chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test normal, Vomiting
Clinical narrative: Later at night throwing up, quite dizzy, had diarrhea. Was dehydrated and had no appetite. Felt so bad that went to ER twice, on 1/23 and 2/28, but should have gone 3 times. On ER got IV and anti-nausea meds. Followed up with doct after ER visits and got pill for vomiting/dizziness but made it worse. Today still vomiting; diarrhea subsided 2 weeks ago. Allergist recommended flu vaccine.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Eye movement disorder, Headache, Musculoskeletal stiffness, Pyrexia, Rash
Clinical narrative: After receiving 4th injection (HPV9), child became stiff, unresponsive, eyes rolled back but child recovered immediately. Encouraged mom to FU with PMD. Spoke w/mom for FU call and mom verbalized child developed headaches, rash to left arm and fever 100.5 these symptoms developed 12 to 24 hours after injections. Returned to school 3-17-16, but still had rash to left arm.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: After receiving 4th injection (HPV9), child became stiff, unresponsive, eyes rolled back but child recovered immediately. Encouraged mom to FU with PMD. Spoke w/mom for FU call and mom verbalized child developed headaches, rash to left arm and fever 100.5 these symptoms developed 12 to 24 hours after injections. Returned to school 3-17-16, but still had rash to left arm.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Patient having blood in stool today.  No other signs or symptoms present.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Full blood count, Laboratory test, Pruritus generalised, Rash
Clinical narrative: Rash on extremities and intense itching all over body.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt said arm swollen and turned red the next day.  Her arm continued to swell and the red spot continued to get larger and feel warm to the touch.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Fatigue, Malaise, Peripheral swelling, Skin warm
Clinical narrative: Right arm swelling, warmth, erythema.  Malaise, fatigue.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Rash generalised
Clinical narrative: Devolved "sandpaper rash" "All over" day after vaccine.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: Patient experienced pain for the first two weeks, which she thought was normal, then kept experiencing pain off and on for the next few months including numbness, heaviness, radiating pain down to her arm.  No knots or bumps were noticed.
Age: 55.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Expired product administered
Clinical narrative: Hep A vaccine given on 3/16/16 had expiration date of 3/7/16.
Age: 1.53
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: 18 month old baby given "KINRIX", which is for ages 4 to 6 years. Child did not have any reactions to the vaccine, but the wrong vaccine was given.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: PATIENT WAS GIVEN EXPIRED ZOSTER IMMUNIZATION ON 16MAR2016. THE EXPIRATION DATE IS 15MAR2016.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal behaviour, Crying, Depressed level of consciousness, Eye movement disorder, Feeling hot
Clinical narrative: HIGH PITCHED INCONSOLABLE CRYING, EYES ROLLING UPWARD, LETHARGY, UNABLE TO HOLD HEAD UPRIGHT, HEAD SWELLING, INTENSE HEAT FROM ANTERIOR FONTANEL, SEMI CONSCIOUS, MONITORED AT HOME BY REGISTERED NURSE AND 3 ADULTS, NIGHT AND DAY, GRADUAL IMPROVEMENT OVER A 5 DAY PERIOD, SOME RESIDUAL EFFECTS SUCH AS UNUSUAL BEHAVIORS, HEAD BANGING, SCREAMING, POSSIBLE COGNITIVE DELAYS APPEARING THEREAFTER.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Head banging, Lethargy, Posture abnormal, Screaming, Swelling
Clinical narrative: HIGH PITCHED INCONSOLABLE CRYING, EYES ROLLING UPWARD, LETHARGY, UNABLE TO HOLD HEAD UPRIGHT, HEAD SWELLING, INTENSE HEAT FROM ANTERIOR FONTANEL, SEMI CONSCIOUS, MONITORED AT HOME BY REGISTERED NURSE AND 3 ADULTS, NIGHT AND DAY, GRADUAL IMPROVEMENT OVER A 5 DAY PERIOD, SOME RESIDUAL EFFECTS SUCH AS UNUSUAL BEHAVIORS, HEAD BANGING, SCREAMING, POSSIBLE COGNITIVE DELAYS APPEARING THEREAFTER.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Localized area of erythema; appearance consistent with hives along the arm where the injection was given; pt treated with Benadryl/cool compress.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Immediate post-injection reaction, Vaccination site pain
