chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Aches, chills, fatigue.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Patient reported soreness, numbness and tingling of arm and fingers. No sign of respiratory distress, only slight redness at injection sight, did not improve worsen or improve after several hours, patient call MD to report, MD asked patient to come in.
Age: 0.76
Sex: F
Vaccine: FLUX
Symptoms: Electroencephalogram normal, Seizure, Unresponsive to stimuli
Clinical narrative: Seizure lasting a couple mins than my daughter was unresponsive.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Pt developed large painful induration at the injection site.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Vaccine positive rechallenge, Wheezing
Clinical narrative: Frequent, harsh, dry cough with mild wheezing.  He reports it has happened after every flu shot he has received in past.  Lasts about 6 weeks.  Starts within 24 hours of shot.  Happened again with this administration.  All were inactivated vaccines.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: ADMINISTERED HEP B INJECTION WITHOUT AIR BUBBLES. HALF WAY THROUGH INJECTION DONOR STATED INJECTION SHOT WAS HURTING. DONOR HAS WELT ON RIGHT SHOULDER AREA. HARD, SWOLLEN AND WARM TO TOUCH. DONOR STATES ARM HURTS WHEN MOVED. DONOR FEELS TIRED, AND SHAKEY.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Injection site warmth, Nervousness, Pain, Pain in extremity, Urticaria
Clinical narrative: ADMINISTERED HEP B INJECTION WITHOUT AIR BUBBLES. HALF WAY THROUGH INJECTION DONOR STATED INJECTION SHOT WAS HURTING. DONOR HAS WELT ON RIGHT SHOULDER AREA. HARD, SWOLLEN AND WARM TO TOUCH. DONOR STATES ARM HURTS WHEN MOVED. DONOR FEELS TIRED, AND SHAKEY.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Lip swelling
Clinical narrative: Site swelling ice was applied, lip swelling, epi was administered 0.5 ML left arm. Taken to Hospital by ambulance. Patient in good condition slight swelling lips only.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Flushing, Paraesthesia oral
Clinical narrative: Tingling tongue, getting worse, flushing and BP up from 138/82 to 172/112 within 40 minutes of the dose.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: Possible Arthus-Type reaction. Patient presented to clinic on 10/28/15 with 10cm circular erythematous, edematous, firm lesion with well defined margins on right thigh. Lesion had central darkening at location of injection. Area of erythema was tender to touch. Patient also reported that region was itchy.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site reaction, Skin lesion
Clinical narrative: Possible Arthus-Type reaction. Patient presented to clinic on 10/28/15 with 10cm circular erythematous, edematous, firm lesion with well defined margins on right thigh. Lesion had central darkening at location of injection. Area of erythema was tender to touch. Patient also reported that region was itchy.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm red, painful, warm to touch, swollen.
Age: 58.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Pt called us on 10/28/2015 to inform us that her LEFT arm had been extremely sore and painful. She describes the pain as a dull soreness that has radiated from her shoulder into her neck and has not gotten better after 2 days.
Age: 24.0
Sex: M
Vaccine: FLU4, HPV4, TDAP
Symptoms: Dizziness, Face injury, Fall, Seizure like phenomena, Tremor
Clinical narrative: Pt fell down after receving the flu vaccine on the righ arm. Fell down on  his face, pt felt lightheaded right after receiving the flu vaccine. "Nurse observed shaking of patient's body described as like having seizure".
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Swelling and induration at injection site that didn't resolve.
Age: 88.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea
Clinical narrative: Patient reported trouble breathing.  Epinephrine was administered and within 1 minute, patient was breathing normally.  Patient had previously received flu shot at another pharmacy without our knowledge and came in requesting flu vaccine here.  EMT was called to the scene. Patient did not want to go to the ER. Patient was seen and released on site.  Followed up with patient at home and she reported no other side effects
Age: 88.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Diarrhoea, Dyspnoea, Immediate post-injection reaction, Malaise, Nausea
Clinical narrative: Patient reported trouble breathing.  Epinephrine was administered and within 1 minute, patient was breathing normally.  Patient had previously received flu shot at another pharmacy without our knowledge and came in requesting flu vaccine here.  EMT was called to the scene. Patient did not want to go to the ER. Patient was seen and released on site.  Followed up with patient at home and she reported no other side effects
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: EE states that soon after had his intradermal flu vaccine left arm at site began to swell about size of a marble, hot to touch red, and painful which is to be expected after this type of flu vaccine.  He also states that even a month out when moves arm in a certain position that his left arm at flu vaccine site still hurts that he describes as deep and aching pain around the entire deltoid muscle.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site urticaria, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Child complained of pain about 1 hour after administration. Next morning, mother reports the child had a 3 inch radius red hive at injection site. Mother stated over the next 2 days, both arms were purple, swollen and painful.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Skin discolouration
Clinical narrative: Child complained of pain about 1 hour after administration. Next morning, mother reports the child had a 3 inch radius red hive at injection site. Mother stated over the next 2 days, both arms were purple, swollen and painful.
