chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient was administered her first SHINGRIX dose in the pharmacy on 5/3/18. She came into the pharmacy again on 5/19/18 and reported that she experienced an injection site reaction from the vaccine. She stated that on day 2 or 3 after getting the vaccine her arm got quite sore and there was a red, swollen area around the injection site. She said that the area was warm and it got itchy as well. She went to see her primary doctor a week or two after getting the vaccine to have the area looked at. The physician told her not to receive the second dose of SHINGRIX. Patient told me that her arm stayed itchy and sore for a couple weeks, but it has since resolved.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient was administered her first SHINGRIX dose in the pharmacy on 5/3/18. She came into the pharmacy again on 5/19/18 and reported that she experienced an injection site reaction from the vaccine. She stated that on day 2 or 3 after getting the vaccine her arm got quite sore and there was a red, swollen area around the injection site. She said that the area was warm and it got itchy as well. She went to see her primary doctor a week or two after getting the vaccine to have the area looked at. The physician told her not to receive the second dose of SHINGRIX. Patient told me that her arm stayed itchy and sore for a couple weeks, but it has since resolved.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a currently 18 years old patient of unknown gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 06-APR-2015, 03-AUG-2015 and 29-SEP-2015, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route of administration were not provided) for prophylaxis. The patient was 13 years old at the moment of vaccination. The administered schedule was not congruent with the recommended one. The patient did not experience any adverse event.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified adult patients of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patients were vaccinated with the pediatric/adolescent dose of VAQTA for prophylaxis (dose, route of administration, lot number and expiration date were not reported) as their initial dose. Nevertheless, no adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 24-NOV-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. On or about 11-DEC-2015 the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The patient has been prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
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 male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and 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 of herpes zoster, also known as shingles and other complications. On or about 16-JAN-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, 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 has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Drug ineffective
Clinical narrative: This spontaneous report was received from a consumer and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions or medical history provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX vial (exact dose, route of administration, lot# and expiration date were not reported) to prevent shingles. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patient was told that ZOSTAVAX was ineffective. However, the reporter stated she was also vaccinated with a dose of ZOSTAVAX in approximately 2015 (reported as 3 years ago) and did not get shingles. The outcome of the event and the relatedness between the event and ZOSTAVAX were not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 17-MAY-2018, the patient was vaccinated with an expired dose of Oka/MerckVARIVAX injection (lot # M009764, expiration date 23-FEB-2018) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent (manufacturer unknown). The reported believed the suspect vaccine was administered intramuscularly instead of subcutaneously. No adverse effects were reported.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac function test normal, Chest pain
Clinical narrative: Patient had chest pains after vaccine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Mobility decreased, Pain in extremity
Clinical narrative: Extremely sore arm, almost couldn't move it. Redness at injection site. Flu-like symptoms.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain, Myalgia
Clinical narrative: No atypical sx reported. Muscle/injection site soreness. Injected subcutaneous vs intramuscular 1st dose.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Loss of consciousness, Nausea, Vomiting
Clinical narrative: Pt reported to EdDpresenting with N/V/D had dizziness and briefly became unconscious this has all occurred within 30min of vaccine administration.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Asthenia, Eye movement disorder, Fatigue, Hyperhidrosis, Malaise
Clinical narrative: Approximately 1-2 min. after receiving vaccines while sitting upright in a chair, pt's head went back, eyes rolled back and her arms flexed. After calling her name a few times pt. responded by looking forward. After questioning her if she felt ok she replied "just tired." Pt nodded her head yes when asked if she knew where she was. Pt. reported she felt sick and gagged but did not vomit. Pt became pale and began sweating. She was then assisted to table by mother and nursing staff. She  drank some water  and laid down. Pt reported she just felt tired and weak. Prior to getting vaccines pt. had blood drawn for lipid panel and was fasting.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Muscle contractions involuntary, Pallor, Posture abnormal, Retching
Clinical narrative: Approximately 1-2 min. after receiving vaccines while sitting upright in a chair, pt's head went back, eyes rolled back and her arms flexed. After calling her name a few times pt. responded by looking forward. After questioning her if she felt ok she replied "just tired." Pt nodded her head yes when asked if she knew where she was. Pt. reported she felt sick and gagged but did not vomit. Pt became pale and began sweating. She was then assisted to table by mother and nursing staff. She  drank some water  and laid down. Pt reported she just felt tired and weak. Prior to getting vaccines pt. had blood drawn for lipid panel and was fasting.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: May 17, 2018, at night, she had headache, ache and fever 102 not helped by Tylenol/ibuprofen. Severe pain and had to take Norco. She was advised by pharmacist to call emergency if not better. She went to emergency room 5/19/18 and was treated with antibiotic and pain meds (toradol, morphine, prednisone, Benadryl).
