chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: When she woke up on the morning of the 19th, I noticed right away that her leg looked a little swollen and when I pulled her pajamas off she had a bright red circle roughly 4 inches in diameter and it was sore to the touch she said. By the end of the day it had spread another inch. I took her into the doctor's office and a nurse snuck us into a room to look at her leg and they thought that she must have just tensed her muscle when the vaccine was given and said it should go away by end of the day and suggested giving her motrin. By the next day the redness was still spreading. By now it was the entire width of her leg and wrapping around that was all red. I gave her motrin again and had her put ice on it throughout the day. When she woke up on the 21st the center started to look bruised, then the outside was still red, so the redness is slowly fading and turning into a bruise.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Had a sore arm the first day of vaccination, but starting the morning after, I had low grade fever, body aches, chills which forced me to bed for the entire day with no help from taking TYLENOL.  The next day I still experience the same symptoms but less severe. Symptoms seem to have abated by next day, but still a very sore arm at injection site.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Photophobia
Clinical narrative: Immediately after reaction patient developed severe headache and photophobia. Slight dizziness.  normal HR and BP. Given ibuprofen 300mg x 1 dose and fluids. Symptoms persisted in office for more than 30 minutes. Pt was discharged home and advised to increase fluids and eats well balance meal.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Arm ached and was hot to the touch and red and swollen for more than one week I had both nausea and vomiting and diarrhea.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Vomiting
Clinical narrative: Arm ached and was hot to the touch and red and swollen for more than one week I had both nausea and vomiting and diarrhea.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Vaccine placed in incorrect position in left arm. It was placed too high and too posterior. As soon as contents injected I experienced immediate 9 out of 10 pain and intense pain and tingling down lateral arm including 4th and fifth digit. This pain continued to worsen of over the next 7-10 days and now I have intense shoulder pain and am unable to lift my arm above my head.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered at inappropriate site
Clinical narrative: Vaccine placed in incorrect position in left arm. It was placed too high and too posterior. As soon as contents injected I experienced immediate 9 out of 10 pain and intense pain and tingling down lateral arm including 4th and fifth digit. This pain continued to worsen of over the next 7-10 days and now I have intense shoulder pain and am unable to lift my arm above my head.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 09-OCT-2018, the patient was vaccinated with ROTATEQ, lot # N005618, expiration date 04-OCT-2018 (dose, frequency was not reported) for prophylaxis. On 09-OCT-2018, the patient experienced expired product administered. No adverse effects reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant therapies included sterile diluent (lot # R022280, expiration date: 6-OCT-2019). On 09-OCT-2018, the patient was vaccinated with M-M-R II (lot # M027637, expiration date: 02-JUN-2018) dose 1 for prophylaxis (strength, dose, route of administration and site of administration were not reported). The patient reported that, on 09-OCT-2018, the patient was vaccinated with an expired dose of M-M-R II (lot # M027637, expiration date: 02-JUN-2018) dose 1 for prophylaxis (strength, dose, route of administration and site of administration were not reported) and the patient was supposed to receive PROQUAD (lot number, albumin status and expiration date were not reported) (expired product administered) (wrong vaccine administered).  No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 26-JUL-2012, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (strength, route, dosage schedule, and lot number were not provided). The vaccine did not prevent shingles as intended (vaccination failure) and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 24-SEP-2015, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered (emotional distress) significant medical expenses, pain, suffering (emotional distress) and other damages (injury). The outcome of the events was unknown. Vaccination failure, emotional distress, injury, pain and herpes zoster were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-OCT-2014, the patient was inoculated with ZOSTAVAX for routine adult health maintenance for the prevention of shingles (strength, route, dosage schedule, and lot number were not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 19-JAN-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered and would continue suffering significant medical expenses, pain, suffering and other damages on unspecified dates. The final outcome of the events was not specified and they were considered to be related to ZOSTAVAX.