chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 55-year-old female patient. The patient had no pertinent medical history. She had drug reactions/allergies to unspecified pain medicine and unspecified antibiotics. The patient was not pregnant. On 27-FEB-2017, the patient was vaccinated with ZOSTAVAX (lot # M033219, expiration date: 18-AUG-2017, vaccination) (dose and injection site were not provided) at the pharmacy. There was no concomitant medications. On 28-FEB-2017, the patient developed an unspecified rash (unspecified location on the body) and pain at the injection site (the site was unknown by the reporter). On 02-MAR-2017, the patient came to the pharmacy and the pharmacist described a red swollen area the size of a fist with a center the size of a kiwi, that was hard and darker. On an unspecified date, the patient took diphenhydramine hydrochloride (BENADRYL) for the rash. She has not consulted with her primary physician yet. Laboratory diagnostic studies were not performed. The outcome of the events was reported as not recovered, at the time of the report. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a vaccine coordinator and refers to multiple, unknown patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX injection, lot# reported as M040139 with expiration date: 28-SEP-2018, lot# M028552 with expiration date: 07-JUN-2018, lot# M006729 with expiration date: 08-FEB-2018 (dose and route of administration were not reported). Multiple excursions had place that required the multiple excursion form to be sent, therefore temperature and time frame information was unknown. There was no previous temperature excursion. Digital data logger was used. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medication, drug reactions or allergies was provided. The patient was administered 5 doses of Haemophilus influenzae type b (Hib) containing vaccines on the following dates. On 04-JAN-2016, he was given the first dose of PENTACEL (dose and route of administration not provided). The second dose was administered on 11-MAR-2016. On 16-MAY-2016, the patient was vaccinated with the first dose of LIQUID PEDVAXHIB (dose, lot #, expiration date and route of administration not provided). He received subsequent two doses of LIQUID PEDVAXHIB on 29-DEC-2016 and 03-MAR-2017. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Peripheral swelling
Clinical narrative: Information has been received from Pfizer (manufacturer control# 2017058517) on 06-MAR-2017. This spontaneous report as received from a pharmacist referred to two female patients who were 65 years of age or older. Information about medical history, concurrent condition and concomitant medication was unspecified. On unknown dates the patients were vaccinated with PNEUMOVAX 23 (lot#, dosage, frequency and route unspecified) for prophylaxis. On unknown dates the patients experienced the swollen arm and pain at the injection site due to vaccination. The outcome of the events was unknown. The reporter considered the events to be related to PNEUMOVAX 23. This case is one of three reports received from the same reporter. Additional information is expected. Sender's Comments: US-009507513-1703USA002520.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL 9 which had Lot number reported as M037700 with expiry date on 01-JUN-2019; lot # M017983 with expiry date on 30-MAY-2018 and lot # M034780 with expiration date on 14-APR-2019 (strength and route were not reported) for prophylaxis, however no adverse effects reported.  It was reported that the vaccines were exposed to temperature of > 8 but <25 Centigrade range for a time frame of 1 hour and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA008048: US-009507513-1703USA001827: US-009507513-1703USA008051: US-009507513-1703USA001850: US-009507513-1703USA008047: US-009507513-1703USA008049: US-009507513-1703USA008052:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of ZOSTAVAX which had Lot number  M019646 with expiry date on 18-JUL-2017 and lot # M038864 with expiry date on 12-DEC-2017 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of > -10 but <8 Centigrade range for a time frame of 1 hour and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. ; Sender's Comments: US-009507513-1703USA008046: US-009507513-1703USA008048: US-009507513-1703USA008049: US-009507513-1703USA008050: US-009507513-1703USA008051: US-009507513-1703USA008052: US-009507513-1703USA001827:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of PNEUMOVAX 23 which had Lot number M038359 with expiry date on 13-MAY-2018 and lot # M039060 with expiry date on 22-MAY-2018 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of > 8 but <25 Centigrade range for a time frame of 1 hour and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA008046: US-009507513-1703USA008047: US-009507513-1703USA008049: US-009507513-1703USA008050: US-009507513-1703USA008051: US-009507513-1703USA008052: US-009507513-1703USA001827.