chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, PPV
Symptoms: Blood test, Respiration abnormal, Swelling face, Urticaria
Clinical narrative: My son began whole entire face, neck, and arms area broke out in hives, his face became swollen. Began to complain about his breathing a little bit.
Age: 71.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: SORE, RED, ITCHY, A MONTH LATER.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient complains her arm still hurts from where vaccine was administered.
Age: 28.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Axillary pain, Injection site pain, Injection site swelling, Swelling
Clinical narrative: Arm very painful and swollen (from inj. site to armpit).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling in right leg. Painful and hot to touch-Chief complaint. 9x4 cm area of right thigh-non tender-physical exam. Pt started on BACTRIM 40mg-200mg/5ml and HYTONE 2.5% topical cream to left thigh-contact derm.
Age: 1.0
Sex: M
Vaccine: FLU4, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: "Red spot with a lump on the right upper thigh."
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Musculoskeletal disorder, Pain, Sleep disorder
Clinical narrative: Could not sleep on arm for over 2 months. Loss of normal arm use-Putting on clothes, taking off clothes. pain when trying to do normal movement of upper arm. It's still there.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Tremor
Clinical narrative: Severe shaking, chills and headache for 24 to 30 hours.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: After flu shot, experienced soreness in arm for 2 wks, then it began to throb occasionally and she started experiencing weakness in the shoulder/arm. She can't lift her arm over her head. Has had several weeks of physical therapy.
Age: 43.0
Sex: F
Vaccine: FLU3, FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Middle insomnia, Muscular weakness, Sleep disorder
Clinical narrative: Pain at injection site, started evening of injection (L) deltoid. Pain increases and decreases depending on the day. Pain radiates down upper arm. Pain makes it difficult to sleep on left side, waking me up at night. There is now decreased range of motion and weakness to (L) arm. Tried ibuprofen with minimal results, tried ice and heat.
Age: 43.0
Sex: F
Vaccine: FLU3, FLUC4
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Pain at injection site, started evening of injection (L) deltoid. Pain increases and decreases depending on the day. Pain radiates down upper arm. Pain makes it difficult to sleep on left side, waking me up at night. There is now decreased range of motion and weakness to (L) arm. Tried ibuprofen with minimal results, tried ice and heat.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Reddened (R) arm, swollen, warm to touch.
Age: 11.0
Sex: F
Vaccine: DTAP, FLU4, MNQ
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None known.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Arthralgia, Erythema, Joint swelling, Pruritus
Clinical narrative: Swelling, redness, itching, and pain in both knees. Treatment - ibuprofen / BENADRYL.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: Red, swollen, hard, hot from shoulder to elbow. BENADRYL, ibuprofen, ice.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, raised, warm, painful (feels like a rug burn) 4 x 6 area with circle around injection site.
Age: 0.83
Sex: M
Vaccine: HPVX
Symptoms: Wrong patient received medication
Clinical narrative: None, patient was given vaccination to wrong patient in nursing error.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen at inj. site.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR
Symptoms: Seizure, Vomiting
Clinical narrative: Emesis on 12/17/16. Standing in crib, had generalized Sz - duration 3-4 min. EMS transported to ED. Given NSS bolus and ZOFRAN and discharged.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP, HEPA, HPV9, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Left arm redness, swelling, itching, hot to touch. (L18.5 ins x W16 ins).
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Got a severe pain where the shot was given and couldn't move my arm at all. The upper arm and the elbow were badly swollen for 5 days.