Clinical narrative: Pain at the vaccination site (left shoulder). Has been in constant pain immediately after Tdap vaccine on 02/18/2016, it has been 4 weeks and the pain is still there.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Second dose of MMR vaccine.  Only shot received.  Red, swollen, red, hard, sore to touch welt just below injection site immediately after shot administered. Approx 2 inches in diameter, also with red streaking. After 2-3 hours, streaking was gone and welt increased in size to 3 inches in diameter. Sore to touch but not painful. Called doctor following morning, 03/17/16, and they advised warm compress and motrin for pain. Do not seem concerned or care at all.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Injection site streaking, Injection site swelling, Urticaria
Clinical narrative: Second dose of MMR vaccine.  Only shot received.  Red, swollen, red, hard, sore to touch welt just below injection site immediately after shot administered. Approx 2 inches in diameter, also with red streaking. After 2-3 hours, streaking was gone and welt increased in size to 3 inches in diameter. Sore to touch but not painful. Called doctor following morning, 03/17/16, and they advised warm compress and motrin for pain. Do not seem concerned or care at all.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Activities of daily living impaired, Arthralgia, Contusion, Headache, Hypoaesthesia
Clinical narrative: Has been having aches and joint pains since the 11th. Received Gardasil # 1 in our office on the 10th. Has not had any URI symptoms last week or this week. No fever noted. The pain is not in the legs any more, but the arms have gotten worse. She played Tues and Wed in the volleyball tournament. She is used to playing in volleyball. When she finished playing volleyball yesterday she had numbness from her armpits down to her forearms. Her fingers had sensation. The numbness lasted until she fell asleep. When she woke up this morning she could feel her arms, but they hurt very badly. The discomfort is on both arms. First noticed a mild headache on Sunday and had had a mild headache at least every other day since then. Did not eat any new foods or nut containing foods last week. She stayed home from practice on Monday because of the discomfort. It hurt a little bit to walk when her legs were hurting but on Tuesday the leg pain was gone and has not come back since then. The bruise on her right knee has gotten bigger. Had a spontaneous bruise on her right knee first noticed on Sunday, but does not remember hitting knee, as there was no volleyball last weekend. Mother has been giving Tylenol and not ibuprofen since Monday. Prior to Tues & Wed this week, last volleyball play was on the 10th for a routine practice which was uneventful, and prior to getting Gardasil vaccine. Gardasil was given in left deltoid.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Limb discomfort, Pain, Pain in extremity, Sensory disturbance
Clinical narrative: Has been having aches and joint pains since the 11th. Received Gardasil # 1 in our office on the 10th. Has not had any URI symptoms last week or this week. No fever noted. The pain is not in the legs any more, but the arms have gotten worse. She played Tues and Wed in the volleyball tournament. She is used to playing in volleyball. When she finished playing volleyball yesterday she had numbness from her armpits down to her forearms. Her fingers had sensation. The numbness lasted until she fell asleep. When she woke up this morning she could feel her arms, but they hurt very badly. The discomfort is on both arms. First noticed a mild headache on Sunday and had had a mild headache at least every other day since then. Did not eat any new foods or nut containing foods last week. She stayed home from practice on Monday because of the discomfort. It hurt a little bit to walk when her legs were hurting but on Tuesday the leg pain was gone and has not come back since then. The bruise on her right knee has gotten bigger. Had a spontaneous bruise on her right knee first noticed on Sunday, but does not remember hitting knee, as there was no volleyball last weekend. Mother has been giving Tylenol and not ibuprofen since Monday. Prior to Tues & Wed this week, last volleyball play was on the 10th for a routine practice which was uneventful, and prior to getting Gardasil vaccine. Gardasil was given in left deltoid.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: Redness and heat at injection site, followed by lightheadedness, dizziness and nausea later that day and morning of the next day.  Thought she was getting better mid day of the third day after getting the shot.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash vesicular, Scab
Clinical narrative: Patient is complaining of a vesicular rash on her abdomen. A few of the lesions have crusted over and it is very itchy. She used topical Benadryl with no relief.