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of ROTATEQ which had Lot number  M007301 with expiry date on 19-NOV-2017 and lot # M034799 with expiry date on 01-FEB-2018 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of > 8 but <25 Centigrade range for a time frame of 1 hour and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. ; Sender's Comments: US-009507513-1703USA008046: US-009507513-1703USA008047: US-009507513-1703USA008048: US-009507513-1703USA001850: US-009507513-1703USA008051: US-009507513-1703USA008052: US-009507513-1703USA001827:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB which had Lot number M036153 with expiry date on 31-MAY-2018 and lot # M029233 with expiry date on 09-AUG-2018 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of > 8 but <25 Centigrade range for a time frame of 1 hour and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA008046: US-009507513-1703USA008047: US-009507513-1703USA008048: US-009507513-1703USA008049: US-009507513-1703USA008051: US-009507513-1703USA008052: US-009507513-1703USA001827.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of VAQTA which had Lot number  M040421 with expiry date on 26-MAY-2017 and lot # M036459 with expiry date on 18-JAN-2018 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of > 8 but <25 Centigrade range for a time frame of 1 hour and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA008046: US-009507513-1703USA008047: US-009507513-1703USA008048: US-009507513-1703USA008049: US-009507513-1703USA008050: US-009507513-1703USA008052: US-009507513-1703USA001827:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients. The patient's medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # M036057, expiration date 18-MAY-2019) via intramuscular injection for prophylaxis. No adverse effect was reported. No product quality complaint (PQC) was involved. The vaccine was stored in temperature between 46 degrees Fahrenheit and 77 degrees Fahrenheit for 5 hours and 50 minutes. "Data logger" was involved and there was no previous temperature excursion. This is one of several reports from the some source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA009130: US-009507513-1703USA001072:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients. The patient's medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M038209, expiration date 23-APR-2018) via oral route for prophylaxis. No adverse effect was reported. No product quality complaint (PQC) was involved. The vaccine was stored in temperature between 46 degrees Fahrenheit and 77 degrees Fahrenheit for 5 hours and 50 minutes. "Data logger" was involved and there was no previous temperature excursion. This is one of several reports from the some source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001072: US-009507513-1703USA009129:
Sex: F
Vaccine: FLUX
Symptoms: Intervertebral disc disorder, Osteoarthritis, Rheumatic disorder, Spinal operation
Clinical narrative: This spontaneous case, initially received on 09-Mar-2017, was reported by a health professional and concerns a female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN) for indication not reported. Dose regimen: Not reported, Route of administration: Not Reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date following vaccination, the patient experienced acute rheumatological events (medically significant, outcome: not reported), extensive cervical [reconstruction] (outcome: not reported), degenerative joint disease / osteoarthritis (outcome: not reported), [extensive cervical] reconstruction (medically significant, outcome: not reported). It is not known whether the patient's osteoarthritis, degenerative joint disease and extensive cervical reconstruction occurred before or after the patient received the flu vaccine. Sender's Comments: Listedness: Brand of Influenza vaccination not specified. Assessment according to CCSI for CSL's Inactivated Influenza Virus Vaccine, rheumatic disorder, spinal operation, osteoarthritis and intervertebral disc disorder are all unlisted. Causality: Unassessable. Time to event onset following vaccination, patient age, medical history, sequence of events and event description not provided. The events described are suggestive of as long standing degenerative disorder unrelated to vaccination. Overall there is insufficient information, hence causality is unassessable.