Age: 54.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: To ZOSTAVAX. Large area (2 inches x 3 inches) raised, red, warm/hot and swollen where vaccine administered (48 hours later) will ice tonight and call us tomorrow.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Pyrexia, Rash
Clinical narrative: Pt received Flu vaccine on 10-20-15 - within 1 1/2 hrs arm pain - 7 1/2 hrs later fever, chills, nausea - fever, headache, rash next couple days temp 104.2.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Rash, Vomiting
Clinical narrative: Temp > 103 degrees, vomiting; rash on face, arms and chest.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site oedema
Clinical narrative: Erythema, edema to entire left upper extremity (vaccine site L deltoid) from shoulder to elbow. Also w fever. Required hospitalization due to concern for cellulitis vs vaccine reaction.
Age: 26.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Swollen red bump that was itchy, warm to the touch.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: INJECTION SITE REACTION BEGAN NEXT DAY, BUT THIS AM WORSENED BEYOND JUST REDNESS. AREA OF REDNESS EXPANDED, SWELLED, AND WAS WARM TO THE TOUCH. PT REPORTED GENERAL FEELING OF MALAISE.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Local reaction
Clinical narrative: Development of local reaction and cellulitis 5x5 developed 1-2 days after injection. Clinidamycin  300 mg T.I.D for 10 days.
Age: 60.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Cellulitis, Local reaction
Clinical narrative: Development of local reaction and cellulitis sxs developed 1-2 days after injection KEFLEX 500mg T.I.D x 10 days.
Age: 42.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Pyrexia, Skin warm, Swelling, Tenderness
Clinical narrative: Swelling, redness measuring 2"x3", hot to touch, painful to touch. Slight fever.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Injection site rash
Clinical narrative: Has rash 1 month post flu shot.  Localized to silver dollar size around site of injection.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Chills, Dyspnoea, Pyrexia
Clinical narrative: The patient felt chilled and had shortness of breath.  Later in the eveing a fever and chest pain developed.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site rash, Pruritus, Sleep disorder
Clinical narrative: Pt called about 11:45 today, Wednesday 10-28-15, and told me that she received a flu shot on Monday, 10-26-15. On Tuesday night or early Wednesday morning, patient said that she woke in the middle of the night with big, red, itchy welts and she said that the welts were all over her body; Her husband recommended Benadryl so she took some. The welts "cleared up quickly, within about 30 minutes" most had receded. After 90 minutes there was still some evidence of welts but her skin was nearly back to normal. At some point she realized that she still had a beige band-aid on her shoulder. When she took it off, the skin beneath the adhesive part was "red and bumpy." The skin under the gauze portion of the band-aid was not irritated as much. We discussed the possibly of this being a flu vaccine reaction or a latex allergy. I told her that I'd do learn more and call her back. Patient received Quad Flu 0.5cc, lot #UI432AE from RN at about 1:40 pm on 10-26-15. Health Department advised pt to visit PCP to discuss reaction and determine if future flu vaccinations would be recommended.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Pt called about 11:45 today, Wednesday 10-28-15, and told me that she received a flu shot on Monday, 10-26-15. On Tuesday night or early Wednesday morning, patient said that she woke in the middle of the night with big, red, itchy welts and she said that the welts were all over her body; Her husband recommended Benadryl so she took some. The welts "cleared up quickly, within about 30 minutes" most had receded. After 90 minutes there was still some evidence of welts but her skin was nearly back to normal. At some point she realized that she still had a beige band-aid on her shoulder. When she took it off, the skin beneath the adhesive part was "red and bumpy." The skin under the gauze portion of the band-aid was not irritated as much. We discussed the possibly of this being a flu vaccine reaction or a latex allergy. I told her that I'd do learn more and call her back. Patient received Quad Flu 0.5cc, lot #UI432AE from RN at about 1:40 pm on 10-26-15. Health Department advised pt to visit PCP to discuss reaction and determine if future flu vaccinations would be recommended.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoacusis
Clinical narrative: Heard a sound in ear that sounded like a central air conditioner being on. When I left the location the sound persisted. I later realized that the hearing from my right ear changed and when I listen to the phone on right ear then the sound is diminished and the sound when the phone is ringing sounds different from right to left ear.
