chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Joint swelling
Clinical narrative: This is a non-serious spontaneous case, initially received from a pharmacist on 10-Dec-2018, concerning a female patient of an unspecified age. The patient had no medical history and allergies. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal [route of administration: intramuscular, anatomical location: right arm, dose, batch number, expiry date, trade name and manufacturer: not reported] for an unknown indication. On an unspecified date, the patient was administered non-company suspect vaccine PNEUMOVAX 23 (route of administration: intramuscular, anatomical location: right arm, batch number: R018735 and expiry date: 06-Apr-2020, dose, trade name and manufacturer: not reported) for pneumonia. It was reported that, both suspect and co-suspect vaccines were given in the same arm. On an unspecified date after vaccination, the patient developed erythema in the right arm and swelling in elbow (reported as unspecified). On an unspecified date, the patient self-medicated with topical BENADRYL and topical cortisone cream (drug unspecified) but had no relief. On 03-Dec-2018, the patient returned to the pharmacy and the pharmacist advised the patient to take oral BENADRYL (unspecified dose). The outcome of the events was not recovered. Reporter's Comments: A female patient of an unspecified age experienced erythema in right arm and swelling of elbow on unspecified date after the administration of suspect vaccine INN Flu Vaccine Seasonal and non-company suspect vaccine vaccine PNEUMOVAX 23. It was reported that both the vaccines were given in the same arm. The company assessed the causality of the events erythema in right arm and swelling of elbows as unassessable due to lack of onset latency regarding the events. The company assessed the causality of the event drug administration error as not related due to accidental nature of the event.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Feeling abnormal, Gait disturbance, Hypoaesthesia
Clinical narrative: When the shot was injected, I felt it shoot across my chest from the left shoulder to my right shoulder and the nurse said that was weird. An hour and half later my left leg became muscle bound, cramping, twitching and painful in shin, ankle, calf & thigh.  That night I could not sleep from excruciating pain in these same areas.  This went on for weeks and then there was numbness in shin and instep of foot.  I also had the chills for several weeks.  Finally the symptoms slowly diminished and as of today I only still have a slight gate imbalance.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Muscle spasms, Muscle twitching, Pain, Pain in extremity
Clinical narrative: When the shot was injected, I felt it shoot across my chest from the left shoulder to my right shoulder and the nurse said that was weird. An hour and half later my left leg became muscle bound, cramping, twitching and painful in shin, ankle, calf & thigh.  That night I could not sleep from excruciating pain in these same areas.  This went on for weeks and then there was numbness in shin and instep of foot.  I also had the chills for several weeks.  Finally the symptoms slowly diminished and as of today I only still have a slight gate imbalance.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: X-ray
Clinical narrative: When the shot was injected, I felt it shoot across my chest from the left shoulder to my right shoulder and the nurse said that was weird. An hour and half later my left leg became muscle bound, cramping, twitching and painful in shin, ankle, calf & thigh.  That night I could not sleep from excruciating pain in these same areas.  This went on for weeks and then there was numbness in shin and instep of foot.  I also had the chills for several weeks.  Finally the symptoms slowly diminished and as of today I only still have a slight gate imbalance.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site haemorrhage, Injection site pain, Vaccine positive rechallenge
Clinical narrative: pain at injection site; bleeding at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 2Y9R4, expiry date 28th June 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (For tolerance to the 1st dose of Shingrix, refer case US2019080707).   On 4th April 2019, the patient received the 2nd dose of Shingrix. On 4th April 2019, less than a day after receiving Shingrix, the patient experienced injection site hemorrhage. On an unknown date, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On 4th April 2019, the outcome of the injection site hemorrhage was recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site hemorrhage to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced pain on his right deltoid after receiving the Shingrix vaccine into the right deltoid. The patient continued to experience the pain at the time of reporting.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Nausea
