chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site reaction, Paraesthesia
Clinical narrative: Patient received second dose of shingrix 6/10/20 and reported tingling and numbness and injection site reaction shortly after injection. The tingling and numbness in her left arm has continued since. She went to her provider (Dr. @ medical clinic) and they prescribed a steroid which she plans to pick up.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Patient received his vaccine in the afternoon of 6/24 and by the early evening, was feeling nauseous. Patient spent the next two days in bed resting and was too nauseous to eat anything more than tea and crackers. Patient was taken to the hospital for evaluation in the afternoon of 6/27.
Age: 1.0
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site rash, Injection site reaction, Pyrexia
Clinical narrative: Develop low grade fever/ elevated temperature 99-100.8 F starting around 6/22/2020. Then red pox like sores appeared on chest, stomach, back, face, arms, legs and feet on 6/24/2020
Age: 1.0
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: Develop low grade fever/ elevated temperature 99-100.8 F starting around 6/22/2020. Then red pox like sores appeared on chest, stomach, back, face, arms, legs and feet on 6/24/2020
Age: 11.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Numbness of right arm
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Feeling cold, Feeling hot, Hyperventilation, Injection site inflammation
Clinical narrative: 10 AM 6/27/2020 SHOT ADMINISTERED IM TO LEFT ARM.   PER PT ACCOUNT: 11PM 6/26/20 REPORT OF FEELING HOT/COLD/FEVERISH, SHAKING, TROUBLE BREATHING, HYPERVENTILATING, SORE MUSCLE (NO VISIBLE INFLAMMATION AT INJECTION SITE), TROUBLE ELEVATING ARM. PT SYMPTOMS DID NOT ABATE UNTIL 10AM 06/27/2020.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia, Pyrexia, Tremor
Clinical narrative: 10 AM 6/27/2020 SHOT ADMINISTERED IM TO LEFT ARM.   PER PT ACCOUNT: 11PM 6/26/20 REPORT OF FEELING HOT/COLD/FEVERISH, SHAKING, TROUBLE BREATHING, HYPERVENTILATING, SORE MUSCLE (NO VISIBLE INFLAMMATION AT INJECTION SITE), TROUBLE ELEVATING ARM. PT SYMPTOMS DID NOT ABATE UNTIL 10AM 06/27/2020.
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Erythema, Headache, Insomnia, Pain
Clinical narrative: extreme pain, redness and swelling in left arm almost to the elbow.  Worse on front of arm than the side where the injection was.  Fever and chills to 101 degrees. Headache, body aches, inability to sleep.
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: extreme pain, redness and swelling in left arm almost to the elbow.  Worse on front of arm than the side where the injection was.  Fever and chills to 101 degrees. Headache, body aches, inability to sleep.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Hyperaesthesia, Pain, Pain in extremity
Clinical narrative: Severe lower back pain, right side. Severe leg pain, right leg. "shooting pain" above right knee. Severe skin sensitivity right leg between knee and groin front and inner thigh. Adverse events have lasted months. Appointment with MD Dr. on 7/15/2019.   Received Famciclovir [500 MG Oral Tablet - Take 1 Tablet Every 8 Hours For 7 Days.] 2nd visit 7/25/2019, received Gabapentin, taken 2,100 mg daily until 12/1/2019. Daily Advil, Tylenol and/or Aleve continue to this day.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: Head ache and shivers, lasting 12 hours for shivers and still lasting for headache, after 16 hours
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arrhythmia, Feeling hot, Peripheral swelling
Clinical narrative: SWELLING IN HER LEFT ARM STARING FROM 6-24-20 TILL 6-28-20, WITH HOTTNESS FEELING. SHE WENT TO HER DOCTOR, SHE SAID HER HEART RHYTHM WAS ABNORMAL TOO. SHE TRIED ICE BAG , BUT IT DOES NOT WORK.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Injection site rash, Injection site reaction, Injection site warmth
Clinical narrative: Localized reaction around the injection site. Red, warm to touch, rash like. Patient also stated feeling under the weather and achy
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Pain
Clinical narrative: Localized reaction around the injection site. Red, warm to touch, rash like. Patient also stated feeling under the weather and achy
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Lethargy, Myalgia, Peripheral swelling
