chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPVX, MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient was inadvertently given Menactra instead of the ordered HPV vaccine; Initial information received on 17-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case ID 2019SA111884 and 2019SA111891 (same reporter).  This case involves a 15 years old male patient who was inadvertently vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6151AA, expiry date: 16-Mar-2020, via unknown route in the right arm on 17-Apr-2019 instead of HPV vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medications reported.  It is an actual medication error case due to wrong vaccine administered. It was reported that patient had received the Menactra at 11 years for routine vaccination and at 15 years the patient was inadvertently given Menactra instead of HPV vaccine.  It was not reported whether the patient experienced any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 35.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Patient was administered the pediatric/adolescent dosages of Hep A (Havrix) at 0.5 mL and Hep B (Recombivax HB) at 0.5 mL, instead of the adult dosages of Hep A (Havrix) at 1 mL and Hep B (Engerix-B) at 1 mL. Error was not made known until the following morning on 3/7/2019 when another Medical Assistant was entering the vaccine information on Vac Trak. Patient made an appointment for a lab test in the following week, and staff planned on administering the correct dosages of Hep A and Hep B at that appointment. Patient ended up cancelling the appointment. Patient was notified of the vaccine errors via phone call on 4/24/19. Patient is currently working on a boat for an unknown specified amount of time, but will call Health Center for the correct vaccines when he is back in the area.
Age: 28.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Erythema, Eye swelling, Nasal oedema, Pruritus, Rash
Clinical narrative: By patient reported only not seen at time of event.Came 2 weeks later to be seen. Reported and had iphone pictures of rash that developed after initial pruritus face distal forearm and distal legs.2days later slight swelling of eye and bridge of nose.s/s restored in one - one and a half weeks. Only a slight fine erythrema on the distal forearms on 4/23/2019
Age: 28.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Eye swelling, Hypersensitivity, Nasal oedema, Rash papular, Rash pruritic
Clinical narrative: By patient reported only not seen at time of event.Came 2 weeks later to be seen. Reported and had iphone pictures of rash that developed after initial pruritus face distal forearm and distal legs.2days later slight swelling of eye and bridge of nose.s/s restored in one - one and a half weeks. Only a slight fine erythrema on the distal forearms on 4/23/2019
Age: 28.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Urticaria
Clinical narrative: By patient reported only not seen at time of event.Came 2 weeks later to be seen. Reported and had iphone pictures of rash that developed after initial pruritus face distal forearm and distal legs.2days later slight swelling of eye and bridge of nose.s/s restored in one - one and a half weeks. Only a slight fine erythrema on the distal forearms on 4/23/2019
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Rash macular
Clinical narrative: Within 5 minutes of vaccination, patient's upper left arm began to get a red and blotchy rash around injection sites.  Patient's Pediatrician assessed him, no shortness of breath, upon MD's assessment.  No itchiness at site reported by child.  Per MD order, gave child Benadryl 12.5 mg by mouth and watched child for approximately 20 minutes. Rash/blotchy areas had almost disappeared before child left the clinic.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site erythema, Injection site inflammation, Injection site pain, Insomnia
Clinical narrative: PAIN AND INFLAMMATION AND REDNESS INITIALLY, NOW JUST PAIN AND INFLAMMATION AT INJECTION SITE. ALSO HAVE PAIN IN THE NECK AND UPPER BACK AND LEFT SHOULDER. CANNOT SLEEP SINCE VACCINE WAS ADMINISTERED.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: PAIN AND INFLAMMATION AND REDNESS INITIALLY, NOW JUST PAIN AND INFLAMMATION AT INJECTION SITE. ALSO HAVE PAIN IN THE NECK AND UPPER BACK AND LEFT SHOULDER. CANNOT SLEEP SINCE VACCINE WAS ADMINISTERED.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity
Clinical narrative: LEFT ARM PAIN  LEFT SHOULDER AND WRIST PAIN  LEFT HAND PAIN
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, IPV, RV1
Symptoms: Constipation, Crying, Injection site swelling, Insomnia, Pyrexia
Clinical narrative: Extreme swelling at the site, uncontrollable screaming and crying for 3 days straight, high fever, unable to sleep, and constipation.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, IPV, RV1
Symptoms: Screaming
