chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from Nurse, referring to 4 patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications wee not reported. In 2017, between 18-JAN-2017 and 07-FEB-2017, the patients were vaccinated with an improperly stored dose of VARIVAX with lot # M009764 and expiration date on 23-FEB-2018 (anatomical route of vaccination was not provided) for prophylaxis. The Nurse stated that, VARIVAX, was exposed to a temperature of  > -10°C but < 8°C, > -15°C but < -l0°C, for a time frame of 13 days, 80 hours. Data logger was not involved. Furthermore, it was reported that VARIVAX, was never expose to a temperature excursion before and that no product quality issue was involved. Additionally, no adverse events were suffered. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007841: US-009507513-1702USA007842: US-009507513-1702USA007843:
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: CSF culture positive, Headache, Meningitis aseptic, Nuclear magnetic resonance imaging brain normal, Scan with contrast normal
Clinical narrative: This spontaneous report was received from a physician and refers to a 11 year old immunocompetent male patient. Who had no chickenpox exposure or no history of breakthrough disease, he did not have shingles or rash. Additionally, there were not  drug reactions, allergies and concomitant therapies. On an unknown date, the patient was vaccinated with a dose of VARIVAX (route, anatomical place of vaccination, dose, dose number, lot# and expiration date were not provided), for prophylaxis. On 20-DEC-2016, the patient began having headache and vomiting and subsequently presented with aseptic meningitis. Subsequently, on 23-DEC-2016, the patient tested positive for varicella zoster virus in cerebrospinal fluid (varicella virus test positive). Additionally, a Magnetic resonance imaging (MRI) angio performed in approximately, December 2016 showed no venous fluid but, MRI of brain with contrasts showed no intracranial process. On 22-DEC-2016, the patient was hospitalized and received Acyclovir intravenous 350 mg (10mg/kg) every 8 hours for 10 days as treatment. Approximately, in January 2017 the patient recovered from the events and on 02-JAN-2017 the patient was discharged. The reporter considered the events as life threatening and serious. Nevertheless, the reporter did not provide a causality assessment between VARIVAX and the events. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Varicella virus test positive, Vomiting
Clinical narrative: This spontaneous report was received from a physician and refers to a 11 year old immunocompetent male patient. Who had no chickenpox exposure or no history of breakthrough disease, he did not have shingles or rash. Additionally, there were not  drug reactions, allergies and concomitant therapies. On an unknown date, the patient was vaccinated with a dose of VARIVAX (route, anatomical place of vaccination, dose, dose number, lot# and expiration date were not provided), for prophylaxis. On 20-DEC-2016, the patient began having headache and vomiting and subsequently presented with aseptic meningitis. Subsequently, on 23-DEC-2016, the patient tested positive for varicella zoster virus in cerebrospinal fluid (varicella virus test positive). Additionally, a Magnetic resonance imaging (MRI) angio performed in approximately, December 2016 showed no venous fluid but, MRI of brain with contrasts showed no intracranial process. On 22-DEC-2016, the patient was hospitalized and received Acyclovir intravenous 350 mg (10mg/kg) every 8 hours for 10 days as treatment. Approximately, in January 2017 the patient recovered from the events and on 02-JAN-2017 the patient was discharged. The reporter considered the events as life threatening and serious. Nevertheless, the reporter did not provide a causality assessment between VARIVAX and the events. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from Nurse, referring to 15 patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications wee not reported. In 2017, between 18-JAN-2017 and 07-FEB-2017, the patients were vaccinated with an improperly stored dose of PROQUAD with lot # M033215 and expiration date on 09-JAN-2018 (anatomical route of vaccination was not provided) for prophylaxis. The Nurse stated that, PROQUAD, was exposed to a temperature of  > -10°C but < 8°C, > -15°C but < -10°C, for a time frame of 13 days, 80 hours. Data logger was not involved. Furthermore, it was reported that PROQUAD, was never expose to a temperature excursion before and that no product quality issue was involved. Additionally, no adverse events were suffered. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004171: US-009507513-1702USA007842: US-009507513-1702USA007843.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from Nurse, referring to 2 patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications wee not reported. In 2017, between 18-JAN-2017 and 07-FEB-2017, the patients were vaccinated with an improperly stored dose of LIQUID PEDVAXHIB with lot # M036056 and expiration date on 18-MAY-2019 (anatomical route of vaccination was not provided) for prophylaxis. The Nurse stated that, LIQUID PEDVAXHIB, was exposed to a temperature between 0 °C and 2 °C, for a time frame of 208 hours. Data logger was not involved. Furthermore, it was reported that LIQUID PEDVAXHIB, was never expose to a temperature excursion before and that no product quality issue was involved. Additionally, no adverse events were suffered. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007841: US-009507513-1702USA007843: US-009507513-1702USA004171:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from Nurse, referring to 5 patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications wee not reported. In 2017, between 18-JAN-2017 and 07-FEB-2017, the patients were vaccinated with an improperly stored dose of GARDASIL 9 with lot # L037554 and expiration date on 25-DEC-2017(anatomical route of vaccination was not provided) for prophylaxis. The Nurse stated that, GARDASIL 9, was exposed to a temperature between 0 °C and 2 °C, for a time frame of 208 hours. Data logger was not involved. Furthermore, it was reported that GARDASIL 9, was never expose to a temperature excursion before and that no product quality issue was involved. Additionally, no adverse events were suffered. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA004171: US-009507513-1702USA007841: US-009507513-1702USA007842:
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a consumer (patient's husband) via phone on 06 Feb 2017. This case was linked with case 2017SA021364 (same reporter, same vaccine and same event). This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date in November 2016. Patient's medical history and concomitant medications were not reported. On an unknown date (reported as "just last week"), following the vaccination, the patient was ended up getting the flu. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of the document held by sender: none.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Bronchitis, Chills, Cough, Feeling of body temperature change, Headache
Clinical narrative: Initial unsolicited report received from a consumer (patient) via other company (Pfizer) (Manufacturer Report Number: 2016553116) on 07-Feb-2017. This case involves a patient (gender and age were not reported) who was vaccinated with INFLUENZA VACCINE (Flu Shot) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) at approximately 11 A.M. on 10-Nov-2016. Patient's medical history and concomitant medications were not reported. On 13-Nov-2016, three days following the vaccination, the patient had developed typical flu symptoms included bad head cold, runny nose, sneezing, coughing, hot and cold spells, chills, headache. On an unknown date, following the vaccination, the patient had developed sinus infection and suspected bronchial infection. Laboratory investigations were not reported. As corrective treatment, the patient had received 875 mg/125 mg dose of amoxicillin/clavulanic acid started on 21-Nov-2016. The outcome of all the events was not recovered (reported as events were still going). List of documents held by sender: none.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Influenza, Nasopharyngitis, Rhinorrhoea, Sinusitis, Sneezing
Clinical narrative: Initial unsolicited report received from a consumer (patient) via other company (Pfizer) (Manufacturer Report Number: 2016553116) on 07-Feb-2017. This case involves a patient (gender and age were not reported) who was vaccinated with INFLUENZA VACCINE (Flu Shot) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) at approximately 11 A.M. on 10-Nov-2016. Patient's medical history and concomitant medications were not reported. On 13-Nov-2016, three days following the vaccination, the patient had developed typical flu symptoms included bad head cold, runny nose, sneezing, coughing, hot and cold spells, chills, headache. On an unknown date, following the vaccination, the patient had developed sinus infection and suspected bronchial infection. Laboratory investigations were not reported. As corrective treatment, the patient had received 875 mg/125 mg dose of amoxicillin/clavulanic acid started on 21-Nov-2016. The outcome of all the events was not recovered (reported as events were still going). List of documents held by sender: none.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Influenza, Rhinorrhoea, Sinusitis, Sneezing, Viral upper respiratory tract infection
Clinical narrative: Initial unsolicited report received from a consumer (patient) via other company (Pfizer) (Manufacturer Report Number: 2016553116) on 07-Feb-2017. This case involves a patient (gender and age were not reported) who was vaccinated with INFLUENZA VACCINE (Flu Shot) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) at approximately 11 A.M. on 10-Nov-2016. Patient's medical history and concomitant medications were not reported. On 13-Nov-2016, three days following the vaccination, the patient had developed typical flu symptoms included bad head cold, runny nose, sneezing, coughing, hot and cold spells, chills, headache. On an unknown date, following the vaccination, the patient had developed sinus infection and suspected bronchial infection. Laboratory investigations were not reported. As corrective treatment, the patient had received 875 mg/125 mg dose of amoxicillin/clavulanic acid started on 21-Nov-2016. The outcome of all the events was not recovered (reported as events were still going). List of documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via patient through other company (Pfizer) (Manufacturer Report Number: 2016533800) on 07-Feb-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (TETANUS VACCINE) (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient had allergy to tetanus vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: FLU4, HEP, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site. No treatment completed by patient. Notified health department on 2/17/17. Patient showed nurse picture of redness. No redness noted on 2/17/17.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Dizziness, Loss of consciousness
Clinical narrative: Patient received three vaccines, after receiving vaccines patient sat in office for another 15 minutes. Patient was then taken to checkout then left the clinic. Patient was leaving the building when patients father stated that he had to catch patient because he passed out. Patient did not hit head father grabbed him and put him in chair. Paramedic's where called by downstairs guard. Clinic nurses went downstairs to check on patient. Patient was alert and feeling better, patient stated that he did not feel dizzy anymore and was feeling much better. Paramedic came and assested patient, patient's blood pressure and blood sugar was checked and within normal limits. Patient did not go to hospital. Patient was assisted to the car and left with no complications.
Age: 0.5
Sex: F
Vaccine: DTPHIB, OPV
Symptoms: Autism spectrum disorder, Crying, Dyskinesia, Insomnia, Muscle rigidity
Clinical narrative: Fever, close-mouthed high-pitched scream, seemed unable to open her mouth, crying, fitful, rigid body, inconsolable, wouldn't sleep.
Age: 0.5
Sex: F
Vaccine: DTPHIB, OPV
Symptoms: Pyrexia, Screaming, Seizure
Clinical narrative: Fever, close-mouthed high-pitched scream, seemed unable to open her mouth, crying, fitful, rigid body, inconsolable, wouldn't sleep.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Haemorrhage, Pruritus
Clinical narrative: Every since the day that I got the 2nd dose of the GARDASIL shot, my skin has been itching. I did not take the third dose because of this reason. I have to take Zyrtec everyday. If I don't, I break out in hives and my skin itches so bad to he point of bleeding. I have reported this to doctors numerous times, and nothing has ever been done about it. I've just been told to continue taking Zyrtec. I was  patient, and I had the immunization through the OB/GYN department.
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Fatigue, Lymphadenopathy, Malaise, Musculoskeletal stiffness
Clinical narrative: Pt. state he developed a fever, rash, swelling of the glands in his neck, joint pain and stiffness, fatigue, and an overall sense of illness.  This lasted for 4-5 days.
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Pt. state he developed a fever, rash, swelling of the glands in his neck, joint pain and stiffness, fatigue, and an overall sense of illness.  This lasted for 4-5 days.
Age: 31.0
Sex: M
Vaccine: FLU3, HEPAB
Symptoms: Body temperature increased, Chills, Crying, Headache, Injection site discomfort
Clinical narrative: Temperature increased around 11AM to 99.4, 1pm 100.5, 4pm 103.8. Severe chills, uncontrollable convulsing, weeping, fire like pain in all muscles, loss of consciousness (black out), extreme discomfort at injection site, entire arm swelling, low blood circulation in entire body (turned purple), pale, extreme headache.
Age: 31.0
Sex: M
Vaccine: FLU3, HEPAB
Symptoms: Loss of consciousness, Myalgia, Pain, Pallor, Peripheral swelling
Clinical narrative: Temperature increased around 11AM to 99.4, 1pm 100.5, 4pm 103.8. Severe chills, uncontrollable convulsing, weeping, fire like pain in all muscles, loss of consciousness (black out), extreme discomfort at injection site, entire arm swelling, low blood circulation in entire body (turned purple), pale, extreme headache.
Age: 31.0
Sex: M
Vaccine: FLU3, HEPAB
Symptoms: Poor peripheral circulation, Seizure, Skin discolouration
Clinical narrative: Temperature increased around 11AM to 99.4, 1pm 100.5, 4pm 103.8. Severe chills, uncontrollable convulsing, weeping, fire like pain in all muscles, loss of consciousness (black out), extreme discomfort at injection site, entire arm swelling, low blood circulation in entire body (turned purple), pale, extreme headache.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Swelling of 3.5 inches at injection site and fever of 102.6 degrees F.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Cough, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt had PNEUMOVAX on 2/1/17, to (R) arm. Over next couple of days pt developed sunburn type rash to whole body and cough. (R) arm swelled at injection site, warm to touch, tender. Temp of 101-7. As of 2/8/17 symptoms improving.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Pt had PNEUMOVAX on 2/1/17, to (R) arm. Over next couple of days pt developed sunburn type rash to whole body and cough. (R) arm swelled at injection site, warm to touch, tender. Temp of 101-7. As of 2/8/17 symptoms improving.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash. Influenza 0.5 ml once.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Skin rash.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Lethargy, Pyrexia
Clinical narrative: High fever 102+ and lethargy for 72 hours following the vaccination. Rotated Tylenol and Motrin and used a cool cloth/tepid bath to bring down fever that reached 104.9 (02/15/2017).
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Lip swelling, Swelling face, Urticaria
Clinical narrative: Swelling on lip and cheek, patient self administered Benadryl and symptoms resolved. Than on 2/16/17 at aprox 1800, patient reports he had hives on abdomen. Patient self administered Benadryl and symptoms resolved.
Age: 18.0
Sex: M
Vaccine: HEP, HPV9, MMR, MNQ, TDAP, VARCEL, HEP, HPV9, MMR, MNQ, TDAP, VARCEL
Symptoms: Blood glucose normal, Hyperhidrosis, Pallor, Presyncope
Clinical narrative: Possible vasovagal episode / vs vaccine reaction  while having his blood drawn in 4th Floor Lab. Patient found sitting in lab chair pale, diaphoretic - Responsive, without report of loss of consciousness. Patient had also received 6 vaccines earlier today in the office - HPV (1st dose), MENACTRA (1st dose) Tdap (1st dose) MMR and Varicella (2nd doses) and Hep B (2nd dose). He had been monitored x 15 minutes in provider's office after vaccine administration and had displayed no weakness, hives, dizziness after vaccines' administration. In LAB 09:45 AM: Vital Signs BP: 96/68, HR:46, 02 Sat: 98%, BS: 82 (after administration of 4 Oz OJ) - No rash, hives, wheezing -  09:55 AM Blood Sugar 84, BP: 92/62, HR: 67,  patient A+O x 3. crackers, OJ 4 OZ given. Patient stabilized and transferred via W/C  to Family Medicine Dept for further monitoring. Patient monitored x 1 hr: No rash, wheezing, hives, respiratory distress noted VS stable at departure - Mostly likely vasovagal response to blood draw.
Age: 66.0
Sex: F
Vaccine: PNC
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: Localized reaction/ large erythematous area, warm to touch, swelling.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site ulcer, Local reaction
Clinical narrative: 2 in by 3 in ulcer on left deltoid. Localized reaction followed by alteration.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site ulcer
Clinical narrative: 2 in by 3 in ulcer on left deltoid. Localized reaction followed by alteration.
Age: 71.0
Sex: F
Vaccine: HIBV, MNQ, TDAP
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site rash, Injection site swelling, Pruritus
Clinical narrative: Left arm - itchy, burning, welts immediately. Same day - Rash to elbow and bump where injection site.
Age: 71.0
Sex: F
Vaccine: HIBV, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Left arm - itchy, burning, welts immediately. Same day - Rash to elbow and bump where injection site.
Age: 60.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Electromyogram, Guillain-Barre syndrome, Nuclear magnetic resonance imaging
Clinical narrative: Patient received an influenza vaccine on 10-13-16 and subsequently developed Guillain Barre Syndrome.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. The patient's medical history was not reported. In approximately January 2017 (reported as a couple of days ago), the patient was vaccinated with an expired dose of VAQTA (lot #, expiration date, dose, route and site of administration were not reported) for prophylaxis. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L046319 and expiration date 28-SEP-2017; dose was not reported), orally for prophylaxis. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion between 32 and 36 degrees Fahrenheit (0 to 2 degrees Celsius) for two hours. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patients were vaccinated with an improperly stored doses of ROTATEQ, orally, lot number M019706 with expiration date 24-OCT-2017, (dose was not reported) for prophylaxis. On 03-JAN-2017, the vaccines were exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 9.5 hours; Also on these dates from 04-JAN-2017 to 11-JAN-2017; 13-JAN-2017, from 16-JAN-2017 to 20-JAN-2017; from 23-JAN-2017 to 27-JAN-2017; 30-JAN-2017 and 31-JAN-2017, the vaccines were exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 10 hours each day; all of them in the first cycle. In addition on 12-JAN-2017, the vaccines were exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 10.5 hours in the first cycle. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA007376: US-009507513-1702USA007377: US-009507513-1702USA007375:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly storage PEDVAXHIB, lot number as reported M036057, expiration date 18-MAY-2019, lot number M027882, expiration date 14-APR-2019, lot number L042258, expiration date 18-AUG-2018, (strength, dose, dose number, route and  anatomical location were not reported), for prophylaxis. The temperature excursion was reported below 32 Fahrenheit degrees (0 Celsius degrees), time frame of 25 hours 5 minutes. The vaccines did not experience any previous temperature excursion. Digital data logger was involved. No product quality complain was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, HPV9, MMR, PPV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative concerning to an unspecified patient of unknown age and gender. Medical history and concurrent conditions were not provided. The medical assistant reported that the patient may have received one of the improperly stored lots on an unspecified date. Medical assistant stated that she was not sure which of the vaccines the unspecified patient received. There was no concomitant medication provided. No adverse effect reported. Names of vaccines involved: RECOMBIVAX HB lot # M034894, the expiration date: 11-NOV-2018 (dose and route were not reported) for prophylaxis. Other possible suspect therapies included M-M-R II lot# reported as M029918, expiration date: 13-JUN-2018, lot# M028130, the expiration date: 03-JUN-2018, lot# M006544, the expiration date: 03-FEB-2018, or lot# M017348, the expiration date: 06-APR-2018 (dose and route were not reported) for prophylaxis, VAQTA lot# M033611, the expiration date: 02-MAR-2018 or lot# reported as M038572, the expiration date: 11-MAR-2018 (dose and route were not reported) for prophylaxis, GARDASIL 9 lot# M034780, the expiration date: 15-APR-2019, lot# M032650, the expiration date: 31-MAY-2019 (dose and route were not reported), PNEUMOVAX23 lot# M032635, the expiration date: 05-MAY-2018, lot # M043987, the expiration date: 30-JUN-2018, lot# M036161, the expiration date: 06-MAY-2018, lot#  M036728, the expiration date: 20-MAY-2018 (dose and route were not reported) for prophylaxis or ROTATEQ orally lot# reported as M0381807, the expiration date: 02-APR-2018, lot# M038744, the expiration date: 26-APR-2018, lot# M038717, the expiration date: 24-APR-2018 or lot# M025572, the expiration date 20-JAN-2018 (dose was not provided) for prophylaxis. The temperature excursion reported was >46°F but <77°F during 30 minutes registered in a data logger. There was no previous temperature excursion. No Product Quality Complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, referring to an unspecified number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 12-JAN-2017, the patients were vaccinated with an improperly stored dose of ROTATEQ, orally, with lot # M019691 and expiration date on 02-NOV-2017 for prophylaxis. The reported stated, that ROTATEQ, was exposed to a temperature of > 46 °F but < 77 °F, for 7 hours and 39 minutes. Data logger was reported. Furthermore, it was reported that, on an unknown date, ROTATEQ was exposed to a previous temperature excursion of 32 °F and 36 °F for 78 minutes. Additionally, no adverse effects were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA007859:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions or concomitant medications were not reported. On 07-FEB-2017, the patient was inadvertently administered with an expired dose of PNEUMOVAX 23 intramuscularly (lot # L024129, expiration date: 21-JAN-2017), for prophylaxis. No adverse events were reported. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; expired dose of GARDASIL 9 was administered to a patient; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender.  On 04-FEB-2017, the patient was vaccinated with an expired dose of GARDASIL 9 for prophylaxis (expiry date  29-JAN-2017; dose, route and lot number not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly storage VAQTA, lot number M033611, expiration date 02-MAR-2018, lot number M027879, expiration date 24-JAN-2018, lot number M047658, expiration date 28-OCT-2017, (strength, dose, dose number, route and  anatomical location were not reported), for prophylaxis. The temperature excursion was reported below 32 Fahrenheit degrees (0 Celsius degrees), time frame of 25 hours 5 minutes. The vaccines did not experience any previous temperature excursion. Digital data logger was involved. No product quality complain was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007383: US-009507513-1702USA007382: US-009507513-1702USA002897: US-009507513-1702USA007381:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly storage RECOMBIVAX HB, lot number as reported M020929, expiration date 11-AUG-2018, lot number L048236, expiration date 31-MAR-2018, lot number M037248, expiration date 21-FEB-2019, lot number M018625, expiration date 11-AUG-2018, (strength, dose, dose number, route and  anatomical location were not reported), for prophylaxis. The temperature excursion was reported below 32 Fahrenheit degrees (0 Celsius degrees), time frame of 25 hours 5 minutes. The vaccines did not experience any previous temperature excursion. Digital data logger was involved. No product quality complain was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007383: US-009507513-1702USA007382: US-009507513-1702USA007380: US-009507513-1702USA002897:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly storage GARDASIL 9, lot number as reported M035486, expiration date 05-JUN-2019, lot number M023169, expiration date 13-JUN-2018, lot number M030380, expiration date 01-FEB-2019, lot number M036059, expiration date 03-JUN-2019, lot number M032650, expiration date 31-MAR-2019, (strength, dose, dose number, route and anatomical location were not reported), for prophylaxis. The temperature excursion was reported below 32 Fahrenheit degrees (0 Celsius degrees), time frame of 25 hours 5 minutes. The vaccines did not experience any previous temperature excursion. Digital data logger was involved. No product quality complain was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA007383: US-009507513-1702USA002897: US-009507513-1702USA007380: US-009507513-1702USA007381.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant 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 16-FEB-2017, the patient was vaccinated with expired dose of GARDASIL injection, lot # L007531, expiration date 04-NOV-2016 (dose and route of administration were not reported). There was no adverse event reported. No product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse referring to 5 unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. In January 2017 (reported as between 10-JAN-2017 through 30-JAN-2017), the patients were vaccinated with improperly stored doses of ROTATEQ liquid, orally, lot # M031807 expiration date 02-APR-2018 (strength and dose were not provided) for prophylaxis. On an unspecified date, the vaccine was exposed to a temperature between 32 Fahrenheit degrees and 36 Fahrenheit degrees for 12 hours. There was no previous temperature excursion. No adverse effects were reported. The call was placed because of a Digital Data logger. This is one of several report from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA001084:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, referring to an unspecified number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 12-JAN-2017, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB, with lot # L044694 and expiration date on 04-FEB-2018 (anatomical route of vaccination was not provided) for prophylaxis. The reported stated, that RECOMBIVAX HB, was exposed to a temperature of > 46 °F but < 77 °F, for 7 hours and 39 minutes. Data logger was reported. Furthermore, it was reported that, on an unknown date, RECOMBIVAX HB was exposed to a previous temperature excursion of 32 °F and 36 °F for 78 minutes. Additionally, no adverse effects were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA004201:
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Local swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales Representative. This nurse reported similar events for three patients. This is the third of three reports. An elderly female patient received PREVNAR 13, (lot R33240, exp. date Mar2018, NDC number: 0005197101) at single dose on 01Feb2017 for immunization. On unknown date the patient experienced symptoms of redness at injection site, itching to the site, and heat to the site 1-2 days post injection, local swelling. The outcome of the events was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017063634 same reporter/drug/event, different patient; US-PFIZER INC-2017063627 same reporter/drug, similar events/patient.
