chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Injection site nodule, Peripheral swelling, Pyrexia
Clinical narrative: A few hours after the patient received both vaccines, she began to have a "knot" at the injection site of the PNEUMOVAX 23. Over the next few hours, she began to have chills, fever, swelling of the arm which progressed to cover from the elbow to the axillary. She also experienced redness, which the patient described like a sunburn, on her arm. Patient called the pharmacy the next morning to report the reaction. She did state that symptoms had improved slightly but wanted us to be aware. I told her we would report it on the VAERS system.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Injection site warmth, Oropharyngeal pain
Clinical narrative: Patient was taken to hospital for severe vomiting; was given an antiemetic by IV. Patient states she also suffered dizziness, sore throat, and body aches. Patient also states that she has redness and swelling at site of injections and it is also red and hot at the site of injections.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pain, Vomiting
Clinical narrative: Patient was taken to hospital for severe vomiting; was given an antiemetic by IV. Patient states she also suffered dizziness, sore throat, and body aches. Patient also states that she has redness and swelling at site of injections and it is also red and hot at the site of injections.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Vomiting
Clinical narrative: 3 hours after injection, mom brought patient back to clinic to report patient had vomited and had mild back pain. No fever, vitals were all normal. Alert, oriented. Patient was assessed by this provider, no chills, no shakes, no hives, no throat closing, no swelling. Discussed with mom to go home and rest and do a BRAT diet with patient and TYLENOL for pain; if patient has hives, throat closing, confusion, fever, then mom agreed to take her to urgent care or ER. However, I did contact CDC who referred me to health department and was connected with local epidemiologist, who said although it is highly unlikely the patient is undergoing a reaction due to the vaccination (based on timing and symptoms) to err on the side of caution and refer patient to go to urgent care. I did call mom and leave a detailed voice mail at this time for her to go to urgent care and to call me back. At this time I am waiting her call back, will attempt to call her again in a bit.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal distension, Abdominal pain, Constipation, Fatigue, Functional gastrointestinal disorder
Clinical narrative: Chronic fatigue, headaches, pneumonia, abdominal cramping, bloating, constipation most started within a month of receiving vaccine.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Laboratory test normal, Pneumonia
Clinical narrative: Chronic fatigue, headaches, pneumonia, abdominal cramping, bloating, constipation most started within a month of receiving vaccine.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Pt presented to the pharmacy on 8/26 with prescriptions (2 days after the PPSV vaccination) for antibiotic and steroid cream. He stated that his right arm has become swollen and itching after receiving the PPSV 23 vaccine and so he went to the local emergency room and was given those 2 prescriptions for his problem. He said the swelling and itching is improving but has not completely resolved.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling, Pain
Clinical narrative: Major swelling at injection site, redness and pain; started night of injection; reported 3 days later.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pyrexia, Throat tightness
Clinical narrative: Sore throat, closed throat, fever over 102 lasting for 48 hours. Patient took BENADRYL and symptoms eased up after a few minutes but sore throat and fever lasted for 48 hours.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site warmth, Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: The patient came in to the pharmacy 2 days after receiving the vaccination. She stated that the reaction began the day after the injection, but it had progressed to its current state earlier in the same day that she came in. She complained of soreness and a "heavy" feeling in her arm. She showed me her arm and it was noticeably red and swollen. The redness was approximately 5 inches in length. The patient also stated that the site was hot to the touch. I suggested that she be seen at a nearby urgent care clinic so they could assess the level of the issue. The patient was receptive to the advice and was polite in all of our interactions.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash
Clinical narrative: I have not seen, but the patient's husband described as a rash from the injection site down to the elbow.
Age: 19.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Vision blurred, Vitreous floaters
Clinical narrative: @ 11am the next day after receiving vaccine pt had a headache that lasted an hour; @ 7pm that day he started having blurry vision and floaters on right eye; pt came to clinic 8/26/17 to be evaluated.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: She had red and raised swelling and itchiness at site of injection that spread from shoulder to elbow that occurred half an hour after receiving vaccine. Referred her to urgent care.