Clinical narrative: Extreme swelling at the site, uncontrollable screaming and crying for 3 days straight, high fever, unable to sleep, and constipation.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, RV1, UNK
Symptoms: Crying, Head banging, Injection site swelling, Insomnia, Pyrexia
Clinical narrative: Extreme swelling at injecting site and high fever. Uncontrollable screaming and crying for 3 days straight. Unable to sleep. Constant head banging.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, RV1, UNK
Symptoms: Screaming
Clinical narrative: Extreme swelling at injecting site and high fever. Uncontrollable screaming and crying for 3 days straight. Unable to sleep. Constant head banging.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Painful and erythematous injection site extending to axilla with fever beginning around 12-16 hours after vaccine.  In clinic , two days later with fever and injection site reaction
Age: 62.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Paraesthesia oral, Urticaria, Vital signs measurement
Clinical narrative: Patient developed urticaria and tongue and mouth felt tingly 2 hours after vaccine administration.  She returned to clinc.  She was administered EpiPen x1 and SoluMedrol 125mg im injection.  She developed rigours.   vital signs stable, no shortness of breath or syncope or dizziness.  She was sent to ER via 911 when rigours would not improve.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Insomnia, Pain, Pain in extremity, X-ray limb normal
Clinical narrative: Within one-half hour of flu injection in left upper arm, severe aching pain occurred in the entire left arm . This pain lessened and pain in the left shoulder with movment developed. Over time, aching, burning, or throbbing pain occurred in various areas pf the left arm throughout the day, eventually causing an inability to sleep. MD (primary physican, internist) was seen  on 12/11/2018 and ice therpy was recommended. With no improvment in one month, Dr. recommended seeing an orthopedic surgeon. Dr. was seen on 3/22/2019. An Xray of the left shoulder was taken showing no abnormalities of the bony stuctures. Prednisone taper was prescibed and physical therapy 2-3 times per week for 6-8 weeks. I am currently in the fifth week of PT. Pain in left arm has lessened and left shoulder pain with movement has lessened.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient received improperly stored PROQUAD; This spontaneous report was received from a nurse referring to an female children. Information about  pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.  On 17-APR-2019, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (therapy type: recombinant Human albumin (rHA); lot # R024020 with expiration date 19-FEB-2020; lot # R022574 with expiration date 04-FEB-2020; strength, dose detail and route were not provided) for prophylaxis (product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was reconstituted with properly stored sterile diluent (lot & expiration date was unknown by reporter).   The vaccines were exposed to temperature excursion of 6 fahrenheit degree to 14 fahrenheit degree (also reported as 9.1 fahrenheit degree) for 45 minutes. The vaccines were exposed to previous temperature excursion of 6 degree Celsius to 14 fahrenheit degree (also reported as 11.28 fahrenheit degree) for 15 minutes. No adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA010534: US-009507513-1904USA010535: US-009507513-1904USA010533: US-009507513-1904USA010531: US-009507513-11904USA010532:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Patient received unspecified dose of VAQTA that was improperly stored.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions and allergies were not reported.  On 23-MAR-2019, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) (lot number: R021233, expiration date: 05-SEP-2019), intramuscular for prophylaxis. Administered vaccine was stored in a temperature of 50.1 degrees Fahrenheit (F) for 1 hour and 55 minutes, and below 36 degrees F for 235 minutes. There was a previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Patient received unspecified dose of RECOMBIVAX that was improperly stored.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions and allergies were not reported.  On 18-MAR-2019, the patient was vaccinated with an improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot number: R012001, expiration date: 06-NOV-2020), intramuscular for prophylaxis. Administered vaccine was stored in a temperature of 50.1 degrees Fahrenheit (F) for 1 hour and 55 minutes, and below 36 degrees F for 290 minutes. There was a previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: F