Age: 0.83
Sex: M
Vaccine: PNC13
Symptoms: Breath sounds abnormal, Dyskinesia, Screaming, Staring, Tremor
Clinical narrative: 1/24/17 on way home from MD office after receiving PREVNAR, patient woke up twice screaming, shaking. Later that night woke up 3 times with heavy breathing, shaking, jerking, eyes not moving just staring blankly.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site induration
Clinical narrative: 4.5" x 5.25" area of redness, induration with central area, 2.75" x 2.25", of bruising - all surrounding shot site. Seen on day 3 after shot, no systemic symptoms. No treatment except BENADRYL.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Joint swelling, Mydriasis, Urticaria
Clinical narrative: Received MMR at 0730 am. 8 am covered in hives, ankles swollen, pupils dilated. Took 50 mg BENADRYL by mouth. MMR ingredients include hydrolyzed gelatin! (Beef and pork connective tissue) 4 hour reaction.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Eye swelling, Pruritus
Clinical narrative: Bilateral eye swelling with erythema and itching. Patient also complained of foot itching. Patient given BENADRYL in office and referred to ER.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to patient. (Expired 1/21/17, given 1/24/17).
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Severe arm pain began 2 hours after injection reduced arm mobility, cannot raise arm.
Age: 26.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site reaction, Rash, Rash vesicular
Clinical narrative: Approx. 14 days post vaccination with varicella vaccine pt developed a vesicular eruption in the left deltoid area (injection site) f/b an eruption upper torso.
Age: 30.0
Sex: M
Vaccine: HEP, HEPA, TDAP, TYP
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness, lightheadedness mild nausea approximately 24 hours post vaccine.
Age: 38.0
Sex: M
Vaccine: MMR
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Pallor, Syncope
Clinical narrative: Pt. complained about being light headed after the shot - RPh noticed pt. face turn pale and pt. fainted briefly for 3-5 sec. Pt. regained consciousness and had a sweaty forehead. We monitored pt. Gave him some water and had pt. lay down. MA checked BP and O.
Sex: M
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Mom said patient received the shots about 4pm. At 9pm complained (R) foot/leg felt like pins and needles then had pain mostly in thigh. He slept though the night. Pain continued the next day all day in thigh, went to bed woke up pain was gone.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Crying, Dizziness postural, Lip swelling, Pallor, Urticaria
Clinical narrative: 1/27/17 Pt. stated she was seeing white spots and became very pale, had pt. lay down and she was crying, was given Gatorade and said she was a little light headed when she stood up. 1/28/17 AM Pt. went to ER and was given Prednisone and BENADRYL. Follow up in one week with provider. Symptoms were swollen lips and hives all over body.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Visual impairment
Clinical narrative: 1/27/17 Pt. stated she was seeing white spots and became very pale, had pt. lay down and she was crying, was given Gatorade and said she was a little light headed when she stood up. 1/28/17 AM Pt. went to ER and was given Prednisone and BENADRYL. Follow up in one week with provider. Symptoms were swollen lips and hives all over body.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Face injury, Lip injury, Syncope
Clinical narrative: Pt got first HPV GARDASIL vaccine and was walking to bathroom and fainted impacting (L) cheek and chin and lower lip.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Diagnosed with cellulitis in left arm, by urgent care, on 1/15/17.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Diagnosed with cellulitis in left arm, by urgent care, on 1/15/17.
Age: 72.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Middle insomnia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient received vaccine at 11 am and started having pain in arm/shoulder around supper time. Also, patient reported a "silver dollar" sized red swollen area at injection site. The pain was waking patient up at night we recommended cold compress, ibuprofen, and to call MD. The pain has improved, but not yet resolved and patient still cannot "reach for items" 4 days later.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site pain, Injection site warmth, Swelling
Clinical narrative: On 2/1/17 day of injection at night patient felt increase in pain and warm sensation on injection site. 2/2/17 patient noticed redness and swelling.
Age: 21.0
Sex: U
Vaccine: RAB
Symptoms: Lymph node pain
Clinical narrative: No local site rxn. No fever. Marble size (L) cervical lymph node tender. No redness.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMRV, VARCEL
Symptoms: Drug administration error, Extra dose administered
Clinical narrative: Administration error. Pt family notified.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Pt. had swelling and redness at injection site. Fever reaching 102 degrees. Pain in left arm.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Pt started having soreness in his arm starting 3 days after the vaccine and progressed to muscle weakness and trouble lifting his arm.