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On about 30-JUN-2014, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On about 28-JUL-2013, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as severe herpes zoster. On or about 02-SEP-2014, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as severe herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages on unspecified dates, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 05-JUN-2015, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, lot # and expiration date were not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 16-JUN-2015, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as shingles. The patient was prescribed VALTREX and VICODIN for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, pain, suffering, and other damages. At the time of the report, the outcome of the events was unknown. Additionally, the causal assessment between the aforementioned events and vaccination with ZOSTAVAX was reported as related. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a register nurse referring to a 30 year old female patient. On 16-OCT-2018 the patient was vaccinated with M-M-R II lot # N024701, subcutaneous for prophylaxis. Concomitant therapies included sterile diluent (DSM). The patient became pregnant with LMP of 07-AUG-2018 and EDD of 14-MAY-2019. Initial exposure to M-M-R II was at 10 week(s). The pregnancy outcome was outcome pending. On 16-OCT-2018, the patient experienced exposure during pregnancy and experienced product use issue.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site warmth, Product administered at inappropriate site, Vaccination site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 54-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. The patient's past medical history included influenza (in 2003). Previously administered products included Flu vaccine (present yearly flu shot, received from 2004 and every year without any adverse event). On 1st October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On 3rd October 2018, 2 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site warmth were not recovered/not resolved. The reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site warmth to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: In 2003, the patient got flu infection and every year since then she has received the flu shot but never had a side effect until now. On Monday, the patient received the FLUARIX QUADRIVALENT 2018-2019 season vaccine. It was asked to the patient that which arm vaccine was administered and she said left. Also, if it was the left deltoid and she said it seemed lower than the deltoid, like the triceps. The patient said it was about 4 to 5 inches above the elbow and about 4 to 5 inches below the shoulder. The patient was not sure if vaccine was given subcutaneously or intramuscularly. On the day of reporting, the patient noticed that where she got the vaccine it was red and swollen about a 4 to 5 inch diameter. It was hot to the touch. It was not painful and not itchy. The patient has denied permission to contact their physician (because she was switching doctors).
Sex: M
Vaccine: HEP
Symptoms: Injection site induration, Injection site mass
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a infant male patient who received ENGERIX B for prophylaxis. On an unknown date, the patient received ENGERIX B. On an unknown date, less than a month after receiving ENGERIX B, the patient experienced injection site lump and injection site induration. On an unknown date, the outcome of the injection site lump and injection site induration were unknown. It was unknown if the reporter considered the injection site lump and injection site induration to be related to ENGERIX B. Additional details were provided as follows: This case was reported via click to chat. The pharmacist reported, she was wondering about a potential side effect of ENGERIX-B, specifically the "hard lump" around the injection site. The pharmacist further asked if there was any information about the duration of that lump. The pharmacist do not have the lot and expiration date, as he/she did not give the patient the immunization. The pharmacist was trying to answer a parent question. The pharmacist stated that the case might have already been reported, though was unsure.
Age: 70.0
Sex: M
Vaccine: TDAP
Symptoms: Decreased appetite, Diarrhoea, Injection site swelling, Mobility decreased, Pyrexia
Clinical narrative: Pt called 2/8/11 to report reaction. Lt. upper arm was swollen the size of a grapefruit, thinks he had a fever, had diarrhea and unable to eat or get out of bed on Sat.-2/5. Stated that it is getting better every day since and he is on the mend. Fever, Diarrhea and swelling, loss of appetite.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Peripheral swelling, Pyrexia
Clinical narrative: Swelling on her arm the size of her palm, chills. Fever. Ibuprofen, bag.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Pt reports with redness, resembling a bulls-eye, dark red in the center measure 2 cm in diameter, swelling and redness surrounding this dark red center measuring 9cm in diameter. Pt has some burning, itching, and warmth, no fever (97.6 tympanic). And swelling, warmth, itching. Aspirin 325 mg.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Insomnia, Pain, Pyrexia
Clinical narrative: Within 6 hours; fever, chills, aches and pains, insomnia. Fever lasted about 36 hours. Exhaustion. Very incapacitating.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Patient stated after having his vaccination on a Friday morning, by the afternoon he started to feel ill. He complained of arm pain, fever and chills that lasted through Saturday until he finally felt better when he woke on the following Sunday morning. He reported that he had to cancel his plans on Saturday and stay home because he felt so bad. He also noted that his sister had a similar reaction and that him and her both had chicken pox as adults.