Sex: F
Vaccine: DTP
Symptoms: Abasia, Intellectual disability, Physical disability, Seizure, Speech disorder
Clinical narrative: Initial unsolicited report received from a consumer (Patient's sister) via other company, Pfizer (Reference number-2017074827) on 07-Mar-2017. This case involves a female patient (age was not reported) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (DTP) (lot number, expiration date, route of administration, site of administration, dose and dose in series were not reported) on an unknown day of 1983 (reported as six month dose). The medical history and concomitant medications were not reported. On an unknown day of 1983, three hours of following the vaccination, the patient developed seizure and it caused the patient to be mentally and physically handicapped, the patient never walked and talked. "The patient was like an one year old in the body of a 13 year old". The laboratory test and the corrective treatment were not reported. The outcome of the event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event seizure. List of the documents held by sender: none.; Sender's Comments: Patient received DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (Mfr Unk) following which patient had seizure within 3 hours, mentally and physically handicap and patient never walked and talked. Time to onset is compatible, but additional information regarding patient's medical history, concomitant medications and past vaccination and its tolerance are needed to further assess the role of vaccine. Based on available information the role of vaccine cannot be assessed.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Pain, Pruritus, Swelling
Clinical narrative: Swelling, redness, bruising, throbbing pain, itchiness.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Otitis media acute, Pyrexia, Rash generalised, Rhinitis
Clinical narrative: Fever immediately following vaccination as well as the following symptoms beginning 7/27/2014: Full body rash, fever, Otitis Media and onset of speech delay.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Speech disorder
Clinical narrative: Fever immediately following vaccination as well as the following symptoms beginning 7/27/2014: Full body rash, fever, Otitis Media and onset of speech delay.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin ulcer
Clinical narrative: Information has been received from a currently 63 year old female patient referring to herself. The patient had no concomitant medication, pertinent medical history or drug reactions/allergies. In 2012, the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, dose, lot# and expiration date were unknown)for prevention of shingles.    The patient stated since she had the ZOSTAVAX injection, she had experienced multiple episodes of unspecified rashes and itching, on her neck, arms, and thighs. The patient stated she also developed sores on her skin. The consumer stated that she was presently experiencing the same symptoms. The consumer stated she had various unspecified tests done to help determine the cause of her symptoms, but no positive determination had ever been made. No specific treatment was provided. There was no lab diagnostics studies performed or treatment given for the events. The patient sought medical attention by seeing physician. The consumer stated she had inquired as to whether her symptoms were a result of the ZOSTAVAX injection, but it was not determined. The outcome of the events was reported as not recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Ovarian failure
Clinical narrative: Information was received from a 29 year old non-pregnant female physician assistant via company representative, referring to herself. The patient's medical history and drug reactions/allergies were not provided. Concomitant therapy included MIRENA. Since an unspecified date in 2006 to an unspecified date in 2007, the patient was vaccinated with 3 dose series of GARDASIL (lot#, expiration date, dose and route were unknown) as routine vaccination. Subsequently on an unknown date (reported as "recently") after vaccination, the patient was diagnosed with ovarian insufficiency. The patient had seen an unspecified gynecologist for medical attention, and would be receiving an unspecified injectable medication for In-vitro Fertilization (IVF) treatment. The outcome of ovarian insufficiency was unknown. The causality between ovarian insufficiency and GARDASIL  was unknown. Product quality complaint was not involved in this event. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA012207.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Confusional state, Coordination abnormal, Fatigue, Pyrexia
Clinical narrative: This spontaneous report was received from a nurse referring to a 27 year old non-pregnant female patient with neither pertinent medical history nor drug reactions/allergies. The patient was not taking any concomitant medication. On 06-MAR-2017, the patient was vaccinated with GARDASIL 9 (lot # M037770, expiration date 01-JUN-2019) for prophylaxis (dose and route of administration were not reported). On the evening of 06-MAR-2017, the patient reported experiencing fever (100F taken orally) (pyrexia), confusion (confusional state), tiredness (fatigue) and bumping into things (coordination abnormal). No treatment was given for the adverse events and no laboratory diagnostic studies were performed. The outcome of the events was reported as not recovered. Causality relationship between the events and GARDASIL 9 was not reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, Drug dose omission, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a currently 29 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, reported as "right before age 26", the patient was vaccinated with her first dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not provided) for prophylaxis. The reporter noted that the patient was missing doses because she was 29 years of age at the time of reporting and would like to complete the 3 dose series. No adverse effects were reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPVX
Symptoms: Delivery, Exposure during pregnancy, Pregnancy test urine positive, Ultrasound antenatal screen