Age: 69.0
Sex: F
Vaccine: HEPA, MMR, PPV
Symptoms: Documented hypersensitivity to administered product, Vaccination complication
Clinical narrative: Pt received multiple vaccines during one visit. Received MMR, HepA, and Pneumococcal vaccination.  VAQTA was the only vaccine that listed latex as an ingredient and due to the pt's report of allergy to Latex, it is assumed that the reaction was to the Hep A vaccine. However, since multiple vaccines were administered in one arm, it is not possible to definitively determine which was the offending agent.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Pyrexia, Swelling
Clinical narrative: Fever, pain at injection site, redness, swelling.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Patient said they had a large red welt that covered the arm, was very itchy and swollen. Has gone down in size the next day but still itchy. Has had both of these vaccines before with no previous reactions. Recommended for her to apply cold compress to swollen area, could taken BENADRYL for itching.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Headache, Injection site swelling, Insomnia, Pain, Pain in extremity
Clinical narrative: Patient came in on 08/25/17 and reported soreness of the arm. Arm had redness, some swelling around the injection site. She reported body aches and headache and also reported that she was having trouble going to sleep. She was asked to take TYLENOL and see her doctor if symptoms do not improve. Tried to reach her today to check on her and unable to reach her.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site hypoaesthesia
Clinical narrative: Patient stated that the injection site felt numb/like the injection was still being administered. This was immediately after the injection. Ice was applied, which the patient stated made it feel better. Patient remained in the immunization booth with administering pharmacist for approximately 10 minutes at which time, the patient said he was starting to feel better. Patient and his wife stated they had shopping to do in the store, stated they wanted to do their shopping and stop back before they left the store. Patient continued to use the ice pack while shopping. Approximately 10 minutes latter, he returned with his wife and stated that he was "back to normal" at which time they both left the store. The patient was called at 2:55 PM, his wife answered the telephone with him in the background. She stated that he was doing fine, I asked if he was "back to normal", she stated "yes".
Age: 71.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Head discomfort, Pain in extremity
Clinical narrative: Patient was administered PNEUMOVAX and FLUAD on the same arm by the pharmacist on duty on 08/24/17. Patient came in on 08/26/17 and reported soreness and redness of the arm. Also reported heavy headedness. Redness was noticed almost around the upper arm. Patient was asked to take TYLENOL for soreness and asked to see a doctor if no improvement. Tried Calling in the evening and was unable to reach. Left voicemail.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Headache, Myalgia, Retching
Clinical narrative: Increase in blood pressure, dry heaves, possible temperature, headache, muscle aches.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Inflammation, Rash
Clinical narrative: Rash and inflammation the size of a tennis ball manifested 4 inches below site of injection.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local reaction, Skin warm, Urticaria
Clinical narrative: Localized reaction, large red welt that is warm to the touch- no prior reactions to vaccinations.
Age: 20.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site rash, Rash
Clinical narrative: After receiving flu vaccine, patient had circular rash around injection site and rash on left side of trunk/chest/torso. Thought it could be due to immunization or working outside in the heat.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient arm was red and swollen around injection site. No pain, no fever no difficulty breathing.
Age: 77.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Chills, Injection site abscess, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient reported pain, swelling and heat from the immunization in the left arm. Patient reported chills/fever as well (symptoms).
Age: 45.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Feeling hot, Injection site erythema
Clinical narrative: Red area on upper right arm where vaccine administered. As of 8/26 AM, spread to about 3" by 6". Told to take BENADRYL and see provider today if no improvement.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Raised red bump on left arm approx 2 inches from site of vaccine administration. Referred to physician.
Age: 18.0
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Redness, swelling, rash at injection site. Reported by mother 2 days post immunization.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood urine present, Colonoscopy, Cystitis, Cystitis interstitial, Cystoscopy
Clinical narrative: After the second shot I started feeling fatigue and aches. After the third shot it felt like I had a full blown bladder infection. I ended up peeing blood a few days later. After months and months of tests doctors concluded that I have Interstitial Cystitis and fibromyalgia. Now, almost 5 years later I am still suffering from these conditions. Multiple hospital visits from severe pain. Multiple lost jobs and years of school missed.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Fibromyalgia, Impaired work ability, Loss of personal independence in daily activities, Pain
Clinical narrative: After the second shot I started feeling fatigue and aches. After the third shot it felt like I had a full blown bladder infection. I ended up peeing blood a few days later. After months and months of tests doctors concluded that I have Interstitial Cystitis and fibromyalgia. Now, almost 5 years later I am still suffering from these conditions. Multiple hospital visits from severe pain. Multiple lost jobs and years of school missed.
