chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Frequent bowel movements, Injection site erythema, Injection site inflammation, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old male patient. The patient's concurrent conditions included diabetes mellitus and hypertension. On 13-SEP-2016, the patient was vaccinated with ZOSTAVAX (lot # reported as M020902, expiry date: 18-SEP-2017), at a dose of 0.65 ml, once (route: subcutaneous). Concomitant therapies included metformin, PRINIVIL, JANUVIA and glipizide. On 14-SEP-2016, at mid-day, patient's injection site was inflamed, very red and patient experienced itching. On the same day in the evening, patient experienced frequency of stools, resulting in stomach irritation and decreased urine output. The patient did not receive any treatment for the events. The outcome and causality of the events were unknown. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Urine output decreased
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old male patient. The patient's concurrent conditions included diabetes mellitus and hypertension. On 13-SEP-2016, the patient was vaccinated with ZOSTAVAX (lot # reported as M020902, expiry date: 18-SEP-2017), at a dose of 0.65 ml, once (route: subcutaneous). Concomitant therapies included metformin, PRINIVIL, JANUVIA and glipizide. On 14-SEP-2016, at mid-day, patient's injection site was inflamed, very red and patient experienced itching. On the same day in the evening, patient experienced frequency of stools, resulting in stomach irritation and decreased urine output. The patient did not receive any treatment for the events. The outcome and causality of the events were unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Patient presented on 9/23/2016 with c/o swelling and mild pain at the left elbow 2 day after PNEUMOVAX 23 vaccine. Patient prescribed KEFLEX 500mg capsule 1 cap BID X10 days. Patient encouraged to take antibiotic and return in one week for evaluation.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: 2 hours after injection (vaccine given 9:30am 9/15/16) patients arm became red swollen and painful unable to lift.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Patient called a different location and spoke to pharmacist and complained of severe pain and stated she thought the shot was given too high.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Large knot in left upper arm, approximately 5" x 3.6" with tenderness, redness and hot to the touch. Aching in joints in arm/shoulder as well as into hip and legs. Symptoms appeared within few minutes of administration of vaccine.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Muscular weakness, Pain in extremity, Rash macular
Clinical narrative: Injection site reaction, redness and swelling. Pt. felt weak with pain on left arm with red blotches on injection arm. Symptoms occurred a "few" days after administration. Pt went to hospital, received treatment and recovered.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Swollen tongue, Throat irritation
Clinical narrative: Influenza vaccine given 9-21-16. About 20 minutes later c/o throat itching and hard to breathe - has allergy to eggs but is able to eat eggs and has taken vaccine before. Placed in room given DEPO-MEDROL 80mg IM, BENADRYL 25mg IM and 25mg P.O. Cannot take Epinephrine. O2 per NC at 4 liters. After 60 minutes felt better and returned to work with OK from physician. About 45 minutes to an hour later patient experienced a second episode where her tongue started swelling and again-felt like she couldn't breathe as well as she had. Dr. was notified and patient received KENALOG 80mg IM and 50mg of BENADRYL IM and was observed for an hour and felt like her tongue was no longer swelling and patient was able to have someone drive her home. Patient stated that during the night she felt like her tongue was swelling again and took another 50mg of BENADRYL by mouth. Patient returned to work the next day.
Age: 71.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Swelling, warmth, blistering of skin on arm where administered in left arm.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling in injection site area (on left arm below injection site area) - warm to touch; pt not having any other symptoms-consulted MD (PCP)
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Blood electrolytes normal, Generalised tonic-clonic seizure
Clinical narrative: Tonic clonic seizure at 10Am on 9/24/16 without incontinence. Seen in ER, Normal PE and electrolytes.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Soreness 9/14. Redness and itch 9/15. Mild redness below site of injection (L) arm. Some swelling seems to have gotten lower each day to level of the elbow; BENADRYL and see PCP 9/19.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Adverse reaction
Clinical narrative: KINRIX and MMRV in (L) arm. Antibiotic treated, for 10 days.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hypoaesthesia oral, Paraesthesia oral, Sensation of foreign body
Clinical narrative: 3-4 min. after vaccine became lightheaded. Laid down. Approximately 10 min later lips felt tingly and numb and felt like "something" was in her throat. Moved to stretcher. Anesthesia on unit assessed pt while waiting for medical response team. Lightheaded, tingly and feeling in throat continued for 30 min. then gone.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Type III immune complex mediated reaction
Clinical narrative: The morning after the immunization, developed erythema and induration of the skin overlying the left deltoid. Seen 9/22, DX'd with arthus reaction, given loratadine PO by myself at my office.