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Common solicited: pain, redness and swelling at the injection site, headache. Other symptoms included itching and nausea. Treatment recommendations included OTC (diphenhydramine HCL 25 mg) according to directions on box. Outcome: currently monitoring.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: Common solicited: pain, redness and swelling at the injection site, headache. Other symptoms included itching and nausea. Treatment recommendations included OTC (diphenhydramine HCL 25 mg) according to directions on box. Outcome: currently monitoring.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Lethargy
Clinical narrative: Pt stated almost immedicately (same day) he became very fatigued. No fever, but lethargic. It lasted for 3 days for him.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Soreness in arm, swelling in lymph node of associated arm.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Very sore arm, rash on length of upper arm.
Age: 39.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Swelling and hardness around injections site within minutes of receiving vaccine.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site reaction, Rash generalised, Skin lesion
Clinical narrative: MOP reported lesions around site approximately 10 day after administration. Full body rash 12 days after administration of vaccines.
Age: 56.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Immediate post-injection reaction, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt stated arm was sore right after shot and continued to be sore. Pt stated when she changed her clothes in the am, two days later, noted arm was beet red, hot, swollen, from her shoulder to her elbow. Pt stated she called another clinic she goes to urgent care line and was told to ice arm and alternate ibuprofen with tylenol, for pain.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site swelling, Lethargy
Clinical narrative: At about 26 hours after immunization, patient had severe nausea and headache. This was followed up by soreness throughout her body and arthritis type pain in her joints. A few hours later her arm had begun to swell and the injection site swelled and became bright red. This swelling went up her arm and into her neck on the left side. Her lymph nodes became swollen. Two days after injection, she developed an itch throughout her body that persisted for 24 hours and she became lethargic.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Nausea, Pain, Peripheral swelling, Pruritus generalised
Clinical narrative: At about 26 hours after immunization, patient had severe nausea and headache. This was followed up by soreness throughout her body and arthritis type pain in her joints. A few hours later her arm had begun to swell and the injection site swelled and became bright red. This swelling went up her arm and into her neck on the left side. Her lymph nodes became swollen. Two days after injection, she developed an itch throughout her body that persisted for 24 hours and she became lethargic.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: At about 26 hours after immunization, patient had severe nausea and headache. This was followed up by soreness throughout her body and arthritis type pain in her joints. A few hours later her arm had begun to swell and the injection site swelled and became bright red. This swelling went up her arm and into her neck on the left side. Her lymph nodes became swollen. Two days after injection, she developed an itch throughout her body that persisted for 24 hours and she became lethargic.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever of 100. Patient instructed to take TYLENOL or other fever reducing medication and monitor.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Initially the injection redness area was about the size of a quarter. The circle of redness has expanded to almost her elbow and is very tender.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 08-MAY-2018, the patient was inadvertently vaccinated with a dose of PROQUAD injection via subcutaneous route, lot # M039447 with expiration date on 08-MAY-2018. No adverse events were reported.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was scheduled for vaccines in office today. Vaccines from today's visit included Tdap, MENVEO, and GARDASIL 9. Pt had previously received Tdap vaccine with PE on 05/07/2018. No adverse event witnessed and no treatment needed - just a duplicate dose of vaccine given.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Left upper arm medial aspect with a 14 x 14 cm in longest dimension erythematous, edematous with central area darker with firm tender area. Patient states area is very painful to touch. Increased warmth to touch. No drainage noted. Acute illness with fever 101.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Left upper arm medial aspect with a 14 x 14 cm in longest dimension erythematous, edematous with central area darker with firm tender area. Patient states area is very painful to touch. Increased warmth to touch. No drainage noted. Acute illness with fever 101.
