chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Myalgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old male patient. No concurrent conditions, medical history or allergy/drug reactions were reported. On 03-NOV-2014, the patient was vaccinated with ZOSTAVAX subcutaneously (lot # K009773, expiration date: October 2015) (dose and strength were not reported). No concomitant medications were reported. The pharmacist reported that almost immediately after the administration of the ZOSTAVAX, the patient began to experience muscle pain (myalgia) when he tried to lift his arm above shoulder. Because of this pain, the patient had a limited range of motion and had not been able to lift his arm above the shoulder. The pharmacist did not know if this was the patient's left arm or right arm. The patient sought medical attention - called and spoke with reporting pharmacist. Lab tests were reported as unspecified. The outcome of myalgia was reported as not recovered. There were not product quality complaints (PQC) involved. The reporter's causality assessment was not provided. No further information was provided. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4, MNQ
Symptoms: Fall, Head injury, Suture insertion, Syncope
Clinical narrative: Information has been received from a physician via a field representative referring to an 18 year old male patient. No relevant medical history or concurrent conditions were reported. On 27-JUL-2015, the patient was vaccinated with GARDASIL (lot#, expiration date, strength, dose and route not reported). Concomitant medications were not reported. On 27-JUL-2015, the patient fainted, fell off of the exam table and hit his head after he received his GARDASIL vaccination. He was then taken to an unspecified Emergency Room (ER) where he was given 12 stitches for his injury. It was unknown how long the patient was in the ER. The outcome of the events was unknown. Causality assessment was not provided. There was no product quality complaint involved. Follow-up information has been received from the reporting physician concerning the patient with cephalosporin allergy on 03-SEP-2015. There were no adverse events following prior vaccination. In the afternoon of 27-JUL-2015, the patient was vaccinated with his first dose of GARDASIL (lot# K010215, expiration date not reported) intramuscularly in the deltoid region. Concomitant medication included  the second dose of MENACTRA. The patient had no illness at time of vaccination. Within a few minutes of receiving vaccines, the patient fainted while sitting on exam table. He then fell off the table onto his face, causing a laceration to his eyelid and eyebrow. After regaining consciousness and becoming stable, he was sent to ER where he was evaluated for head injuries and received sutures. A Computed Tomography (CT) was performed in the ER (result not provided). The outcome of the events was recovered on 06-AUG-2015. The events were considered as medically significant by the reporting physician. Additional information is not expected as all correspondence has been received. Information regarding the reporter, patient, product, event and narrative were updated.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4, MNQ
Symptoms: Computerised tomogram, Eyelid injury, Fall, Head injury, Laceration
Clinical narrative: Information has been received from a physician via a field representative referring to an 18 year old male patient. No relevant medical history or concurrent conditions were reported. On 27-JUL-2015, the patient was vaccinated with GARDASIL (lot#, expiration date, strength, dose and route not reported). Concomitant medications were not reported. On 27-JUL-2015, the patient fainted, fell off of the exam table and hit his head after he received his GARDASIL vaccination. He was then taken to an unspecified Emergency Room (ER) where he was given 12 stitches for his injury. It was unknown how long the patient was in the ER. The outcome of the events was unknown. Causality assessment was not provided. There was no product quality complaint involved. Follow-up information has been received from the reporting physician concerning the patient with cephalosporin allergy on 03-SEP-2015. There were no adverse events following prior vaccination. In the afternoon of 27-JUL-2015, the patient was vaccinated with his first dose of GARDASIL (lot# K010215, expiration date not reported) intramuscularly in the deltoid region. Concomitant medication included  the second dose of MENACTRA. The patient had no illness at time of vaccination. Within a few minutes of receiving vaccines, the patient fainted while sitting on exam table. He then fell off the table onto his face, causing a laceration to his eyelid and eyebrow. After regaining consciousness and becoming stable, he was sent to ER where he was evaluated for head injuries and received sutures. A Computed Tomography (CT) was performed in the ER (result not provided). The outcome of the events was recovered on 06-AUG-2015. The events were considered as medically significant by the reporting physician. Additional information is not expected as all correspondence has been received. Information regarding the reporter, patient, product, event and narrative were updated.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4, MNQ