Clinical narrative: Patient's arm became warm, red, and swollen 12-24 hours after vaccination.  He reported the area of inflammation was about the size of a baseball at the worst point. About 60 hours after vaccination is when patient brought this to our attention so that we could report it, at that point patient's arm was red and only mildly swollen.  Patient reported feeling lethargic and having muscle aches all over his body, and that had subsided at about 60 hours post vaccination.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Patient's arm became warm, red, and swollen 12-24 hours after vaccination.  He reported the area of inflammation was about the size of a baseball at the worst point. About 60 hours after vaccination is when patient brought this to our attention so that we could report it, at that point patient's arm was red and only mildly swollen.  Patient reported feeling lethargic and having muscle aches all over his body, and that had subsided at about 60 hours post vaccination.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain, Rash erythematous
Clinical narrative: Pt states 5-6 flat red spots, ~1/2" wide, with "microblisters" in the center of each one that have bruise-like soreness only upon depression of the area, slowly developed below the injection site starting about 18 hours after the injection. Pt states no similar reaction after 1st injection, and no other issues with this 2nd injection. Pt denies exposure to anything else (ex: poison ivy, etc) that could have caused a similar type of response.  Recommended a dose of Benadryl and watch for any resolution. If rash started to resolve, recommended a 2nd dose of Benadryl. If rash continued or worsened, advised ER or paging PCP.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient reported a very sore arm and redness that extended from the vaccine administration site half way down his upper arm.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: REDNESS AND SWELLING ON ARM
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Injection site pain, Pyrexia
Clinical narrative: Moderate pain at the injection site,  fever 100.2, chills, overall weakness.  Side effects 36 hrs. duration
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Genital rash
Clinical narrative: patient describes rash in his genital area which began about 24 hours after receiving vaccine
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash erythematous, Rash macular
Clinical narrative: VACCINE ADMINISTERED ON 6/26/20. ADVERSE EVENT REPORTED AND SYMPTOMS DEVELOPED ON 6/28/20. SYMPTOMS REPORTED: SPLOTCHY RED RASH WITH SMALL RAISED BUMPS LOCATED ON THE STOMACH, CHEST AND BACK, NO ITCHING, NO RAISED WHEALS, NO PAIN, NO BREATHING COMPLICATIONS, NO SITE REACTION (OTHER THAN MUSCLE PAIN AT INJECTION SITE ON DAY OF INJECTION), NO LYMPH PAIN IN INJECTED ARM.  PT STATES THIS REACTION IS SIMILIAR TO HER LAST FLU SHOT THAT CONTAINED THIMERASOL. REPORTED SYMPTOMS WERE NOT PRESENT DAY OF INJECTION AND PT THINKS SHE MAY HAVE HAD MILD RASH DAY AFTER INJECTION BUT IS UNSURE.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: I had a slight  rash  and fever.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: patient described having a rash that appeared on her left bicep two days after receiving vaccination and last for 2 days before she appeared to have no signs or symptoms of a rash
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: About 6 hours after receiving my second dose of Shingrix by Glaxosmithkline, I had fever of about 100 degrees, chills, body aches,  and fatigue.  My symptoms lasted approximately 16  hours and then I was completely better.  The same thing happened in January 2020 after my first dose, although I didn?t report it.  My bad!
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Dry skin, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: The day after the vaccine 6/9, right thigh became very hard, swollen and deep red about 3 inches.  This continued to spread the next day, until it covered her thigh from her knee to an inch below her groin.  It also spread toward the back of her thigh.  It did not seem to be painful, though a little itchy.  We gave her benedryl several times.  The morning of 6/11 it seemed to stabilize and very slowly receded over the next few weeks.  It is now 6/28 and she still has just a 3 inch discoloration of her skin (mottled and darker than surrounding skin and a little rough).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Livedo reticularis, Skin discolouration
Clinical narrative: The day after the vaccine 6/9, right thigh became very hard, swollen and deep red about 3 inches.  This continued to spread the next day, until it covered her thigh from her knee to an inch below her groin.  It also spread toward the back of her thigh.  It did not seem to be painful, though a little itchy.  We gave her benedryl several times.  The morning of 6/11 it seemed to stabilize and very slowly receded over the next few weeks.  It is now 6/28 and she still has just a 3 inch discoloration of her skin (mottled and darker than surrounding skin and a little rough).