Clinical narrative: pain at injection site; nausea; flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number LA5RC, expiry date 22nd May 2021) for prophylaxis.   On 1st February 2019, the patient received the 1st dose of Shingrix (intramuscular). On 2nd February 2019, 1 days after receiving Shingrix, the patient experienced injection site pain, nausea and flu like symptoms. On 4th February 2019, the outcome of the injection site pain was recovered/resolved. On 6th April 2019, the outcome of the nausea and flu like symptoms were recovered/resolved.   It was unknown if the reporter considered the injection site pain, nausea and flu like symptoms to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced pain on his left deltoid after receiving the Shingrix vaccine into the left deltoid. The patient experienced nausea and flu like symptoms for 63 days. For tolerance to the 2nd dose of Shingrix, refer case US2019GSK086420. There was a discrepancy in the reported outcomes in XML and the ones autoloaded in the Argus, however, outcome captured as per Argus.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: Syringe failed and resulted in unknown, but relatively large amount of vaccine running down patient's arm
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Abdominal pain, Blood urea increased, Full blood count normal, Headache, Metabolic function test abnormal
Clinical narrative: severe headache, low grade fever, severe abdominal pain, emesis X 1, pallor
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Pallor, Pyrexia, Vomiting
Clinical narrative: severe headache, low grade fever, severe abdominal pain, emesis X 1, pallor
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site induration, Injection site rash, Pruritus
Clinical narrative: pink in duration and rash at injection site and around underarm with itching
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events.  Pediatric dose given. It should have been an adult dose.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: (L) arm swelling redness > 15cm.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: SHE SAID THAT HER ARM BEGAN TO SWELL THE NEXT DAY AND STAYED SWOLLEN FOR ABOUT A MONTH AFTER THE INJECTION.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Hypopnoea, Injection site pain
Clinical narrative: Beginning approximately 6 hours after the injection, pain at injection site and low-grade fever (~100 degrees). Overnight, higher fever and extreme pain throughout my body, particularly at joints. Unsure whether shaking was due to chills or reaction to pain, but breathing was impacted by level of pain. (My husband thought I was having trouble breathing - it was more that I was taking shallow breaths because of the pain level).  Fever continued intermittently for approximately 48 hours, with fatigue associated with it.  Pain at injection site was enough to wake me up at night for 4 nights.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Pain, Pyrexia, Tremor
Clinical narrative: Beginning approximately 6 hours after the injection, pain at injection site and low-grade fever (~100 degrees). Overnight, higher fever and extreme pain throughout my body, particularly at joints. Unsure whether shaking was due to chills or reaction to pain, but breathing was impacted by level of pain. (My husband thought I was having trouble breathing - it was more that I was taking shallow breaths because of the pain level).  Fever continued intermittently for approximately 48 hours, with fatigue associated with it.  Pain at injection site was enough to wake me up at night for 4 nights.
Sex: F
Vaccine: RV5
Symptoms: Body temperature increased, Irritability, Ocular hyperaemia, Product administered to patient of inappropriate age, Selective eating disorder
Clinical narrative: I called mother of patient because she requested that a VAERS report be submitted. because her daughter was mistakenly given Rotateq prior to 6 weeks of age. Mother states pt. vomited after receiving Rotateq vaccine. Pt. displayed irritability and difficulty feeding x 3 days post vaccination. Mom noted bilateral sclera redness and measured temperatures in the 99 range for 2 days post vaccination. Mom notes that the patient's skin color has changed and  has a "brownish tone. " Pt. has been evaluated by a physician outside of our practice.
Sex: F
Vaccine: RV5
Symptoms: Skin discolouration, Vomiting
Clinical narrative: I called mother of patient because she requested that a VAERS report be submitted. because her daughter was mistakenly given Rotateq prior to 6 weeks of age. Mother states pt. vomited after receiving Rotateq vaccine. Pt. displayed irritability and difficulty feeding x 3 days post vaccination. Mom noted bilateral sclera redness and measured temperatures in the 99 range for 2 days post vaccination. Mom notes that the patient's skin color has changed and  has a "brownish tone. " Pt. has been evaluated by a physician outside of our practice.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Pallor