Symptoms: Loss of consciousness, Suture insertion, Syncope
Clinical narrative: Information has been received from a physician via a field representative referring to an 18 year old male patient. No relevant medical history or concurrent conditions were reported. On 27-JUL-2015, the patient was vaccinated with GARDASIL (lot#, expiration date, strength, dose and route not reported). Concomitant medications were not reported. On 27-JUL-2015, the patient fainted, fell off of the exam table and hit his head after he received his GARDASIL vaccination. He was then taken to an unspecified Emergency Room (ER) where he was given 12 stitches for his injury. It was unknown how long the patient was in the ER. The outcome of the events was unknown. Causality assessment was not provided. There was no product quality complaint involved. Follow-up information has been received from the reporting physician concerning the patient with cephalosporin allergy on 03-SEP-2015. There were no adverse events following prior vaccination. In the afternoon of 27-JUL-2015, the patient was vaccinated with his first dose of GARDASIL (lot# K010215, expiration date not reported) intramuscularly in the deltoid region. Concomitant medication included  the second dose of MENACTRA. The patient had no illness at time of vaccination. Within a few minutes of receiving vaccines, the patient fainted while sitting on exam table. He then fell off the table onto his face, causing a laceration to his eyelid and eyebrow. After regaining consciousness and becoming stable, he was sent to ER where he was evaluated for head injuries and received sutures. A Computed Tomography (CT) was performed in the ER (result not provided). The outcome of the events was recovered on 06-AUG-2015. The events were considered as medically significant by the reporting physician. Additional information is not expected as all correspondence has been received. Information regarding the reporter, patient, product, event and narrative were updated.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Severe shoulder pain, inability to move shoulder because of pain, pain 8/10 on pain scale.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Heart rate abnormal, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Itching at inj. site immediately, severe headache within 30 minutes, felt like heart was doing flip flops within 2 hours, became sweaty and very tired that afternoon. On 9-5 developed hives around my neck with heat and swelling at inj. site. Used topical Benadryl on neck. Today (9-6-15) still itching on neck and site is swollen and hot.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Pruritus, Urticaria
Clinical narrative: Itching at inj. site immediately, severe headache within 30 minutes, felt like heart was doing flip flops within 2 hours, became sweaty and very tired that afternoon. On 9-5 developed hives around my neck with heat and swelling at inj. site. Used topical Benadryl on neck. Today (9-6-15) still itching on neck and site is swollen and hot.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Erythema, induration, warmth, tenderness of injection site, measuring 7 cm. Pain in arm and shoulder of R upper extremity where injection given.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling
Clinical narrative: The patient said she was fine on Friday and Saturday, until the evening on Saturday she said the area was itchy and a quarter size as far as swelling. She called Sunday AM and said the swelling had increased, so I found out her medications. She had been on Benadryl. That was not working, so I suggested she go to the ER. I am going to follow up with her today.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Rash erythematous, Vaccination site reaction
Clinical narrative: Large red rash on arm around where she was vaccinated.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 4 days after injection, the injection site is red, itchy, swollen, hard, and warm to the touch, the redness is spreading down the arm, patient is taking Bendaryl 25 mg twice daily and using hydrocortisone 1% cream.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient's wife reported patient has developed welps (1 on each knee, 1 at the left groin, and 1 at the left shoulder blade.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Headachy most of next day- in evening 9-4 noticed itching and redness at injection site. 9/5 - continuing today 9/6 redness, itching, heat and swelling of injection site- swollen site size of 1/1.5 inches and red.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Anaphylactic reaction, Pharyngeal oedema, Throat tightness
Clinical narrative: Pt stated she had anaphylaxis (throat swelling and closure) at around 10pm.
