chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Back pain, Chest pain, Musculoskeletal stiffness, Peripheral swelling, Rash erythematous
Clinical narrative: At 9:30am on 9/26/15 patient came to the pharmacy with red dots and rash all over body mostly on her arms, chest and stomach. She stated that on 9/24/15 between 2 and 2:30pm, she received 3 vaccinations. She came home and went to bed, 6 hours later her thumbs swelled up, her hands were stiff. Her chest was on fire. Her back felt like someone hit it with a hammer. The patient said she took Naproxyn that she has at home and felt okay. In the morning of 9/26/15, the patient woke up with red spots and itchy rash on her body. I recommended her to use topical Benadryl cream and Zyrtec tablets to alleviate the itch. I also recommended her to take Benadryl at night only to help her sleep (itch and hives). I warned her about the drowsiness side effect of both over the counter antihistamines, mostly Benadryl. At 4:15pm later that day, I followed up with the patient and she stated that the Benadryl cream works very well. She said " I will be okay". I advised the patient to call the Pharmacy with any questions and keep us informed.
Age: 63.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: At 9:30am on 9/26/15 patient came to the pharmacy with red dots and rash all over body mostly on her arms, chest and stomach. She stated that on 9/24/15 between 2 and 2:30pm, she received 3 vaccinations. She came home and went to bed, 6 hours later her thumbs swelled up, her hands were stiff. Her chest was on fire. Her back felt like someone hit it with a hammer. The patient said she took Naproxyn that she has at home and felt okay. In the morning of 9/26/15, the patient woke up with red spots and itchy rash on her body. I recommended her to use topical Benadryl cream and Zyrtec tablets to alleviate the itch. I also recommended her to take Benadryl at night only to help her sleep (itch and hives). I warned her about the drowsiness side effect of both over the counter antihistamines, mostly Benadryl. At 4:15pm later that day, I followed up with the patient and she stated that the Benadryl cream works very well. She said " I will be okay". I advised the patient to call the Pharmacy with any questions and keep us informed.
Age: 39.0
Sex: M
Vaccine: FLUX
Symptoms: Conjunctivitis, Diarrhoea, Dyspnoea, Rhinorrhoea
Clinical narrative: Conjunctivitis, progressing into shortness of breath, runny nose and diarrhea.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Flushing
Clinical narrative: A while after receiving Prevnar 13 on 09-25-15, patient experienced uncontrollable shaking of both of her fore arms.  She also experienced a flushed face, bubbly, peeling lips, and dizziness.  She needed assistance walking due to the dizziness.  On 09-26-15 patient felt aches, chills, fatigue, and lack of appetite, and some dizziness.  Patient no longer had uncontrollable fore arm shaking or bubbly peeling lips or flushed face.  Patient has not sought treatment.  She reported her experience to me on 09-26-15.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Gait disturbance, Lip blister, Lip exfoliation, Pain, Tremor
Clinical narrative: A while after receiving Prevnar 13 on 09-25-15, patient experienced uncontrollable shaking of both of her fore arms.  She also experienced a flushed face, bubbly, peeling lips, and dizziness.  She needed assistance walking due to the dizziness.  On 09-26-15 patient felt aches, chills, fatigue, and lack of appetite, and some dizziness.  Patient no longer had uncontrollable fore arm shaking or bubbly peeling lips or flushed face.  Patient has not sought treatment.  She reported her experience to me on 09-26-15.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Local swelling, Nasal congestion, Swelling face, Vision blurred
Clinical narrative: Left side of face swollen/neck also. Coughing. Nose stopped up. Eyes felt like film. 7:30 pm symptoms started vaccinated at 4:15 pm.
Age: 57.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Swelling, warm to the touch, hardening, redness.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injection site swelling, Pain
Clinical narrative: Pt called and complained of weakness and soreness after flu shot. Initially thought she had a virus, but then she said her arm had been swollen from injection site to elbow. Referred to MD. Allergy?? Following up w/ MD in one week.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Fatigue
Clinical narrative: Pt. called me (9/26/15)-stated was very tired, got chills, felt like every joint in her body ache. Pt stated she might go into walk-in clinic. Pt was mad!