Age: 69.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Patient requested that all her shots were to be given in her left arm only because she needed her right arm pain-free. Shots were given at least 2 inches apart on left upper arm intramuscularly. Patient complains of pain and rashes at the site of vaccination and a slightly elevated but flat swollen raised round patch of skin at site of vaccination. Patient called her doctor on 03/16/2016 but doctor told her to call the pharmacy and did not recommend anything. She came to the pharmacy on 03/17/2016 and spoke with another pharmacist who told her to take Benadryl and use cortisone cream on the swollen site over-the-counter until she could see the doctor, if the swelling does not resolve. I called her today (03/17/2016) at about 6:15pm and spoke with her, she admits to the pain subsiding somewhat and the swelling going down, but she would make an appointment with the doctor in the morning of 03/18/2016.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: (L) upper arm: some edema, erythematous measuring approx. 8x10 cm. No c/o itching. Tx applied ice pack.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of ZOSTAVAX (lot # L034727, expiration date 09-DEC-2016, strength, dose, dose# and route unknown) which were previously exposed to temperature outside of the recommended range. Temperature was 8.1F and time frame was 6 hours. No adverse reactions reported. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: FLUMIST given 3-11-16 exp 3-9-16. Medimmune case # IL257901.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and healthcare worker (medical assistant) refers to multiple patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored (temperature excursion: 28-OCT-2015 to 13.17 F and 11-SEP-2015 to 13.13 F, time frame: worst case 10 minutes each occasion, cumulative excursion: 13.17 for 40 minutes) doses of VARIVAX (Merck) with lot/batch # L05299, expiry date 17-FEB-2017 and lot/batch # L011084, expiry date 01-APR-2017 (dose, dose number, vaccination site and route of administration not provided). Concomitant therapies were not reported. It was also reported that, on unspecified dates, additional doses of improperly stored (temperature excursion: 5.71F, time frame: 20 minutes) VARIVAX (Merck) with lot/batch # L011084, expiry date 01-APR-2017 (dose, dose number, vaccination site and route of administration not provided) were administered to the patients. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of the several reports from the same reporter link. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed erythema and swelling left upper arm in deltoid region around vaccine site.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 14-APR-2015, the patient was vaccinated with improperly stored (temperature excursion: 32 F, time frame: 4 days) GARDASIL lot # J013277, expiry date 06-AUG-2015 (dose, strength, route, dose number, vaccination site unspecified). There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not reported. Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: I inadvertently gave child VFC Tdap IM rather than VFC DTaP IM. Injected (R) thigh.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). Concomitant therapies were not provided. On an unknown date, the patient developed "a mild case of shingles". At the time of the report, the patient' outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker/certified medical assistant refers to 3 patients of unknown demographics. The patients were vaccinated with improperly stored VAQTA (lot # L023232, expiry date: 25-FEB-2017) that was exposed to the following conditions: Temperature of 47.3f for 1 hour and 24 minutes. There was no previous temperature excursion. The temperature excursion was because of a data logger. It was confirmed that the improperly stored vaccines was administered to the patients. No adverse symptoms reported. The outcome was unknown. No product quality complaint was involved. 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 as received from a healthcare worker/certified medical assistant refers to 3 patients of unknown demographics. The patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L027733, expiry date: 13-SEP-2017) that was exposed to the following conditions: Temperature of 47.3F for 1 hour and 24 minutes. There was no previous temperature excursion. The temperature excursion was because of a data logger. It was confirmed that the improperly stored vaccine was administered to the patients. No adverse symptoms reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker/certified medical assistant refers to 4 patients of unknown demographics. The patients were vaccinated with improperly stored ROTATEQ (lot # L026741, expiry date: 18-MAY-2017) that was exposed to the following conditions: Temperature of 47.3F for 1 hour and 24 minutes. There was no previous temperature excursion. The temperature excursion was because of a data logger. It was confirmed that the improperly stored vaccine was administered to the patients. No adverse symptoms reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Blood test, Bradyphrenia, Cognitive disorder, Computerised tomogram, Hallucination, visual