Age: 0.5
Sex: M
Vaccine: MMR
Symptoms: Aphasia, Autism, Autism spectrum disorder, Decreased eye contact
Clinical narrative: He quit making eye contact, stopped babbling, lost a lot of progress that had been achieved.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered at inappropriate site, Injection site pain, Sleep disorder
Clinical narrative: During the night after the BOOSTRIX TDAP vaccine, I had sever pain in the shoulder and upper arm region where the shot was administered.  On 03 Feb, I returned to pharmacy and explained the problem and it was stated by the Pharmacist that the shot was administered too high on the arm. Pharmacy recommended a homeopathic ointment to ease the pain.  Today I have been unable to sleep due to the pain and the pain persists to date 04 February 2017.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity, Peripheral swelling
Clinical narrative: Arm pain and swelling, worst around 10 pm on same day of vaccine.  Feels a little better the following morning, but still pain around shoulder and injection site.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 6cm x 6cm slightly raised, warm, and slightly firm circular area on left upper arm where vaccine was given without any pain/tenderness on palpation, no drainage/fluid or streaking; was seen 1/30/17 for area spreading again without signs of underlying cellulitis/infection. No difficulty breathing.
Age: 45.0
Sex: M
Vaccine: TTOX
Symptoms: Asthenia, Nerve conduction studies, Orthopaedic examination, Paraesthesia, X-ray
Clinical narrative: Tetanus shot was in left arm. Tingling of left thumb and left pointer finger as well as significant loss of left tricep strength.
Age: 45.0
Sex: M
Vaccine: TTOX
Symptoms: X-ray limb
Clinical narrative: Tetanus shot was in left arm. Tingling of left thumb and left pointer finger as well as significant loss of left tricep strength.
Age: 35.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: In addition to swelling and redness on and around the injection site, the patient also had an unusual red line extending on the surface of the skin from the arm to the neck but the mark was far above the injection site so it did not look like an infection.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Painful left hand/wrist. Injection was in left arm. Very painful hand and thumb continued for approximately 20 days and began to ease.
Age: 0.75
Sex: F
Vaccine: HEP, IPV
Symptoms: Diarrhoea, Fatigue, Hypersomnia, Pyrexia, Vomiting
Clinical narrative: Fever, diarrhea, vomiting, sleeping more than normal, tired.
Age: 57.0
Sex: F
Vaccine: HEPAB
Symptoms: Burning sensation, Drug administered at inappropriate site, Hypoaesthesia, Immediate post-injection reaction, Joint range of motion decreased
Clinical narrative: Twin RX given high up in left shoulder. I immediately felt burning, stinging, severe pain, numbness and tingling all the way down my arm. Now, 2 weeks later, pain with certain movements, limited range of motion, hurts when lying on side.
Age: 57.0
Sex: F
Vaccine: HEPAB
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Twin RX given high up in left shoulder. I immediately felt burning, stinging, severe pain, numbness and tingling all the way down my arm. Now, 2 weeks later, pain with certain movements, limited range of motion, hurts when lying on side.
Age: 62.0
Sex: F
Vaccine: HEPAB
Symptoms: Peripheral swelling, Throat tightness
Clinical narrative: A few hours after injection, patient's arm began to swell and she felt as though her throat was closing.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Headache, Influenza like illness, Pain in extremity, Paranasal sinus discomfort
Clinical narrative: Patient reported headache and flu-like symptoms following vaccination. The next day patient experienced redness of the skin (inflammation) increased sinus pressure and pain in the legs (body pain).
