was unknown. The relatedness of the events to the therapy with hepatitis b vaccine (recombinant) (Manufacturer unknown) was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD from lot # M044719 with expiration date on 07-MAY-2018; and lot # N014758 with expiration date on 08-NOV-2018 (strength, dose, route of administration or anatomical location were not provided); along with a properly stored sterile diluent (manufacturer unknown) with lot # N016189 and expiration date on 13-AUG-2019; both administered for prophylaxis. The storage temperature was -14 to -10 degrees Celsius (°C), for a timeframe of 26 minutes. There was a previous temperature excursion at -14 to -10 °C for 1 hour. No adverse effects were reported. No product quality complaint (PQC) was involved.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered pharmacist and refers to a 63 year old patient of unknown gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 06-JUL-2017, the patient was vaccinated with an improperly stored ZOSTAVAX, lot number M041087 with expiration date 03-JAN-2018 (dosage schedule, anatomical location and route of administration not provided) for prophylaxis, reconstituted with properly stored diluent (MRK INJ). The administered vaccine was exposed to a temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 1 hour. Previous temperature excursion was reported as 6 degree Fahrenheit to 14 degree Fahrenheit for 45 minutes. The call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010696: US-009507513-1708USA010732: US-009507513-1709USA014570: US-009507513-1709USA014571: US-009507513-1709USA014572: US-009507513-1709USA014573: US-009507513-1709USA014574: US-009507513-1709USA014575: US-009507513-1709USA014576: US-009507513-1709USA014577.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered pharmacist and refers to a 69 year old patient of unknown gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 09-JUL-2017, the patient was vaccinated with an improperly stored ZOSTAVAX, lot number M041087 with expiration date 03-JAN-2018 (dosage schedule, anatomical location and route of administration not provided) for prophylaxis, reconstituted with properly stored diluent (MRK INJ). The administered vaccine was exposed to a temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 1 hour. Previous temperature excursion was reported as 6 degree Fahrenheit to 14 degree Fahrenheit for 45 minutes. The call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010696: US-009507513-1708USA010732: US-009507513-1709USA014569: US-009507513-1709USA014571: US-009507513-1709USA014572: US-009507513-1709USA014573: US-009507513-1709USA014574: US-009507513-1709USA014575: US-009507513-1709USA014576: US-009507513-1709USA014577.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered pharmacist and refers to a 73 year old patient of unknown gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 10-JUL-2017, the patient was vaccinated with an improperly stored ZOSTAVAX, lot number M041087 with expiration date 03-JAN-2018 (dosage schedule, anatomical location and route of administration not provided) for prophylaxis, reconstituted with properly stored diluent (MRK INJ). The administered vaccine was exposed to a temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 1 hour. Previous temperature excursion was reported as 6 degree Fahrenheit to 14 degree Fahrenheit for 45 minutes. The call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010696: US-009507513-1708USA010732: US-009507513-1709USA014569: US-009507513-1709USA014570: US-009507513-1709USA014572: US-009507513-1709USA014573: US-009507513-1709USA014574: US-009507513-1709USA014575: US-009507513-1709USA014576: US-009507513-1709USA014577.
Age: 80.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered pharmacist and refers to an 80 year old patient of unknown gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 11-JUL-2017, the patient was vaccinated with an improperly stored ZOSTAVAX, lot number M041087 with expiration date 03-JAN-2018 (dosage schedule, anatomical location and route of administration not provided) for prophylaxis, reconstituted with properly stored diluent (MRK INJ). The administered vaccine was exposed to a temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 1 hour. Previous temperature excursion was reported as 6 degree Fahrenheit to 14 degree Fahrenheit for 45 minutes. The call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010696: US-009507513-1708USA010732: US-009507513-1709USA014569: US-009507513-1709USA014570: US-009507513-1709USA014571: US-009507513-1709USA014573: US-009507513-1709USA014574: US-009507513-1709USA014575: US-009507513-1709USA014576: US-009507513-1709USA014577.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a first dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, a year later, the patient received a second dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported) for an unknown reason. No adverse effects were reported.
