chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Diet refusal, Feeding tube user, Infantile spasms, Injection site erythema, Injection site pain
Clinical narrative: About an hour after his shots his leg started to swell and within 24 hours it was twice it's size, bright red and it could not be touched without causing pain. He had inconsolable screaming for about 72 hour period, from the moment he woke up to the time he slept. Very lethargic and was not interested in eating and had to be completely tube fed. He also began having clusters of infantile spasms. All of this lasted roughly a week, with the seizures lessening over an additional weeks time. He is severely delayed at this time but as of right now I have no idea if he has sustained permanent neurological damage due to the seizures.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site swelling, Lethargy, Screaming, Seizure
Clinical narrative: About an hour after his shots his leg started to swell and within 24 hours it was twice it's size, bright red and it could not be touched without causing pain. He had inconsolable screaming for about 72 hour period, from the moment he woke up to the time he slept. Very lethargic and was not interested in eating and had to be completely tube fed. He also began having clusters of infantile spasms. All of this lasted roughly a week, with the seizures lessening over an additional weeks time. He is severely delayed at this time but as of right now I have no idea if he has sustained permanent neurological damage due to the seizures.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Head injury, Syncope
Clinical narrative: Patient was given vaccine in our administration area and asked to remain sitting in the chair until she felt ready to stand up. When she felt ready, she stood up and her male partner sat down to receive his vaccine. His vaccine was administered and both patients were alert and talking to one another. As I turned my back to return to the pharmacy, I heard a loud thud and realized the female patient had fainted and hit her head on either the pharmacy counter or the floor. Staff was called and an incident report filed. EMS was called and checked her on the scene but further care from them was refused by the patient. Patient was advised to report to an ER but decided to get checked out at a nearby Urgent Care.
Age: 35.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash, Swelling
Clinical narrative: Pt stated he got bumps, swelling and rash on face and neck the next day after receiving the flu shot. Pt took cetirizine the next day in evening. He came to pharmacy the following day. I advised him to take BENADRYL 25mg at night. Pt said his swelling and bumps had decreased but he was going to his primary care for follow up.
Age: 68.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Arthralgia, Chills, Dizziness, Feeling cold, Feeling hot
Clinical narrative: Lightheadedness, couldn't think straight, nausea, joint aches, severe shaking, shivers, very cold, then hot (but no fever), headache.
Age: 68.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Headache, Mental impairment, Nausea, Tremor
Clinical narrative: Lightheadedness, couldn't think straight, nausea, joint aches, severe shaking, shivers, very cold, then hot (but no fever), headache.
Age: 71.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Redness and swelling in the arm. Patient described as a rash. Informed to take TYLENOL and apply ice.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Rotavirus test positive
Clinical narrative: Profuse watery diarrhea for 10 days after rotavirus vaccination.
Age: 44.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Erythema, Impaired work ability, Musculoskeletal disorder, Nausea
Clinical narrative: PATIENT HAS REPORTED FEVER, CHILLS/SHAKING, NAUSEA/VOMITING AND MISSED WORK FRIDAY THRU MONDAY DUE TO REACTION. LEFT ARM DECREASED FUNCTIONING DUE TO PAIN/SWELLING/REDNESS.
Age: 44.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Tremor, Vomiting
Clinical narrative: PATIENT HAS REPORTED FEVER, CHILLS/SHAKING, NAUSEA/VOMITING AND MISSED WORK FRIDAY THRU MONDAY DUE TO REACTION. LEFT ARM DECREASED FUNCTIONING DUE TO PAIN/SWELLING/REDNESS.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Systemic inflammatory response syndrome
Clinical narrative: Cellulitis with systemic inflammatory response requiring IV antibiotics and hospital admission.
Age: 51.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Retching
Clinical narrative: Chills, sweats, dry heaves, fatigue.