Age: 26.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pain, X-ray limb normal
Clinical narrative: PATIENT COMPLAINED OF SORENESS OF UPPER LEFT ARM.  PATIENT WAS ADVISED TO APPLY ICE TO THE AREA AND IF THE SORENESS CONTINUED TO TAKE IBUPROFEN OR ACETAMINOPHEN. PATIENT WAS TAKEN TO A WALK IN CLINIC AND PRESCRIBED A MEDROL DOSE PACK ON 9/4/2015. XRAYS REVEALED NO DAMAGE TO BONE OR SURROUNDING AREA.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Eye discharge, Eye irritation, Eye pruritus, Vision blurred
Clinical narrative: PATIENT PRESENTED TO PHARMACY ON 09/05/15 AND STATED ON THE EVENING OF HER IMMUNIZATION AT OR AROUND 9 P.M. PT. EXPERIENCED ITCHY, IRRITABLE EYES AND DESCRIBED FEELING A "FILM" OVER THE EYES AND HAD "MUCOUS" IN CORNERS OF BOTH EYES. PT. ALSO STATED THAT THIS HAPPENED TO HER IN THE LATE 80'S OR EARLY 90'S AFTER RECEIVING A FLU SHOT.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported redness, swelling, itching, and pain at the injection site following receiving Zostavax. It seemed to be an allergic reaction. The patient did report going to the emergency room and being treated at a local hospital.
Age: 1.31
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Left leg (injection site) redness, swelling, and firmness.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Pruritus generalised, Urticaria
Clinical narrative: Hives with blister and itchings over body and limbs.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Paraesthesia
Clinical narrative: Patient received vaccine at 5:30pm and presented back to the pharmacy at 5:50pm after shopping. She stated that initially after receiving the vaccine that her upper arm and face felt tingling and different. She said that the tingling slowly started to go away and become less intense but that it still felt different. Upon questioning she did not feel like it was an allergic reaction, that her breathing was affected, or that she had any itching. She also stated that the tingling had almost went away and that it had not spread to anywhere else in her body. I told her to make sure to keep an eye on it and to follow up with me the next day to make sure it had resolved. I called the patient at 7pm on 9/6/15 to make sure the patient was ok and she stated that the tingling had stopped and she no longer had any side effects. I told her to keep a close eye on it and seek emergency medical attention if the tingling came back at all especially in the next two weeks since it could be an adverse reaction from the vaccine called Guillain-Barre syndrome.
Age: 75.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: PATIENT REPORTED SEVERE PAIN/SWELLING AT INJECTION SITE. UPON PHARMACIST EXAMINIATION, SITE HAD SOME SWELLING/REDNESS, BUT ELBOW ON SAME ARM AS INJECTION SITE WAS SEVERELY SWOLLEN.
Age: 75.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Arthralgia, Arthritis, Injection site pain, Injection site swelling
Clinical narrative: PATIENT REPORTED SEVERE PAIN/SWELLING AT INJECTION SITE. UPON PHARMACIST EXAMINIATION, SITE HAD SOME SWELLING/REDNESS, BUT ELBOW ON SAME ARM AS INJECTION SITE WAS SEVERELY SWOLLEN.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site mass, Injection site rash, Tenderness
Clinical narrative: Patient complained of tenderness, lump, and mild rash at the injection. No shortness of breath or difficulty breathing.