Clinical narrative: Information was received from a registered nurse concerning a 24 year old female who on 16-APR-2016, was vaccinated with either GARDASIL (HPV4) or GARDASIL 9 (lot number, expiration date, dosage and route of administration unknown) and became pregnant. There was no concomitant medication. Past medical history was unknown. Last menstrual period (LMP): 24-APR-2016. Estimated date of delivery (EDD): 29-JAN-2017. The patient's pregnancy was confirmed with a "urine test and ultrasound" on unspecified dates. The patient delivered a full-term infant at an unspecified facility and had a "normal delivery" (Apgar scores, gender, weight, length and head circumference not provided). The nurse reported the baby was in "normal health."  No further information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medication were not provided. On 20-MAR-2017, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 intramuscularly, once, lot # L035686, which expired on 16-FEB-2017. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Inflammation, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Initial unsolicited report received from consumer on 07 Mar 2017. This case involves a male patient (age not reported) who was vaccinated with first dose of FLUZONE ID (Batch number: UT5570BA, expiry date: 30 Jun 2017, dose, route of administration was not reported) via intradermal route in deltoid on 24 Oct 2016. The patient's medical history including illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown and concomitant medications were not reported. On 25 Oct 2016, one day following the vaccination, the patient experienced raised red hot area about the size of a small doughnut at the top of his deltoid with some pain at injection site. Reported that he went to his doctor to receive the Flu Vaccine and they have advised him they gave him Fluzone ID. It was reported that patient was worried that may be doctor gave him a different medicine or he received expired vaccine. On an unspecified date, post vaccination, the patient had numbness and tingling in his entire arm. It was reported that, patient plans to see his family doctor again on 21 Mar 2017 (patient hoped to get to the bottom of the issue). Patient required ER visit. Lab data was reported as none. Corrective treatment was not reported. On an unspecified date, the patient was recovered from the event inflammation localized and vaccination site reaction (reported as swelling and pain resolved). The patient was not recovered from the event numbness and tingling ("reported as still has it today"). List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Vaccination site swelling
Clinical narrative: Initial unsolicited report received from consumer on 07 Mar 2017. This case involves a male patient (age not reported) who was vaccinated with first dose of FLUZONE ID (Batch number: UT5570BA, expiry date: 30 Jun 2017, dose, route of administration was not reported) via intradermal route in deltoid on 24 Oct 2016. The patient's medical history including illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown and concomitant medications were not reported. On 25 Oct 2016, one day following the vaccination, the patient experienced raised red hot area about the size of a small doughnut at the top of his deltoid with some pain at injection site. Reported that he went to his doctor to receive the Flu Vaccine and they have advised him they gave him Fluzone ID. It was reported that patient was worried that may be doctor gave him a different medicine or he received expired vaccine. On an unspecified date, post vaccination, the patient had numbness and tingling in his entire arm. It was reported that, patient plans to see his family doctor again on 21 Mar 2017 (patient hoped to get to the bottom of the issue). Patient required ER visit. Lab data was reported as none. Corrective treatment was not reported. On an unspecified date, the patient was recovered from the event inflammation localized and vaccination site reaction (reported as swelling and pain resolved). The patient was not recovered from the event numbness and tingling ("reported as still has it today"). List of documents held by sender: none.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe pain at injection site.  Unable to lift arm.
Age: 0.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Urticaria
Clinical narrative: Hives across belly and some on the back, they lasted all day gave dose of benadryl with no improvement. Next day hives from previous day had gone down but new hives showed up upon waking.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Burning sensation, Cardiac monitoring normal, Decreased appetite, Dyspnoea
Clinical narrative: Pain in my arm (right side) has never stopped hurting every AM when I wake there is limited motion and stiffness, burning sensations in my arm, lack of energy to the point of weakness. I was sicker than heck all of Nov, Dec / body pain. I've had a MRI of my arm and I had to wear a heart monitor for 21 day to make sure it was just my heart acting up. On Sept 13, 2016, I received the FLUZONE vaccine. After a week or two I noticed that my right arm was still hurting at the injection site and that I had a knot or lump under the skin. I knew this wasn't normal because I had gotten a flu shot every year for over 12 years and never had any issues. I used a muscle pain cream on the area but that only gave me an hour or so of relief. I called my primary care and reported the issue. All of Nov and Dec 2016 I wasn't feeling well at all I dealt with very painful body aches, weakness, loss of appetite to present, lack of energy. On Jan 24, 2017, I had a routine visit with my Cardiologist I told him about the lack of energy, shortness of breath, he in turn ordered me to wear a heart monitor for 21 days because I'm Afib. The results came back showing my heart was not making me feel ill. On Jan 31, 2017, I went to a Infectious Disease Specialists and also that same day I had a MRI done on my arm. Every morning my right arm is very stiff and painful from my shoulder to elbow with limited range of motion.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site nodule, Injection site pain, Malaise, Musculoskeletal stiffness