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient received improperly stored PROQUAD; Information was received from a nurse referring to an female child. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.  On 17-APR-2019, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (therapy type: recombinant Human albumin (rHA); lot # R024020 with expiration date 19-FEB-2020; lot # R022574 with expiration date 04-FEB-2020; strength, dose detail and route were not provided) for prophylaxis (product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was reconstituted with properly stored sterile diluent (lot & expiration date was unknown by reporter).   The vaccines were exposed to temperature excursion of 6 fahrenheit degree to 14 fahrenheit degree (also reported as 9.1 fahrenheit degree) for 45 minutes. The vaccines were exposed to previous temperature excursion of 6 degree Celsius to 14 fahrenheit degree (also reported as 11.28 fahrenheit degree) for 15 minutes. No adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA010532: US-009507513-1904USA008214: US-009507513-1904USA010533: US-009507513-1904USA010534: US-009507513-1904USA010535:
Sex: M
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient received improperly stored VARIVAX; This spontaneous report was received from a nurse referring to an male child.. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.  On 16-APR-2019, the patient received improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R026548, and expiration date  17-SEP-2020 strength, dose detail and route were not provided) for prophylaxis (product storage error). The varicella virus vaccine live (Oka/Merck) (VARIVAX)was reconstituted with properly stored sterile diluent (lot & expiration date was unknown by reporter).   The vaccines were exposed to temperature excursion of 6 fahrenheit degree to 14 fahrenheit degree (also reported as 7.64 fahrenheit degree) for 45 minutes. The vaccines were exposed to previous temperature excursion of 6 degree Celsius to 14 fahrenheit degree (also reported as 11.28 fahrenheit degree) for 1 hour. No adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1904USA008214: US-009507513-1904USA010534: US-009507513-1904USA010535: US-009507513-1904USA010531: US-009507513-1904USA010532:
Age: 49.0
Sex: F
Vaccine: FLUN4
Symptoms: Mycobacterium tuberculosis complex test positive, Pain
Clinical narrative: TESTED POSITIVE FOR TB; ACHY; A spontaneous report has been received from a consumer. The report concerns a female patient of Unknown ethnic origin (age 49 years).    The patient's past and current medical history included asthma (ongoing). The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine (live, attenuated)) (batch number Unk) once/single administration, via nasal route, for flu season on an unknown date.     Patient reports that she has had no problems with Flumist nasal spray but she had gotten achy (preferred term: Pain) the same day usually when receiving the Flumist nasal spray and would take Tylenol for the aches and it passes and then she was fine and that was minimal compared to the complications from the shots she had been forced to take, explained as she has had TDAP and Tuberculosis and MMR and wanted to chop her arms off, and it made her feel like it was more painful to keep the limbs than to lose them and then said she was told by the hospital that she did not have a reaction to the TB test but she tested positive for TB (Tuberculosis) (preferred term: Tuberculosis) but she did not have TB. Patient reiterated that the side effect of being achy from Flumist nasal spray was minimal further explained as she did not want to cut her head or her body cut off or her limbs removed when she takes the Flumist nasal spray. She was terrified of needles and that has been something she cannot overcome even with a hypnotist and she was prone to getting the flu.    The patient recovered from of achy on an unspecified date. The outcome of tested positive for TB was unknown.     The events achy and tested positive for TB were considered non-serious.     The reporter considered the following event(s) related to treatment with Flumist Quadrivalent (influenza vaccine (live, attenuated)): achy.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: Intussusception
Clinical narrative: Patient had intussusception
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain
Clinical narrative: My arm at the site of injection became VERY sore, and in the middle of the night that I had the injection, I woke up shivering uncontrollably. My arm remained VERY sore for two days afterward.   My arm still is sore, but significantly less. My treatment was TYLENOL, which helped. I tried ice but the site was too tender to touch.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site streaking, Pain, Pyrexia
Clinical narrative: Awakened the day after injection feeling achy all over, tired and had a fever. Felt like I had the flu.  Later that day I noticed red streak that wrapped around my arm near the injection site about 2 inches wide. I felt so weak at times during the day that I had to lay down and rest before I could finish my errands for the day. I took TYLENOL every 4 hours and took a dose of BENADRYL that night. Today I feel much better. The fever and aches are gone. The rash is still visible but improved.