Clinical narrative: Patient administered HPV Gardasil at 11:00 a.m. and advised to wait in room to make sure no reactions to vaccine. Dad came out of room at  and stated that " she fell backwards in the bed and she looks very pale"
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills
Clinical narrative: Pt reports severe chills starting around 3-4am. Symptoms then changed to pain, specifically in her joints. Symptoms are improving at time of call (1010am), but still lingering.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Erythema, Immediate post-injection reaction, Induration, Limb mass, Local reaction
Clinical narrative: Local reaction initially immediately after injection with mild red erythematous surrounding.  After 1 week the location reaction appears to harden and a month later it was noted to have cystic like mass deep seed nearby the injection site.  Patient is other wise well and not in acute distress.  No further work up performed at this point.  Patient was referred to peds surgery for evaluation of mass and removal.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody positive, Arthralgia, Blood test normal, C-reactive protein normal
Clinical narrative: Flu symptoms presented on April 20-23 - in bed for 3 days with achy muscles and joints.  The flu-like symptoms resolved by April 25.   The on May 2 - left little finger, right middle finger, and both wrists were swollen and painful, hot to the touch with a loss of full mobility.  Fatigue was also noticed.  Dr. ran blood work to rule out RA as mother has RA.  All tests came back negative except ANA was positive.  Rest, ice, vitamin C, zinc, extra fluids - treatment similar to treating flu or a cold.  Symptoms fully resolved by May 13, 2019.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Influenza, Joint swelling, Mobility decreased, Myalgia
Clinical narrative: Flu symptoms presented on April 20-23 - in bed for 3 days with achy muscles and joints.  The flu-like symptoms resolved by April 25.   The on May 2 - left little finger, right middle finger, and both wrists were swollen and painful, hot to the touch with a loss of full mobility.  Fatigue was also noticed.  Dr. ran blood work to rule out RA as mother has RA.  All tests came back negative except ANA was positive.  Rest, ice, vitamin C, zinc, extra fluids - treatment similar to treating flu or a cold.  Symptoms fully resolved by May 13, 2019.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Red blood cell sedimentation rate normal, Rheumatoid factor negative, Skin warm
Clinical narrative: Flu symptoms presented on April 20-23 - in bed for 3 days with achy muscles and joints.  The flu-like symptoms resolved by April 25.   The on May 2 - left little finger, right middle finger, and both wrists were swollen and painful, hot to the touch with a loss of full mobility.  Fatigue was also noticed.  Dr. ran blood work to rule out RA as mother has RA.  All tests came back negative except ANA was positive.  Rest, ice, vitamin C, zinc, extra fluids - treatment similar to treating flu or a cold.  Symptoms fully resolved by May 13, 2019.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, pain and swelling at injection site approximately 24-36 hours after injection
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: My left arm below the injection site got very red and felt hot to the touch.  The redness spread down to the elbow and my upper arm was swollen. I had experienced these symptoms previously with injections and it was the weekend, so I did not see a doctor and the  redness started to fade after three days.  This happens to me now each time I get a shot.  The worst was a Tetanus shot where my arm was red, swollen, and very hard to the touch and it stayed that way for over a week.  My physician feels I may be allergic to the preservatives in injections.  She wants me to get a Shingles shot because of my age and I am very worried about getting one.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Severe pain, swelling, redness to left deltoid/shoulder area.  Vaccine given 5/13/19.  Seen in office 5/15/19 with Dr.  Toradol given for pain.  Naproxen script given.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site bruising, Injection site pruritus, Injection site vesicles, Pyrexia
Clinical narrative: Fever of 101.7, chills and itching that started on awakening the next morning, as listed in the side effects on the info sheet.  However, large (2 inches across) bruise that resolved into a blister at the injection site.  Blister has reduced in size but is still visible 2 weeks after the shot (today, 5/14).  Itching and blisters at my original shingles site (I had shingles in July 2014).