Sex: U
Vaccine: PPV
Symptoms: Pneumonia, Pneumonia pneumococcal
Clinical narrative: This is a spontaneous report from a non-contactable physician via a Pfizer sales representative. A patient of unknown age and gender received on an unspecified date PREVNAR 13 at single dose and PNEUMOVAX, both for immunization. Medical history and concomitant medications were not reported. The physician mentioned that the patient had pneumonia symptoms that were consistent with pneumococcal pneumonia. The patient received both pneumococcal 13-val conj vac (dipht crm197 protein) and pneumococcal vaccine. Outcome was not reported. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVNAR 13 in this patient cannot be excluded. Further information like serotyping results is needed for a full medical assessment.
Age: 11.0
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Injection site vesicles, Pain
Clinical narrative: Redness from hip to knee joint. Blister at injection site on outer thigh. Pain with walking, no pain with touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Oedema peripheral, Skin discolouration, Urticaria
Clinical narrative: Hives started 9/21/16. Seen in office 09/22/16 for widespread hives, edema of arms and purpleness of lower extremities. The patient is a 4 year old child presenting with widespread hives for 1 days. He is accompanied by maternal grandmother. Parent/patient had tried BENADRYL and ibuprofen- last doses today at 10:15am.
Age: 31.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm extremely red, swollen, and warm to touch.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a multiple unspecified patients of unknown age and gender. No pertinent medical history and drug reactions/Allergies were reported. On unspecified dates the multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX (lot # K015994 and expiry date 23-SEP-2016) (lot # L000455 and expiry date 06-JAN-2017) (lot # L004654 and expiry date 11-FEB-2017) (lot # M000760 and expiry date 06-JAN-2018) (lot # M000762 and expiry date 06-JAN-2018) (lot # M006731 and expiry date 09-FEB-2018) (lot # M010482 and expiry date 01-MAR-2018) (lot # M014908 and expiry date 25-MAR-2018) (lot # M017290 and expiry date 07-APR-2018) (lot # M019643 and expiry date 20-APR-2018) (dosing regimen and frequency were not reported for all the lots). No concomitant medications were reported. The vaccine was exposed to temperature of 32 Fahrenheit for 165 hours. Previous temperature excursions reported as on 04-AUG-2016, the vaccine was exposed to temperature of 7.8 Fahrenheit for 1 day and on 08-AUG-2016, the vaccine was exposed to 6.6 Fahrenheit for 1 hour and 48 hours. No adverse effects were reported. No product quality complaint (PQC) was reported. No additional information was provided. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swollen and painful arm. Patient taking TYLENOL for pain. Seen by provider 9/24/16. Patient to continue with TYLENOL and to apply cold compresses.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 9/22/16 vaccine site red, hot, swollen. 9/23/16 her arm from her shoulder to her elbow was swollen, red, hot. 9/26/16 swelling and redness better but not gone, not hot to the touch.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Anaemia, Contusion, Decreased appetite, Fatigue, Hypersomnia
Clinical narrative: Swollen arm, fatigue - first day. Bruise on arm and other body parts, does nothing but sleep, wouldn't eat - second day. He had blood work done a week later and he was anemic, low red and white blood cells and platelets. Still has a lump and bruise at injection site. has to go in for routine blood work every two weeks - today 09/26/2016.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site bruising, Injection site mass, Peripheral swelling, Platelet count decreased, Red blood cell count decreased
Clinical narrative: Swollen arm, fatigue - first day. Bruise on arm and other body parts, does nothing but sleep, wouldn't eat - second day. He had blood work done a week later and he was anemic, low red and white blood cells and platelets. Still has a lump and bruise at injection site. has to go in for routine blood work every two weeks - today 09/26/2016.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: White blood cell count decreased
Clinical narrative: Swollen arm, fatigue - first day. Bruise on arm and other body parts, does nothing but sleep, wouldn't eat - second day. He had blood work done a week later and he was anemic, low red and white blood cells and platelets. Still has a lump and bruise at injection site. has to go in for routine blood work every two weeks - today 09/26/2016.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Vomiting, fever, chills.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Fatigue, Hyperhidrosis, Muscular weakness, Myalgia
