chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling hot, Herpes zoster, Influenza like illness, Pain
Clinical narrative: painful, itchy rash on the left side of her butt; Shingles; felt like the flu; fever; shaking; pain in body; chills; body felt warm to the touch; rash; the rash had blisters as well; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included etanercept (Embrel).   On 11th June 2019, the patient received the 1st dose of Shingrix. In June 2019, 14 days after receiving Shingrix, the patient experienced shingles, influenza like illness, fever, tremor, general body pain, chills, feeling hot, itchy rash and blistery rash. On an unknown date, the patient experienced painful rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and itchy rash were not recovered/not resolved and the outcome of the influenza like illness, fever, tremor, general body pain and chills were recovered/resolved and the outcome of the feeling hot was unknown and the outcome of the blistery rash and painful rash were recovering/resolving.   It was unknown if the reporter considered the shingles, influenza like illness, fever, tremor, general body pain, chills, feeling hot, itchy rash, blistery rash and painful rash to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received dose of Shingrix in the right arm. After vaccination with Shingrix, the patient experienced flu like symptoms chills, fever, body pain, shaking and her body felt warm to the touch. The patient stated that, 2 weeks after receiving the vaccine, she developed a painful, itchy rash on the left side of her butt and it was going down the left leg. The patient stated that the rash had blisters as well. The patient went to saw her doctor and was diagnosed with Shingles and the doctor gave her Valtrex to keep the rash from spreading. 14 days, after vaccination with Shingrix, the patient experienced itchy rash, shingles and blistery rash. The patient consented to follow up. Emergency room visit was required. There was discrepancy between the outcome reported in the structured field (recovered and not recovered) and the outcome reported in the source document (recovered with sequel and recovering)
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Rash pruritic, Rash vesicular, Skin warm
Clinical narrative: painful, itchy rash on the left side of her butt; Shingles; felt like the flu; fever; shaking; pain in body; chills; body felt warm to the touch; rash; the rash had blisters as well; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included etanercept (Embrel).   On 11th June 2019, the patient received the 1st dose of Shingrix. In June 2019, 14 days after receiving Shingrix, the patient experienced shingles, influenza like illness, fever, tremor, general body pain, chills, feeling hot, itchy rash and blistery rash. On an unknown date, the patient experienced painful rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and itchy rash were not recovered/not resolved and the outcome of the influenza like illness, fever, tremor, general body pain and chills were recovered/resolved and the outcome of the feeling hot was unknown and the outcome of the blistery rash and painful rash were recovering/resolving.   It was unknown if the reporter considered the shingles, influenza like illness, fever, tremor, general body pain, chills, feeling hot, itchy rash, blistery rash and painful rash to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received dose of Shingrix in the right arm. After vaccination with Shingrix, the patient experienced flu like symptoms chills, fever, body pain, shaking and her body felt warm to the touch. The patient stated that, 2 weeks after receiving the vaccine, she developed a painful, itchy rash on the left side of her butt and it was going down the left leg. The patient stated that the rash had blisters as well. The patient went to saw her doctor and was diagnosed with Shingles and the doctor gave her Valtrex to keep the rash from spreading. 14 days, after vaccination with Shingrix, the patient experienced itchy rash, shingles and blistery rash. The patient consented to follow up. Emergency room visit was required. There was discrepancy between the outcome reported in the structured field (recovered and not recovered) and the outcome reported in the source document (recovered with sequel and recovering)
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tremor
Clinical narrative: painful, itchy rash on the left side of her butt; Shingles; felt like the flu; fever; shaking; pain in body; chills; body felt warm to the touch; rash; the rash had blisters as well; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included etanercept (Embrel).   On 11th June 2019, the patient received the 1st dose of Shingrix. In June 2019, 14 days after receiving Shingrix, the patient experienced shingles, influenza like illness, fever, tremor, general body pain, chills, feeling hot, itchy rash and blistery rash. On an unknown date, the patient experienced painful rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and itchy rash were not recovered/not resolved and the outcome of the influenza like illness, fever, tremor, general body pain and chills were recovered/resolved and the outcome of the feeling hot was unknown and the outcome of the blistery rash and painful rash were recovering/resolving.   It was unknown if the reporter considered the shingles, influenza like illness, fever, tremor, general body pain, chills, feeling hot, itchy rash, blistery rash and painful rash to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received dose of Shingrix in the right arm. After vaccination with Shingrix, the patient experienced flu like symptoms chills, fever, body pain, shaking and her body felt warm to the touch. The patient stated that, 2 weeks after receiving the vaccine, she developed a painful, itchy rash on the left side of her butt and it was going down the left leg. The patient stated that the rash had blisters as well. The patient went to saw her doctor and was diagnosed with Shingles and the doctor gave her Valtrex to keep the rash from spreading. 14 days, after vaccination with Shingrix, the patient experienced itchy rash, shingles and blistery rash. The patient consented to follow up. Emergency room visit was required. There was discrepancy between the outcome reported in the structured field (recovered and not recovered) and the outcome reported in the source document (recovered with sequel and recovering)