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Pain in extremity, Vaccination error
Clinical narrative: -Right arm pain -General Malaise -Pt. thinks this vaccine gave the reaction since it was done in error (not needed)
Sex: U
Vaccine: HIBV, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported.; patient received improperly stored pedvax on 22-JUN-2020; This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Concomitant therapies, medical history, concurrent conditions and historical drugs were not provided.  On 22-JUN-2020, the patient received an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) Lot # S023646 and expiration date 31-MAR-2022 . Information regarding dose, and route of administration was not provided.  Temperature excursion was reported as follows: above 47°F/ 9°C 9.15°C for 15 minutes and a previous excursion above 47°F/9°C 8.62°C for 11 minutes.  The call was made due to a digital data logger. No additional adverse effect reported.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Bladder pain, Culture urine negative, Cystitis interstitial, Pollakiuria, Urine analysis
Clinical narrative: -(Had  5 hospital visits in month of May following vaccination) -Interstitial cystitis -Bladder pain for 6 months -Constant urination (up to 80x a day) -Was sleeping with a diaper at night two months after vaccination due to being sleep deprived  -Was prescribed ditropan and elavil but had no relief with either medication -Bladder flare up became tolerable (around November/ December) once I stated take high doses of turmeric to -lower inflammation  -as of 6/28/2020 I still have bladder pain symptoms
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received vaccines following a temperature excursion; No adverse effects were reported in any patients; This spontaneous report was received from a nurse referring to an unknown number of patients of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.        On an unknown date, the patients were vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) therapy type: rHA, (lot number R000551, expiration date 08-JAN-2020); measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) therapy type: rHA, (lot number S002494, expiration date 23-JUL-2020); and varicella virus vaccine live (oka/merck) (VARIVAX) (lot number S002084, expiration date 21-JAN-2021); all vaccines for prophylaxis (strengths, doses, routes of administration, and anatomical locations were not provided).   These vaccines followed a temperature excursion (Product storage error). No adverse effects were reported in any patients. The storage temperatures were unknown. Previous temperature excursion and time frame were unknown by reporter. The data logger present but not functioning.  This report was considered as non-valid due to lack of patient identifiers.  As of 25-JUN-2020, a telephone attempt trying to obtain additional information have been unsuccessful.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: 14 unspecified patients received improperly stored doses of ROTATEQ; This spontaneous report was received from a nurse referring 14 unspecified patients of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.    On unspecified dates from 16-DEC-2019 to 03-JAN-2020, the patients received improperly stored doses (product storage error) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R033255 and expiration date 26-JUN-2020; strength, dose, frequency and route were not reported) for prophylaxis. The vaccine underwent highest temperature above 47 degrees Fahrenheit (48.7 Fahrenheit) for a duration of 1 hour and 24 minutes. There was no previous temperature excursion and the call was because of data logger.   This is a non-valid case due to lack of patient identifiers.  As of 25-JUN-2020, a telephone attempt trying to obtain additional information have been unsuccessful.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information regarding the pt's pertinent medical history, drug reactions or allergies, and concomitant medications was provided. On or about 02-FEB-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), as prescribed and/or administered by a healthcare provider at the medical clinic, for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider at a hospital for shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries; including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered as not recovered. The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. In or about 2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a healthcare provider at a clinic for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was unknown and the causal relationship between shingles and zoster vaccine live (ZOSTAVAX) was considered related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 17-DEC-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a pharmacist in a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a certified physician assistant for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was unknown and the causal relationship between shingles and zoster vaccine live (ZOSTAVAX) was considered related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 09-FEB-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot #, expiration date were unknown) for the prevention of shingles and routine health maintenance. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was diagnosed with shingles and suffered post-herpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX); pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries; also suffered serious, progressive, permanent and incurable injuries; as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles and post-herpetic neuralgia was considered as not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was considered related. Upon internal review, the events were considered as disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 09-FEB-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot #, expiration date were unknown) for the prevention of shingles and routine health maintenance. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX); pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries; also suffered serious, progressive, permanent and incurable injuries; as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was considered as not recovered. The causal relationship between shingles and zoster vaccine live (ZOSTAVAX) was considered related. Upon internal review, the event was considered as disabling.
