chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient has complained of a sore arm since the vaccine. Nothing topically but hurts to raise arm or move in any direction upward. He is interested if this has occurred with anyone else. Condition are still persisting today.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, X-ray limb normal
Clinical narrative: She experienced immediate pain at site followed by difficulty with range of motion of right shoulder and arm, pain radiated to top of shoulder area. After 2-3 weeks of pain and decreased range of motion, she sought care at Urgent Care. Urgent Care provider instructed her to apply ice to the area, take MOTRIN and prescribed range of motion exercises. She followed instructions and pain persisted. She saw her primary care provider and x-ray of right shoulder ordered. Normal findings. Returned to primary care provider on 10/27/2017 and pain was getting better. Primary care provider referred to physical therapy and she went to one session today, 10/30/2017. Range of motion exercises provided and shoulder iced. Pain has decreased and range of motion is better.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Pain, Peripheral swelling, Skin warm
Clinical narrative: Swollen arm, hot to the touch, head aches, body aches, and pain. Took ibuprofen and iced the area. She is better.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Patient called to report abnormal swelling on the left arm extending from just below the arm pit and extending to below elbow. Over the weekend it was fairly swollen but patient stated it seems to be resolving and is less swollen now but still not completely resolved.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red, hot area at injection site. 2.5" wide & 3.5" long. Tender to touch. Not itchy.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Haemoglobin normal, Streptococcus test negative, Vaccination complication
Clinical narrative: She contracted what i thought was scarlet fever nearly two months after injections but all symptoms also line up with the adverse reactions to the GARDASIL 9 shot.
Age: 26.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Dizziness, Pallor, Peripheral coldness
Clinical narrative: Client came in for vaccination for job assignment. Client received the following vaccines Tdap, HepA  and Typhoid. Client stated I get nervous when I get shots. After shots client looked paled and cold to touch. Reported feeling a little dizzy applied cold compress to neck. Taken to exam room monitored vital signs 3:50 106/71 P49 O2 sat 99, 4:00 112/72 P 48, 4:05 113/78 64 02 sat 98. Client also reported had only eaten a piece of cake. Client was given cracker and a bottle of water. Later reported feeling better. Client appeared stable dismissed at 4:15.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Gait disturbance, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Patient reported numbness and loss of use of her left arm. She reported being weak and barely able to walk. She went to the ER today (after 4 days) to receive fluids and is feeling better.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Presyncope
Clinical narrative: Approximately 3 minutes after vaccination patient experienced a pre-syncopal/syncopal event. She was advised to stay seated and put her head between her knees. She was able to follow commands, had a normal pulse throughout. She stated she felt like vomiting. She was observed for an additional 10 minutes in which she was fully alert., cooperative, able to follow commands, and stated feeling better. She was able to stand and walk steadily and was escorted out of the clinic by her parent (father)
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Angiogram, Angiogram cerebral, Asthenia, Back pain
Clinical narrative: Slight Fever, Severe Aching muscles, especially in your back, arms and legs. Chills and sweats, Headache, Stomach and back pain. Dry, persistent cough, Fatigue, extreme weakness, vomiting.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Chest X-ray, Chills, Cough, Fatigue
Clinical narrative: Slight Fever, Severe Aching muscles, especially in your back, arms and legs. Chills and sweats, Headache, Stomach and back pain. Dry, persistent cough, Fatigue, extreme weakness, vomiting.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hyperhidrosis, Laboratory test, Myalgia, Nuclear magnetic resonance imaging
Clinical narrative: Slight Fever, Severe Aching muscles, especially in your back, arms and legs. Chills and sweats, Headache, Stomach and back pain. Dry, persistent cough, Fatigue, extreme weakness, vomiting.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Ultrasound scan, Vomiting
Clinical narrative: Slight Fever, Severe Aching muscles, especially in your back, arms and legs. Chills and sweats, Headache, Stomach and back pain. Dry, persistent cough, Fatigue, extreme weakness, vomiting.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Chills, Cough, Decreased appetite, Fatigue, Influenza like illness
Clinical narrative: 2 days after receiving the vaccination she had flu like symptoms, body aches, fever chills. 3-4 days later, felt better, then 9/30, got cold that went away, but had symptoms of fever, extreme fatigue, naggy cough, lack/ no appetite. She still feels sick and has a lot of coughing, but the coughing has been getting better.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: 2 days after receiving the vaccination she had flu like symptoms, body aches, fever chills. 3-4 days later, felt better, then 9/30, got cold that went away, but had symptoms of fever, extreme fatigue, naggy cough, lack/ no appetite. She still feels sick and has a lot of coughing, but the coughing has been getting better.