Sex: U
Vaccine: RV5
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product use complaint
Clinical narrative: This spontaneous report as received from a medical assistant, refers to two unspecified patients of unknown age and gender. The patients' pertinent medical history, their concomitant medications, and information about their drug reactions or allergies history were not provided. The medical assistant reported that, on an unspecified date, the two unspecified patients were administered one dose of ROTATEQ, orally, for prophylaxis (lot numbers and expiration dates were unknown by the medical assistant). The medical assistant reported that, the doses were administered to the two patients after she had difficulty opening the two separate ROTATEQ vials (product use complaint, circumstance or information capable of leading to medication error). No adverse effects were reported. It was reported that, vaccination with ROTATEQ was continued. Upon receipt of follow-up information, this case is now valid as patient demographics were received. Follow-up information was received from medical assistant through a telephone call on 22-OCT-2018. This report refers to two infants under 9 months. The reporter stated that they were able to open the vials of ROTATEQ after initial difficulty and administered the doses to two unspecified infant patients. No adverse effects occurred following the vaccine administration.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report received from a medical assistant refers to multiple unspecified patients. The patients' medical history, drug reactions/allergies and concomitant drugs were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored vaccines: either ROTATEQ (dose and route of administration were not provided) lot # N030175, expiration date 16-JUN-2019, or with PEDVAXHIB (dose and route of administration were not provided) lot # reported as: R000855 (non-valid), expiration date reported as: 24-SEP-2020, both for prophylaxis. The vaccines were stored at temperature 47 Fahrenheit degrees (F) to 77 F for 30 minutes as per data logger. Previous temperature excursions included storage at 47 F to 77 F for 30 minutes. There were no adverse effects reported. This case is considered to be non-valid due to the lack of patients' identifiers. This is an amended report. This case had been routed to distribution in error. It was re-routed to non-valid workflow.
Age: 2.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from an unspecified healthcare provider and refers to a 30 months old patient of unknown gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported. On 12-SEP-2018, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. The reported stated that the patient has experienced no adverse effects.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 5 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-APR-2018, the patient was vaccinated with an improperly stored dose of lot # N015623 with an expiry date of 15-NOV-2018 (Strength, frequency, route and anatomical location were not reported) for prophylaxis. On 03-APR-201, a 11 minute temperature excursion of -13.3 degrees Celsius occurred as advised by the nurse. All other temperatures were in range and average temperatures remained stable. The vaccine was in the freezer at the of excursion. The nurse advised that this was a "supported temperature excursion" since it was between -10 and -14 (Units unspecified) for a period of 11 minutes and that supply could remain in stock and was viable. No previous temperature excursion occurred. No adverse vaccine reactions were reported. The call was because of a data logger. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 5 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-JUN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD recombinant Human albumin (rHA) or human serum albumin (HSA) of lot # N015623 with an expiry date of 15-NOV-2018 (Strength, frequency, route and anatomical location were not reported) for prophylaxis. On 03-APR-2018, a 11 minute temperature excursion of -13.3 degrees Celsius occurred as advised by the nurse. All other temperatures were in range and average temperatures remained stable. The vaccine was in the freezer at the time of excursion. The nurse advised that this was a "supported temperature excursion" since it was between -10 and -14 (Units unspecified) for a period of 11 minutes and that the supply could remain in stock and was viable. No previous temperature excursion occurred. No adverse vaccine reactions were reported. The call was because of a data logger. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 17-year-old patient of unknown gender. The patient pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 23-OCT-2018, the patient was vaccinated with fourth dose of GARDASIL 9, intramuscularly (exact dose, lot# and expiration date were not reported) for prophylaxis (Incorrect dose administered). No adverse effects reported.
