chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Itchy, red, swollen rash covering most of inside upper arm between shoulder and elbow. Hot to the touch. Only small tender bump at injection site - Dr gave BENADRYL and MEDROL dosepak, expected full recovery.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Itchy, red, swollen rash covering most of inside upper arm between shoulder and elbow. Hot to the touch. Only small tender bump at injection site - Dr gave BENADRYL and MEDROL dosepak, expected full recovery.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via company representative regarding a female patient of unknown age. Information on concurrent conditions, medical history and drug allergies of the patient were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot, expiry date, route, anatomical location, dose#, dose units were not specified). Concomitant therapies included prednisone (manufacturer unknown). On an unknown date, it was reported that the patient developed shingles after receiving ZOSTAVAX (drug ineffective). The patient had sought medical attention for the adverse events. The outcome of herpes zoster and drug ineffective was unknown at the time of reporting. There was no Product Quality Concerns (PQC) involved. Reporting physician did not provide the causal relationship of the events with ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician via company representative refers to a female patient of unknown age. The patient's pertinent medical history and drug allergies were unspecified. On an unknown date, the patient was vaccinated with GARDASIL (one dose of three doses) intramuscularly, when she was 3-4 weeks pregnant. The patient was not showing signs of pregnancy when she was vaccinated. It was not specified which dose in the series the patient had received. The patient was not experiencing any untoward effects. The patient did not sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practitioner nurse referring to a female patient of unknown age. On 20-JUL-2015, the patient was vaccinated with first dose of GARDASIL (0.5 ml, once, lot #: K008931, expiry: 04-MAR-2017). On 25-DEC-2015 the patient was vaccinated with second dose of GARDASIL (0.5 ml, once, lot #: L018286, expiry date: in April 2017) (extra dose administered). On 29-JAN-2016 (reported as "today"), the patient was in the office to receive the third dose of GARDASIL but the nurse did not give her the third dose yet. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to 7 unspecified patients of unknown age and gender. On unknown dates the patients each was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # K009892, expiry date: 11-JAN-2016, exposure on 10 F for 28.86 hours). The nurse confirmed that all doses of PROQUAD (Merck) were administered prior to its labeled expiration date and all vaccines had not been temperature excursion previously. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella virus test negative
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (Merck) (route, lot number and expiration date were not provided). Then on an unknown date, the patient was vaccinated with the second dose of VARIVAX (Merck) (route, lot number and expiration date were not provided). Concomitant therapy information was not provided. On an unknown date, the patient got an antibody test negative as the patient had an unspecified blood test for varicella antibody titers and tested seronegative for varicella immunity. It was unknown if the patient sought medical attention. The outcome of antibody test negative was unknown. The pharmacist did not rate the relationship of the event to VARIVAX (Merck). 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 pharmacist concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 11-FEB-2016, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (dose, frequency, anatomical location or route were not specified) lot # K009107, expiration date; 21-JAN-2016. Concomitant medications were not provided. No adverse event was informed. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 14 year old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with the first dose of RECOMBIVAX HB 10mcg/ml, 1 ml (route, lot number and expiration date were not provided). On an unknown date, reported as separated by three months from the first dose, the patient was vaccinated with the second dose of RECOMBIVAX HB 10 mcg/ml, 1 ml (route, lot number and expiration date were not provided). Concomitant therapy information was not provided. On an unknown date, there was an inappropriate schedule of drug administration as the patient received a RECOMBIVAX HB series of 2 doses separated by 3 months. No adverse event was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12 year old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown dates, the patient was vaccinated with the first dose of RECOMBIVAX HB 10mcg/ml, 1 ml (route, lot number and expiration date were not provided). On an unknown date, reported as separated by three months from the first dose, the patient was vaccinated with the second dose of RECOMBIVAX HB 10mcg/ml, 1 ml (route, lot number and expiration date were not provided). Concomitant therapy information was not provided. On an unknown date, there was an inappropriate schedule of drug administration as the patient received a RECOMBIVAX HB series of 2 doses separated by 3 months. No adverse event was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On an unknown date the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot # L034724, expiry date 09-DEC-2016) (dose and route unspecified), which was improperly stored under 8 degree Centigrade for 4 weeks. Other suspect and concomitant therapies were not reported. No adverse effects 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 medical assistant and refers to multiple unspecified patients of unknown age and gender. Patients concurrent conditions, medical history and concomitant medications were unknown. It was reported that doses of ROTATEQ Lot # L013203, expiry date 28-JAN-2017, oral route (dose was not reported) that had been exposed a 34 degrees F for less than 30 minutes, were given to unspecified patients on unspecified dates. It was also confirmed that the vaccine had no previous excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. 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 medical assistant and refers to multiple unspecified patients of unknown age and gender. Patients concurrent conditions, medical history and concomitant medications were unknown. It was reported that doses of GARDASIL 9 Lot # L020015, expiry date 16-AUG-2017 (dose and administration route were not reported) that had been exposed a 34 degree F for less than 30 minutes, were given to unspecified patients on unspecified dates. It was also confirmed that the vaccine had no previous excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. 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 medical assistant and refers to multiple unspecified patients of unknown age and gender. Patients concurrent conditions, medical history and concomitant medications were unknown. It was reported that doses of GARDASIL Lot # K011562, expiry date 08-APR-2017 (dose and administration route were not reported) that had been exposed a 34 degrees F for less than 30 minutes, were given to unspecified patients on unspecified dates. It was also confirmed that the vaccine had no previous excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. 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 referring to unspecified patients. Patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA lot # L023232 and expiry date 25-FEB-2017 (strength, dose, frequency and route were not reported). Concomitant medications were not provided. No adverse effects were reported and no product quality complaint was involved. 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 referring to unspecified number of unspecified patients. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 lot # L016429 and expiry date 09-AUG-2-17 (strength, dose, frequency and route were not reported). Concomitant medications were not provided. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, lot # and route were unknown). On an unknown date, following administration of ZOSTAVAX, the patient sought medical attention at an unspecified emergency department where it was confirmed that the patient had developed shingles. The outcome of the event was unknown. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Diarrhoea, Ear infection, Rhinorrhoea, Vomiting
Clinical narrative: Information has been received from a female consumer concerning her daughter, a 2 year old female patient. The patient had nervous twitch 3 or 4 weeks. A physician advised for the patient to get vaccine, so on 08-JAN-2016 (also reported as 28-JAN-201), the patient was vaccinated with a dose of M-M-R II, lot # K007108 (expiration date and route unspecified), 1 shot, by the physician. Concomitant therapies included ethinyl estradiol, levonorgestrel (daily) and vitamins (unspecified). On 13-JAN-2016, the patient experienced vomiting for 10 days following the vaccination. In addition on the same day, the patient also experienced an ear infection, runny nose, cough and diarrhea. The patient sought medical attention by office visiting on an unknown date in January 2016. Treatment was given for the events, and the physician prescribed an unspecified antibiotic for the vomiting and diarrhea. M-M-R II was not reintroduced. The outcome of the events was reported as not resolved. The relatedness of the events and M-M-R II was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 11-FEB-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB, lot number K008988, expiration date 04-FEB-2016 (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot #: L035878, expiration date on 11-AUG-2018 (route, dose and anatomical location were not reported). Concomitant therapies were not provided. It was noted that the PEDVAXHIB was expose 256 hours to "anything" below 36F temperature and 10.5 hours to a temperature of 30.2F. No adverse events were reported. No product quality issue was involved. Additional information has been requested.