Age: 82.0
Sex: F
Vaccine: FLUR4
Symptoms: Dizziness, Nausea, Palpitations, Respiratory rate increased
Clinical narrative: Sudden onset of severe dizziness at 7 pm (approx 10 hours after she received flu shot) on 10/18/18 with palpitations, nausea and fast breathing - took Valium 2 mg and Zofran 4 mg, symptoms improved and she fell asleep, she awoke at 5 am with palpitations and mild nausea - took half tab Valium (1 mg) and Zofran and symptoms resolved, went to sleep again and symptoms did not recur.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Influenza like illness
Clinical narrative: Flu-like symptoms, aching all over, chills, nausea, diarrhea, tiredness, low grade fever, headache, head congestion. Had taken MOTRIN the day of immunization at suggestion of the Pharmacist.  Symptoms started when I woke up the next day (10/21/18). Continued to take MOTRIN, slept, rested. It's now the 2nd day after the immunization (Monday, 10/22/18) and I'm feeling much better but still not back to normal.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia, Sinus congestion
Clinical narrative: Flu-like symptoms, aching all over, chills, nausea, diarrhea, tiredness, low grade fever, headache, head congestion. Had taken MOTRIN the day of immunization at suggestion of the Pharmacist.  Symptoms started when I woke up the next day (10/21/18). Continued to take MOTRIN, slept, rested. It's now the 2nd day after the immunization (Monday, 10/22/18) and I'm feeling much better but still not back to normal.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Full fledged case of shingles, lots of pain and a rash from front to back at chest level, right side.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Full fledged case of shingles, lots of pain and a rash from front to back at chest level, right side.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient came to pharmacy on 10-19-18 in the evening and complained that her arm has hurt since she received her immunization in August. Have been unable to contact patient to get additional information needed at this time. Have message in to primary care doctor.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood test normal, Blood thyroid stimulating hormone increased, Feeling jittery, Hypoaesthesia, Injection site pain
Clinical narrative: Approximately 30 to 45 minutes after the vaccination I started to feel somewhat jittery and my left hand and into wrist became numb and tingly (pins and needles). Then my right hand started to feel the same way. My face started to itch some and my tongue felt tingly also. I took 25mg of diphenhydramine and waited to see if symptoms subsided. The itchiness in my face and the tingling in my tongue went away in about 30 minutes however the jitteriness and the symptoms in my hands remained. The only symptom at the injection site was slight pain and warm to touch. I was at the ER approximately 2.5 hours and slept while waiting on the blood lab work to come back. When I woke the jittery feeling had subsided however the tingling in my hands remained. I was discharged and the tingling in my hands was gone the next morning when I woke.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site warmth, Paraesthesia, Paraesthesia oral, Pruritus
Clinical narrative: Approximately 30 to 45 minutes after the vaccination I started to feel somewhat jittery and my left hand and into wrist became numb and tingly (pins and needles). Then my right hand started to feel the same way. My face started to itch some and my tongue felt tingly also. I took 25mg of diphenhydramine and waited to see if symptoms subsided. The itchiness in my face and the tingling in my tongue went away in about 30 minutes however the jitteriness and the symptoms in my hands remained. The only symptom at the injection site was slight pain and warm to touch. I was at the ER approximately 2.5 hours and slept while waiting on the blood lab work to come back. When I woke the jittery feeling had subsided however the tingling in my hands remained. I was discharged and the tingling in my hands was gone the next morning when I woke.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain in extremity, Vaccination site pain
Clinical narrative: A couple of hours later arm hurt like if falling off body; pain at vaccination site. Put ice on it; did not take any medicine. Saturday felt sick on stomach, excruciating headache; spent in bed from 10-4pm. Started to gradually get better; it took 5-6 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash, swelling,heat and itching at local injection site. Pt took OTC BENADRYL.
Age: 74.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Ear pain, Fatigue, Headache, Injection site pain, Insomnia
Clinical narrative: Day of injection (10/17/2018): Increasing pain at the site of the shot, spreading to shoulder and neck. Very painful upper arm; sore stiff neck; and headache prevented sleep that night. Did not respond to Ibuprofen. One day later (10/18/2018): Fatigue and mild pain in upper left arm. Two Days later (10/19/2018): Less pain in upper arm. Beginning ca. 11:00 am pain in and around lower left ear. Touching that area or turning the head excruciatingly painful. Duller pain radiated down jaw into neck. Pain persisted for 9 hours.