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: On injection felt shooting pain down, sore immediately gave ibuprofen/ice worked then stopped after 2 days so changed to TYLENOL and ice still using and symptoms are getting worse.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site warmth, Musculoskeletal pain
Clinical narrative: Injection site next day was hot and red, pain radiated to neck and shoulder and had "flu-like symptoms".
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain
Clinical narrative: Injection site next day was hot and red, pain radiated to neck and shoulder and had "flu-like symptoms".
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Trigeminal neuralgia
Clinical narrative: Patient's upper face went numb for 5 days. After going to the ED. She was informed that it was trigeminal neuralgia from the high dose flu shot. (right trigeminal nerve).
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Erythema, Induration, Inflammation, Pyrexia, Rash
Clinical narrative: Fever 12 hours after vaccine given which lasted 5 days inflammation of arm, rash, redness, hot and hard treated with antibiotics and nausea medication.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Skin warm
Clinical narrative: Fever 12 hours after vaccine given which lasted 5 days inflammation of arm, rash, redness, hot and hard treated with antibiotics and nausea medication.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Warm, raised, red rash approx. 10cm below injection site. Injection site is unremarkable. No pain no itch. 5cm in diameter not round.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. Approximately in 2015 (reported as "in June into July"), unspecified number of patients received unspecified doses of ROTATEQ (orally; dose, lot # and expiry date were not provided) that were improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. Approximately in 2015 (reported as "in June into July"), unspecified number of patients received unspecified doses of VAQTA (dose, route of administration, lot # and expiry date were not provided) that were improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an adolescent male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 08-AUG-2014 (at the age of 16 years old), the patient was vaccinated with his first dose in series of GARDASIL (dose, route of administration, lot # and expiration date were not reported). On 14-SEP-2015 (at the age of 17 years old), he was administered his second dose in series with GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old patient. On 17-SEP-2015, the 4 month old patient was vaccinated with doses of MMR II, (Merck) VARIVAX, VAQTA, poliovirus vaccine inactivated (unspecified) and DTAP. No adverse effects were reported. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Pruritus, Rash, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old male patient. The patient had no pertinent medical history and no drug reactions or allergies. On 22-MAY-2015, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, in the posterior left arm, inadvertently via intramuscular route, lot # L003217, expiration date 30-APR-2016. The patient was concomitantly taking multiple unspecified medications. In approximately August 2015 (reported as "about a month ago"), the patient developed a small bump on  his left side which turned into an elevated rash that looked "like hives covering his whole left side". The reporting pharmacist stated that the patient was using an unspecified topical steroid that was giving relief from the itching (onset approximately in 2015), but was not slowing down the progression of the rash and it's size. The patient sought medical attention via going back to the pharmacy. No lab diagnostic studies were performed. By the time of the report, the patient did not recover from the adverse events. Casual relationship between the adverse events and vaccination with ZOSTAVAX was not assessed by the reporter. Additional information has been requested.
