chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypersensitivity, Injection site inflammation, Injection site pain, Pain
Clinical narrative: Large inflamed area at injection site day after injection. Pain and size of irritation continually increased. Patient sought medical attention and was told she had an allergic reaction and mild case of shingles.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin irritation
Clinical narrative: Large inflamed area at injection site day after injection. Pain and size of irritation continually increased. Patient sought medical attention and was told she had an allergic reaction and mild case of shingles.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: Red rash at/around injection site.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Oedema peripheral
Clinical narrative: Left arm eryth swelling pain in axilla.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to patients of unknown age. It was reported that MMR II (lot # and expiration date unspecified) had been improperly stored at 47-52F for almost entire month of September at one of the clinics and some doses might have been administered to patients. Specific number of patients was unknown. It was unspecified whether the patients sought for medical attention. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to patients of unknown age. It was reported that PNEUMOVAX 23 (lot # and expiration date unspecified) had been improperly stored at 47-52F for almost entire month of September at one of the clinics and some doses might have been administered to patients. Specific number of patients was unknown. It was unspecified whether the patients sought for medical attention. The outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Herpes zoster, Injection site erythema, Injection site pain, Nausea
Clinical narrative: This spontaneous report as received from a 68 years old patient refers to herself. On 27-OCT-2012 the patient was vaccinated subcutaneously with one dose of ZOSTAVAX (Lot# and dose not reported). Concomitant medications included metoprolol and lisinopril. "About a week ago" on approximately 29-OCT-2012 the patient experienced injection site pain and redness, nausea and diarrhea after receiving ZOSTAVAX. Patient stated that she had shingles outbreak at this time, in about November 2012. Patient did not seek for medical attention. No treatment was given. No lab diagnostic studies were performed. Adverse events were not improved. At the time of this report the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a physician concerning multiple patients who were vaccinated with doses of ZOSTAVAX (lot# not reported) in October 2012. This physician reported that multiple patients, age and genders unknown received the ZOSTAVAX injection, unknown dose and frequency for vaccinations on unknown dates in the month of October 2012. All the patients' relevant medical history, concomitant medications, and past drug history were unknown. On 20-OCT-2012 the office staff realized all the ZOSTAVAX vaccines had expiration date of 05-OCT-2012 and they had been giving them to patients all month. It was unknown if there was any relevant laboratory data. As of 20-OCT-2012 it was unknown if any of the patients would get the ZOSTAVAX again, and the outcome of multiple patients receiving expired ZOSTAVAX vaccines were unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot # was reported as H011431, expiration date was 12-SEP-2013, dose and route were unknown) on 01-NOV-2012, that had been exposed to temperatures of 56 degrees F for 19 hours. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 patients of unknown age. The patients was vaccinated with ZOSTAVAX (lot# unspecified). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patients experienced injection site reactions after receiving ZOSTAVAX included mild swelling, warmth and redness around injection site. No treatment information was reported. The outcome of mild swelling, warmth and redness around injection site was unknown. The patient had sought medical attention via spoke to the pharmacist. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age, unknown gender. The patient was vaccinated subcutaneously with a single dose of ZOSTAVAX (lot # 671144/1269AA, expiration date 05-NOV-2012) on 06-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was inadvertently administered ZOSTAVAX on 11/06/2012 that had expired on 11/05/2012. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Endotracheal intubation, Intensive care, Neck pain
Clinical narrative: Information has been received from a claims administrator (claim number 30120955527-0001), concerning a patient who on 18-AUG-2012, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot# not reported). The patient sustained an allergic reaction after receiving the vaccine. It was unknown if the patient sought medical attention. At the time of reporting, the outcome was unknown. Additional information is not expected.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a claims administrator (claim number 30120955527-0001), concerning a patient who on 18-AUG-2012, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot# not reported). The patient sustained an allergic reaction after receiving the vaccine. It was unknown if the patient sought medical attention. At the time of reporting, the outcome was unknown. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Blood test, Computerised tomogram, Dehydration, Muscle spasms