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 17-year-old female patient who received MENVEO (batch number M14097, expiry date 31st December 2015). Concomitant products included NECON. On 23rd July 2015, the patient received MENVEO. On 23rd July 2015, 10 min after receiving MENVEO, the patient experienced seizure (serious criteria GSK medically significant and other: As per reporter) and nausea. On an unknown date, the patient experienced nocturnal awakening and thinking slow. On an unknown date, the outcome of the seizure was resolved with sequelae and the outcome of the nausea was recovered/resolved and the outcome of the nocturnal awakening and thinking slow were not recovered/not resolved. The reporter considered the seizure, nausea, nocturnal awakening and thinking slow to be related to MENVEO. Additional details were received as follows: The reporter was the legal guardian via marriage of the patient. The reporter stated that, the patient was nauseous within minutes of the injection and once she exited the office on the way to the car she experienced a full blown seizure, which occurred about 10 minutes after the injection. She was seen at the local Emergency room, where blood work observation and a computerized tomography (CT) scan were performed. In those results noted that the patient had experienced a seizure. She had been followed up by a neurologist and the reporter stated the patient was still (at the time of reporting) experiencing side effects of slow cognition meaning she can't process things as quickly and she awakened in the night and saw shadows of things not present. The case was legally significant and requesting compensation related to emergency room visit and continued side effects. The reporter stated that health care provider reported this incident to manufacturer already. The caller reported that the VIS form was not provided before the vaccination but done so by the office on the way out, leaving the office after the visit due to the nausea she was having.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Middle insomnia, Nausea, Seizure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 17-year-old female patient who received MENVEO (batch number M14097, expiry date 31st December 2015). Concomitant products included NECON. On 23rd July 2015, the patient received MENVEO. On 23rd July 2015, 10 min after receiving MENVEO, the patient experienced seizure (serious criteria GSK medically significant and other: As per reporter) and nausea. On an unknown date, the patient experienced nocturnal awakening and thinking slow. On an unknown date, the outcome of the seizure was resolved with sequelae and the outcome of the nausea was recovered/resolved and the outcome of the nocturnal awakening and thinking slow were not recovered/not resolved. The reporter considered the seizure, nausea, nocturnal awakening and thinking slow to be related to MENVEO. Additional details were received as follows: The reporter was the legal guardian via marriage of the patient. The reporter stated that, the patient was nauseous within minutes of the injection and once she exited the office on the way to the car she experienced a full blown seizure, which occurred about 10 minutes after the injection. She was seen at the local Emergency room, where blood work observation and a computerized tomography (CT) scan were performed. In those results noted that the patient had experienced a seizure. She had been followed up by a neurologist and the reporter stated the patient was still (at the time of reporting) experiencing side effects of slow cognition meaning she can't process things as quickly and she awakened in the night and saw shadows of things not present. The case was legally significant and requesting compensation related to emergency room visit and continued side effects. The reporter stated that health care provider reported this incident to manufacturer already. The caller reported that the VIS form was not provided before the vaccination but done so by the office on the way out, leaving the office after the visit due to the nausea she was having.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Injection site swelling, Local swelling, Tinnitus
Clinical narrative: Swelling from ear to finger tips with severe pain could not sleep for 2 nights dizzy; diarrhea; arm numb from elbow to ring and baby finger; Pain in hand when trying to grip something. Ringing in ears - balance off. Still having humming in ears balance off; still numb from elbow to finger tips (ring and baby fingers)