Age: 50.0
Sex: U
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 50 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. The patient did not have any known drug reactions or allergies. On 25-SEP-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # N021171, expiration date 01-NOV-2018 (dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent (lot# M035268, expiration date 19-apr-2019). Other suspect therapies included FLUARIX (dose, route of administration, lot# and expiration date were not reported) administered in opposite arm on the same day. On 26-SEP-2017, a day after injection, the patient experienced injection site reaction that gradually developed: swelling, round red area, itching and warmth. There was no rash. The patient visited pharmacy on 28-SEP-2017. No treatment was given for the events. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. The relatedness between the events and the suspect drugs was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions included a renal transplant, that was performed "recently" (date unknown) that required a chronic unspecified immunosuppressant therapy. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, lot # and expiry date were not reported) for prophylaxis; that was received along with sterile diluent (MERCK) (dose, route, lot # and expiry date were not reported). No adverse effect reported. No product quality complaint (PQC) involved.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report received from a non-contactable pharmacist via a Pfizer sales representative. The pharmacist reported similar events for 3 patients. This is the 1st of 3 reports. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration, in left arm, on an unspecified date, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced pain when administering PREVNAR 13 on an unspecified date, with unknown outcome. No follow-up attempts possible. No further information expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2017420663 Same reporter/drug/event, different patient; US-PFIZER INC-2017420666 Same reporter/drug/event, different patient.
Age: 19.0
Sex: M
Vaccine: FLUX, MENB
Symptoms: Chills, Pyrexia, Tuberculin test
Clinical narrative: This is a spontaneous report from a contactable Physician communicated to a Pfizer sales representative. This physician reported similar events for 4 patients, this is the third of 4 reports. A 19 years old male patient of an unspecified ethnicity received on 19Sep2017 the second dose of TRUMENBA (lot# S26985), intramuscular at single dose, in the deltoid and influenza vaccine (FLU SHOT), via an unspecified route of administration both for immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of meningococcal group b rlp2086 for immunisation. The patient underwent tuberculin test on unspecified date. On 19Sep2017 the patient experienced fever of 102 F and chills after receiving vaccine. Mother of patient called the office later the evening after the patient got the vaccine to report the events. The doctor asked that the patient get Ibuprofen. The office followed up three days later and the patient was fine. The patient recovered on unspecified date in Sep2017. Sender's Comments: Linked Report(s): US-PFIZER INC-2017421689 same reporter/product, different patient/event.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Dizziness, Fatigue, Malaise, Vertigo
Clinical narrative: Joint aches; particularly in neck, wrists, hands, knee, ankles, and feet. Tired, generally 'not feeling well'.  Took ibuprofen and improved for short duration. Notable Dizziness / vertigo throughout day.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Back pain, Chest discomfort, Erythema, Feeling hot, Flushing
Clinical narrative: Just a minute or two after the shot I felt all hot and flushed, my face and chest were bright red and then I had the feeling of a vice-like grip on my chest. The pharmacist told me to sit down and then the vice-like grip went to my low back and hurt so much I had to stand. Within another few minutes these symptoms disappeared. I have felt shaky ever since.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Muscle tightness, Nervousness
Clinical narrative: Just a minute or two after the shot I felt all hot and flushed, my face and chest were bright red and then I had the feeling of a vice-like grip on my chest. The pharmacist told me to sit down and then the vice-like grip went to my low back and hurt so much I had to stand. Within another few minutes these symptoms disappeared. I have felt shaky ever since.
Age: 22.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, chills, sore throat ~7 hours after being immunized.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Feeling of body temperature change, Pyrexia, Rash, Rash macular
Clinical narrative: Patient received influenza vaccine at 2pm, around 7pm she noticed red, blotchy spots all over her upper trunk, stomach and back area that were warm to touch, no itching voiced, she then had several bouts of diarrhea and having periods of hot/cold with fever. She continued throughout the night with these symptoms. She stated that symptoms subsided about 430am and she felt much better and by 11am all symptoms were gone. She did take Tylenol for the fever.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Patient received influenza vaccine at 2pm, around 7pm she noticed red, blotchy spots all over her upper trunk, stomach and back area that were warm to touch, no itching voiced, she then had several bouts of diarrhea and having periods of hot/cold with fever. She continued throughout the night with these symptoms. She stated that symptoms subsided about 430am and she felt much better and by 11am all symptoms were gone. She did take Tylenol for the fever.