Clinical narrative: Case number PHEH2012US022136 is an initial spontaneous report received from a consumer on 07 Nov 2012: This report refers to a 74-years-old female patient. She was vaccinated with FLUVIRIN (batch number: 1205201) intramuscularly on 05 Oct 2012. On 06 Oct 2012 she began to have severe diarrhea and vomiting. In on the morning on 06 Oct 2012 she had severe cramps and she fainted. She went to see her physician on 08 Oct 2012 and 09 Oct 2012. She had blood tests, urine tests, magnetic resonance imaging and ultrasound done; however no results were provided. She was placed on ciprofloxacin and promethazine and had antibiotics injection. On 09 Oct 2012 she began to feel better. She lost eight pounds of weight. The physician said it was a bacterial infection. No further information about seriousness, outcome and causality was provided.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging, Syncope, Urine analysis
Clinical narrative: Case number PHEH2012US022136 is an initial spontaneous report received from a consumer on 07 Nov 2012: This report refers to a 74-years-old female patient. She was vaccinated with FLUVIRIN (batch number: 1205201) intramuscularly on 05 Oct 2012. On 06 Oct 2012 she began to have severe diarrhea and vomiting. In on the morning on 06 Oct 2012 she had severe cramps and she fainted. She went to see her physician on 08 Oct 2012 and 09 Oct 2012. She had blood tests, urine tests, magnetic resonance imaging and ultrasound done; however no results were provided. She was placed on ciprofloxacin and promethazine and had antibiotics injection. On 09 Oct 2012 she began to feel better. She lost eight pounds of weight. The physician said it was a bacterial infection. No further information about seriousness, outcome and causality was provided.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bacterial infection, Blood test, Diarrhoea, Muscle spasms, Nuclear magnetic resonance imaging
Clinical narrative: Case number PHEH2012US022136 is an initial spontaneous report received from a consumer on 07 Nov 2012: This report refers to a 74-years-old female patient. She was vaccinated with FLUVIRIN (batch number: 1205201) intramuscularly on 05 Oct 2012. On 06 Oct 2012 she began to have severe diarrhea and vomiting. In on the morning on 06 Oct 2012 she had severe cramps and she fainted. She went to see her physician on 08 Oct 2012 and 09 Oct 2012. She had blood tests, urine tests, magnetic resonance imaging and ultrasound done; however no results were provided. She was placed on ciprofloxacin and promethazine and had antibiotics injection. On 09 Oct 2012 she began to feel better. She lost eight pounds of weight. The physician said it was a bacterial infection. No further information about seriousness, outcome and causality was provided.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Syncope, Ultrasound scan, Urine analysis, Vomiting, Weight decreased
Clinical narrative: Case number PHEH2012US022136 is an initial spontaneous report received from a consumer on 07 Nov 2012: This report refers to a 74-years-old female patient. She was vaccinated with FLUVIRIN (batch number: 1205201) intramuscularly on 05 Oct 2012. On 06 Oct 2012 she began to have severe diarrhea and vomiting. In on the morning on 06 Oct 2012 she had severe cramps and she fainted. She went to see her physician on 08 Oct 2012 and 09 Oct 2012. She had blood tests, urine tests, magnetic resonance imaging and ultrasound done; however no results were provided. She was placed on ciprofloxacin and promethazine and had antibiotics injection. On 09 Oct 2012 she began to feel better. She lost eight pounds of weight. The physician said it was a bacterial infection. No further information about seriousness, outcome and causality was provided.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Chest pain, Dyspnoea, Eye swelling, Heart rate increased, Oedema peripheral
Clinical narrative: R arm edema 5inch X 7 inch, eyes swollen shortness of breath, rapid pulse and chest pain.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Skin warm, Vomiting
Clinical narrative: R arm edema 5inch X 7 inch, eyes swollen shortness of breath, rapid pulse and chest pain.
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Chest pain, Dyspnoea, Eye swelling, Heart rate increased, Oedema peripheral
Clinical narrative: Rt arm edema and hot to touch. Area 5 in. x 7 in. Eyes swollen shut, SOB, rapid pulse, chest pain and vomiting. Life threatening and required ER and Dr. Visit.
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Skin warm, Vomiting
Clinical narrative: Rt arm edema and hot to touch. Area 5 in. x 7 in. Eyes swollen shut, SOB, rapid pulse, chest pain and vomiting. Life threatening and required ER and Dr. Visit.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling hot, Pruritus, Swelling
Clinical narrative: Extreme swelling, itching, and warmth.  Began 9 day course of Steroids on 10/23/2012 after visiting the Urgent Care.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: ABSENT PERIOD FOR 2 MONTHS AFTER GARDASIL 1ST SHOT.
Age: 0.44
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Cerebral ventricle dilatation, Congenital central nervous system anomaly, Developmental delay, Nuclear magnetic resonance imaging brain abnormal, Partial seizures
Clinical narrative: Seizure - focal in both legs.