Age: 13.0
Sex: M
Vaccine: FLUX, HEPA, HPV9
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: My son was given Menactra today in error.  He had already received the vaccine on 03/27/2015.  We requested meningitis B vaccine. The office gave him Menactra. This represents an overdose of the stated dose of vaccine. Doctor office did not think it required reporting but I disagree. Overdose should be considered an adverse event.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Dyskinesia, Eye movement disorder, Fall, Loss of consciousness, Malaise
Clinical narrative: Notes: Pt was instructed by MA to stay sitting for 10 minutes administration of HPV vaccine. HPV and flu vaccine given, approx 1 minute after HPV vaccine, pt stated to mom she didn't feel well, was sitting and then fell back onto table and started making jerking movements, eyes rolled back- BP was 118/68, pulse ox ws 98, Pulse was 72, pt came to in approx 1 minute, aware of person place and time, stayed laying for 2 minutes then sitting for 5 minutes and returned to normal. Mother and pts younger brother in room during entire incident, MA was called in when pt fell on table, I was called in by MA and was in room until pt stablilized. I discussed in detail that pt fainting and having jerking movement is a known side effect of HPV vaccine. Pt did not have seizure activity (no hx of seizures as well). Mother to make known to other providers pts vaccine reaction this time and be cautious with subsequent flu vaccines as well (likely HPV vaccine reaction but pt did recieve Flu vaccine at same time so needs to be aware). This is pts 3rd HPV vaccine and she has completed the series- had never had reaction to HPV before. Mother reassured that this is a known HPV side effect- cdc information printed and given to her for more information. No injuries sustained during this incident.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Activities of daily living impaired, Dyskinesia, Fall, Loss of consciousness, Syncope
Clinical narrative: Pt was given HPV vaccine and had adverse reaction- Per MA, after vaccine as administered, pt fainted and fell back onto table, she made some jerking movements and then became awake, mother and MA were with pt entire time. Pt vitals with pulse ox 98, heart rate and respirations within normal limits, BP 120/70 lying down. Pt AAO X3, says she remembers getting vaccine, then she says she "saw mickey mouse" and woke up lying down on the table. Pt tolerated sitting in room for 10 minutes, excused for rest of school day per moms request. We will wait for other vaccines at next PE, I reviewed all known side effects with mother, reassurance that this is a common and known side effect- gave her HPV information so she can choose if she wants to continue with series. Advised rtc if any further concerns or symptoms rest of the day.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Vaccination complication
Clinical narrative: Pt was given HPV vaccine and had adverse reaction- Per MA, after vaccine as administered, pt fainted and fell back onto table, she made some jerking movements and then became awake, mother and MA were with pt entire time. Pt vitals with pulse ox 98, heart rate and respirations within normal limits, BP 120/70 lying down. Pt AAO X3, says she remembers getting vaccine, then she says she "saw mickey mouse" and woke up lying down on the table. Pt tolerated sitting in room for 10 minutes, excused for rest of school day per moms request. We will wait for other vaccines at next PE, I reviewed all known side effects with mother, reassurance that this is a common and known side effect- gave her HPV information so she can choose if she wants to continue with series. Advised rtc if any further concerns or symptoms rest of the day.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Culture, Injection site pain, Pyrexia, Rash, Swelling
Clinical narrative: Skin rash/swelling/pain on the injection side and fever.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: White blood cell count normal
Clinical narrative: Skin rash/swelling/pain on the injection side and fever.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Head discomfort
Clinical narrative: Light headedness, dizziness, full headedness.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling
Clinical narrative: Swelling of the upper lip. Pt was evaluated 10/23/2015 in the office, treated with prednisone, Zyrtec, Zantac, Benadryl. Swelling decreased over 10/24 & 10/25 & was gone by 10/26. No additional symptoms presented.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Headache, Heart rate increased, Nausea, Pain
Clinical narrative: Focal headache, rash on neck and chest. Nausea, vomiting, rapid pulse, body aches and weekness, ringing in ears.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Tinnitus, Vomiting
Clinical narrative: Focal headache, rash on neck and chest. Nausea, vomiting, rapid pulse, body aches and weekness, ringing in ears.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose normal, Loss of consciousness, Somnolence