Age: 30.0
Sex: M
Vaccine: DTAP
Symptoms: Asthenia, Erythema, Fatigue, Pain in extremity, Swelling
Clinical narrative: Fatigue, total body weakness, left arm pain, redness and swelling.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Feeling hot, Pain, Peripheral swelling
Clinical narrative: Swelling, itchy, very hot, very painful, at 9:30 doubled in size at 11 am, went to the Dr. Took Claritin and applied cortisone cream as directed, took Benadryl at night, woke up today with arm more swollen, larger red area, and a has more pain. On her shoulder blade she has a small bump like blister.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Swelling
Clinical narrative: Swelling, itchy, very hot, very painful, at 9:30 doubled in size at 11 am, went to the Dr. Took Claritin and applied cortisone cream as directed, took Benadryl at night, woke up today with arm more swollen, larger red area, and a has more pain. On her shoulder blade she has a small bump like blister.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy skin, Pemphigoid
Clinical narrative: DEVELOPMENT OF BULLOUS PEMPHIGOID APPROXIMATELY 3 WEEKS AFTER RECEIVING HIGH DOSE FLUZONE.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a mother referring to her son, a 14 year old male patient. The patient did not have pertinent medical history or drug reactions/allergies. On 03-AUG-2015 the patient was vaccinated with the third dose of GARDASIL 9 (lot#, expiration date and dose were unknown) intramuscularly. There were no concomitant therapies. On 03-AUG-2015, within 15 minutes of receiving the vaccine, the patient "broke out in hives." The patient was given an unspecified steroid injection and it was effective. Within 24 hours of August 3, 2015 the patient "broke out again with hives." The mother took the patient back to the physician on 06-AUG-2015 and the patient was given ZYRTEC and received an oral unspecified steroid. No lab diagnostics studies were performed. The patient was recovered within 7 days after his last physician's visit on an unknown date in August 2015. Upon internal review, the patient broke out in hives and was given an unspecified steroid injection was considered to be medical significant event. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Dyspnoea, Hypersensitivity, Rash generalised, Vaccination complication
Clinical narrative: Information has been received from a mother referring to her son, a 14 year old male patient. The patient did not have pertinent medical history or drug reactions/allergies. On 03-AUG-2015 the patient was vaccinated with the third dose of GARDASIL 9 (lot#, expiration date and dose were unknown) intramuscularly. There were no concomitant therapies. On 03-AUG-2015, within 15 minutes of receiving the vaccine, the patient "broke out in hives." The patient was given an unspecified steroid injection and it was effective. Within 24 hours of August 3, 2015 the patient "broke out again with hives." The mother took the patient back to the physician on 06-AUG-2015 and the patient was given ZYRTEC and received an oral unspecified steroid. No lab diagnostics studies were performed. The patient was recovered within 7 days after his last physician's visit on an unknown date in August 2015. Upon internal review, the patient broke out in hives and was given an unspecified steroid injection was considered to be medical significant event. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: (L) hand and finger tingling feels like pinpricks. Hurt when vaccine entered muscle and not needle stick.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Influenza like illness, Nausea, Pyrexia
Clinical narrative: Vomit, nausea, flu-like sxs, fever>99F. Pateint reported that she doing better, but was still weak & tired.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Vomit, nausea, flu-like sxs, fever>99F. Pateint reported that she doing better, but was still weak & tired.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effect was reported. There were no product quality complaints (PQC) involved. No additional information was provided. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with doses of improperly stored (Oka/Merck). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV2
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with doses of improperly stored GARDASIL 9. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with doses of improperly stored GARDASIL. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with doses of improperly stored ROTATEQ. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with doses of improperly stored PNEUMOVAX 23. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with doses of improperly stored M-M-R II. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. Information regarding relevant medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous, lot # not reported) to prevent shingles. Information regarding concomitant medications was not reported. "Two days after" receiving ZOSTAVAX (date unspecified), the patient developed cellulitis (unspecified location on body). The patient was seen by an unspecified physician (unspecified date) and was prescribed a "low dose" unspecified antibiotic. No lab diagnostics studies were performed. The outcome of cellulitis was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history were not reported. On multiple unspecified dates, multiple unspecified patients were administered improperly stored GARDASIL 9 (Lot number L000610 was an invalid lot number for GARDASIL 9), expiration date 31-JAN-2017, strength, dose, frequency and route were unknown). The patient's concomitant medication was not reported. No adverse effect was reported. There was no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 20-AUG-2015 the patient inadvertently received an expired dose of GARDASIL (dose, strength and route were not reported) lot # H020002 with expiry date: 08-AUG-2015. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-AUG-2015 the patient inadvertently received an expired first dose of GARDASIL (dose, strength and route were not reported) lot # H020002 with expiry date: 08-AUG-2015. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 28-AUG-2015 the patient inadvertently received an expired first dose of GARDASIL (dose, strength and route were not reported) lot # H0200025 with expiry date: 08-AUG-2015. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-AUG-2015 the patient inadvertently received an expired first dose of GARDASIL (dose, strength and route were not reported) lot # H020002 with expiry date: 08-AUG-2015. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 13-AUG-2015 the patient inadvertently received an expired first dose of GARDASIL (dose, strength and route were not reported) lot # H020002 with expiry date: 08-AUG-2015. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with PROQUAD (Merck) (batch#/lot# L010143, expiration date, route and dose were unknown) which were exposed to temperatures outside of the recommended range. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: 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 GARDASIL (lot # K010574 with expiration date of 08-APR-2017, dose strength and route unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # L004740 with expiration date of 16-NOV-2017, dose, strength and route unknown). No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of oral, ROTATEQ (lot # K020182 with expiration date of 25-JUN-2016, dose and strength unknown). No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. On an unknown date the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # K010337, expiry date 22-JUL-2016) (dosage, strength and route were not reported). There was no concomitant medication reported. At the time of the report, no adverse event was reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On 26-AUG-2015 the patient was vaccinated with an expired dose of M-M-R II (dose, route not reported, lot # reported as J009830 with expiration date 28-JUN-2015). Concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEP, HPV4, HEP, HPV9
Symptoms: Blood thyroid stimulating hormone, Electrocardiogram, Full blood count, Hypoxia, Laboratory test
Clinical narrative: This spontaneous  report was received from a physician via a company representative, referring to a 22 year old female patient. The patient's medical history included syncope. On 29-AUG-2015, the patient was vaccinated intramuscularly with the first dose of the series GARDASIL 9 0.5 ml, (lot # K026247, expiration date January 2015). Co-suspect therapy included RECOMBIVAX HB (dose, frequency, lot # and expiry date were not provided). On 29-AUG-2015, after receiving the first dose of GARDASIL 9 and RECOMBIVAX HB, the patient placed a call to 911 at an unspecified time to report she experienced seizures, syncope and convulsions. The patient was treated with oxygen and dexamethasone. At the time of the report, the vaccination series of GARDASIL 9 was discontinued. At the time of the report, the outcome of seizures and syncope was unknown. The reporter's causality assessment between seizures and syncope, and suspect therapies was not provided. Upon internal review, the event of seizure/convulsion was considered serious due to other important medical event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEP, HPV4, HEP, HPV9
Symptoms: Metabolic function test, Postictal state, Seizure, Syncope, Tonic clonic movements
Clinical narrative: This spontaneous  report was received from a physician via a company representative, referring to a 22 year old female patient. The patient's medical history included syncope. On 29-AUG-2015, the patient was vaccinated intramuscularly with the first dose of the series GARDASIL 9 0.5 ml, (lot # K026247, expiration date January 2015). Co-suspect therapy included RECOMBIVAX HB (dose, frequency, lot # and expiry date were not provided). On 29-AUG-2015, after receiving the first dose of GARDASIL 9 and RECOMBIVAX HB, the patient placed a call to 911 at an unspecified time to report she experienced seizures, syncope and convulsions. The patient was treated with oxygen and dexamethasone. At the time of the report, the vaccination series of GARDASIL 9 was discontinued. At the time of the report, the outcome of seizures and syncope was unknown. The reporter's causality assessment between seizures and syncope, and suspect therapies was not provided. Upon internal review, the event of seizure/convulsion was considered serious due to other important medical event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEP, HPV4, HEP, HPV9
Symptoms: Seizure, Syncope
Clinical narrative: This spontaneous  report was received from a physician via a company representative, referring to a 22 year old female patient. The patient's medical history included syncope. On 29-AUG-2015, the patient was vaccinated intramuscularly with the first dose of the series GARDASIL 9 0.5 ml, (lot # K026247, expiration date January 2015). Co-suspect therapy included RECOMBIVAX HB (dose, frequency, lot # and expiry date were not provided). On 29-AUG-2015, after receiving the first dose of GARDASIL 9 and RECOMBIVAX HB, the patient placed a call to 911 at an unspecified time to report she experienced seizures, syncope and convulsions. The patient was treated with oxygen and dexamethasone. At the time of the report, the vaccination series of GARDASIL 9 was discontinued. At the time of the report, the outcome of seizures and syncope was unknown. The reporter's causality assessment between seizures and syncope, and suspect therapies was not provided. Upon internal review, the event of seizure/convulsion was considered serious due to other important medical event. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Joint swelling, Pyrexia, Rash
Clinical narrative: Fever, rash on legs, and swelling of his ankles.