Age: 33.0
Sex: F
Vaccine: HEPAB, TDAP, VARCEL
Symptoms: Arthralgia, Blister, Erythema, Fatigue, Headache
Clinical narrative: 4/5/2018 VARIVAX. 4/13/2018 Nausea, fatigue and joint aches. 4/15/2018 rash LEFT arm then spreading. Headache and light sensitivity. O) well appearing T 99.7, neck supple, LEFT lateral upper arm (site of injection) several grouped clear vesicles on bed base Face, upper extremity torso with isolated clear vesicles on red base P) BENADRYL at HS, Acetamiophen, Ibuprofen prn, No ASA. Self isolation, No clinicals ZOVIRAX 800 mg QID x 5 days.
Age: 33.0
Sex: F
Vaccine: HEPAB, TDAP, VARCEL
Symptoms: Injection site vesicles, Nausea, Photophobia, Rash
Clinical narrative: 4/5/2018 VARIVAX. 4/13/2018 Nausea, fatigue and joint aches. 4/15/2018 rash LEFT arm then spreading. Headache and light sensitivity. O) well appearing T 99.7, neck supple, LEFT lateral upper arm (site of injection) several grouped clear vesicles on bed base Face, upper extremity torso with isolated clear vesicles on red base P) BENADRYL at HS, Acetamiophen, Ibuprofen prn, No ASA. Self isolation, No clinicals ZOVIRAX 800 mg QID x 5 days.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: Patient was given MENACTRA and should have had Meningitis B vaccine. No symptoms.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient called 05/21/2018 with a red rash to cheeks. No other s/s. Family will continue to monitor will call back if worsens.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red, warm injection site area.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Colitis, Condition aggravated
Clinical narrative: I gave the patient the vaccine on 05/17/2018. The patient has stated that he has had a flare up of his colitis ever since receiving the vaccine. Patient also states that this is the first episode of his colitis that he has had in a long time.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Hep A given first. HPV 9 given second. Client fainted immediately after administration. Fainting spell lasted approx 5-10 seconds. Cool, wet towel placed on client's forehead. Client laid down. Drank water. Observed for 5 minutes in clinic. Client left talking/walking with father.
Age: 61.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: Onset of rash on chest and neck with a low grade fever and headache. Went to local Urgent Care Center for medical care. Denied respiratory distress.
Age: 63.0
Sex: M
Vaccine: HEPAB
Symptoms: Eye movement disorder, Musculoskeletal stiffness, Syncope
Clinical narrative: Patient stopped in our pharmacy wanting a Hep A&B vaccination. We entered his info into computer and ran TWINRIX thru on our Standing Order. I reviewed standing order questionnaire, then reviewed with patient. He stated he felt fine and had no fever. I then administered vaccination. I reviewed possible side effects he could possibly expect and it was recommended he wait around in pharmacy area or store for around 20 minutes, then patient proceeded to leave but then asked if he could just sit in IMZ area, I said yes. I came back in pharmacy to finish paperwork, then after 2 to 3 minutes I was giving paperwork to technician to enter into service admin, I glanced out at patient, which I noticed he was collapsing and sliding out of chair onto the floor. I ran out of pharmacy toward patient to assist, which I noticed patient being stiff, eyes rolled back, I had my technician call 911, then grabbed patient and shook he, calling out his name. After about 10-15 seconds, patient came to and EMTs arrived, assessing the patient.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Rash
Clinical narrative: On May 22, 2018 patient came into the pharmacy and asked if he should get a second SHINGRIX shot. He said he had a rash that has not gone away since he got the shot on 4/2/2018. He showed me his left shoulder. It had six "pock marks" of varying sizes. When asked he said they were itchy but not excessive.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest X-ray normal, Fatigue, Full blood count normal, Lethargy, Pain
Clinical narrative: Low grade fever, body aches, fatigue, lethargy, tingling in all extremities and head.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Low grade fever, body aches, fatigue, lethargy, tingling in all extremities and head.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Red, painful rash that got worse over the first 48 hours but has been getting better over the last 24. No other symptoms.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia
Clinical narrative: Patient had severe myalgia which presented a week after vaccine was given. Patient is slowly improving but still has muscle pain.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bedridden, Injection site pain, Insomnia, Musculoskeletal pain, Myalgia
Clinical narrative: Patient had severe myalgia which presented a week after vaccine was given. Patient is slowly improving but still has muscle pain.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Patient had severe myalgia which presented a week after vaccine was given. Patient is slowly improving but still has muscle pain.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Lymphadenopathy, Skin irritation