Age: 67.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 67 years old female patient. The patient had no pertinent medical history or allergies. Concomitant therapies were not reported. On 15-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly in the right arm for prophylaxis (lot # R018735, expiration date: 06-APR-2020; dose not reported). Other suspect therapies included influenza virus vaccine (unspecified) in the left arm. On an unknown date in October 2018, the patient experienced "redness and swelling which extended from the right inner arm past the elbow, and the injection site area was hot to touch." The patient was "examined" by the physician on an unspecified date and was treated with BENADRYL 25 MG and ibuprofen 600 MG. No laboratory tests were performed. On an unknown date in October 2018, the patient recovered from the events. A lot check was requested by the investigator. The causality between the events and the suspect vaccines was not reported.
Age: 67.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 67 years old female patient. The patient had no pertinent medical history or allergies. Concomitant therapies were not reported. On 15-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly in the right arm for prophylaxis (lot # R018735, expiration date: 06-APR-2020; dose not reported). Other suspect therapies included influenza virus vaccine (unspecified) in the left arm. On an unknown date in October 2018, the patient experienced "redness and swelling which extended from the right inner arm past the elbow, and the injection site area was hot to touch." The patient was "examined" by the physician on an unspecified date and was treated with BENADRYL 25 MG and ibuprofen 600 MG. No laboratory tests were performed. On an unknown date in October 2018, the patient recovered from the events. A lot check was requested by the investigator. The causality between the events and the suspect vaccines was not reported.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Product administered at inappropriate site
Clinical narrative: Patient reported going to her doctors on oct 15th to receive antibiotic rx due to cellulitis. Dr believed flu shot was not placed in right part of her arm.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Confusional state, Injection site erythema, Injection site pain, Neurological examination normal
Clinical narrative: Approximately 24 hours following SHINGRIX administration at a pharmacy, the patient had confusion, global weakness for several hours. Went to sleep as usual without seeking care that night, followed up in clinic the following day and felt normal. Normal neurologic exam and vitals the day of clinic visit (10/29). Mild erythema and tenderness in right arm injection site.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Ultrasound scan normal
Clinical narrative: Red swollen bicep on left arm, warm to the touch, saw pt on 10/23/18.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dysphonia, Malaise, Pain, Rhinorrhoea
Clinical narrative: Sniffles, severe hoarseness, chills, aches, general malaise .
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pyrexia
Clinical narrative: Pt. started with a fairly high fever (102 degrees) that same evening, took ibuprofen. The next day it had still not broken, but was lower at 99.4 degrees and generally not feeling well. Fever finally broke late Friday (10/26/18).
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Dizziness.
Sex: U
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever of 100-102 starting from 12 hours after vaccine, lasting for 12 hours.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient stated had redness and swelling at site of the injection after the immunization. She said it has disapated but is still some soreness. She stated she had no other signs of allergic reaction.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient reports breaking out in hives approximately 13-14 hours post flu shot. No airway involvement.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Patient states she had redness that progressed on the Left upper arm starting on 10-24-18 after receiving vaccine on 10-23-18. Patient also c/o pain at the injection site.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dry throat, Headache, Injection site pain, Injection site reaction, Pain
Clinical narrative: Soreness in muscles of entire upper right arm, red blotches over affected area, painful when touched, headache, feeling ache and dry throat.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash macular
Clinical narrative: Soreness in muscles of entire upper right arm, red blotches over affected area, painful when touched, headache, feeling ache and dry throat.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMRV
Symptoms: Viral rash
Clinical narrative: Viral exanthem. No treatment. Resolved in 4-5 days.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Generalised erythema, Haemorrhage, Injection site pain