Age: 87.0
Sex: M
Vaccine: TDAP
Symptoms: Dyskinesia, Swelling face, Tenderness
Clinical narrative: Pt. received vaccine Feb 1st late pm. Within 24 hours pt. experienced swelling at the lower left jaw line. Pt. reports pain upon touch and difficulty opening his mouth.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Arm (upper) sore, shoulder area sore, hurt to raise arm.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Abasia, Aphasia, Autism, Developmental delay, Ear infection
Clinical narrative: Child came home and immediately went to sleep, coming down with a 105 fever within an hour. A few days later her whole body is covered in measles spots from head to toe. After the spots passed the child ceased all previous development, and stopped walking and speaking for well over a year. Developed chronic ear infections, sinus infections, GI issues, food allergies and was diagnosed as Autistic within 6 months to a year. Previously developmentally normal.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Food allergy, Gastrointestinal disorder, Measles, Pyrexia, Rash generalised
Clinical narrative: Child came home and immediately went to sleep, coming down with a 105 fever within an hour. A few days later her whole body is covered in measles spots from head to toe. After the spots passed the child ceased all previous development, and stopped walking and speaking for well over a year. Developed chronic ear infections, sinus infections, GI issues, food allergies and was diagnosed as Autistic within 6 months to a year. Previously developmentally normal.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Sinusitis, Somnolence
Clinical narrative: Child came home and immediately went to sleep, coming down with a 105 fever within an hour. A few days later her whole body is covered in measles spots from head to toe. After the spots passed the child ceased all previous development, and stopped walking and speaking for well over a year. Developed chronic ear infections, sinus infections, GI issues, food allergies and was diagnosed as Autistic within 6 months to a year. Previously developmentally normal.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Aggression, Condition aggravated, Constipation, Decreased appetite
Clinical narrative: Severe constipation, loss of appetite, severe aggression and behavioral health issues, worsening of eczema.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Eczema
Clinical narrative: Severe constipation, loss of appetite, severe aggression and behavioral health issues, worsening of eczema.
Age: 56.0
Sex: M
Vaccine: FLU4, TD
Symptoms: Arthralgia, Exercise tolerance decreased, Fatigue, Immediate post-injection reaction, Neck pain
Clinical narrative: Immediate reaction was sore throat and severe redness in eyes, followed by months of facial tingling, head tingling, chest tingling, neck pain, bicep pain, leg pain, restless legs, knee pain, fatigue, and reduced endurance. Issues continue as of 2/5/2017.
Age: 56.0
Sex: M
Vaccine: FLU4, TD
Symptoms: Nuclear magnetic resonance imaging brain normal, Ocular hyperaemia, Oropharyngeal pain, Pain in extremity, Paraesthesia
Clinical narrative: Immediate reaction was sore throat and severe redness in eyes, followed by months of facial tingling, head tingling, chest tingling, neck pain, bicep pain, leg pain, restless legs, knee pain, fatigue, and reduced endurance. Issues continue as of 2/5/2017.
Age: 56.0
Sex: M
Vaccine: FLU4, TD
Symptoms: Restless legs syndrome
Clinical narrative: Immediate reaction was sore throat and severe redness in eyes, followed by months of facial tingling, head tingling, chest tingling, neck pain, bicep pain, leg pain, restless legs, knee pain, fatigue, and reduced endurance. Issues continue as of 2/5/2017.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Diffuse urticarial which lasted for 2 weeks. Treated with Benadryl, Claritin and orapred.
Age: 1.5
Sex: M
Vaccine: HBHEPB, MMR
Symptoms: Arthralgia, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: Fever, lack of appetite, fatigue, headache, joint pain, dizziness, sensitivity to light.
Age: 1.5
Sex: M
Vaccine: HBHEPB, MMR
Symptoms: Photophobia, Pyrexia
Clinical narrative: Fever, lack of appetite, fatigue, headache, joint pain, dizziness, sensitivity to light.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus
Clinical narrative: Pt complained of itching on both thighs. Noticed symptoms described earlier.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Blood test, Complex partial seizures, Computerised tomogram, Electroencephalogram, Nuclear magnetic resonance imaging
Clinical narrative: Complex partial seizure while driving. Taken to local ER for testing.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Sleep study
Clinical narrative: Complex partial seizure while driving. Taken to local ER for testing.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Insomnia, Nerve injury
Clinical narrative: Severe pain in left shoulder. Started to not be able to lift my left arm up or outwards. Caused trouble sleeping. Arm numbness at night when sleeping on left side. Worsened over a weeks time. Called doctor and was told to take ibuprofen for swelling and possible nerve damage. Phoned in on 02/03/17 in AM to get appt that day at 3:30PM. PA confirmed nerve damage, prescribed prednisone for 9 days. Check back in at the end of the medicine to see if any better.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: Severe pain in left shoulder. Started to not be able to lift my left arm up or outwards. Caused trouble sleeping. Arm numbness at night when sleeping on left side. Worsened over a weeks time. Called doctor and was told to take ibuprofen for swelling and possible nerve damage. Phoned in on 02/03/17 in AM to get appt that day at 3:30PM. PA confirmed nerve damage, prescribed prednisone for 9 days. Check back in at the end of the medicine to see if any better.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Hyperhidrosis, Swelling, Tremor
Clinical narrative: Pt stated that the needle looked bigger but assured her that it's the same size as last yr. She couldn't really relax her arm when the vaccine was given and told her there's a bit of swelling but should be ok. After leaving the room, male companion came and said she's on the floor. Went to check her and told her 911 is being called. She was sweating and shaking when EMT came. After 5 mins, Pt came back to the pharmacy and said she was fine. They left to go home.