Age: 0.11
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 40 days old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-SEP-2015, the patient was inadvertently vaccinated with a dose of VAQTA (dose, route of administration, lot # and expiration date were not reported) instead of an intended dose of RECOMBIVAX HB. No adverse effects were reported. The error occurred due to miscommunication between staff members as to which product was intended for administration. No product confusion was reported. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On 01-SEP-2015, the patient was vaccinated subcutaneously with the improperly stored, second dose of (Merck) VARIVAX (lot number K008823 and expiration date 16-JUN-2016) (dose was not reported). Concomitant therapy was not reported. No adverse effect was reported. The reporter did not know when the patient was administered the first dose of (Merck) VARIVAX. 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 registered nurse 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 history provided. On an unknown date, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (route of administration, lot # and expiration date not reported). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date in 2009, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). The patient received the second dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported) on 20-JUL-2015. It was confirmed that the third dose of GARDASIL was not administered to the patient. There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) 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 registered nurse refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. Approximately in 2015 (reported as "in June into July"), unspecified number of patients received unspecified doses of RECOMBIVAX HB (dose, route of administration, lot # and expiry date were not provided) that were improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. Approximately in 2015 (reported as "in June or July"), unspecified number of patients received unspecified doses of GARDASIL (dose, route of administration, lot # and expiry date were not provided) that were improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. 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 other certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of incorrectly stored RECOMBIVAX HB (dose and route were not reported) lot # K012874, expiration date 09-JUN-2016. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unknown dates, an unspecified number of patients received doses of RECOMBIVAX HB (lot # L010595, expiration date 12-NOV-2016; lot # K024552. expiration date 22-OCT-2016; dose, frequency, indication and route of administration were not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unknown dates, an unspecified number of patients received doses of GARDASIL 9 (lot # L014198, expiration date 05-SEP-2017; lot# L004741, expiration date 04-MAR-2017; dose frequency, indication and route of administration were not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patient were vaccinated with a doses of incorrectly stored ROTATEQ lot # K015816, expiration date 29-MAY-2016, orally. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple patients of unknown age and gender. The patients' concurrent condition, medical history or concomitant medications were not reported. On unknown dates, unspecified patients were vaccinated with improperly stored ZOSTAVAX lot # L012478, expiry date 10-JUL-2016 (dose and route of administration were unspecified). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unknown dates, an unspecified number of patients received doses of VAQTA (lot # K005323, expiration date 10-FEB-2017; lot# L021361, expiration date 30-MAR-2017; dose, frequency, indication and route of administration were not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. On 14-AUG-2015, the patient was vaccinated with incorrectly stored dose of VAQTA (route of administration, dose and frequency were not reported, lot #L009445 with expiration date: 01-JUN-2017). No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patient were vaccinated with a doses of incorrectly stored VAQTA lot # K009506, expiration date 22-SEP-2016. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 70 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 18-SEP-2015, the patient was vaccinated with a dose of (Merck) VARIVAX lot # L013068, expiration date 14-APR-2017 (strength, dose and route of administration were not provided). The patient should have received ZOSTAVAX. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 21-SEP-2015, the patient was vaccinated with the improperly stored dose of (Merck) VARIVAX (lot number reported as L020000 and expiration date 02-JUN-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a female patient of unknown age via company representative. The patient was reporting on herself. No pertinent medical history and drug reactions or allergies were reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and expiration date were not reported). Concomitant therapy was not provided. On an unknown date (reported as "after administration with ZOSTAVAX"), the patient experienced pain. The outcome of pain and the relatedness between pain and ZOSTAVAX were both not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. On 18-AUG-2015, the patient was vaccinated with incorrectly stored dose of VAQTA (route of administration, dose and frequency were not reported, lot #L009445 with expiration date: 01-JUN-2017). No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to unspecified patients of unknown demographics. On an unknown date (also reported as since 09-APR-2015) the patients were vaccinated with GARDASIL (dose, route, frequency unspecified). It was reported that the vaccine which was exposed to temperatures outside of the recommended range, have been administered to unspecified patients on unspecified dates since 09-APR-2015. No adverse effects have been reported. It was also reported that administrative worker, called back to evaluate the same doses, which were previously exposed to temperatures outside of the recommended range, and have been administered to patients. No additional information was provided. All telephone attempts to obtain follow-up information have been unsuccessful on 23-SEP-2015. This is one of the two reports from the same reporter. Additional information has been requested. Narrative updated.