Clinical narrative: Pt lost consciousness for a few seconds, then was groggy for a few seconds, then recovered.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Eyelid oedema, Fatigue, Hypersomnia, Lacrimation increased
Clinical narrative: Per patient himself, he describes the reactions happen about 1 to 1&1/2 hour after getting vaccinated. Rash appears on back, eyes dwell up with water & can't even open eyes, non-stop coughing & sneezing. Patient get exhausted & sleep straight for 12 hours. (no swelling of lips, tongue, or face & no difficulty breathing.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Sneezing
Clinical narrative: Per patient himself, he describes the reactions happen about 1 to 1&1/2 hour after getting vaccinated. Rash appears on back, eyes dwell up with water & can't even open eyes, non-stop coughing & sneezing. Patient get exhausted & sleep straight for 12 hours. (no swelling of lips, tongue, or face & no difficulty breathing.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: PATIENT COMPLAIN SORENESS AT THE SITE OF INJECTION RADIATING TO THE INJECTED ARM.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Headache
Clinical narrative: Headache- moderate intensity, lasting for about 6 hrs until 11PM.  No other symptoms.  No treatment taken; spontaneously resolved without sequelae.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Huge red, swollen, itchy site. Warm to touch. Injection not given in deltoid muscle. Injection was actually given below the deltoid muscle.
Age: 67.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: Soreness from injection, but not at injection site.  Soreness radiates to upper deltoid muscle and has lasted until present date 10/28/2015.
Sex: F
Vaccine: DTAPIPV
Symptoms: Bordetella test negative, Infection, Pertussis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pertussis in a female patient who received KINRIX (batch number EP2A3, expiry date unknown). On 22nd October 2014, the patient received KINRIX. On an unknown date, 1 year after receiving KINRIX, the patient experienced pertussis (serious criteria GSK medically significant) and infection. The patient was treated with BACTRIM. On an unknown date, the outcome of the pertussis and infection were unknown. It was unknown if the reporter considered the pertussis and infection to be related to KINRIX. Additional details were provided as follows: The patient received KINRIX last year on 22nd October 2014. According to the reporter, at the time of reporting, approximately 1 year after vaccination when the patient was 6 years of age, the patient was diagnosed with pertussis. The pertussis culture was negative for this patient but 3 out of 6 house-hold family members had positive pertussis culture. He thought that this patient's pertussis culture came out negative because the patient was taking BACTRIM for an infection (not related to suspected pertussis).
Age: 88.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient hot PREVNAR 13 in (R) deltoid and FLUZONE HD in left deltoid on 10-19-15. On 10-25-15, she developed redness, swelling, itching and warmth in her right arm. On 10-28-15, it is less red but still itches.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling of mid arm.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: Onset of erythema, induration, warmth at injec site within approximately 6 hrs to 8 hrs of injection - subjective fever also noted by patient.
Age: 10.0
Sex: U
Vaccine: FLUN4, HPV9, MENB
Symptoms: Headache, Nausea, Pyrexia, Streptococcus test negative, Vomiting
Clinical narrative: Nausea, headache, fever. Left clinic with extreme frontal headache. Came into clinic next day with fever 102. Strep test (-). Vomiting and nausea.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Cellulitis, Peripheral swelling, Pruritus
Clinical narrative: Pt. stated that the evening of shot arm was swollen and itchy. I advised her to use BENADRYL cream and call MD -> next day still worse, MD dx cellulitis and gave doxycycline. Pt is recovering I advised to continue antibiotic until gone.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised
Clinical narrative: 48 y/o male patient states he had a systemic rash 4 days after receiving flu vaccine. Pt states he had "bumps and all over" and was itching. Pt. did not seek immediate care but was advised by a pharmacist to take BENADRYL PO. Patient took said medication and states that it has helped relieve the symptoms. Pt. states he had recently (10-27) visited his primary care for an annual physical abd brought up concern. He was advised to let the rash and itching run its natural course and taken BENADRYL PRN. No further worsening of symptoms reported to date 10-28-15.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Pruritus, Rash
Clinical narrative: Rash around arm, itching - started 10-17-15 trouble breathing. Went to urgent care on 10-20-15 given prednisone and albuterol.