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site haematoma, Injection site induration
Clinical narrative: 2.5 x 3.5 inch area of induration and erythema/bruising to right anterior thigh.  No tenderness or warmth noted on exam. No treatment, parent advised to monitor and call back with new/worsening s/s.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Injection site haematoma, Nausea
Clinical narrative: Hematoma to injection site. Dizziness, nausea.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Fatigue, Headache, Herpes zoster, Hypersensitivity
Clinical narrative: Headache, itchy eyes, stiff neck on the right (vaccine was given in right arm), body aches, fatigue. This passed within 24 hours EXCEPT for stiff neck and sore arm. Still feel some slight lingering soreness in the area as of today's date (11/12/2012).  Extreme nasal allergy reaction experienced on 11/1 (around 9 pm) for the next 24 hours.  First ever shingles outbreak started on 11/4; diagnosed on 11/9/12.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Headache, itchy eyes, stiff neck on the right (vaccine was given in right arm), body aches, fatigue. This passed within 24 hours EXCEPT for stiff neck and sore arm. Still feel some slight lingering soreness in the area as of today's date (11/12/2012).  Extreme nasal allergy reaction experienced on 11/1 (around 9 pm) for the next 24 hours.  First ever shingles outbreak started on 11/4; diagnosed on 11/9/12.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Client attended the flu shot clinic.  She received a 0.5cc Influenza injection, Sanofi, Lot# UH734AC, Expiration date 6/30/13, in the right deltiod muscle at 1826 hours.  Student nurse administered the dose with her instructor supervising.  After receiving the injection the client went to sit at the waiting area with her dad.  At 1830 hours the client told her dad she felt faint.  He told her to put her head on the table and called for assistance.  This nurse assisted the client to sit and then lie on the floor with her feet elevated on the seat of the table.  School nurse retreived a wrapped cold pack to apply to the client's forehead.  At 1835 hours this nurse assessed vitals: Blood pressure 110/66, pulse 72, respirations 16.  At this time the client's dad reported that the client was tested a year ago for Wolf-Parkinson-White syndrome.  Client stated she felt better after 5 minutes had past.  At that time school nurse took over for RN.  RN and this nurse then allowed the client to sit up against a pillar for support.  RN gave the client a Capri Sun juice and a fun pack bag of Skittles.  This nurse reassessed vitals at 1844 hours: Blood pressure 112/66, pulse 80, respirations 16.  Client stated she felt better, no dizziness or nausea.  She stood up without support or problems and was monitored another 5 minutes.  Client was released with her parents.  This nurse called to follow up with the client's parents the next day (11/9/12) at 0818 hours, but had to leave a message.  This nurse then called to report the incident to the client's physician at 0822 hours, but had to leave a message.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dysphagia, Dyspnoea, Erythema
Clinical narrative: 10 AM onset severe HA, then feeling of difficulty in breathing and swallowing, symptoms worsened and by 1pm presented to physician with facial reddening, fatigue, irritative cough.  Was given Benadryl 50mg IM and sent to ER for further eval. c/o throat and upper chest "heaviness".  Was given IV fluids, SoluMedrol IV, Pepcid IV and albuterol nebulizer tx.  Felt better after tx and was sent home.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Throat irritation
Clinical narrative: 10 AM onset severe HA, then feeling of difficulty in breathing and swallowing, symptoms worsened and by 1pm presented to physician with facial reddening, fatigue, irritative cough.  Was given Benadryl 50mg IM and sent to ER for further eval. c/o throat and upper chest "heaviness".  Was given IV fluids, SoluMedrol IV, Pepcid IV and albuterol nebulizer tx.  Felt better after tx and was sent home.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Hyperaesthesia, Influenza like illness, Injection site erythema
Clinical narrative: Pneumonia vaccine.  24 hours after injection, flu like joint/muscle pain, sensitive skin, chills during evening (8-10 PM).  4 inch x 3 inch oval redness as site of pneumonia vaccine injection, which lasted 4 days.  Flu symptoms lasted approximately 36 hours.  Took aspirin to start and then Benadryl.  Applied Benadryl cream to arm/site of injection.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Pneumonia vaccine.  24 hours after injection, flu like joint/muscle pain, sensitive skin, chills during evening (8-10 PM).  4 inch x 3 inch oval redness as site of pneumonia vaccine injection, which lasted 4 days.  Flu symptoms lasted approximately 36 hours.  Took aspirin to start and then Benadryl.  Applied Benadryl cream to arm/site of injection.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Swollen tongue
Clinical narrative: Pt receive vaccine at pharmacy, about 30 minutes after getting home her tongue and lips began to swell.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Chills, Feeling hot, Injection site haematoma, Injection site pain
Clinical narrative: At 4:00 AM she awoke feeling hot and chilled. She did not take her temp. Her rt. arm was sore & bruised where the injection had been placed. She took Motrin and felt better. On 11/08/20012 she went to the ER and was diagnosed with Right arm cellulitis and given Bactrim DS. On 11/12/2012 she was seen in Orientation and arm was much better.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Headache, Nausea, Pyrexia
Clinical narrative: Fever, nausea, body weakness, headache.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: Chills, shivering, joint pain, fever.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Lymphadenopathy, Nausea, Neuralgia, Pain in extremity
Clinical narrative: Wednesday received flu shot; Thursday into Friday arm sore and then neck glands swollen.  Friday developed fever of 100 and nauseous.  Saturday headache and nerve-like pain from neck to spinal cord.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Wednesday received flu shot; Thursday into Friday arm sore and then neck glands swollen.  Friday developed fever of 100 and nauseous.  Saturday headache and nerve-like pain from neck to spinal cord.