Age: 67.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Blood pressure increased, Hypersensitivity, Immunodeficiency, Impaired work ability, Joint swelling
Clinical narrative: Swelling of neck  EN-swelling knees, elbow rash High BP Poor eyesight
Age: 67.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Loss of personal independence in daily activities, Pharyngeal swelling
Clinical narrative: Swelling of neck  EN-swelling knees, elbow rash High BP Poor eyesight
Age: 67.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Hypertension, Joint swelling, Rash, Swelling, Visual impairment
Clinical narrative: Swelling of neck  EN-swelling knees, elbow rash High BP Poor eyesight
Age: 79.0
Sex: F
Vaccine: UNK, VARZOS, UNK, UNK, VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Computerised tomogram head, Dehydration, Differential white blood cell count
Clinical narrative: arm became paralyzed necessitating an ER visit; pt took tylenol and per pt, that led to vomiting
Age: 79.0
Sex: F
Vaccine: UNK, VARZOS, UNK, UNK, VARZOS
Symptoms: Full blood count, Headache, Hypersensitivity, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: arm became paralyzed necessitating an ER visit; pt took tylenol and per pt, that led to vomiting
Age: 79.0
Sex: F
Vaccine: UNK, VARZOS, UNK, UNK, VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: arm became paralyzed necessitating an ER visit; pt took tylenol and per pt, that led to vomiting
Age: 79.0
Sex: F
Vaccine: UNK, VARZOS, UNK, UNK, VARZOS
Symptoms: Loss of personal independence in daily activities, Metabolic function test, Pain, Pain in extremity, Urine analysis
Clinical narrative: arm became paralyzed necessitating an ER visit; pt took tylenol and per pt, that led to vomiting
Age: 79.0
Sex: F
Vaccine: UNK, VARZOS, UNK, UNK, VARZOS
Symptoms: Vomiting
Clinical narrative: arm became paralyzed necessitating an ER visit; pt took tylenol and per pt, that led to vomiting
Age: 79.0
Sex: F
Vaccine: UNK, VARZOS, UNK, UNK, VARZOS
Symptoms: Monoplegia, Vomiting
Clinical narrative: arm became paralyzed necessitating an ER visit; pt took tylenol and per pt, that led to vomiting
Age: 79.0
Sex: F
Vaccine: UNK, VARZOS, UNK, UNK, VARZOS
Symptoms: Abdominal pain upper, Computerised tomogram head, Dehydration, Headache, Impaired work ability
Clinical narrative: arm became paralyzed necessitating an ER visit; pt took tylenol and per pt, that led to vomiting
Age: 79.0
Sex: F
Vaccine: UNK, VARZOS, UNK, UNK, VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity, Vomiting
Clinical narrative: arm became paralyzed necessitating an ER visit; pt took tylenol and per pt, that led to vomiting
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Headache, Heart rate increased, Heart rate irregular, Pyrexia
Clinical narrative: Increase Pulse rate; Fever; Shaking; Weakness; This case was reported by a pharmacist via call center representative and described the occurrence of pulse rate increased in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 21st October 2021) for prophylaxis.   On 5th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced pulse rate increased, fever, tremor and weakness. On an unknown date, the outcome of the pulse rate increased, fever, tremor and weakness were unknown.   It was unknown if the reporter considered the pulse rate increased, fever, tremor and weakness to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on the left deltoid. The patient experienced increased pulse rate, fever, shaking and weakness. The reporter wanted to know how to proceed.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Tremor
Clinical narrative: Increase Pulse rate; Fever; Shaking; Weakness; This case was reported by a pharmacist via call center representative and described the occurrence of pulse rate increased in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 21st October 2021) for prophylaxis.   On 5th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced pulse rate increased, fever, tremor and weakness. On an unknown date, the outcome of the pulse rate increased, fever, tremor and weakness were unknown.   It was unknown if the reporter considered the pulse rate increased, fever, tremor and weakness to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on the left deltoid. The patient experienced increased pulse rate, fever, shaking and weakness. The reporter wanted to know how to proceed.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Heart rate increased, Pyrexia, Tremor
Clinical narrative: Increase Pulse rate; Fever; Shaking; Weakness; This case was reported by a pharmacist via call center representative and described the occurrence of pulse rate increased in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 21st October 2021) for prophylaxis.   On 5th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced pulse rate increased, fever, tremor and weakness. On an unknown date, the outcome of the pulse rate increased, fever, tremor and weakness were unknown.   It was unknown if the reporter considered the pulse rate increased, fever, tremor and weakness to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on the left deltoid. The patient experienced increased pulse rate, fever, shaking and weakness. The reporter wanted to know how to proceed.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Alopecia
