chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of Menactra was given to a 12 years old patient, No AE; Initial information was received on 09-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a 12-years-old male patient who was vaccinated with a 0.5 ml first dose of an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6208AB and expiration date 08-Jul-2020) via an intramuscular route at an unknown administration site on 08-Sep-2020 for prophylactic vaccination (latency was same day).  The patient's medical history, concomitant medication, past medical treatment, vaccination and family history were not provided.  The patient had concomitantly received a dose of vaccine DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  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.
Sex: U
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: FLUZONE QUADRIVALENT given to a 67 year old instead of FLUZONE HIGH-DOSE QUADRIVALENT, no AE; Initial information received on 10-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 67 years old patient (unknown gender) who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]  (lot number and expiration date were not reported) (PT:Wrong product administered) as prophylactic vaccination on an unknown date.   Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was an actual medication error case due to wrong vaccine administered.  No adverse event reported at the time of reporting.  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.  There will be no information on the batch number for this case.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: reported hives on left thigh and left abdomen  took benadryl 25 mg approx 9 pm 9/15/20  no hives 9/16/20
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Nausea, Pyrexia
Clinical narrative: September 3, 2020 feverbetween 100.2 and 100.8 for approximately 12 hours. Redness of injection site for one week.  Sept. 3, 2020, mid afernoon, one brief dizzy spell and wave of nausea.  No vomiting.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea
Clinical narrative: chills and shivering for about 3 hours, nausea for about 24 hours
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: muscle aches, fever, rigors. Treatment - ibuprofen & APAP. improved temp to 99.7 F. Symptoms improved within 24 hours
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Injection site pruritus, Oropharyngeal pain, Pruritus, Sensation of foreign body
Clinical narrative: Approx. 12 hours after dose, I experienced itchy skin on both my wrists, ankles and near the dose site of my left arm. About 2 hours later, I developed hives at those areas. I also had a mild sore throat most of the day on 9/15 (like I had a lump in my throat) and was very fatigued on 9/16/20. I took the 25 mg. of my daily allergy medicine listed in this form. I took this dose on 9/15 & 9/16.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Approx. 12 hours after dose, I experienced itchy skin on both my wrists, ankles and near the dose site of my left arm. About 2 hours later, I developed hives at those areas. I also had a mild sore throat most of the day on 9/15 (like I had a lump in my throat) and was very fatigued on 9/16/20. I took the 25 mg. of my daily allergy medicine listed in this form. I took this dose on 9/15 & 9/16.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given a high dose flu vaccine and is not yet 65 years of age.
Sex: F
Vaccine: PPV
Symptoms: Crohn's disease, Immunodeficiency
Clinical narrative: Crohn's disease; is immunocompromised; there was no more data than that in the PI. Limited data due to caller hanging up.; received PNEUMOVAX 23 on 04/2015 and 05/2015; This spontaneous report as received from a patient's mother, refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On an unknown date in April 2015, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dose, route of administration, lot number and expiration date were not reported); on an unknown date in May 2015, she received the next dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dose, route of administration, lot number and expiration date were not reported), both as prophylaxis. On unknown dates (it was not stated if it was before or after pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccination), the patient experienced Crohn's disease and immunodeficiency (as it was stated that she was immunocompromised). She was taking a chemo type pill every day for Crohn's disease. The patient's physician wanted to do the re-vaccination. However, the patient's mother wanted to know if that was safe and was upset due to limited data according pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The outcome of Crohn's disease and immunodeficiency was determined to be not recovered.  The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.  Upon internal review, the events of Crohn's disease and immunodeficiency were determined to be medically significant.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: administered improperly stored VARlVAX; This spontaneous report was received from a medical assistant and refers to a 12-month-old female patient. On 25-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038701 has been verified to be a valid lot number, expiration date: 01-DEC-2021, subcutaneously (formulation, strength, exact dose and frequency were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion of (-9 to 8 Celsius degree) (-6.1 Celsius degree) (multiple excursions). Time frame was unknown by reporter. Data logger was involved. There were no previous excursions reported. No additional information provided.  Multiple temperature excursion: Improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S032355 has been verified to be a valid lot number, expiration date: 14-OCT-2021 (formulation, strength, exact dose, route of administration and frequency were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion of (-14 to -10 Celsius degree) (-6.1 Celsius degree) for 13 hours. Time frame for 129 hours. Data logger was involved. There were no previous excursions reported.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given high dose flu vaccine and is not yet 65 years of age.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Migraine, Pharyngeal swelling
