chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.42
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 5 months old female patient. There was no information about the patient's pertinent medical history, and drug reactions or allergies provided. On 09-JAN-2017, the patient was mistakenly vaccinated with a dose of PROQUAD injection (lot# M009745, expiration date 23-AUG-2017; dose and route of administration were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician, via company representative, referring to a patient of unknown age and gender. The patient's  medical history, concomitant therapies and concurrent conditions were not provided. On unknown dates, the patient was vaccinated with  2 doses of VARIVAX (lot/batch #, expiration date, route of administration and dose were not provided) for prophylaxis, and subsequently had negative varicella titers (antibody test negative). At the time of the report the outcome of antibody test negative was unknown. The reporting physician did not rate the causality assessment between the Antibody test negative and VARIVAX. Additional information is not expected since the physician refused to be contacted.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a dentist, via a company representative, referring to a female patient of unknown age. Her medical history, concomitant therapies and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot/batch, expiration date, dose and route of administration were not provided) for prophylaxis. On an unspecified date, the patient developed a rash. It was not specified how long after receiving ZOSTAVAX the patient developed the rash. It was reported that the patient sought medical attention (spoke with an unspecified physician). At the time of the report the outcome of rash was unknown. The reporting dentist did not rate the causality assessment between the rash and ZOSTAVAX. Additional information is not expected dentist refused to be contacted.
Age: 1.25
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to a one year old patient of unknown gender. There was no information about the patient's drug reactions, allergies, pertinent medical history and concomitant therapies provided. On 25-JAN-2017, the patient was vaccinated with an expired dose of M-M-R II (lot # L001336 with expiry date of 13-JAN-2017; dose and route of administration were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unspecified date in 2012, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis. Then, on an unknown date in 2017, another dose of ZOSTAVAX 19400 Plaque-forming unit (PFU) with lot number M036297 and expiration date of 14-NOV-2017 (dose, route of administration and anatomical location were unknown) was given to the patient for the same indication. There were no adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX subcutaneous injection (strength and dose were not reported) (lot # M032638, expiration date 04-OCT-2017) for prophylaxis. According to the reporter, ZOSTAVAX doses were exposed to the following temperatures excursions: 2 hours and 12 minutes between more than 5 degrees Fahrenheit (F) but less than 14 F, for 48 minutes between more than 14 F but less than 46 F, and for 8 hours and 15 minutes between more than 5 F but less than 14 F. No adverse effects were reported. A digital data logger was involved. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005004: US-009507513-1702USA005005:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician's assistant and refers to unspecified multiple patients of unknown ages and genders. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patients were vaccinated with a dose of improperly stored PNEUMOVAX23 (lot #, expiration date, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was stored at a  recorded temperature of 34.84 Farenheit (1.57 Celsius) for 19 hours. It was unknown by the reporter if there was previous temperature excursion.  No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test, Nerve injury
Clinical narrative: This spontaneous report was received from a 77-year-old female patient reporting on herself with drug hypersensitivity to Codeine and no pertinent medial history reported. However, it was mentioned that the patient was taken concomitant therapies, but the patient refused to disclose them. On an unspecified date in 2008, the patient was vaccinated with a dose of ZOSTAVAX, dose and frequency reported as "1 vaccine" (dose number, route, anatomical location, lot number and expiration date were not reported), for prophylaxis reported as to prevent the shingles. In August 2015, the patient experienced a serious case of shingles (Herpes Zoster). Later, on an unspecified date (also reported as "after the shingles"), she had some permanent nerve damage (Nerve injury) which covered her midriff and her back. Additionally, the patient reported that she underwent laboratory tests (unspecified) twice a year (results not provided). On an unspecified date, the patient sought medical attention (information was not provided), and as a result, she was prescribed with different medications (unspecified). The patient reported that for 10 days she took some antiviral (unspecified) and then pain pills (unspecified) but she only took the pain pills once or twice since that medication did not make her feel good. At the time of this report, it was unknown if the patient recovered or not from the adverse events and she currently took "gabentin". The causal relationship between the adverse events and the therapy with ZOSTAVAX was not provided. No product quality complaint was involved. The reporter considered serious case of shingles (Herpes Zoster) to be medically significant. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD subcutaneous injection (strength and dose were not reported) (lot # M007964, expiration date 15-AUG-2017; lot # L046508, expiration date 17-MAY-2017). According to the reporter, PROQUAD doses were exposed to the following temperatures excursions: 2 hours and 12 minutes between more than 5 degrees Fahrenheit (F) but less than 14 F, for 48 minutes more than 14 F and  less than 46 F, and for 8 hours and 15 minutes more than 5 F and less than 14 F. No adverse effects were reported. A digital data logger was involved. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA005005: US-009507513-1702USA001693.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX subcutaneous injection (strength and dose were not reported) (lot # L010148, expiration date 24-MAR-2017; lot # L046887, expiration date 23-NOV-2017; lot # M017292, expiration date 07-APR-2018; lot # M023382, expiration date 11-MAY-2018; lot # M025867, expiration date 24-MAY-2018; lot # M033904, expiration date 20-JUL-2018) for prophylaxis. According to the reporter, VARIVAX doses were exposed to the following temperatures excursions: 2 hours and 12 minutes between more than 5 degrees Fahrenheit (F) and less than 14 F, for 48 minutes between more than 14 F but less than 46 F, and for 8 hours and 15 minutes between more than 5 F and less than14 F. No adverse effects were reported. A digital data logger was involved. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA001693: US-009507513-1702USA005004:
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Injection site pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. An 85-year-old female patient received PREVNAR 13, via an unspecified route of administration in upper left arm, on 15Sep2015, at single dose, for immunisation. The patient received PREVNAR 13 at doctor's office. Relevant medical history included ongoing arthritis from 2015, ongoing degenerative back disease from 2015 (11 different issues with her back all diagnosed around the same time), spondylitis from 2015, kidney disorder, walking difficulty (couldn't walk on her left leg, had shooting pains), sciatic nerve injury, spinal disorder, hip injury/contusion of hip (hurt herself on hip which needed emergency room and doctor prescription), herniated disc, tremendous back pain. Concomitant medications were not reported. Previously the patient received influenza vaccine (unspecified trade name), about 30 or 40 years before, for immunisation and experienced drug ineffective and pneumococcal vaccine (PNEUMOCOCCAL CONJUGATE VACCINE), a long time before, for immunisation. The patient experienced chronic injection site pain (very painful) on 15Sep2015 with outcome of recovering (improved), she couldn't move her arm very well from an unspecified date with outcome of unknown, needed help getting dressed because couldn't move arm very well from an unspecified date with outcome of not recovered, pain was underneath the shoulder below the armpit down to elbow and underneath the fatty inner side of her arm on an unspecified date with outcome of unknown, shoulder pain on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of the events and included treatment with pain relievers from Sep2015 to unknown. The patient thought the shot was given improperly, as was given high up on her left shoulder. The patient did not think her experience had anything to do with Prevnar 13 itself. It was related to the person giving the vaccine shot. Issue was the vaccinator and how putting the medication, that gave the side effect, not the product.
Age: 69.0
Sex: F
Vaccine: FLU4, PNC13, FLUX, PNC13
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 69-years-old female patient received PREVNAR 13 , via an unspecified route of administration on 24Oct2016 at single dose for immunization in right arm.  On the same day the patient received influenza vaccine in her butt. The patient medical history was not reported, and unspecified concomitant medication were ongoing.   The patient previously took influenza vaccine and experienced injection site pain. The patient experienced joint pain in both knees and  joint pain in both thumbs in Nov2016 a week to 10 days after vaccination, with outcome of not recovered.  Doctor prescribed Diclofenac SOD EC 75mg to take one tablet twice a day.  Was advised to take it for 3 days, but she took it for 4 days.  While taking it, things got much better, so she stopped it.  Within a couple of days, the pain came back.
