chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Cellulitis, Injection site pruritus, Pain, Pyrexia
Clinical narrative: Fever, bodyaches, cellulitis on her arm, itching at the site of injection on her left arm
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Muscle twitching, Tic
Clinical narrative: TIC (twitch) left side of face x 4d Has improved.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Urticaria to face, neck, upper extremities, thorax Itchy Rash Given Benadryl and observed for 2 hours in clinic. Rash & itching subsided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Blood test, Dehydration, Gait disturbance
Clinical narrative: Following Shingrix on 7/14/2019 patient had weakness in legs, trouble walking, joint pain, headaches. Also, severe neck pain. Mostly settled in lower back. First ER visit bloodwork on Tuesday, July 16. Second ER July 17. Patient reported excessive thirst; dehydration.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Muscular weakness, Neck pain, Thirst
Clinical narrative: Following Shingrix on 7/14/2019 patient had weakness in legs, trouble walking, joint pain, headaches. Also, severe neck pain. Mostly settled in lower back. First ER visit bloodwork on Tuesday, July 16. Second ER July 17. Patient reported excessive thirst; dehydration.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Feeling hot, Immediate post-injection reaction, Loss of consciousness, Pallor
Clinical narrative: FEELING HOT; IMMEDIATE POST-INJECTION REACTION; LOSS OF CONSCIOUSNESS; Pallor; TINNITUS; UNRESPONSIVE TO STIMULI; lightened; vagovagal reaction in response to vaccine; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (agency No. 739337).  This spontaneous report concerning a concerning a currently 11 years old female patient. At the reporting time, the patient didn't have current illness, but she visited the emergency room ("not sure if it was in the last month") for right arm pain. There was no historical condition or other medication. Information regarding prior vaccinations was not provided.  On 01-MAR-2018 the patient was vaccine with the 2 dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot: N022952, expiration date 14-JUN-2020, intramuscular on her left arm, for prophylaxis.   On 01-MAR-2018 right after vaccine was given, the patient became hot, pale and became unresponsive for less than 30 seconds. The patient was evaluated, vital signs were done patient was lying down with her feet raised. The patient stated she felt ringing in her ears before she passed out but none after coming to. The patient was observed for 25 minutes and then she was allowed to leave. Because the patient did not have symptoms. The patient was to follow up next "Thursday" in clinic. Precautions were given to patient's mother by the doctor. The outcome of the events was reported as recovered on 01-MAR-2018. Additionally, the reporter did not provide causality assessment between the events and vaccination with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).  Follow up information has been received from a nurse on 23-MAY-2019. The patient was 11 years old at vaccination time. The patient was not pregnant at vaccination time. The patient was white and not Hispanic or Latino. The patient had no adverse event following any previous vaccine. At 09:50 on 01-MAR-2018, the patient was vaccine with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). At 09:50 on 01-MAR-2018, the events started.  Follow up information has been received from a nurse on 18-JUN-2019.  The patient's demographics were updated. The patient did not have illness at the time of vaccination and no known drug allergies. On 01-MAR-2018, the patient patient became hot and lightened (dizziness) after HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). She was seen by a physician who had the patient lay down with feet elevated and the diagnosis improved. The physician stated that the vasovagal reaction was in response to vaccine (presyncope). The outcome of dizziness was reported as recovered on an unknown date. The outcome of presyncope was unknown. The causal relationship between dizziness and presyncope with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Presyncope, Tinnitus, Unresponsive to stimuli