Clinical narrative: The day following the injection, the patient's arm became very red below the the injection site. 48 hours following the injection, she developed what appears to be a swollen lymph node that is palpable and irritated.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: After a couple of hours pain at injection site for 4-5 days. 1 to 10 scale a 7. Very slight pain if you touch the area after 5 days for a few more days. Redness at injection site for 3 days. Size approx 3-4 inches dia. Believe there was slight swelling but masked by pain. Heat (Warm to touch) generated at injection site for 2-3 days. Had slight fatigue but that may have nothing to do with injection.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: After a couple of hours pain at injection site for 4-5 days. 1 to 10 scale a 7. Very slight pain if you touch the area after 5 days for a few more days. Redness at injection site for 3 days. Size approx 3-4 inches dia. Believe there was slight swelling but masked by pain. Heat (Warm to touch) generated at injection site for 2-3 days. Had slight fatigue but that may have nothing to do with injection.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Feeding disorder, Headache, Insomnia, Loss of personal independence in daily activities
Clinical narrative: Moderate pain in arm interfering with activity day 2 to 5. Pain radiated up neck and ear/jaw area. I have old left shoulder rotater cuff injury, long healed. Had surgical manipulation and long term PT.  Reminded me of that experience. Vertigo and nausea intermittent incidents during days 2 to 5 severe enough, for example, I had to abort a grocery shopping trip in the middle and was unable to drive another time. Nearly continous headache, earache and jaw/teeth pain on left side (trigemic nerve irritation). Day 2 to 7. Severity fluxuated but at times made it impossivle to eat (jaw pain) or sleep. Frequency of severe pain level episodes tapered after day 5.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neck pain, Pain in extremity, Pain in jaw, Toothache
Clinical narrative: Moderate pain in arm interfering with activity day 2 to 5. Pain radiated up neck and ear/jaw area. I have old left shoulder rotater cuff injury, long healed. Had surgical manipulation and long term PT.  Reminded me of that experience. Vertigo and nausea intermittent incidents during days 2 to 5 severe enough, for example, I had to abort a grocery shopping trip in the middle and was unable to drive another time. Nearly continous headache, earache and jaw/teeth pain on left side (trigemic nerve irritation). Day 2 to 7. Severity fluxuated but at times made it impossivle to eat (jaw pain) or sleep. Frequency of severe pain level episodes tapered after day 5.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Moderate pain in arm interfering with activity day 2 to 5. Pain radiated up neck and ear/jaw area. I have old left shoulder rotater cuff injury, long healed. Had surgical manipulation and long term PT.  Reminded me of that experience. Vertigo and nausea intermittent incidents during days 2 to 5 severe enough, for example, I had to abort a grocery shopping trip in the middle and was unable to drive another time. Nearly continous headache, earache and jaw/teeth pain on left side (trigemic nerve irritation). Day 2 to 7. Severity fluxuated but at times made it impossivle to eat (jaw pain) or sleep. Frequency of severe pain level episodes tapered after day 5.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Fever, red tender swollen arm, upset stomach.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age. The patient's concurrent conditions and medical history were not reported. The patient's concomitant therapy included DILUENT MRK INJ. On 18-MAY-2018, the patient was vaccinated with a dose of Oka/Merck VARIVAX (0.5 ml, once), lot # N027628, expiration date: 04-OCT-2019 via intramuscular route (product storage error, incorrect route of drug administration). The DILUENT MRK INJ was properly stored. No adverse events were reported. The temperature range was from 6 degree Fahrenheit to 14 degree Fahrenheit (max 10F) and time frame was 2 hours. No previous temperature excursions were reported. The call was from a digital data logger. No product quality complaint (PQC) was reported.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, Swelling, bruising and pain at injection site. Over 4 days, symtoms got worse and redness around injection site expanded. Customer was treated with topical steroid as well as an oral steroid from a doctor.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Client was administered an expired vaccine expired on 19 May 2018 and it was administered on 21 May 2018. Client tolerated vaccination well at time of administration.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: RASH, HOT, SWOLLEN AND PAINFUL ARM THAT LASTED FOR 3-4 DAYS, PATIENT ALSO MIGHT HAVE EXPERIENCED HER THROAT CLOSING IN BUT WAS NOT SURE IF IT WAS BECAUSE OF ANXIETY.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Injection site induration, Injection site irritation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient stated she felt slight tenderness and warmth to injection site. Area is hard and slightly swollen. Gave her cold compress and made ibuprophen available to her. Clinic contacted and she was referred to urgent care. Clinic stated it was slightly irritated. Prescribed her BENADRYL, HYDROCORDISONE CREAM, and warm compress to area.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever of 100°. Sore arm.