Age: 14.0
Sex: M
Vaccine: HEPA, HEPA, HEPA, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse symptoms; The patient recieved adult and pedriatic doses of VAQTA; This spontaneous report was received from the physician regarding a 14-year-old male patient. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 01-JUL-2015, the patient received an adult dose of Hepatitis A Vaccine, Inactivated (VAQTA) (strength 50/1 units per milliliter (U/ml)) and on 28-AUG-2015, she received a pediatric dose of Hepatitis A Vaccine, Inactivated (VAQTA) (strength 25/0.5 U/ml) (lot# and expiration date for both vaccines were unknown); The physician stated that on 12-JUN-2020, the patient who was 19-year-old, received a pediatric dose of  Hepatitis A Vaccine, Inactivated (VAQTA) (strength 25/0.5 U/ml) (Lot# S037574, expiration date 10-APR-2021). All vaccines were given for prophylaxis (dose, route and anatomical site of administration and vaccination schedule for all vaccines were not provided). No adverse symptoms were reported.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S037574; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 18.0
Sex: U
Vaccine: HPV9, MNQ
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: the patient experienced no symptoms; the patient was accidentally administered a fourth dose of Gardasil 9 instead of Menactra; This spontaneous report was received from a medical assistant, referring to an 18-year-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant medications were not disclosed.  On 23-JUN-2020, the patient went to the office for the administration of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA). However, the patient was accidentally administered a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly, as prophylaxis (extra dose administered) (strength, and anatomical vaccination site were not provided, lot number and expiration date were unknown by the reporter) instead of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA). The medical assistant reported that there was no product confusion involved in the administration of the fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Later that same day, the patient was administered the dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) (strength, dose number, frequency, route of administration, anatomical vaccination site, and indication were not provided, lot number and expiration date were unknown by the reporter). The patient experienced no symptoms.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Gait inability, Pain in extremity, Pyrexia, Weight bearing difficulty
Clinical narrative: Dr informed us, if reaction, it would be 7-10 after, possibly fever, due to live vax   Patient became intolerable itchy, with fever over 101.  She described pain in her legs, could not put weight on legs, and lost ability to walk.  Dr office called and we were told to give her motrin
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE EVENT. PATIENT TOLERATED THE INJECTION WELL. Injection given on 6/29/2020 had expired on 5/31/2020.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Myalgia
Clinical narrative: MALAISE, FATIGUE, MUSCLE ACHES THROUGHOUT ENTIRE BODY.   WORST THROUGH 24 HOURS.  MILD MUSCLE ACHES AT36-48 HOURS. MALAISE AND FATIGUE HAVE RESOLVED ON DAY 2
Age: 1.67
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Eating disorder, Mouth ulceration
Clinical narrative: Patient was having trouble eating on 06/26/2020 then went to the ER 06/27/2020 and  the doctor found ulcers in the patients mouth and said it was from receiving vaccinations on 06/23/2020
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: Gave the patient 2 of the same imms, Trumembe abd Bexsero
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no patient experienced symptoms; improperly stored doses administered; This spontaneous report was received from a registered nurse and refers to a patient of unknown gender and age. No  information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.  On 08-JUN-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, (lot # 1660666, expiration date 22-MAR-2021) (dose, frequency and strength were not provided) for prophylaxis. Administered dose of vaccine had temperature of 9.4 degrees Celsius during a time frame of 35 minutes. There was no previous temperature excursion. Digital data logger was involved.   The patient did not experience any symptoms.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2006USA005639: US-009507513-2006USA005638: US-009507513-2006USA005637: US-009507513-2006USA005635: US-009507513-2006USA005636:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no patient experienced symptoms; improperly stored doses administered; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. No  information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.  On 08-JUN-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ ) orally, lot # 1660666, expiration date 22-MAR-2021, (dose, frequency and strength were not provided) for prophylaxis. Administered dose of vaccine had temperature of 9,4 degrees Celsius during a time frame of 35 minutes. There was no previous temperature excursion. Digital data logger was involved.   The patient did not experience any symptoms.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2006USA005638: US-009507513-2006USA005595: US-009507513-2006USA005639: US-009507513-2006USA005636: US-009507513-2006USA005635:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no patient experienced symptoms; improperly stored doses administered; This spontaneous report was received from a registered nurse and refers to a patient of unknown gender and age. No  information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.  