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling & erythema at injection site, 12cm diameter
Age: 0.83
Sex: F
Vaccine: MMR, MMRV, UNK, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects were reported; the patient was administered a dose of an unknown Measles vaccine on 12-JUN-2015, then administered a dose of MMR II on 30-NOV-2015; This spontaneous report was received from a medical assistant and a clinical coordinator referring to a 16 months old female patient. Information about pertinent medical history, drug reactions/allergies. The patient's concomitant therapies included the fifth dose of (the number of previous doses was reported as 4) diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (MRC-5), tetanus toxoid (QUADRACEL) (manufacture Sanofi, lot# was reported as C5532AA, in the left thigh) and tuberculin purified protein derivative (TUBERSOL) (lot# was reported as C5482AA, in the left forearm, manufacture was not reported, the number of previous doses was unknown).  On 12-JUN-2015, the patient was vaccinated with a dose of unknown measles vaccine, (manufacture unknown, dose detail, route, lot # and expiration date were not reported) for unknown indication.   On 30-NOV-2015, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose detail, route, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).  On 11-APR-2019, the patient was vaccinated with the first (the number of previous doses was reported as 0) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneously in the right thigh, therapy type was rHA (recombinant Human albumin), lot# R030794 with expiration date 22-APR-2020 (dose detail was not reported) for prophylaxis. On the same date, the patient also vaccinated with the sterile diluent (strength, dose, frequency, route, lot # and expiration date were not reported), the fifth dose of (the number of previous doses was reported as 4) hepatitis b virus vaccine (unspecified) (manufacture GlaxoSmithKline, lot# was reported as 97LJ2, in the right thigh, dose detail, route, and expiration date were not reported) for an unknown indication. The clinical coordinator also reported that the patient was a new patient, vaccines were preloaded at the time of visit, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was order and given. At the time of the visit, later after vaccine record was reviewed by another nurse, realized measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not needed, both parents was notified by the doctor. The patient did not require any prescription drug treatment for the experience. There was not have temperature excursion occurred after read from the digital data logger either. No adverse effects were reported.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No adverse effects; the patient has now discovered that she was approximately two-weeks pregnant at the time of vaccination; This prospective spontaneous report was received from a physician's assistant and refers to a 24-year-old female patient.   There was no information concerning the patient's pertinent medical history, concomitant medications, concurrent conditions or allergies provided.    On 25-MAR-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) subcutaneously, lot # R019391, expiration date: 05-JUL-2020, albumin status rHA (strength and dose were not provided) for prophylaxis. On an unknown date, reported as "now", the patient discovered that she was approximately two-weeks pregnant at the time of vaccination. The last menstrual period (LMP) was 11-MAR-2019, estimated date of delivery (EDD) was 16-DEC-2019. There were no adverse effects reported. The outcome of pregnancy was pending. There was no treatment given for adverse event, no medical attention was seek, no intervention to prevent serious criteria and no significant disability or incapacity and no product quality complaint presented.
Sex: F
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; received a dose of M-M-R II which was reconstituted with expired STERILE DILUENT; This spontaneous report as received from a pharmacist refers to a 48-year-old female patient. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 26-APR-2019, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) , recombinant human albumin (rHA) (lot # R019391, expiration date 05-JUL-2020) (frequency, dose, strength, and route of administration were not reported) for prophylaxis, which was reconstituted with expired sterile diluent (lot # M026304, expiration date: 13-MAR-2019) (frequency, dose, strength, and route of administration were not reported). Both the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and sterile diluent were properly stored and had no previous temperature excursions. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 14 year old patient was administered a dose of proquad; no adverse effects reported; This spontaneous report was received from a registered nurse via company representative and refers to a 14-year-old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (exact dose, route of administration, lot # and expiration date were not provided), for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Condition aggravated, Fatigue, Gait disturbance
Clinical narrative: Difficulty walking; pain in both knees; Weakness in legs; Lower back pain; Fatigue; Headache; Sorearm; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis and acute back pain.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, 14 days after receiving Shingrix, the patient experienced walking difficulty, knee pain, lower extremities weakness of and back pain aggravated. On an unknown date, the patient experienced fatigue, headache and pain in arm. On an unknown date, the outcome of the fatigue, headache and pain in arm were recovered/resolved and the outcome of the walking difficulty, knee pain, lower extremities weakness of and back pain aggravated were unknown.   It was unknown if the reporter considered the fatigue, headache, pain in arm, walking difficulty, knee pain, lower extremities weakness of and back pain aggravated to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient herself.  About 3 weeks ago (of the date of reporting), the patient received dose 1 of Shingrix, in the left arm. About 2 weeks post vaccination, the patient started experiencing hard time walking, pain in both knees and more dominant in the right knee, weakness in legs and more lower back pain than usual. The patient experienced sore arm and headache which lasted for 4 days, and fatigue which lasted for 5 days.  The patient referred to health care professional.  The patient consented to follow up.  No further details were provided.  The reporter also reported adverse event for her husband, refer case US2019080737.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Muscular weakness, Pain in extremity