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare workers referring to a 30 to 40 patients of unknown age and gender. Since an unknown date in September 2015 (the vaccinations occurred within the past 2 weeks) the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and frequency were not reported, lot # K026246 with expiration date: 28-JAN-2017 and lot # L007560 with expiration date: 15-JUN-2017). No adverse effects reported. This is one of the several reports received from the same reporter. Additional information is not expected. Reporters did not wish to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified nursing assistant referring to an unspecified patient of unknown age and gender. No information on their medical history, concurrent conditions or concomitant drugs was provided. On 21-AUG-2015, the patient was administered a dose of improperly stored GARDASIL 9 (dose and route of vaccination were not reported, lot # L004741 exp. date: 04-MAR-2017). No adverse events have been reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. In 2014 (reported as "last year"), the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported). In 2015 (reported as "this year") the patient was administered another dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' concurrent condition, medical history or concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX, (strength, dose, frequency and route of administration were not reported), (lot # K011804 expiration date: 21-AUG-2016, lot # L002868 expiration date: 27-JAN-2017, lot # K015943 expiration date: 23-SEP-2016, lot # L001332 expiration date: 13-JAN-2017, lot # L004654 expiration date: 11-FEB-2017, lot # K015994 expiration date: 23-SEP-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patient were vaccinated with a doses of incorrectly stored GARDASIL lot # J003727, expiration date 07-NOV-2015. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient's pertinent medical history included removal of lymph nodes from her left arm several years ago and had no known drug allergies. On 17-SEP-2015, the patient was vaccinated with 0.5 ml PNEUMOVAX 23 (lot # L008664 and expiry date: 03-NOV-2016) intramuscularly in the left arm. Concomitant medications were none. On 17-SEP-2015 several hours post administration, the patient experienced redness, warmth and swelling of her left arm from vaccine administration site to elbow. The patient went to the pharmacist for treatment advice and was recommended ice to site and BENADRYL. At the time of reporting (unknown date in September 2015), the outcome of redness was reported as recovered/resolved. The outcome of warmth and swelling was reported as not recovered/not resolved (reported as continued). The relatedness of the events with PNEUMOVAX23 was not 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 Certified Medical Assistant and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On an unknown day, an unspecified number of patients received doses of ROTATEQ (lot # L008574, expiration date 22-NOV-2016; lot# L013188, expiration date 02-NOV-2016; lot# K020182, expiration date 26-JUN-2016; lot# K008139, expiration date 15-APR-2016; dose, frequency and indication were not reported), orally, that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse regarding 9 patients of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 23-JUN-2015, the patient were vaccinated with improperly stored dose of VARIVAX (Merck) lot# K021484 and expiry date: 03-NOV-2016. No adverse effect was reported. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient had no concomitant medications, no pertinent medical history and no drug reactions/allergies. On 07-MAY-2015, the patient was vaccinated with the dose of PNEUMOVAX 23 (0.5 ml, subcutaneous injection, lot# reported as 1003188, expiration date 06-JUL-2016). On 08-MAY-2015 (also reported as the next day), the patient experienced an injection site reaction described as "a swollen arm, severe muscle aches, redness, warm to the touch, and a fever of 100 degrees". Medical attention was sought via office visit and treatment prescribed for the patient was an unspecified dose of TYLENOL and doxycycline 100 mg capsule twice a day. No lab diagnostic studies were performed. The patient recovered "a couple of days after". The reporter did not assessed the causality between the adverse events and PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient had no concomitant medications, no pertinent medical history and no drug reactions/allergies. On 07-MAY-2015, the patient was vaccinated with the dose of PNEUMOVAX 23 (0.5 ml, subcutaneous injection, lot# reported as 1003188, expiration date 06-JUL-2016). On 08-MAY-2015 (also reported as the next day), the patient experienced an injection site reaction described as "a swollen arm, severe muscle aches, redness, warm to the touch, and a fever of 100 degrees". Medical attention was sought via office visit and treatment prescribed for the patient was an unspecified dose of TYLENOL and doxycycline 100 mg capsule twice a day. No lab diagnostic studies were performed. The patient recovered "a couple of days after". The reporter did not assessed the causality between the adverse events and PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: MMR