Age: 23.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Fatigue, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms. Muscle aches, fatigue, and feeling dizzy.
Age: 67.0
Sex: M
Vaccine: FLUA3, HEPAB
Symptoms: Pruritus generalised, Throat tightness, Urticaria
Clinical narrative: Pharmacist and manager of store, administered both vaccines on 10/19/2017. Patient developed a reaction 24 hours after the administration of the vaccines. He stated he went to see his doctor, who gave him steroid shots which seemingly stopped the severe reaction (hives, ichiness all over body, and throat closing). He stated the steroid shot didn't last long and the reaction started. His doctor phoned in an order for prednisone 20 mg tablets on 10/30/17 to stop the reaction. Employee did not notice any hives or swollen spots at the time of consultation on 10/30/17. Patient inquired if he should get the next dosage and employee referred him to consult his physician. (Note: patient had requested accelerated dosing schedule due to travel). He received one dosage thus far on 10/19/17.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Axillary pain, Breast pain, Contusion, Decreased appetite, Lethargy
Clinical narrative: Pt has pain in left arm which is radiating to her axilla area and into her breast area. She reports no appetite and feeling rather lethargic. She also states she has bruising on left arm. She had fallen earlier in the week and had a bruise on her elbow.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Pt has pain in left arm which is radiating to her axilla area and into her breast area. She reports no appetite and feeling rather lethargic. She also states she has bruising on left arm. She had fallen earlier in the week and had a bruise on her elbow.
Age: 39.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: Severe left arm pain with 3" redness, fever of 102+ for two days, severe aches and pains.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Abnormal sensation in eye, Nodule, Skin warm, Swollen tongue, Throat tightness
Clinical narrative: Throat closing, tongue swelling, eyes felt hot, knot with heat, went to ER and got BENADRYL shot.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Nasopharyngitis, Pruritus, Rash erythematous
Clinical narrative: Patient experienced adverse event following a flu vaccine. Pt received the vaccine on 10/27/17, reports red bumps on her chest on 10/28/17 that wasn't itchy. Today 10/30/17 pt states she developed more red bumps/rash on stomach and on arms (crease of elbow). The only itchy areas appear to be on the chest (severity:  mild itchiness). No injection site pains/rash. Pt states she does not have allergies to neomycin, eggs or latex. Has not taken any new medications or foods or used any new soaps or detergents. Pt has had a flu shot before (around 13 years ago) with no issues. States she had cold like symptoms that she attributed to the shot and has not gotten it since. Per my recommendation, she will visit her primary care provider tomorrow.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Administration site swelling, Injection site erythema, Injection site inflammation
Clinical narrative: Patient said her arm felt fine for the first couple days. Then she noticed some swelling below the site of administration. It appeared lower than what I would expect for a localized reaction. She said it didn't hurt but it was noticeably inflamed, slightly raised, and pink/red. She had a routine doctor appointment today and the nurse saw it and told her to come back to the pharmacy.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm became red hot and slightly swollen the day following the injection.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Bedridden, Dizziness, Hyperhidrosis, Injection site pain
Clinical narrative: Patient states he had sweating, pain, swollen arm at injection site, and dizziness/weakness, and was bedridden for most of the day.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Patient states he had sweating, pain, swollen arm at injection site, and dizziness/weakness, and was bedridden for most of the day.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Blood test normal, Dizziness, Fatigue, Headache
Clinical narrative: The following day after vaccine, symptoms were fever, dizziness, headache, fatigue, body aches, joint pain, flu like symptoms, nausea. The third day, symptoms remained, went to ER, tested negative for flu, positive for UTI. Diagnosed with reaction to vaccine and UTI. Day 4 symptoms remain without fever and little improvement.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Influenza like illness, Influenza virus test negative, Nausea, Pain, Pyrexia
Clinical narrative: The following day after vaccine, symptoms were fever, dizziness, headache, fatigue, body aches, joint pain, flu like symptoms, nausea. The third day, symptoms remained, went to ER, tested negative for flu, positive for UTI. Diagnosed with reaction to vaccine and UTI. Day 4 symptoms remain without fever and little improvement.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Urinary tract infection, Urine analysis abnormal, Vaccination complication
Clinical narrative: The following day after vaccine, symptoms were fever, dizziness, headache, fatigue, body aches, joint pain, flu like symptoms, nausea. The third day, symptoms remained, went to ER, tested negative for flu, positive for UTI. Diagnosed with reaction to vaccine and UTI. Day 4 symptoms remain without fever and little improvement.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient reporting pain/soreness in arm/shoulder. Patient says pain still in area. Patient believes may be related to flu shot.