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Balance disorder, Diarrhoea, Dizziness, Hypoaesthesia, Insomnia
Clinical narrative: Swelling from ear to finger tips with severe pain could not sleep for 2 nights dizzy; diarrhea; arm numb from elbow to ring and baby finger; Pain in hand when trying to grip something. Ringing in ears - balance off. Still having humming in ears balance off; still numb from elbow to finger tips (ring and baby fingers)
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Pain in extremity, Swelling, Tinnitus
Clinical narrative: Swelling from ear to finger tips with severe pain could not sleep for 2 nights dizzy; diarrhea; arm numb from elbow to ring and baby finger; Pain in hand when trying to grip something. Ringing in ears - balance off. Still having humming in ears balance off; still numb from elbow to finger tips (ring and baby fingers)
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a 18-year-old female patient who received BEXSERO (batch number 149001, expiry date 30th September 2016). On 1st March 2016, the patient received BEXSERO .5 mg/ml. On 8th March 2016, 7 days after receiving BEXSERO, the patient experienced induration and redness. In March 2016, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, induration and redness were unknown. It was unknown if the reporter considered the pain in arm, induration and redness to be related to BEXSERO. Additional details were provided as follows: In March 2016, less than a week after receiving BEXSERO, the patient experienced tenderness on the upper arm. On 8th March 2016, the patient noticed redness and induration medial and lateral injection site. There was no redness or induration at the injection site. It was unknown if the injection site of BEXSERO was upper arm.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a 18-year-old female patient who received BEXSERO (batch number 149001, expiry date 30th September 2016). On 1st March 2016, the patient received BEXSERO .5 mg/ml. On 8th March 2016, 7 days after receiving BEXSERO, the patient experienced induration and redness. In March 2016, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, induration and redness were unknown. It was unknown if the reporter considered the pain in arm, induration and redness to be related to BEXSERO. Additional details were provided as follows: In March 2016, less than a week after receiving BEXSERO, the patient experienced tenderness on the upper arm. On 8th March 2016, the patient noticed redness and induration medial and lateral injection site. There was no redness or induration at the injection site. It was unknown if the injection site of BEXSERO was upper arm.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Tenderness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a 18-year-old female patient who received BEXSERO (batch number 149001, expiry date 30th September 2016). On 1st March 2016, the patient received BEXSERO .5 mg/ml. On 8th March 2016, 7 days after receiving BEXSERO, the patient experienced induration and redness. In March 2016, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, induration and redness were unknown. It was unknown if the reporter considered the pain in arm, induration and redness to be related to BEXSERO. Additional details were provided as follows: In March 2016, less than a week after receiving BEXSERO, the patient experienced tenderness on the upper arm. On 8th March 2016, the patient noticed redness and induration medial and lateral injection site. There was no redness or induration at the injection site. It was unknown if the injection site of BEXSERO was upper arm.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Autonomic nervous system imbalance, Blood testosterone decreased, Dry eye, Dry mouth, Erectile dysfunction
Clinical narrative: Autonomic dysfunction - orthostatic intolerance, dry eyes, dry mouth, palpitations, tachycardia, malabsorption (loss of documented 40 lbs), gastrointestinal motility dysfunction, low blood pressure, new food intolerance, muscle weakness, erectile dysfunction, low testosterone, sweating dysfunction, panic attacks and numbness/tingling of extremities.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Food intolerance, Gastrointestinal motility disorder, Hypoaesthesia, Hypotension, Malabsorption
Clinical narrative: Autonomic dysfunction - orthostatic intolerance, dry eyes, dry mouth, palpitations, tachycardia, malabsorption (loss of documented 40 lbs), gastrointestinal motility dysfunction, low blood pressure, new food intolerance, muscle weakness, erectile dysfunction, low testosterone, sweating dysfunction, panic attacks and numbness/tingling of extremities.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Orthostatic intolerance, Palpitations, Panic attack, Paraesthesia