Age: 29.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Chills, Dizziness, Hyperhidrosis, Injection site bruising, Injection site erythema
Clinical narrative: PATIENT WAS EXPERIENCING CHILLS, SWEATS, LIGHTHEADED, AND DIZZINESS. SWOLLEN, RED & BRUISED IN THE AREA OF SHOT. PAIN IN ARM. SPOKE WITH PHYSICIAN, HE ADVISED PT TO TAKE MOTRIN OR TYLENOL, AND TO ICE SITE. IF GETS WORSE GO TO ER OR URGENT CARE.
Age: 29.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: PATIENT WAS EXPERIENCING CHILLS, SWEATS, LIGHTHEADED, AND DIZZINESS. SWOLLEN, RED & BRUISED IN THE AREA OF SHOT. PAIN IN ARM. SPOKE WITH PHYSICIAN, HE ADVISED PT TO TAKE MOTRIN OR TYLENOL, AND TO ICE SITE. IF GETS WORSE GO TO ER OR URGENT CARE.
Age: 68.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: NONE PATIENT IS FEELING FINE NO PROBLEMS EXPLAINED WHAT HAPPENED.
Age: 59.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Erythema, Injection site erythema, Peripheral swelling
Clinical narrative: PATIENT GOT ALL THE THREE VACCINES IN THE LEFT ARM. PATIENT DID NOT HAVE AN IMMEDIATE REACTION TO THE VACCINES. PATIENT GOT THE VACCINE TOWARD THE CLOSING OF THE PHARMACY (7 PM) AT 6:30 PM. PATIENT CAME TO THE PHARMACY TODAY ON 08/27/2017 AT 11:00 AM AND SHOWED THAT HE HAD A REACTION TO THE VACCINE. PATIENT GOT MEDICAL ATTENTION PRIOR TO COMING TO THE PHARMACY. PATIENT'S LEFT ARM SHOWS SWOLLEN AND RED. THE REDNESS IS MORE PRONOUNCED 5-6 INCHES BELOW THE SITE OF ADMINISTRATION OF THE VACCINE-TOWARDS THE ELBOW JOINT ON THE FRONT. THE SITE OF ADMINISTRATION WAS LEFT DELTOID MUSCLE.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 27 weeks gestation, 1st pregnancy. Reaction: redness at site of injection (size is increasing), firm bump at site of injection, warmth.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: Patient fainted after approximately 5 to 10 minutes after receipt of vaccine.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Loss of personal independence in daily activities
Clinical narrative: Severe pain in shoulder joint making normal daily activities difficult to perform. Pain began a couple hours after injection and got progressively worse. Ice and heat were used to reduce symptoms.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Patient had vaccine on 8/18 and presented on 8/21 with mother with left arm edema, erythema and warm to touch. Left arm measured 11cm x 10cm edema and erythema noted. No pain with palpation. Denied numbness and tingling. Patient prescribed BENADRYL 8/21 and instructed to RTC if s/s persist or worsen. Mother verbalized understanding.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt came in on 8-27-2017 and complained right arm where ZOSTAVAX injection given very red, swollen, and warm to the touch. Started day after injection and became worse. Pt is following up with MD to see if any follow up treatment is required.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported to pharmacy redness, swelling, and pain on upper left arm around 3pm. She said it began when she woke up in morning and was progressively getting worse and expanding in area. She went to a walk-in clinic to have it seen by a doctor. The doctor prescribed an antibiotic, cephalexin at 4:30pm.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Malaise, Pain in extremity, Skin warm
Clinical narrative: Patient reported abnormal soreness on right arm, a patch of heated redness around underarms and chest area on right side. Also reported forehead and cheeks on face being heated and red, and felt as if getting sick. Patient states she has recovered and is feeling a lot better after 6 days.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMR, VARCEL
Symptoms: Blister, Rash generalised, Scab, Varicella post vaccine
Clinical narrative: Patient broke out in a chicken pox rash within hours of shot being administered. Started on her buttocks and proceeded to spread all over her body except for palms of hands, feet, and face. There were several variations of the rash on her body including initial bumps blisters filled with clear fluid and scabs. Her whole body was covered in rash by 1400 on Saturday. Rash was not itchy and did not present with any fever. From onset of rash to dissipation was 8 days. Treatment was mostly supportive including corn starch, bathing, lots of fluid, and lots of rest. Mother called the nurse line at the clinic and was told not to bring child in and that this couldn't possibly be a vaccine reaction because they don't ever see more than a few spots as a vaccine reaction. Child had several hundred spots all over her entire body.