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. The patients concomitant therapies, medical history and concurrent conditions were not reported. On an unknown dates in August 2015 (reported as some time in August 2015), the patients were vaccination with unspecified doses of MMR II injection, lot # K024038, expiration date 26-NOV-2016 (route of administration and dose were not provided) that were improperly stored. No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
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. The patients concomitant therapies, medical history and concurrent conditions were not reported. On an unknown dates in August 2015 (reported as some time in August 2015), the patients were vaccinated with unspecified doses of PEDVAXHIB injection, lot # L004740, expiration date 16-NOV-2017 (route of administration and dose were not provided) that were improperly stored. No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare workers referring to a 30 to 40 patients of unknown age and gender. Since an unknown date in September 2015 (the vaccinations occurred within the past 2 weeks) the patients were vaccinated with improperly stored doses of (Merck) PROQUAD (dose and frequency were not reported, lot #K022448 with expiration date: 13-MAY-2016, lot #K025766 with expiration date: 08-JUN-2016). No adverse effect reported. This is one of the several reports received from the same reporter. Additional information is not expected. Reporters did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare workers referring to a 30 to 40 patients of unknown age and gender. Since an unknown date in September 2015 (the vaccinations occurred within the past 2 weeks) the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose and frequency were not reported, lot # L004655 with expiration date: 11-FEB-2017, lot# L013067 with expiration date: 14-APR-2017). No adverse effects reported. This is one of the several reports received from the same reporter. Additional information is not expected. Reporters did not wish to be contacted.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient with asthma and chronic pain. The patient did not have any drug reactions or allergies. Concomitant therapies included PROAIR, TYLENOL with CODEINE #3, DYAZIDE and enalapril maleate (manufacturer unknown). On 30-DEC-2014, the patient was vaccinated with the first dose of ZOSTAVAX (lot #K012786, exp. date 28-NOV-2015, dose not reported, subcutaneously, injection site not reported). On 20-SEP-2015, the patient was inadvertently vaccinated with the second dose of ZOSTAVAX (lot #L011529, exp. date 03-JUL-2016, dose not reported, subcutaneously in the right arm). On 20-SEP-2015, the patient experienced injection site pain. On 21-SEP-2015, the patient experienced injection site redness and injection site swelling. The patient sought medical attention by visiting the pharmacist. She was treated with BENADRYL. No lab diagnostic studies were performed. The outcome of injection site pain, injection site swelling and injection site redness was reported as not recovered. The relatedness between the adverse events and ZOSTAVAX was not provided. 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 healthcare workers referring to a 30 to 40 patients of unknown age and gender. Since an unknown date in September 2015 (the vaccinations occurred within the past 2 weeks) the patients were vaccinated with improperly stored doses of ROTATEQ (orally, dose and frequency were not reported, lot #K023537 with expiration date: 22-JUN-2016). No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected. Reporters did not wish to be contacted.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Upper 3rd rt arm red, swollen and tender 3 x 2 cm.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash erythematous
Clinical narrative: Mon 9/21/15: Received shingles vaccines. Tue 9/22/15: Red itchy rash, skin feels "thicker", wrapped arm in gauze and tape. Wed - Red itchy rash - blisters small, wrapped arm as above. Thursday, Sept 24, 2015 -AM: Removed wrap - seems like all small blisters cleared one large blister filled with clear yellow fluid. Rewrapped arm. Afternoon went back to pharmacy and talked to pharmacist who gave me the shingles vaccine. He stated "I don't believe its from the shingle vaccine - I believe you have an infection. Friday, Sept 24th, 2015. went to Dr's appt. Arm unwrapped and the blister is large and now I have additional small blisters along the top of the large blister (which looks like an inflated balloon). arm rewrapped and your number was given to me. Was told to put  neosporin on it and keep it wrapped. Sometime during the day the blister popped a little and now there's a sac with fluid in it. Saturday, Sept 26th, 2015 - AM: Skin is red and itchy - skin is "thick". Sac empty. Do not dee any blisters at this time.  Saturday Sept 26th, 2015 PM: Left bandage off today. Skin is red and itches once in a while. Skin is still "thick". I don't see any blisters at this time. I waited until the weekend to send in form along with these attached notes. I have pictures taken on my cell phone and I want our company to see these. I am not exaggerating these blisters and what my arm looks like. How can I send pictures to your company from my cell phone?