Clinical narrative: She experience throat swelling about 20 minutes after she left the store.  She then drive herself to the hospital where she was treated and she also experience a migraine headache. She was treated with epinephrine and benadryl
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Patient became a little bit dizzy.   Patient also had blood drawn.  Patient was given juice and crackers and with in 15 minutes felt better.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose normal, Cellulitis, Chest X-ray normal, Electrocardiogram normal, Injection site erythema
Clinical narrative: Mom called after hours at 8:00pm to report left are soreness, red, swollen at injection site, fever 103F and vomited once.  On 9/9/2020 at 7:45 am pt passed out at home,  Was taken to hospital ER at 10 am.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Loss of consciousness, Pyrexia, Urine analysis normal
Clinical narrative: Mom called after hours at 8:00pm to report left are soreness, red, swollen at injection site, fever 103F and vomited once.  On 9/9/2020 at 7:45 am pt passed out at home,  Was taken to hospital ER at 10 am.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Mom called after hours at 8:00pm to report left are soreness, red, swollen at injection site, fever 103F and vomited once.  On 9/9/2020 at 7:45 am pt passed out at home,  Was taken to hospital ER at 10 am.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: sudden onset chills, fever (101.3), body aches, headache. Mostly subsided 10 hours later.
Age: 51.0
Sex: M
Vaccine: FLUX, HEPA, VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Feeling drunk, Pyrexia
Clinical narrative: beginning approximately 11:45 pm on the day of the vaccine, severe chills such that the whole bed was shaking, couldn?t get warm, fever about 101 F. Woke up at 4:30 am with pulse of 130 and fever of 100.7 F. Chills gone by then. As the morning wore on, funny taste in mouth, stomach isn such that there?s a loss of appetite. Feeling almost inebriated. Fatigue.
Age: 51.0
Sex: M
Vaccine: FLUX, HEPA, VARZOS
Symptoms: Taste disorder
Clinical narrative: beginning approximately 11:45 pm on the day of the vaccine, severe chills such that the whole bed was shaking, couldn?t get warm, fever about 101 F. Woke up at 4:30 am with pulse of 130 and fever of 100.7 F. Chills gone by then. As the morning wore on, funny taste in mouth, stomach isn such that there?s a loss of appetite. Feeling almost inebriated. Fatigue.
Age: 37.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site reaction, Limb discomfort, Nodule, Peripheral swelling
Clinical narrative: Yesterday patient noticed that the injection site was turning blotchy and red. Then later noticed swelling, itching, a nodule, and tenderness where a shirt sleeve causes discomfort.
Age: 37.0
Sex: F
Vaccine: ANTH
Symptoms: Pruritus, Rash macular, Tenderness
Clinical narrative: Yesterday patient noticed that the injection site was turning blotchy and red. Then later noticed swelling, itching, a nodule, and tenderness where a shirt sleeve causes discomfort.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Injected limb mobility decreased, Peripheral swelling
Clinical narrative: Patient received fluzone HD and pnemovax23 on Friday 9/11 and came by on Monday 9/14 reporting swelling and bruising on right arm. She stated she could not move the arm much on the weekend but can move it now. Swelling is still presenting but seems to be getting better
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Biopsy bladder normal, Biopsy urethra normal, Culture urine negative, Cystoscopy normal, Prostate examination normal
Clinical narrative: Within a week or two after immunization, I developed urethral spasms and urinary dribbling. This occurred for the next 8 weeks or so. I am a physician myself so I sought the evaluation from a urologist (Dr) who evaluated my condition. I had a urinalysis, urine culture, voiding dynamics, post void residual, prostate exam, as well as finally a cystoscopy with brush biopsy. All of my tests were normal. The urinary dribbling self resolved eventually after a couple of months and has not recurred since.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Urethral spasm, Urinary incontinence, Urine analysis normal, Urodynamics measurement
Clinical narrative: Within a week or two after immunization, I developed urethral spasms and urinary dribbling. This occurred for the next 8 weeks or so. I am a physician myself so I sought the evaluation from a urologist (Dr) who evaluated my condition. I had a urinalysis, urine culture, voiding dynamics, post void residual, prostate exam, as well as finally a cystoscopy with brush biopsy. All of my tests were normal. The urinary dribbling self resolved eventually after a couple of months and has not recurred since.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Limb discomfort, Mobility decreased, Nausea, Pain in extremity
Clinical narrative: Extremely sore arm, felt heavy and trouble lifting it. Had red blotches a few inches from the injection site.  Had nausea and vomiting that evening (one time).