Age: 0.42
Sex: M
Vaccine: HIBV
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Approximately 36 hours (1.5 days) after vaccination, profuse and voluminous yellow-bile vomiting almost every hour (13 times throughout the first day). No food was able to be kept down during, except approximately 2 ounces of Pedialyte toward end of day and a dropperful of Gripe water. After the first day of vomiting, vomiting slowed to every few (4 to 6) hours. After 10 days (when this form is being filled out) there have only been 3 days where he has not vomited, and frequency has slowed considerably to only once a day (if he does vomit). Extreme diarrhea beginning 58 hours after vaccination. Lasted approximately 4 days, after which stools were runny. Solid poop beginning approximately 6 days after the first bout of diarrhea.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, hot raised at injection site.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Salivary hypersecretion
Clinical narrative: The evening the patient received the injections the patient experienced a lot of redness that looked like bad sunburn on his upper arm. It looked very swollen as well. The redness and swelling was on the same arm he received injections in, but it was not near the deltoid, but more on the back of the arm, almost toward the armpit. These symptoms, along with very extreme fatigue, and watery mouth almost as if he were going to throw up, occurred the evening of 8/23/17 and the redness and swelling were still visible on 8/26/17 upon presentation to the pharmacy. On 8/26/17 he no longer felt fatigue or watery mouth, so appeared to be getting better. No treatment was needed at that point, but he was instructed to visit his doctor's office if it was not getting better in the next day or so.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Pain
Clinical narrative: Patient had a bullseye rash at site of VARIVAX injection two days later, which progressed to a baseball sized rash that was throbbing, itching, and painful.
Sex: U
Vaccine: FLU4, PNC13
Symptoms: Diarrhoea, Injection site rash, Injection site swelling
Clinical narrative: Patient had bad swelling and rash from PREVNAR site (right upper arm) for almost seven days and watery diarrhea for four days. After eight days patient reported the adverse effects to the pharmacist with no longer aforementioned adverse events.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Reported 3 days later that the arm was slightly red and swollen, some pain in the area of the vaccination, some fever.
Age: 72.0
Sex: M
Vaccine: FLUA3
Symptoms: Dyskinesia, Muscle twitching, Pruritus, Urticaria
Clinical narrative: Patient experienced twitching in his legs and neck turned involuntarily. He is currently still experiencing some twitching 48 hours following vaccination, he developed a few hives on his arm and toes. Currently has hive on arm, but no longer itches.
Age: 70.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red and swollen area PNEUMOVAX vaccine very painful. Patient thinks it may be infected.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Vertigo
Clinical narrative: Vertigo (BPPV) - Treatment: Meclizine 25 mg, ondansetron, 4 mg.
Age: 11.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Abdominal pain, Pyrexia, Rash vesicular, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Approx. 2 and a half weeks after getting the Varicella Vaccine and only 2 days after MMR 2, my son developed severe stomach pain. He also had liver disease and the hospital says that they did not know what it was from. We went to the ER 2/25/17 and was sent home after a dose of morphine. The pain got worse and we returned to the ER 2/27/17 and he was admitted. On 3/2/17 he started developing spots all over his body that looked alot like chicken pox. This was ignored for several days until I asked for a Varicella test. It was confirmed he had Varicella Viremia. He was covered in small chicken pox that were very itchy and hard to heal as he was very ill. His stomach pain never really went away until he transplanted May 16. He was on 24 days of Acyclovir (inpatient and at home through PICC line to clear the infection). Negative VZV PCR March 23, 2017.
Age: 11.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Abdominal pain upper, Central venous catheterisation, Condition aggravated, Liver disorder, Liver transplant
Clinical narrative: Approx. 2 and a half weeks after getting the Varicella Vaccine and only 2 days after MMR 2, my son developed severe stomach pain. He also had liver disease and the hospital says that they did not know what it was from. We went to the ER 2/25/17 and was sent home after a dose of morphine. The pain got worse and we returned to the ER 2/27/17 and he was admitted. On 3/2/17 he started developing spots all over his body that looked alot like chicken pox. This was ignored for several days until I asked for a Varicella test. It was confirmed he had Varicella Viremia. He was covered in small chicken pox that were very itchy and hard to heal as he was very ill. His stomach pain never really went away until he transplanted May 16. He was on 24 days of Acyclovir (inpatient and at home through PICC line to clear the infection). Negative VZV PCR March 23, 2017.