Clinical narrative: Autonomic dysfunction - orthostatic intolerance, dry eyes, dry mouth, palpitations, tachycardia, malabsorption (loss of documented 40 lbs), gastrointestinal motility dysfunction, low blood pressure, new food intolerance, muscle weakness, erectile dysfunction, low testosterone, sweating dysfunction, panic attacks and numbness/tingling of extremities.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Serum ferritin increased, Smooth muscle antibody positive, Sweat test abnormal, Tachycardia, Tilt table test positive
Clinical narrative: Autonomic dysfunction - orthostatic intolerance, dry eyes, dry mouth, palpitations, tachycardia, malabsorption (loss of documented 40 lbs), gastrointestinal motility dysfunction, low blood pressure, new food intolerance, muscle weakness, erectile dysfunction, low testosterone, sweating dysfunction, panic attacks and numbness/tingling of extremities.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Weight decreased
Clinical narrative: Autonomic dysfunction - orthostatic intolerance, dry eyes, dry mouth, palpitations, tachycardia, malabsorption (loss of documented 40 lbs), gastrointestinal motility dysfunction, low blood pressure, new food intolerance, muscle weakness, erectile dysfunction, low testosterone, sweating dysfunction, panic attacks and numbness/tingling of extremities.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a physician assistant via field representative refers to a 16 year old female patient. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant medications were not reported. The patient was not pregnant. On an unknown date in 2015, the patient was vaccinated with first dose of GARDASIL via intramuscular route. On an unknown date, the patient experienced high fevers which occurred 12 hours after receipt of GARDASIL and was subsequently hospitalized for three days. The patient declined getting second and third/final dose of GARDASIL due to the event. The outcome of the event was reported as recovered. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dupuytren's contracture, Synovial cyst
Clinical narrative: Developed a ganglion cyst on left foot then three days later developed Dupuytrens Contractures.
Age: 49.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Body temperature increased, Cellulitis, Disseminated varicella zoster vaccine virus infection, Immunoglobulin therapy, Polymerase chain reaction positive
Clinical narrative: Vesicular/papular rash spreading on neck, face, back, chest, abdomen and legs. Not in a dermatomal distribution. Some lesions crusted over.  Temperature of 102. Treated with IV acyclovir and IV immunoglobulin in addition to IV antibiotics for left chest wall cellulitis. Discharge dx: disseminated varicella zoster. She was vaccinated as part of her immigration process.
Age: 49.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Rash papular, Rash vesicular, Scab, Varicella virus test positive
Clinical narrative: Vesicular/papular rash spreading on neck, face, back, chest, abdomen and legs. Not in a dermatomal distribution. Some lesions crusted over.  Temperature of 102. Treated with IV acyclovir and IV immunoglobulin in addition to IV antibiotics for left chest wall cellulitis. Discharge dx: disseminated varicella zoster. She was vaccinated as part of her immigration process.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Acne, Rash erythematous, Rash pruritic, Scab
Clinical narrative: Child had many itchy, red, raised bumbs all over his right side and under his arm.  After a day they turned into small pimples.  Now, two weeks later, they are scabbed over but are still itchy.
Age: 31.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Body temperature increased, Dizziness, Headache
Clinical narrative: Low grade temp. Headache. Dizzy. Head hurt.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Ear pain, Malaise, Paralysis, Pyrexia
Clinical narrative: 10/21/15 Malaise. Symptoms continued until hospitalized on 11/10/15 with high fever. 11/17/15 Went to doctor - still having low fever, malaise and ear pain. Hospitalized 11/18/15 weakness, paralysis.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site injury, Pain in extremity
Clinical narrative: Sore left arm. After one month went to doctor. Limited arm movement. Diagnosed w/SIRVA and received a steroid shot in bursa. Physical therapy for next month. Still limited movement and pain. will be going to an orthopedic surgeon in April 2016.
Age: 1.09
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Blood culture, C-reactive protein, Culture urine, Differential white blood cell count, Full blood count
Clinical narrative: On and off fever since 3/10/16 - 101F/rectal for 5 days circular blanching rashes on trunk since 3/10/16 (intermittent macular).
Age: 1.09
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Pallor, Pyrexia, Rash, Rash macular, Urine analysis
Clinical narrative: On and off fever since 3/10/16 - 101F/rectal for 5 days circular blanching rashes on trunk since 3/10/16 (intermittent macular).