Sex: U
Vaccine: PNC13
Symptoms: Adverse reaction, Incorrect product storage
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for 15 patients. This is the 2nd of 15 reports.  A patient of an unspecified age, gender and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017) via an unspecified route of administration, on an unspecified date, at single dose, for immunization.  The patient medical history and concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter, product, event, different patient.
Sex: F
Vaccine: PNC13
Symptoms: Adverse reaction, Incorrect product storage
Clinical narrative: This is a spontaneous report from a contactable nurse calling from physician's office who reported similar events for 15 patients. This is the 3rd of 15 reports. A female patient of an unspecified age and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017) via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter/drug/AE, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Adverse reaction, Incorrect product storage
Clinical narrative: This is a spontaneous report from a contactable nurse calling from physician's office who reported similar events for 15 patients. This is the 5th of 15 reports. A patient of an unspecified gender, age and race/ethnicity received PREVNAR 13 (Lot. N4385, expiry date 31Oct2017) on an unknown date, single dose, for immunization. Relevant medical history and concomitant medications were unknown. The vaccine was administered to this patient after a temperature excursion. On an unspecified date, the patient experienced severe reactions on arm. Clinical outcome was unknown at time of this report.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter/drug/AE, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Adverse reaction, Incorrect product storage
Clinical narrative: This is a spontaneous report from a contactable nurse calling from physician's office who reported similar events for 15 patients. This is the 9th of 15 reports. A patient of an unspecified age, gender and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017) via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter/drug/AE, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Adverse reaction, Incorrect product storage
Clinical narrative: This is a spontaneous report from a contactable nurse calling from physician's office who reported similar events for 15 patients. This is the 11th of 15 reports. A patient of an unspecified age, gender and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017) via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter/drug/AE, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Adverse reaction, Incorrect product storage
Clinical narrative: This is a spontaneous report from a contactable nurse calling from physician's office who reported similar events for 15 patients. This is the 12th of 15 reports. A patient of an unspecified age, gender and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017) via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter/drug/AE, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Adverse reaction, Incorrect product storage
Clinical narrative: This is a spontaneous report from a contactable nurse calling from physician's office who reported similar events for 15 patients. This is the 8th of 15 reports. A patient of an unspecified age, gender and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017) via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter/drug/AE, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Adverse reaction, Incorrect product storage
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for 15 patients. This is the 14th of 15 reports.  A patient of an unspecified age, gender and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017) via an unspecified route of administration, on an unspecified date, at single dose, for immunization.  The patient medical history and concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter, product, event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Adverse reaction, Incorrect product storage
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for 15 patients. This is the 15th of 15 reports.  A patient of an unspecified age, gender and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017) via an unspecified route of administration, on an unspecified date, at single dose, for immunization.  The patient medical history and concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter, product, event, different patient.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Local swelling, Mass, Peripheral swelling, Pruritus
Clinical narrative: This is a spontaneous report from a contactable healthcare professional via a Pfizer sales representative. A 78-year-old male patient received PREVNAR 13 on 31Jan2017, in right arm, at single dose, for immunisation. Medical history included upset stomach, blood pressure abnormal and cholesterol abnormal. Concomitant medications included lansoprazole once daily for upset stomach, ramipril once daily for blood pressure, atorvastatin for cholesterol, acetylsalicylic acid (ASPIRIN) 81 mg, daily and fish oil.  After the patient had the vaccine, couple of hours later, on 31Jan2017, he got a lump under his skin, it was red and itchy and warm to the touch and there was localised swelling but then it swelled up and took over his whole upper arm. He had no other side effects. The patient visited the Doctor and was better. Treatment received: none. Laboratory tests: none. The final outcome of each reported event was unknown.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: This is a spontaneous report from a contactable healthcare professional via a Pfizer sales representative. A 78-year-old male patient received PREVNAR 13 on 31Jan2017, in right arm, at single dose, for immunisation. Medical history included upset stomach, blood pressure abnormal and cholesterol abnormal. Concomitant medications included lansoprazole once daily for upset stomach, ramipril once daily for blood pressure, atorvastatin for cholesterol, acetylsalicylic acid (ASPIRIN) 81 mg, daily and fish oil.  After the patient had the vaccine, couple of hours later, on 31Jan2017, he got a lump under his skin, it was red and itchy and warm to the touch and there was localised swelling but then it swelled up and took over his whole upper arm. He had no other side effects. The patient visited the Doctor and was better. Treatment received: none. Laboratory tests: none. The final outcome of each reported event was unknown.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Disorientation, Dizziness, Fatigue, Headache, Hypotension
Clinical narrative: Within 2 minutes of receiving FLUZONE, she became lightheaded and had near syncope. She was taken to room to lie down and within 10 minutes stated she was nauseated and had a headache. B/P was low at 102/60 which was within her normal range. She improved enough to be taken home within 1/2 hour. Around 6:00 a phone call to patient was made and she stated she was very tired but was feeling somewhat better. (This was on a Friday) Monday, the patient was again contacted and reported that she had woken up with sweats 3 x during the night and felt slightly disoriented. She felt better on 2/11/17 when she awoke but felt fatigued the whole day. She states that she is now feeling much better now (2/13/17) "just a little tired yet".
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Night sweats, Presyncope
Clinical narrative: Within 2 minutes of receiving FLUZONE, she became lightheaded and had near syncope. She was taken to room to lie down and within 10 minutes stated she was nauseated and had a headache. B/P was low at 102/60 which was within her normal range. She improved enough to be taken home within 1/2 hour. Around 6:00 a phone call to patient was made and she stated she was very tired but was feeling somewhat better. (This was on a Friday) Monday, the patient was again contacted and reported that she had woken up with sweats 3 x during the night and felt slightly disoriented. She felt better on 2/11/17 when she awoke but felt fatigued the whole day. She states that she is now feeling much better now (2/13/17) "just a little tired yet".
Age: 24.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient did not have any side effects or symptoms. This was a vaccine error, an adult patient was given a pediatric dose Hepatitis A.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pain, Urinary incontinence
Clinical narrative: Severe swelling and intense pain to her arm at injection site. Pt noted pain also to her entire body (skin,muscle) that was so intense she couldn't control her bladder at one point. Pt strongly considered going to ER but didn't.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Dyspnoea, Hyperventilation
Clinical narrative: Hyperventilation, SOB.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Anxiety, Depression, Diplegia, Guillain-Barre syndrome, Hyperventilation
Clinical narrative: Hyperventilation, SOB.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Intensive care, Sensory loss, Walking aid user, Wheelchair user
Clinical narrative: Hyperventilation, SOB.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: The patient has developed Guillain-Barre syndrome.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain, Sleep disorder
Clinical narrative: After getting flu shot, numbness in right hand. Then I cannot sleep on my right side because it causes pain.