Age: 11.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Malaise, Polymerase chain reaction positive, Rash generalised, Rash pruritic, Rash vesicular
Clinical narrative: Approx. 2 and a half weeks after getting the Varicella Vaccine and only 2 days after MMR 2, my son developed severe stomach pain. He also had liver disease and the hospital says that they did not know what it was from. We went to the ER 2/25/17 and was sent home after a dose of morphine. The pain got worse and we returned to the ER 2/27/17 and he was admitted. On 3/2/17 he started developing spots all over his body that looked alot like chicken pox. This was ignored for several days until I asked for a Varicella test. It was confirmed he had Varicella Viremia. He was covered in small chicken pox that were very itchy and hard to heal as he was very ill. His stomach pain never really went away until he transplanted May 16. He was on 24 days of Acyclovir (inpatient and at home through PICC line to clear the infection). Negative VZV PCR March 23, 2017.
Age: 11.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Varicella post vaccine, Varicella virus test positive, Viraemia
Clinical narrative: Approx. 2 and a half weeks after getting the Varicella Vaccine and only 2 days after MMR 2, my son developed severe stomach pain. He also had liver disease and the hospital says that they did not know what it was from. We went to the ER 2/25/17 and was sent home after a dose of morphine. The pain got worse and we returned to the ER 2/27/17 and he was admitted. On 3/2/17 he started developing spots all over his body that looked alot like chicken pox. This was ignored for several days until I asked for a Varicella test. It was confirmed he had Varicella Viremia. He was covered in small chicken pox that were very itchy and hard to heal as he was very ill. His stomach pain never really went away until he transplanted May 16. He was on 24 days of Acyclovir (inpatient and at home through PICC line to clear the infection). Negative VZV PCR March 23, 2017.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash pruritic
Clinical narrative: The patient received 2 vaccines on 7/24/17. HepA and DTaP. That evening he begun to have an itchy erythematous popular rash on bilateral lower extremities and to a lesser extent upper extremities. He had no wheezing or trouble breathing. His mother applied hydrocortisone cream and the rash improved overnight, though it is still present to a lessor extent. He should  still be able to receive vaccines in the future despite this minor allergic reaction.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Hypersensitivity, Injection site reaction, Rash, Rash papular, Rash pruritic
Clinical narrative: The patient received 2 vaccines on 7/24/17. HepA and DTaP. That evening he begun to have an itchy erythematous popular rash on bilateral lower extremities and to a lesser extent upper extremities. He had no wheezing or trouble breathing. His mother applied hydrocortisone cream and the rash improved overnight, though it is still present to a lessor extent. He should  still be able to receive vaccines in the future despite this minor allergic reaction.
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Staring
Clinical narrative: Initial unsolicited report received from a nurse on 15-Aug-2017. This case involves a two month old female (age reported as 9 weeks) patient who was vaccinated with a first dose of PENTACEL batch number- C5316AA, expiry date 13-Feb-2018 via intramuscular route in left thigh, ROTATEQ batch number- M035456 via oral route and PREVNAR 13 (Batch number: R48402) intramuscularly in right thigh (expiry date, dose not reported for all the vaccines) on 14-Jun-2017. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at the time of vaccination was none. Any other vaccinations within four weeks of vaccinations included- RECOMBIVAX-HB given on 06-May-2017. On 14-Jun-2017, 2-3 hours following vaccination the patient had staring episodes approximately every 10 minutes, and that they lasted 10 minutes. The mother reported that she was unable to get the infant out of the staring episode. Patient was referred to a neurologist. Laboratory investigations and corrective treatment were not reported. The staring episodes lasted until the end of the day, and that they have not occurred since. The patient recovered from the event. List of documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, FLU4, PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Injection site erythema