Clinical narrative: Pain in my arm (right side) has never stopped hurting every AM when I wake there is limited motion and stiffness, burning sensations in my arm, lack of energy to the point of weakness. I was sicker than heck all of Nov, Dec / body pain. I've had a MRI of my arm and I had to wear a heart monitor for 21 day to make sure it was just my heart acting up. On Sept 13, 2016, I received the FLUZONE vaccine. After a week or two I noticed that my right arm was still hurting at the injection site and that I had a knot or lump under the skin. I knew this wasn't normal because I had gotten a flu shot every year for over 12 years and never had any issues. I used a muscle pain cream on the area but that only gave me an hour or so of relief. I called my primary care and reported the issue. All of Nov and Dec 2016 I wasn't feeling well at all I dealt with very painful body aches, weakness, loss of appetite to present, lack of energy. On Jan 24, 2017, I had a routine visit with my Cardiologist I told him about the lack of energy, shortness of breath, he in turn ordered me to wear a heart monitor for 21 days because I'm Afib. The results came back showing my heart was not making me feel ill. On Jan 31, 2017, I went to a Infectious Disease Specialists and also that same day I had a MRI done on my arm. Every morning my right arm is very stiff and painful from my shoulder to elbow with limited range of motion.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: Pain in my arm (right side) has never stopped hurting every AM when I wake there is limited motion and stiffness, burning sensations in my arm, lack of energy to the point of weakness. I was sicker than heck all of Nov, Dec / body pain. I've had a MRI of my arm and I had to wear a heart monitor for 21 day to make sure it was just my heart acting up. On Sept 13, 2016, I received the FLUZONE vaccine. After a week or two I noticed that my right arm was still hurting at the injection site and that I had a knot or lump under the skin. I knew this wasn't normal because I had gotten a flu shot every year for over 12 years and never had any issues. I used a muscle pain cream on the area but that only gave me an hour or so of relief. I called my primary care and reported the issue. All of Nov and Dec 2016 I wasn't feeling well at all I dealt with very painful body aches, weakness, loss of appetite to present, lack of energy. On Jan 24, 2017, I had a routine visit with my Cardiologist I told him about the lack of energy, shortness of breath, he in turn ordered me to wear a heart monitor for 21 days because I'm Afib. The results came back showing my heart was not making me feel ill. On Jan 31, 2017, I went to a Infectious Disease Specialists and also that same day I had a MRI done on my arm. Every morning my right arm is very stiff and painful from my shoulder to elbow with limited range of motion.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Body temperature increased, Decreased appetite, Irritability
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 2 month old female patient. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 24-FEB-2017, the patient was vaccinated with one dose of LIQUID PEDVAXHIB injection (exact dose, route of administration, anatomical location, lot # and expiry date were not reported) and one dose of PENTACEL (formulation, exact dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis. On 24-FEB-2017, unspecified time after receiving the two vaccinations, the patient was irritable, had decreased appetite and had a temperature of 99 Fahrenheit degrees. The patient received acetaminophen (TYLENOL) on an unspecified date in 2017, after the vaccination. The outcome of the events was reported was reported as recovering. The reporter did not provide the causality assessment between the events and LIQUID PEDVAXHIB. Additional information is not expected as there was no consent for further contact.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Condition aggravated, Swelling face, Urticaria
Clinical narrative: This spontaneous report was received from a physician and a medical assistant, referring to a 50 year old male patient with tick-borne meat allergy and no drug reactions/allergies. The patient's medical history and concomitant medications were not reported. It was informed that the patient had facial swelling and hives at the time of vaccination. On 03-MAR-2017, the patient was vaccinated with PNEUMOVAX 23 (lot # M043987, expiration date 30-JUN-2018) as a routine vaccine (dose and route of administration were not reported). On 03-MAR-2017 as well, 6 hrs after the vaccination, the patient's facial swelling and hives worsened. Medical assistant reported that the patient self treated with unspecified antihistamines and that, as of the evening of 05-MAR-2017, her symptoms began to subside. The patient was fully recovered as of the morning of 06-MAR-2017. No laboratory diagnostic studies were performed. Causality relationship between the events and PNEUMOVAX 23 was not reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot # reported as M038856, expiration date 14-SEP-2018, subcutaneously; site and dose were not provided), reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # and expiration date were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of 6 to 14 Fahrenheit degrees (-14 to -10 Celsius degrees) for 14 days before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA009367.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies, drug reactions, allergies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # M007279 with expiration date on 09-FEB-2019 and M011667 with expiration date on 08-MAR-2018 (dose and route of administration were not reported), reconstituted with properly stored sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 9 degrees Celsius and 25 degrees Celsius for 19 minutes. A digital data logger was involved. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA009357.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies, drug reactions, allergies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M031807 with expiration date on 02-APR-2018 and lot# reported as M038724 with expiration date on 24-APR-2018 (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 9 degrees Celsius and 25 degrees Celsius for 19 minutes. A digital data logger was involved. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA009262:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to 5 unspecified patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot # M024702, expiration date 18-MAY-2018, subcutaneously; site and doses were not provided), reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # and expiration date were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 6 to 14 Fahrenheit degrees (-14 to -10 Celsius degrees) for 14 days before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007889:
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2017076814) on 07-Mar-2017. This case involves a female patient (onset age not reported) who was vaccinated with a dose of TETANUS VACCINE AND TOXOID (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date following vaccination (Latency unknown), the patient experienced allergy to tetanus vaccines and toxoid. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Headache, Neck pain
Clinical narrative: Headache at night, followed by worsening headache in AM along with neck pain.  Mother will phone with any change in symptoms.