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: On 4/22/19, after immunization patient noticed small bruise at site, and on 4/23/19 bruise appeared larger. On 4/24/19 patient noticed her upper arm was red and warm to the touch . On 4/24/19, patient came into center and red area measured 4 1/2 " long X  3 1/4 " wide. Area was very warm to the touch.  While interviewing patient she asked for ice pack and it was given. Advised to go to ER or Urgent Care, donor agreed.
Age: 0.33
Sex: M
Vaccine: DTAP, DTAPIPV, HIBV, PNC13, RV1
Symptoms: Injection site reaction, Injection site swelling, Rash
Clinical narrative: Within a few hours, both legs broke out in a swollen, painful rash that lasted for weeks.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Oral herpes
Clinical narrative: Patient complained developing fever blisters 4 days later that lasted 1 week. He applied some BLISTEX on them. Also complained feeling dizzy 4 days later and lasted 5 days. He did not take any medication for the dizziness but felt better 5 days later.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Nasal congestion, Pain in extremity, Wheezing
Clinical narrative: At 12:00 am she woke up stuffed up and her throat and lungs were tight and she was wheezing.  At that point she took a puff of her VENTOLIN inhaler to help open up her lungs, that seemed to help a little. In the morning she took her daily dose of ZYRTEC and called us to let us know what happened. My pharmacist advised her to call her Dr to see if they want to give her prednisone. Her arm she said was fine just a little sore. She did say that she did have a bad reaction to the PNEUMOVAX and was told she was not to get that one ever again.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Flu type symptoms; Redness and swelling at injection site.
Age: 30.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient received varicella dose on 02/27/2019.  At the time patient was not aware she was pregnant.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Pt reported symptoms of weakness, headache, fever, nausea, soreness at injection site.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site discolouration, Injection site nodule
Clinical narrative: Patient has a knot under the skin in her left upper arm. The skin on the arm around where the shot was given is a ligther color compared to her normal skin color. There is a tattoo present on the arm, as well.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Rhinorrhoea, Vomiting
Clinical narrative: PATIENT EXPRESSED SHE HAD A FLU LIKE SYMPTOMS 2 NIGHTS IN A ROW PROCEEDING HER VACCINATION WITH SHINGRIX. THESE SYMPTOMS WERE (TOTAL BODY ACHE, RUNNY NOSE, AND VOMITING).
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Somnolence, Urinary incontinence
Clinical narrative: Extreme drowsiness, urinary incontinence, headache, sore arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Myalgia
Clinical narrative: I woke up the next day with an intense headache and joint/muscle pain. On a scale of 1-10, with 10 being the most intense, my  pain throughout the day was a 9. Ibuprofen, 800mg administered several times throughout the day had no effect on the pain levels. By the next morning, the pain had dissipated, but I was feeling weak and tired. This state got better throughout that second day.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Started with small bump, turned very red and hard, warm to touch. Made markings on her arm to see where it was at 6:00pm. No other symptoms at that time.  Next day (4/24/19) nothing suspicious during the day, around 6:00 pm noticed the redness moved past the marking lines, and it was still warm to the touch as well as hard.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash generalised
Clinical narrative: Painful rash developed on body, 4/22/19. Patient saw dermatologist 4/24 diagnosis as shingles, issued valacyclovir and tramadol.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Patient called to the pharmacy on 4/23/19 and reported the adverse events. She reported a rash on her arm over the weekend which went a way after using calamine lotion. She also reported of arm pain/swelling and hand/ finger numbness.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient reported that arm became itchy, red, warm at injection site.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Local reaction, Pruritus, Rash, Skin warm
Clinical narrative: Large local reaction with rash. Patient complains ichyness and it is warm to the touch. Mother gave Benadryl and ice yesterday at the start of side of effects. The rash has spread further on day four, when they returned to the clinic.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchospasm, Dyspnoea, Laboratory test normal, Lung disorder, Pyrexia
