chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.34
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: Information has been received from a physician referring to a 4 months old female patient with milk protein allergy, poor weight gain and reflux. The patient did not have drug reactions/allergies. On 02-OCT-2015, the patient was vaccinated with the first dose of ROTATEQ (lot #, expiration date and dose unspecified) orally as "age appropriate vaccine" and there was no adverse effect reported. On 03-DEC-2015 the patient received the second dose of ROTATEQ (lot # unspecified, expiration date 02-NOV-2016, 2ml) orally. There was no concomitant medication taken. On an unspecified date in December 2015, the patient developed blood and mucus in the stools. The patient's mother had sought medical attention by calling the office. No treatment was given for the events. None lab diagnostics studies was performed. The outcome of the events was reported as not recovered. Causality was not provided. The physician considered the adverse events to be significant disability or incapacity because it would cause decreased growth and poor weight gain in the patient. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Mucous stools, Vomiting
Clinical narrative: Information has been received from a physician referring to a 4 months old female patient with milk protein allergy, poor weight gain and reflux. The patient did not have drug reactions/allergies. On 02-OCT-2015, the patient was vaccinated with the first dose of ROTATEQ (lot #, expiration date and dose unspecified) orally as "age appropriate vaccine" and there was no adverse effect reported. On 03-DEC-2015 the patient received the second dose of ROTATEQ (lot # unspecified, expiration date 02-NOV-2016, 2ml) orally. There was no concomitant medication taken. On an unspecified date in December 2015, the patient developed blood and mucus in the stools. The patient's mother had sought medical attention by calling the office. No treatment was given for the events. None lab diagnostics studies was performed. The outcome of the events was reported as not recovered. Causality was not provided. The physician considered the adverse events to be significant disability or incapacity because it would cause decreased growth and poor weight gain in the patient. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Bedridden, Injury, Wheelchair user
Clinical narrative: This spontaneous report as received from other source as part of a marketing research-program, refers to unspecified patients of unknown demographics. The medical history and concurrent conditions of the patients were not reported. On an unknown date, the patient was vaccinated with GARDASIL of unknown strength (dose, frequency, lot number not reported). Concomitant medications were not reported. The reporter was sharing the experiences of some of the GARDASIL vaccine injury patients and stated that some patients who had GARDASIL have been in wheel chairs and bed bound. The outcome of the events was unknown. The reporter considered the events to be related to GARDASIL. The reporter considered the events to be disabling. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Rash erythematous, Skin warm
Clinical narrative: Patient had mild, red, warm to touch rash developed couple days after the shot. They complain their arm hurts, but pain has gone down.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reactions. Given PREVNAR 13 twice.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Bone pain, Chills, Diarrhoea, Malaise
Clinical narrative: Patient complains of fever, chills, aggravated asthma, nausea, diarrhea, and "pain in her bones". Reports feeling very sick. Reports this has happened 10 years ago after a flu shot, but this information was not given during vaccine questionnaire.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pyrexia
Clinical narrative: Patient complains of fever, chills, aggravated asthma, nausea, diarrhea, and "pain in her bones". Reports feeling very sick. Reports this has happened 10 years ago after a flu shot, but this information was not given during vaccine questionnaire.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Large 2 1/2 x 2" raised and indurated red, warm lesion on left deltoid muscle.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Skin lesion
Clinical narrative: Large 2 1/2 x 2" raised and indurated red, warm lesion on left deltoid muscle.
Age: 1.85
Sex: F
Vaccine: DTAP, FLU4, HEPA, HIBV
Symptoms: Urticaria
Clinical narrative: Urticaria on face, limbs, arms, and legs. Recommend benadryl q 4hr, Zyrtec prn, refer to allergist for evaluation.
Age: 48.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Fever, Swelling, Severe Pain.