Age: 1.8
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a 20 month old patient of unknown gender. No concurrent or historical conditions were reported. On 14-DEC-2016 and again on 08-FEB-2016 the patient was vaccinated with VAQTA (Lot numbers and expiration dates were unspecified), dose, route and frequency were unknown. No concomitant mediations were reported. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site induration
Clinical narrative: Information has been received from a pharmacist referring to a 48 year old female patient who was some type of healthcare provider. The patient had no drug reactions or allergies. The patient told that on 28-JAN-2016, she might have been vaccinated with a dose of ZOSTAVAX (dose unknown, lot # reported as L027321, expiry date: 21-OCT-2016) via intradermal route instead of subcutaneous route. On an unknown date, the patient experienced induration around injection site which was a common reaction for intradermal injection (according to the patient). The other pharmacist who actually administered ZOSTAVAX to the patient stated that she was certain that she administered ZOSTAVAX via subcutaneous route. The outcome of induration around injection site and causality between induration around injection site and ZOSTAVAX were not reported. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abscess, Cellulitis, Erythema, Induration, Urticaria
Clinical narrative: Information has been received from a pharmacist referring to a 48 year old female patient who was some type of healthcare provider. The patient had no drug reactions or allergies. The patient told that on 28-JAN-2016, she might have been vaccinated with a dose of ZOSTAVAX (dose unknown, lot # reported as L027321, expiry date: 21-OCT-2016) via intradermal route instead of subcutaneous route. On an unknown date, the patient experienced induration around injection site which was a common reaction for intradermal injection (according to the patient). The other pharmacist who actually administered ZOSTAVAX to the patient stated that she was certain that she administered ZOSTAVAX via subcutaneous route. The outcome of induration around injection site and causality between induration around injection site and ZOSTAVAX were not 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 Certified Medical Assistant referring to unspecified number of unspecified patients. Patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # L019298 and expiry date 22-JUN-2017 (strength, dose, frequency and route were not reported). Concomitant medications were not provided. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Hypoaesthesia, Muscular weakness, Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: VERY SORE LEFT ARM, lasted a few days and went away.  Started again in beginning of November with severe pain when sleeping on shoulder and certain movements.  Now it hurts mostly with certain movements only.  Also have numbness, weakness in both hands when sleeping and during the day.  Hands are numb during night regardless of which side I sleep on.  Not sure if more neuropathy or from the flu shot.  Had MRI of neck 2 weeks ago.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity, Sleep disorder
Clinical narrative: VERY SORE LEFT ARM, lasted a few days and went away.  Started again in beginning of November with severe pain when sleeping on shoulder and certain movements.  Now it hurts mostly with certain movements only.  Also have numbness, weakness in both hands when sleeping and during the day.  Hands are numb during night regardless of which side I sleep on.  Not sure if more neuropathy or from the flu shot.  Had MRI of neck 2 weeks ago.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Inflammation, Injection site reaction, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: Left shoulder impingement and recommended physical therapy.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: 101.3 fever, body chills, aches.
Age: 77.0
Sex: F
Vaccine: FLUX, UNK, FLUX
Symptoms: Injection site pain, Mobility decreased, Muscular weakness, Myalgia, Sleep disorder
Clinical narrative: Periodic but persistent severe arm pain in left arm in area of flu shot.  Periodic muscle aching, moderate weakness and reduced range of motion in my upper arm - often the pain will wake me from sleep if I'm resting on my left arm.  I wait for it to subside, and it does.  Because I have had this problem when receiving the flu shot for the past three or four years I have requested the shot be given in my hip but was told that location is not available to me - only the arm.
Age: 77.0
Sex: F
Vaccine: FLUX, UNK, FLUX
Symptoms: Asthenia, Injection site pain, Joint range of motion decreased, Myalgia, Sleep disorder
Clinical narrative: Periodic but persistent severe arm pain in left arm in area of flu shot.  Periodic muscle aching, moderate weakness and reduced range of motion in my upper arm - often the pain will wake me from sleep if I'm resting on my left arm.  I wait for it to subside, and it does.  Because I have had this problem when receiving the flu shot for the past three or four years I have requested the shot be given in my hip but was told that location is not available to me - only the arm.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Aching upper arm. Restricted motion.  Continues to this day.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Headache, Nausea, Somnolence
Clinical narrative: Very sleepy with joint pain.  Still have headache and joint pain, somewhat sleepy and mild nausea as 02/14/2016.