Clinical narrative: Violent chills for 2 hours, sweats for 12 hours, prostration for 24 hours, muscle weakness and pain continuing at 72 hour point.  200 mg. Ibuprofen every 6 hours gave significant relief of muscle pain.  Still very weak.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Fatigue, Headache, Hypersomnia, Insomnia
Clinical narrative: Arthralgia, difficulty moving arm, myalgia, decreased sleep, headache, hypersomnia irritability, fatigue.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Irritability, Mobility decreased, Myalgia
Clinical narrative: Arthralgia, difficulty moving arm, myalgia, decreased sleep, headache, hypersomnia irritability, fatigue.
Age: 54.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Influenza A virus test negative, Influenza virus test negative, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Injection site pain, redness, and fever requiring Medrol dosepak and Benadryl. Symptoms resolved on 9/25/16 without the use of antibiotics.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Disorientation, Dizziness, Erythema, Fatigue, Mobility decreased
Clinical narrative: Red, warm, swollen and sore arm. Dizziness, disoriented, fatigue, and exhaustion. Had difficulty raising his left arm.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Red, warm, swollen and sore arm. Dizziness, disoriented, fatigue, and exhaustion. Had difficulty raising his left arm.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Mother contacted on 9/24/16 at early afternoon to advise that her daughter had experienced redness, swelling at site.  Family doctor advised cellulitis and prescribed antibiotic.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented with a swollen, red area at the subcutaneous site of the Zostavax injection.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Swelling and Redness, warmth in area of shot. The areas was approximately an 1 and half inches in diameter. She also experienced rash that developed on Sat on both the right leg and left. Patient did take a BENADRYL.
Age: 96.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Right arm is red and hot (from shoulder to elbow) to the touch. Patient states it started late Saturday evening after receiving the vaccine on Friday.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Radiculitis brachial
Clinical narrative: Patient called with complaints similar to brachial neuritis with complaints of shoulder pain which wakes her up at night.  She had tried ibuprofen and ice with no relief.  She received a prescription for diclofenac on 9/23/16. Unknown exact date of onset of symptoms.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: Patients left arm has a red hard circular bump the size of a golf ball.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Swelling aproximately 2 inches below the shot.  The swelling was in a broad band 3" x 4" across her right arm.
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: On 9/26/16, patient claims that arm is still hurting with muscle soreness upon raising arm above shoulder height or stretching the deltoid muscle. He reports thickness of Fluad was more painful than his usual flu injections.
Age: 66.0
Sex: F
Vaccine: FLUX, PNC13, TDAP, VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash/itching encompassing most of upper left arm -- treated with oral diphenhydramine and ranitidine.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered
Clinical narrative: MMRV vaccine administered and varicella vaccine administered.
Age: 17.0
Sex: F
Vaccine: MENB, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Red, Swelling, warm around area of vaccination, approximately 2x3 inches in size. Patient reports difficulty moving arm for approximately 2-3 days after vaccination.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site rash
Clinical narrative: Pt developed red, shingles-like rash at site of vaccine injection on left arm and wrapping counter-clockwise around to involve area over left tricep and left shoulder. Pt advised to seek consultation with her PCP.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Injection site abscess, Injection site pain
Clinical narrative: Developed large tender abscess on upper left arm.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red sore swollen leg at the injection site with uncontrollable crying.