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Case number PHHY2015US155640 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 598438) on 24 Nov 2015. This report refers to a 46 year old female patient. Her current condition included high blood pressure. Her concomitant medications included lisinopril for high blood pressure and metformin for pre-diabetes prevention. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the right arm on 29 Sep 2015 (when she went for her routine checkup). On 01 Oct 2015, she experienced severe arm pain and muscle weakness. The outcome of the event was unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 35.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Injection site pain, Wrong drug administered
Clinical narrative: Information has been received from a nurse (reported also as a Registered Nurse), concerning to a 35 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-JAN-2017, the patient was inadvertently vaccinated with a dose of ZOSTAVAX subcutaneously, lot # M036297 and expiration date on 14-NOV-2017 (strength, dose and anatomical location were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a nurse (reported also as a Registered Nurse), concerning to a 35 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-JAN-2017, the patient was inadvertently vaccinated with a dose of ZOSTAVAX subcutaneously, lot # M036297 and expiration date on 14-NOV-2017 (strength, dose and anatomical location were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLUX, FLU4, FLUX
Symptoms: Burning sensation, Injection site hypersensitivity, Injection site pain, Paraesthesia
Clinical narrative: Skin sensitivity at injection site since injection (no redness). Pt requested this be reported.
Age: 58.0
Sex: F
Vaccine: FLUX, FLU4, FLUX
Symptoms: Hyperaesthesia, Injection site reaction
Clinical narrative: Skin sensitivity at injection site since injection (no redness). Pt requested this be reported.
Age: 58.0
Sex: F
Vaccine: FLUX, FLU4, FLUX
Symptoms: Burning sensation, Hyperaesthesia, Injection site pain, Injection site reaction, Paraesthesia
Clinical narrative: Skin sensitivity at injection site since injection (no redness). Pt requested this be reported.
Age: 61.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Facial paralysis, Hypoaesthesia, Lumbar puncture, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Patient says he suffered Bell's palsy 18 days after shingles vaccination was administered. Patient called me on 02/04/17 to ask for the lot # because he wanted to report the incident.
Age: 61.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Facial paralysis, Hypoaesthesia, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Patient says he suffered Bell's palsy 18 days after shingles vaccination was administered. Patient called me on 02/04/17 to ask for the lot # because he wanted to report the incident.
Age: 61.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Facial paralysis
Clinical narrative: Patient says he suffered Bell's palsy 18 days after shingles vaccination was administered. Patient called me on 02/04/17 to ask for the lot # because he wanted to report the incident.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Pt received PREVNAR 13 on 1/29/17. Patient noticed redness and itching on 12/4/17 and took a Zyrtec OTC for one dose. The patient noticed the redness and rash increasing and came to the pharmacy on 2/5/17. The RPh on duty called the on call MD and he instructed her to take a dose of Benadryl and followup with primary care MD in the morning.