Age: 0.23
Sex: M
Vaccine: PNC13
Symptoms: Hyperacusis, Screaming
Clinical narrative: He was very sensitive to any sudden or loud noise for about two weeks and still is to some extent. Let out loud terrified scream at any sudden or loud noise.
Age: 77.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Bursitis, Needle issue, Pain in extremity, Sleep disorder
Clinical narrative: Extreme pain in vaccinated arm. Worse at night. Could not sleep.
Age: 44.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: STRONG ARM AND SHOULDER PAIN.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: PATIENT SAID AREA STARTED ITCHING. SHE BOUGHT BENADRYL AND TOOK. DAYS LATER ARM BEGAN TO FEEL HOT, GOT RED AND SWOLLEN. PATIENT REPORTED TO ME ON MONDAY 02/08/2016. I OFFERED TO CALL AND MAKE DOCTOR'S APPOINTMENT, PATIENT DECLINED, SAID SHE WOULD CHECK WITH DOCTOR HERSELF. WAITED TO SEE HOW PATIENT DOING. CHECKED WITH PATIENT ON 02/13/2016, SAID ARM IS STILL A LITTLE SWOLLEN BUT REDNESS AND HEAT HAVE DISAPPEARED.
Age: 61.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Pain, Tenderness
Clinical narrative: Patient said her arm was sore at sight of injection and it hurt to move it. It got better each day, and is no longer difficult to move but sore to touch.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Abdominal pain upper, Blood glucose increased, Feeding disorder, Headache, Nausea
Clinical narrative: Headache, fever, blood sugar elevated and stomach ache.  Couldn't eat for 30 days so lost 20 pounds so went to emergency room.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Weight decreased
Clinical narrative: Headache, fever, blood sugar elevated and stomach ache.  Couldn't eat for 30 days so lost 20 pounds so went to emergency room.
Age: 1.23
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Asterixis, Feeling abnormal, Gastrointestinal disorder, Speech disorder
Clinical narrative: Excessive biting, hand flapping, running in circles, talking gibberish, brain fog...
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site bruising
Clinical narrative: BRUISING AT AND AROUND THE AREA OF INJECTION, BRUISING IS EVIDENT TODAY (2/14/16) IN AN AREA OF 4 INCH DIAMETER.  NO SWELLING OR HARDNESS OBSERVED.
Age: 51.0
Sex: F
Vaccine: FLUC3, TDAP, FLUC3, TDAP
Symptoms: Dizziness, Injected limb mobility decreased, Injection site pain, Neck pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Sore upper right arm, more than previous shot, and sore right shoulder, progressively got worse with range of motion limited, painful to move arm at different angles and especially upwards and lifting things that are not very heavy at different angles. At night my arm throbs and now the shoulder pain is felt on the right side of my neck. Also, right before leaving store, I got very faint and light headed
Age: 51.0
Sex: F
Vaccine: FLUC3, TDAP, FLUC3, TDAP
Symptoms: Pain, Tendon disorder
Clinical narrative: Sore upper right arm, more than previous shot, and sore right shoulder, progressively got worse with range of motion limited, painful to move arm at different angles and especially upwards and lifting things that are not very heavy at different angles. At night my arm throbs and now the shoulder pain is felt on the right side of my neck. Also, right before leaving store, I got very faint and light headed
Age: 51.0
Sex: F
Vaccine: FLUC3, TDAP, FLUC3, TDAP
Symptoms: Dizziness, Injection site movement impairment, Injection site pain, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Sore upper right arm, more than previous shot, and sore right shoulder, progressively got worse with range of motion limited, painful to move arm at different angles and especially upwards and lifting things that are not very heavy at different angles. At night my arm throbs and now the shoulder pain is felt on the right side of my neck. Also, right before leaving store, I got very faint and light headed
Age: 51.0
Sex: F
Vaccine: FLUC3, TDAP, FLUC3, TDAP
Symptoms: Neck pain, Nuclear magnetic resonance imaging abnormal, Pain, Tendon disorder
Clinical narrative: Sore upper right arm, more than previous shot, and sore right shoulder, progressively got worse with range of motion limited, painful to move arm at different angles and especially upwards and lifting things that are not very heavy at different angles. At night my arm throbs and now the shoulder pain is felt on the right side of my neck. Also, right before leaving store, I got very faint and light headed