Age: 55.0
Sex: F
Vaccine: DTAP
Symptoms: Chest discomfort, Dizziness, Headache, Hypertension, Nausea
Clinical narrative: Vomiting every few minutes, nausea, extreme headache, high BP, woozy, chest pressure.
Age: 55.0
Sex: F
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: Vomiting every few minutes, nausea, extreme headache, high BP, woozy, chest pressure.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Vaccination site swelling
Clinical narrative: Pt was having swelling of the vaccinated arm from midway between her shoulder and elbow up to her shoulder. The swelling felt like fluid.
Age: 16.0
Sex: M
Vaccine: FLU4, MEN, MENB
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Headache, vomiting and fever.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: Patient returned to inform us he was having non-specific pain from the wrist up around his shoulder and to his chest in the same arm in which he received his flu shot. His Left arm to be specific.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PPV
Symptoms: Crying, Insomnia, Pyrexia
Clinical narrative: Excessive crying, sleeplessness, fever 101.7.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site pruritus, Pallor, Vaccination site induration, Vaccination site warmth
Clinical narrative: 9/17 was doing fine until this am - now has red area of induration and heat where he got vaccinations - doesn't seem to hurt, maybe only itch a little - redness is not spreading. 9/19/16 Skin: Mildly erythematous patch on anterior left thigh 10x10cm without pustules or satellite lesions. Blanches. Minimal induration over injection site, no mass or fluctuance. Not seemingly tender. Not warm to touch.  9/23/16 Skin: No laceration, no lesion, no petechiae and no purpura noted. Rash is not papular, not pustular and not vesicular. He is not diaphoretic. There is erythema. Anterior left thigh erythema. Blanchable. No lesions. Skin not firm. Borders regular and not raised. Non-tender, not warm.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Flushing, Pain in extremity, Pharyngeal oedema, Pruritus
Clinical narrative: Patient states that on the evening of the 23rd her left arm started hurting, she had flushing, itching, and throat swelling.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea, Faeces discoloured, Mucous stools
Clinical narrative: Approximately 8 to 10 green, watery, mucusy stools daily x 16 days. Has not yet resolved.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Head injury, Headache, Heart rate abnormal, Hypotension, Pallor
Clinical narrative: Fainted 3 minutes after receiving vaccine and was out for 60 seconds. Upon coming to, was shaking almost seizure-like but stopped upon becoming fully alert. Face & lips extremely pale with very low blood pressure and heart rate which improved in 15 minutes after lying down and drinking water. All occured while in physicians office in front of the nurse. Blurred vision and ringing in ears lasted 1 hour and headache still persists 6 hours later, which might be from bumping her head on the cabinet when she fainted.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure like phenomena, Syncope, Tinnitus, Tremor, Vision blurred
Clinical narrative: Fainted 3 minutes after receiving vaccine and was out for 60 seconds. Upon coming to, was shaking almost seizure-like but stopped upon becoming fully alert. Face & lips extremely pale with very low blood pressure and heart rate which improved in 15 minutes after lying down and drinking water. All occured while in physicians office in front of the nurse. Blurred vision and ringing in ears lasted 1 hour and headache still persists 6 hours later, which might be from bumping her head on the cabinet when she fainted.
Age: 41.0
Sex: F
Vaccine: FLU3, TYP
Symptoms: Blood test normal, Facial paralysis, Hypoaesthesia, Tinea capitis, Tongue disorder
Clinical narrative: Numbness and tingling to entire left extremity, migrated mid-line down to left side of rib cage. Also migrated to left side of neck and face, resulting in left side facial drooping with tongue thickening. No respiratory involvement.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, red, hot area starting 2 inches below injection site. Not sure if related to shots but walk-in clinic gave KEFLEX just in case.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Myalgia, Neck pain, Pain, Paraesthesia
Clinical narrative: Vaccine given in right arm but left arm became tingly, and a continuous dull pain began in the left armpit with random sharp pain occurring intermittently. Pain began to radiate to the neck. Also chills/shivers and full body muscle pains began 9/26/2016.