Clinical narrative: Initial unsolicited report received from a pharmacist on 18-AUG-2017. This case involves a 73-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI808AB) and PNEUMOVAX 23 (batch number: M039060) (Expiry date, Dose, route and dose in series were not reported) in the right deltoid on 15-AUG-2017 for all vaccines. Patient is allergic to codeine and having Diabetic Mellitus Cirrhosis Autoimmune Disorder. Patient's Illness at time of vaccination was reported as none. Other medical history and previous medications were not reported. Patients concomitant medications were not reported. On 15-AUG-2017, few after following vaccination, patient started experiencing pain at the injection site and on 16-AUG-2017 in the next morning, few hours after vaccination, patient had redness that stopped at the elbow. Patient initially advised the vaccinating Pharmacist that she had no medical history and at the time of reporting she let reporter know of her large history. 17-AUG-2017, two days following vaccination, the redness had progressed to her wrist and her family took her to the emergency room. Lab tests were reported as unknown as patient was unable to provide information. As corrective treatment, patient received antibiotics and was discharged after she was evaluated in the emergency. The outcome of all events was reported as not recovered. List of documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, FLU4, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Initial unsolicited report received from a pharmacist on 18-AUG-2017. This case involves a 73-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI808AB) and PNEUMOVAX 23 (batch number: M039060) (Expiry date, Dose, route and dose in series were not reported) in the right deltoid on 15-AUG-2017 for all vaccines. Patient is allergic to codeine and having Diabetic Mellitus Cirrhosis Autoimmune Disorder. Patient's Illness at time of vaccination was reported as none. Other medical history and previous medications were not reported. Patients concomitant medications were not reported. On 15-AUG-2017, few after following vaccination, patient started experiencing pain at the injection site and on 16-AUG-2017 in the next morning, few hours after vaccination, patient had redness that stopped at the elbow. Patient initially advised the vaccinating Pharmacist that she had no medical history and at the time of reporting she let reporter know of her large history. 17-AUG-2017, two days following vaccination, the redness had progressed to her wrist and her family took her to the emergency room. Lab tests were reported as unknown as patient was unable to provide information. As corrective treatment, patient received antibiotics and was discharged after she was evaluated in the emergency. The outcome of all events was reported as not recovered. List of documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, FLU4, PPV, FLU3, PPV
Symptoms: Erythema, Injection site pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 18-AUG-2017. This case involves a 73-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI808AB) and PNEUMOVAX 23 (batch number: M039060) (Expiry date, Dose, route and dose in series were not reported) in the right deltoid on 15-AUG-2017 for all vaccines. Patient is allergic to codeine and having Diabetic Mellitus Cirrhosis Autoimmune Disorder. Patient's Illness at time of vaccination was reported as none. Other medical history and previous medications were not reported. Patients concomitant medications were not reported. On 15-AUG-2017, few after following vaccination, patient started experiencing pain at the injection site and on 16-AUG-2017 in the next morning, few hours after vaccination, patient had redness that stopped at the elbow. Patient initially advised the vaccinating Pharmacist that she had no medical history and at the time of reporting she let reporter know of her large history. 17-AUG-2017, two days following vaccination, the redness had progressed to her wrist and her family took her to the emergency room. Lab tests were reported as unknown as patient was unable to provide information. As corrective treatment, patient received antibiotics and was discharged after she was evaluated in the emergency. The outcome of all events was reported as not recovered. List of documents held by sender: none.
Age: 1.0
Sex: F
Vaccine: MMRV, UNK, UNK
Symptoms: Crying, Pyrexia, Rash generalised
Clinical narrative: Fever, rash all over body, cries all day and has symptoms about 1 week.