Clinical narrative: FEELING HOT; IMMEDIATE POST-INJECTION REACTION; LOSS OF CONSCIOUSNESS; Pallor; TINNITUS; UNRESPONSIVE TO STIMULI; lightened; vagovagal reaction in response to vaccine; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (agency No. 739337).  This spontaneous report concerning a concerning a currently 11 years old female patient. At the reporting time, the patient didn't have current illness, but she visited the emergency room ("not sure if it was in the last month") for right arm pain. There was no historical condition or other medication. Information regarding prior vaccinations was not provided.  On 01-MAR-2018 the patient was vaccine with the 2 dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot: N022952, expiration date 14-JUN-2020, intramuscular on her left arm, for prophylaxis.   On 01-MAR-2018 right after vaccine was given, the patient became hot, pale and became unresponsive for less than 30 seconds. The patient was evaluated, vital signs were done patient was lying down with her feet raised. The patient stated she felt ringing in her ears before she passed out but none after coming to. The patient was observed for 25 minutes and then she was allowed to leave. Because the patient did not have symptoms. The patient was to follow up next "Thursday" in clinic. Precautions were given to patient's mother by the doctor. The outcome of the events was reported as recovered on 01-MAR-2018. Additionally, the reporter did not provide causality assessment between the events and vaccination with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).  Follow up information has been received from a nurse on 23-MAY-2019. The patient was 11 years old at vaccination time. The patient was not pregnant at vaccination time. The patient was white and not Hispanic or Latino. The patient had no adverse event following any previous vaccine. At 09:50 on 01-MAR-2018, the patient was vaccine with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). At 09:50 on 01-MAR-2018, the events started.  Follow up information has been received from a nurse on 18-JUN-2019.  The patient's demographics were updated. The patient did not have illness at the time of vaccination and no known drug allergies. On 01-MAR-2018, the patient patient became hot and lightened (dizziness) after HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). She was seen by a physician who had the patient lay down with feet elevated and the diagnosis improved. The physician stated that the vasovagal reaction was in response to vaccine (presyncope). The outcome of dizziness was reported as recovered on an unknown date. The outcome of presyncope was unknown. The causal relationship between dizziness and presyncope with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Oedema peripheral, Rash, Rash pruritic
Clinical narrative: Left hand swollen and red; hand swollen; Itchy rash on arms, abdomen and legs; itchy rash on arms, abdomen and legs; Itchy rash on arms, abdomen and legs; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act." The patient's other medication included "Djes(OCP)"  This spontaneous report refers to a 18 year old female patient. On 19-MAR-2018 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # N022952 dose 2, intramuscular in the right arm for prophylaxis. On 19-MAR-2018, the patient experienced pruritic rash in arms, abdomen and legs, and she had her left hand erythematous and edematous. The patient was treated with Methylprednisolone 4mg oral table therapy pack. The outcome of erythema, rash pruritic, rash and oedema peripheral was unknown. The Agency did not mention the causality assessment between the event  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination.  Follow up information has been received form a heath care professional on 23-MAY-2019. At 19-MAR-2018 14:20(previously reported as on 19-MAR-2018), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose 1(previously reported as dose 2)).  It was reported that on 19-MAR-2018 pm the patient experienced rash in the trunk. The outcome of the event and the causality assessment with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination were unknown.  Follow up information has been received form the same heath care professional on 27-JUN-2019. Concomitant medications included "Djes(OCP)"(manufactured by other agency)(previous reported as other medication). The patient's information and vaccine adminstration information were updated. From 20-MAR-2018 to 26-MAR-2018, the patient was treated with Methylprednisolone (Medrol) 4mg oral table therapy pack. The outcome of left hand swollen and red, itchy rash on arms, abdomen and legs were recovered on 25-MAR-2018 (previously reported as unknown).
Age: 58.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Pain, Rash erythematous
Clinical narrative: Injection site soreness/ upper arm hurt; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced injection site pain after receiving 1st dose of Shingrix vaccine. The patient's upper arm hurt a few days. The patient inquired whether it was a possible side effect. This case has been linked to the US2019AMR110306, reported for the dose 2 of the same patient.
Age: 58.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection site soreness/ upper arm hurt; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced injection site pain after receiving 1st dose of Shingrix vaccine. The patient's upper arm hurt a few days. The patient inquired whether it was a possible side effect. This case has been linked to the US2019AMR110306, reported for the dose 2 of the same patient.