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Fatigue, Feeling cold, Pyrexia
Clinical narrative: Patient felt tired and cold at work today. When she arrived home, she took her temperature. She had a fever of 101.8 degrees. Suggested treatment: rest, TYLENOL and to contact doctor if fever persists or increases.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Disorientation, Dizziness, Hyperhidrosis, Loss of consciousness, Vomiting
Clinical narrative: Patient passed out sitting up in a chair a couple minutes after the vaccination was given while I was holding the cotton ball to his arm. Patient was visibly anxious prior to the vaccination and stated to me that he doesn't do well with shots. After a couple of seconds the patient came to,  he was disoriented and visible sweating. Nurses came over from the clinic next door to assist while the paramedics were in route. The patient stated to have not ate all day. Patient asked for water, said he felt fine but was a little dizzy. The paramedics arrived, checked the patient's vitals during this time the patient vomited up the water.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT SUBSEQUENTLY TREATED FOR CELLULITIS WITH KEFLEX. PATIENT REPORTED PAIN, SWELLING, REDNESS, TENDERNESS AND WARMTH AT INJECTION, WITH VOMITING AND NAUSEA.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Vomiting
Clinical narrative: PATIENT SUBSEQUENTLY TREATED FOR CELLULITIS WITH KEFLEX. PATIENT REPORTED PAIN, SWELLING, REDNESS, TENDERNESS AND WARMTH AT INJECTION, WITH VOMITING AND NAUSEA.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: The patient reported pain extending from her elbow to her shoulder that presented a few hours following the injection. She stated she had some difficulty lifting her arm. She stated it hurt more than previous IM injections, including the first shot in the SHINGRIX series. She tried an OTC pain reliever with little success. I counseled her to also use a hot pack. This is currently the same day as the vaccination so outcomes are yet to be determined.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Patient called the evening of 5/14/18 complaining of severe arm pain. I called the patient on 5/16/18 to follow up with her, she reported improvement. On 5/21/18, patient was in the store and indicated that her arm still has pulsing/throbbing pain and reduced range of motion.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site streaking, Injection site swelling
Clinical narrative: Patient noticed a red bump approximately 4" in diameter the morning after receiving her vaccination.  She reported pain, swelling, heat, and itching at the site. She denied any fever, chills, or systemic effects other than general fatigue she thought might be attributed to the vaccine. She came to the pharmacy approximately 72 hours after receiving the vaccination. She said the injection/reaction site had not gotten better or worse since the morning after her shot. There was a small red streak coming from the site, but she said it had reduced in color since the morning. I advised her to monitor for signs of infection/worsening of the site and to contact her doctor the next morning to be seen and evaluated.  I called her about 24 hours after she came to us. She reported that the red area was shrinking and she was feeling a "little better."
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Patient noticed a red bump approximately 4" in diameter the morning after receiving her vaccination.  She reported pain, swelling, heat, and itching at the site. She denied any fever, chills, or systemic effects other than general fatigue she thought might be attributed to the vaccine. She came to the pharmacy approximately 72 hours after receiving the vaccination. She said the injection/reaction site had not gotten better or worse since the morning after her shot. There was a small red streak coming from the site, but she said it had reduced in color since the morning. I advised her to monitor for signs of infection/worsening of the site and to contact her doctor the next morning to be seen and evaluated.  I called her about 24 hours after she came to us. She reported that the red area was shrinking and she was feeling a "little better."