Age: 56.0
Sex: F
Vaccine: FLU3, PNC13, TDAP, VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Arm/hand pain and swelling. Hand throbbing. She said she went to Dr and they gave her pain meds for the pain/throbbing. Still experiencing pain/throbbing/tingling 1 week after immunization, but swelling is gone.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage
Clinical narrative: Blood pooled around the injection site and traveled down his arm and up around his shoulder area. Pt was on COUMADIN and had a similar reaction when he was in a car accident.
Age: 62.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Chest pain, Pain, Tachycardia, Urticaria
Clinical narrative: Hives, all over body aches, chest pain, tachycardia.
Age: 62.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Blood test, Chest X-ray, Chest pain, Chills
Clinical narrative: Hives, all over body aches, chest pain, tachycardia.
Age: 62.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Headache, Pyrexia
Clinical narrative: Hives, all over body aches, chest pain, tachycardia.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left arm with large, warm, area of swelling extending from site of injection distally to a few centimeters below elbow. Edges serpentigious minimally tender, no other rashes.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Skin lesion
Clinical narrative: 7 cm x 7 cm erythematous, well - demarcated lesion on right upper arm. Slight warmth and tenderness. Advised cold compresses, MOTRIN of 6-8 hr prn pain. BENADRYL and steroid cream.
Sex: F
Vaccine: FLU4
Symptoms: Local swelling, Upper extremity mass
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of local swelling in a female patient who received FLULAVAL quadrivalent. In 2015, the patient received FLULAVAL quadrivalent .5 ml. On an unknown date, an unknown time after receiving FLULAVAL quadrivalent, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was unknown. It was unknown if the reporter considered the local swelling to be related to FLULAVAL quadrivalent. Additional details were provided as follows: In 2015, the patient experienced lump on the arm after vaccination with FLULAVAL QIV. The patient's information or lot number and expiration date of the vaccine were not available.
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a male patient who received FLUARIX Quadrivalent. Concurrent medical conditions included mental disability. In October 2015, the patient received FLUARIX Quadrivalent. On an unknown date, less than a month after receiving FLUARIX Quadrivalent, the patient experienced tingling of extremity and mobility decreased. On an unknown date, the outcome of the tingling of extremity and mobility decreased were not recovered/not resolved. The reporter considered the tingling of extremity and mobility decreased to be related to FLUARIX Quadrivalent. Additional details were provided as follows: The patient stated he had the FLUARIX shot about two weeks ago and was losing mobility in his right arm. He also indicated his arm was tingling all the way down his right arm into his hand. He said he had been to 3 therapies and nothing was working. The patient was demanding to have any reports of adverse events with this medication in the last few months to be mailed to him.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Hyperventilation, Nausea
Clinical narrative: Patient sat for about 12-15 minutes after getting ZOSTER shot. She was extremely nervous prior. She left when asked to stay for a little longer, hyperventilating and said she was going to vomit. 911 was called vitals taken no AE occurred after shot (immediately).
Age: 58.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Genital rash, Injection site erythema, Injection site swelling, Rash
Clinical narrative: Right upper area became swollen and red at injection site. Rash developed on right arm, chest, left ram, torso, and private areas on 10-22-15.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 16 week old patient of unknown gender. The patient's pertinent medical history, drug reaction or allergies and concomitant medications were not reported. On an unknown date, the patient was in the office and was possibly going to receiving orally the first dose from the series of ROTATEQ (dose, lot# and expiry date were not reported). During the phone call, the physician reported that the patient had not yet received the first dose of ROTATEQ. No adverse effects were reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a 65 year old male patient with cardiovascular disorder (CV), as part of a marketing research program titled "HCC adult vaccine location journey" (Project #15-1340) conducted by the planning shop intl., refers to himself. On an unknown date, the patient was vaccinated with a dose of PENUMOVAX23 (dose, route and lot # unknown). Concomitant therapy was not reported. ON an unknown date the patient experienced soreness at injection site. The outcome of the event was recovered in February 2015. The patient also experienced soreness at injection site after vaccination of ZOSTAVAX, (captured in MARRS#1510USA09011). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown demographic. On unknown dates these patients were vaccinated with improperly stored doses of GARDASIL (K011562 expiry: 08-APR-2017) (dose and route were unspecified). No adverse effect were reported. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several cases received from the same source. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Hyperhidrosis, Influenza like illness, Pruritus
Clinical narrative: Itching, sweating, shortness of breath, flu-like symptoms, patient called pulmonologist and he prescribed prednisone via telephone rx to pharmacy.