Age: 18.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Blood test, Cardiac function test, Computerised tomogram, Dizziness, Electroencephalogram
Clinical narrative: 10/21/2014 - Severe headache, blur vision, light sensitive, dizziness, passed, out went to ER was diagnosed with Vertigo; 10/22/2014-Same symptoms as the above, went to ER and was diagnosed with Syncope; Same month 23/27/30/31- Had same symptoms as above, but this time didn't go to ER; Have more but running out of time to fill in all dates and events.
Age: 18.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Headache, Loss of consciousness, Neurological examination, Nuclear magnetic resonance imaging, Photophobia
Clinical narrative: 10/21/2014 - Severe headache, blur vision, light sensitive, dizziness, passed, out went to ER was diagnosed with Vertigo; 10/22/2014-Same symptoms as the above, went to ER and was diagnosed with Syncope; Same month 23/27/30/31- Had same symptoms as above, but this time didn't go to ER; Have more but running out of time to fill in all dates and events.
Age: 18.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Syncope, Vertigo, Vision blurred
Clinical narrative: 10/21/2014 - Severe headache, blur vision, light sensitive, dizziness, passed, out went to ER was diagnosed with Vertigo; 10/22/2014-Same symptoms as the above, went to ER and was diagnosed with Syncope; Same month 23/27/30/31- Had same symptoms as above, but this time didn't go to ER; Have more but running out of time to fill in all dates and events.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 10/24/17 8pm: injection site was puffed up, red, and hot. RPh counseled pt to wait couple days, and it may be self-limiting. 10/26/17, affected area got larger and symptoms was worse, pt went to urgent care and got prescribed KEFLEX.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Pain, Rash
Clinical narrative: Rash and Muscle stiffness and pain.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient came in on 10/27/17 with c/o redness, increased warmth, and pain at the site of injections (right deltoid). Afebrile, but has cellulitis at the site. Given BACTRIM DS bid x 10 days. She will f/u in 1 week for a recheck.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic, Swelling
Clinical narrative: Bump under skin. Itchy, scratchy, rash.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia, Rash, Rash erythematous, Urticaria
Clinical narrative: He had fever to 100.5 and fussiness on 10/22/17. Rash started 10/23/17 on back, across abdomen, left arm and right leg. Rash is described as red with irregular wheals of various sizes. Rash completely resolved on 10/26/17. He only had one day of low grade fever 10/22/17.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Below injection site, left deltoid. Measures 12 cm x 14 cm. Red, warm to touch, surface area hardened, 8-9 on pain scale of 10 when bumped. Temp 99.8 F with TYLENOL 90 min. previous.
Age: 11.0
Sex: F
Vaccine: FLUC4
Symptoms: Eye movement disorder, Hunger, Loss of consciousness, Posture abnormal, Sensory loss
Clinical narrative: Child passed out for about 3-5seconds after Flu shot head and eyes rolled back, dropped phone she was watching a video on came back up. Gave her orange juice, she initially said she could not feel body after and was hungry but was fine after the drink.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: C/O (L) arm red and warm approx 4" diameter (she stated) around injection site. "Redness started late Friday and lasted until Sunday morning. It moved from site down my upper arm midway between elbow and shoulder".
