chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Abdominal pain upper, Sensation of foreign body
Clinical narrative: Patient came in to the pharmacy 4 days after the flu shot has been administered and said she had know in her throat 3 hours after the administration and pain in the abdomen/stomach area and she went to the ER where she was given Benadryl shot and she was OK afterwards.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Slow onset itchiness including head and all over body. No visible rashes and injection site looks fine.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, and pain around injection site.  Patient reported that it was difficult to lift arm up a day after injection.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Oral herpes
Clinical narrative: Patient reports she had fever blisters after receiving the flu vaccine, and she believes they were due to the vaccine.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Malaise, Nausea, Pyrexia
Clinical narrative: Patient's wife reported physical illness (fever, nausea, diarrha) which she believes was due to the flu shot.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Lymphadenopathy, Rash generalised, Rash pruritic
Clinical narrative: Very itchy rash all over body,especially on left side (same side that shot was given on) large swollen gland under left armpit (same arm that shot was given in).
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Skin discolouration, Vision blurred, Visual field defect
Clinical narrative: Patient experienced feeling faint, blurred/blacked out peripheral vision, dizziness, sweats, loss of typical skin color a few minutes after receiving a flu vaccine. Patient recovered within 30 minutes after sitting down, eating, drinking water, placing a cold towel on forehead. He had not eaten the morning before receiving the vaccine and was nervous about the needle and receiving a flu shot. Explained that nerves along with not eating can cause changes in blood pressure and blood sugar that could cause his symptoms. He felt fully recovered and back to normal within 30 minutes.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills, fever, headache, body aches.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives on knees, upper thighs, ankles, lower calves, elbows and arms. Noticed on ankles around 3 PM and slowly spread to other areas. Applied cortisone and took a BENADRYL.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pt received FLUZONE HD and PNEUMOVAX 23 in left arm. Patient stated that at night on 10/12/16 she started experiencing redness, swelling, and aching in her left arm. Patient stated that the affected area does not itch. Patient came to pharmacy on 10/14/16 to notify pharmacist of symptoms. Patient was directed to see her doctor regarding her symptoms, but declined.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Arm swelling, pain, erythema, "unable to make a fist." Symptoms partially subsided after 36 hours, but still erythema and slight swelling.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal discomfort, Myalgia, Nausea, Pallor, Vomiting
Clinical narrative: Woke up with nausea and stomach bothering him. Late afternoon muscle aches, paleness and vomiting.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness swelling warmth in arm that immunization was given.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itching over large areas of the body.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Mobility decreased, Neck pain
Clinical narrative: SORENESS AND PAIN AT SITE OF INJECTION RADIATING TO NECK AREA. PATIENT HAS DIFFICULY LIFTING ARM.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Rash erythematous
Clinical narrative: PT PRESENTED TO PHARMACY ON WED 10/12/16 WITH A RED RASH ON HER ARM FOLLOWING VACCINATION.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Dyskinesia, Grunting, Hypotension, Immediate post-injection reaction, Posturing
Clinical narrative: Immediately after vaccination, pt displayed seizure-like activity lasting approximately 15 seconds, including unresponsiveness, posturing with arms tucked up to chest, jerking movements, and snorting/grunting respirations. Immediately following this event the patient was oriented to place, time, self, and situation, and neurologically intact. No apparent injury was sustained and patient denied any pain/distress. Pt was able to recall receiving vaccine. Pt stated this had never happened to her before, but that she does become light-headed with injections/blood draws. Vitals signs following this event were within normal limits except for hypotension of 81/59.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: Immediately after vaccination, pt displayed seizure-like activity lasting approximately 15 seconds, including unresponsiveness, posturing with arms tucked up to chest, jerking movements, and snorting/grunting respirations. Immediately following this event the patient was oriented to place, time, self, and situation, and neurologically intact. No apparent injury was sustained and patient denied any pain/distress. Pt was able to recall receiving vaccine. Pt stated this had never happened to her before, but that she does become light-headed with injections/blood draws. Vitals signs following this event were within normal limits except for hypotension of 81/59.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Musculoskeletal chest pain, Rash pustular