Age: 18.0
Sex: F
Vaccine: VARZOS, MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse referring to a 18 year old female patient. Information about medical history, concurrent condition and concomitant medication was not reported. On 20-OCT-2015 the patient received a dose of ZOSTAVAX (lot# L015417 with expiration date of 01-AUG-2016, 0.5 ml, subcutaneous, instead of (Oka/Merck) VARIVAX (wrong vaccine administered). No adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARZOS, MMR
Symptoms: Brain injury, Medication error, Road traffic accident, Wheelchair user
Clinical narrative: Information has been received from a registered nurse referring to a 18 year old female patient. Information about medical history, concurrent condition and concomitant medication was not reported. On 20-OCT-2015 the patient received a dose of ZOSTAVAX (lot# L015417 with expiration date of 01-AUG-2016, 0.5 ml, subcutaneous, instead of (Oka/Merck) VARIVAX (wrong vaccine administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were unknown. On 21-OCT-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K008884, expiration date 20-SEP-2015,, dose: 0.65 ml) subcutaneously (expired product administered). Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 2 month old male patient. No concomitant medications and medical history were reported. On 16-OCT-2015 the patient was vaccinated with M-M-R II with batch number-L009214, expiry date 17-MAR-2017, dose, route and anatomical location unspecified) in error (inappropriate schedule of drug administration). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The events were considered to be not related to M-M-R II. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot#J007946, exp. 24-MAR-2016) (incorrect product storage). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (lot # K016278, exp. 21-APR-2016) (incorrect product storage). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports 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 registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with unspecified number of improperly stored RECOMBIVAX HB (dose and route not provided) (lot number #K016005, expiration date: 27-AUG-2016; lot number #L003193, expiration date: 10-NOV-2016). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. No concurrent conditions or medical history was reported. On an unknown date, the patients were vaccinated with improperly stored Liquid PEDVAXHIB (lot # J008426, exp. 10-APR-2016) (incorrect product storage). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information was received on 15-OCT-2015 from a pharmacist reporting on a male patient (age and birth date not reported). On approximately 06-OCT-2015 or 07-OCT-2015 the patient received a dose of ZOSTAVAX (lot number, and dose not reported. ON 08-OCT-15 the pharmacist was at a flu clinic which the patient consulted her and told her he had developed "a few bumps around the injection site". The pharmacist recommended that he put some BENADRYL cream on the arm in case is experiencing an allergic reaction The patient was otherwise healthy and not in distress. The pharmacist did not know whether he was developing a rash and she believes that the patient may have received the dose of ZOSTAVAX intramuscularly rather than subcutaneously. The pharmacist had no other information on the patient at the time of the report as she works in another store and does not have access to the records. The outcome of the events is unknown. The reporter did not specify the relationship of the vaccine to the patient's events. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a 66 year old male patient with cardiovascular disorder (CV), as part of a marketing research program titled "HCC adult vaccine location journey" (project # 15-1340) conducted by the planning shop intl, refers to himself.   On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# unknown). Concomitant therapy was not reported. On an unknown date the patient experienced soreness at injection site. The outcome of the event was recovered in February 2015. The patient also experienced soreness at injection site after vaccination of PNEUMOVAX23. (captured in MARRS#1510USA013303). This is one of the reports concerning the same patient. Additional information has been requested.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old patient of unknown gender. The patient's medical history was not reported. ON 26-OCT-2015, the patient was vaccinated with an expired dose of ZOSTAVAX lot # K0009810, expiration date reported as 10-OCT-2015 (dose, route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patient of unknown age and gender. On an unknown dates, the patients were vaccinated with doses of PROQUAD (Merck) lot # L011080, expiration date 01-OCT-2016 and lot # L031602, expiration date 18-FEB-2017 which were exposed to temperatures outside of the recommended range. No adverse experiences have been reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL (lot # J006850, exp. 31-MAR-2016). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On 14-AUG-2017 the patient was vaccinated with the first dose of GARDASIL. On 23-OCT-2015 the patient was vaccinated with the second dose of GARDASIL (lot # L014415  with expiration date on 24-JUL-2017, dose, strength and route unknown). No adverse effect reported. 