Age: 38.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Arthropathy, Injection site pain
Clinical narrative: Pinched pain at site of injection in upper arm that affects use of shoulder.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 05-JAN-2017, the 6-month-old patient was vaccinated with the first dose of ROTATEQ oral liquid (orally; lot # M007311, expiration date 30-JAN-2017; dose was not provided). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 10-JAN-2017 from a registered nurse regarding multiple unspecified patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, multiple unspecified patients received doses of PROQUAD (lot number and expiration not reported) or VARIVAX (lot number and expiration not reported) for prophylaxis which underwent defrost cycles. No adverse effects 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 immunization coordinator via a company representative refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies and medical history provided. On an unknown date, the patient was vaccinated with a improperly stored dose of PROQUAD injection (lot # reported as M025690, dose, route of administration and expiration date were not reported). No adverse reaction was reported. The administered vaccine had been stored in the refrigerator for over a week before patient's vaccination. It was unknown by the reporter if data logger was involved. The reporter did not have information about the previous temperature excursion. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004601: US-009507513-1701USA004601.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-JAN-2017, the patient was vaccinated with expired dose of the VAQTA lot#L030442, expiry date 19-DEC-2016 (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified pharmacy technician and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided. On 13-JAN-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # M033335, expiration date 11-OCT-2017 (dose and route of administration were not reported). There were no adverse events reported. Product quality complaint (PQC) was not involved. Administered dose of vaccine was exposed to the temperature of 47 degrees Fahrenheit for 17 hours (date unspecified). A digital data logger was not involved. There were no previous temperature excursions. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received from a physician's assistant concerning a patient (gender unknown). The physician's assistant reported that the patient, aged 8 months and 13 days old, received a third dose of ROTATEQ (dosage, lot number, expiration date, and route of administration not provided) on 17-JAN-2017.  Dates of prior doses not provided.  No information was provided regarding the patient's medical history or concomitant medication.  No side effects were reported.  No further information was available. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: DTAP, MNQ, MNQ, TDAP
Symptoms: Abdominal pain, Nausea, Peripheral swelling, Skin warm, Vomiting
Clinical narrative: This spontaneous report was received from a patient's mother via a company representative and refers to a 13 or 14 year old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 19-JAN-2017, the patient was vaccinated with VARIVAX (dose, route of administration, lot# and expiration date were not reported) for prevention of varicella. On the same day, the patient was administered a dose of unspecified meningococcal vaccine (manufacturer unknown) (dose, route of administration, lot# and expiration date were not provided). On an unspecified date in 2017, reported as shortly after the vaccinations, the patient experienced abdominal pain, nausea, vomiting and swelling of his whole arm, which was also "hot to touch". The mother stated that she attempted to take the patient to the emergency room but was not seen due to the long waiting period. The mother stated she did not go to any other physician for care. There was no treatment given for the events. The outcome of the events was unknown. The relatedness between the events and VARIVAX and unspecified meningococcal vaccine (manufacturer unknown) was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: DTAP, MNQ, MNQ, TDAP
Symptoms: Aortic aneurysm, Nausea, Peripheral swelling, Skin abrasion, Vomiting
Clinical narrative: This spontaneous report was received from a patient's mother via a company representative and refers to a 13 or 14 year old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 19-JAN-2017, the patient was vaccinated with VARIVAX (dose, route of administration, lot# and expiration date were not reported) for prevention of varicella. On the same day, the patient was administered a dose of unspecified meningococcal vaccine (manufacturer unknown) (dose, route of administration, lot# and expiration date were not provided). On an unspecified date in 2017, reported as shortly after the vaccinations, the patient experienced abdominal pain, nausea, vomiting and swelling of his whole arm, which was also "hot to touch". The mother stated that she attempted to take the patient to the emergency room but was not