Age: 19.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, redness and swelling at the site of injection (upper posterior left arm) progressed to a larger area with more pain and warmth over the two days following the injection. central area (2x3cm of induration with spreading redness about 6x10cm).  Warmth at site and pain.  Treated for possible cellulitis with clindamycin for 7 days.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Hypersensitivity
Clinical narrative: In the left arm start a allergic reaction that progress to a cellulitis. Treatment, prednisone 10mg BENADRYL 25mg and AUGMENTIN 875mg.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L013206, expiration date 29-JAN-2017, dose and route were unknown). The vaccines were stored under 34.5 F (Min) and 37.9 F (Max) for 24 hours. There was no previous temperature excursions. It was called because of a "data logger". No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The physician reported that the patient "years ago" had a titer drawn an unspecified time after receiving VARIVAX (lot #, dose, frequency and administration route unspecified) which resulted negative. Action taken with VARIVAX was not applicable. The outcome of the event was not reported. The reporter did not provide the causal relatiobnship of the event and VARIVAX. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia, Limb discomfort, Paraesthesia
Clinical narrative: Case number PHHY2014US171468, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 545442) website on 29 Dec 2014. This report refers to a 19-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly into the left arm on 26 Sep 2014. On the same day after the vaccination, the patient started to experience numbness and tingling around the injected area. Later the tingling had spread down the arm over the night and the limb was feeling heavy. The final outcome of the events was unknown. The events were reported as non-serious. Causality was not reported.
Age: 40.0
Sex: M
Vaccine: ANTH, JEV1, SMALL
Symptoms: Eye pain, Headache, Migraine
Clinical narrative: This unsolicited case was received on 04-Jan-2016 via a third party query tool search on the VAERS database, under reference number 595968. This case involves a 40-years old male patient who received the following vaccinations on 13-Jul-2015: A dose of ACAM2000, lot number-VV04003A, manufacturer: Sanofi Pasteur Biologics Co in the left arm via an "Intradermal", an first dose of Biothrax, lot number- FAV410A, manufacturer: Emergent) in right arm via intramuscular route and a dose of Ixiaro, lot number- JEV13M54E, manufacturer: Intercell in right arm via intramuscular route. The patient had taken OTC (over the counter) medications as concomitant medications. Patient's medical history and current illnesses was reported as none. Prior vaccination details were not provided. On 15-Jul-2015, 2 days post vaccination; patient experienced constant migraines 2-3 days after receiving his first dose of Anthrax. Pain is dull across the eyes and temples or top of scalp with daily occurrence. No laboratory investigations were performed and corrective treatments were not reported. The outcome of the events was reported as unknown. List of documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Blood test, Electromyogram, Muscle electrostimulation therapy, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report was received from a 58 years old female consumer regarding herself. No historical or concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot# unspecified) vial. Concomitant therapy included PRILOSEC. Later, on an unknown date, the patient developed shingles on her face. On 11-NOV-2015, the patient was vaccinated with the second dose of ZOSTAVAX (lot# unspecified) vial, (extra dose administered). On 12-NOV-2015, the patient began to experience pain in the hip and severe pain in her foot. The patient sought medical attention. The physician gave her a few unspecified shots for pain. The patient stayed in bed for a few days with ice packs. On an unspecified date, the patient underwent magnetic resonance imaging (MRI) and the results indicated a bulging disk in her back. On an unknown date, the patient was diagnosed with foot drop for which she was given a steroid injection. On an unknown date, the patient underwent physical therapy and an electromyography (EMG) test for one leg. On an unknown date, the patient underwent x-ray. No Product Quality Complaint (PQC) was reported. The outcome of shingles on face, pain in the hip, severe pain in foot and foot drop were not reported. Causality assessment was not provided. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Orthosis user, Pain in extremity, Peroneal nerve palsy, Sciatica, X-ray