Clinical narrative: Had generalized redness, tenderness, pain at injection site. Next day, experienced fever, chills, nausea and diarrhea. Following day, lips and mouth broke out with approx. 15 large cold sores (fever blisters) many bleeding and painful. Took L-Lysine tabs and applied ABREVA as directed on pkg. Cold sores were painful and unsightly. Was unable to attend pre-planned events due to concerns. Took approx. 7-10 days for sores to heal. Have residual scarring on lips/mouth area. Contacted Pharm D who did vaccination with concerns. No info re: cold sores showed up. Looked at monograph as well as CDC website which provided no insight. Contacted my daughter, a Pharm D, and former drug information specialist who contacted her colleagues. No one was aware of any such reported reactions.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Oral herpes, Pain, Pyrexia, Scar
Clinical narrative: Had generalized redness, tenderness, pain at injection site. Next day, experienced fever, chills, nausea and diarrhea. Following day, lips and mouth broke out with approx. 15 large cold sores (fever blisters) many bleeding and painful. Took L-Lysine tabs and applied ABREVA as directed on pkg. Cold sores were painful and unsightly. Was unable to attend pre-planned events due to concerns. Took approx. 7-10 days for sores to heal. Have residual scarring on lips/mouth area. Contacted Pharm D who did vaccination with concerns. No info re: cold sores showed up. Looked at monograph as well as CDC website which provided no insight. Contacted my daughter, a Pharm D, and former drug information specialist who contacted her colleagues. No one was aware of any such reported reactions.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Had generalized redness, tenderness, pain at injection site. Next day, experienced fever, chills, nausea and diarrhea. Following day, lips and mouth broke out with approx. 15 large cold sores (fever blisters) many bleeding and painful. Took L-Lysine tabs and applied ABREVA as directed on pkg. Cold sores were painful and unsightly. Was unable to attend pre-planned events due to concerns. Took approx. 7-10 days for sores to heal. Have residual scarring on lips/mouth area. Contacted Pharm D who did vaccination with concerns. No info re: cold sores showed up. Looked at monograph as well as CDC website which provided no insight. Contacted my daughter, a Pharm D, and former drug information specialist who contacted her colleagues. No one was aware of any such reported reactions.
Age: 51.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Pain/soreness/muscle aches LUE. See 10/25/18 note details.
Age: 74.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Blood test, Chest X-ray, Gait disturbance, Mobility decreased, Pain
Clinical narrative: I don't know if the pneumonia shot gave me the pneumonia or reaction to shot. I hurt all over my body and could hardly walk. My feet felt like I was walking on pins and needles. I could not close my hands they still hurt till this day 10/23/18. At ER they gave me this Etodolac 200mg, 2 times per day by Dr. I guess this medication is helping. I thought I was gona die that's how bad it was.
Age: 74.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: I don't know if the pneumonia shot gave me the pneumonia or reaction to shot. I hurt all over my body and could hardly walk. My feet felt like I was walking on pins and needles. I could not close my hands they still hurt till this day 10/23/18. At ER they gave me this Etodolac 200mg, 2 times per day by Dr. I guess this medication is helping. I thought I was gona die that's how bad it was.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, TTOX
Symptoms: Splenectomy
Clinical narrative: Pt came in office for well visit-due for 10/4/18 vaccine update. Pt ask to also get tetanus vaccine-Had her spleen remove and it been greater than 10 years. Pt was given Tetanus IM (R) middle deltoid Flu vaccine IM (R) posterior deltoid.
Age: 18.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: October 23, 2018: BEXSERO and Influenza vaccines both given in right deltoid. October 24, 2018: Redness, swelling and pain at injection site /Right deltoid. Nodule felt at injection site. October 25, 2018 swelling going down. October 26, 2018: Redness and warmth felt and nodule palpated by MD on exam. No swelling. No red appearance.
Age: 54.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction, Pruritus
Clinical narrative: Patient had almost immediate local reaction. Patient was c/o itchiness and there was moderate amount of erythema surrounding the injection site. Patient was kept in office to monitor. Ice was applied to site. After site was iced for 15 minutes, patient continued to have golf ball sized erythema and some warmth and hardness to injection site. Patient was not worsening, denied headache, difficulty breathing, or tightness of itchiness in throat. She was instructed to continue to ice site on and off throughout the day, take TYLENOL or Ibuprofen, and could use BENADRYL cream for the local reaction. Patient was instructed that if begins to worsen at all to call our office or go to the emergency room. Patient was agreeable to plan.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Cheilitis, Erythema, Fatigue, Mass, Pyrexia
Clinical narrative: Fever of 101 degrees and tiredness. Red lumps/rash on my upper lip similar to herpes but all over.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Fever of 101 degrees and tiredness. Red lumps/rash on my upper lip similar to herpes but all over.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: I am having difficulty moving the arm where the shot was administered and severe pain in the shoulder.