Clinical narrative: hair loss; This case was reported by a pharmacist via call center representative and described the occurrence of hair loss in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 92M54, expiry date 2nd June 2021) for prophylaxis.   On 11th May 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was unknown.   It was unknown if the reporter considered the hair loss to be related to Shingrix.  Additional details were reported as follows: The patient experienced hair loss. The reporter stated that, the patient called him asking if Shingrix could cause hair loss. The patient was unaware of the time the hair loss started.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Skin induration
Clinical narrative: Large (approx 5x5"), red, hard reaction on arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: 102 fever, headache, bodyaches
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Cellulitis, Erythema, Pain, Skin warm
Clinical narrative: Painful to touch, visible area of erythema, hot to touch. Treatment for cellulitis with Sulfamethaxazole 160mg tab.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site nodule, Rash, Urticaria
Clinical narrative: Hives, raised rash, non-pustular to bilateral arms. After 1 week still have some nodules remaim on upper left arm near the injection site.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: LEFT ARM PAIN.  THEN LEFT NECK PAIN, HARD TO MOVE HEAD. HEADACHE. CHILLS. CHATTERING TEETH.  SHAKING ARMS. FEVER. SEVERE LEG PAIN.  HAD TO HOLD ONTO FURNITURE TO WALK.  LEGS HURT JUST LAYING IN BED.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Tremor, Walking aid user
Clinical narrative: LEFT ARM PAIN.  THEN LEFT NECK PAIN, HARD TO MOVE HEAD. HEADACHE. CHILLS. CHATTERING TEETH.  SHAKING ARMS. FEVER. SEVERE LEG PAIN.  HAD TO HOLD ONTO FURNITURE TO WALK.  LEGS HURT JUST LAYING IN BED.
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus infection, Vaccination failure
Clinical narrative: the patient (no demographics provided) was administered ROTATEQ (date not specified) but subsequently "became sick with rota virus and developed diarrhea.; the patient (no demographics provided) was administered ROTATEQ (date not specified) but subsequently "became sick with rota virus and developed diarrhea.; Information has been received from a physician via a company employee referring to a 1 year old male patient. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was unknown.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ)(lot#, expiration date, strength, dose and frequency were unknown) orally for prophylaxis.         On an unknown date after the vaccination(reported as "a long time ago"), the patient "became sick with rotavirus and developed diarrhea" (diarrhoea rotavirus and vaccination failure). It was unknown if treatment was given for the events. The outcome of the events was unknown. The causality assessment was not provided by the reporter.  Upon internal review, diarrhoea rotavirus was determined to be medically significant.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient received improperly stored VARIVAX; Information has been received from a medical assistant referring to a 12 months old male patient. The patient's pertinent medical history and drug reactions/allergies were not provided.  On 19-JUN-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R030612, expiration date 23-OCT-2020, for prophylaxis (strength, dose, frequency and route were not provided) (improper storage of product in use). The varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effects reported. The outcome of the events was unknown.  The storage temperatures of the varicella virus vaccine live (oka/merck) (VARIVAX) were reported as between -14 and -10 degree Celsius (-13 degree Celsius) for a time frame of 30 minutes, 9 to 25 degree Celsius (17.8 degree Celsius, multiple) for a time frame of 32 minutes. There was no previous temperature excursion. The call was due to a data logger.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; improperly stored dose administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-JUN-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin)(PROQUAD) injection, lot # R020678, expiration date: 15-JAN-2020 (exact dose, injection site and route of administration were not reported) for prophylaxis. The vaccine experienced a temperature excursion from -14 degrees Celsius to -10 degrees Celsius (-12.09 degrees Celsius) for 5 hours 30 minutes. The digital data logger was involved in recording the temperature excursion details. Previous temperature excursion had occurred with total time in the range from -14 degrees Celsius to -10 degrees Celsius (-13.61 degrees Celsius) for 2 hours 20 minutes. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event reported; Administration of dose three of GARDASIL 9 shorter than recommended interval; This spontaneous report was received from a healthcare worker, referring to a 26-year-old patient of unknown gender. The patient's historical conditions, medical history, concurrent conditions, drug reactions or allergies were not reported.  On 09-APR-2019, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis, lot # R008163, expiration date on 18-NOV-2020 (dose, strength and route of administration were not reported).   On 29-MAY-2019, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis, lot # R008163, expiration date on 18-NOV-2020 (dose, strength and route of administration were not reported).  On 25-JUN-2019, the patient received the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis, lot # R008163, expiration date on 18-NOV-2020 (dose, strength and route of administration were not reported).   It was reported that the third dose of of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was administered within one month of dose two of of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), shorter than recommended (inappropriate schedule of vaccine administered). No adverse effects reported.