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 registered nurse referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On an unknown date the patient was vaccinated with the first dose of GARDASIL 9 (lot #, expiry date, dose, route unspecified (interchange of vaccine products). No adverse effect reported.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date in 2014, the patient vaccinated with a first dose of ZOSTAVAX (lot #, expiration date, dose and route were unknown). Then on 24-SEP-2015, the patient was inadvertently administered a second dose of ZOSTAVAX (lot#, expiration date, dose and route were unknown) (extra dose administered). The patient's concomitant medication was not reported.  On 25-SEP-2015 the patient developed a "half-dollar sized raised area of redness" at the injection site. The reported stated that the patient did not have an adverse effect after the first dose of ZOSTAVAX. No treatment was given to the patient. No lab diagnostics studies were performed. The patient had came to the pharmacy for medical attention. The outcome of th events was reported as recovering/resolving. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 20-OCT-2015, the patient was vaccinated with expired dose of M-M-R II, therapy type rHA (lot # J013131, expiration date 17-OCT-2015, dose, anatomical location and route of administration were not reported) second dose. No adverse events were 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 healthcare worker refers to an unspecified number of patient as of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ oral liquid, orally, lot # K011948, expiration date 07-JUN-2016 (dose was not reported). No adverse effect was 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: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown demographics. No medical history, concurrent conditions or concomitant therapies were reported. On unknown dates, the patiens were vaccinated with improperly stored doses of RECOMBIVAX HB (lot #, doses, route of administration and anatomical location were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as the reporter did not wish to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown demographics. No medical history, concurrent conditions or concomitant therapies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot #, dose, route of administration and anatomical location were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as the reporter did not wish to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown demographics. No medical history, concurrent conditions or concomitant therapies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (lot #, dose and anatomical location were not provided). No adverse effects were reported. This ss one of several reports received from the same reporter. Additional information is not expected, as the reporter did not wish to be contacted.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown demographics. No medical history, concurrent conditions or concomitant therapies were reported. ON unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot #, dose, route of administration and anatomical location were not provided). No adverse effects were reported. This is one of several reports received from the same reporter Additional information is not expected, as the reporter did not wish to be contacted.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Patient received PREVNAR 13 vaccine Thurs 10/22/15. Developed baseball sized rash at injection site over weekend. Reported to pharmacy on 10/26/15. Advised to the diphenhydramine and contact MD. MD advised same treatment.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown demographics. No medical history, concurrent conditions or concomitant therapies were reported. On unknown dates, ,the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot #, dose, route of administration and anatomical location were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as the reporter did not wish to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored GARDASIL injection, lot # K011562, expiration date 08-APR-2017 (dose, dose number and route of administration were not reported). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On 22-OCT-2015 the patient was inadvertently vaccinated with one dose of Liquid PEDVAXHIB (lot # L014429 with expiration date of 15-MAR-2018, dose, strength and route unknown) and one dose of another dose PENTACEL. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse when refers to less than 10 unspecified patients of an unknown age and gender. The patients concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored Liquid PEDVAXHIB (lot # L009649, expiration date 29-NOV-2017) and possibly another Liquid PEDVAXHIB) with an unspecified lot number. No adverse effects were reported. Additional information has been requested.
Age: 28.0
Sex: U
Vaccine: YF
Symptoms: Abdominal pain, Dizziness, Nausea
Clinical narrative: Severe dizziness, could noy sit had to lie down. Followed by severe abdominal pain in few min 7-10 mis. Then paramedics came, was very nauseated too.
Age: 91.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: On 10/21/15, the patient had a chiropractor visit (did a standard adjustment of her shoulder blade - no topical products used). On 10/22/15, she came to the pharmacy with itching and extensive redness and swelling at the injection site. She was fine for the week after the PREVNAR infection. It has since gotten much better and is now just a "little pink".