Age: 43.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper
Clinical narrative: Oral Typhoid vaccine. Only after last dose. Sharp stomach pains lasting 5 days. For 2 days they came on frequently, then for three days only after I ate. I nearly went to the hospital. I have previously had adverse reactions to the typhoid injection (Flu symptoms the first time, and swollen lymph nodes the second time). That's why I took the oral vaccine this time. I have had many other vaccines and never had any reactions.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Burning sensation, Erythema, Induration, Injection site erythema
Clinical narrative: Injection site painful, swollen, itching, red, burning, hard, spreading to underarm, continuing through 09/07/2015, the date of report.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Injection site painful, swollen, itching, red, burning, hard, spreading to underarm, continuing through 09/07/2015, the date of report.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Injection site painful, swollen, itching, red, burning, hard, spreading to underarm, continuing through 09/07/2015, the date of report.
Age: 37.0
Sex: M
Vaccine: DTAP, FLU3, PPV
Symptoms: Blood culture, Chest X-ray, Electrocardiogram, Erythema, Peripheral swelling
Clinical narrative: Patient's arm was tender, became red, warm and swollen.  Patient went to ER and was prescribed antibiotics.
Age: 37.0
Sex: M
Vaccine: DTAP, FLU3, PPV
Symptoms: Skin warm, Tenderness
Clinical narrative: Patient's arm was tender, became red, warm and swollen.  Patient went to ER and was prescribed antibiotics.
Age: 16.0
Sex: M
Vaccine: HPVX, HPV4, MNQ
Symptoms: Abnormal behaviour, Dizziness, Laboratory test normal, Syncope, Visual impairment
Clinical narrative: Behavior changes all night, vision changes, fainting, dizzy stars first day until today she still make changes with take care or her on the Hospital.
Age: 16.0
Sex: M
Vaccine: HPVX, HPV4, MNQ
Symptoms: Blood test, Computerised tomogram, Dizziness, Eye pain, Nuclear magnetic resonance imaging
Clinical narrative: Behavior changes all night, vision changes, fainting, dizzy stars first day until today she still make changes with take care or her on the Hospital.
Age: 16.0
Sex: M
Vaccine: HPVX, HPV4, MNQ
Symptoms: Photophobia, Syncope, Vision blurred
Clinical narrative: Behavior changes all night, vision changes, fainting, dizzy stars first day until today she still make changes with take care or her on the Hospital.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Fatigue, Orthostatic hypotension, Visual impairment
Clinical narrative: Dizziness, Visual change, Fatigue, Postural hypotension (10-15 min); Lay down until symptoms resolved.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: He had two grand mal seizures after the Varicella Vaccine. One on 1/12/15 & another on 1/29/15. He has had no seizures since the adverse reaction from the vaccine.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Decreased appetite, Fatigue, Feeling hot, Pyrexia
Clinical narrative: She was more tired than usual, appetite started to lessen, she got really hot by 9/3/15.  She had a fever of 104, I gave Tylenol and went to ER.  They gave her ibuprofen. Her fever returned to normal on Friday 9/7/15. Fever was the only real noticable symptom.  I have no doubt it was the vaccine.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Muscle spasms, Nausea, Rash macular
Clinical narrative: Pink, blotchy color on left arm (arm the shot was given in) lasted a week. Arm cramps in left arm. Headaches that last a week. Nauseous.