Clinical narrative: Patient reported that the opposite side to injection, near his rib, felt sharp/pinching pain after receiving immunizaiton, also redness/pus in small spot on opposite rib side to where vaccination was received.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Fall, Seizure
Clinical narrative: Fell off a kitchen island then started seizing. Hard to know when seizure happened after or proceeding the fall. Went to ER and was transported by ambulance to hospital. Doctor unsure if post vaccination caused seizure.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT'S SITE OF INJECTION ON LEFT ARM WAS STILL SWOLLEN, RED, AND HAD A SLIGHT RASH AROUND IT. THE SITE WAS WARM TO THE TOUCH AND STATED PAIN IN ARM RADIATING TO SHOULDER WHICH IS VERY RARE ACCORDING TO CDC VIS.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Pain at the arm. feeling tired. with no fever or any side effect.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Decreased appetite, Dizziness, Erythema, Hyperhidrosis, Mobility decreased
Clinical narrative: Lightheaded while walking in store after vaccine. Got worse when got home. By 8pm, arm was so sore that could hardly lift it up, hot to touch. Bu midnight, she couldn't touch left arm because it was so sore. Patient had fever at night because woke up sweating. Did not sleep well at all. Next morning left arm was sore when woke up. Arm was red around arm all the way to elbow; area was warm. Had fever all day. At night took ibuprofen (2 tablets) to be able to sleep. Did not feel like eating much all day. Today feels like getting better. Right arm just had a little soreness. A safe-barrier bandage was used for both vaccines. Pt has not called vaccine administrator yet.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Poor quality sleep, Pyrexia, Skin warm
Clinical narrative: Lightheaded while walking in store after vaccine. Got worse when got home. By 8pm, arm was so sore that could hardly lift it up, hot to touch. Bu midnight, she couldn't touch left arm because it was so sore. Patient had fever at night because woke up sweating. Did not sleep well at all. Next morning left arm was sore when woke up. Arm was red around arm all the way to elbow; area was warm. Had fever all day. At night took ibuprofen (2 tablets) to be able to sleep. Did not feel like eating much all day. Today feels like getting better. Right arm just had a little soreness. A safe-barrier bandage was used for both vaccines. Pt has not called vaccine administrator yet.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Product quality issue, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 51-year-old female patient who received FLUARIX QUADRILVALENT (batch number AF29T, expiry date 25th June 2017). On 24th September 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 25 September 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced fever and general body pain. On an unknown date, the patient experienced pharmaceutical product complaint. In September 2016, the outcome of the fever and general body pain were recovered/resolved. On an unknown date, the outcome of the pharmaceutical product complaint was unknown. The reporter considered the fever and general body pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by the nurse, who herself was the patient. The nurse reported that she experienced fever and body aches after receiving FLUARIX QUADRIVALENT in her left deltoid. The nurse reported that vaccine was given to 3 healthcare providers. She insisted AF29T particular batch of vaccine was defective as this batch was producing adverse symptoms, which were not experienced in previous year's vaccines. She was unable to credit per content. This was one of the 3 cases reported by the same reporter.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Paraesthesia
Clinical narrative: On 9/15 he received a high dose flu shot in his left arm. Lot# UI679AA exp: 4/9/16 Following the administration the next day the area was red and event had a bruised look to it. It then became itchy and he also has developed a pain radiating to the anterior shoulder and down his tricep area. The pain has remained relatively stable. He notes some days he thinks that it is getting much better then the next day is it painful again. There is still an area of redness at the injection site. He had full ROM but lifting his arms above the head does elicit the pain and also can cause a tingling in his hands. He denies any injury to the areas. He does have history of a SLAP tear that he recovered from month ago. The recent pain does not limit his activity, he is still playing golf and doing his yard work with no issues. He has tried ibuprofen at night and it does help him sleep better.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus, Injection site scab
Clinical narrative: On 9/15 he received a high dose flu shot in his left arm. Lot# UI679AA exp: 4/9/16 Following the administration the next day the area was red and event had a bruised look to it. It then became itchy and he also has developed a pain radiating to the anterior shoulder and down his tricep area. The pain has remained relatively stable. He notes some days he thinks that it is getting much better then the next day is it painful again. There is still an area of redness at the injection site. He had full ROM but lifting his arms above the head does elicit the pain and also can cause a tingling in his hands. He denies any injury to the areas. He does have history of a SLAP tear that he recovered from month ago. The recent pain does not limit his activity, he is still playing golf and doing his yard work with no issues. He has tried ibuprofen at night and it does help him sleep better.