On 05-JUN-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial orally, (lot # 1660666, expiration date 22-MAR-2021) (dose, frequency and strength were not provided) for prophylaxis. Administered dose of vaccine was exposed to temperature of  9.4 degrees Celsius during a time frame of 35 minutes. There was no previous temperature excursion. Digital data logger was involved.   The patient did not experience any symptoms.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2006USA005638: US-009507513-2006USA005637: US-009507513-2006USA005636: US-009507513-2006USA005635: US-009507513-2006USA005595:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: unspecified dose in PROQUAD immunization series were administered after being improperly stored; No symptoms or additional adverse effects reported.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 02-JUN-2020, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot# S022914, expiration date 19-JAN-2021 (strength, dose and route of administration were not reported) reconstituted in properly stored sterile diluent for prophylaxis.  On an unknown date, the dose of the vaccine was exposed to temperature excursion at -14.06 Celsius degrees (C) for 10 minutes. There were previous temperature excursions at -14.28 C for 55 minutes, -13.72 C for 55 minutes and -12.92 C for 5 hours. The call was due to digital data logger. No symptoms or additional adverse effects reported.
Age: 0.58
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; incorrect product storage; This spontaneous report was received from a nurse referring to a 7 months old male patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 16-JUN-2020, the patient was inadvertently vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # S030966, expiration date was 14-APR-2022) (exact dose and route of administration were not reported) for prophylaxis (product storage error). The administered doses experienced a temperature excursion of 35.2 degrees Fahrenheit (F) for 42 minutes. There were no previous temperature excursions. The temperature excursions were detected by a data logger. No additional adverse event.
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; a 4 1/2 month old baby received his first dose of ROTATEQ today; This spontaneous report was received from a nurse referring to a 4 1/2 months male patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 18-JUN-2020 (reported as today), the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml (lot # was reported as 16620944, expiration date was reported as 16-APR-2021) (strength, exact dose and route of administration were not reported) for prophylaxis (inappropriate age at vaccine administration). No additional adverse effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received improperly stored dose; No additional adverse effect reported; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 19-JUN-2020, the patient was vaccinated an improperly stored dose of with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # S023646, expiration date 31-MAR-2022, unspecified route (strength, dose, anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature above 47 degrees fahrenheit/9 degrees celsius (9.15 C) during 15 minutes. There was a previous temperature excursion above 47 degrees fahrenheit/9 degrees celsius (8.62 C) during 11 minutes. It was reported that digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 08-SEP-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider at an outpatient clinic for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to inoculation with zoster vaccine live (ZOSTAVAX), the pt was treated by a healthcare provider at an outpatient clinic for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 20.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient experienced no symptoms; a dose of PROQUAD was administered to a 20 year old on 6/22/2020; This spontaneous report was received from an office manager and refers to a 20-year-old patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies was not provided.  On 22-JUN-2020, the patient was vaccinated at inappropriate age with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # S027467, expiration date not reported, but upon internal review established as 02-MAR-2021, subcutaneously (exact dose, dose number and vaccination site were not provided) for prophylaxis. The patient experienced no symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at injection site; This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Flu shot (3 days prior to the Shingles 1st dose vacinnation) and Shingrix with an associated reaction of adverse event (received 1st dose in November 2019, refer case US2020AMR096078).   On 17th June 2020, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient would not be responding because the patient also had the Flu shot 3 days prior to the Shingles vaccination.  It would be unfair to say the side effects experienced were linked to your vaccination.  It could have been caused by the Flu vaccination or a combination of the 2 medications together. The patient able finally to get the second Shingles shot from my Primary Care physician this week and so far, so good beyond soreness at injection site and led to lengthening of vaccination schedule.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR096078:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Nausea