Clinical narrative: High Fever 103-104+ for 10 days, lungs and bronchial tubes shutting down, loss of breathing. Today is 02/24/19 and I am still being treated with medications to keep my lungs and bronchial tubes open. Additional medical added on 04/17/19 due to a possible additional attack to my lungs and bronchial tubes. I am on 2 types on inhalers and steroids just to be able to breathe. I have been on more medications then I can list here. All prescribed by Dr. of Emergency Room.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Tremor
Clinical narrative: When I got the 1st SHINGRIX vaccine, I got a few chicken pox-like blisters that quickly went away and I did not report it. The second dosage of the SHINGRIX vaccine on 4/23/19 caused a different reaction. At about 11:30 that evening, I began to feel like I was getting a fever, my teeth began to chatter, and I began to shake. I went to bed and got warmed up and went to sleep. Around 1 a.m. that morning, I woke up with the same symptoms. I took my temperature and it was only slightly elevated (99), but I took some EXTRA-STRENGTH TYLENOL and went back to sleep. I went to work but I felt a tiny bit all day as if I had a fever so I took two aspirin in the am and the pm. I am feeling much better, but there's still a bit of lingering body aches as if I had a very low-grade fever.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: 101.5 fever. Sore muscles, sore arm.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site mass
Clinical narrative: Small lump in thigh about the size of a quilting needle head where vaccine was given.  Showed up about 36 hours after shot was given and lasted about a week.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Dizziness, Feeling abnormal, Injection site swelling, Nausea
Clinical narrative: Generalized aches and chills, states "wasn't right", warm to touch, nausea, swelling of arm of injection site (slightly) and states felt "woozy".
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Pain, Skin warm
Clinical narrative: Generalized aches and chills, states "wasn't right", warm to touch, nausea, swelling of arm of injection site (slightly) and states felt "woozy".
Age: 17.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Induration, Rash
Clinical narrative: Vaccines were given on (R) deltoid area. Pt. started with a rash that a day after and started to spread down her arm, very hard to the touch, painful, no itching.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Crying, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative, Urinary system X-ray
Clinical narrative: fever (Tmax 102.6) and crying inconsolably seen at ER flu (-) RSV (-) KUB (-) seen in office normal exam, reassurance given
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: X-ray normal
Clinical narrative: fever (Tmax 102.6) and crying inconsolably seen at ER flu (-) RSV (-) KUB (-) seen in office normal exam, reassurance given
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Papule, Varicella virus test
Clinical narrative: Patient developed, 19 vesicles on pink base on (Lt) arm. Several erythematous discrete papules. Some with tiny vesicles in the center on the left flank. Patient on Rx: VALTREX.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Peripheral swelling, Vaccination complication
Clinical narrative: BUE redness with swelling post immunization. Erythema measuring 8x9 cm at each site.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of peripheral neuropathy in a 67-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose was received on unknown date). On 6th December 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced peripheral neuropathy (serious criteria GSK medically significant). On an unknown date, the outcome of the peripheral neuropathy was not recovered/not resolved. It was unknown if the reporter considered the peripheral neuropathy to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in left arm. The last dose was received by the patient and he noted shortly after that he experienced peripheral neuropathy bilaterally in his toes. The patient had not notified his physician yet but was encouraged to do so. The patient denied any issues with the first dose. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The experienced shingles after receiving SHINGRIX vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for infection, time to onset for event and laboratory confirmation for infection were not provided.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Mobility decreased, Tremor
Clinical narrative: Pain at injection site limiting mobility after about 6 hr, extreme chills with uncontrollable shaking  at about 12 hours and headache at about 18 hr.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects; a patient was administered an expired dose of PNEUMOVAX 23; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 10-APR-2019, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# N024717, expiration date was 06-APR-2019,dose was not provided), intramuscularly, for prophylaxis. No adverse effects were reported.