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patient were vaccinated an improperly stored doses of ROTATEQ (orally, dose was not reported, lot # L006184 with expiration date 13-DEC-2016 or lot # L027067 with an expiration date 06-APR-2017). There was no adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypersensitivity
Clinical narrative: Information has been received from a nurse practitioner referring to an approximately 76 year old female patient with no pertinent medical history or drug allergies. On 16-APR-2007, the patient was vaccinated with 0.65 ml dose of ZOSTAVAX (lot# reported as 0015U, expiration date August 2015) via subcutaneous route. The patient was also on unspecified medications and supplements, described as "multiple pages of medications". Approximately in 2015 (reported as "8 years later"), the patient had a case of shingles. No lab diagnostics studies were performed. The nurse practitioner reported that the patient's present status was not "completely recovered", with a "a little bit of hypersensitivity in the areas" (unspecified which areas, event onset date not reported). Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
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. Information on concurrent condition, medical history or concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L043213 and expiry date 28-AUG-2017 (dose and route not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Details of temperature excursion: Temperature: 48 F Time frame: Undetermined, excursion occurred over the course of several days in February cumulative time frame was not provided Previous excursion: No Data logger involved: Yes. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 3-year-old male patient. The patient's concurrent conditions were not reported. The patient's medical history included swollen lymph node. The patient had no concomitant medications. On 14-MAR-2016, the patient was vaccinated with the first dose of VARIVAX (Merck) subcutaneously, in the left thigh, lot# L037561, expiration date: 29-SEP-2017 (dose was not reported). On the same day, the patient was accidentally vaccinated with the first dose of PROQUAD (Merck) recombinant human albumin (rHA) subcutaneously, in the left thigh, lot# L046509, expiration date: 17-MAY-2017 (dose was not reported) instead of regular M-M-R II. The patient received double Varicella dose. At the time of the report, it was unknown if the patient would receive anymore VARIVAX (Merck) or PROQUAD (Merck). Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Product name confusion, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 16-MAR-2016, during the same vaccination session, the patient received PROQUAD (Merck) lot # L045676, expiry date 09-MAY-2017 (dose, route and site of administration were not reported) and VARIVAX (Merck) lot # L037561, expiry date 29-SEP-2017 (dose, route and site of administration were not reported). The patient was accidentally vaccinated with PROQUAD (Merck) instead of M-M-R II which was the intended vaccine. The reporter said, who was also the person who administered the vaccines, that she confused these two vaccines, as she did not know PROQUAD existed. 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 vocational nurse refers to multiple unspecified patients. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients received improperly stored PROQUAD (Merck) (lot # L041629, expiry date 22-APR-2017 and lot # reported as L050908, expiry date 14-JUN-2017) (dose, route and site of administration were not reported). No adverse effects were reported. Temperature excursion was noted as 11 Fahrenheit for 40 minutes. Also, previous temperature excursion was reported as multiple defrost cycles. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 17-MAR-2016, the patient was administered an expired dose of VARIVAX (Merck) subcutaneously, lot # K003409, expiration date 06-MAR-2016 (dose not reported). No adverse effect reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 76 years old female patient of unknown age with cardiac issues (also reported as medical history) and allergy to polyethylene glycol. In approximately 2014 (reported as about 2 years ago), the patient was vaccinated with ZOSTAVAX (dose, route, lot# and expiration date were not reported). The patient was on unspecified cardiac medications. About 2 weeks after vaccination, the patient started getting large hives on her body which had been an ongoing issue ever since. The patient had sought unspecified medical attention and had been administering unspecified topical products for treatment. The patient did not recover. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated an improperly stored doses of M-M-R II (dose and route were not reported, lot # L012480 with expiration date 10-APR-2017 or lot #L020189 with expiration date 03-JUN-2017). There was no adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Computerised tomogram head normal, Dyspnoea, Headache, Hypersensitivity, Peripheral swelling
Clinical narrative: Breathing problems (1 day), itching, high fever (1 day), pain on side of head (3-4 days), arm swelling (entire).