Age: 74.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain, Pain, Pain in jaw, Tenderness
Clinical narrative: Day of injection (10/17/2018): Increasing pain at the site of the shot, spreading to shoulder and neck. Very painful upper arm; sore stiff neck; and headache prevented sleep that night. Did not respond to Ibuprofen. One day later (10/18/2018): Fatigue and mild pain in upper left arm. Two Days later (10/19/2018): Less pain in upper arm. Beginning ca. 11:00 am pain in and around lower left ear. Touching that area or turning the head excruciatingly painful. Duller pain radiated down jaw into neck. Pain persisted for 9 hours.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Hypoaesthesia, Injection site erythema, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Muscle twitching; Arm pain/tingling; Soreness/achiness; Burning/numbing sensation from site of injection to hand; Swelling at site of injection; Redness at the site of injection.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site paraesthesia, Injection site reaction, Injection site swelling, Muscle twitching, Pain in extremity
Clinical narrative: Muscle twitching; Arm pain/tingling; Soreness/achiness; Burning/numbing sensation from site of injection to hand; Swelling at site of injection; Redness at the site of injection.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Muscle twitching; Arm pain/tingling; Soreness/achiness; Burning/numbing sensation from site of injection to hand; Swelling at site of injection; Redness at the site of injection.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site haemorrhage, Injection site swelling
Clinical narrative: Patient experienced bleeding at the injection site and immediate bruising and "goose egg" at site. I applied pressure with a cotton ball and stopped bleeding after 1-2 minutes. Once it was clotted, I went ahead and gently rubbed the deltoid to get the immunization to go into the muscle. I had the patient use some exercises to increase blood flow to the muscle to help immunization get absorbed. After 5 minutes, the swelling had gone down. Patient was instructed to apply a cold compress if it was uncomfortable and to follow up with pharmacy if any questions.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Client came to clinic at 4pm on 10/19/18 with parents. Parents concerned about swelling, redness and warmth at injection site. Mom had just noticed the swelling that morning. Advised to use cold compress. To outline swollen area with ink and if swelling spread further or symptoms of fever, difficulty breathing, hives to go directly to urgent care or ED.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient was given SHINGRIX vaccine approximately 11:05 a.m. and stayed in the store afterwards as instructed to make sure she felt ok. Later on that evening she reported that around "dinner time" she started having hives and welts on her torso and went to the emergency room where she was instructed to take BENADRYL and follow up with her primary care provider.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Injection site joint pain, Pain
Clinical narrative: Pt concerned site of recent Tdap vaccine (11 days ago 4-12-13) left upper arm, constant pain rating 3-4/10 with movement, states, it's like it's in the joint, it doesn't hurt when I touch the skin. Denies any redness/swelling, fever/chills. Arthralgia. Acetaminophen 650 mg UD.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Dyspnoea, Heart rate increased, Heart rate irregular, Productive cough
Clinical narrative: Pt presented to the clinic 5/16/16 asking for a cough medication for new onset cough. Pt has a sleep study tomorrow at the clinic, concerned the cough will interfere with that process. Stated, I slept a little better last night, I took some TYLENOL but I just wanted something if I need it. Pt received the PREVNAR 13 vaccine 5-10-16. Cough started 5-12-16. Stated, it feels like my bronchial tubes are being ripped out every time I cough. Concerned this is a reaction to the vaccine. Cough is mostly nonproductive, if any phlegm is expectorated color is white. Reports occasional increased shortness of breath with activity, this is not a new finding for him. Denies any fever/chills or congestion. VS entered into CPRS, noted increased irregular heart rate. Pt stated this is known to him with DX of A fib managed by Anticoag/Warfarin therapy. Increased heart rate may be attributed by coughing episodes. Has not taken any OTC cold medication only cough drops. Lungs clear anterior/posterior chest. O2 sat 97%. Afebrile. Medications reconciled, complaint with prescribed regimen. Took am medications this morning 8am. Complaint with BiPAP. Reviewed case with PCP's colleague, prescription written and given for contract pharmacy for cough medication with Codeine. Reviewed potential side effects of drowsiness. To take medication with him and inform the sleep lab staff. Instructed to drink plenty of fluids, warm fluids can ease the cough reflex. To call if symptoms worsen or fail to clear. Pt verbalized understanding. Cough wheeze and tachycardia. Codeine/guaifenesin 10 ml QID.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site rash, Injection site swelling, Rash
Clinical narrative: Pt called nurse on 10-5-12, states has a small orange sized injection site rash, slightly swollen. No itching, pain, fever/chills. Rash and diarrhea.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Tongue discomfort