Age: 0.44
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Rash papular
Clinical narrative: Rash papular began 11/9/12.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Confusional state, Fatigue, Injection site pain
Clinical narrative: Pain in upper left arm, just below where shot was given, and elbow when moving arm laterally up and when reaching up, and when reaching up and over to the right. Also mental cloudiness and extreme fatigue. All this still continues up to this date (11/12/2012) and is all at the same rate. No decrease or increase of pain or fatigue or confusion. Haven't sought Dr. yet. Similar happened last year (2011) with shot...but not as bad as this 2012 shot and eventually it went away. Thought 2011 was from shot in bad spot and delivered poorly, but the same is happening this year, only worse.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Drug hypersensitivity, Headache, Hypersensitivity, Injection site discolouration, Injection site swelling
Clinical narrative: After receiving the pneumonia vaccination on 06/22/2012, I began to see swelling and discoloration in my left arm at the point of entry for the vaccination. I began to develop a head ache and slight fever. By the next morning, 06/23/2012, I had a temperature of over 100, my arm was severely swollen and discolored. I had a head ache and body ache. That afternoon I went to the Emergency Room where they stated I was having an allergic reaction to the vaccination I had received the day before, by the time I reached the hospital my temperature was 103 and my arm had gotten much bigger. I was given Bactrim as an antibiotic and also some medicine for pain. After taking the Bactrim, I had another allergic reaction to that medicine which sent me back to the ER on 06/25.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain, Pyrexia, Skin discolouration
Clinical narrative: After receiving the pneumonia vaccination on 06/22/2012, I began to see swelling and discoloration in my left arm at the point of entry for the vaccination. I began to develop a head ache and slight fever. By the next morning, 06/23/2012, I had a temperature of over 100, my arm was severely swollen and discolored. I had a head ache and body ache. That afternoon I went to the Emergency Room where they stated I was having an allergic reaction to the vaccination I had received the day before, by the time I reached the hospital my temperature was 103 and my arm had gotten much bigger. I was given Bactrim as an antibiotic and also some medicine for pain. After taking the Bactrim, I had another allergic reaction to that medicine which sent me back to the ER on 06/25.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Pain in extremity, X-ray
Clinical narrative: Extreme pain in right shoulder, right arm and forearm.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Rash
Clinical narrative: Patient came to pharmacy complaining that he is having the burning sensation at the right side of his abdomen e.g. like sunburn. There was no rash or pain. Patient was directed to the doctor with the possible adverse reaction from Zostavax. On 11/11/2012 his doctor had prescribe him Acyclovir 800mg 5 times a day for 7 days. When patient came to pick his prescription he mentioned me that he is having a mild rash but no pain at the same site he has a burning sensation.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Chills, Erythema, Pyrexia
Clinical narrative: Chills, fever, red shoulder. Evaluated 11/11/12 in urgent care: no fever but BP uncharacteristically low SBP 80.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site rash, Rash
Clinical narrative: Given shingles vaccine L deltoid 11/07, then 3 days later developed L arm rash below deltoid and down forearm, with L hand numbness.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Confusional state, Dizziness, Nuclear magnetic resonance imaging
Clinical narrative: Dizziness, confusion.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Raised area at site of vaccine. Turned warm and red.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Pain, Pyrexia
Clinical narrative: Diarrhea, fever, aches, chills.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Pruritus, Rash, Rash vesicular
Clinical narrative: Zoster like rash on face, pain and itching.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Paraesthesia, Swelling face, VIIth nerve paralysis