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Adacel were inadvertently administered to a patient intravenously rather than intramuscularly; Initial information received on 18-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 26 years old male patient who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot C5609AA, exp date: 04-Apr-2021, via intravenous route rather than intramuscular route in unknown administration site on 17-Jul-2019.  The patient's past medical history included Upper limb fracture (arm broke). The patient's past medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate route of vaccination.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: Adacel were inadvertently administered to a patient intravenously rather than intramuscularly; Initial information received on 18-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 26 years old male patient who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot C5609AA, exp date: 04-Apr-2021, via intravenous route rather than intramuscular route in unknown administration site on 17-Jul-2019.  The patient's past medical history included Upper limb fracture (arm broke). The patient's past medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate route of vaccination.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site discolouration, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: 6/25/19: 5 cm red and tender and sl. raised around shot site left arm. Red raised tender area, 7/6/19: Pain when she pushes on it. Dark area surrounding injection site. Nodule in the center. 4.5 cm x 1.5 cm hyperpigmented mark, 2.5 cm nodule in center.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Antineutrophil cytoplasmic antibody, Antinuclear antibody, C-reactive protein, Condition aggravated, Differential white blood cell count
Clinical narrative: Patient had history of HSP for which the vaccine triggered recurrence of HSP - purpura to both legs, with moderate hematuria and proteinuria
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Full blood count, Haematuria, Henoch-Schonlein purpura, Metabolic function test, Proteinuria
Clinical narrative: Patient had history of HSP for which the vaccine triggered recurrence of HSP - purpura to both legs, with moderate hematuria and proteinuria
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Purpura, Urine analysis, Urine calcium/creatinine ratio, Urine protein/creatinine ratio
Clinical narrative: Patient had history of HSP for which the vaccine triggered recurrence of HSP - purpura to both legs, with moderate hematuria and proteinuria
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Improperly stored vaccine administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-JUL-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection, lot # S003326, expiration date: 02-AUG-2020 (exact dose, site and route of administration were not reported) for prophylaxis. No adverse event was reported. The vaccine experienced a temperature excursion from -9 degrees Celsius to 8 degrees Celsius (-0.4 degrees Celsius) for 20 hours. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA010133: US-009507513-1907USA010132:
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: She got the second dose of GARDASIL on 24-MAY-2011; Her arm felt "a little bruised"; "may have hit a nerve"; Her arm "hurt a lot"; patient thinks the 1st shot "may have hit a nerve."; This spontaneous report was received from a currently 18 year old female patient regarding herself. The patient had no concomitant medications, no concurrent conditions nor medical history and no drug reactions or allergies.      On 20-JUN-2008, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (Lot No.0152X has been verified to be a valid lot number for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), expiration date not reported, but upon internal validation established as 09-NOV-2009), with a dose of 0.5 milliliter, intramuscular, for human papillomavirus (HPV) prophylaxis (frequency was not provided).  On the same date (reported as "after receiving the first shot"), the patient recalls that her arm "hurt a lot" (pain in extremity), because she thought that the 1st shot "might have hit a nerve" (nerve injury) and her arm felt "a little bruised" (contusion). Furthermore, it was also reported that the patient did not seek for medical attention and also that no treatment was given for the experienced events. On approximately June 2008 (reported as "lasted  a couple of days"), the patient recovered form the experienced events.    On 24-MAY-2011, the patient was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (Lot No.1569Z), for human papillomavirus (HPV) prophylaxis (strength, dose, route, frequency and expiration date were not provided) with no reportable side effects occurring and on 20-DEC-2011,  the patient was vaccinated with the third and final dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (Lot No.291AA has been verified to be a valid lot number for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), expiration date not reported, but upon internal validation established as 12-APR-2014), for human papillomavirus (HPV) prophylaxis (strength, dose, route and frequency were not provided) with no reportable side effects.        The causal relationship between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and the reported events was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: The patient had an unspecified "tick bite" on the same arm of vaccination; The patient experienced hives on unspecified areas of the body; This spontaneous report was received from a physician via company representative and referring to a female patient of an age reported between 11 or 13 years old. There was no information provided about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or medical history.  On 08-JUL-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly for prevention of human papillomavirus (HPV) (strength, dosage schedule, lot number and expiration date were not reported).  On the same date, the patient developed hives (urticaria) on different areas of her body, it was also reported that the patient had an unspecified "tick bite" (arthropod bite) on the same vaccinated arm. It was reported that the patient sough for medical attention and received treatment (unspecified) for urticaria. The outcome of the aforementioned events was unknown at the reporting time.    Furthermore, it was unknown by the reporter if any laboratory diagnostic or studies were performed.   The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the events was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Improperly stored vaccine administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-JUL-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection, lot # S003326, expiration date: 02-AUG-2020 (exact dose, site and route of administration were not reported) for prophylaxis. No adverse event was reported. The vaccine experienced a temperature excursion from -9 degrees Celsius to 8 degrees Celsius (-0.4 degrees Celsius) for 20 hours. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001776: US-009507513-1907USA010133:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Improperly stored vaccine administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-JUL-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (rHA)(oka-merck) virus vaccine live (PROQUAD) injection, lot # S003326, expiration date: 02-AUG-2020 (exact dose, site and route of administration were not reported) for prophylaxis. The vaccine experienced a temperature excursion from -9 degrees Celsius to 8 degrees Celsius (-0.4 degrees Celsius) for 20 hours. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001776: US-009507513-1907USA010132:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 03-APR-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 15-APR-2019,  the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 15-APR-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 16-APR-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 17-APR-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 22-APR-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 01-MAY-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 02-MAY-2019,  the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373: