chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Incomplete course of vaccination, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blister in a 74-year-old male patient who received SHINGRIX. Concomitant products included FAMVIR. On 13th February 2018, the patient received SHINGRIX (intramuscular). On 15th February 2018, 2 days after receiving SHINGRIX, the patient experienced blister. On 16th February 2018, the patient experienced chest tenderness. On an unknown date, the outcome of the blister and chest tenderness were recovering/resolving. The reporter considered the blister and chest tenderness to be unrelated to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in the right deltoid. The patient experienced blisters on left side of back. Three days after vaccination with SHINGRIX, the patient's left side of chest was sensitive to touch. The patient stated that, his physician was aware of the adverse effects and had prescribed antibiotic for seven days which would end on 26th February 2018. The patient was advised to continue to follow-up with his physician regarding the issues. The patient denied permission to contact his physician.
Age: 0.42
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical student refers to a 6-month-old patient (gender was not reported). On 12-FEB-2018, the 6-month-old patient was vaccinated with a dose of GARDASIL 9 lot # N020352, expiration date 10-APR-2020 for prophylaxis. No adverse effects were reported.
Age: 34.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a 34 year old female patient. No information about the patient's medical history, concurrent conditions and drug reactions or allergies was provided. The patient had no concomitant medications. The patient historical drugs included TDAP for prophylaxis on 08-JAN-2018. On 12-FEB-2018, the patient was vaccinated with improperly stored doses of Oka/Merck VARIVAX dose 1, subcutaneous in the right arm, (Lot # M030138 with an expiration date in 15-JUN-2018), and (wistar ra 27-3) M-M-R II dose 2, subcutaneous in the left arm, therapy type (rHA), (Lot # M028130 with an expiration date in 03-JUN-2018), for prophylaxis, that underwent multiples temperatures excursions from -14 degrees Celsius to -10 degrees Celsius during a maximum time frame of 7 hours, Digital data logger was involved. Nevertheless, it was reported that both vaccines were reconstituted with properly stored sterile diluent (manufacturer unknown). No adverse effects were reported and no product quality complaint was involved.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Nausea, Pain in extremity, Vomiting
Clinical narrative: This spontaneous report was received from a medical assistant (who is also the patient's parent) via a company representative, and refers to her daughter, an 11 year old female patient. The patient had no medical history, concurrent condition or drug reactions/allergies. On 04-AUG-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection, intramuscular in the left deltoid, (lot # N004799 with an expiration date in 15-NOV-2019), (dose and frequency were not provided). Concomitant therapies included MENACTRA and BOOSTRIX. On an unspecified date in August 2017 (reported as "within 6 hours of receiving the dose"), the patient developed nausea and vomiting. Moreover, on an unspecified date in August 2017, the patient experienced arm pain for 24 hours and malaise for 48 hours. Additionally, it was reported that the patient did not seek for medical attention, no treatment was prescribed for the events and no laboratories studies were performed, as after 48 hours the symptoms were self-resolving. At the time of reporting, the outcome of pain in extremity, vomiting, nausea and malaise was reported as recovered after 48 hours on an unspecified date in August 2017. The causal relationship between the events and GARDASIL 9 was not provided.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Right arm swollen to touch and painful.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Impaired work ability, Pain, Pyrexia, Thinking abnormal
Clinical narrative: The patient experienced extreme tiredness, low grade fever, aches from neck down, and what she described as fuzzy or cloudy thinking. This lasted for 3 days. She was unable to work for 2 of those days.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Hypersensitivity, Induration, Skin warm, Swelling
Clinical narrative: Localized hypersensitivity reaction, red, swollen, hot, hard.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Urticaria
Clinical narrative: Hives (all over legs, top to bottom; top of hands; arms) and leg/joint (knee) pain that started a few days after shot. Treated with BENADRYL but would come back as BENADRYL wore off. Lasted for 3-4 days.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Altered state of consciousness, Dizziness, Feeling abnormal, Nervousness
Clinical narrative: Shortly after receiving the injection, I got lightheaded and felt like I might pass out. For several minutes it got gradually worse until about 5-10 minutes when it started to subside. I was told this is likely a nervous reaction, however it doesn't seem like that to me. It felt like I was high on something for a few minutes after I received the injection. I've felt very similar reactions to injections in the past and it's surprisingly similar every time independently of how much I calm myself beforehand. The reaction also isn't immediate, it takes a minute or two to begin. That's why it seems like a physical response vs a nervous response.
Age: 18.0
Sex: F
Vaccine: TYP
Symptoms: Swelling face
Clinical narrative: Mother describes patient experiencing facial swelling the following morning. She was seen in the urgent care center. Pt did not have any issues with her airway. No treatment was provided.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Local redness, pain and warmth of injection site. Some itching. Local swelling (R) deltoid injection site. No fever. No wheezing.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Eye movement disorder, Tremor, Vomiting
Clinical narrative: Parent states that patient started to roll eyes behind head and shake in the middle of the night. He woke and vomited.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Altered state of consciousness, Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Within 5 minutes of vaccines patient became pale, sweaty, dizzy and felt like he was going to pass out and throw up. BP 80/50. HR 98. Alert, oriented, articulate. With cold rag to neck, rest, pedal exercises and popsicle patient felt fine and color returned and vs WNL within 10 minutes, left office in well condition.