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Eye swelling, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received on 12-JAN-2017 from a medical assistant who reported that a one year-old female patient received routine vaccinations of VAQTA (Dose, route of administration, site of administration, Lot number and expiration date were not reported) and VARIVAX (Dose, route of administration, site of administration, Lot number and expiration date were not reported) (Reference MARRS # 1702USA006062). The exact date of vaccinations was not specified.  The female patient had a pertinent medical history of anemia. The female patient had no concomitant medications and no drug reactions/allergies. The medical assistant reported that the patient experienced redness and swelling at the injection site, followed by swelling of one eye after receiving unspecified doses of VAQTA and VARIVAX. Treatment of the events was unknown. The medical assistant reported that this occurred on an unspecified date a couple of months ago, and the patient is now fully recovered.  No additional information was available. Additional information has been requested. This is one of two reports for the same patient.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse, who reported that an unspecified number of patients (demographics not provided) received an improperly stored dose of PROQUAD (albumin status unknown), lot # L039268, expiration date 05-APR-2017, (dose number, dosage and route of administration not provided), for prophylaxis.  No adverse effects reported. Temperature excursion reported as: Temperature: > 15°C but < -10°C; highest temperature -14°C. Time frame: 20 minutes. Previous temperature excursions reported as: -14°C for 10 minutes, -13°C for 40 minutes, -13°C for 4 hours 20 minutes, -13°C for 1 hour 40 minutes, -8°C for 3 hours 40 minutes, -9°C for 13 hours, -11°C for 63 hours. No further details provided. Additional information has been requested.; Sender's Comments: US-009507513-1702USA006075:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 19-JAN-2017 from a health care worker regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 18-JAN-2017, the patient was vaccinated with a dose of M-M-R II lot # K021950 expiration 10-NOV-2016, 0.5 ml, subcutaneous for prophylaxis after it had expired. No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L038503, expiration date 18-DEC-2017 (dose and route of administration were not reported). There was no adverse effect reported. The vaccine underwent three separate temperature excursions. In the first excursion the vaccine was exposed to temperature between 0 to 2 degrees Celsius for 5 hours and 39 minutes. In the second temperature excursion the vaccine was exposed to temperature between 8 to 25 degrees Celsius for 1 hour and 15 minutes. In the third excursion the vaccine was exposed to temperature between 8 and 25 degrees Celsius for 14 hours and 57 minutes. Data logger was involved. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (lot # L027733, expiration date 13-SEP-2017; lot # M018645, expiration date: 31-MAY-2018; dose and route of administration were not provided). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of above 46 but below 77 degrees Fahrenheit for 40 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA006072.
Age: 1.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician and refers to a 12 month old patient. No information about the patient's medical history, concurrent conditions, drug reaction or allergies and concomitant therapies was provided. On 30-JAN-2017, the patient was vaccinated with ZOSTAVAX injection, lot # reported as M042503, expiration date: 18-AUG-2017 (dose and route of administration were not reported) instead of VARIVAX. Medical assistant, who made an error, was in hurry and grabbed the wrong vaccine. The patient did not experience any adverse effect. Product quality complaint was not involved. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional and refers to a 13 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-JAN-2017, the patient was vaccinated with with an expired dose of VARIVAX lot # L002870, expiry date 27-JAN-2017 (exact dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Product quality complaint (PQC) was not involved. Additional information is not expected as there was no consent to contact the physician.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications were not reported. In January 2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis. It was reported that, PNEUMOVAX23, was exposed to multiple excursions, for more than 2 cycles, below 32 °F, the coldest cycle being reported was 26 °F. Nevertheless, the vaccine was not exposed to any pervious temperature excursions. Data logger was not involved. Furthermore, no adverse event was reported and no product quality issue was involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 01-FEB-2017, the patient was vaccinated with VARIVAX subcutaneously, which had lot # of M027342, an expiration date of 01-JUN-2018 (dose and anatomical place of vaccination were not provided), for prophylaxis. Nevertheless, on the same day, the patient found out that she was pregnant. Nevertheless, the patient's last menstrual period (LMP), estimated date of delivery (EDD), the number of weeks of the pregnancy, the outcome of pregnancy and the fetal outcome was not know. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Eye swelling, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received on 12-JAN-2017 from a medical assistant who reported that a one year-old female patient received routine vaccinations of VAQTA (Dose, route of administration, site of administration, Lot number and expiration date were not reported) (Reference MARRS # 1701USA006001) and VARIVAX (Dose, route of administration, site of administration, Lot number and expiration date were not reported). The exact date of vaccinations was not specified.  The female patient had a pertinent medical history of anemia. The female patient had no concomitant medications and no drug reactions/allergies. The medical assistant reported that the patient experienced redness and swelling at the injection site, followed by swelling of one eye after receiving unspecified doses of VAQTA and VARIVAX. Treatment of the events was unknown. The medical assistant reported that this occurred on an unspecified date "a couple of months ago," and the patient is now fully recovered. No additional information was available. Additional information has been requested. This is one of two reports for the same patient.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection (lot # M027884, expiration date 19-APR-201; lot # M027883, expiration date: 15-APR-2019; dose and route of administration were not provided). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of above 46 but below 77 degrees Fahrenheit for 40 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA006072: US-009507513-1702USA006073: US-009507513-1701USA012827.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of vaccinated with GARDASIL 9 injection (lot # M034780, expiration date 15-APR-2019; lot # M016193, expiration date: 24-APR-2018; dose and route of administration were not provided). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of above 46 but below 77 degrees Fahrenheit for 40 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012827: US-009507513-1702USA006073: US-009507513-1702USA006071:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection (lot # M029680, expiration date 17-JAN-2018; lot # M038359, expiration date: 13-MAY-2018; lot # M036728, expiration date: 20-MAY-2018; dose and route of administration were not provided). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of above 46 but below 77 degrees Fahrenheit for 40 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA006072: US-009507513-1701USA012827: US-009507513-1702USA006071.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Blood test, Lumbar puncture, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Tingling /Weakness, went to ER, was admitted for observation, went back other times and was admitted again 2/9/17, no diagnosis made, sent home to follow up with neurologist for EMG, no appointment available until March 20, 2016.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Tingling /Weakness, went to ER, was admitted for observation, went back other times and was admitted again 2/9/17, no diagnosis made, sent home to follow up with neurologist for EMG, no appointment available until March 20, 2016.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Injection site reaction (redness and a small rash  at the site). No fever.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Computerised tomogram head, Injection site reaction, Laboratory test, Muscular weakness, Nuclear magnetic resonance imaging brain
Clinical narrative: Weakness of right arm and right leg.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: X-ray
Clinical narrative: Weakness of right arm and right leg.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture negative, Blood test normal, Chest X-ray normal, Computerised tomogram head normal, Hypotonia
Clinical narrative: Weakness of right arm and right leg.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site reaction, Mobility decreased, Muscular weakness, Nuclear magnetic resonance imaging normal, Pain
Clinical narrative: Weakness of right arm and right leg.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Pain in extremity, X-ray limb normal
Clinical narrative: Weakness of right arm and right leg.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Loss of consciousness, Pallor, Respiratory rate decreased, Vomiting
Clinical narrative: Two minutes after flu vaccine administered, child's face flushed, made choking sounds, vomited, lost consciousness, face turned pale, decreased respirations.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Culture, Skin lesion
Clinical narrative: LESION APPEARED OVER BODY.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Area of redness on the skin surrounding site of injection and extending up to 4-6 inches from injection site, skin warm to the touch.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Local swelling, Oropharyngeal pain, Respiration abnormal
Clinical narrative: Right-sided swelling of neck, sore throat, audible respirations, BP 202/120.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received on 17-JAN-2017 from a nurse regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 17-JAN-2017 the patient was inadvertently vaccinated with GARDASIL 9 lot # M028323, expiration 26-SEP-2017 unknown route for prophylaxis while 4 weeks 3 days pregnant at the time of the administration. No adverse effects reported. No further information was reported. The LMP and EDD are not known. The outcome of exposure during pregnancy and no adverse event is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist regarding an adult female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were unknown by the reporter. On an unknown date (reported as "on an unspecified time in the past"), the patient started therapy with ZOSTAVAX vial 19400 plaque-forming units (PFU) (dose, frequency, lot number and expiration date were not provided) for prophylaxis. On an unknown date (reported as "at an unspecified time after receiving ZOSTAVAX), the patient developed a case of shingles (herpes zoster). The reported had no details on the amount of time which elapsed between the dose of ZOSTAVAX and when she developed the event. It was unknown if the patient sought medical attention for the event. At the reporting time, the patient did not have an active case of herpes zoster. The reporter did not provide a causality assessment between the suspect vaccine and the event. Additional information is not expected as the reporter refused additional contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse and refers to unspecified patients of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patients were vaccinated with an improperly storage dose of VAQTA, lot # K018181 and expiration date of 04-JUN-2017, (route of administration and anatomical location were not reported) for prophylaxis, which was stored at a lowest recorded temperature of 32 Fahrenheit (0 Celsius) and a highest temperature of 36 Fahrenheit (2.2 Celsius) for 34 days, the entire 24 hours each day, and lowest recorded temperature of 46 Fahrenheit (7.7 Celsius) and a highest of 77 Fahrenheit (25 Celsius) for 24 hours. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA002769: US-009507513-1702USA002770: US-009507513-1701USA012928.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (dose, strength, and route of administration were not reported) (lot # M028553, expiration date 07-JUN-2018) for prophylaxis. According to the reporter, VARIVAX doses were exposed to the following temperatures excursions: 2 hours and 20 minutes between >-15 degrees Celsius (C) and <-10 C. No adverse effects were reported. A digital data logger was involved. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: When I woke up I noticed that area around injection site was swollen, red, itchy, and radiating heat. Size is about 2 inches circumference around.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Patient experienced mild rash at injection site. Rash seems to be spreading. Site is tender to touch.