Clinical narrative: Difficulty walking; pain in both knees; Weakness in legs; Lower back pain; Fatigue; Headache; Sorearm; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis and acute back pain.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, 14 days after receiving Shingrix, the patient experienced walking difficulty, knee pain, lower extremities weakness of and back pain aggravated. On an unknown date, the patient experienced fatigue, headache and pain in arm. On an unknown date, the outcome of the fatigue, headache and pain in arm were recovered/resolved and the outcome of the walking difficulty, knee pain, lower extremities weakness of and back pain aggravated were unknown.   It was unknown if the reporter considered the fatigue, headache, pain in arm, walking difficulty, knee pain, lower extremities weakness of and back pain aggravated to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient herself.  About 3 weeks ago (of the date of reporting), the patient received dose 1 of Shingrix, in the left arm. About 2 weeks post vaccination, the patient started experiencing hard time walking, pain in both knees and more dominant in the right knee, weakness in legs and more lower back pain than usual. The patient experienced sore arm and headache which lasted for 4 days, and fatigue which lasted for 5 days.  The patient referred to health care professional.  The patient consented to follow up.  No further details were provided.  The reporter also reported adverse event for her husband, refer case US2019080737.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Wrong route of administration; big red swollen bump at injection site; big red swollen bump at injection site; big red swollen bump at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd February 2019, the patient received the 2nd dose of Shingrix (subcutaneous). On 23rd February 2019, less than a day after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site swelling, injection site erythema and injection site lump. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site lump were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site lump to be related to Shingrix.  Additional details were reported as follows: The patient received the Shingrix subcutaneously, which led to incorrect route of vaccine administration. The patient developed a big red swollen bump at the injection site that went away after 3 days.  The pharmacist did not know the lot number or expiry date.  The dose was given at a different pharmacy.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Rash
Clinical narrative: moderate rash X 48 hours , mild lympadenopathy,
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was given . No adverse effects were observed in client before leaving clinic at around 10:45 am 5/15/2019. Expected side effects from vaccine were given to Mom and explained on VIS. Instructed Mom to contact MD if anything else out of ordinary occurred. GLaxo SMith Kline contacted about expired vaccine given.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Dysphemia
Clinical narrative: Approximately 4-6 days after my son was vaccinated with his first Hep B shot, he developed a pretty moderate sudden onset of stuttering, that lasted a few months and gradually slowed down to nearly being gone.
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Dysphemia
Clinical narrative: After 3rd Hep B shot, my five year old son started stuttering suddenly again the following night after vaccination.  He developed an onset moderate stutter after his first Hep B shot few days after and it had subsided in the following months and was gone. Then came back 24 hours after last shot. It is mostly gone now, it gradually gets better in the next few months following shot.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; one patient was administered an irmroperly stored dose of PROQUAD; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided. Concomitant therapies included sterile diluent.  On 08-MAY-2019, the patient was vaccinated subcutaneously with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S002503, expiration date 23-JUL-2020, albumin status rHA (recombinant Human albumin) (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 7 degrees Celsius for 72 hours.  Data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No known adverse effects; a patient received a dose of VARIVAX via the intramuscula route in error; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 10-MAY-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # R013303, expiry date: 08-MAY-2020, intramuscularly (dose and anatomical location were not provided) for prophylaxis. The vaccine was administered via a intramuscular route in error. No adverse effects were reported.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; patient received improperly stored PROQUAD; This spontaneous report was received from a registered nurse and refers to a 4-year-old male patient.     The patient's pertinent medical history, drug reactions, allergies were not reported.  On 13-MAY-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot # R030800, expiration date on 22-APR-2020 (strength, dose and route of administration were not reported) for prophylaxis. It was reported that the vaccine was exposed to a temperature -9 degrees Celsius to 8 degrees Celsius (-7.4 degrees Celsius) for 4 hours. There was no previous temperature excursion. Data logger was involved. Measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with properly stored sterile diluent (lot number R007087, expiration date on 20-JAN-2021). No product quality complaint (PQC) was associated with this report. No adverse effects were reported.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: injection site Soreness; Swelling at injection site; itchy; hot to touch- injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number HB2B2, expiry date 13th April 2020) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Shingrix. On 20th April 2019, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site itching and injection site warmth. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site swelling, injection site itching and injection site warmth were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site itching and injection site warmth to be related to Shingrix.  Additional details were provided as follows: Twenty four (24) hours after receiving a dose of Shingrix the patient reported to have swelling in arm, itchy, and hot to touch. At the time of this report, 3 weeks later the arm was still sore.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number P57AA, expiry date 5th July 2020) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.