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, chills, aches.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Injection site bruising, Pain in extremity
Clinical narrative: Large bruise on upper left arm - covers most of upper arm - burning and pain in arm.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a non-health professional via call center representative and descried the occurrence of injection site erythema in a 57-year-old female patient who received FLULAVAL QUADRIVALENT. Co-suspect products included FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT and FLULAVAL QUADRIVALENT. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site erythema, injection site swelling, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related FLULAVAL QUADRIVALENT. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age vaccination was not reported. Office manager of clinic who was also the patient reported for the past years she received FLULAVAL QIV and developed a red swollen area on arm at the injection site. No further information was reported regarding the event.
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a infant female patient who received FLULAVAL Quadrivalent (batch number 4373E, expiry date unknown). In October 2017, the patient received FLULAVAL Quadrivalent. In October 2017, less than a day after receiving FLULAVAL Quadrivalent, the patient experienced hives, generalized rash and rash. The patient was treated with NOS BENADRYL. On an unknown date, the outcome of the hives, generalized rash and rash were recovering/resolving. The reporter considered the hives, generalized rash and rash to be almost certainly related to FLULAVAL Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported, but it could be 20 or 21 months. The healthcare professional reported that, the patient received FLULAVAL Quadrivalent vaccine sometime between 16th October 2017 and 21st October 2017. The patient experienced hives and rash on the face and bumps on the body within 18 hours after receiving the vaccine. The patient received BENADRYL and the symptoms subsided. The HCP was almost certain that, the FLULAVAL Quadrivalent had caused the outbreak. No additional information was given.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy started 6 days after the shot (diagnosed by ER MD).
Age: 29.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: Red rash, raised above skin over the abdomen and upper and lower extremities which has caused itching. Dx urticaria
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Local reaction, Malaise, Pain, Pyrexia, Wrong drug administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of local reaction in a 15-year-old male patient who received FLUARIX QUADRIVALENT (batch number ZG3S5, expiry date 6th June 2017). Previously administered products included Flumist (received with no previous reports of reaction). On 26th October 2016, the patient received FLUARIX QUADRIVALENT. In October 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced local reaction, malaise, fever and general body pain. The patient was treated MEDROL. On an unknown date, the outcome of the local reaction and malaise were recovered/resolved and the outcome of the fever and general body pain were unknown. It was unknown if the reporter considered the local reaction, malaise, fever and general body pain to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The case was received from Certified Medical Assistant. The patient received a dose of FLUARIX QUADRIVALENT (preservation-free GSK flu vaccine) and one day after vaccination developed 5.5 inch localized reaction, low-grade fever, malaise and body aches. The patient's mother reported to the office the following day after administration that the reactions had occurred but the exact time frame of when reactions began was unknown. The patient had a follow up appointment with the nurse practitioner. The patient was unable to receive Flumist again due to his age and was administered FLUARIX QUADRIVALENT instead, which led to wrong vaccine administered. No further information was reported regarding the event.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Mobility decreased, Nausea, Pain, Pyrexia, Syncope
Clinical narrative: Fainted, unable to raise right arm due to pain, pain right side of body, nausea, fever, body ache.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Culture throat, Dry eye, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Both eyes were red tearing heavily. 1st it was dry then yellow discharge also throat was ceasing up and some wheezing from prior to flu shot. Urgent Care gave her Doxycycline, Ciprofloxacin eye drop Bu she did not take it B/C i's not red.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Purulent discharge, Throat tightness, Wheezing
Clinical narrative: Both eyes were red tearing heavily. 1st it was dry then yellow discharge also throat was ceasing up and some wheezing from prior to flu shot. Urgent Care gave her Doxycycline, Ciprofloxacin eye drop Bu she did not take it B/C i's not red.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Diarrhoea, Headache, Injection site erythema, Injection site nodule