seen due to the long waiting period. The mother stated she did not go to any other physician for care. There was no treatment given for the events. The outcome of the events was unknown. The relatedness between the events and VARIVAX and unspecified meningococcal vaccine (manufacturer unknown) 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 registered nurse and refers to three patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 17-JAN-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M034780, expiration date 15-04-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 32 degrees Fahrenheit and 36 degrees Fahrenheit for 2 hours and 30 minutes and below 32 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not reported. On 28-AUG-2015, the patient was vaccinated with a dose of GARDASIL injection, intramuscularly, lot # K010215 (exact dose and expiry date were not reported). Then, on 02-SEP-2016, the patient was vaccinated with a dose of GARDASIL 9 injection, intramuscularly, lot # M018810 (exact dose and expiry date were not reported). It was not reported what caused an interchange of vaccine products. No adverse effects were reported. Product quality complaint was not involved. 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 medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an multiple unspecified dates, the patients were inadvertently administered improperly stored doses of VARIVAX lot numbers M033212 and M032358; expiration dates 13-JUL-2018 and 05-JUL-2018 respectively (dose, route of administration and anatomical location were not provided) for prophylaxis. There was no adverse effect reported. Administered doses of VARIVAX were exposed to a temperature excursion of 5°C for 2 hours. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient had no concomitant medications, pertinent medical history, drug reactions nor allergies. On 18-JAN-2017, the patient was vaccinated with ZOSTAVAX subcutaneously (dose, anatomical location, lot# and expiry date were not reported). On an unknown date in January 2017, the patient experienced headaches and body aches. Unspecified treatment was given for the events. No lab diagnostic studies were performed. At the time of the report, the patient did not recover from the events. The patient sought medical attention by contacting the pharmacist. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. On unknown dates, the patients were vaccinated with 4 improperly stored doses of VARIVAX (lot # M034583 with an expiration date of 27-JUL-2018, and  lot # reported as M373008  with an expiration date of 25-AUG-2018; strength, dose and route of administration were not provided) for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 56 minutes at a temperature between 14 and 46 degrees Fahrenheit on an unspecified date. No previous temperature excursion was reported and a data logger issue was involved. Additionally, a product quality complaint (PQC) was not reported. Additional information is not expected because there was no consent to contact the physician.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse, referring unspecified patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with an unspecified number of improperly stored doses PROQUAD for prophylaxis (lot number reported as M037010 with expiration date of 21-FEB-2018 and lot number L039268 with expiration date of 05-APR-2017) (strength, dosage schedule, route of administration and anatomical location were not reported). No concomitant medications were provided. No adverse effects were reported. The doses of the vaccine with lot number M037010 experienced a temperature excursion greater than -15 Celsius (C) degrees and less than  -10 C degrees range for 10 minutes. There was a previous temperature excursion with the same temperature range for 3 hours and 55 minutes. The doses of the vaccine with lot number L039268 experienced a temperature excursion greater than -15 C degrees and less than -10 C degrees for 10 minutes range and there was a previous temperature excursion with the same temperature range for 70 hours and 50 minutes and  another temperature excursion with a temperature greater than -10 C degrees and less than 8 C degrees for 16 hours and 40 minutes. The aforementioned temperature was identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA001699:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a female patient of an unknown age, referring to a herself. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX injection  (1 single injection subcutaneously) for protection against herpes zoster (strength, lot number and expiration date were not provided). On an unknown date, 6 years post receiving a ZOSTAVAX injection, the patient experienced shingles. As a result of the shingles she was admitted into the hospital for an unspecified amount of time and length. Unspecified treatment was given for the adverse event and no product quality complaint was involved. The outcome of herpes zoster was unknown, as the relatedness with ZOSTAVAX. Additional information is not expected as there was no consent for follow-up.