Sex: M
Vaccine: FLU4
Symptoms: Injury associated with device, Underdose
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of needle injury in a 6-year-old male patient who received FLUARIX QUADRIVALENT (batch number 4Z27T, expiry date 25th June 2017). On an unknown date, the patient received FLURAIX QUADRIVALENT. On an unknown date, immediately after receiving FLUARIX QUADRIVALENT, the patient experienced needle injury and underdose. On an unknown date, the outcome of the needle injury and underdose were unknown. It was unknown if the reporter considered the needle injury to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. Health care professional reports that the needle scratched across the patient's skin. Reporter was unsure if the full dose was administered, which let to underdose.
Sex: U
Vaccine: FLU4
Symptoms: Eye allergy
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of eye allergy in a patient who received FLULAVAL QUADRIVLENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced eye allergy. On an unknown date, the outcome of the eye allergy was unknown. It was unknown if the reporter considered the eye allergy to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The pharmacy technician called to report that the patient was given a GSK Flu Quadrivalent (did not get which one) vaccine that was allergic to Thimerosal, which caused a reaction to her eyes,. The reporter placed the call on hold before getting additional information. He called back again, but was told to call back in 10 minutes. After 10 minutes, again the reporter was called back and was told it was a very long wait.
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain, Product quality issue, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a adult female patient who received FLUARIX QUADRIVALENT (batch number AF29T, expiry date 25th June 2017). Concomitant products included PNEUMOVAX. On 24th September 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 25th September 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced fever and general body pain. On an unknown date, the patient experienced pharmaceutical product complaint. In September 2016, the outcome of the fever and general body pain were recovered/resolved. On an unknown date, the outcome of the pharmaceutical product complaint was unknown. The reporter considered the fever and general body pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. The age at vaccination was not reported. The patient reported that she experienced fever and body aches after receiving FLUARIX QUADRIVALENT in her right deltoid. On the same day, the patient received PNEUMOVAX vaccine concomitantly. The nurse reported that vaccine was given to 3 health care providers. She insisted AF29T particular batch of vaccine was defective and this batch was producing adverse symptoms, which were not experienced in previous year's vaccines. She was unable to credit per content. This is on of the 3 cases reported by the same reporter.
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain, Product quality issue, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a adult male patient who received FLUARIX QUADRIVALENT (batch number AF29T, expiry date 25th June 2017). Concomitant products included PNEUMOVAX. On 24th September 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 25th September 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced fever and general body pain. On an unknown date, the patient experienced pharmaceutical product complaint. In September 2016, the outcome of the fever and general body pain were recovered/resolved. On an unknown date, the outcome of the pharmaceutical product complaint was unknown. The reporter considered the fever and general body pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. The age at vaccination was not reported. The patient reported that she experienced fever and body aches after receiving FLUARIX QUADRIVALENT in his right deltoid. On the same day, the patient received PNEUMOVAX vaccine concomitantly. The nurse reported that vaccine was given to 3 health care providers. She insisted AF29T particular batch of vaccine was defective as this batch was producing adverse symptoms, which were not experienced in previous year's vaccines. She was unable to credit per content. This was one of the 3 cases reported by the same reporter.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Itching rash since 10/3 is taking BENADRYL.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Arm still sore 2 weeks after shot - was going to urgent care for other issue and was supposed to call back w/update - no response.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Patient receive flu vaccine between 11:30-12:30pm 10/12/16 and called the main office at 2:30pm to report shortness of breath and tightness in chest. Was seen by RN at 2:35pm at work site, EMS called and told pt she needed to be seen by an MD. Pt refused ambulance ride but rode with husband to ER. Patient was not given meds (Epi/BENADRYL) by EMS.