Clinical narrative: Complains of burning sensation on his tongue, noted 12-11-13, the day after he received three vaccines at this PCP appt. Flu, Pneumonia and Tdap vaccine. Describes the feeling as like he drank some hot coffee and burned his tongue but he has not. Today symptoms are slightly improving. Denies any difficulty swallowing or breathing. Eating small bites
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site pain, Mass, Myalgia, Pain in extremity
Clinical narrative: Reason for contact: Complains of sore arm where PNEUMOVAX was given yesterday. Lump noted size of a golf ball, no redness. Experiencing chills. Has applied ice and taken TYLENOL. Denies any shortness of breath, wheezing, fast heart rate, dizziness, hives, high fever or behavior changes. Plan of care: Instructed to continue to apply ice and taking TYLENOL. Reviewed VIS sheet/potential side effects and those he should seek emergency evaluation for. Myalgia and sore arm with lump noted size of golf ball, no redness. Having chills as well.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 59-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number 59TS2, expiry date May 2019) for prophylaxis. On 5th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On 5th October 2018, immediately after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site itching, injection site erythema, injection site warmth, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site itching, injection site erythema, injection site warmth, injection site pain and injection site swelling were recovering/resolving. It was unknown if the reporter considered the injection site itching, injection site erythema, injection site warmth, injection site pain and injection site swelling to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The patient revived FLULAVAL vaccine on the left deltoid. Shortly after vaccination, the patient experienced warmth, circular redness, puffiness and itching at around the injection site.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 59-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number 59TS2, expiry date May 2019) for prophylaxis. On 5th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On 5th October 2018, immediately after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site itching, injection site erythema, injection site warmth, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site itching, injection site erythema, injection site warmth, injection site pain and injection site swelling were recovering/resolving. It was unknown if the reporter considered the injection site itching, injection site erythema, injection site warmth, injection site pain and injection site swelling to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The patient revived FLULAVAL vaccine on the left deltoid. Shortly after vaccination, the patient experienced warmth, circular redness, puffiness and itching at around the injection site.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 74-year-old female patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. On 9th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities and skin warm. On an unknown date, the outcome of the erythema of extremities and skin warm were recovered/resolved. It was unknown if the reporter considered the erythema of extremities and skin warm to be related to SHINGRIX. Additional details were reported as follows: In 2018 after vaccination, the patient experienced a really red upper arm and that was hot to the touch. The events were lasted for a few days.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site nodule, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in an unspecified number of an adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site lump and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site lump and injection site warmth were unknown. It was unknown if the reporter considered the injection site erythema, injection site lump and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not provided but was captured adult as per vaccine indication. The pharmacist stated that she has had several patients who reported that after receiving the SHINGRIX vaccine, they experienced warmness, redness, and a knot at the injection site. The pharmacist did not have any additional or specific details regarding these patients. This case is 1 of the 3 linked cases reported by same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of dizziness in a female patient who received FLUARIX QUADRIVALENT 2018-2019 season) for prophylaxis. On 3rd October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On 4th October 2018, 1 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced dizziness, chills, fever and swelling arm. On an unknown date, the outcome of the dizziness, chills, fever and swelling arm were unknown. The reporter considered the dizziness, chills, fever and swelling arm to be probably related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced dizzy, chills, slight fever and arm was swollen. The patient stated that, she would inform her oncologist about the adverse events. The patient was also suggested, to contact the GlaxoSmithKline health center where the patient was vaccinated.