Age: 79.0
Sex: F
Vaccine: FLUA3
Symptoms: Decreased appetite, Herpes zoster, Malaise, Rash
Clinical narrative: Came down with shingles, sick not feeling well. Slept, loss of appetite, large rash on left side under armpit.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Left arm is very sore, lifting arm above shoulder height is extremely painful. Unable to lift 5 lb weight with out pain and not able to lift above shoulder height. Muscle is very sore, even to the touch right at the injection site. In the morning after sleeping arm is extremely stiff and painful to move, after moving it muscle seems to relax and is not as painful, but sore most of the day. I have been using it to see if things will get better but after 3 weeks it is not getting better. I do not feel like this is a reaction to the actual flu but the way it was injected, possibly?
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: Upper arm, swollen, red, firm and warm to touch.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Persistent shoulder pain, unable to move shoulder for two weeks.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: Employee upper arm red, swollen, firm and hot to touch. Also had hives break out on face and neck.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Epistaxis, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Acute onset of headache vomiting and fatigue about 12 hours after vaccine. No sign of local reaction at site of vaccine. Headache and fatigue and nausea lasted about 72 hours with associated fever to 102 one nosebleed. Seen in office x 2 negative strep normal UA.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Streptococcus test negative, Urine analysis normal, Vomiting
Clinical narrative: Acute onset of headache vomiting and fatigue about 12 hours after vaccine. No sign of local reaction at site of vaccine. Headache and fatigue and nausea lasted about 72 hours with associated fever to 102 one nosebleed. Seen in office x 2 negative strep normal UA.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient given hep A #2 too early, interval too short after last dose. First dose given 5/14/18, Second dose given 10/22/18. No adverse reaction reported, just reporting med error.
Age: 95.0
Sex: F
Vaccine: FLUA3
Symptoms: Rash, Rash pruritic
Clinical narrative: DAUGHTER REFERS THAT PATIENT HAVE A RASH ( ITCHY SMALL BALLS ) 3 DAYS AFTER GETTING THE VACCINE. NO FEVER, NO REDNESS, NO HOT AREA. TODAY 10/29/2018 PATIENT STILL HAVE THE SMALL ITCHY BALLS IN THE ARM.
Age: 51.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Cough, Dyspnoea, Hypoaesthesia oral, Ocular hyperaemia, Pharyngeal oedema
Clinical narrative: 2 hours after injection a cough started for about 15 min. Then followed by red eyes and some swelling. Progressed to numb lips shortness of breath and throat swelling.
Age: 51.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Swelling
Clinical narrative: 2 hours after injection a cough started for about 15 min. Then followed by red eyes and some swelling. Progressed to numb lips shortness of breath and throat swelling.
Age: 51.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Anaphylactic reaction, Cough, Erythema, Hypoaesthesia oral, Lacrimation increased
Clinical narrative: 2 hours after injection a cough started for about 15 min. Then followed by red eyes and some swelling. Progressed to numb lips shortness of breath and throat swelling.