Age: 1.58
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Cyanosis, Electrocardiogram normal, Pyrexia
Clinical narrative: R arm extension, less than 1 minute, cyanosis at the lips and distal extremities, responsive at the time. Was febrile. Called EMS and was transported to local hospital. Keppra dose that patient was already on was increased. Patient was well appearing in the ER.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Chills, Decreased appetite, Headache, Heart rate increased
Clinical narrative: Pressure and slight numbness down arm. Pm 09/03/15, 1/2 a day. Pain in knees just from getting from sitting position, pm 09/03/15. Ongoing, only slight pm 09/07/15. Hip pain radiating from knees. Hives/rash 09/04/15 unknown. First left arm where injection administered, then right forearm and check. Fever unknown, checked on 09/05/15 pm, ranging from 99.3 F to 102.5F. Ongoing, last checked 09/07/15 @ 7:30 Pm. Chills, shivering. Headache 09/05/15 mild, moderate, PM 09/05/15. ONGOING. NAUSEA 09/06/15 am. Increased HR 106-122, 09/06/15 AM. Ongoing. Decreased appetite 09/05/15 pm. Ongoing, on and off. Sore throat, noticed on 09/07/15, but doesn't hurt to swallow, no difficulty breathing. Slightly swollen. Swollen lymph nodes (2 on left side of neck) one midway down neckband smaller one in hairline, tender, swollen, moveable 09/07/15 (noticed) pm.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Lymph node pain, Lymphadenopathy, Nausea, Oropharyngeal pain
Clinical narrative: Pressure and slight numbness down arm. Pm 09/03/15, 1/2 a day. Pain in knees just from getting from sitting position, pm 09/03/15. Ongoing, only slight pm 09/07/15. Hip pain radiating from knees. Hives/rash 09/04/15 unknown. First left arm where injection administered, then right forearm and check. Fever unknown, checked on 09/05/15 pm, ranging from 99.3 F to 102.5F. Ongoing, last checked 09/07/15 @ 7:30 Pm. Chills, shivering. Headache 09/05/15 mild, moderate, PM 09/05/15. ONGOING. NAUSEA 09/06/15 am. Increased HR 106-122, 09/06/15 AM. Ongoing. Decreased appetite 09/05/15 pm. Ongoing, on and off. Sore throat, noticed on 09/07/15, but doesn't hurt to swallow, no difficulty breathing. Slightly swollen. Swollen lymph nodes (2 on left side of neck) one midway down neckband smaller one in hairline, tender, swollen, moveable 09/07/15 (noticed) pm.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Rash, Swelling, Urticaria
Clinical narrative: Pressure and slight numbness down arm. Pm 09/03/15, 1/2 a day. Pain in knees just from getting from sitting position, pm 09/03/15. Ongoing, only slight pm 09/07/15. Hip pain radiating from knees. Hives/rash 09/04/15 unknown. First left arm where injection administered, then right forearm and check. Fever unknown, checked on 09/05/15 pm, ranging from 99.3 F to 102.5F. Ongoing, last checked 09/07/15 @ 7:30 Pm. Chills, shivering. Headache 09/05/15 mild, moderate, PM 09/05/15. ONGOING. NAUSEA 09/06/15 am. Increased HR 106-122, 09/06/15 AM. Ongoing. Decreased appetite 09/05/15 pm. Ongoing, on and off. Sore throat, noticed on 09/07/15, but doesn't hurt to swallow, no difficulty breathing. Slightly swollen. Swollen lymph nodes (2 on left side of neck) one midway down neckband smaller one in hairline, tender, swollen, moveable 09/07/15 (noticed) pm.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician as a part of Market Research program refers to a 67 year old male patient. The patient's medical history included an unspecified cancer. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not reported). On an unknown date, the patient experienced post herpetic neuralgia (PHN) and blistering rash. The reporter stated the it was the worst case of post herpetic neuralgia the reporter ever seen. The outcome of post herpetic neuralgia was reported as not recovered (the patient was still on medications) and the outcome of blistering rash was unknown. The primary care physician considered PHN to be related to suspect product and the relatedness between blistering rash and ZOSTAVAX was not reported. The events post herpetic neuralgia was considered to be medically significant by reporter. Additional information is not expected, as the reporter did not wish to be contacted.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Seizure
Clinical narrative: Patient had a mild seizure after getting the flu shot (FLUARIX QUAD 2015-2016) less than 10 seconds. Pt. recovered. Fire department came and check all his vitals.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Local reaction, Pain
Clinical narrative: Severe body aches. Very localized reaction at injection site (LA).