Age: 20.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Urticaria
Clinical narrative: The morning after PREVNAR vaccine the patient experienced hives and itching on both arms, back, chest, and scalp. She took antihistamines which helped some. As of Tuesday, February 14th it was getting better. I advised to keep taking antihistamine and Aveeno baths.
Age: 23.0
Sex: M
Vaccine: HPV9, TDAP, YF
Symptoms: Abdominal distension, Headache, Immediate post-injection reaction, Pallor, Respiratory rate increased
Clinical narrative: Patient immediately went pale after injection of the HPV 9 vaccine, pt c/o tunnel vision and seeing black spots. He broke out in a full body sweat and breathing became rapid. He also c/o abdominal tightness. This nurse talked patient through breathing techniques and applied a cool clothe to forehead and back of neck. The patient laid on the floor for about an hour recovering and under continuous observation. Vital signs within normal limits taken twice.   No emergency medications administered. Pt left the clinic with c/o a headache.
Age: 23.0
Sex: M
Vaccine: HPV9, TDAP, YF
Symptoms: Tunnel vision, Visual impairment
Clinical narrative: Patient immediately went pale after injection of the HPV 9 vaccine, pt c/o tunnel vision and seeing black spots. He broke out in a full body sweat and breathing became rapid. He also c/o abdominal tightness. This nurse talked patient through breathing techniques and applied a cool clothe to forehead and back of neck. The patient laid on the floor for about an hour recovering and under continuous observation. Vital signs within normal limits taken twice.   No emergency medications administered. Pt left the clinic with c/o a headache.
Age: 22.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Dizziness
Clinical narrative: Patient felt light-headed and dizzy, lost track of time and events.
Age: 18.0
Sex: M
Vaccine: HEPAB
Symptoms: Cough, Urticaria
Clinical narrative: Patient report slight cough with hives noted on arm, hands, trunk, and back of neck. Over the counter Benadryl taken self administered at 2;20 pm observed by nursing staff. Hives resolved at 2:45 and patient released to self care.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Patient was supposed to get varicella vaccine , and  instead received  ZOSTAVAX vaccine.
Age: 28.0
Sex: F
Vaccine: YF
Symptoms: Headache, Injection site pain, Joint stiffness, Musculoskeletal stiffness, Neck pain
Clinical narrative: 4:30 pm Dull headache. 02/11/2017: AM Sore arm at injection site. PM: Progressively worsening elbow and shoulder stiffness/soreness with continued headache. 02/12/2017: PM onset of neck stiffness with continued left arm soreness/stiffness and dull headache. 02/13/2015: 11 am On set of stiff left wrist. Difficulty with typing with left hand. Worsening left arm stiffness/soreness and shooting pain down left arm. PM onset of pins and needles sensation in left hand and fingers. 02/14/15: Continued headache, left arm stiffness/soreness and tingling sensation down left arm, hand and finger tips. Neck pain worse when looking down.