Age: 0.42
Sex: U
Vaccine: PNC13
Symptoms: Injection site reaction, Rash maculo-papular
Clinical narrative: it may be due to a delayed hypersensitivity reaction to a component in the vaccine, active or inactive; maculopapular lesions right around the injection site; This is a spontaneous report from a contactable physician (allergist). A 5-month-old patient of an unspecified gender received the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. This allergist reported that the patient received an initial dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and experienced maculopapular lesions right around the injection site. The physician who administered the injection felt it may be due to a delayed hypersensitivity reaction to a component in the vaccine, active or inactive, and the patient was referred to the allergist for possible patch testing and further evaluation. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: HEPA, MENB
Symptoms: Injected limb mobility decreased, Injection site pain, Swelling
Clinical narrative: Pain to arm she received Trumenba along with localized swelling and difficulty rising arm; Pain to arm she received Trumenba along with localized swelling and difficulty rising arm; Pain to arm she received Trumenba along with localized swelling and difficulty rising arm; This is a spontaneous report from contactable Nurse reporting on behalf of physician, via Pfizer Sales Representative.  A 18-year-old female patient on 30Apr2019 received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on  at single dose in one arm and hepatitis A vaccine (HEPATITIS A) to other arm, both for immunization.  The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced pain to arm where she received meningococcal group b rlp2086 along with localized swelling and difficulty rising arm. The events were non- serious. The physician advised patient warm compresses 4x/day and warm shower. The outcome of the events was unknown.   The information on the batch/lot number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: An area 1-2 inches from the injection site that was sore and bruised; An area 1-2 inches from the injection site that was sore and bruised; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported same events for two patients. This is the first of two reports.  An elderly female patient of an unspecified age (age: >65 year old) received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced an area 1-2 inches from the injection site that was sore and bruised on an unspecified date. The events recovered on an unspecified date in 7-10 days.  Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019201610 same reporter/drug/event, different patients;US-PFIZER INC-2019201610 same reporter/drug/event, different patients
Sex: M
Vaccine: MENB
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable Physician via Pfizer sales representative.   A 17-year-old male patient, getting school form completed, received the 1st dose of meningococcal group b rlp2086 (TRUMENBA) via an unspecified route of administration at single dose on an unspecified date for immunisation.   The patient medical history was not reported.  No concomitant medication at the time of the event, he was not taking any other medications.  The patient experienced dizziness on an unspecified date after the administration of the vaccine.  The outcome of the event was unknown.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Abnormal behaviour, Autism spectrum disorder, Crying, Learning disorder, Memory impairment
Clinical narrative: She was doing everything on time when she was less than a month like sitting down on time, crawling, and talking and all of a sudden when she got her 1 year old shots she completely changed on me in like 3 days she started crying more and learning less and forgetting. It's really hard sometimes.
Age: 27.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Influenza like illness, Pain, Pyrexia
Clinical narrative: High fever (from 100/101 to maxing at 102.7) for four full days following vaccination (received vaccination on Thurs., fever persisted Fri.-Mon.) Flu-like vomitting and diarrhea for 3+ days Chills/body shakes and aches
Age: 27.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor, Vomiting
Clinical narrative: High fever (from 100/101 to maxing at 102.7) for four full days following vaccination (received vaccination on Thurs., fever persisted Fri.-Mon.) Flu-like vomitting and diarrhea for 3+ days Chills/body shakes and aches
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: Red area the size of 2 quarters  appeared - no vesicles
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Influenza like illness, Injection site erythema, Malaise
Clinical narrative: By 8pm started feeling achy, and with flu-like symptoms which lasted for about 3 days. On the first night, had body aches and took Advil which helped relief symptoms a little.  Patient also felt tired and had little energy; patient still went to work but did not feel well.  On Thursday morning, patient felt tingling on back so took 1 Famvir; only took 1 as read that it was a contraindication on paperwork.  Patient also spoke to a pharmacist about taking Famvir.   Patient reports vaccination site was red, warm, and had an itchy feeling near elbow; no bumps seen. Patient still feels tingling 6 days later.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Pruritus, Vaccination site warmth
Clinical narrative: By 8pm started feeling achy, and with flu-like symptoms which lasted for about 3 days. On the first night, had body aches and took Advil which helped relief symptoms a little.  Patient also felt tired and had little energy; patient still went to work but did not feel well.  On Thursday morning, patient felt tingling on back so took 1 Famvir; only took 1 as read that it was a contraindication on paperwork.  Patient also spoke to a pharmacist about taking Famvir.   Patient reports vaccination site was red, warm, and had an itchy feeling near elbow; no bumps seen. Patient still feels tingling 6 days later.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chest discomfort, Chills, Headache, Nausea