Age: 48.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site reaction
Clinical narrative: Fever, Swelling, Severe Pain.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: PREVNAR 13 injection given in left deltoid on 12/3/15. Patient presented today with 4 inch x 2 inch reddened area on left deltoid. Area warm to touch and area hardened with palpation. Physician assessed site. Placed patient on KEFLEX 500mg 4 times per day for 7 days.
Age: 23.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Contusion, Erythema, Peripheral swelling, Pruritus
Clinical narrative: Swelling of upper arm, redness of upper arm, itching, bruising, lasted 3 weeks. Took BENADRYL - didn't work.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Eye pain, Ophthalmological examination normal, Visual acuity tests normal, Visual impairment
Clinical narrative: Pt received FLUMIST on 12/2/15 and then on 12/4/15, woke up c//o eye pain (L eye) and was unable to see doctor optho exam WNL; no other s/s besides loss of color vision in L eye. Pt will be seeing opthalmology specialist on 12/14/15.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 21-OCT-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (dose, frequency and route were not reported) lot # L002213, expiration date 21-JUL-2016. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Limb injury, Product package associated injury, Product quality issue
Clinical narrative: Information has been received from a healthcare professional referring to a female patient of unknown age. On an unknown date, the patient in reaching into the box to remove the vial of ZOSTAVAX (lot# L031271, expiration date: November 2016, route and dose were unknown) without looking another healthcare worker, so she was pricked in finger. This was how the broken vial was discovered. Product quality complains (PQC) was filed. The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a health professional referring to a 16 month old patient. On 03-AUG-2015 the patient was inadvertently administered vaccinated with ZOSTAVAX lot # L003218, expiration date: 30-APR-2016, (dose, route and application site were not reported) (drug administered to patient of inappropriate age). No adverse effect reported. No medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received form a nurse referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with VARIVAX (Merck) (lot# L020000, expiration date 02-JUN-2017; lot# L027287, expiration date 21-JUL-2017; lot# L021211, expiration date 10-JUN-2017) which were exposed to temperatures outside of the recommended range (incorrect product storage). No adverse effects have been reported. 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: Information has been received from a licensed nurse practitioner referring to unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K009482, expiration date 06-MAR-2017, route and dose not provided). No adverse effects were reported. This is one of several reports received from the same source. 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 registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (orally, unknown strength and dose) Lot # K020181 with expiry date of 24-JUN-2016 or lot # L008996 with expiry date of 01-DEC-2016 or lot # L000434 with expiry date of 10-JUL-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (unknown strength and dose) lot # L016428 and expiry date of 30-JUL-2017. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple patients of an unknown age and gender. No information regarding the patients' concurrent conditions and medical history was provided. On an unknown dates, multiple patients were vaccinated with an unspecified number of doses of improperly stored ROTATEQ lot# K021484, expiration date: 13-MAY-2016 or lot# K010224, expiration date: 25-FEB-2016 (orally; dose was not reported). The patients' concomitant therapy was not reported. There were no adverse effects reported. Product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates the patients were vaccinated with doses of improperly stored doses of M-M-R II (Lot# L012480; Expiration date: 10-APR-2017, Lot# L003856; Expiration date: 05-FEB-2017, Lot# reported as L009544; Expiration date: 19-MAR-2017). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested. Product information, event information and the narrative had been updated.