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Neuropathy peripheral
Clinical narrative: Limb neuropathy-like symptoms of left arm.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Aphasia, Asterixis, Autism spectrum disorder, Catatonia, Decreased eye contact
Clinical narrative: High fever, screaming initially. Personality change. Stopped talking, stopped looking at us...was no longer there.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Full blood count normal, Personality change, Pyrexia, Screaming, Toe walking
Clinical narrative: High fever, screaming initially. Personality change. Stopped talking, stopped looking at us...was no longer there.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: High fever, screaming initially. Personality change. Stopped talking, stopped looking at us...was no longer there.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient experienced redness and swelling that took up half of her arm. She also states the site has been itchy.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 weeks old infant. The patient's concurrent conditions, medical history and drug allergies were not reported. On 11-NOV-2016, the patient was vaccinated with a dose of ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017; and a dose of PEDVAXHIB from lot # M025194 (route and expiry date unknown), both for prophylaxis; which were improperly stored. Concomitant medications were not reported. The vaccines were exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 was changed from Company Number to Linked Report. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia, Salivary gland enlargement
Clinical narrative: This spontaneous report was received from a physician referring to a currently 7 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 21-JUL-2010, the patient was vaccinated with a dose of M-M-R II lot number reported as: 10594, expiration date on 24-JUL-2011 (strength, dose number, route and anatomical location were not provided) for prophylaxis. On 24-FEB-2014, the patient was vaccinated with a dose of PROQUAD lot number reported as: J011326, expiration date on 13-MAR-2020 (strength, dose number, route and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced swollen salivary glands and fever. It was reported that on 06-MAR-2017, the patient went to the physician office and was treated with clindamycin. At the time of the report, the outcome of salivary gland enlargement and pyrexia was reported as recovered on an unspecified date in 2017. The reporter did not assess the relatedness between enlargement and pyrexia and suspect therapies. This is one of several reports received from the same reporter. Lot number 10594 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. Lot number J011326 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live. Additional information is not expected, since no consent to contact the reporter was provided. This is an amended report, as corrected. The reference type for the number US-009507513-1703USA006841 was changed from Company Number to Linked Report. Sender's Comments: US-009507513-1703USA008042: US-009507513-1703USA006841: US-009507513-1703USA006841: US-009507513-1704USA008485: US-009507513-1704USA008486.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Influenza, Pyrexia, Salivary gland enlargement
Clinical narrative: This spontaneous report was received from a physician referring to a 5 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 07-JUN-2011, the patient was vaccinated with a dose of M-M-R II lot number reported as: 1618Z, expiration date on 18-NOV-2012 (strength, dose number, route and anatomical location were not provided) for prophylaxis. On 22-AUG-2015, the patient was vaccinated with a dose of PROQUAD lot number: L009210, expiration date on 17-SEP-2016 (strength, dose number, route and anatomical location were not provided) for prophylaxis. On 27-FEB-2017 the patient was diagnosed with the Influenza. On 03-MAR-2017, the patient went to the physician office with swollen salivary glands and fever, then, on an unspecified date in 2017, the patient went to the emergency room for worsening symptoms of salivary gland enlargement and pyrexia. It was reported that the patient was treated with unspecified antibiotic. On 10-MAR-2017, the patient was in an office visit and was recovering. The reporter did not assess the relatedness between all adverse events and suspect therapies. This is one of several reports received from the same reporter. Lot number 1618Z has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live with HSA as albumin status. Additional information is not expected, since no consent to contact the reporter was provided. This is an amended report, as corrected. The reference type for the number US-009507513-1703USA006841 was changed from Company Number to Linked Report. Sender's Comments: US-009507513-1703USA008042: US-009507513-1703USA006841: US-009507513-1704USA008484: US-009507513-1703USA006841: US-009507513-1704USA008486.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. 15-MAY-2017, the patient was vaccinated with an improperly stored dose of M-M-R II lot# M029229, albumin status of recombinant human albumin (rHA) (exact dose, route of administration, anatomical location and expiry date were not reported). The dose of the vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). Administered dose of vaccine underwent a temperature excursion of 48 degrees Fahrenheit (F) for 30 minutes. Digital data logger was not involved. There were no previous excursions reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as all information has already been obtained. This is an amended report, as corrected. The reference type for US-009507513-1704USA000587 was changed to Linked Report (previously reported as company number). Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA001660: US-009507513-1704USA000587: US-009507513-1705USA012939: US-009507513-1705USA012940: US-009507513-1705USA012941: US-009507513-1705USA012938: US-009507513-1705USA012937: US-009507513-1705USA012935: US-009507513-1705USA012934: US-009507513-1705USA012932: US-009507513-1705USA012933: US-009507513-1704USA000587: US-009507513-1705USA012953: US-009507513-1705USA012954: US-009507513-1705USA012955: US-009507513-1705USA012956: US-009507513-1705USA012963: US-009507513-1705USA012964: US-009507513-1705USA012965: US-009507513-1705USA012966: US-009507513-1705USA012967.