Age: 6.0
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Complained of swelling and fever at site of injection. Follow-up - Grandfather of patient stated that the redness and itching was gone the next day after patient received the vaccine. No medical care was sought and no medications were given.
Age: 56.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: Administration of AFLURIA and PREVNAR 13 in same arm on 10/6/2016. On 10/13/2016, she called saying her arm was very sore and "a little red". I told her to take ibuprofen and ice arm. Since 2 week went by from administration and pain still. Suggesting a dr look at arm if she feels it is necessary.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pain, Pyrexia, Vaccination complication
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of general body pain in a 38-year-old female patient who received Flu Seasonal TIV Dresden. On an unknown date, the patient received Influenza vaccine. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced general body pain, fever and chills. On an unknown date, the outcome of the general body pain, fever and chills were recovered/resolved. It was unknown if the reporter considered the general body pain, fever and chills to be related to Influenza vaccine. Additional details were provided as follows: In 2006, the patient experienced severe adverse reaction to a flu vaccine. The reporter did not know whether it was a GSK product or not. The reporter did not have lot number or expiration dates.
Age: 1.08
Sex: F
Vaccine: FLU4, HEPA, MMR, VARZOS
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Clinical administered ZOSTAVAX in error, was to receive varicella, physician contacted mother and advised may get chickenpox or rash and to continue to monitor. Provider f/u w/mother next morning no sym or adverse reactions noted.
Age: 0.08
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Flu vaccine given to 2 month old no adverse event patient is not having symptoms or other reaction.
Age: 54.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain, Peripheral swelling, Pyrexia, Rash erythematous
Clinical narrative: Patient was given Pneumococcal-23 IM and Flu vaccine IM in left deltoid. Patient left arm was swollen and red rash below injection sites. Patient developed, body aches and fever (low-grade). Patient advised to use TYLENOL, Ibuprofen and cold compress.
Age: 1.0
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Had redness at site of Hepatitis A vaccine right thigh 10/13/16, by 10/14/16 enlarged redness with warmth/hardness to 9 x 7 cm red area. Doctor gave pt cephalexin 250 mg/5cc 1 tsp BID x 10 days. No temp.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neuralgia, Pain
Clinical narrative: Pain in area of shot. Especially when lifting. Feels like nerve pain.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised, Swelling
Clinical narrative: Swelling rash all over her body.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Lip swelling, Malaise, Tremor
Clinical narrative: Swollen lips, numbness on chin, shaky. "Not feeling well". Saw Primary and was given cetirizine 20mg one Daily, Methylprednisolone dose pak 6 day.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Localized swelling, mild erythema at vaccine site.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Localized rash to arm, itchy. Advised Ibuprofen, BENADRYL and hydrocortisone.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient reported full body hives starting day after immunization. Patient self treated with OTC diphenhydramine. Symptoms started within 7 hours after immunization.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Rash
Clinical narrative: After administration on ZOSTAVAX; rash present on abdomen. Itching and redness at site of injection. Patient given diphenhydramine 50 mg PO and was monitored for 90 minutes. Patient left the office in stable condition. No progression of symptoms.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Injection site erythema, Lip swelling
Clinical narrative: Eyes and lips swollen. Redness of injection site. Urgent care recommended MEDROL dose pak, Triamcinolone cream and ALLEGRA.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: 9/28/16 - Evening - Patient noticed her arm was itching, lifted her sleeve and arm was bright red. Very sore worse than a normal vaccine warm to the touch.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Pain
Clinical narrative: Severe shoulder pain (right) upon movement of arm.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Peripheral swelling, Pyrexia
Clinical narrative: Fever, swollen arm, ache and pain at injection site.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and soreness at injection site starting 12 hours or so after vaccination. Patient will apply ice and take OTC Anti-inflammatory.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth to touch, itching, some swelling with no pain. Occurred on upper right arm. Noticed by mother of patient 10/12/2016. The whole right upper arm appears red.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Swelling
Clinical narrative: Patient some swelling and pain 24 hrs later. 72 hrs later had MD check and decide a mild reaction.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving FLUARIX QUAD 2016-17 vaccine.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Pt received vaccine on Thrs. Friday pt complained about sore body and flu symptoms. Saturday pt developed redness, soreness, swollen site about 4 inches in diameter. Told pt to apply ice, take APAP and go to ER if symptoms worsen.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling -> size of hand, lasted 2 days, warm to touch, redness.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, TDAP, VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Skin infection
Clinical narrative: Lateral right upper arm red and swollen. Redness appear more like like allergic reaction. KEFLEX 500mg BID x7days; BENARDYL 50mg PRN. Skin infection.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Aches, fever, headache; treated w/ADVIL.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Chest discomfort, Injection site pain, Pyrexia
Clinical narrative: Pain at injection site. 99 degree F fever. Positive tight chest (or asthma pt not sure).