Sex: F
Vaccine: HPVX
Symptoms: Asthenia, Malaise, Personality change
Clinical narrative: This spontaneous report was received on a newspaper article and refers to multiple female patient of unknown age. The patients' medical history and concurrent condition were not reported. The patients on an unknown date were vaccinated with Quadrivalent HPV vaccine (manufacturer unknown) (dosing information not provided). Concomitant medication were not reported. On an unknown date it was reported that the patients were very sick, totally debilitated, and their personalities had changed. Action taken with quadrivalent HPV vaccine (manufacturer unknown) was not applicable. The outcome of the events Malaise, Asthenia, and Personality change were unknown. The reporter did not provide the causality assessment between the events and quadrivalent HPV vaccine (manufacturer unknown). This case is linked to the case 1512USA000013 and 1512USA001052. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Drug administered at inappropriate site, Electromyogram, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Immediate pain not normal with flu shot.  Couldn't lift my arm up.  Have limited use of my arm and constant pain, sometimes numbness in fingers.  Both doctors I have seen agreed shot was given too high and has caused possible nerve damage or SIRVA.  Have spent money on a doctors visit, specialist (neurologist), blood work, ultrasound, and a course of steroids.  Will begin physical therapy and need future testing with the nerologist in January.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Mobility decreased, Pain in extremity, Ultrasound scan
Clinical narrative: Immediate pain not normal with flu shot.  Couldn't lift my arm up.  Have limited use of my arm and constant pain, sometimes numbness in fingers.  Both doctors I have seen agreed shot was given too high and has caused possible nerve damage or SIRVA.  Have spent money on a doctors visit, specialist (neurologist), blood work, ultrasound, and a course of steroids.  Will begin physical therapy and need future testing with the nerologist in January.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Hypoaesthesia, Paraesthesia, Peripheral swelling, Skin warm
Clinical narrative: Swelling, red, hot to touch, numbness, tingling to left arm.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Malaise, Pain
Clinical narrative: Patient reported general malaise and soreness.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: L arm deltoid arm redness, itching, warm to touch.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 23-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, frequency and route were not reported) lot # reported as L0010144, expiration date 24-MAR-2017. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 21-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, frequency and route were not reported) lot # reported as L0010144, expiration date 24-MAR-2017. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 22-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, frequency and route were not reported) lot # reported as L0010144, expiration date 24-MAR-2017. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse refers to a patient of unknown age and gender. On 19-OCT-2015 the patient was vaccinated with the first dose in the HPV series with GARDASIL (dose, lot #, route and application site were not reported). On 07-DEC-2015, the patient came to the office to receive the second dose in the HPV series with GARDASIL 9 (dose, lot #, route and application site were not reported) (interchange of vaccine products). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 20-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, frequency and route were not reported) lot # reported as L0010144, expiration date 24-MAR-2017. No adverse effects have been reported. 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: This spontaneous report as received from a physician refers a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 23-OCT-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (dose, frequency and route were not reported) lot # L002213, expiration date 21-JUL-2016. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: FLUX, PNC13, PPV
Symptoms: Feeling abnormal, Malaise
Clinical narrative: This spontaneous report was received from a pharmacist via field representative refers to a female patient, over 65 years old or may be in her seventies. Information regarding her medical history, concurrent conditions and drug reactions/allergies were unspecified. On an unknown date the patient was vaccinated with PNEUMOVAX 23 probably in the deltoid region. Other suspect therapies included PREVNAR 13 and an unknown flu vaccine. No concomitant medications were reported. The field representative stated that the patient called back the next day vaccination and complained of feeling really crappy and horrible. Patient told that she was mad at the pharmacy because she claimed that it was his fault that she felt that way. Reporting field representative stated that he did not know the dates of when the events occurred, but he knew that it was longer than five days ago. The events lasted for five days and the patient was now fine. Reporting field representative had no information of any other medications, medical conditions or investigations related to the reported events. He only knew that the pharmacist monitored the patient for a few days. It was unknown if the patient required an emergency room or doctor visit. The outcome of the events were reported as completely recovered. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 21-OCT-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (dose, frequency and route were not reported) lot # L002213, expiration date 21-JUL-2016. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: Information has been received from a pharmacist referring to a 66 year old female patient. The patient's pertinent medical history included hypertension, rheumatoid arthritis and gastrooesophageal reflux disease (GERD). The patient was allergic to erythromycin. In June 2012, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously (lot # 1716AA, expiration date 02-FEB-2013, strength unknown). The patient took unspecified medications as concomitant Medication. On 12-NOV-2015 (reported as three weeks ago), the patient experienced unspecified blisters on the left side of her stomach and she was seen in the office by the physician on 03-DEC-2015. The patient was diagnosed with shingles by the physician and was prescribed acyclovir on the same day. No lab test was performed. The outcome of the event was reported as not recovered. Causality between event and ZOSTAVA was not 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 nurse referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with PROQUAD (Merck) (lot# L033698, expiration date 28-FEB-2017; lot# L024124, expiration date 30-DEC-2016; lot# L030587, expiration date 10-FEB-2017) which were exposed to temperatures outside of the recommended range (incorrect product storage). No adverse effects have been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed nurse practitioner referring to unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # K016005, expiration date 27-AUG-2016, route and dose not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Fever 101+, severe headache, muscle aches, sweating, took ibuprofen, OOW x 3 days.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (unknown strength and dose) lot # K0088409 and expiry date of 04-MAR-2016. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Headache, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Hours after high dose flu injection pt reports head/neck pain, uncontrollable shaking, pain from injection site to hand. Next day her arm turned warm, red, et very painful from above the injection site to just above the elbow.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Tremor
Clinical narrative: Hours after high dose flu injection pt reports head/neck pain, uncontrollable shaking, pain from injection site to hand. Next day her arm turned warm, red, et very painful from above the injection site to just above the elbow.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-DEC-2015 during the same visit, the patient was vaccinated with PROQUAD (Merck) lot # L027634, expiration date: 21-JAN-2017 and VARIVAX (Merck) lot # K010442, expiration date: 22-JUL-2017. No adverse experience was reported. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site inflammation, Injection site pain, Mobility decreased, Myalgia
Clinical narrative: Burning pain in deltoid and trapezius muscle, limited range of motion in neck, inflammation and pain at the site of administration 10 weeks post shot.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy skin and hives.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Constipation, Frequent bowel movements, Malaise, Musculoskeletal pain, Paraesthesia
Clinical narrative: "Tingly skin", constipation X 2-3 days, the more frequent bowel movements (not diarrhea), no rash, no redness, increase in shoulder pain, general malaise.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Constipation, Frequent bowel movements, Injection site erythema, Malaise, Musculoskeletal pain
Clinical narrative: "Tingly skin", constipation X 2-3 days, the more frequent bowel movements (not diarrhea), no rash, no redness, increase in shoulder pain, general malaise.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia
Clinical narrative: "Tingly skin", constipation X 2-3 days, the more frequent bowel movements (not diarrhea), no rash, no redness, increase in shoulder pain, general malaise.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: Burning at bedtime.  The next day swelling, redness and warmth from top of shoulder down to elbow.  Burning, tenderness and discomfort with ROM.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Burning at bedtime.  The next day swelling, redness and warmth from top of shoulder down to elbow.  Burning, tenderness and discomfort with ROM.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA (unknown strength, route and dose) lot # L002717 and expiry date of 02-JUN-2017. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of ROTATEQ lot # L000568 expiration date 10-JUL-2016 (oral as default, indication and dose number were not reported), and lot # L008053 expiration date 30-NOV-2016 were given to unspecified patients on unspecified dates. No adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of the several reports of the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed nurse practitioner referring to unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # K025002, expiration date 20-JUL-2017, route and dose not provided). No adverse effects were reported. This is one of several reports received from the same source. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed nurse practitioner referring to unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # K010224, expiration date 13-MAY-2016, route and dose not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenopia, Dizziness, Fatigue, Headache, Muscular weakness