Clinical narrative: Developed left facial swelling and tingling, with mild left facial droop.  Resolved quickly over 4-6 hours.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient experienced lightheadedness after administration of the influenza vaccine. Patient was subsequently put in a lying position with feet up, given juice, evaluated by physician and was monitored for 15 minutes.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Choking, Cough, Throat tightness
Clinical narrative: Coughing, choking, feeling like throat closing-  pt took Benadryl and was instructed to go to clinic or emergency room.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: As of 48 hours later, have a 3-inch diameter welt surrounding injection site (hot, itchy, sore, heavy) and additional small bump at needle injection point.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Sensation of heaviness
Clinical narrative: As of 48 hours later, have a 3-inch diameter welt surrounding injection site (hot, itchy, sore, heavy) and additional small bump at needle injection point.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Back pain, Herpes zoster, Laboratory test abnormal, Neuralgia
Clinical narrative: PAIN IN UPPER LEFT ABDOMEN ALONG WITH PAIN IN LEFT MID BACK REGION STARTING ON 10/29/2012. SHINGLES BREAK OUT BEGINNING AT 9PM ON 11/8/2012 WITH FULL RASH ON LEFT SIDE STOMACH AND MID BACK ON 11/09/2012 ALONG WITH RADIATING NERVE PAIN IN THE AREAS OF RASH.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: PAIN IN UPPER LEFT ABDOMEN ALONG WITH PAIN IN LEFT MID BACK REGION STARTING ON 10/29/2012. SHINGLES BREAK OUT BEGINNING AT 9PM ON 11/8/2012 WITH FULL RASH ON LEFT SIDE STOMACH AND MID BACK ON 11/09/2012 ALONG WITH RADIATING NERVE PAIN IN THE AREAS OF RASH.
Age: 31.0
Sex: M
Vaccine: DTAP
Symptoms: Induration, Swelling
Clinical narrative: Prolonged swelling and hardening.
Age: 84.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Computerised tomogram, Gait disturbance, Muscle contractions involuntary, Pneumonia
Clinical narrative: This spontaneous report as received from a other health professional (Registered Nurse) refers that on herself of age a 84 years old. The patient explained that she developed bilateral pneumonia on 30-MAY-2012 after receiving 0.5 ml PNEUMOVAX 23, 2-3 year ago (approximately on 2009). Concomitant medications included: possible received influenza virus vaccine (unspecified) concurrently (approximately on 2009). On an unknown date, computed tomography scan was performed (results not provided). The patient sought medical attention. The patient stated that she was given LEVAQUIN as treatment which "sucked up her muscles" to the point that she could hardly walk. The outcome of these events were not provided. On an unknown date, the patient recovered from bilateral pneumonia. The relatedness for bilateral pneumonia was unknown for PNEUMOVAX 23. The reporter considered the event bilateral pneumonia to be disabling. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dysphagia, Pruritus generalised, Urticaria
Clinical narrative: Case number PHEH2012US020569 is an initial spontaneous report from pharmacist received on 12 Oct 2012. This case refers to 30-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 12241P) intramuscularly on 10 Oct 2012. Two hours after the vaccine administration, the patient experienced chest pain, difficulty swallowing, hives and itchiness all over the body. The patient was treated with corticosteroids, ATIVAN and BENADRYL for the events. The outcome of events was reported as complete recovery as of an unspecified date. Following internal review on 05 Nov 2012, for the information received on 12 Oct 2012, the following correction was done. The seriousness of the events chest pain, difficulty swallowing, hives and itchiness all over the body was assessed as serious (medically significant).
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Discomfort, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Red and warm hard knot at injection site. (Right side). Right side joint pain and body felt heavy. Currently still knot and painful to touch/itchy but not as bad today (10/29).
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: Red and warm hard knot at injection site. (Right side). Right side joint pain and body felt heavy. Currently still knot and painful to touch/itchy but not as bad today (10/29).