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Infection, Rash erythematous, Rash pruritic, Skin texture abnormal
Clinical narrative: Mon 9/21/15: Received shingles vaccines. Tue 9/22/15: Red itchy rash, skin feels "thicker", wrapped arm in gauze and tape. Wed - Red itchy rash - blisters small, wrapped arm as above. Thursday, Sept 24, 2015 -AM: Removed wrap - seems like all small blisters cleared one large blister filled with clear yellow fluid. Rewrapped arm. Afternoon went back to pharmacy and talked to pharmacist who gave me the shingles vaccine. He stated "I don't believe its from the shingle vaccine - I believe you have an infection. Friday, Sept 24th, 2015. went to Dr's appt. Arm unwrapped and the blister is large and now I have additional small blisters along the top of the large blister (which looks like an inflated balloon). arm rewrapped and your number was given to me. Was told to put  neosporin on it and keep it wrapped. Sometime during the day the blister popped a little and now there's a sac with fluid in it. Saturday, Sept 26th, 2015 - AM: Skin is red and itchy - skin is "thick". Sac empty. Do not dee any blisters at this time.  Saturday Sept 26th, 2015 PM: Left bandage off today. Skin is red and itches once in a while. Skin is still "thick". I don't see any blisters at this time. I waited until the weekend to send in form along with these attached notes. I have pictures taken on my cell phone and I want our company to see these. I am not exaggerating these blisters and what my arm looks like. How can I send pictures to your company from my cell phone?
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: Patient called us and said she went to the hospital and was diagnosed with an allergic reaction to vaccine. Patient stated she is fine now.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Hypersensitivity
Clinical narrative: Patient called us and said she went to the hospital and was diagnosed with an allergic reaction to vaccine. Patient stated she is fine now.
Age: 20.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Injection site pain, Musculoskeletal disorder, Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe pain in arm and shoulder, particularly in underside muscle of arm that was administered shot. Neither Ibuprofen nor Naproxen are helping, arm is barely usable and sometimes causes disruption and difficulty performing tasks in daily life.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Short electric shock-like sensation that travels from the left foot (above the heel) to the upper thigh. This happened twice on the afternoon after the vaccine, and once the following morning (today).
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS AND SWELLING ON INJECTION SITE.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cellulitis, Chills, Dizziness, Gingival bleeding, Injection site pain
Clinical narrative: REDNESS AND SWELLING ON INJECTION SITE.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling
Clinical narrative: REDNESS AND SWELLING ON INJECTION SITE.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Intra-ocular injection, Malaise, Tremor
Clinical narrative: Patient reported on 9/21/15 4:00 pm that she was shaky and did not feel well. She called a neighbor and she was taken to the hospital. She also reported having an injection in her eye at the doctor's office in her 9/21 report (informed post vaccination).