Clinical narrative: Initial unsolicited report received from a consumer on 30 November 2015. This case involves 68-years-old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, dose in series were not reported) intramuscularly on left arm on 06 October 2015. Illness at time of vaccination was reported as none as per patient and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as some statins. Concomitant medications were not reported. On 07 October 2015, one day following the vaccination, the patient had experienced eye strain, blurred vision, intermittent lightheadedness, headache, fatigue, weakness of both arms. Symptoms were persisted on 30 November 2015. The patient diagnosed with the separation of vitreous from retina. The patient required ER/doctor visit. The patient's laboratory data and corrective treatment was not reported. The patient was not recovered from the events. It was reported that the patient would continue to follow up with eye doctor. It was also reported that he had an appointment with own primary care physician for evaluation of other symptoms. Upon internal medical review, the case was considered as serious due to important medical event: separation of vitreous from retina. List of documents held by sender: none.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Retinal detachment, Vision blurred
Clinical narrative: Initial unsolicited report received from a consumer on 30 November 2015. This case involves 68-years-old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, dose in series were not reported) intramuscularly on left arm on 06 October 2015. Illness at time of vaccination was reported as none as per patient and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as some statins. Concomitant medications were not reported. On 07 October 2015, one day following the vaccination, the patient had experienced eye strain, blurred vision, intermittent lightheadedness, headache, fatigue, weakness of both arms. Symptoms were persisted on 30 November 2015. The patient diagnosed with the separation of vitreous from retina. The patient required ER/doctor visit. The patient's laboratory data and corrective treatment was not reported. The patient was not recovered from the events. It was reported that the patient would continue to follow up with eye doctor. It was also reported that he had an appointment with own primary care physician for evaluation of other symptoms. Upon internal medical review, the case was considered as serious due to important medical event: separation of vitreous from retina. List of documents held by sender: none.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Liver abscess, Pyrexia, Streptococcal bacteraemia
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 70-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 25Nov2015 at 0.5 ml, single. Medical history included ongoing diabetes and ongoing hypertension. Concomitant medications were not reported. The patient got a fever right after he received the vaccine on 25Nov2015 and he had it for 2 days. He finally went to the Emergency Department where he was diagnosed with strep bacteremia and liver abscesses on 27Nov2015 and he was hospitalized on the same day. The patient is still currently hospitalized on antibiotics for the streptococcal bacteremia. The outcome for the events streptococcal bacteremia and liver abscesses was not resolved while for fever was resolved on 27Nov2015.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed nurse practitioner referring to unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (lot # reported as K015375, expiration date 18-SEP-2016, route and dose not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple, unspecified patients. The patients' concurrent conditions, medical history and concomitant therapies were not reported. From 23-AUG-2015 to 02-OCT-2015, the patients were vaccinated with doses of improperly stored VARIVAX (Merck) lot # L016127 with expiration date 06-MAY-2017 and lot # L011083 with expiration date: 23-AUG-2017. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: FLUX, MMR
Symptoms: Autism, Brain injury, Regressive behaviour
Clinical narrative: Initial unsolicited report received from a non-healthcare professional via other company (Pfizer) on 02 December 2015. Manufacturer control number: 2015420182. This case involves a male patient (age reported as "2") who was vaccinated with a dose of influenza vaccine (manufacturer: unknown, batch number, expiry date, route and site of administration were not reported) and a dose of MMR (manufacturer: unknown, batch number, expiry date, route and site of administration were not reported) both vaccines were administered on an unspecified date. The patient medical history and concomitant  medications were not reported. On an unspecified date, following the vaccination, the patient regressed into autism. It was reported that he was fine prior to that, he took a bullet for the head and resulted in an injury to his brain. Lab data and corrective treatment were not reported. The outcome of event was not reported. Upon internal review, the case was considered serious because of important medical events; injury to his brain and autism. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Mononeuropathy, Polyneuropathy
Clinical narrative: Initial unsolicited report received from a consumer via other company on 3 December 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of Flu shot (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient also received XYREM as a co-suspect, on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, the patient experienced mononeuropathy and polyneuropathy from flu shot. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. Upon internal review, company assessed the event of polyneuropathy as serious and important medical event. List of documents held by sender: none.