Age: 73.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pruritus, Pyrexia
Clinical narrative: Breathing problems (1 day), itching, high fever (1 day), pain on side of head (3-4 days), arm swelling (entire).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated an improperly stored doses of GARDASIL (dose and route were not reported, lot #L040459 with expiration date 06-APR-2017 or lot # K008931 with expiration date 04-MAR-2017). There was no adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, Gene mutation identification test positive
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, regarding a 5 year old female patient with recurrent infections since age 2 months, hypogammaglobulinemia and atypical heterozygous Artemis mutations associated with an unrelated gene mutation. It was reported that the patient was immunodeficient. It was also stated that the patient's mother with an isolated similar heterozygous Artemis mutation was asymptomatic. The patient had low immunoglobulin G (IgG), immunoglobulin A (IgA) and immunoglobulin M (IgM), low CD4+ and high CD8+ percent of T cells. On an unknown date, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (PPV23), injection, (dose, route of administration and injection site were not reported) and pneumococcal 13v conj vaccine (crm197) (PCV13), (formulation, dose, route of administration and injection site were not reported) for an unknown indication. There were no concomitant medications reported. On an unspecified date, the patient developed failed antibody responses to Pneumococcal polysaccharide and Conjugate vaccines, PPV23 and PCV13 respectively. Genetics performed on an unspecified date revealed a missense mutation of exon 6 of the DCLREC1 gene I: c.457G>A; p.G153R. Other mutations found on DCLREC1 reported as unlikely association. The outcome of failed antibody responses to Pneumococcal polysaccharide and Conjugate vaccines was unknown at the time of the report. The authors considered the event to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). This is one of two reports received from the same literature article (cross reference with MARRS#1603USA007632). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a health care professional refers to unspecified patients of unknown demographics. Approximately in 2016 (also reported as "unspecified dates since 09-FEB-2016") the patients were vaccinated with improperly stored PROQUAD (Merck) (dosing regimen unspecified) (L044056/ exp. 02-MAY-2017; L032761/ exp. 24-FEB-2017; L042818/ exp. 26-APR-2017). This request was originally opened on 09-FEB-2016 to evaluate improperly stored vaccines. The healthcare worker called back to evaluate the same doses, which were previously exposed to temperatures outside of the recommended range, and had been administered to patients since this service request was opened. Healthcare worker reported that doses of the following, which were exposed to the following conditions, were administered to unspecified patients: temperature: -10.96C, Time frame: 15 hours, previous temperature excursion: -11.51C for 15 hours. It was not a call because of a data logger. No additional information was provided. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered, 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. Information on concurrent condition, medical history or concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L029617 and expiry date 19-MAY-2017 (dose and route not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Details of temperature excursion: Temperature: 48 F. Time frame: Undetermined, excursion occurred over the course of several days in February cumulative time frame was not provided. Previous excursion: No. Data logger involved: Yes. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to unspecified patients of unknown demographics. Approximately in 2016 (also reported as "unspecified dates since 09-FEB-2016") the patients were vaccinated with improperly stored VARIVAX (Merck) (dosing regimen unspecified) (L034372/ expiry. 08-SEP-2017; L011083/ expiry. 01-APR-2017; K002927/ expiry. 26-FEB-2016; K008824/ expiry. 19-JUN-2016). This request was originally opened on 09-FEB-2016 to evaluate improperly stored vaccines. The healthcare worker called back to evaluate the same doses, which were previously exposed to temperatures outside of the recommended range, and had been administered to patients since this service request was opened. Healthcare worker reported that doses of the following, which were exposed to the following conditions, were administered to unspecified patients: temperature: -10.96C, Time frame: 15 hours, previous temperature excursion: -11.51C for 15 hours. It was not a call because of a data logger. No additional information was provided. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and drug reactions/allergies were not reported. The reporter stated that the patient was administered the first dose of GARDASIL 9 (dose, route, lot# and expiration date unknown) on 11-NOV-2015, the second dose of GARDASIL 9 (dose, route, lot# and expiration date unknown) on 21-JAN-2016 and the third dose of GARDASIL 9 (lot # L045711, expiration date 08-MAY-2017, dose and route unknown) on 16-MAR-2016. No adverse effect was reported. Additional information has been requested.