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Red, swollen, hot area at elbow and slightly above. Pt advised to use ice, ibuprofen and seek medical attention if not improved. Pt. saw MD next day (9/6/15).
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Redness, warmth, soreness on left arm in roughly an 8 x 5 in circle.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of drug administration, Injection site haematoma, Injection site haemorrhage, Pain
Clinical narrative: Information has been received from a physician regarding a 4 year old patient of unknown gender. The patient had no drug reactions/allergies. The patient was diagnosed with hand, foot and mouth disease on 24-AUG-2015 (reported as "one week ago") and the patient was treated with MOTRIN as needed. The physician stated that the patient had not received MOTRIN "in three days" (stopped date on approximately 28-AUG-2015) and that the patient had recovered from hand, foot and mouth disease in approximately August 2015. On 31-AUG-2015 the patient was vaccinated with a dose of PROQUAD (Merck) (lot # K018143, expiration date: 10-APR-2016, intramuscular). On the same day the patient experienced bleeding and the formation of an unspecified size hematoma at the injection site. The physician reported that the dose was administered into the patient's unspecified deltoid muscle, and the patient reported pain (incorrect route of drug administration). The physician stated that the bleeding lasted "15 minutes" and the bleeding resolved at the time of reporting. Liquid TYLENOL was given for the adverse events and no lab diagnostics performed. The physician did not think this infection was from one week ago or the MOTRIN therapy contributed to the formation of the hematoma. At the time of reporting, the outcome of hematoma at the injection site and pain were reported as recovering. Causality between the events and PROQUAD (Merck) was not provided. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Rash, Rash pruritic, Skin warm
Clinical narrative: Information has been received from a 62 year old female patient referring to herself. The patient had no drug allergies. Concurrent condition included blood pressure abnormal and thyroid function abnormal. On an unknown date of March 2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, strength and route unknown). Concomitant therapies included unspecified blood pressure medication, unspecified thyroid medication, aspirin, XANAX and cyanocobalamin. The patient reported that one to two days after receiving ZOSTAVAX, her shoulder down to her elbow (right or left side was unspecified) was "swollen, beet red, and hot." The patient also reported that there was an unspecified "lump as big as a fist" and that it "hurt for weeks." Then, on an unknown date the patient broke out in an unspecified rash across her chest, upper shoulders and back. The rash was "big red welts and blisters filled with water" and itchy. The patient sought medical attention by seeing the doctor. The doctor prescribed an unspecified dose of BENADRYL and home medicated ibuprofen as needed. The doctor suggested the lesions be washed with lemon juice, rubbing alcohol and soap and cool water. No lab diagnostics study was performed. The patient was not recovered from the events. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Upper extremity mass, Urticaria
Clinical narrative: Information has been received from a 62 year old female patient referring to herself. The patient had no drug allergies. Concurrent condition included blood pressure abnormal and thyroid function abnormal. On an unknown date of March 2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, strength and route unknown). Concomitant therapies included unspecified blood pressure medication, unspecified thyroid medication, aspirin, XANAX and cyanocobalamin. The patient reported that one to two days after receiving ZOSTAVAX, her shoulder down to her elbow (right or left side was unspecified) was "swollen, beet red, and hot." The patient also reported that there was an unspecified "lump as big as a fist" and that it "hurt for weeks." Then, on an unknown date the patient broke out in an unspecified rash across her chest, upper shoulders and back. The rash was "big red welts and blisters filled with water" and itchy. The patient sought medical attention by seeing the doctor. The doctor prescribed an unspecified dose of BENADRYL and home medicated ibuprofen as needed. The doctor suggested the lesions be washed with lemon juice, rubbing alcohol and soap and cool water. No lab diagnostics study was performed. The patient was not recovered from the events. 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 unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent condition were not reported. On unknown dates, two doses of improperly stored ZOSTAVAX (lot # L015416, expiration date reported as 01-AUG-201, dos, frequency and route were unknown) had been administered to patients. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.