Sex: F
Vaccine: MEN
Symptoms: Encephalitis, Mental disorder
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent friend) on 04-Dec-2015. This case is linked with 2015SA206305 and 2015SA206306 (same reporter). This case involves a female patient (age not reported), who was vaccinated with Meningococcal vaccine (manufacturer: unknown, batch number: unknown, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, after vaccination, the patient experienced encephalitis and mentally challenged. Laboratory investigations and corrective treatment were not reported. The outcome of the event encephalitis was reported as recovered with sequelae and the outcome of mentally challenged was reported as not recovered. Upon internal review, the case was considered as serious due to important medical events encephalitis and mentally challenged. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: TTOX
Symptoms: Cold urticaria
Clinical narrative: I began experiencing hive to cold weather and cold water. Anything below about 60 my body develops hive on exposed skin and covered such as face, neck, thighs, feet, hands. Also known as Urticaria.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: Itching, red blemishes two months at this time. Under care of dermatologist.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Cellulitis, Headache, Pain in extremity, Pyrexia
Clinical narrative: Cellulitis (Dx), fever, sore arm, headache. Day after vaccine SEPTRA DS given to pt.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Malaise, Pain, Swelling
Clinical narrative: Pain within first 2 hours, redness and swelling after that. Systemic feelings of malaise started approx 24 hours after vaccine.
Age: 1.23
Sex: M
Vaccine: FLU3, HEPA, HIBV
Symptoms: Apparent life threatening event, Febrile convulsion, Pyrexia
Clinical narrative: High fever 103 associated with apparent life threatening event/febrile seizure.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Hard, bright red painful and swollen injection site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash, Skin warm, Urticaria
Clinical narrative: Headache day after vaccine. About 3 hours after, patient face felt hot. Hives and rash started 3 days later. MD gave pt Prednisone and VALTREX.
Age: 21.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Injection site swelling, Nausea, Product use issue
Clinical narrative: Information has been received from a physician assistant via a company representative referring to a 21 year old non-pregnant female patient with type 1 diabetes mellitus. On 06-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # L014420, once, in the right deltoid, route and dose unknown) for diabetes (product use issue). Concomitant therapies included influenza virus vaccine (unspecified) in the left deltoid. On 06-NOV-2015, after vaccination, the patient developed pain in the right deltoid where she received the shot (injection site pain), limited swelling (injection site swelling) and nausea. The patient visited the physician fro medical attention and received ibuprofen for treatment. The patient recovered from the injection site pain, nausea and injection site swelling on 12-NOV-2015 (also reported that "all this events lasted for five days after receiving the vaccine"). Vaccination with PNEUMOVAX23 was reported as 'not discontinued'. Additional information has been requested.
Age: 1.6
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV, MMRV, PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Swelling, redness, approx 30mm by 20mm.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Urticaria
Clinical narrative: Information has been received via field representative from a nurse referring to an 11 year old female patient with allergic to unspecified antibiotics. On 07-DEC-2015 the patient was vaccinated with her first dose of GARDASIL 9 (intramuscular, dose and lot # were unknown). Concomitant therapy included MENACTRA, vaccinated on the same day in the same unspecified arm. Later that evening, the patient developed hives on her chest. The patient sought medical attention via office visit. BENADRYL was given to treat the event. The nurse was unsure at this time if the 2nd and 3rd series of GARDASIL 9 would be given to the patient due to the hives. The outcome of the event was unknown. The causality was not reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness to site. Approx. 50 mm by 55 mm.
Sex: U
Vaccine: MENB
Symptoms: Visual impairment
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of visual disturbance in a patient who received BEXSERO (batch number 146101, expiry date April 2016). On 9th April 2015, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced visual disturbance. On an unknown date, the outcome of the visual disturbance was unknown. It was unknown if the reporter considered the visual disturbance to be related to BEXSERO. Additional details were provided as follows: The patient was 11 or 15 years old. The patient's vision was adversely affected. This case was linked to case US2015GSK173014 (same reporter).