Clinical narrative: Reports approximately 5 hours after immunization developed HA, body aches to joints, nausea with vomiting. Noticed redness and warmth to site of injection. 10/28 fever, vomiting, diarrhea and body aches, redness to Injection site about size of dollar bill. Sunday symptoms started to resolve vomiting ceased 1030 am. Monday morning no further fever, Injection site with small nodule, nor redness or warmth.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Reports approximately 5 hours after immunization developed HA, body aches to joints, nausea with vomiting. Noticed redness and warmth to site of injection. 10/28 fever, vomiting, diarrhea and body aches, redness to Injection site about size of dollar bill. Sunday symptoms started to resolve vomiting ceased 1030 am. Monday morning no further fever, Injection site with small nodule, nor redness or warmth.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Headache, Mobility decreased, Pain in extremity
Clinical narrative: After leaving clinic and returning to car, experienced pain in neck radiating across and down back and both arms. She stated that she "couldn't move which lasted for about 20 minutes as extreme (husband wanted to take her to the hospital but she decided to go home) and then on an off after. Did subside after a couple of hours, but had extreme headache and fever of 99.6. Headache lasted all night; took TYLENOL PM every few hours, and woke up still with a dull ache. "Husband called health district on 10/27/17 at ask whether we had heard of reactions such as this, which we have not. Explained that a VAERS report would be filed. Called patient on 10/30 for additional information. Feeling fine at the time of interview.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: After leaving clinic and returning to car, experienced pain in neck radiating across and down back and both arms. She stated that she "couldn't move which lasted for about 20 minutes as extreme (husband wanted to take her to the hospital but she decided to go home) and then on an off after. Did subside after a couple of hours, but had extreme headache and fever of 99.6. Headache lasted all night; took TYLENOL PM every few hours, and woke up still with a dull ache. "Husband called health district on 10/27/17 at ask whether we had heard of reactions such as this, which we have not. Explained that a VAERS report would be filed. Called patient on 10/30 for additional information. Feeling fine at the time of interview.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema multiforme, Rash
Clinical narrative: Rash - erythema multiforme 5 days after flu vaccine given. Patient on prednisone and rash improving.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Immunization site swelled up and was warm to touch per customer. She applied cold compress and used ALEVE and the following day the customer said warmth was gone and swelling decreased.
Age: 19.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Injection site swelling
Clinical narrative: Significant swelling of left upper arm-regard office visit 10/27. Possible recession reaction, but we treated as possible infection with antibiotic.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: Diagnosed as Bell's Palsy by MD on 10/30/17. Partial facial paralysis.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient developed rashes around her chests and back after 2-3 days she received high dose flu shot (FLUZONE). Pt claimed it is very itchy and is not getting any better after she took BENADRYL and cortisone cream.
Age: 1.33
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported.  Since 23-AUG-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) which had the lot # N008829, expiration date 16-MAR-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided.  Additionally, it was reported that the lowest temperature was 34 and the higher was 50 degrees Fahrenheit for 46 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved.   Follow up information was received from the physician on 16-OCT-2017 and on 27-OCT-2017.  This report refers to 16 months old patient.   On 26-AUG-2017, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).   This is one case from several cases from the same reporter.; Sender's Comments:  US-009507513-1709USA007325: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1710USA015222: US-009507513-1710USA015223: US-009507513-1709USA012770:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported.  Since 23-AUG-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) which had the lot # N008829, expiration date 16-MAR-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided.  Additionally, it was reported that the lowest temperature was 34 and the higher was 50 degrees Fahrenheit for 46 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved.   Follow up information was received from the physician on 16-OCT-2017 and on 27-OCT-2017.  This report refers to 12 months old patient.   On 30-AUG-2017, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).   This is one case from several cases from the same reporter.; Sender's Comments:  US-009507513-1709USA007325: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012770: US-009507513-1710USA015221: US-009507513-1710USA015223:
Age: 1.42
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported.  Since 23-AUG-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) which had the lot # N008829, expiration date 16-MAR-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided.  Additionally, it was reported that the lowest temperature was 34 and the higher was 50 degrees Fahrenheit for 46 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved.   Follow up information was received from the physician on 16-OCT-2017 and on 27-OCT-2017.  This report refers to 17 months old patient.   On 08-SEP-2017, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).   This is one case from several cases from the same reporter.; Sender's Comments:  US-009507513-1709USA007325: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1710USA015222: US-009507513-1710USA015221: US-009507513-1709USA012770:
Age: 0.33
Sex: U
Vaccine: HIBV, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; the patient had been administered doses of vaccines that were improperly stored; This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported.  Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided.  Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit  and the highest was 54 degrees Fahrenheit  for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved.  This is one case from several cases from the same reporter.  Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported.  Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis .  Additionally, it was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved.  This is one case from several cases from the same reporter.  Follow up information was received from the physician on 16-OCT-2017. The patient was vaccinated on 17-MAY-2017, while the patient was 4 months old. The patient's and the patient's guardian's identifiers were provided.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA007325:
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Acute kidney injury, Asthenia, Blood creatine phosphokinase increased, Blood creatinine increased, Blood urine present
Clinical narrative: Resident receive influenza vaccine on right arm (deltoid) around noon on 10/23/17; that evening felt warm/feverish and during night became confused and weak and fell in his room. He thinks he was on the floor for about 30 minutes (he denies laying on his right arm where he had received the flu vaccine). Nursing evaluated him and found him weak with a low grade fever (100.2), nausea, general body aches, chills, lightheaded/dizziness, diaphoresis, confusion. He was sent to the local hospital and found to have an elevated CK which increased to 19,000 and a small bump in his Creatinine. Patient was diagnosed with Rhabdomyolysis and AKI. Resident was given IV fluid at the hospital. Temp. at the hospital 101 per resident.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Confusional state, Dizziness, Fall, Hyperhidrosis
Clinical narrative: Resident receive influenza vaccine on right arm (deltoid) around noon on 10/23/17; that evening felt warm/feverish and during night became confused and weak and fell in his room. He thinks he was on the floor for about 30 minutes (he denies laying on his right arm where he had received the flu vaccine). Nursing evaluated him and found him weak with a low grade fever (100.2), nausea, general body aches, chills, lightheaded/dizziness, diaphoresis, confusion. He was sent to the local hospital and found to have an elevated CK which increased to 19,000 and a small bump in his Creatinine. Patient was diagnosed with Rhabdomyolysis and AKI. Resident was given IV fluid at the hospital. Temp. at the hospital 101 per resident.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Muscle injury, Nausea, Pain, Pyrexia, Red blood cells urine positive
Clinical narrative: Resident receive influenza vaccine on right arm (deltoid) around noon on 10/23/17; that evening felt warm/feverish and during night became confused and weak and fell in his room. He thinks he was on the floor for about 30 minutes (he denies laying on his right arm where he had received the flu vaccine). Nursing evaluated him and found him weak with a low grade fever (100.2), nausea, general body aches, chills, lightheaded/dizziness, diaphoresis, confusion. He was sent to the local hospital and found to have an elevated CK which increased to 19,000 and a small bump in his Creatinine. Patient was diagnosed with Rhabdomyolysis and AKI. Resident was given IV fluid at the hospital. Temp. at the hospital 101 per resident.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Rhabdomyolysis, Skin warm