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Tremor
Clinical narrative: Chills, violent shaking, followed by shooting pains in several joints. Chills lasted two hours. Joint pains lasted about four hours. This morning, 9/27/2015, weakness & fatigue were pronounced for about six hours.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Swelling, redness, warmth left upper arm of 23cm x 16cm.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Altered state of consciousness, Cold sweat, Dizziness, Headache, Hypoaesthesia
Clinical narrative: Patient experienced visual disburbances where she saw all black and was spotty, she had ringing in her ears, numbness down her arm on the side of the vaccine, felt clammy, and HR was 60. Was dizzy and felt like she was going to pass out. I had her sit for about 20 minutes and drink cold water. She felt better and left. She had a headache later on that night.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Tinnitus, Visual impairment
Clinical narrative: Patient experienced visual disburbances where she saw all black and was spotty, she had ringing in her ears, numbness down her arm on the side of the vaccine, felt clammy, and HR was 60. Was dizzy and felt like she was going to pass out. I had her sit for about 20 minutes and drink cold water. She felt better and left. She had a headache later on that night.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain, swelling, redness, and itching at injection site.  Recommended antihistamine, cold compresses, and analgesic.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Vaccination site inflammation, Vaccination site warmth
Clinical narrative: Patient's left arm turned red and is warm to the touch in area of vaccine (upper left arm). Patient stated the red area kept spreading so she went to see a doctor.  He told her that it was nothing to worry about but he gave her a Medrol dose pak to help with the inflammation.  Doctor advised her that since she is over age 65, she will not need another pneumonia shot again in the future.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised
Clinical narrative: Onset of rash, starting on the neck and upper trunk and then extending to the face and arms and legs and whole body.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cough, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling (left arm edema), redness, soreness of upper left arm from Pneumovax23 injection. Pt iced left arm. She also took Aleve. Symptoms were not worsening after 24 hours and she felt ice and ibuprofen helped. She also noted she developed cough overnight, but the cough is not worsening and she had no shortness of breath or swelling of airways associated with it.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Blood pressure increased, Chills, Headache, Heart rate increased, Hot flush
Clinical narrative: I awoke with sever head and body aches all over.  Nest day 9/25/2015 had a increase heartbeat and slightly higher than normal blood pressure.  Also had hot flashes followed by cold chills.  Still feeling lethargic.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Lethargy, Pain
Clinical narrative: I awoke with sever head and body aches all over.  Nest day 9/25/2015 had a increase heartbeat and slightly higher than normal blood pressure.  Also had hot flashes followed by cold chills.  Still feeling lethargic.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Dizziness, Fatigue, Nausea, Oropharyngeal pain
Clinical narrative: On 09/09/2015 at 6:00 PM patient arrived home, she felt fatigued, and nauses. On 09/10/15 woke up with congestion, nausea, light headedness, cough. Cough was dry and non productive, sore throat. Treatment rest, fluids 2 tablets of naproxen, tussin DM and musin X D.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Respiratory tract congestion
Clinical narrative: On 09/09/2015 at 6:00 PM patient arrived home, she felt fatigued, and nauses. On 09/10/15 woke up with congestion, nausea, light headedness, cough. Cough was dry and non productive, sore throat. Treatment rest, fluids 2 tablets of naproxen, tussin DM and musin X D.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient experienced redness surrounding injection site. Area was warm to the touch and remained red 4 days after administration. Ice pack has been applied to the area.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RVX
Symptoms: Blood test, Pyrexia, Urine analysis
Clinical narrative: High fever of 101.5 F beginning at 9pm.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Blood test, Chest X-ray, Chills, Computerised tomogram abdomen
Clinical narrative: Fever, chills, sweats, diarrhea, severe stomach pain, malaise, nausea, occipital neuralgia. All symptoms were ongoing and lasted until 9/27/2015.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram head, Diarrhoea, Hyperhidrosis, Malaise, Nausea
Clinical narrative: Fever, chills, sweats, diarrhea, severe stomach pain, malaise, nausea, occipital neuralgia. All symptoms were ongoing and lasted until 9/27/2015.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Occipital neuralgia, Pyrexia, Urine analysis
Clinical narrative: Fever, chills, sweats, diarrhea, severe stomach pain, malaise, nausea, occipital neuralgia. All symptoms were ongoing and lasted until 9/27/2015.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Fatigue, Lethargy, Pain in extremity, Peripheral swelling
Clinical narrative: Arm was sore, swollen, hot, and red within 2 hours of shot. By today the redness and swelling is 3" to 4" in diameter.  I am fatigued, lethargic.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Arm was sore, swollen, hot, and red within 2 hours of shot. By today the redness and swelling is 3" to 4" in diameter.  I am fatigued, lethargic.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Balance disorder, Disorientation, Hallucination, visual, Vertigo
Clinical narrative: Vertigo. No rash, or fever or nausea. Lack of balance. Lighted clock face moved up and down in the dark when I was still. Disorientation.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, Pyrexia
Clinical narrative: Extremely painful arm (from shoulder to wrist), fever ranging from 100 to 103 for three days, body aches and stiffness.