Clinical narrative: This spontaneous report was received from a 58 years old female consumer regarding herself. No historical or concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot# unspecified) vial. Concomitant therapy included PRILOSEC. Later, on an unknown date, the patient developed shingles on her face. On 11-NOV-2015, the patient was vaccinated with the second dose of ZOSTAVAX (lot# unspecified) vial, (extra dose administered). On 12-NOV-2015, the patient began to experience pain in the hip and severe pain in her foot. The patient sought medical attention. The physician gave her a few unspecified shots for pain. The patient stayed in bed for a few days with ice packs. On an unspecified date, the patient underwent magnetic resonance imaging (MRI) and the results indicated a bulging disk in her back. On an unknown date, the patient was diagnosed with foot drop for which she was given a steroid injection. On an unknown date, the patient underwent physical therapy and an electromyography (EMG) test for one leg. On an unknown date, the patient underwent x-ray. No Product Quality Complaint (PQC) was reported. The outcome of shingles on face, pain in the hip, severe pain in foot and foot drop were not reported. Causality assessment was not provided. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Electromyogram, Extra dose administered, Herpes zoster, Intervertebral disc protrusion
Clinical narrative: This spontaneous report was received from a 58 years old female consumer regarding herself. No historical or concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot# unspecified) vial. Concomitant therapy included PRILOSEC. Later, on an unknown date, the patient developed shingles on her face. On 11-NOV-2015, the patient was vaccinated with the second dose of ZOSTAVAX (lot# unspecified) vial, (extra dose administered). On 12-NOV-2015, the patient began to experience pain in the hip and severe pain in her foot. The patient sought medical attention. The physician gave her a few unspecified shots for pain. The patient stayed in bed for a few days with ice packs. On an unspecified date, the patient underwent magnetic resonance imaging (MRI) and the results indicated a bulging disk in her back. On an unknown date, the patient was diagnosed with foot drop for which she was given a steroid injection. On an unknown date, the patient underwent physical therapy and an electromyography (EMG) test for one leg. On an unknown date, the patient underwent x-ray. No Product Quality Complaint (PQC) was reported. The outcome of shingles on face, pain in the hip, severe pain in foot and foot drop were not reported. Causality assessment was not provided. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity, Peroneal nerve palsy, X-ray
Clinical narrative: This spontaneous report was received from a 58 years old female consumer regarding herself. No historical or concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot# unspecified) vial. Concomitant therapy included PRILOSEC. Later, on an unknown date, the patient developed shingles on her face. On 11-NOV-2015, the patient was vaccinated with the second dose of ZOSTAVAX (lot# unspecified) vial, (extra dose administered). On 12-NOV-2015, the patient began to experience pain in the hip and severe pain in her foot. The patient sought medical attention. The physician gave her a few unspecified shots for pain. The patient stayed in bed for a few days with ice packs. On an unspecified date, the patient underwent magnetic resonance imaging (MRI) and the results indicated a bulging disk in her back. On an unknown date, the patient was diagnosed with foot drop for which she was given a steroid injection. On an unknown date, the patient underwent physical therapy and an electromyography (EMG) test for one leg. On an unknown date, the patient underwent x-ray. No Product Quality Complaint (PQC) was reported. The outcome of shingles on face, pain in the hip, severe pain in foot and foot drop were not reported. Causality assessment was not provided. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Localized Swelling, redness, heat, and mass at the site.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, heat, and raised bump at site.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain
Clinical narrative: Aching muscle in use of upper arm. This still persists after 5 months especially when raising my arm.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Hyperhidrosis, Malaise, Nausea