Sex: U
Vaccine: VARZOS
Symptoms: Dry eye, Keratitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of corneal inflammation in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included corneal abrasion (30 years before the reporting date). In July 2018, the patient received the 1st dose of SHINGRIX. On 1st August 2018, 14 days after receiving SHINGRIX, the patient experienced corneal inflammation and eye dryness. On an unknown date, the outcome of the corneal inflammation and eye dryness were unknown. It was unknown if the reporter considered the corneal inflammation and eye dryness to be related to SHINGRIX. Additional details were reported as follows: The patient asked if she could have corneal herpes without a rash and was asking could she get other symptoms. The patient developed right eye corneal inflammation and severe dry eye 2 weeks after vaccination with SHINGRIX. Since 1st August 2018, the patient had these problems. The ophthalmologist said if it was a corneal issue caused by a dose of SHINGRIX the patient would have a rash. The patient had a corneal abrasion 30 years ago and was told that area of the cornea was weak causing patient to have this problem. It might be just a coincidence, but the patient was leary about getting 2nd shot of SHINGRIX. The patient would be seen by the physician the next week of reporting. The patient's left eye was fine. The patient was asking, if corneal herpes could be adding to this. The patient was asking, whether ophthalmologist should be able to tell the difference between a herpes virus or a corneal scar.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 30th January 2018, the patient received the 1st dose of SHINGRIX. On 24th April 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving doses of SHINGRIX, the patient continued to have shingles outbreaks. The patient was asking whether there was anything that the patient should or should not do to reduce or lessen outbreaks. This case was considered as suspected vaccination failure as the vaccination schedule and the time to onset for Shingles was not provided at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX on an unknown deltoid. The batch number and expiry date were not reported. The soreness was lasted for 1.5 days. The reporter had denied permission to contact their physician. This case has been linked with case US2018187570, reported by the same reporter.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Pyrexia
Clinical narrative: TC from pt. to report reaction to ZOSTAVAX vaccine. Received the vaccine 5-10-11, in the afternoon, 5-11-11 at 2 AM was awakened with itching, generalized body aches and fever of 101.9. No evidence of rash. Pt. reports feeling much better today, just wanted PCP to be aware and document the reaction. Instructed may use OTC antihistamines for generalized itching if needed. Pt. verbalized understanding.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Lethargy, Throat irritation
Clinical narrative: Patient was given 1 dose of FLUZONE QUAD PF 2018-19 Pre-filled syringe at approximately 10:56AM and told to stay around store for 20 mins. At approximately 11:15, patient came back to pharmacy stating that she had an "itchy spot" at the back of her throat and felt "lethargic". I verified that patient did not have any pain or residual reaction at site of injection, itchiness moving throughout body/extremities, swelling, or trouble breathing/constriction of airway. Patient has not had flu shot since age 14 and did not remember any reaction. After confirming with patient she felt in normal state of mind and was not having current severe issues breathing. I gave her 50MG dose (2 x 25MG tabs) diphenhydramine per standing order. I sat with patient and made sure she maintained consciousness, awareness, and normal ability to function and kept her in conversation. I discussed with patient that emergency medical help can be coordinated if patient feels severe reaction or symptoms that may lead to anaphylaxis. Patient denied need for EMT or EMS and wanted to sit and continue to recoup. I re-evaluated patient status every 2 to 3 mins to ensure she was feeling ok and to determine next treatment step per standing order. After 10 mins after initial dose, patient stated "itchiness" felt slightly better and was not getting worse, but feeling still bothersome. She described it as if something were "stuck on back of throat". I verified breathing felt normal and no swelling, tingling, or itchiness was spreading throughout body or extremities to which she denied. I gave her another dose of 50MG diphenhydramine (2 x 25MG tablets) as it seemed to slightly alleviate described "itchiness" and may do more to ensure potentially severe reaction does not escalate. Patient requested to go to bathroom at approximately 11:40AM to which I confirmed that she felt better and could ambulate on her own. I offered a female associate to accompany her to the restroom, but she thought she was feeling better and could go on her own. She returned at approximately 11:44AM and confirmed that she felt better overall with itch, but still slightly lethargic. I sat with patient until approximately 11:52AM when patient's mom arrived as patient had contacted her. At this point, I continued to reevaluate patient status (every 2 to 3 mins) and confirmed that patient felt better overall and was comfortable leaving with mom to go home and rest. I gave patient my contact inform and told her and mom to call me that day to update me on status. I also tried calling patient's phone number at 2:45PM and left a voicemail to contact me as soon as possible to check status. As of this writing, I had not heard back from patient to current status. No epinephrine was administered. Amendment: 10/21/18 4:17PM I spoke with patient's mom and she is doing ok - sleepy from BENADRYL but no systemic reaction or further issues breathing.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Pt. started with itching in face then in arms, presented with an erythematous rash 15 mins after inj. Tx: BENADRYL 50 mgs plus KENALONG 40 1cc.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus, Urticaria
Clinical narrative: Patient came back on 10/19/2018 and showed me her arm in which had redness and small hive like bumps that were itching. Patient came back on 10/22/2018 in which the injection site was very red, and still slightly itchy according to patient. That morning (10/22/18) she outlined the area with a marker to see if it will spread even more. According to the patient the redness was not as prominent and the itching is not as severe.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Lethargy, Nausea
Clinical narrative: Pain at injection site for 2 days. Chills, headache, nausea, lethargy for 1 day following the injection. No symptoms on day 3.