Clinical narrative: Resident receive influenza vaccine on right arm (deltoid) around noon on 10/23/17; that evening felt warm/feverish and during night became confused and weak and fell in his room. He thinks he was on the floor for about 30 minutes (he denies laying on his right arm where he had received the flu vaccine). Nursing evaluated him and found him weak with a low grade fever (100.2), nausea, general body aches, chills, lightheaded/dizziness, diaphoresis, confusion. He was sent to the local hospital and found to have an elevated CK which increased to 19,000 and a small bump in his Creatinine. Patient was diagnosed with Rhabdomyolysis and AKI. Resident was given IV fluid at the hospital. Temp. at the hospital 101 per resident.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient was given a Influenza preservative free 3 and up vaccine. No adverse reactions that I know of.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Arthritis bacterial, Culture wound negative, Decreased appetite, Injection site pain, Joint irrigation
Clinical narrative: Severe R arm/shoulder pain starting hours after immunization. Could not get up. Did not want to eat. Developed urinary incontinence. Patient taken to Hospital ED. Discharged from ER. Re-presented to the hospital for continue severe R arm/shoulder pain on 10/25/17. Admitted. Ultrasound and MRI of R shoulder suggestive of septic arthritis. Underwent IR guided aspiration and surgery for joint irrigation on 10/28/17. Wound cultures are negative to date. Receiving vancomycin and ZOSYN.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Nuclear magnetic resonance imaging abnormal, Therapeutic aspiration, Ultrasound scan abnormal, Urinary incontinence
Clinical narrative: Severe R arm/shoulder pain starting hours after immunization. Could not get up. Did not want to eat. Developed urinary incontinence. Patient taken to Hospital ED. Discharged from ER. Re-presented to the hospital for continue severe R arm/shoulder pain on 10/25/17. Admitted. Ultrasound and MRI of R shoulder suggestive of septic arthritis. Underwent IR guided aspiration and surgery for joint irrigation on 10/28/17. Wound cultures are negative to date. Receiving vancomycin and ZOSYN.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Severe R arm/shoulder pain starting hours after immunization. Could not get up. Did not want to eat. Developed urinary incontinence. Patient taken to Hospital ED. Discharged from ER. Re-presented to the hospital for continue severe R arm/shoulder pain on 10/25/17. Admitted. Ultrasound and MRI of R shoulder suggestive of septic arthritis. Underwent IR guided aspiration and surgery for joint irrigation on 10/28/17. Wound cultures are negative to date. Receiving vancomycin and ZOSYN.
Age: 72.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: This spontaneous report was received from a 72 year old male patient, and a physician, referring to the patient. The patient's concurrent conditions included an allergy to "sulfa drugs". The patient's historical conditions included a meniscus operation and craniocerebral injury. Concomitant therapies included vitamins (unspecified). On 26-SEP-2017, the patient was vaccinated with PNEUMOVAX 23, intramuscularly, (dose, lot #, and expiration date were not provided) for prevention of pneumococcal disease. The patient was also vaccinated on the same date with FLUZONE (dose, route, lot #, and expiration date were not provided) for prophylaxis. On the same date, shortly after the patient was vaccinated, he experienced redness, pain and swelling at the injection site. Then, on an unspecified date in 2017, the patient stated that his entire arm was beet red and it only started to dissipate on Friday (unspecified date). It was still sore and had a trace of redness. The patient did not seek medical attention. Thus, no laboratory diagnostics or studies were performed and no treatment was given. At the time of reporting, the patient had not recovered from the adverse events. Otherwise, the physician stated that he did not give the PNEUMOVAX 23 and FLUZONE or saw the patient for a reaction. The reporter did not assess the relationship between the aforementioned events and therapy with PNEUMOVAX 23 and FLUZONE.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, nurse and physician and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 06-OCT-2017, the patient was vaccinated with GARDASIL 9, intramuscularly (lot # L014198 with expiration date on 05-SEP-2017), reconstituted with a diluent (manufacturer unknown), for prophylaxis. No adverse effects were reported. The physician who requesting information on revaccination of "invalid" dose of GARDASIL 9 administered and not supported.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 68-year-old female patient. The patient's pertinent medical history, concurrent conditions and information about concomitant medications were not reported. The patient had no drug reactions or allergies. Pharmacist reported that the patient received PREVENAR 13 in approximately 2016 (reported as "at least one year ago"), and experienced an injection site reaction, which was red, swollen, "heat", pain and it extended to the elbow. On 02-OCT-2017, the patient was vaccinated with PNEUMOVAX 23, 1 dose, 0.5 ml, intramuscularly in the right arm (lot # N013521 with expiration date on 23-JAN-2017) for routine immunization. In approximately October 2017, the patient experienced the same injection site reaction, which was red, swollen, "heat", pain. Pharmacist reported that patient was seen in the pharmacy, on 5-OCT-2017, when the injection site reaction to the PNEUMOVAX 23, had traveled down the arm, past the elbow and forearm, to the wrist. No laboratory diagnostic studies were performed. No treatment was given for the adverse events. The outcome of the events was not reported (also reported as "On 06-OCT-2017, the pharmacist reported she spoke to patient and injection site reaction was "almost all gone"). The causality between PNEUMOVAX 23 and the event was not reported.