Clinical narrative: headache; no apetite; fell like puking; shivering; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2020, the patient received the 2nd dose of Shingrix. On 18th June 2020, less than a day after receiving Shingrix, the patient experienced chills. On 19th June 2020, the patient experienced headache, appetite lost and nausea. On an unknown date, the outcome of the chills, headache and appetite lost were not recovered/not resolved and the outcome of the nausea was recovered/resolved.   It was unknown if the reporter considered the chills, headache, appetite lost and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix yesterday and was shivering last night (from the day of reporting) and had a headache, no appetite and felt like puking (on the day of reporting). The reporter asked how long would the side effects last and the patient wanted to know would he had fever.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Adverse event, Social problem
Clinical narrative: adverse event; missed my 2 to 6 month window; This case was reported by a consumer and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced adverse event and social problem. On an unknown date, the outcome of the adverse event and social problem were unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The reporter reported that when it was time to have my second dose Shingrix, COVID-19 was spreading and was reluctant to go to the pharmacy for my second shot.  The patient did not want to confuse the Shingrix side effects with COVID-19 symptoms. Therefore, missed the 2 to 6 month window and it's been 9 months at the time of reporting. The reporter asked did the patient had to start all over.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: muscle aches; low grade of fever; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th February 2020, the patient received the 1st dose of Shingrix. On 14th February 2020, 2 days after receiving Shingrix, the patient experienced myalgia and fever. On 16th February 2020, the outcome of the myalgia and fever were recovered/resolved.   It was unknown if the reporter considered the myalgia and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 52 or 53 years. The patient received Shingrix in right arm and had muscle aches and low grade fever.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin warm, Urticaria
Clinical narrative: a red welt appeared an inch below the injections site; arm soreness; warm to the touch; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in January 2020, refer case US2020107091).   On 20th June 2020, the patient received the 2nd dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced pain in arm and skin warm. On 22nd June 2020, the patient experienced erythema urticarial. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the skin warm and erythema urticarial were unknown.   It was unknown if the reporter considered the pain in arm, skin warm and erythema urticarial to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and had arm soreness.   The area was also warm to the touch and was soreness runs about 4 inches in diameter.  At the date of reporting the patient had red welt appeared an inch below the injections site.   The welt was 2 in diameter and 1 high. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020107091:same reporter
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pain in extremity
Clinical narrative: mild achy feeling in her arm; 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 Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (ZOSTAVAX) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and ZOSTAVAX. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Zostavax previously and other flu shots and experienced a mild achy feeling in her arm, however, it was nothing like what she experienced with the Shingrix vaccine. This case linked with US2020107109, US2020AMR107530 and US2020107111, reported by same reporter. It was unknown if the reporter considered the pain in arm to be related to Zostavax.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020107111:same reporter US-GLAXOSMITHKLINE-US2020AMR107530:same reporter US-GLAXOSMITHKLINE-US2020107109:same reporter
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle fatigue
Clinical narrative: muscle fatigue in the injection arm; This case was reported by a nurse via call center representative and described the occurrence of muscle fatigue in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced muscle fatigue. On an unknown date, the outcome of the muscle fatigue was recovered/resolved.   It was unknown if the reporter considered the muscle fatigue to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient herself The injection felt more viscous to the patient. The patient suffered a little muscle fatigue in the injection arm but no systemic reactions. The reporter consented to follow up. For drug tolerance, refer case US2020107074.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020107074:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Haematochezia, Pain, Pyrexia
Clinical narrative: bloody stools; fever; generalized body aches; This case was reported by a consumer via other manufacturer and described the occurrence of blood in stool in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tofacitinib citrate (Xeljanz) tablet for product used for unknown indication.   On an unknown date, the patient received the 2nd dose of Shingrix. On 1st January 2020, the patient started Xeljanz 10 mg at an unknown frequency. On an unknown date, less than a day after receiving Shingrix, the patient experienced blood in stool (serious criteria GSK medically significant), fever and general body pain. The action taken with Xeljanz was unknown. On an unknown date, the outcome of the blood in stool, fever and general body pain were unknown.   It was unknown if the reporter considered the blood in stool, fever and general body pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. Within 24 hours of receiving 2nd Shingrix injection, the patient developed fever, generalized body aches, and bloody stools. It was unknown if the reporter considered the blood in stool, fever and general body pain to be related to Xeljanz. The reporter did not consent to follow up.