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Fatigue, Headache, Injection site reaction, Pain, Rash erythematous
Clinical narrative: This spontaneous report was received from a doctor of pharmacy who refers to a 60 years old female patient with codeine allergy. On 05-NOV-2012, the patient was vaccinated subcutaneously in left arm with a 0.65 ml dose of ZOSTAVAX (lot# reported as H013022, exp. date 09-OCT-2013). Concomitant medications included FLULAVAL given on that same day and cyanocobalamin. On approximately, reported as after vaccination, 05-NOV-2012 the patient experienced fatigue, tenderness, torso aching, headache and feeling "rundown". On 07-NOV-2012 the patient also developed a red, raised rash about the size of a half dollar with irregular borders on her left arm at the injection site. The patient sought unspecified medical attention, at the pharmacy. She did not receive any treatment for adverse event. None laboratory tests were performed. At the time of the report patient's state was reported as not recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Tenderness
Clinical narrative: This spontaneous report was received from a doctor of pharmacy who refers to a 60 years old female patient with codeine allergy. On 05-NOV-2012, the patient was vaccinated subcutaneously in left arm with a 0.65 ml dose of ZOSTAVAX (lot# reported as H013022, exp. date 09-OCT-2013). Concomitant medications included FLULAVAL given on that same day and cyanocobalamin. On approximately, reported as after vaccination, 05-NOV-2012 the patient experienced fatigue, tenderness, torso aching, headache and feeling "rundown". On 07-NOV-2012 the patient also developed a red, raised rash about the size of a half dollar with irregular borders on her left arm at the injection site. The patient sought unspecified medical attention, at the pharmacy. She did not receive any treatment for adverse event. None laboratory tests were performed. At the time of the report patient's state was reported as not recovered. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram, Feeling abnormal, Ocular hyperaemia, Sluggishness, Tongue disorder
Clinical narrative: Had flu shot on Nov. 1st and on Nov 3rd c/o feeling sluggish, beefy tongue, reddened eyes, and "weird" feeling in her mouth. Went to PCP and had EKG with an AHR of 40 BPM. Referred to a cardiologist.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Oral candidiasis
Clinical narrative: Pt developed oral thrush 3 days after vaccine. Emergency room Dr said it could be vaccine & prescribed Nystatin suspension & it resolved.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Shot (Intradermal) administered on 11/8/12. Patient called pharmacy on 11/9/12 describing large red swollen area at injection site ("size of a doughnut"). Warm to touch. Patient instructed to take ALEVE, BENADRYL, and apply ice. 11/10/12: Patient reported redness starting to be lighter, but spreading. Patient instructed to see PCP on Monday.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Lacrimation increased, Sensation of foreign body
Clinical narrative: Pt reported runny eyes, felt like a mass was in her throat, weakness. Pt. went to ER where she received "an IV with steroids".
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose normal, Blood pressure increased, Immediate post-injection reaction, Syncope
Clinical narrative: The patient fainted right after injection. He came to and fainted a second time.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Cough, Erythema, Feeling hot, Pyrexia
Clinical narrative: Received vaccines on Saturday 1130 AM. That evening arm felt hot & pt got chills & fever. Pt treated w/ APAP & cold pack. Took shower & noticed redness. Red spots went down midway on the arm. Pt developed cough on Sunday, fever & chills.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash erythematous
Clinical narrative: Received vaccines on Saturday 1130 AM. That evening arm felt hot & pt got chills & fever. Pt treated w/ APAP & cold pack. Took shower & noticed redness. Red spots went down midway on the arm. Pt developed cough on Sunday, fever & chills.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Pt experienced severe pain at injection site & surrounding area along w/ red rash (lower than injection site), hot to the touch. Recommended pt to take BENADRYL. If not better w/in 24 hours to see Dr.
Age: 13.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Joint range of motion decreased, Oedema peripheral, Pain in extremity
Clinical narrative: Painful, swollen arm w/some numbness in right arm down to hand; no fever. Limited range of motion & abduction for a brief period after shot.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives commencing 10/22/12 (date of vaccine) and recurring 3 more times to date.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site anaesthesia, Injection site pain
Clinical narrative: Vaccine given on 10/19/12, no obvious reaction in 20 min. pt left. Went to ER on 11/9/12 complaining of numbness & pain in LA where vaccine was given. Patient was given NORCO 5/325, ROBAXIN 750mg & LIDODERM patches. Pt. had no breathing problem.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Red skin from head to toe. No itching, no burning.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Headache, Laceration, Rhinalgia, Unresponsive to stimuli
Clinical narrative: Gave guest her flu shot, seemed fine tolerated procedure well. I was walking out of exam room with her mom and heard her fall from exam table to floor. She was unresponsive about 45 seconds but color & VS stable. She was transported by parent car to ER after about 25-30 minutes recovery. She had 2 small facial lacerations & complained of nasal pain, headache.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Onset rash 11/6 or 11/7/12, spreading. Consistent with varicella.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Rash
Clinical narrative: Headache, dizziness, and a skin rash that it has form of scales (white color) for more than 3 weeks and systemic. Patient has not seen a physician for this rash or visited Emergency Room.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Erythema, Pain in extremity, Pyrexia
Clinical narrative: 10/31/12 - Fever, chills 101 Temp. (Lt.) arm very sore, redness, swelling. Dx. cellulitis. ER medical center.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: 10/31/12 - Fever, chills 101 Temp. (Lt.) arm very sore, redness, swelling. Dx. cellulitis. ER medical center.