Age: 0.08
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported; 1-month-old patient received VAQTA; Information has been received from a nurse referring to a 1-month-old patient of unknown gender. Information about concurrent condition, concomitant medication medical history, drug reactions or allergies was not provided.  On 16-APR-2019, the patient received hepatitis a vaccine, inactivated (VAQTA) (lot # R034339, expiration date 23-NOV-2019; strength, dose, route of administration) for prophylaxis (inappropriate age at vaccine administration). No adverse effects was reported.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effects; a 15 weeks old infant was administered their first dose of ROTATEQ; 15 week old infant was administered their first dose of ROTATEQ; This spontaneous report was received from a physician concerning a 15 weeks old infant of an unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, or concomitants medications were not reported.  On 11-APR-2019, the patient was vaccinated for prophylaxis with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (dosage schedule, lot number and expiration date were not reported) (inappropriate schedule of drug administration and inappropriate age at vaccine administration). No adverse effects at the reporting time.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Administered improperly stored doses of Proquad; This spontaneous report was received from medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. The patient's concomitant medication included sterile diluent (DILUENT MRK).  On 15-APR-2019, the patient was vaccinated with 1 dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), lot# R017628 (expiry date 18-DEC-2019) (frequency, strength, route, anatomical location were not provided) for prophylaxis (product storage error). The vaccine was stored at a temperature of -14 Celsius (C)  to -10 C (-11 C) for 30 minutes and also at -9 degree C to 8 degree C (-7.1 Celsius) for 45 minutes. There was no previous temperature excursion. The patient did not experience any adverse effects. The call was because of a data logger. No product quality complaint (PQC) was involved.  This is one of the several reports received from same reporter.; Sender's Comments:  US-009507513-1904USA009353: US-009507513-1904USA009841: US-009507513-1904USA009842: US-009507513-1904USA009841:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Administered improperly stored doses of Proquad; This spontaneous report was received from medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. The patient's concomitant medication included sterile diluent (DILUENT MRK).  On 15-APR-2019, the patient was vaccinated with 1 dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), lot# R017628 (expiry date 18-DEC-2019) (frequency, strength, route, anatomical location were not provided) for prophylaxis (product storage error). The vaccine was stored at a temperature of -14 Celsius (C)  to -10 C (-11 C) for 30 minutes and also at -9 degree C to 8 degree C (-7.1 Celsius) for 45 minutes. There was no previous temperature excursion. The patient did not experience any adverse effects. The call was because of a data logger. No product quality complaint (PQC) was involved.  This is one of the several reports received from same reporter.; Sender's Comments:  US-009507513-1904USA009353: US-009507513-1904USA009840: US-009507513-1904USA009842:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Administered improperly stored dose of Proquad; This spontaneous report was received from medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. The patient's concomitant medication included sterile diluent (DILUENT MRK).  On 16-APR-2019, the patient was vaccinated with 1 dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), lot# R017628 (expiry date 18-DEC-2019) (frequency, strength, route, anatomical location were not provided) for prophylaxis (product storage error). The vaccine was stored at a temperature of -14 Celsius (C)  to -10 C (-11 C) for 30 minutes and also at -9 degree C to 8 degree C (-7.1 Celsius) for 45 minutes. There was no previous temperature excursion. The patient did not experience any adverse effects. The call was because of a data logger. No product quality complaint (PQC) was involved.  This is one of the several reports received from same reporter.; Sender's Comments:  US-009507513-1904USA009840: US-009507513-1904USA009353: US-009507513-1904USA009842: US-009507513-1904USA009842:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No known adverse effects; An adult patient received a pediatric dose of VAQTA; This spontaneous report was received from a nurse and refers to a adult patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, concomitant therapies and drugs or allergies reactions.   On 16-APR-2019, the patient was vaccinated with a pediatric dose of Hepatitis A Vaccine, Inactivated (VAQTA) by intramuscular route and the indication was reported as not applicable (strength, dose, lot number and expiration date were not reported).   The patient received a incorrect dose administered. No adverse effects was reported.   The outcome for the event was reported as unknown.