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Insomnia, Malaise, Myalgia
Clinical narrative: In the evening, I developed pain in the right arm, muscle aches, fever and chills, loss of appetite and a feeling of malaise which lasted about 24 hours. I was only able to sleep for 3 hours.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: In the evening, I developed pain in the right arm, muscle aches, fever and chills, loss of appetite and a feeling of malaise which lasted about 24 hours. I was only able to sleep for 3 hours.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia, Pain, Product administered at inappropriate site
Clinical narrative: Flu shot was given high in my left shoulder and I have suffered with shoulder pain since having the flu shot administered to me. I cant sleep on my left side or lift my arm above my shoulder without feeling pain in my left shoulder. It feels as thought the shot was put in my joint rather than the muscle.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Dizziness, Head injury, Headache, Loss of consciousness, Nausea
Clinical narrative: Patient was given the 3 vaccines intramuscularly, she was then given the PPD. A couple minutes after that she asked if she was supposed to feel dizzy, then she passed out onto the floor from the chair. In the midst of me catching her as she was leaning off the chair she hit her head on the arm rest. Patient regained consciousness after about 7-10 seconds, we left her on the floor for a minute or two. Dr. came in and checked on her. We then helped her to lay on the bed. She began to feel nauseous, she was given an Emesis bag, then started vomiting. She was given water and an ice pack for her head because she complained of a headache where she hit her head. We called her parents to come drive her home, mom arrived about an hour and a half later to get her. Patient felt better, but still was a little nauseous. Dr. spoke to both the patient and her mother before they left.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Vomiting
Clinical narrative: Patient was given the 3 vaccines intramuscularly, she was then given the PPD. A couple minutes after that she asked if she was supposed to feel dizzy, then she passed out onto the floor from the chair. In the midst of me catching her as she was leaning off the chair she hit her head on the arm rest. Patient regained consciousness after about 7-10 seconds, we left her on the floor for a minute or two. Dr. came in and checked on her. We then helped her to lay on the bed. She began to feel nauseous, she was given an Emesis bag, then started vomiting. She was given water and an ice pack for her head because she complained of a headache where she hit her head. We called her parents to come drive her home, mom arrived about an hour and a half later to get her. Patient felt better, but still was a little nauseous. Dr. spoke to both the patient and her mother before they left.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash
Clinical narrative: The morning after (5/3/2018 Thursday morning) the injection patient experience a red rash at the site of injection which was hard and sore. On Friday 5/4 rash got bigger. The rash started to go away slowly and it was gone by Monday 5/7.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Malaise, Pyrexia, Rash
Clinical narrative: The patient started feeling ill on 5-20-18. She described a fever, malaise for the day after. Today she has a rash covering the majority of her torso. Her arm is hot. (She is an amputee and only has one.) She states she can see a pencil size red dot about an inch below the injection site. She stated that she begin taking BENADRYL 50mg. After her description, I recommended her seeking medical attention via the emergency room for probable allergic reaction to some component of the SHINGRIX.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: The patient started feeling ill on 5-20-18. She described a fever, malaise for the day after. Today she has a rash covering the majority of her torso. Her arm is hot. (She is an amputee and only has one.) She states she can see a pencil size red dot about an inch below the injection site. She stated that she begin taking BENADRYL 50mg. After her description, I recommended her seeking medical attention via the emergency room for probable allergic reaction to some component of the SHINGRIX.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Abnormal behaviour, Pyrexia, Rash, Rash vesicular, Somnolence
Clinical narrative: Started with a fever Tuesday following her shots. No other symptoms. Fever was as high 104.2. Took her to emergency Department twice. They put it off as febrile illness. Monday almost a week and a half after shots she started with a blistery rash all over belly and back. And under arms. Still has fever. Only wants to sleep. Drinks a little. Completely not herself.