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular, Vomiting
Clinical narrative: Extremely sore arm, felt heavy and trouble lifting it. Had red blotches a few inches from the injection site.  Had nausea and vomiting that evening (one time).
Age: 65.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Abnormal sensation in eye, Headache, Lethargy, Myalgia, Rash
Clinical narrative: I had seasonal flu and Shingrix 1 at the same time. Next day headache, muscle ache, hot eyes, and lethargy. About 24 hours later I had bilateral bright red rash covering my ribs from underarm region to waist. I assume this was a reaction to Shingrix, but I thought I should report it since it doesn't appear as a common side effect.
Age: 65.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Rash erythematous
Clinical narrative: I had seasonal flu and Shingrix 1 at the same time. Next day headache, muscle ache, hot eyes, and lethargy. About 24 hours later I had bilateral bright red rash covering my ribs from underarm region to waist. I assume this was a reaction to Shingrix, but I thought I should report it since it doesn't appear as a common side effect.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site haemorrhage, Injection site swelling
Clinical narrative: after the vaccine was given, the spot immediately started bleeding and then swelling up turning black and blue. it looked as if an artery was nicked.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 2nd dose of PCV 13 on 09/12/20 which was not due and received previous dose on 05/20/20.  Patient reported no adverse side effects.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: Vaccine administered at 1000 am. Patient had syncope episode at 1001 after vaccine administration. Patient stood up immediately after vaccination administration and was walking to the waiting room for his 15 minute wait period. While walking patient stopped, and collapsed falling backwards and hitting his head. Patient had lost consciousness for about 2 minutes. Patient regained consciousness at 1003 and seemed alert but had difficulty recalling events leading up to him falling and could not recall falling. Patient's vital signs were taken at 1004 BP at 85/56 HR 67 and SPO2 at 100%. Pediatrician was called to respond and performed her assessment. Vitals were rechecked at 1012 BP 92/59 HR 69 SPO2 100%. Patient stated that he was feeling better but still felt a little dizzy. Patient was moved from supine to sitting position at 1024. Vitals rechecked at 1034 BP 94/59 HR:77 SPO2 100%. Patient was moved from sitting to standing at 1040. Patient still had difficulty recalling events but was able to stand and walk properly. Patient was discharged from clinic with concussion precautions and will be reevaluated on 18SEP2020 for progress following event.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Patient has extreme swelling in left deltoid. Spread from just below the shoulder to about 6 inches above the elbow. Raised, red, and tender to touch. Patient has tried icing spot which helped slightly. No medication has been taken.
Age: 70.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received an extra Shingrix vaccination in error on 09/14/2020. Patient already received 2 doses of Shingrix in the past, on 01/09/2020 and  07/24/2020.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Joint range of motion decreased, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: SWELLING OF THE LEFT ARM,  DIFFICULTY BENDING THE ELBOW, ITCH AND PAIN ON ARM.  SHE APPLIED VICKS ON THE INJECTED AREA AND ICE.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Injection site pain, Pain
Clinical narrative: Pain in shoulder area following vaccination. Evaluated on 9/2/2020 and prescribed NSAID for tender to palpation, firm area measuring 1-2inches in right deltoid.  Follow up on 9/9/20 area was less firm to touch and only uncomfortable with movement. Advised additional follow up at that time if no improvement.