Age: 79.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Pain, Pyrexia
Clinical narrative: Weak, fever, achy.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram normal, Hypoaesthesia, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Client stated she Received vaccine 1:30 pm on Monday. Experienced the usual pain at the time of injection. No fever or dyspnea. Pain and soreness increased and became intolerable (10+ pain scale 1-10) radiating to neck and along arm with tingling and numbness in fingers. Called a nurse was told to go to ED immediately to R/O possible MI. Client went around 6AM to hospital ED. Sent home with VICODIN q4-6 hours. Client state there has been no improvement and no relief from pain. Went to primary care provider Dr. Referred to ED. Given TORADOL, ZOFRAN, Hydrocodone 600-mg ibuprofen for home. Still no improvement over the weekend although states that she is now able to move fingers and grab someone's finger, no tingling and numbness since Saturday and can bend at the elbow but cannot lift, abduct or adduct arm. Is trying to follow up with neurologist unable to get appointment today.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Client stated she Received vaccine 1:30 pm on Monday. Experienced the usual pain at the time of injection. No fever or dyspnea. Pain and soreness increased and became intolerable (10+ pain scale 1-10) radiating to neck and along arm with tingling and numbness in fingers. Called a nurse was told to go to ED immediately to R/O possible MI. Client went around 6AM to hospital ED. Sent home with VICODIN q4-6 hours. Client state there has been no improvement and no relief from pain. Went to primary care provider Dr. Referred to ED. Given TORADOL, ZOFRAN, Hydrocodone 600-mg ibuprofen for home. Still no improvement over the weekend although states that she is now able to move fingers and grab someone's finger, no tingling and numbness since Saturday and can bend at the elbow but cannot lift, abduct or adduct arm. Is trying to follow up with neurologist unable to get appointment today.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: L arm swollen, warm and red up to elbow.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Feeling cold, Myalgia, Pyrexia
Clinical narrative: I woke up with a fever and chills and I was dizzy. I put a ice bag behind my head by the cervical spine wrapped in a towel. I also took two aspirin, the fever broke after a few hours. I would have went to the ER or called an ambulance if the symptoms got worse. Muscle aches contained to the next day. This was the first chance I got to report it. I feel okay today.
Age: 39.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Infection, Rash pruritic
Clinical narrative: Itchy bump (infection).
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Diagnosed with HPV.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Rash, fever, body aches.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site redness, swelling, itching, and hot to the touch, extending from elbow to mid-arm (almost shoulder), approximately 6 inches wide.
Age: 77.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Fatigue, Injection site swelling, Pyrexia
Clinical narrative: Pt experienced swelling in her left arm (about 1+1/2 inch in diameter) at injection site and still has it currently; she experienced fever and said she had fatigue for 3 days.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram head abnormal, Dizziness, Fall, Head injury, Loss of consciousness
Clinical narrative: Given HPV #2 at 943am. Asked if had any problems with 1st HPV, denied. Sent to another clinic 10 min away to scoliosis series felt dizzy in xray room, fell and hit head. Unconscious, suffered skull fracture.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Skull fracture
Clinical narrative: Given HPV #2 at 943am. Asked if had any problems with 1st HPV, denied. Sent to another clinic 10 min away to scoliosis series felt dizzy in xray room, fell and hit head. Unconscious, suffered skull fracture.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Deafness unilateral, Fall, Skull fracture, Spinal X-ray, Syncope
Clinical narrative: Given HPV #2 at 943am. Asked if had any problems with 1st HPV, denied. Sent to another clinic 10 min away to scoliosis series felt dizzy in xray room, fell and hit head. Unconscious, suffered skull fracture.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information was concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX 19400 PFU lot # M020902/expiration date - 18-JUL-2017. Temperature was 6.7 F(Fahrenheit), temperature was 30 minutes and call was not because of the data logger. Previous temperature excursion was 12 F for 2 hours. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a physician via company representative regarding unknown number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with PNEUMOVAX 23. Patient contacted physician to seek medical attention. No PQC (product quality complaint) was involved. No concomitant medication was reported. On an unknown date the patients experienced injection site pain. The outcome of injection site pain was reported as resolved. Causality was unknown. 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 registered nurse refers to unknown patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of HPV VLP vaccine (Lot # M016193, expiration date 24-APR-2018 and Lot # reported as L036301, expiration date 20-DEC-2017) (Dose and route were not provided). Concomitant medications were not reported. The temperature excursion details were 9 degree C for 1 hour and 24 minutes. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unknown patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of VARIVAX (Lot # M007287, 12-FEB-2018; M020899, 24-APR-2018; M024683 18-MAY-2018) (Dose and route were not provided). Concomitant medications were not reported. The temperature excursion details were -11.2 C for 1 hour 18 minutes. On lot # M007287, 12-FEB-2018) had an additional excursion of -9 degree C for 2 hours. A second freezer containing different lots of VARIVAX (M006726, 08-FEB-2018; M004328, 26-JAN-2018; L043622, 03-NOV-2017; M024683, 30-SEP-2018) with a temperature excursion of -12.9 degree C for 48 minutes. No adverse effects reported. This is one of several reports 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 registered nurse refers to unknown patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB 2.5/0.5 (Lot# reported as M010611, expiration date 02-JUN-2018; M022077, expiration date 10-MAR-2019; M023718, expiration date 09-MAY-2018) (Dose and route were not provided). Concomitant medications were not reported. The temperature excursion details were 9 degree C for 1 hour 24 minutes, with an additional excursion of 10 degree C for 2 hours for RECOMBIVAX HB lot# M010611, expiration date 02-JUN-2018; M022077, expiration date 10-MAR-2016. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist referred to a 48 year old female patient. The patient's pertinent medical history included Legionnaires disease and allergy to sulfa drugs. She was taking unspecified medications. On 19-SEP-2016, the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, intramuscularly in the right arm. Lot # M027552 with expiration date: 04-FEB-2018. The patient received concomitantly influenza virus vaccine (unspecified) (reported as flu vaccine) in the left arm. It was reported that "within the past 24 hours" after vaccination, the patient developed an unspecified rash at the right armpit with a size reported of "two inches". The pharmacist reported that the patient was scheduled to see her unspecified physician on 21-SEP-2016 regarding the event. The patient did not receive treatment for the event and laboratory diagnostic studies were not performed. There was not a product quality complaint involved. At the time of reporting the outcome of the event was reported as not recovered. The causality assessment between the event and the suspect therapy was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unknown patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of M-M-R II (Lot # L049316, expiration date 03-DEC-2017; M006544, expiration date 03-FEB-2016) (Dose and route were not provided). Concomitant medications were not reported. The temperature excursion details were 9 degree C for 1 hour 24 minutes, with an additional excursion of 10 degree C for 2 hours for M-M-R II Lot # L049316, expiration date 03-DEC-2017. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information was concurrent condition and historical medication. On an 20-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX lot # M020902/ expiration date- 18-JUL-2017. Temperature was 6.7 F (Fahrenheit), temperature was 30 minutes and call was not because of the data logger. Previous temperature excursion was 12 F for 2 hours. No concurrent medication was reported. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient "greater than 65 years of age" with a pertinent medical history of "asthma and chronic obstructive pulmonary disease". The pharmacist reported that the patient had been administered PNEUMOVAX 23 (unspecified lot/expiration date) annually at multiple locations described as "a health department, unspecified physician's office, and other places". On an unspecified date in the year 2011, the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, route, lot # and expiration date were not reported). The dates of administration were unspecified for years: 2012, 2013, and 2015 (drug use for unapproved schedule). The pharmacist reported that the patient also received a dose of PNEUMOVAX 23 (unspecified lot/expiration date) on 27-DEC-2014 and had written documentation. The pharmacist stated that the patient was present to receive his 2016 annual vaccination in a pharmacy on 14-SEP-2016 because his physician told him to get it. The pharmacist had not administered the 2016 annual dose of PNEUMOVAX 23 at time of the report. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, unspecified patients were vaccinated with doses of improperly stored VARIVAX (lot # L041204, expiration date 20-OCT-2017, lot # M004329, expiration date 29-JAN-2018; dose and route were unknown). No adverse reactions was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unknown patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of ROTATEQ (Lot # M007125, expiration date 06-OCT-2017; M004542, expiration date 07-OCT-2017) orally (Dose was not provided). Concomitant medications were not reported. The temperature excursion details were 9 degree C for 1 hour 24 minutes, with an additional excursion of 10 degree C for 2 hours for ROTATEQ (M007125 expiration date 06-OCT-2017). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Large red blotch in a circle around injection site. Pink, itchy, a little swollen.