Age: 21.0
Sex: M
Vaccine: JEV1
Symptoms: Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: 21 year old male with chief complaint of pruritic rash encompassing upper body x1 day after receiving JEV vaccine. Rash red, splotchy, raised. Patient noticed rash when we went to take a shower. Does not report any known allergies. Denies fevers, night sweats, and chills. No medication taken by patient for this issue.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Abnormal dreams, Back pain, Chills, Feeling abnormal, Feeling hot
Clinical narrative: Achy muscles similar to flu, severe pain in low back/could barely walk, alternating chills and hot spells, difficulty sleeping, fever dreams, shaking/trembling hands, rummy head, headache, started in the evening, took a muscle relaxer pill at 03:00am, took 2 EXCEDRIN at 07:00am, called Doctor at 08:00am, started to fell better at 09:00am, saw Doctor at 10:30am, continue to improve throughout the day.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Headache, Insomnia, Myalgia, Pyrexia
Clinical narrative: Achy muscles similar to flu, severe pain in low back/could barely walk, alternating chills and hot spells, difficulty sleeping, fever dreams, shaking/trembling hands, rummy head, headache, started in the evening, took a muscle relaxer pill at 03:00am, took 2 EXCEDRIN at 07:00am, called Doctor at 08:00am, started to fell better at 09:00am, saw Doctor at 10:30am, continue to improve throughout the day.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Achy muscles similar to flu, severe pain in low back/could barely walk, alternating chills and hot spells, difficulty sleeping, fever dreams, shaking/trembling hands, rummy head, headache, started in the evening, took a muscle relaxer pill at 03:00am, took 2 EXCEDRIN at 07:00am, called Doctor at 08:00am, started to fell better at 09:00am, saw Doctor at 10:30am, continue to improve throughout the day.
Age: 1.67
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Blood test normal, Febrile convulsion, Pyrexia, Urine analysis normal
Clinical narrative: Developed febrile seizures and fever over 104-105.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at sight (hard knot 2-3 across), heat, soreness. When I rubbed at it and found the swelling, I took Tylenol & used an ice pack. Then I went to bed for the night. I assume it will be better or gone tomorrow.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Injection site pain, Nausea
Clinical narrative: Aches in head and injection site, stomach cramps, slight nausea, subsiding slowly after a day and a half. I took 1 TYLENOL capsule, which was not effective.
Age: 45.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Angiotensin converting enzyme decreased, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Bartonella test negative, Blood electrolytes normal
Clinical narrative: Started with heaviness on shoulder with pain and fever which normally expected but by noon severe body aches and severe pain on right lateral side of the body from waist up, by night I felt severe pain as if needles needles pricking. Make an appointment with primary care to find out I had developed Cellulitis and started pain medication and antibiotics. On 01/27/2018 I had my regular eye dilation check for Diabetic Retinopathy where the optometrist saw some swelling on the optic nerve. Has a stat MRI and an ophthalmologist appointment on 01/31/2018 where Dr and 2 other Ophthalmologist came to a conclusion that I have developed Optic neuropathy and papilledema. After that had a series of test and specialist appointments for next 2-3 months. The test conducted and MRI as well as spinal tap results were concluded normal. The tests are mentioned below.
Age: 45.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Cellulitis, Diabetic retinopathy, Differential white blood cell count normal, Discomfort, Full blood count normal
Clinical narrative: Started with heaviness on shoulder with pain and fever which normally expected but by noon severe body aches and severe pain on right lateral side of the body from waist up, by night I felt severe pain as if needles needles pricking. Make an appointment with primary care to find out I had developed Cellulitis and started pain medication and antibiotics. On 01/27/2018 I had my regular eye dilation check for Diabetic Retinopathy where the optometrist saw some swelling on the optic nerve. Has a stat MRI and an ophthalmologist appointment on 01/31/2018 where Dr and 2 other Ophthalmologist came to a conclusion that I have developed Optic neuropathy and papilledema. After that had a series of test and specialist appointments for next 2-3 months. The test conducted and MRI as well as spinal tap results were concluded normal. The tests are mentioned below.
Age: 45.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Fungal test negative, HIV test negative, Lumbar puncture normal, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Started with heaviness on shoulder with pain and fever which normally expected but by noon severe body aches and severe pain on right lateral side of the body from waist up, by night I felt severe pain as if needles needles pricking. Make an appointment with primary care to find out I had developed Cellulitis and started pain medication and antibiotics. On 01/27/2018 I had my regular eye dilation check for Diabetic Retinopathy where the optometrist saw some swelling on the optic nerve. Has a stat MRI and an ophthalmologist appointment on 01/31/2018 where Dr and 2 other Ophthalmologist came to a conclusion that I have developed Optic neuropathy and papilledema. After that had a series of test and specialist appointments for next 2-3 months. The test conducted and MRI as well as spinal tap results were concluded normal. The tests are mentioned below.