Age: 29.0
Sex: F
Vaccine: FLU3, MMR, PPV
Symptoms: Chills, Injection site erythema, Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: 10/31 Chills. (R) arm - hot red rash, below injection site. 11/1/12 Fever. Antibiotics (prior) Nov. 1 last day. No fever 24 hours prior to vaccines.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Chills, Dizziness, Flushing, Mobility decreased
Clinical narrative: Oct 31 - First symptoms fever, chills, legs sore. Went home from work. Difficulty in moving Rt. arm. Dizziness, flush feeling. Arm sore for a couple of days.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Oct 31 - First symptoms fever, chills, legs sore. Went home from work. Difficulty in moving Rt. arm. Dizziness, flush feeling. Arm sore for a couple of days.
Age: 54.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral, Pruritus
Clinical narrative: Bay 10/17/12 started to swell & itch, scratching produced redness, swelling. Left arm. 10/18/12 Redness & swelling increased from injection site to elbow. Ice, BENADRYL - swelling decreased.
Age: 54.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Swelling
Clinical narrative: Bay 10/17/12 started to swell & itch, scratching produced redness, swelling. Left arm. 10/18/12 Redness & swelling increased from injection site to elbow. Ice, BENADRYL - swelling decreased.
Age: 22.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Fever, pain and swelling to (L) lateral shoulder. Pt. seen in ER for c/o fever and pain, treated with steroid injection and antibiotics.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling in area surrounding injection site.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a female patient with an unspecified age, pertinent medical history or drug reaction / allergies. On 28-SEP-2009, the patient was vaccinated with the first dose of GARDASIL and on 10-APR-2012, the patient was vaccinated with the second dose of GARDASIL. On 01-NOV-2012, the patient was vaccinated with the third dose of GARDASIL lot # 666596/0766Z, exp date 15-OCT-2012, (dose and route were not reported). No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. There was no adverse effect reported. The patient's outcome was unknown. The events were not related to GARDASIL. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 23.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Oropharyngeal pain, Rhinorrhoea, Sneezing
Clinical narrative: Pt. was on phone saying had runny nose, sneezing, sore throat and headache which started after the next day of the meningitis shot; suggested - CLARITIN, TYLENOL.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Anger, Erythema, Irritability, Oedema peripheral, Urticaria
Clinical narrative: Pt. reports arm swollen, whelps and red lines going around arm. Also reports he was very irritable and short tempered. Pt. called to report and was not seen in office.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling
Clinical narrative: Localized swelling to (L) arm. Onset for x 2-3 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Muscular weakness, Pain in extremity, Urticaria
Clinical narrative: Legs & arms feel like they are on fire - hurt & has no strength in them - has 4 bumps on arms (mo said they were hives but haven't gone away) symptoms started a couple days after vaccination. No redness temp, rash or swelling.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Irritability, Weight gain poor
Clinical narrative: Fussiness and intermittent episodes of inconsolable crying, slowing of rate of weight gain, no obvious relation to feeding times. Per mom "I feel like I took home a different baby."
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site pain, Rash macular, Tenderness
Clinical narrative: Friday (11/9) 0.5 ml PNEUMOVAX IM (L) deltoid Sat (11/10) patient noticed tenderness at inj site. She reported that it wasn't excessive nor severe Sun (11/11) pt calls to report "red blotch" forming below inj site & becoming "very" tender - We referred her to ER where she was treated for cellulitis. ER dr ordered KEFLEX 500 QID x 10d.