Age: 1.33
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised
Clinical narrative: Reported by Grandmother child had a head to toe rash that developed that evening. No other symptoms reported.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Injection site pain, Musculoskeletal pain, Pain, Pain in jaw
Clinical narrative: Patient reports 'pain in back' and describes it as 'throbbing' near shoulder blades, pain in both shoulders and occasional L jaw ache. Patient states pain/aching still 'comes and goes'. Denies any redness, swelling or soreness at injection site. Denies any fever, chills, nausea, vomiting, sweating or SOB. I strongly recommend patient notify MD immediately and get medically evaluated.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Chest pain, Dyspnoea, Injection site erythema, Injection site pain
Clinical narrative: Patient experienced chest pain and shortness of breath. Visit to emergency room ruled out cardiac event. Patient subsequently developed redness and soreness at injection site. The area of the injection site reaction was approximately 4 inches in diameter.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Localized reaction..redness around injection site measuring 4 1/4? horizontally and 2 3/4 vertically ..immunization given at Pharmacy with no reaction other than localized tenderness to touch until 10-22-2018. Reaction reported to Family Medicine but pay phone call. Allergy medication taken at home.
Age: 14.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Abdominal pain, Abdominal pain upper, Anal incontinence, Culture, Dizziness
Clinical narrative: Symptoms include: flu shot and hep A given 5 days prior on 10/18/18 and then on 10/19/18 she had dizziness and headache and had to lay down and rest, each time she would get up she felt a little dizzy so she would lay down and rest and drank some juice. No fainting, no fever, no loss of consciousness, no emesis. Rested and felt better on 10/20/18 with no symptoms. Then on 10/20/18 at church in the morning felt stomach ache and so laid her head in moms lap and then said she "couldn't feel her midsection" and had loss of bowel and bladder control-stool and urine all came out. In 10-15 min, she was able to walk out of church holding onto mom. Went home and showered independently and abd pain got better as day went on. Ate dinner last night and ate this am and has some pain below belly button but no diarrhea, no emesis. Hasn't tried any medicine. When mom asked her if she would have been able to get up and leave if the church has been on fire she said she would not have been able to walk.
Age: 14.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Headache, Urinary incontinence, Urine analysis normal
Clinical narrative: Symptoms include: flu shot and hep A given 5 days prior on 10/18/18 and then on 10/19/18 she had dizziness and headache and had to lay down and rest, each time she would get up she felt a little dizzy so she would lay down and rest and drank some juice. No fainting, no fever, no loss of consciousness, no emesis. Rested and felt better on 10/20/18 with no symptoms. Then on 10/20/18 at church in the morning felt stomach ache and so laid her head in moms lap and then said she "couldn't feel her midsection" and had loss of bowel and bladder control-stool and urine all came out. In 10-15 min, she was able to walk out of church holding onto mom. Went home and showered independently and abd pain got better as day went on. Ate dinner last night and ate this am and has some pain below belly button but no diarrhea, no emesis. Hasn't tried any medicine. When mom asked her if she would have been able to get up and leave if the church has been on fire she said she would not have been able to walk.
Age: 21.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Incorrect route of product administration, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient presented to the Local Health Dept. on 10/4/18 requesting immunizations. It was discovered on our questionnaire patient had received vaccines in the last 4 weeks. She had documentation from her workplace of ZOSTAVAX and TDap given on 9/19/18. Patient had no adverse event due to vaccines given. However, patient is 21 years of age and received ZOSTAVAX which is not recommended for those under the age of 50 as best practice. It appears she was needing Varicella vaccine due to school requirements. The documentation provided by the Nursing Home facility also states it was administered IM which ZOSTAVAX is to be given SQ.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Headache, Rash, Swelling
Clinical narrative: Swelling, rash, pain on right side of head.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Erythema, Hyperhidrosis, Urticaria
Clinical narrative: After Vaccine, child turned red and had welps over entire body and was crying. She also started to sweat, no fever. TYLENOL given, child was able to be consoled and ate and fell asleep, we kept in office for 60 minutes following reaction for observation. Welps and redness went away.