Age: 16.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Drug screen positive, Seizure
Clinical narrative: Seizure about 30 hours after vaccine
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: his second dose in the series was about 1 year ago; no additional AE reported; This spontaneous report as received from a pharmacist and other reporter and refers to a 24-year-old male patient. No information regarding his pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) out of three dose series (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis. In approximately 2019 (reported as about 1 year ago), he received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  Until the reporting day, the patient did not receive the third dose of vaccine which was considered to be an inappropriate schedule of vaccine administration. The pharmacist stated that she looked on the Centers for Disease Control and Prevention's (CDC) website and received direction there. No adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient got 4 injections of the vaccine instead of 3 injections; patient got 4 injections of the vaccine instead of 3 injections; It is unknown what the brand name of the HPV vaccine was; No other AE reported; This spontaneous report was received from a consumer referring to her currently 18-year-old daughter. No information regarding her pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with the first dose of unspecified human papillomavirus (HPV) vaccine (manufacturer unknown), for prophylaxis. On unknown dates, the patient received another 3 doses of vaccine (inappropriate schedule of product administration, extra dose administered). No adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received two doses out of three of GARDASIL 9/ 2nd dose was administered over one year ago; No further AE reported; This spontaneous report was received from a registered nurse and refers to a female patient in her 20's. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a first dose of GARDASIL 9 (exact dose, route and site of administration, lot# and expiry date were not reported) for prophylaxis. On an unknown date, over one year ago, she received second dose of GARDASIL 9. It was also reported that the patient received those two doses a year ago. The reporter wanted to know if third dose could be given or if the series should be restarted. No additional adverse events were reported.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient experienced sore arm after 1st dose of vaccine which resolved within few days. The reporter consented to follow up. This case is linked with case US2020181859, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020181859:same reporter
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain in extremity, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient experienced sore arm after 1st dose of vaccine which resolved within few days. The reporter consented to follow up. This case is linked with case US2020181859, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020181859:same reporter
Age: 21.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Abortion threatened, Exposure during pregnancy, Pregnancy test positive, Vaginal haemorrhage
Clinical narrative: did not know she was pregnant at the time she got the vaccines.; miscarriage symptoms; vaginal bleeding; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of threatened abortion in a 21-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA267A, expiry date 31st March 2021) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number ABXA14BA, expiry date 31st March 2021) for prophylaxis.   On 19th August 2020, the patient received Menveo and Bexsero. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Menveo at an unknown time during the pregnancy. On 2nd September 2020, 14 days after receiving Menveo and Bexsero, the patient experienced threatened abortion (serious criteria GSK medically significant) and vaginal bleeding. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the threatened abortion, vaginal bleeding and vaccine exposure during pregnancy were unknown. The pregnancy was ongoing.   It was unknown if the reporter considered the threatened abortion and vaginal bleeding to be related to Menveo and Bexsero.  Additional details were reported as follows: The patient received Menveo vaccine and Bexsero vaccine. On 27th August 2020, patient's  had a positive pregnancy test result.  The patient did not know she was pregnant at the time she got the vaccines. On 2nd September 2020, the patient went to the emergency room with vaginal bleeding and miscarriage symptoms. On 9th September 2020, the patient had a follow up visit with her obstetrician gynecologisy doctor and reported that all was fine with the pregnancy. The emergency room visit was required.
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Asthenia, Nausea, Pruritus
Clinical narrative: nausea; weakness; anaphylaxis /  admitted / treated for anaphylaxis; itching / still experiencing some itching/itching became worse; This case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 31st July 2020, 2 days after receiving Shingrix, the patient experienced anaphylaxis (serious criteria hospitalization and GSK medically significant) and pruritus (serious criteria hospitalization). On 1st August 2020, the patient experienced nausea (serious criteria hospitalization) and weakness (serious criteria hospitalization). On 10th September 2020, the outcome of the anaphylaxis, nausea and weakness were recovered/resolved. On an unknown date, the outcome of the pruritus was not recovered/not resolved.   The reporter considered the anaphylaxis, pruritus, nausea and weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in left arm. 2 days after receiving Shingrix, the patient began to developed anaphylaxis with itching. The day after that (3 days later), the itching became worse and the patient also started to experienced nausea and weakness. The patient was taken to the hospital where she was admitted for 3 days and treated for anaphylaxis.  The patient's symptoms had resolved except she still experiencing some itching at the time of reporting.  The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Rash, Urticaria
Clinical narrative: rash; Hives; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA268A, expiry date 31st March 2021) for prophylaxis.   Previously administered products included Menveo (received on 1st September 2015).   On 31st August 2020, the patient received Menveo. On 4th September 2020, 4 days after receiving Menveo, the patient experienced rash and hives. On an unknown date, the outcome of the rash and hives were recovered/resolved.   It was unknown if the reporter considered the rash and hives to be related to Menveo.  Additional details were provided as follows: The patient received Menveo and as per the report received from the Emergency Room, the patient was seen at the Emergency room because of rash and hives, which might had developed a day or two earlier.   The HCP did not had information about the location of the hives and rash.  The patient was treated and discharged and was not admitted.  The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Flushing, Lip swelling, Nausea, Periorbital swelling
Clinical narrative: 26 hours after the flu shot I had severe nausea and vomiting Every 20 min or so , that didn?t stop for 2 hours. Worse case of nausea and vomiting I have ever had in my life.  No redness or rash anywhere Else. My face became flush red and swelling around my lips and eyes that I woke up with the next morning.  I am still swollen and red.