Age: 68.0
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Asthenia, Hypoaesthesia, Pain in extremity
Clinical narrative: Right arm pain, weakness, and numbness from upper arm to pinky. Intensity varies with position. Started couple days after vaccine. Got worse and then is starting to get better. Patient use aspirin to treat pain. Patient has physician appt. 9/27/16. Patient believes only ZOSTAVAX in right arm despite documentated otherwise.
Age: 54.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Asthenia, Back pain, Dyspnoea, Urticaria
Clinical narrative: Roughly 15-20 mins after shots were administered as patient was walking out he told his wife that he was feeling weak and his lower back was in excruciating pain. Stated he was having difficulty breathing due to pain, 911 was called and taken to hospital. Wife then reported pt. broke out in hives at hospital.
Age: 68.0
Sex: M
Vaccine: HEP, PNC13, TDAP, VARZOS
Symptoms: Syncope
Clinical narrative: Patient syncope.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Mobility decreased, Pain in extremity, Swelling
Clinical narrative: (1) Flu shot given 9/20/16.  (2) 9/21/16 9:06AM Patient called pharmacy complaining about swollen, burning, arm hurt, hard to move.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient had a flu shot and a PNEUMOVAX 23 shot at the same time, her (L) arm where the PNEUMOVAX was administered became red, puffy, hot to touch with rash spreading even after 2 days of taking BENADRYL. C/O fever, night sweats, chills first 2 nights.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Night sweats, Pyrexia
Clinical narrative: Patient had a flu shot and a PNEUMOVAX 23 shot at the same time, her (L) arm where the PNEUMOVAX was administered became red, puffy, hot to touch with rash spreading even after 2 days of taking BENADRYL. C/O fever, night sweats, chills first 2 nights.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Received flu vaccine Friday 9/23/16, rash appeared and was visible when patient presented 9/26/16. Patient received FLUZONE HD.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Rash generalised, Urticaria
Clinical narrative: 9:00 am. patient presented with rash (hives) starting 09/25/2016, today still presenting rash full body. No shortness of breath or any other symptoms. Advised patient to go see MD. 2:05PM phone call patient, she stated seen by MD this morning and started BENADRYL, rash improving.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: Patient had a small red spot where injection occurred with small blister and slight pain. Patient applied cold compresses and made appt. with dermatologist.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patients mother reports swelling, redness, tenderness, hotness at vaccination site. States swelling was approx. 6 x 2 inches, started just beneath deltoid (right) , extended to just above elbow. Lasted 5 days, mom called local ER, gave daughter TYLENOL and applied ice. Redness resolved. Redness resolved, swelling resolving, but still present.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Skin reaction, Skin warm
Clinical narrative: Client's left arm swelled from shoulder to bend of elbow, red, with heat. Was going to go have doctor look at it.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injection site induration, Pruritus
Clinical narrative: 4 inch wide x 8 inch long redness/itching/induration on right arm starting 3-4 days after injection given. Induration is directly over injection site.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 9/18/16 - Pt developed swelling, red, itchy and warm to touch over R deltoid to right elbow. Length 20 cm, width 15 1/2 cm. Treated with prednisone 20 mg 2 tabs daily x 5 days, triamcinolone acetonide 0.1% external cream twice daily to affected area.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left anterior thigh erythema, swelling, itchy and warmth.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Patient developed maculopapular rash with itchiness after 7 days of vaccinations.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Impaired work ability, Pruritus, Rash pustular