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Diarrhoea
Clinical narrative: Diarrhea which became watery every 10 to 15 minutes. Lasted until 12:00 A.M. No further effects. No additional complaints.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: Slight rash on neck and upper chest area and both arms.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Patient came to the pharmacy complaining of arm soreness.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Haemorrhage, Immediate post-injection reaction, Swelling
Clinical narrative: Bleeding and swelling immediately following immunization, no pain reported.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Patient complain soreness, lump at inj site below skin surface, no exudate, no fever, soreness inflamed.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: After vaccine administration, patient had loss of consciousness for about 5 seconds. Did not hit floor, parent caught. Patient was anxious before vaccine.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Pallor
Clinical narrative: Pt (L) hand middle finger paled and after a few min. color came back.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Developed urticaria 5 min after administration.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised, Urticaria
Clinical narrative: Urticarial rash all over body. Was seen in hospital ER (5 hours after vaccine). Seen in office 1 day after with persistent rash, prescribed BENADRYL.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site papule, Injection site pustule, Injection site swelling, Pain
Clinical narrative: C/o pain after injection. 10/11 awoke with leg swollen. Seen 10/12 with superficial redness 8cm x 11cm over medial aspect of L upper leg. 2mm papule at site of vaccine. Started on cephalexin. 10/14-still minimal swelling, minimal redness. Pustule dry.
Age: 1.5
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Pyrexia, Rash generalised, Rash morbilliform
Clinical narrative: Fever of 101 F noted on 10/12/16 that resolved with acetaminophen. Generalized morbilliform rash noted on 10/14/16. Temp 100.0 F.
Age: 66.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Large area of erythema and swelling  - from right arm shoulder to elbow feels achy, headache. Began evening of injection.
Age: 82.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema
Clinical narrative: Redness spreading from injection site extending to just below the elbow. Outlined, observation recommend, though on antibiotic beginning 10/14/16 for other infection.
Age: 12.0
Sex: M
Vaccine: FLU4, HEPA, MNQ, TDAP
Symptoms: Presyncope
Clinical narrative: Presyncopal episode.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Patient reports severe nausea and vomiting lasting 2 days after injection.
Age: 62.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching at site of injection.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Leg is swollen and warm to touch.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain
Clinical narrative: Pain at injection site radiating through shoulder to neck. Patient unable to raise arm. Has lasted for 1 month.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Haemorrhage, Immediate post-injection reaction, Incorrect route of drug administration, Injection site reaction, Swelling
Clinical narrative: Bleeding after injection. Swollen under skin, injection appeared to have been given subcutaneously rather than intramuscularly as intended. Injection site reactions started immediately after the injection. Treatment for reaction was given in the form of an ice pack. Patient remained at the pharmacy and was icing the injection site for at least five minutes and most likely continued at home.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Patient states flu vaccine was not administered in her deltoid. Had asked for re-administration to deltoid and administrator refused. Site was red, edematous, tender to touch. 10/14/16. Patient declined vitals.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site joint pain, Injection site pain, X-ray limb
Clinical narrative: Severe pain at injection site while vaccine being given. Increased pain and soreness to right shoulder joint, 24 hours later unable to move right shoulder continued with pain and decreased ROM. Saw ortho Dr. on 10/7/16 PT on 10/10/16, continue with PT to improve ROM.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt receive Tdap at clinic instead of influenza (FLUARIX).