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 68-year-old female patient. The patient's pertinent medical history, concurrent conditions and information about concomitant medications were not reported. The patient had no drug reactions or allergies. Pharmacist reported that the patient received PREVENAR 13 in approximately 2016 (reported as "at least one year ago"), and experienced an injection site reaction, which was red, swollen, "heat", pain and it extended to the elbow. On 02-OCT-2017, the patient was vaccinated with PNEUMOVAX 23, 1 dose, 0.5 ml, intramuscularly in the right arm (lot # N013521 with expiration date on 23-JAN-2017) for routine immunization. In approximately October 2017, the patient experienced the same injection site reaction, which was red, swollen, "heat", pain. Pharmacist reported that patient was seen in the pharmacy, on 5-OCT-2017, when the injection site reaction to the PNEUMOVAX 23, had traveled down the arm, past the elbow and forearm, to the wrist. No laboratory diagnostic studies were performed. No treatment was given for the adverse events. The outcome of the events was not reported (also reported as "On 06-OCT-2017, the pharmacist reported she spoke to patient and injection site reaction was "almost all gone"). The causality between PNEUMOVAX 23 and the event was not reported.
Age: 70.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 70 year old female patient with diabetes and an unspecified heart disease. The patient's historical condition was not reported. There was no illness at time of vaccination. Concomitant therapies included FLUARIX and sterile diluent. On 11-OCT-2017, the patient was vaccinated with an improperly stored first dose of ZOSTAVAX with lot # M041511 and expiration date of 08-JAN-2018, subcutaneously in the right deltoid (strength and dose were unknown) for prophylaxis, which was stored from -9 Celsius degrees (°C) to 8°C (-3.3°C) for 5 hours and 45 minutes. There was no previous temperature excursion. Moreover, it was reported that the temperature excursions were detected by a data logger. No adverse effects were reported. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1710USA015410.
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 51 year old female patient with diabetes and hypertension. The patient's medical history included renal transplant and therapy with BETADINE for which she had developed an unspecified drug reaction or allergy. Concomitant therapies included aspirin (manufacturer unknown), LIPITOR, COREG, NOVOLOG, ZOFRAN and PROGRAF. On 17-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 lot number N022703 (expiration date: 27-FEB-2019), intramuscularly in the deltoid, for prophylaxis (strength, dose or units were not reported). At the same time she was also vaccinated with FLUZONE (strength, indication, route, dose, units or lot number were not reported) at the same site in the deltoid area of the same unspecified arm. On 20-OCT-2017, 4 days after onset of therapy the patient experienced "cellulitis like symptom" from the area below the injection site down to the elbow. The outcome of "cellulitis like symptom" was unknown. The relatedness between the event and the suspect therapies was not provided. The patient sought medical attention and received treatment for the adverse event. No laboratory diagnostics or studies were performed. Upon internal review, cellulitis was determined to be medically significant. The reporter considered the event as serious because significant disability or incapacity, due to the patient did not want to move the arm.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from nurse referring to a patient of unknown age and gender. The patient's medical history and drug reactions and allergies were not provided. On 24-OCT-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 for prophylaxis (lot# N003997, expiry date: 20-OCT-2018, dose unknown). No concomitant medications were reported. No adverse effects were reported. The excursion information was as follows: Temperature: 35.8F Time frame: 30 minutes. No previous temperature excursion. Call was because of "digital data logger": Yes.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies and concomitant medications were not reported. On 25-OCT-2017 the patient was inadvertently administered an expired dose of M-M-R II rHA (recombinant human albumin) (lot # L005290, Expiry date: 17-FEB-2017) for prophylaxis. Concomitant therapies included sterile diluent (Lot # N023306, Expiry date: 20-JAN-2020). The diluent used to reconstitute this dose was not expired. No adverse effect reported. There was no product quality complaint involved.