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a 4 years old female patient.The patient did not have pertinent medical history or drug reactions/allergies. Concomitant medication included some unspecified allergy medications. On 25-JUL-2017 (reported as a week prior), the patient was vaccinated with VARIVAX injection (0.5 ml single dose, lot # was not provided) as standard child vaccine from her physician. In July 2017 (reported as last week), the patient developed shingles after receiving VARIVAX. Treatment was given for the adverse event. The outcome of the event was unknown. The causality was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant via a Company representative, referring to a female patient of unknown age. The patient was vaccinated with the first dose of GARDASIL in July 2015, then, in September 2015, was vaccinated with the second dose of GARDASIL. On 13-APR-2016, the patient was vaccinated with a dose of GARDASIL 9, and on 04-AUG-2016, she received a second dose of GARDASIL 9, all of them for prophylaxis (lot#, expiration date and route of administration was unspecified for all vaccinations). No adverse effect was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an X-ray technician concerning an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, frequency, lot #, expiration date and indication unknown). No adverse symptoms were reported. The vaccines were exposed to temperature of 47 F to 77F for an unspecified period of time, there was also a previous temperature excursion of 47 F to 77F for an unspecified period of time. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA011479:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to patients of unknown age and gender. On unknown dates, the patients were vaccinated with ZOSTAVAX lot # N012615, for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On unknown dates, the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event were unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA011266: US-009507513-1708USA011267:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M037248 or lot # M037248. No adverse effects were reported. The digital data logger was involved in recording the temperature excursion. This is one of six reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA005170: US-009507513-1708USA001493: US-009507513-1708USA005169: US-009507513-1708USA005166: US-009507513-1708USA005167:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number patients of unknown age and gender. On unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 lot # M036059 and expiration date: 03-JUN-2019. The GARDASIL 9 was reconstituted with sterile diluent (STERILE DILUENT) which did not undergo a temperature excursion. No adverse effects were reported. The digital data logger was involved in recording the temperature excursion. This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA010646: US-009507513-1708USA010647: US-009507513-1708USA010656:
Age: 35.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Chlamydia test, Exposure during pregnancy, Full blood count, HIV test, Hepatitis B virus test
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse refers to a 35-year-old female patient. The patient pertinent medical history included high risk pregnancy due to age and had no drug reaction or allergies. The patient was pregnant with last menstrual period (LMP) of 12-JUN-2017 and estimated date of delivery (EDD) of 19-MAR-2018. Nurse reported that the patient, who was unaware she was pregnant, received a single dose of M-M-R II vaccine on 29-JUN-2017 by another clinic during immigration process for prophylaxis (indication reported as immigration'). Concomitant medications included calcium, prenatal vitamin and Ranitidine. After vaccination, she had no adverse effects and did not seek medical attention and treatment. The patient had complete blood count (CBC), Rubella, Urine test, Hepatitis B and C, Chlamydia Gonorrhea Blood typing with antibody, pap smear, human immunodeficiency virus (HIV) and the results were not reported. The outcome of pregnancy was pending at the time of report.
Age: 35.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Hepatitis C virus test, Laboratory test, No adverse event, Rubella antibody test, Smear cervix
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse refers to a 35-year-old female patient. The patient pertinent medical history included high risk pregnancy due to age and had no drug reaction or allergies. The patient was pregnant with last menstrual period (LMP) of 12-JUN-2017 and estimated date of delivery (EDD) of 19-MAR-2018. Nurse reported that the patient, who was unaware she was pregnant, received a single dose of M-M-R II vaccine on 29-JUN-2017 by another clinic during immigration process for prophylaxis (indication reported as immigration'). Concomitant medications included calcium, prenatal vitamin and Ranitidine. After vaccination, she had no adverse effects and did not seek medical attention and treatment. The patient had complete blood count (CBC), Rubella, Urine test, Hepatitis B and C, Chlamydia Gonorrhea Blood typing with antibody, pap smear, human immunodeficiency virus (HIV) and the results were not reported. The outcome of pregnancy was pending at the time of report.
Age: 35.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urine analysis
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse refers to a 35-year-old female patient. The patient pertinent medical history included high risk pregnancy due to age and had no drug reaction or allergies. The patient was pregnant with last menstrual period (LMP) of 12-JUN-2017 and estimated date of delivery (EDD) of 19-MAR-2018. Nurse reported that the patient, who was unaware she was pregnant, received a single dose of M-M-R II vaccine on 29-JUN-2017 by another clinic during immigration process for prophylaxis (indication reported as immigration'). Concomitant medications included calcium, prenatal vitamin and Ranitidine. After vaccination, she had no adverse effects and did not seek medical attention and treatment. The patient had complete blood count (CBC), Rubella, Urine test, Hepatitis B and C, Chlamydia Gonorrhea Blood typing with antibody, pap smear, human immunodeficiency virus (HIV) and the results were not reported. The outcome of pregnancy was pending at the time of report.