Age: 60.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt received BOOSTRIX instead of FLUARIX at flu clinic.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt received TDaP instead of Influenza
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt received TDaP instead of influenza.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with incorrectly stored (33.1 F for 90 minutes) doses of VAQTA (lot # M032492, expiration date 02-MAR-2018; dose and route of administration were not reported). No previous excursion was reported. The call was made because of the data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse (also reported as healthcare worker) referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received an improperly stored dose of GARDASIL 9 (lot# M003659, expiration date 20-SEP-2017; lot# M011117, expiration date 07-DEC-2017; dose and route were unknown). No adverse effects were reported. The vaccines were stored under 49.1 Fahrenheit degree for 40 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored ROTATEQ (lot # L042215, expiration date 02-JUN2017; dose unknown) orally. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M023380 with expiration date 11-MAY-2018; lot # M023384 with expiration date 11-MAY-2018; dose and route were not reported). It was reported that the vaccine was improperly stored at -5.6 Celsius (C) for 1 hour and was then back in range. Prior temperature excursions included -12.4 C for 30 minutes and -12.7 C for 26 minutes. No adverse effects were reported. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a medical technician referring to a patient of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 31-MAY-2013, the patient received a dose of GARDASIL (lot#H021346 with expiration date 01-OCT-2015; dose and route were not reported). Then, on 03-OCT-2016 (also reported as "today"), the patient received a dose of GARDASIL 9 (lot # M024261 with expiration date 30-JUL-2018; dose and route were not reported). This was outside the recommendations per the prescribing information of the two vaccine. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple patients of unknown age and gender. The patients' medical histories, concurrent condition and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K007264, expiration date 02-MAR-2017, dose and route not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored GARDASIL 9 (lot # L019297, expiration date 18-AUG-2017; dose and route were unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Blood test abnormal, Lymphadenitis, Therapy non-responder
Clinical narrative: This spontaneous report was received from a 57 year old female patient (who was also a healthcare worker). Patient had no pertinent medical history and was allergic to sulfa. On 15-JUL-2016 the patient was vaccinated with PNEUMOVAX 23 intramuscularly as her doctor recommended it, since she was antibody deficient. On 26-AUG-2016, 'blood work' was performed to see if the vaccine worked and the results showed that the patient did not have a good response to the vaccine (no therapeutic response). There was no further clarifying information on this. The patient then received, on 16-SEP-2016, a second dose of PNEUMOVAX 23 and on an unspecified date after this dose (approximately 2016), she developed inflammation of the lymph nodes in her armpits. The patient did not see her doctor since the second dose of vaccination. No treatment was given. The patient stated that her lymph nodes were still inflamed at the time of the report and hence outcome was considered to be not recovered/resolved. Outcome of 'no therapeutic response' was unknown. Causality assessment was not provided. Additional information is not expected since the patient's physician could not be contacted for further information.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse (also reported as healthcare worker) referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received an improperly stored dose of ROTATEQ (lot# M031802, expiration date 09-NOV-2017; lot# L048854, expiration date 31-AUG-2017; dose unknown) orally. No adverse effects were reported. The vaccines were stored under 49.1 Fahrenheit degree for 40 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, Vaccination error, Vaccination failure
Clinical narrative: Information has been received from a female patient of unknown age. She had severe allergies in general. It was also reported that in the past on an unknown date, the patient had received a flu vaccine (manufacturer unknown) and she had experienced an unknown "allergic reaction" to the vaccination. Information about concomitant medication was not provided. Back in July 2016, the patient received the PNEUMOVAX 23 in smaller doses 5 separate times in her arm to reduce her chance of getting an allergic reaction. On an unspecified date after receiving the PNEUMOVAX 23, she got an antibody titer test showing that the PNEUMOVAX 23 vaccine didn't take and didn't work. The outcome of vaccination failure was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a 69 year old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date in 2015, the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number and expiration date were not reported). Concomitant therapy was not reported. On an unknown date, the patient experienced a full blown case of shingles and was in pain for 2 weeks. The outcome of the event was reported as recovered on an unknown date. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as the reported refused additional contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or drug reactions/allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose, route and site of administration, lot # and expiry date were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown gender and age. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M010212, expiration date 21-JAN-2019, lot # L016427, expiration date 13-APR-2017 and lot # L045117, expiry 06-OCT-2018; dose and route were unknown). No adverse effects were reported. The reporter stated that the vaccines were exposed to 52 Fahrenheit degree for 15 hours and then they backed in range. There were no previous temperature excursion. No product quality complaint was involved. This is one of several reports received from the same reporter. Follow up information has been received on 17-SEP-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative was updated.