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Discomfort, Headache, Insomnia, Nausea, Pain
Clinical narrative: Severe headache, nausea-vomit, restless-can't sleep, body aches, heavy feeling.
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Restlessness, Vomiting
Clinical narrative: Severe headache, nausea-vomit, restless-can't sleep, body aches, heavy feeling.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Upper arm was pink from injection site down to elbow.  Patient stated it was sore and warm to the touch.  Advised patient to take benadryl and APAP, and to use cool compresses.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-MAR-2017, the patient was vaccinated with an expired dose of ZOSTAVAX subcutaneously (lot # L046293, expiration date: 17-FEB-2017; dose was not provided). No adverse effects were reported. 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 medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported. On an 06-MAR-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M034894 with expiration date 11-NOV-2018 or M037771 with expiration date 21-FEB-2019 (not specified by the reported) for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 0 to 2 degrees of Celsius for 2 hours 32 minutes. Previous temperature excursion was between 0 to 2 degrees of Celsius for 8 hours 59 minutes. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA009362:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9 (lot # M036059, expiration date 03-JUN-2019) for prophylaxis (dose and route of administration were not reported). Storage temperature was reported as >46°F but <77°F, for a period of 35 minutes. There were no previous temperature excursion and the information was not obtained from a data logger. No adverse symptoms were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA009375:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 17 years-old patient of an unknown gender. The patient's history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 20-SEP-2016, the patient was vaccinated intramuscularly with GARDASIL 9 first dose and another dose of it was administered later on 26-OCT-2016 (lot #, expiration date, strength and dose were not reported). It was reported that the patient received the third intramuscular dose of GARDASIL 9 with lot # M016193 and expiration date of 24-APR-2018 (strength and dose were not reported) on "either 22-NOV-2016 or 23-NOV-2016". No side effects were reported. No further information was available. No product quality complain (PQC) was involved. 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 Medical assistant referring to unspecified patients of unknown genders. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL 9 which had a lot number M037770 with expiration date on 01-JUN-2019 (strength and route of administration were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 52 grades F (Fahrenheit) for a time frame of 12 hours. There were no previous temperature excursions for vaccines.  The temperature excursion was recorded by a data logger. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA009885: US-009507513-1703USA006986: US-009507513-1703USA006984: US-009507513-1702USA009836:
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Immunisation
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies, and concomitant therapies were unknown by the reporter. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB injection 10/1 microgram/ml (dose, route, lot number and expiration date were not reported) for prophylaxis. On an unspecified date, the patient needed a booster of RECOMBIVAX HB due to low titers (Hepatitis B surface antibody negative) or exposure. It was unknown if the patient sought medical attention, treatment was given or laboratories were performed for the event. The outcome of the event was unknown at the time of reporting. The patient had not received the booster of RECOMBIVAX HB at the reporting time. The reporter did not provide a causality assessment between the event and the suspect vaccine. 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 medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported. On an 06-MAR-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M034894 with expiration date 11-NOV-2018 or M037771 with expiration date 21-FEB-2019 (not specified by the reported) for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 0 to 2 degrees of Celsius for 2 hours 32 minutes. Previous temperature excursion was between 0 to 2 degrees of Celsius for 8 hours 59 minutes. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA002800:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). Storage temperature was reported as >46°F but <77°F, for a period of 35 minutes. There were no previous temperature excursion and the information was not obtained from a data logger. No adverse symptoms were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA003694:
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Dysphagia, Dyspnoea, Feeling hot, Peripheral swelling, Swelling
Clinical narrative: Patient had severe swelling of the left arm, trunk, left breast, and it radiated out to her back. She reported difficulty breathing, difficulty swallowing and felt hot. She took benadryl and it got a little better so she did not go to ER.