Sex: M
Vaccine: HIBV
Symptoms: Blood test abnormal, Neutropenia
Clinical narrative: chronic benign neutropenia; This spontaneous report was received from a registered nurse, who is also the patient's mother and refers to her 18-year-old son. There was no information regarding patient's pertinent medical history, drug reactions, allergies and concomitant therapies provided. On an unknown date, the patient was administered an unspecified meningitis vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for vaccination.  On an unknown date (reported as after the vaccine administration), the patient had an unspecified blood test performed, which showed chronic benign netropoenia (date and details were not provided).  The outcome of the event was reported as not recovered. The causality assessment was not provided.  Upon internal review, the event of chronic benign neutropenia was determined to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient 9 month old may have received the Gardasil 9 shot during a well visit to the doctor/ the nurse may have switched the syringes and accidentally administered the gardasil 9 vaccine to the patient; he patient 9 month old may have received the Gardasil 9 shot during a well visit to the doctor/ the nurse may have switched the syringes and accidentally administered the gardasil 9 vaccine to the patient; No adverse effect; This spontaneous report was received from a consumer who was the patient's mother, regarding a 9-moth-old patient, gender was not provided. Information regarding the patient's past drug allergies / reactions, and medical history, concurrent conditions and concomitant medications was not provided.    On an unspecified date (reported as during a well visit), the patient may had received the vaccination with  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  (strength, dose, frequency, anatomical site of application, lot number and expiration date  were not provided) for prophylaxis;  (product administered to patient of inappropriate age). It was reported that the nurse may have switched the syringes and accidentally administered  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) to the patient (wrong product administered), no product confusion or adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 13-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 19-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 20-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 21-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 25-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 25-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 26-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 26-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 26-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 26-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 27-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889:
Sex: U
Vaccine: MMR, MMRV
Symptoms: Wrong product administered
Clinical narrative: was inadvertently administered a dose of PROQUAD instead of a dose of MMR II; was inadvertently administered a dose of PROQUAD instead of a dose of MMR II; This spontaneous report was received from a medical assistant referring to a 52-years-old patient of an unknown gender. Concomitant medications included sterile diluent. Information about the patient's pertinent medical history, previous drug reactions and allergies were not provided.   It was reported that on 10-JUL-2019, the patient was inadvertently administered a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) by subcutaneous route, in the right arm, for prophylaxis, lot number R026350 and expiration date 15-MAR-2020; instead of a dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) lot number and expiration date were not provided (interchange of vaccine products and wrong product administered). By the time of the report, the patient's outcome from the event was not provided.  The causality assessment between measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) and the occurred event was not provided.
Age: 7.0
Sex: F
Vaccine: MMR
Symptoms: Escherichia test positive, Escherichia urinary tract infection
Clinical narrative: urine test was positive for E coli bacteria/diagnosed with urinary tract infection; This spontaneous report was received from a pharmacy technician and refers to a 7-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 03-JUL-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, lot # and expiration date were not reported) for childhood immunization. On 09-JUL-2019, the patient experienced escherichia urinary tract infection. The patient sought medical attention by seeing the physician on 09-JUL-2019. On 10-JUL-2019, the patient had urine test done which was positive for Escherichia coli bacteria. She was prescribed cefprozil as the treatment for the event. The outcome of escherichia urinary tract infection was reported as not recovered/not resolved at the time of the report. No causality assessment was provided by the reporter.  Upon internal review, the event was determined to be medically significant.