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain, Skin warm, Swelling, Urticaria
Clinical narrative: Large, hot, raised, red, painful swelling/welt lasting 3 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Pt presented to pharmacy with a large raised area that was red and warm to touch - pt complained of no pain - 2 days after injection - pt was to take BENADRYL - pt went to dr and received a steroid ointment.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a female patient of approximately 24 year old concerning herself. The patient's medical history included chlamydia. Not drug reactions. The patient was received the correct dosage regimen from January to February 2011 with a first dose of GARDASIL (dose, route and lot number were not reported). In May to June 2011 the patient received the second dose of GARDASIL (dose, route and lot number were not reported). No other co-suspects were reported. Concomitant medications included: AMBIEN. The patient was diagnosed with human papilloma (HPV) after receiving GARDASIL. The following laboratories were performed: Smear cervix (PAP), HPV test which was positive 2 months ago and a colposcopy. At the time of the report, the patient had not recovered from HPC infection. The relatedness for the event was unknown for GARDASIL. The patient sought unspecified medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot number, dose, route and injection site were not reported) (0.5 ml, 3 shot series) 2 years ago in approximately November 2010 for prevention of HPV from another health care professional. No other co-suspects were reported. No concomitant medications were reported. The patient came back in August 2012 to get the second dose. Then the patient came back in October 2012 to get third dose. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site haematoma, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received a Tdap injection on Wed. 10/31/2012 in the left deltoid area. Left arm and Tdap vial were both cleansed with alcohol. Patient tolerated the procedure well. She reported (via an email several days later) that her arm did have some Increased soreness later that day but she did not feel that is was anything out of the ordinary. She reports that the next morning Thurs. 11/1/2012 she woke up and the soreness had increased so she took Ibuprofen. On Friday 11/2/2012 around noon, she noted an area about 4 inches around the site of the injection site that was bright pink and hot that was going towards her elbow. She came back to the Health Center were the Tdap was administered to have a nurse evaluate it. The nurse Informed her that it looked like she was experiencing a reaction to the vaccine, and if the reaction continues to Increase that she should seek medical attention with a medical provider. On Sat. 11/3/12 she did seek care at a local Urgent care because she stated that the swelling had increased down to her elbow. She was given an antibiotic. On Sunday 11/4/2012 patient stated that when she woke up that morning the swelling redness and warmth had decreased some, but states that the area was more purplish in color and was itchy. She then waited until Monday morning 11/4/2012 and went to her regular provider office. There she was evaluated by a Physician Assistant whom she stated felt the antibiotics were working and the coloring was basically bruising and that the itching was not unusual. The information from 11/3/2012 was reported to me via an email form the patient that I received today 11/12/2012. She reported the incident to us on Friday Nov. 9th via email. We are closed on weekends in the department were the vaccine administered so the VAERS was not completed until today. At the time of this report and per the patient's email she is recovering from the reaction.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: Patient received a Tdap injection on Wed. 10/31/2012 in the left deltoid area. Left arm and Tdap vial were both cleansed with alcohol. Patient tolerated the procedure well. She reported (via an email several days later) that her arm did have some Increased soreness later that day but she did not feel that is was anything out of the ordinary. She reports that the next morning Thurs. 11/1/2012 she woke up and the soreness had increased so she took Ibuprofen. On Friday 11/2/2012 around noon, she noted an area about 4 inches around the site of the injection site that was bright pink and hot that was going towards her elbow. She came back to the Health Center were the Tdap was administered to have a nurse evaluate it. The nurse Informed her that it looked like she was experiencing a reaction to the vaccine, and if the reaction continues to Increase that she should seek medical attention with a medical provider. On Sat. 11/3/12 she did seek care at a local Urgent care because she stated that the swelling had increased down to her elbow. She was given an antibiotic. On Sunday 11/4/2012 patient stated that when she woke up that morning the swelling redness and warmth had decreased some, but states that the area was more purplish in color and was itchy. She then waited until Monday morning 11/4/2012 and went to her regular provider office. There she was evaluated by a Physician Assistant whom she stated felt the antibiotics were working and the coloring was basically bruising and that the itching was not unusual. The information from 11/3/2012 was reported to me via an email form the patient that I received today 11/12/2012. She reported the incident to us on Friday Nov. 9th via email. We are closed on weekends in the department were the vaccine administered so the VAERS was not completed until today. At the time of this report and per the patient's email she is recovering from the reaction.
Age: 0.47
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Insomnia, Mobility decreased, Pyrexia, Screaming, Weight bearing difficulty
Clinical narrative: Immunizations given in clinic on 11/7/12. Mother called office 11/9/12 reporting that daughter could not move her legs, unable to bear wt to (R) extrem while standing & had to sleep sitting up b/c child "screams" if laying down. Inj sites x3 had dot where inj given, no rash, redness, streaking. Fever first 24 hours, resolved. Mother admin. MOTRIN. Recommended TYL. Appt for eval. scheduled, no show. Unable to reach mother by phone.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Nodule
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 years old female patient. The patient was vaccinated with ZOSTAVAX on 26-OCT-2012, via injection in the back of the arm. The dosing regimen was not reported. The patient's medical history and past history were not reported. No other co-suspects were reported. No concomitant medications were reported. On 29-OCT-2012 the patient reported to the pharmacy that she experienced headache, furthermore the whole back of her arm was red. The patient had experienced a knot in her arm, from which she had recovered at the time when she reported the events. The onset dates were not reported. The outcome of the redness of the back of arm and the headache were unknown. No treatment information was reported. The reported relatedness for all reported events was unknown for ZOSTAVAX. Additional information has been requested.