Sex: U
Vaccine: UNK, VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a X-ray technician refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patient might have received improperly stored dose of ZOSTAVAX 19400 Plaque-Forming Units (PFU) or improperly stored dose of M-M-R II, or improperly stored dose of PNEUMOVAX 23, or improperly stored GARDASIL 9, or improperly stored dose of PEDVAXHIB or improperly stored dose of VARIVAX (dose, anatomical location, lot#, expiry date and route of administration were not reported). No adverse effect reported. M-M-R II, PNEUMOVAX 23, GARDASIL 9 and PEDVAXHIB were stored in the temperature greater than 46 Fahrenheit degrees but less than 77 Fahrenheit degrees for 53 hours. ZOSTAVAX and VARIVAX were stored in the temperature greater than 5 Fahrenheit degrees but less tan 14 Fahrenheit degrees for 2 hours 30 minutes. There was no previous temperature excursions. Digital data loggers were involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reaction, allergies and concomitant medications were not reported. The primary reporter stated that on an unknown date, the patients were administered with improperly stored doses of PNEUMOVAX 23, strength, dose, route of administration were not provided (lot # L029306 with expiration date of 13-MAY-2017 and lot # L029306 with expiration date of 23-MAR-2017) for prophylaxis. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit  and 36 degrees Fahrenheit , 1 cycle for 2 hours and 30 minutes. Cumulative time : 8 hours and 30 minutes/ 2 cycles. Data logger was involved. There were previous excursions of 32 degrees Fahrenheit and 36 degrees Fahrenheit (cycles): 1 cycle for 6 hours.The initial excursion was reported on 29-DEC-2016. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unspecified dates, the patients were vaccinated with PROQUAD (lot # M034692 with expiration date: 24-JAN-2018 and lot #: L046509 with expiration date: 17-MAY-2017) (dose, dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 5°F but less than 14 °F for 48 hours and at temperature greater than 14°F but less than 46°F for 72 hours without any previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000247: US-009507513-1702USA000248:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications were not reported. In January 2017, from 20-JAN-2017 to 31-JAN-2017, the patients were vaccinated with improperly stored doses of with PROQUAD (anatomical route of vaccinations was not provided) for prophylaxis. Involved lot # were M022399 with expiration date on 01-NOV-2017, lot # L046508 with expiration date on 17-MAY-2017, lot # M023931 with expiration date in 09-NOV-2017, lot # M035690 with expiration date on 06-FEB-2018, lot # M037012 with expiration date on 21-FEB-2018 and lot # M019233 with expiration date on 17-OCT-2017. It was reported, that , PROQUAD was exposed to a temperature excursion of >5°F but < 14°F (> -15°C but < -10°C), on a time frame of 40 minutes. It was also reported, the the vaccine was not exposed to a previous temperature excursion. Data logger was involved. Furthermore, no adverse events were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA002205:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse, referring unspecified patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with unspecified number of improperly stored doses VARIVAX  for prophylaxis (lot number  M006156 with expiration date of 05-FEB-2018 and lot number M033213 with expiration date of 13-JUL-2018) (strength, dosage schedule, route of administration and anatomical location were not reported). No concomitant medications were provided. No adverse effects were reported. The doses of the vaccine experienced a temperature excursion greater than -15 Celsius (C) degrees and less than -10 C degrees range for 10 minutes and there was a previous temperature excursion with the same temperature range for 70 hours and 50 minutes, and  another temperature excursion with a temperature greater than -10 C degrees and less than 8 C degrees for 16 hours and 40 minutes. The aforementioned temperatures were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012972:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications were not reported. In January 2017, from 20-JAN-2017 to 31-JAN-2017, the patients were vaccinated with improperly stored doses of with VARIVAX (anatomical route of vaccinations was not provided) for prophylaxis. Involved lot # were M025867 with expiration date on 24-MAY-2018, lot # M017292 with expiration date on 07-APR-2018, lot # M033904 with expiration date on 20-JUL-2018, lot # M025864 with expiration date on 24-MAy-2018, lot # M035141 with expiration date on 03-AUG-2018 and lot # M006157 with expiration date on 05-FEB-2018. It was reported, that, VARIVAX was exposed to a temperature excursion of >5°F but < 14°F (> -15°C but < -10°C), on a time frame of 40 minutes. It was also reported, the the vaccine was not exposed to a previous temperature excursion. Data logger was involved. Furthermore, no adverse events were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA001011:
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Ill-defined disorder, Local swelling, Lymph node pain
Clinical narrative: Armpit on injection side was visibly swollen (almost like edema) and pain in armpit while running. When raising arm there was a "zing" to my fingers, almost like impingement on a nerve. 3 days later swelling has subsided somewhat but lymph node pain remains. Lymph nodes on neck and breast seem normal.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Post vaccination fever on 2017-02-01.