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Vomiting
Clinical narrative: 26 hours after the flu shot I had severe nausea and vomiting Every 20 min or so , that didn?t stop for 2 hours. Worse case of nausea and vomiting I have ever had in my life.  No redness or rash anywhere Else. My face became flush red and swelling around my lips and eyes that I woke up with the next morning.  I am still swollen and red.
Age: 38.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Severe chills, headache in rear of head and along neck, intense fatigue
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Hyperhidrosis, Pain, Pyrexia, Syncope
Clinical narrative: Fainted, sweating, blurred vision, fever, chills, body aches
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Vision blurred
Clinical narrative: Fainted, sweating, blurred vision, fever, chills, body aches
Age: 67.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Pain in extremity, Pruritus
Clinical narrative: Left arm hurt, but red bumps appeared on middle back late the next day. (Thursday)  Started itching on the second day (Friday), red spots broke out more broadly, and spread across right back and around to under right breast.  Painful, burning,  and itching. Took pictures and sent them to Doctor.  She responded late on the second day and prescribed Valacyclovir (3 times a day) which we obtained and started taking Saturday morning.  Bumps were more raised that day, but have not spread more, although much of the middle and upper back have the same pain, itching and burning.  Had video meeting with Dr. early Monday.  She said it was Shingles.  We are continuing with Valacyclovir, Tylenol, and occasional baking soda and powder with corn starch, and spray Calamine solution.  Also taking Loratidine.
Age: 67.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Left arm hurt, but red bumps appeared on middle back late the next day. (Thursday)  Started itching on the second day (Friday), red spots broke out more broadly, and spread across right back and around to under right breast.  Painful, burning,  and itching. Took pictures and sent them to Doctor.  She responded late on the second day and prescribed Valacyclovir (3 times a day) which we obtained and started taking Saturday morning.  Bumps were more raised that day, but have not spread more, although much of the middle and upper back have the same pain, itching and burning.  Had video meeting with Dr. early Monday.  She said it was Shingles.  We are continuing with Valacyclovir, Tylenol, and occasional baking soda and powder with corn starch, and spray Calamine solution.  Also taking Loratidine.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Paraesthesia, Pharyngeal paraesthesia, Rash macular
Clinical narrative: started with itchy arm at site, then moved to blotches all over chest, throat and face tingling
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysstasia, Speech disorder, Tremor
Clinical narrative: Patient woke describing what she thought was a seizure .  She was shaking uncontrollably  and felt like she could not speak or wake her husband.  She also said she could not stand.  She did not lose consciousness though.  She also said she now felt fine when telling me about it the next day.  She did not seek medical attention but I did tell her to discuss with her PCP
Age: 92.0
Sex: F
Vaccine: FLUA4
Symptoms: Swelling face
Clinical narrative: SWELLING OF LEFT SIDE OF FACE. PT SAW HER PRIMARY DOCTOR AND HE PRESCRIBED ANTIVIRALS PER PT
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Apparent life threatening event
Clinical narrative: ALTE- mother found infant unresponsive in crib.  Took to ER, recovered on way.  Minimal work-up performed
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt c/o pain, swelling, redness and hot to the touch over entire Lt thigh. Started morning of 09/15/20 after immunization administration. Pt evaluated today in office and treated with benadryl.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: Mild Localized redness and warmth
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pain, Pyrexia, Urticaria