Clinical narrative: Based on additional information received on 01-FEB-2016, this case became medically confirmed. Initial unsolicited report received from a consumer on 19-Oct-2015. This case involves a 38-year-old female patient who was vaccinated with a dose of Adacel (batch number and route of administration was not reported) in left deltoid on 13-Oct-2015. Illness at time of vaccination was reported as allergies (unspecified) and pre-existing physician diagnosed allergies was reported as erythromycin allergy. other medical history and concomitant medications were not reported. On 16-Oct-2015, three days after vaccination, the patient experienced malaise, body ache, fever to 101.7 degree Farenheit, chills, Headache, sweating and nausea. The symptoms persisted and the patient had called a healthcare professional Other Laboratory investigations were not reported. Corrective treatments were not reported. The outcome of all the events was reported as not recovered. Documents held by sender: none. Follow up information received from a pharmacist on 01-Feb-2016. Patient received Adacel (batch number: X4J7D) at 13 October 2015 at approx at 7:30 Am. Patient had no other vaccination within 4 weeks prior. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as azithromycin allergy (initially it was reported as erythromycin allergy). On 14 October 2015, one day following the vaccination patient experienced the events. On an unspecified date, patient had recovered.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Based on additional information received on 01-FEB-2016, this case became medically confirmed. Initial unsolicited report received from a consumer on 19-Oct-2015. This case involves a 38-year-old female patient who was vaccinated with a dose of Adacel (batch number and route of administration was not reported) in left deltoid on 13-Oct-2015. Illness at time of vaccination was reported as allergies (unspecified) and pre-existing physician diagnosed allergies was reported as erythromycin allergy. other medical history and concomitant medications were not reported. On 16-Oct-2015, three days after vaccination, the patient experienced malaise, body ache, fever to 101.7 degree Farenheit, chills, Headache, sweating and nausea. The symptoms persisted and the patient had called a healthcare professional Other Laboratory investigations were not reported. Corrective treatments were not reported. The outcome of all the events was reported as not recovered. Documents held by sender: none. Follow up information received from a pharmacist on 01-Feb-2016. Patient received Adacel (batch number: X4J7D) at 13 October 2015 at approx at 7:30 Am. Patient had no other vaccination within 4 weeks prior. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as azithromycin allergy (initially it was reported as erythromycin allergy). On 14 October 2015, one day following the vaccination patient experienced the events. On an unspecified date, patient had recovered.
Age: 50.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth, Pain in extremity
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 3 November 2015. The case involves a 60-year-old female patient who was vaccinated with a dose of Adacel (batch number, expiration date, dose, dose number, route and site of administration were not reported) and a dose of Pneumovax (batch number, expiration date, dose, dose number, route and site of administration were not reported) both intramuscularly on 22 October 2015. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. Illness at time of vaccination was unknown. Concomitant medical was not reported. On 22 October 2015, three day following the vaccination, the patient experienced cellulitis at the injection site, a red area around the injection site about 12cm in size, hot to touch, central induration size of half a ping pong ball. The patient required ER or doctor visit. Laboratory investigation was not reported. The patient received Keflex as corrective treatment. The patient was on day 10 of Keflex. The outcome of the event was unknown. Follow-up information received from a non-healthcare professional on 28 December 2015. This case involves a 50 years old patient who was vaccinated at private doctor's hospital. On an unknown date, the patient was recovered from all the events. Documents held by sender: none. Follow-up information received from a non-healthcare professional in the United States on 13 January 2016. Batch number and expiry date of Adacel was reported as U5235AA and 08-Jan-2018. Patient received Adacel in upper left arm and pneumonia shot in right upper arm. It was reported that four days prior to vaccination patient was on four day course of prednisone to treat asthma flare up. On 25 October 2015, patient arm was sore and nurse stated that it looked like cellulitis and was diagnosed. Patient was prescribed antibiotic for 10 days. The patient did not require any ER visit. On 26 October 2015, patient went to saw primary care person who had confirmed cellulitis. It was reported that redness subsided within 10 days and induration took nearly a month to go away. Addendum: upon internal review on 2 February 2016 significant correction was performed, to change sequencing of reporter.