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling arm in a 4-year-old male patient who received Influenza vaccine. In 2015, the patient received Influenza vaccine. In 2015, an unknown time after receiving Influenza vaccine, the patient experienced swelling arm. In 2015, the outcome of the swelling arm was recovered/resolved. It was unknown if the reporter considered the swelling arm to be related to Influenza vaccine. Additional details provided were as follows: The patient was reporter's nephew. The patient recently received the unspecified Flu vaccine and had experienced a quite significant swelling on his arm. The event lasted for at least a day. The reporter did not have any further details to provide.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to multiple patients of unknown age and gender. The patients concurrent condition and medical histories were unknown. On an unknown date, the patients were vaccinated with an improperly stored dose of M-M-R II (Lot # and expiration date unspecified) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events 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 as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL (unknown strength and dose) lot # L033347 and expiry date of 23-JUL-2017. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed nurse practitioner referring to unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (lot # K018182, expiration date 12-FEB-2017, route and dose not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Information has been received from a 77 year old female patient concerning herself. The patient had no pertinent medical history or drug reactions/allergies. On 13-JUL-2015, the patient was vaccinated with ZOSTAVAX (dose, route, lot# and expiration date were not reported) in her arm. There was no concomitant medication. On 13-JUL-2015, the patient experienced "pain in her arm at the injection site when she moved her arm while using ZOSTAVAX". On unknown dates, the patient sought medical attention from an unspecified physician on two occasions. No lab diagnostics studies were performed and no treatment was given for the event. The patient reported that she was recovering and the pain in her arm still persisted when she moved her arm. Causality assessment was not reported. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Nausea, Urticaria
Clinical narrative: 5-6 minutes after vaccine mother came from room reporting that patient was feeling nauseated.  Patient then started to have hives on face and neck.  When patient asked if he was having any difficulty breathing he reported yes, a code was called.  Code team responded.  Patient received IM Epi and was taken to ED for observation.  Patient was later discharged home. Spoke with mother next day she reported patient had no further reaction and was same as prior to vaccine.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Hypoacusis, Mobility decreased, Musculoskeletal pain, Paralysis
Clinical narrative: I was given the Hep B vaccine. About 2 hours later, I experienced pain from the shoulder blade up through to my head.  I couldn't move, and my hearing was muffled. I couldn't turn my head. The temporary paralysis feeling lasted 4 hours, but the pain lasted 4 days.  The most severe pain was at the top of my spine just before my head.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Spinal pain
Clinical narrative: I was given the Hep B vaccine. About 2 hours later, I experienced pain from the shoulder blade up through to my head.  I couldn't move, and my hearing was muffled. I couldn't turn my head. The temporary paralysis feeling lasted 4 hours, but the pain lasted 4 days.  The most severe pain was at the top of my spine just before my head.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Hypoacusis, Mobility decreased, Musculoskeletal pain, Paralysis
Clinical narrative: I was given the HEP B vaccine, shot #2.  About 2 hours later, I experienced the same pain from the shoulder blade up through to my head that I did from the first shot of the HEP B vaccine.  I couldn't move, and my hearing was muffled. I couldn't turn my head. The temporary paralysis feeling lasted 4 hours, but the pain lasted 5 days.  The most severe pain was at the top of my spine just before my head just like with shot #1.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Spinal pain, Vaccine positive rechallenge
Clinical narrative: I was given the HEP B vaccine, shot #2.  About 2 hours later, I experienced the same pain from the shoulder blade up through to my head that I did from the first shot of the HEP B vaccine.  I couldn't move, and my hearing was muffled. I couldn't turn my head. The temporary paralysis feeling lasted 4 hours, but the pain lasted 5 days.  The most severe pain was at the top of my spine just before my head just like with shot #1.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting projectile
Clinical narrative: Projectile Vomiting x 1- No treatment at this time. Mother had just breastfed patient prior to vaccine administration.