Clinical narrative: Patient reported nausea, chills, headache, throbbing arm and armpit, tender to touch, tight chest relieved by nebulizer.  Patient encouraged to continue taking Tylenol or Motrin and use cold compress.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Tenderness
Clinical narrative: Patient reported nausea, chills, headache, throbbing arm and armpit, tender to touch, tight chest relieved by nebulizer.  Patient encouraged to continue taking Tylenol or Motrin and use cold compress.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Influenza like illness, Limb discomfort
Clinical narrative: Sore arm;  achy joints (Like the flu) , fatigue
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: about 2 hours after vaccine was given, hives developed on legs b/l.  improved after one dose of Diphenhydramine but  did not resolve.  Seen in office 16hrs after vaccine given and hives persisted on legs. Recommended Diphenhydramine q6hrs until hives resolved.  no other symptoms
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Headache, Injection site pain
Clinical narrative: HEADACHE, TIRED, COLD, SHIVERING,  PAIN & SWELLING AT INJECTION SITE
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: HEADACHE, TIRED, COLD, SHIVERING,  PAIN & SWELLING AT INJECTION SITE
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects reported; the patient was inadvertently administered a dose of VARIVAX intramuscularly rather than subcutaneously; the patient was inadvertently administered a dose of VARIVAX intramuscularly rather than subcutaneously; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies, drug reactions, concurrent conditions and concomitant medications were not reported.  On 08-MAY-2019, the patient was inadvertently vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX), intramuscularly rather than subcutaneously (strength, dose, anatomical location, lot #, and expiration date not reported) indicated for prophylaxis.        No adverse effects were reported.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Injection site rash, Underdose
Clinical narrative: exposure via skin contact; Inadvertent exposure to vaccine; rash; underdose; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2019, the patient received the 1st dose of Shingrix. On 3rd May 2019, less than a day after receiving Shingrix, the patient experienced injection site rash and accidental underdose. On an unknown date, the patient experienced exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the injection site rash, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's daughter. It was reported that the patient received Shingrix either on 3rd May 2019 or 4th May 2019 on an unknown arm. It was reported that a family member told her that the patient received a partial dose of Shingrix, and some of it ran down her arm, which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine and she developed rash where the vaccine ran down her arm.  The patient did not consent to follow-up.  The reporter declined to provide the details of her mother's experience and did not know other details. This was the only information available and was documented.  The reporter was unsure if this case was reported to GSK previously.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. An 18-year-old male patient received the first dose of meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history was not reported. Concomitant medication included meningococcal vaccine conj (MENINGOCOCCAL CONJUGATE) for immunization. The patient experienced flu like symptoms 12 hours post vaccination. The outcome of the event was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for 3 patients. This is the third of 3 reports.  A patient of unspecified age and gender received first dose of meningococcal group b rlp2086 (TRUMENBA), at single dose and second dose of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), both via an unspecified route of administration on the same unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced flu like symptoms on an unspecified date for 3 days with outcome of unknown.  The information on the lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019166742 Same reporter/products/events, different patients;US-PFIZER INC-2019170863 Same reporter/products/events, different patients
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Developed rash in the mid and upper part of back and on chest; This is a spontaneous report from a contactable consumer.  A 7-month-old male patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: W51943 and expiration date: Jul2020), intramuscular on 07May2019 at 0.5 ml, single for childhood immunization.  The patient had no medical history and concomitant medications.  The patient previously took PREVNAR 13 for immunization.  The patient developed rash in the mid and upper part of back and on chest on 07May2019. The outcome of the event was recovered on an unspecified date.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had (2) doses of varicella, A Proquad (MMRV) and a varicella was given on the same day. No adverse reaction from extra vaccine given. Made follow up phone call mother on 5-14-19.
Age: 7.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: RMA gave Kinrix instead of Tdap. Patient is fine but I advised RMA to give Tdap and Ipol separate. She gave Kinrix because she forgot.
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Lymphadenopathy, Nasopharyngitis, Pharyngeal inflammation
Clinical narrative: 58yo f developed sensation of enlarged cervical lymph  nodes 5/12/19, also mild inflamed throat, dizziness  and head cold sxs.
Age: 8.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: RMA gave Kinrix instead of Tdap. Patient is fine but I had advise RMA to give Tdap and Ipol separate. She gave Kinrix because she thought of one shot over two shots.