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a 35 year old female patient, regarding herself. The patient had no pertinent medical history or drug reactions/allergies. Patient's concomitant medication included levothyroxine sodium (manufacturer unknown). On "Friday", 07-OCT-2016, the patient was at her primary care's office to be vaccinated with (unspecified) DTaP and her nurse recommended (Oka/Merck) VARIVAX (lot number not known) too because the patient had only one dose previously (on unspecified date). On "Sunday", 09-OCT-2016, the patient developed a red, raised rash (injection site erythema) about the size of a quarter and it was a little sore (injection site pain), all on the injection site of where (Oka/Merck) VARIVAX was administered. The patient sought no medical attention and no treatment was given for the events. No lab diagnostic test were performed. "Today", on 10-OCT-2016 the patient reported that the rash "had diminished (outcome considered recovering) and the redness was about gone (outcome considered recovered). The patient also reported that she did not feel any pain or soreness at the injection site anymore (outcome considered recovered). Causality assessment was not provided. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Poor quality sleep
Clinical narrative: Information has been received from a female patient of unknown age referring to herself, who was not pregnant. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 03-OCT-2016, the patient received a dose of PNEUMOVAX 23 injection (lot#, expiration date, dose and route were unknown). A few hours later, the patient began to experience severe pain at the injection site. The pain continued throughout the night and she was awakened by the pain. The patient contacted her physician by phone but did not receive any treatment. The outcome of the events was reported as not recovered/not resolved. The causality assessment between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the incorrectly stored (33.1 F for 90 minutes) doses of ROTATEQ (orally, lot # M012495, expiration date 09-OCT-2017; dose was not reported). No previous excursion was reported. The call was made because of the data logger. No adverse effects were reported. This is one of several reports received form the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Immunoglobulins abnormal
Clinical narrative: Information has been received from a registered nurse referring to a 62 year old female patient. Information regarding concomitant medication and drug reactions/allergies was unknown. The patient had the diagnosed of an unknown immunoglobulin disorder prior to receiving PNEUMOVAX 23. On an unknown in May 2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date, dose and route were unknown). On an unknown date in 2016 (reported as "recently"), the patient was seen by an unspecified physician who was planning treatment (unspecified) for the unknown immunoglobulin disorder at the reporting time. It was unknown if the condition of unknown immunoglobulin disorder changed or worsened since May 2016. The causality between the event and the vaccine was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 12-OCT-2015 the patient was vaccinated with the first dose of ZOSTAVAX subcutaneously (dose, lot #, expiration date were not reported). On 05-OCT-2016, the patient was vaccinated with the second dose of ZOSTAVAX subcutaneously (dose, lot #, expiration date were not reported. There was no known adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Information has been received from a pharmacist referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On unknown dates, the patients were vaccinated with ZOSTAVAX (dose, route, lot# and expiration date were not reported). On unknown dates, the patients felt "itchy" at the injection site for an unknown amount of time. At the time of reporting, the outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M004116, expiration date 12-OCT-2017, dose and route not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to 4 patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or drug reactions/allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # L030589, expiry date 10-FEB-2017 (dose, route and site of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # M026874 expiry date 19-JUL-2017; dose and route were not reported). The doses were stored under temperature of 14F for 7 days and there was no data logger involved. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.