Age: 51.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Ocular hyperaemia, Swelling face, Throat tightness
Clinical narrative: 2 hours after injection a cough started for about 15 min. Then followed by red eyes and some swelling. Progressed to numb lips shortness of breath and throat swelling.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Reported at 10/21/18, patient stated redness at injection site that was "red and hot" and abnormally large. No hives, blistering, pus or swelling below the elbow reported. Hand and fingers not swollen or red. Discomfort reported. Patient instructed to seek physician evaluation. 10/22/18, patient evaluated by physician. Photograph presented to pharmacist on duty and swelling was upper arm, reddish purple down to elbow. Patient reported she measured it to be swollen "1 inch larger" than the other arm. Measurement device not reported.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Skin discolouration
Clinical narrative: Reported at 10/21/18, patient stated redness at injection site that was "red and hot" and abnormally large. No hives, blistering, pus or swelling below the elbow reported. Hand and fingers not swollen or red. Discomfort reported. Patient instructed to seek physician evaluation. 10/22/18, patient evaluated by physician. Photograph presented to pharmacist on duty and swelling was upper arm, reddish purple down to elbow. Patient reported she measured it to be swollen "1 inch larger" than the other arm. Measurement device not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On an unknown date the patient may have been administered with an improperly stored dose of VARIVAX lot # R017636, subcutaneous for prophylaxis diluted with properly stored sterile diluent. No adverse effects reported. The vaccine was exposed to a temperature of -14 to -10 (-13.6) Celsius degrees for a timeframe of 11 hours. It was found because of a digital data logger. There were no previous excursions.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a medical assistant and refers to unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N026812, expiration date 22-JUN-2020 (exact dose, route of administration and anatomical localization were not provided). No adverse effects were reported. Data logger was involved. Administered doses of GARDASIL 9 lot # N026812 were exposed to the temperature excursion of below 32 degrees Fahrenheit for 3 hours. Previous temperature excursions of 32 degrees Fahrenheit to 35 degrees Fahrenheit for 4 hours and 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1 hour 30 minutes were reported. This is a non-valid case due to lack of the patients' identifiers. Follow-up was received on 22-OCT-2018. On 22-OCT-2018, a telephone call was placed to the medical assistant. The phone call went straight to voicemail. A message was left providing reason for the call, case reference number, contact number and a request for a retumed phone call. This is a non-valid report and should have been forwarded to the Non-valid workflow, instead of being distributed. Therefore, it is being sent to distribution for the last time to notify all recipients.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions or allergies provided. On 08-OCT-2018, the patient was vaccinated with M-M-R II (lot# N032757; expiration date: 20-NOV-2019; therapy type: rHa) and with VARIVAX (lot# M041514; expiration date: 11-OCT-2018), both via intramuscular route for prophylaxis. No adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a physician refers to a 11-week-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant drugs were not provided. On an unknown date, the patient inadvertently received a dose of PNEUMOVAX 23 lot # R012713, expiration date: 03-AUG-2019 (exact dose and route of administration were not provided), for prophylaxis, instead of PREVNAR. There were no adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Neuropathy peripheral
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around MAY 2017, the patient was vaccinated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for its intended purpose: the prevention of shingles. Shortly thereafter, the patient suffered headaches and neuropathy in her hand and foot. As a direct and proximate result of the vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his (Conflicting information, as patient is reported as a female) condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The reporter considered the events of headaches and neuropathy in her hand and foot to be related to ZOSTAVAX. Upon internal review, the event neuropathy in her hand and foot was determined to be medically significant. The events of headaches and neuropathy in her hand and foot were considered to be disabling. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 5 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-APR-2018, the patient was vaccinated with an improperly stored dose of PROQUAD recombinant Human albumin (rHA) or human serum albumin (HSA) of lot # N015623 with an expiry date of 15-NOV-2018 (Strength, frequency, route and anatomical location were not reported) for prophylaxis. On 03-APR-2018, a 11 minute temperature excursion of -13.3 degrees Celsius occurred as advised by the nurse. All other temperatures were in range and average temperatures remained stable. The vaccine was in the freezer at the time of excursion (Product storage error). The nurse advised that this was a "supported temperature excursion" since it was between -10 and -14 (Units unspecified) for a period of 11 minutes and that the supply could remain in stock and was viable. No previous temperature excursion occurred. No adverse vaccine reactions were reported. The call was because of a data logger. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 6 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-APR-2018, the patient was vaccinated with an improperly stored dose of PROQUAD recombinant Human albumin (rHA) or human serum albumin (HSA) of lot # N015623 with an expiry date of 15-NOV-2018 (Strength, frequency, route and anatomical location were not reported) for prophylaxis. On 03-APR-2018, a 11 minute temperature excursion of -13.3 degrees Celsius occurred as advised by the nurse. All other temperatures were in range and average temperatures remained stable. The vaccine was in the freezer at the time of excursion. The nurse advised that this was a "supported temperature excursion" since it was between -10 and -14 (Units unspecified) for a period of 11 minutes and that the supply could remain in stock and was viable. No previous temperature excursion occurred. No adverse vaccine reactions were reported. The call was because of a data logger. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Ear discomfort, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: This spontaneous report was received from a 66 year old female patient, who was referring to herself. The patient's medical history included dry eye and drug hypersensitivity to DEMEROL. The patient's other medical history, concurrent conditions were not reported. On 11-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 injection, route of administration reported as "injection" for prevention of pneumococcal disease (strength, dose, frequency, lot #, expiration date were not reported). Concomitant therapies included TRANXENE, RESTASIS and CLIMARA. On 12-OCT-2018, the patient woke up during the night with a fever and a headache. The patient also reported that she woke up in the morning with a large lump about 2 inches below the injection site which she reported as being rock hard like a stone, was painful, and could not move her arm. The patient reported that on 13-OCT-2018, reported as the following day, the lump started to go away and there were 4 red blotches that appear to be hives in that arm area. The patient also reported that she was using a hydrocortisone cream as well as BENADRYL for treatment. The patient also had diarrhea for a 3 day duration as well as pressure in her right ear and pain and swelling on her glands on her right side that was puffy. No lab diagnostics/studies were performed. The patient sought medical attention and spoke with physician. The patient was currently getting better although she was still had a pain in her neck. Outcome of the events was reported as recovering. Outcome of the pain in her neck was considered as not recovered. Causal relatedness was not provided.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Mass, Mobility decreased, Neck pain, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a 66 year old female patient, who was referring to herself. The patient's medical history included dry eye and drug hypersensitivity to DEMEROL. The patient's other medical history, concurrent conditions were not reported. On 11-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 injection, route of administration reported as "injection" for prevention of pneumococcal disease (strength, dose, frequency, lot #, expiration date were not reported). Concomitant therapies included TRANXENE, RESTASIS and CLIMARA. On 12-OCT-2018, the patient woke up during the night with a fever and a headache. The patient also reported that she woke up in the morning with a large lump about 2 inches below the injection site which she reported as being rock hard like a stone, was painful, and could not move her arm. The patient reported that on 13-OCT-2018, reported as the following day, the lump started to go away and there were 4 red blotches that appear to be hives in that arm area. The patient also reported that she was using a hydrocortisone cream as well as BENADRYL for treatment. The patient also had diarrhea for a 3 day duration as well as pressure in her right ear and pain and swelling on her glands on her right side that was puffy. No lab diagnostics/studies were performed. The patient sought medical attention and spoke with physician. The patient was currently getting better although she was still had a pain in her neck. Outcome of the events was reported as recovering. Outcome of the pain in her neck was considered as not recovered. Causal relatedness was not provided.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular
Clinical narrative: This spontaneous report was received from a 66 year old female patient, who was referring to herself. The patient's medical history included dry eye and drug hypersensitivity to DEMEROL. The patient's other medical history, concurrent conditions were not reported. On 11-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 injection, route of administration reported as "injection" for prevention of pneumococcal disease (strength, dose, frequency, lot #, expiration date were not reported). Concomitant therapies included TRANXENE, RESTASIS and CLIMARA. On 12-OCT-2018, the patient woke up during the night with a fever and a headache. The patient also reported that she woke up in the morning with a large lump about 2 inches below the injection site which she reported as being rock hard like a stone, was painful, and could not move her arm. The patient reported that on 13-OCT-2018, reported as the following day, the lump started to go away and there were 4 red blotches that appear to be hives in that arm area. The patient also reported that she was using a hydrocortisone cream as well as BENADRYL for treatment. The patient also had diarrhea for a 3 day duration as well as pressure in her right ear and pain and swelling on her glands on her right side that was puffy. No lab diagnostics/studies were performed. The patient sought medical attention and spoke with physician. The patient was currently getting better although she was still had a pain in her neck. Outcome of the events was reported as recovering. Outcome of the pain in her neck was considered as not recovered. Causal relatedness was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness unilateral, Cerebrovascular accident
Clinical narrative: Information has been received on 24-OCT-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In or about April 2017, the patient received the ZOSTAVAX (lot number and expiration unknown) unknown route for its intended purpose: the prevention of shingles. Shortly thereafter, the patient suffered vision loss in one eye and strokes. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of ZOSTAVAX. Vision loss in one eye and strokes were disabling. Upon internal review, vision loss in one eye and strokes were considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Cervix carcinoma
Clinical narrative: This spontaneous report was received from a physician and refers to unspecified female patients of unknown age. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with GARDASIL 9 (route, dose, lot # and frequency not reported) for prophylaxis. On unknown dates, the patient experienced cervical cancer. The outcome of the cervical cancer and the causality assessment were not provided.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 24-OCT-2018, the patient was vaccinated with an expired dose of VAQTA intramuscularly (lot # N020689 and expiration date 22-OCT-2018) for prophylaxis. No adverse effect was reported.
Age: 51.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 51-year-old male patient who received FLUARIX QUADRIVALENT (batch number 74BL5, expiry date 30th June 2019) for prophylaxis. Co-suspect products included ADACEL for prophylaxis. On 4th October 2018, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) and the 1st dose of ADACEL (intramuscular). On 5th October 2018, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient received FLUARIX QUADRIVALENT and ADACEL on the left deltoid. Subsequently, the patient experienced pain in the vaccinated arm. It was sore to the touch and sore upon movement.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Herpes zoster, Injected limb mobility decreased, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received at the age of 60 years). On 26th May 2018, the patient received the 1st dose of SHINGRIX. On 8th October 2018, 135 days after receiving SHINGRIX, the patient experienced shingles, discomfort, raised rash, localized erythema, itchy rash and sunburn-like rash. On 12th October 2018, the patient experienced injected limb mobility decreased and painful rash. In October 2018, the patient experienced shooting pain. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles, discomfort, injected limb mobility decreased, itchy rash, painful rash and sunburn-like rash were unknown and the outcome of the raised rash was recovered/resolved and the outcome of the localized erythema and shooting pain were not recovered/not resolved. It was unknown if the reporter considered the shingles, discomfort, injected limb mobility decreased, raised rash, localized erythema, itchy rash, painful rash, sunburn-like rash and shooting pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for himself. The patient received SHINGRIX in the right arm. On 8th October 2018, the patient noticed itch on the back of his right shoulder. There were two red spots. This spread to his front right shoulder, the right side of his chest, under his right arm pit, and the right side of his back. These areas were itchy. The patient said that there was a lot of discomfort and it felt like a sunburn. By Monday and Tuesday before the date of reporting, the spots, which he now referred to as a rash, became raised. He went to his family physician on Friday, 12th October 2018 and was prescribed VALTREX. The rash was very painful on Friday, Saturday and Sunday, forcing him to have to sleep upright because he could not lay on the rash and he could not lift his right arm. On 15th October 2018, he has significantly less pain (60-70 percent resolved). On the date of reporting, there was less pain than on Monday, redness was still present but the rash was no longer raised. Every now and then he gets a shooting pain that will last for 2-3 seconds, causing him to flinch and then it was gone.