Age: 45.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Nuclear magnetic resonance imaging brain normal, Optic neuropathy, Pain, Papilloedema, Paraesthesia
Clinical narrative: Started with heaviness on shoulder with pain and fever which normally expected but by noon severe body aches and severe pain on right lateral side of the body from waist up, by night I felt severe pain as if needles needles pricking. Make an appointment with primary care to find out I had developed Cellulitis and started pain medication and antibiotics. On 01/27/2018 I had my regular eye dilation check for Diabetic Retinopathy where the optometrist saw some swelling on the optic nerve. Has a stat MRI and an ophthalmologist appointment on 01/31/2018 where Dr and 2 other Ophthalmologist came to a conclusion that I have developed Optic neuropathy and papilledema. After that had a series of test and specialist appointments for next 2-3 months. The test conducted and MRI as well as spinal tap results were concluded normal. The tests are mentioned below.
Age: 45.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Pupil dilation procedure, Pyrexia, Red blood cell sedimentation rate normal, Toxoplasma serology negative, Treponema test negative
Clinical narrative: Started with heaviness on shoulder with pain and fever which normally expected but by noon severe body aches and severe pain on right lateral side of the body from waist up, by night I felt severe pain as if needles needles pricking. Make an appointment with primary care to find out I had developed Cellulitis and started pain medication and antibiotics. On 01/27/2018 I had my regular eye dilation check for Diabetic Retinopathy where the optometrist saw some swelling on the optic nerve. Has a stat MRI and an ophthalmologist appointment on 01/31/2018 where Dr and 2 other Ophthalmologist came to a conclusion that I have developed Optic neuropathy and papilledema. After that had a series of test and specialist appointments for next 2-3 months. The test conducted and MRI as well as spinal tap results were concluded normal. The tests are mentioned below.
Age: 45.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Blood test normal, Cellulitis, Injection site pain, Laboratory test normal, Lumbar puncture normal
Clinical narrative: Started with heaviness on shoulder with pain and fever which normally expected but by noon severe body aches and severe pain on right lateral side of the body from waist up, by night I felt severe pain as if needles needles pricking. Make an appointment with primary care to find out I had developed Cellulitis and started pain medication and antibiotics. On 01/27/2018 I had my regular eye dilation check for Diabetic Retinopathy where the optometrist saw some swelling on the optic nerve. Has a stat MRI and an ophthalmologist appointment on 01/31/2018 where Dr and 2 other Ophthalmologist came to a conclusion that I have developed Optic neuropathy and papilledema. After that had a series of test and specialist appointments for next 2-3 months. The test conducted and MRI as well as spinal tap results were concluded normal. The tests are mentioned below.
Age: 45.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Optic neuritis, Pain, Pain in extremity, Visual impairment
Clinical narrative: Started with heaviness on shoulder with pain and fever which normally expected but by noon severe body aches and severe pain on right lateral side of the body from waist up, by night I felt severe pain as if needles needles pricking. Make an appointment with primary care to find out I had developed Cellulitis and started pain medication and antibiotics. On 01/27/2018 I had my regular eye dilation check for Diabetic Retinopathy where the optometrist saw some swelling on the optic nerve. Has a stat MRI and an ophthalmologist appointment on 01/31/2018 where Dr and 2 other Ophthalmologist came to a conclusion that I have developed Optic neuropathy and papilledema. After that had a series of test and specialist appointments for next 2-3 months. The test conducted and MRI as well as spinal tap results were concluded normal. The tests are mentioned below.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Injection site pain, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: Soreness at injection site. After about 2wks started to get severe pain in both shoulders and biceps. Used TYLENOL and ice packs. Pain is still persistent. Hurts mostly when arm is in motion. Also having pain in knees.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Soreness at injection site. After about 2wks started to get severe pain in both shoulders and biceps. Used TYLENOL and ice packs. Pain is still persistent. Hurts mostly when arm is in motion. Also having pain in knees.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Musculoskeletal pain, Myalgia
Clinical narrative: Normal soreness at injection site. After about 2 wks severe pain in shoulders and biceps. Ice bag and TYLENOL were used. Pain still elevated, hasn't decreased.