Age: 26.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. A patient of an unspecified age, gender ethnicity and race received PREVNAR 13 on an unknown date, at 0.5 ml, single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced pain and limited mobility in arm. Clinical outcome was unknown at time of this report.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site warmth
Clinical narrative: This is a spontaneous report from a Pfizer-Sponsored Program, Pfizer RXPathways. A contactable pharmacist reported that a 74-year-old female patient of an unspecified race received PREVNAR 13 (lot R19477, expiry date Jan2018, NDC number 00005197102) on 06Feb2017 at 0.5 ml single for immunisation. The patient was diabetic. Concomitant medication included gabapentin, 300 mg, 3x/day. On 11Feb2017 the patient was having a reaction around the vaccination area described as: hot, itchy, pain, red. Pain and itchiness were going down to the arm every day and it was all down to the elbow at the time of report. As treatment the patient took some paracetamol (TYLENOL) and then levocetirizine (XYZAL) which was not helping. All these events had not yet resolved at the time of report. The reporting pharmacist also stated that nobody prescribed her PREVNAR 13. Laboratory test: none. The reporter considered that the events were related to the suspect vaccine and added that even though it was a delayed reaction and vibrating all the way down, did not think it was due to an injury that she had recently.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer who reported 2 cases, this one of the 2 cases. A 66-year-old female patient received PREVNAR 13 (Lot# R12276, Exp date Feb2018, NDC 0051971-02), via an unspecified route of administration in left deltoid, on 20Jan2017, at 0.5 ml single, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced cellulitis on 30Jan2017 with outcome of unknown, redness on 24Jan2017 with outcome of unknown and swelling on 24Jan2017 with outcome of unknown. Therapeutic measures were taken as a result of cellulitis and included treatment with KEFLEX.
Age: 51.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Hyperhidrosis, Nausea, Throat tightness
Clinical narrative: Our clinic was contacted by the patients place of work and they stated she was feeling nauseous and sweating. I informed them of what signs to look for concerning anaphylaxis and when to call the ambulance. They called back 10 minutes later and stated that once I got off the phone the patient started saying her throat was feeling like it was closing so they contacted 911.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Pt. called 1/31/17 and reported hives and erythematous painful rash after administration of 23 valent pneumococcal vaccine on 1/30/17. Pt. used topical diphenhydramine with no relief, and was instructed to take diphenhydramine 25-50 mg orally TID p.r.n. rash and to visit the ER if symptoms do not resolve or get worse.
Age: 66.0
Sex: F
Vaccine: DTAP, FLU3, PPV
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Right arm achy and sore Monday and Tuesday, Wednesday has reddened area below injection site which has increased and is traveling down arm. She has not had a fever.
Age: 51.0
Sex: M
Vaccine: FLUX, VARCEL, FLUX, VARCEL
Symptoms: Chills, Depression, Fatigue, Feeling cold, Injection site rash
Clinical narrative: This spontaneous report was received from a 51 year old male consumer referring by himself. The patient's medical history and concurrent conditions were not reported. On 03-FEB-2017, the patient was vaccinated with the 1st dose of VARIVAX parenteral injection in the left arm (lot # and expiry date were not reported) to prevent chicken pox. On the same day, he was also vaccinated with a dose of influenza virus vaccine (unspecified) (flu shot) in the right arm. The patient was using Unspecified concomitant medications. On 03-FEB-2017, the patient developed an injection site rash in the arm where VARIVAX was administered. Afterwards, the patient felt chilled (feeling cold) and tired (fatigue). The rash persisted for three days so, he was treated with diphenhydramine hydrochloride (BENADRYL). He felt better now and the rash was gone but he was still tired. He suspected that he might feel tired as a result of depression. The patient said he has no recollection of ever having chicken pox or a vaccination against chicken pox and suspected that was why he was administered VARIVAX and not ZOSTAVAX (wrong drug administered). He was still considering taking his second dose of VARIVAX but had not made the final decision at this time. The outcome of feeling cold and fatigue was reported as covering/resolving. The outcome of depression and wrong drug administered was unknown. The outcome of injection site rash was reported as recovered/resolved on an unknown date. No causal relationship was rated between the events and the VARIVAX therapy. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: FLUX, VARCEL, FLUX, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a 51 year old male consumer referring by himself. The patient's medical history and concurrent conditions were not reported. On 03-FEB-2017, the patient was vaccinated with the 1st dose of VARIVAX parenteral injection in the left arm (lot # and expiry date were not reported) to prevent chicken pox. On the same day, he was also vaccinated with a dose of influenza virus vaccine (unspecified) (flu shot) in the right arm. The patient was using Unspecified concomitant medications. On 03-FEB-2017, the patient developed an injection site rash in the arm where VARIVAX was administered. Afterwards, the patient felt chilled (feeling cold) and tired (fatigue). The rash persisted for three days so, he was treated with diphenhydramine hydrochloride (BENADRYL). He felt better now and the rash was gone but he was still tired. He suspected that he might feel tired as a result of depression. The patient said he has no recollection of ever having chicken pox or a vaccination against chicken pox and suspected that was why he was administered VARIVAX and not ZOSTAVAX (wrong drug administered). He was still considering taking his second dose of VARIVAX but had not made the final decision at this time. The outcome of feeling cold and fatigue was reported as covering/resolving. The outcome of depression and wrong drug administered was unknown. The outcome of injection site rash was reported as recovered/resolved on an unknown date. No causal relationship was rated between the events and the VARIVAX therapy. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly storage ROTATEQ, lot number as reported M012454, expiration date 25-JAN-2018, lot number as reported M02254, expiration date 15-NOV-2017, lot number as reported M037636, expiration date 06-APR-2018, lot number M018958, expiration date 03-MAR-2018, lot number M019706, expiration date 24-OCT-2017, (strength, dose, dose number, route and  anatomical location were not reported), for prophylaxis. The temperature excursion was reported below 32 Fahrenheit degrees (0 Celsius degrees), time frame of 25 hours 5 minutes. The vaccines did not experience any previous temperature excursion. Digital data logger was involved. No product quality complain was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA002897: US-009507513-1702USA007382: US-009507513-1702USA007380: US-009507513-1702USA007381.
Sex: F
Vaccine: HEP
Symptoms: Caesarean section, Hepatitis B, Hepatitis B DNA increased, Hepatitis B surface antigen positive, Vaccination failure
Clinical narrative: This literature marketed report as received from the authors of the published article, concerns an infant baby girl. The patient's mother, who had chronic hepatitis B, delivered her at age 28. During her first pregnancy, she was recommended to schedule standard active and passive immunoprophylaxis with hepatitis B immune globulin and hepatitis b vaccine (recombinant) (manufacturer unknown)  vaccination for her, to be administered within 12 hours of birth, followed by additional two doses to complete the vaccination series. An infant was born via a caesarean section. On an unknown date, she was noted to have the presence of hepatitis B surface antigen (HBsAg) and high levels of hepatitis B virus deoxyribonucleic acid (HBV) DNA (vaccination failure). The outcome of the event was unknown. The authors considered the event to be related to Hepatitis B Vaccine (Recombinant) (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site inflammation
Clinical narrative: Patient was given subcutaneously in left upper arm. Patient had a allergy reaction when it became red and inflamed. She took BENADRYL and it went away. Allergy was from ZOSTAVAX.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: On 2/13/17, Pt. received QUADRACEL (DTaP and IPV) in upper (L) deltoid and Influenza (multi dose vial) in lower (L) deltoid on 2/13/17. Developed redness, swelling at site noted in am of 2/14/17. Pt. seen 2/15/17. Has cellulitis 10 cm x 13 cm noted from Influenza site extending down to elbow. Given PO cephalexin (250/5 ml) 10 ml BID x 10 days and BENADRYL PO PRN, cool compresses PRN.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Injection site warmth, Pyrexia, Rash
Clinical narrative: RASH, FEVER, WARMNESS AT SITE OF INJECTION.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEP, PNC13, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Not aware of any adverse reaction that patient may have. Patient receive PEDIARIX in addition to extra dose of Hep B pediatric dose.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: Large area of redness, induration, tenderness, and increased warmth at site vaccine was administered (right tricep area).  Size of reaction site is 4.5 cm x 7 cm.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Skin warm, Ultrasound scan normal
Clinical narrative: Patient called. Her arm was red, hot, and painful. Appointment made.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Condition aggravated, Crying, Exaggerated startle response, Gastrooesophageal reflux disease
Clinical narrative: Inconsolable crying, Exaggerated Startle Reflex, followed by high-pitched crying repeating every 2 min, worsening of reflux for 4 days following vaccinations.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient was given adult dose of Hepatitis A vaccine. No adverse reactions reported.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ, HEPA, HPV9, MENB, MNQ
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Muscular weakness, Nausea
Clinical narrative: Nausea & Tired. went to bed. woke up this morning with nausea, temp of 99, feeling weak and tired.  Stated right arm feels numb and weak.