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effect reported; Pharmacy intern states that dose of M-M-R II was administered the intramuscular route; This spontaneous report was received from a pharmacy intern and refers to a patient of unknown age and gender. No information was provided regarding the patient's concurrent condition, medical history, concomitant therapies and drugs or allergies reactions were reported.  On 19-APR-2019, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) by intramuscular route, for prophylaxis, lot # R001658 and expiration date of 17-JAN-2020 (strength, dose and anatomical route were not reported).  On the same date, the patient experienced incorrect route of product administration. No adverse effects reported.   The outcome for the event was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster, Ophthalmic herpes zoster, Vth nerve injury
Clinical narrative: This spontaneous report has been received from an approximately 45 year-old female patient reporting herself. The patient's medical history included chicken pox and shingles. Her concurrent conditions included trigeminal neuralgia, breast cancer and allergy to codeine. Concomitant medications included esomeprazole sodium (NEXIUM) and acyclovir. On an unspecified date in 2013 (reported as "about 6 years ago"), the patient was vaccinated with ZOSTAVAX vial, one shot/one time in her upper arm (strength, dose, route, lot number and expiration date not reported) for shingles. On an unspecified date in 2013 (reported as "about 2013"), the patient experienced re occurrence of shingles (herpes zoster). The singles had moved to the patient'seyes (ophthalmic herpes zoster) on a date not specified. Additionally, the patient's trigeminal nerve was damaged (Vth nerve injury). The patient sought for medical attentions and was hospitalized for three-four days at a local medical center. She received treatment for the events (unspecified) and blood test were performed but the results were not reported. At the reporting time, the patient had not recovered from the aforementioned events. The causal relationship between ZOSTAVAX and the events was not provided. Upon internal review, the event ophthalmic herpes zoster was determined to be medically significant.
Sex: M
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient received improperly stored VARIVAX; This spontaneous report was received from a nurse referring to an male child.. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.  On 16-APR-2019, the patient received improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R026548, and expiration date  17-SEP-2020 strength, dose detail and route were not provided) for prophylaxis (product storage error). The varicella virus vaccine live (Oka/Merck) (VARIVAX)was reconstituted with properly stored sterile diluent (lot & expiration date was unknown by reporter).   The vaccines were exposed to temperature excursion of 6 fahrenheit degree to 14 fahrenheit degree (also reported as 7.64 fahrenheit degree) for 45 minutes. The vaccines were exposed to previous temperature excursion of 6 degree Celsius to 14 fahrenheit degree (also reported as 11.28 fahrenheit degree) for 1 hour. No adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA008214: US-009507513-1904USA010531: US-009507513-1904USA010534: US-009507513-1904USA010533: US-009507513-1904USA010535:
Sex: M
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient received improperly stored VARIVAX; This spontaneous report was received from a nurse referring to an male child.. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.  On 17-APR-2019, the patient received improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R026548, and expiration date  17-SEP-2020 strength, dose detail and route were not provided) for prophylaxis (product storage error). The varicella virus vaccine live (Oka/Merck) (VARIVAX)was reconstituted with properly stored sterile diluent (lot & expiration date was unknown by reporter).   The vaccines were exposed to temperature excursion of 6 fahrenheit degree to 14 fahrenheit degree (also reported as 7.64 fahrenheit degree) for 45 minutes. The vaccines were exposed to previous temperature excursion of 6 degree Celsius to 14 fahrenheit degree (also reported as 11.28 fahrenheit degree) for 1 hour. No adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1904USA008214: US-009507513-1904USA010535: US-009507513-1904USA010531: US-009507513-1904USA010532: US-009507513-1904USA010533:
Sex: F
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient received improperly stored VARIVAX; This spontaneous report was received from a nurse referring to an female child.Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.  On 18-APR-2019, the patient received improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R026548, and expiration date  17-SEP-2020 strength, dose detail and route were not provided) for prophylaxis (product storage error). The varicella virus vaccine live (Oka/Merck) (VARIVAX)was reconstituted with properly stored sterile diluent (lot & expiration date was unknown by reporter).   The vaccines were exposed to temperature excursion of 6 fahrenheit degree to 14 fahrenheit degree (also reported as 7.64 fahrenheit degree) for 45 minutes. The vaccines were exposed to previous temperature excursion of 6 degree Celsius to 14 fahrenheit degree (also reported as 11.28 fahrenheit degree) for 1 hour. No adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA008214:
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects reported; A patient received a dose of MMR II via intramuscular; This spontaneous report has been received from a pharmacist and referring to a patient of unknown age and gender.   The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not provided.  On 23-APR-2019, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) intramuscularly (Inappropriate route of vaccination)(dosing details, frequency, anatomical site, lot number and expiration date were not provided) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; The administration of an one separate dose of an improperly stored vaccine, PEDVAX HIB, to one separate patient; This spontaneous report was received from a nurse, regarding a identify patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.   On 19-APR-2019, the patient was vaccinated with with improperly stored stored doses Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) injection, intramuscular in the thigh, lot number N000238, and expiration date 25-OCT-2019 (dosage was not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion and time frame of 35.7 for 0 minutes and 35.9 for 0 minutes. There was previous temperature excursion of 34.7 Fahrenheit  for 2 hours and 30 minutes. Data logger was involved.  This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-1904USA010692:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of an unknown age and an unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported. On 23-APR-2019, the patient was inadvertently vaccinated with an expired dose of GARDASIL 9 lot # M033583 with expiration date 14-APR-2019, intramuscularly (dose detail was not reported) for prophylaxis. No adverse effect was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Insomnia, Malaise, Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm, general body pain, difficulty sleeping, ear pain and malaise. On an unknown date, the outcome of the pain in arm, general body pain, difficulty sleeping, ear pain and malaise were unknown. It was unknown if the reporter considered the pain in arm, general body pain, difficulty sleeping, ear pain and malaise to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient who herself was a Pharmacist. The patient experienced arm soreness, body aches, trouble sleeping, leg pain, ear pain and malaise after receiving a dose of SHINGRIX. The patient commented that she was unsure if all of those symptoms were due to the SHINGRIX. No additional details were provided.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Laboratory test, Pain in extremity, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 69-year-old male patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included shingles (diagnose with shingles 20 years ago). On 8th April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th April 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm. On 16th April 2019, the patient experienced allergic reaction and rash. On an unknown date, the outcome of the allergic reaction was unknown and the outcome of the pain in arm was recovered/resolved and the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the allergic reaction, pain in arm and rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for himself. The patient received a dose SHINGRIX on left arm in a physician's office. Lot number was not known. The patient reported that he experienced a sore arm that lasted for 8 days. Eight days after receiving SHINGRIX, the patient also experienced rash to the bottom of the injection site on the left arm, behind the back of the left arm, and across the forehead and above the eyebrows. The patient was seen by a physician but no diagnosis was made. The physician said that the patient might have been allergic to the vaccine. The patient was tested and would consult with a specialist. The reporter gave consent to be followed up.
Age: 23.0
Sex: U
Vaccine: MENB
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Pt had nausea and almost fainted. Pt had chills, possible fever, body aches all over. Stomach cramps, diarrhea, fatigue, and headache. Symptoms lasted 24 hours.
Age: 23.0
Sex: U
Vaccine: MENB
Symptoms: Nausea, Pain, Presyncope
Clinical narrative: Pt had nausea and almost fainted. Pt had chills, possible fever, body aches all over. Stomach cramps, diarrhea, fatigue, and headache. Symptoms lasted 24 hours.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: PT RECEIVED VACC AROUND 4:30PM TUESDAY THE 23. PT STARTED EXPERIENCING FLU LIKE SYMPTOMS 1;00 THE NEXT DAY. FEVER OF 101. CHILLS, MUSCLE PAIN.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Gait disturbance
Clinical narrative: Chills and marked shivering over a period of approximately 3 hours. The shivering was extreme enough at the outset that it was difficult to walk. Initially, heavy bedclothes and an electric blanket had little effect. The effects gradually decreased so that sleep was possible by the 4th hour. No effects were apparent by 7:30 am.