Age: 86.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Dizziness, Flushing
Clinical narrative: Patient became light headed and was flushing. I instructed her to sit down and asked her if she had any trouble breathing etc. Within 10 minutes flushing and light headedness had subsided and patient began to feel better.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Shot was given in the left arm. That day I had normal soreness in my arm. However, it has been three weeks now and the soreness continues. I have trouble raising my arm and fully extending it. It continually feels like the muscle is sore and when I go to bed I have trouble finding a position for the arm that does not hurt. I have not sought any treatment yet. I am just hoping that it will get better over time.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMRV
Symptoms: Injection site haematoma, Injection site swelling, Ultrasound scan abnormal
Clinical narrative: Patient received vaccines listed on 3/30/17. After vaccine administration mother noticed small bump at the area. Was seen in clinic on 7/14/17 to assess the bump on right thigh and ultrasound was ordered and completed on 7/26/17. Patient returned to clinic for an additional appt on 9/12/17 due to area increasing in size. Since then the size of the area has increased and area spread according to mother's reports and patient was taken to ER recently. There she was given instructions to wrap, massage area and apply cold/heat.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: 15 minutes after administration, a localized allergic reaction was noted. Injection site was red, raised and warm to the touch. Redness measures 3cm x 4cm. Dr. ordered Diphenhydramine 12.5mg to be given orally to pt. Patient was kept for 30 more minutes of observation. Redness was dissipating with no other change noted to the site. Patient was asymptomatic for any respiratory distress.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site pain, Injection site swelling, Rash
Clinical narrative: Patient stated she developed a rash and her arm began to swell at injection site. She complained of having pain around area.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, HIBV
Symptoms: Gait disturbance, Gait inability, Malaise, Muscular weakness, Nuclear magnetic resonance imaging brain
Clinical narrative: Patient was sick needed albuterol high fever developed abnormal gait walked with left leg to side regressed to crawling still has muscle weakness with no reason why.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, HIBV
Symptoms: Nuclear magnetic resonance imaging spinal, Pyrexia
Clinical narrative: Patient was sick needed albuterol high fever developed abnormal gait walked with left leg to side regressed to crawling still has muscle weakness with no reason why.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Irregular breathing, Pulse absent, Resuscitation, Unresponsive to stimuli
Clinical narrative: PATIENT WAS MOVED FROM CHAIR IN IMMUNIZATION ROOM TO A WAITING ROOM CHAIR WITH HELP OF DAUGHTER DUE TO HER AGE. WITHIN A MINUTE OR TWO OF SITTING DOWN SHE BECAME UNRESPONSIVE AND BEGAN AGONAL BREATHING. THE NURSE PRACTITIONER DETECTED NO PULSE AND IMMEDIATELY BEGAN CPR WHILE 911 WAS CALLED. ABOUT A MINUTE LATER PATIENT GASPED FOR AIR, WAS ROLLED ON HER SIDE, AND SLOWLY GAINED CONSCIOUSNESS AND BEGAN TO TALK. PAREMEDICS ARRIVED AFTER A FEW MINUTES AND EVALUATED HER AND TOOK HER TO A LOCAL HOSPITAL.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash, Skin warm
Clinical narrative: Patient reported a rash/swollen red portion on right upper arm that extended down to elbow region. Patient stated it was itchy, warm and swollen that subsided however rash left.
Age: 66.0
Sex: F
Vaccine: FLUC4
Symptoms: Sensation of foreign body, Swollen tongue
Clinical narrative: About 20 minutes after the vaccination, the patient experienced globus sensation of the throat. She felt as though her tongue was also swelling up, although no visible angioedema was noted. Her symptoms began to worsen over the next 10 minutes. She was treated with epinephrine 0.3mg and cetirizine 10mg, and she stated that she began to feel better, with complete resolution of symptoms in about 40 minutes. The patient was released to home.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Angioedema, Eye swelling, Lip swelling, Swelling face
Clinical narrative: Patient was home and called office after-hours on-call pediatrician for lip swelling and facial/eye swelling. She was advised to seek care in the ER. There, she was diagnosed with angioedema and given epinephrine as well as diphenhydramine. Patient was discharged home, stable, with prescriptions for epinephrine auto-injector and oral diphenhydramine. Never complained of any respiratory symptoms. No new foods nor products used on the day of the vaccination. The only new thing were the three vaccines that never received previously.