Clinical narrative: On 9-20-16 pt began having pustules erupt on arms and face that itch. Pt had received VARIVAX vaccine 9-16-16. Pt returned to office on 9-26-16 and symptoms reported to Dr. No treatment. Pt instructed to avoid work until 10-10-16.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unknown patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of VAQTA 25/0.5 (Lot # M015290, expiration date 20-SEP-2017 and Lot 3 reported as M022924, expiration date 24-JAN-2018) (Dose and route were not provided). Concomitant medications were not reported. The temperature excursion details were 9 degree C for 1 hour 24 minutes. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Heart rate increased, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: High fever, cough, rapid heartbeat, arm is red/swollen at injection site and is difficult to use this arm. Using BACTRIM DS 800-160 + BENADRYL + NSAIDS.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: High fever, cough, rapid heartbeat, arm is red/swollen at injection site and is difficult to use this arm. Using BACTRIM DS 800-160 + BENADRYL + NSAIDS.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Nausea, Pallor, Vomiting
Clinical narrative: C/O lightheadedness, skin pale, nausea, vomiting. Laid pt flat and elevated feet, turned to the side after vomiting stopped. Offered Gatorade and pretzels. BP 124/82, HR 62, R16, T 97.2 orally. Was DC'd home with mother ambulating/denied any complaints.
Age: 16.0
Sex: F
Vaccine: HEP, HPV9, IPV, MENB, MMR, MNQ, TDAP, VARCEL
Symptoms: Pruritus generalised
Clinical narrative: 1045 after receiving vaccines pt c/o itching all over the body. Gave epi pen 0.15 mg IM. Call 911. No wheezing noted, throat's redness or swelling. No rash or hives notes, it alert and o x 3. Pt sent to ER to monitor with Tx and sent home.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vaccine administered at 1500. Fever began at 2100, vomiting at 2200. Profuse vomiting for the next 18 hours with fever to 102.8 degrees F. The fever resolved to return the next day to 99.5.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient had little red bumps appear all over neck and shoulders within 24 hours of receiving vaccine. They persisted for over 3 weeks but were improving. She asked prescribed about them at check-up.
Age: 44.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Acupuncture, Back pain, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Pt. states 3 weeks after injection she experienced extreme pain in her shoulder, arm, neck and upper back. She saw her PCP who felt it was due to vaccine. She was placed on Prednisone x 5 days and then an 11 day taper after the 5 days which didn't help. Has seen chiropractor and acupunction. No relief.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever up to 100 degrees -> for one day. Injection site swollen, red -> for approx. 2 days. Went to primary care clinic-staff/doctor reported patient had allergies -> placed on MEDROL DOSE PACK/FLONASE spray/CLARITIN.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 21-SEP-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K016294, expiry date: 28-APR-2016) intramuscularly. No adverse effects were 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: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX, 0.65ml subcutaneously, (lot # L015417, expiry date 16-AUG-2016 (also reported as 21-SEP-2016). No adverse effects were reported. The outcome of expired product administered and no adverse event was unknown. Additional information is expected.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Information regarding pertinent medical history, drug reaction or allergies and concomitant therapy were not reported. On 14-SEP-2016, the patient was inadvertently administered with an expired dose of PEDVAXHIB (lot # J011963, expiry date: 20-JUN-2016 and dosing details were not provided). No adverse effects were reported. There was no product quality complaint (PQC) involved. 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 referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 08-SEP-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # I044917 which had an expiration date on 05-OCT-2018) (dose, dose number, frequency and route were not reported). No adverse effects reported. Concomitant medication information was not provided. No product quality complaint (PQC) was involved. Additional information has been requested.