Clinical narrative: 1 day after vaccination, patient states she experienced fever, chills, and body aches. 3 days after vaccination, she reported that she noticed welt on back of neck and under eyelid. Patient understood that fever/bodyaches/chills are possible adverse reaction but was not sure if welts are from vaccine. Patient was advised to see her PCP to make sure welts are not from other causes.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blister, Headache, Influenza like illness, Rash
Clinical narrative: following a day of some mild flu-like symptoms (severe headache and joint pain), by day  three after injection I developed a rash on the back of my right hand that, over the course of days 4 and 5 post-injection has spread to my left hand, right thigh, and belly. There is currently only one blister, and that is on my right hand.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Syringe issue, Underdose
Clinical narrative: during administration the needle became loose from the syringe and the patient did not receive a full dose of the vaccine; it is not certain how much the patient actually received as the liquid sprayed out from the head of the syringe; during administration the needle became loose from the syringe/the needle came off; the liquid sprayed out from the head of the syringe/the vaccine sprayed out from the head of the syringe; the needle breaking/where the needle has become unattached from the syringe involving PROQUAD; The reporter is wondering if this is an issue with the viscosity of the PROQUAD; This spontaneous report was received from an office manager, referring to a 4-year-old male patient. Information about pertinent medical history, drug reactions or allergies was not applicable. Concomitant therapy included sterile diluent.  It was reported that on an unknown date in August 2020 (reported as in the last 2 weeks), the patient was receiving measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (vaccine recombinant human albumin (rHA)) (lot# S035110, expiration date 03-MAY-2021; strength, dose, route, anatomical location were not reported) for prophylaxis.   However, there was an issue with the vaccine and the needle was breaking. The measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) was already reconstituted, and during administration when the nurse pushed down on the syringe plunger to administer the vaccine, the needle came off and the vaccine sprayed out from the head of the syringe (also reported as the needle became loose from the syringe/the needle had became unattached from the syringe), the patient therefore only received a partial dose of the vaccine, but it was unclear how much the patient actually received. The patient was not re-dosed at the reporting time. It was also reported the physician would likely re-dose the patient at a later date. The reporter was also wondering if this was an issue with the viscosity of the vaccine (also reported that the viscosity of the vaccine did not appear any different). The reporter believed that the entire diluent was able to be mixed with lyophilized vaccine and the produce quality compliance (PQC) occurred during the time of attempted patient administration. The diluent was shipped with the measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) and they were received at the same time. Office manager verified it was a carton of 10. No lot number was available for the diluent. The reporter reported that they ordered vaccines (diluent and syringes) through vaccine shop and the needles were ordered separately from a medical supplier (5/8th inch safety needle 25g, syringe size unknown used).
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, Incorrect route of product administration
Clinical narrative: expired PROQUAD that was administered to a patient; 1 dose im; This spontaneous report was received from a physician concerning a 4-year-old patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were unknown.  On 31-AUG-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (lot # S005879, expiration date: 25-AUG-2020) intramuscularly for prophylaxis (expired vaccine used, incorrect route of product administration). The vaccine was noted to be expired after administration.