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site joint pain, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: Initial unsolicited report received from a Nurse on 01 February 2016. This case involves 56-year-old female patient who was vaccinated with first dose of Adacel (batch number not reported) intramuscularly on left deltoid on 11 January 2016. The patient has also received a dose of Tenivac (batch number not reported) intramuscularly on left deltoid on 17 December 2015. The patient's medical history includes vaccination with many doses of Tenivac vaccine and had sulfa allergy. The patient's illness at time of vaccination was reported as none and concomitant medications were not reported. On 12 January 2016, 1 day following the vaccination with Adacel vaccine and 26 days following the vaccination with Tenivac vaccine, the patient's left arm was sore, unable to lift left arm and it hurts to move the arm. The arm was stiff up to the neck and shoulder joint hurts. The arm hurts down to the elbow. The patient required ER/doctor visit. Laboratory data was not reported. The patient's corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender: none/yes.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Initial unsolicited report received from a Nurse on 01 February 2016. This case involves 56-year-old female patient who was vaccinated with first dose of Adacel (batch number not reported) intramuscularly on left deltoid on 11 January 2016. The patient has also received a dose of Tenivac (batch number not reported) intramuscularly on left deltoid on 17 December 2015. The patient's medical history includes vaccination with many doses of Tenivac vaccine and had sulfa allergy. The patient's illness at time of vaccination was reported as none and concomitant medications were not reported. On 12 January 2016, 1 day following the vaccination with Adacel vaccine and 26 days following the vaccination with Tenivac vaccine, the patient's left arm was sore, unable to lift left arm and it hurts to move the arm. The arm was stiff up to the neck and shoulder joint hurts. The arm hurts down to the elbow. The patient required ER/doctor visit. Laboratory data was not reported. The patient's corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender: none/yes.
Age: 1.33
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Swelling face, Urticaria
Clinical narrative: Initial unsolicited report received from a nurse on 26 January 2016. This case involves 16-month-old (reported as 1-year-old) female patient who was vaccinated with second dose of INFLUENZA QUADRIVAL A-B VACCINE (Fluzone) (batch number-U5338BA, expiry date- 30 June 2016) intramuscularly on thigh on 13 November 2015. The patient had also received second dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (Daptacel) (batch number-C4781AA, expiry date- 25 July 2017) intramuscularly on thigh and third dose of HEPATITIS A VACCINE (HEP A.) (batch number not reported) intramuscularly on thigh on 20 January 2016. The patient's medical history includes vaccination with three doses of Pentacel and had not experienced any adverse events and illness at time of vaccination, birth defects, medical conditions were reported as none. The patient's pre-existing physician diagnosed allergies were reported as no known allergy. The patient's concomitant medications were not reported. On 17 November 2015, four days following the vaccination with FLUZONE vaccine, the patient had experienced diffuse urticaria initially concentrated to her trunk. On an unspecified date, the patient had experienced facial swelling, hand swelling and diffuse hives. On an unspecified date, 4 days following the vaccination with Hep A and Daptacel vaccine, the patient had experienced hives again. The patient required ER/doctor visit. Laboratory data was not reported. Initially the patient had received CLARITIN and ranitidine and later on the patient had received OTC medications as corrective treatment. The patient was recovered from event urticaria on trunk. The outcome of events facial swelling hand swelling and diffuse hives was reported as not recovered. List of documents held by sender: none.