Age: 23.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered to patient; This spontaneous report was received from a licensed practical nurse and refers to a 23-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  20-AUG-2020, the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5 milliliter (strength, route of administration, anatomical location were not reported; lot number S008151 was confirmed to be valid, expiration date 20-NOV-2021) for prophylaxis. Administered dose of vaccine was stored in a temperature of 48.39 degrees Fahrenheit for 1 hour and 45 minutes. Data logger was involved. There were no previous excursions reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: S008151; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: The patient was administered improperly stored PROQUAD; Information has been received from a medical assistant and refers to a 4 year old female patient. There was no information regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.  03-SEP-2020, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T005406 with expiration date of 12-AUG-2021, subcutaneous for well check (route of administration and anatomical location were not reported), which were stored in the range of -14 Celsius degrees to -10 Celsius degrees for 116 hours and -9 Celsius degrees to 8 Celsius degrees (-6.1 Celsius degrees) for 13 hours (multiple excursions) with a time frame of 129 hours. No previous temperature excursion was reported. Measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was reconstituted with properly stored sterile diluent (MRK STERILE DILUENT).  Digital data logger was involved.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: administered improperly stored PROQUAD; This spontaneous report as received from a medical assistant and refers to a female patient of unknown age. On 24-AUG-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T005406 has been verified to be a valid lot number, expiration date: 12-AUG-2021, subcutaneously (formulation, strength, exact dose and frequency were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent.  Administered dose of vaccine experienced the temperature excursion of (-9 to 8 degrees Celsius) (-6.1) (multiple excursions). Time frame was unknown by reporter. Data logger was involved. There were no previous excursions reported. No additional information provided.  Multiple temperature excursion: Improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T005406 has been verified to be a valid lot number, expiration date: 12-AUG-2021 (formulation, strength, exact dose, route of administration and frequency were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion of (-14 to -10 degrees Celsius) for 116 hours and (-9 to 8 degrees Celsius) (-6.1) for 13 hours. Time frame for 129 hours. Data logger was involved. There were no previous excursions reported.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: more soreness; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer and shingles. Concomitant products included Herpes zoster (Shingrix).   In July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had more soreness after the 2nd shot. It resolved quickly after the first and took about a week to resolve after the 2nd.   The reporter consented to follow up. This case has been linked with US2020180914 and US2020180921, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020180914:same reporter US-GLAXOSMITHKLINE-US2020180921:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: booster vaccine 14 days ago / I have come down with shingles; This case was reported by a other health professional and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. 14 days ago, the patient received booster vaccine. The patient experienced shingles that believe might have come from the vaccine. The patient had been to the emergency room twice in the past week and they can't discover anything related to this pain. The patient was hoping you might have anyone come down with similar maladies. This case has been linked with case US2020AMR181691 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR181691:same reporter, wife case
Sex: F
Vaccine: VARZOS
Symptoms: Pelvic pain
Clinical narrative: pelvic pain; This case was reported by a other health professional and described the occurrence of pelvic pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pelvic pain. On an unknown date, the outcome of the pelvic pain was unknown.   The reporter considered the pelvic pain to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. 14 days ago, the patient received booster vaccine. The patient experienced mysterious pelvic pain that believe might have come from the vaccine. The patient had been to the emergency room twice in the past week and they can't discover anything related to this pain. The patient was hoping you might have anyone come down with similar maladies. This case has been linked with case US2020AMR181685 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR181685:same reporter
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Peripheral coldness
Clinical narrative: chills ("freezing"); freezing hands and toes; This case was reported by a consumer via call center representative and described the occurrence of chills in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included raynaud's disease.   On 8th September 2020, the patient received the 2nd dose of Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced chills and cold hands & feet. In September 2020, the outcome of the chills and cold hands & feet were recovered/resolved.   It was unknown if the reporter considered the chills and cold hands & feet to be related to Shingrix.  Additional details were provided as follows: The patient received shingrix on left arm. The patient stated, she had freezing hands and toes for about one and half hour. The reporter was not sure if the chills (freezing) to her hands and toes might not have been from that disease. The reaction was gone the next day. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Lip swelling
Clinical narrative: Lip swelling 4-6 hours after. no stridor, angioedema, or fever continued for 36 hours and has improved
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Body temperature increased, Dizziness, Nausea, Vertigo
Clinical narrative: Day after vaccine, woke up incredibly dizzy (room was spinning) and nauseated. Temperature was 99.3. Went away throughout the day. The following day (2 days after vaccine) no dizziness, no nausea, and temperature back to 98.6.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Diarrhoea, Nausea
Clinical narrative: GI upset, nausea, diarrhea
Age: 0.25
Sex: F
Vaccine: DTAP
Symptoms: Constipation, Cytogenetic analysis, Dyskinesia, Escherichia test, Excessive eye blinking
Clinical narrative: After 2 weeks from date of administration of DTAP vaccination, patient began to stare at her fist in a non-purposeful way. Patient repeatedly stared at her fist for sensory stemming. 3/15/19 Pt presented with severe and ongoing to this day constipation with no previous stooling difficulties. The action was not normal developmental exploration of her hand. Beginning 4/13/19, patient's symptoms worsened to hand flapping, non-communicable humming, rocking in long sitting position, and twirling of ankles. Pt began abnormal staring and rapid blinking spells. The beginning of June 2019, patient began stages of crawling. However, patient exhibited insidious left leg weakness/hemiplegia with upper extremities not affected. Patient continues to have left leg weakness and gastrointestinal difficulties.