Age: 7.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: No adverse reactions noted after vaccine given.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Dysarthria, Electroencephalogram, Fatigue, Feeling abnormal
Clinical narrative: Extreme fatigue, dizziness, fogginess, slurred speech, headaches, nystagmus. Extreme fatigue started within 2 weeks of injection and remainder of symptoms followed. Daughter would look out window on sunny day and say "it's raining outside". Signs observed by classmates and family members. The second injection in Nov, noted extreme fatigue and fogginess but third (final injection) were followed by the above.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Laboratory test, Nuclear magnetic resonance imaging, Nystagmus
Clinical narrative: Extreme fatigue, dizziness, fogginess, slurred speech, headaches, nystagmus. Extreme fatigue started within 2 weeks of injection and remainder of symptoms followed. Daughter would look out window on sunny day and say "it's raining outside". Signs observed by classmates and family members. The second injection in Nov, noted extreme fatigue and fogginess but third (final injection) were followed by the above.
Age: 56.0
Sex: F
Vaccine: IPV, TYP
Symptoms: Erythema, Feeling hot
Clinical narrative: Patient stated feeling hot all night and this morning. She also stated having her face really red, denied swelling. Symptoms started yesterday around 6 pm.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Mass, Musculoskeletal stiffness, Pain, Skin warm
Clinical narrative: 2 days S/P vaccine developed approx. 3 inches in diameter swollen firm mass. Warm and painful to touch. Oral temp of 99.5 and stiff neck.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Swelling, Ultrasound scan normal
Clinical narrative: 2 days S/P vaccine developed approx. 3 inches in diameter swollen firm mass. Warm and painful to touch. Oral temp of 99.5 and stiff neck.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Was given PNEUMOVAX on 2/22/18 in upper left arm. Was very sore & swollen for a few days, on 2/27/18 started to notice rash ~ 8 x 20 cm patch of erythema and warmth centered on left deltoid. No streak or fluctuance. Patient treated with doxycycline hyclate 100 mg tablet - for 10 days to cover possible infection.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Incorrect product formulation administered
Clinical narrative: The PENTACEL was incorrectly mixed prior to administration. Two vials of diluent were combined and administered. The vial with the powder Hib was not used.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX. Concomitant products included lisinopril and metoprolol. On 23rd February 2018 10:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, joint pain, injection site rash, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site rash, injection site swelling and injection site erythema were not recovered/not resolved and the outcome of the joint pain was recovering/resolving. It was unknown if the reporter considered the injection site pain, joint pain, injection site rash, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient was receiving Multivitamins as concomitant drug. The patient was administered SHINGRIX in the left deltoid. The patient planned to follow-up with her physician on an unknown date.
Age: 48.0
Sex: M
Vaccine: RAB
Symptoms: Antibody test negative, Inappropriate schedule of drug administration, Therapeutic response decreased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a 48-year-old male patient who received Rabies Vaccine. Co-suspect products included Rabies Vaccine and Rabies Vaccine. On 5th April 2010, the patient received Rabies Vaccine. On 12th April 2010, the patient received Rabies Vaccine. On 29th April 2010, the patient received Rabies Vaccine. On 29th April 2010, not applicable after receiving Rabies Vaccine and Rabies Vaccine, not applicable after receiving Rabies Vaccine and Rabies Vaccine and unknown after receiving Rabies Vaccine, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased and inappropriate schedule of vaccine administered were unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Additional details were provided as follows: The age at vaccination was not reported. Back in 2010 the patient received an unknown rabies vaccine for what reporting registered nurse believed was pre-exposure. The dates were 5th April, 12th April and 29th April. The patient had blood titers drawn, and the patient's titers were reportedly low. Reporting registered nurse did not have titer level information.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a female patient who received BOOSTRIX (batch number 3K44J, expiry date 17th October 2019). Concurrent medical conditions included sulfonamide allergy. Concomitant products included TAXOTERE. On 19th February 2018, the patient received BOOSTRIX. On an unknown date, the dose was an unknown dose. On 23rd February 2018, 4 days after receiving BOOSTRIX, the patient experienced injection site swelling, injection site erythema, injection site vesicles and rash. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site vesicles and rash were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site vesicles and rash to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient was not pregnant. The reporter stated that the patient had a sulfa allergy. The patient received BOOSTRIX on left deltoid. The patient developed swelling, redness, and bleps or vesicles around the injection site. A blep or rash had also developed on the patient's wrist. The patient also had a PPD placed on the same arm as the BOOSTRIX. The reporter stated that the patient was currently on TAXOTERE. The reporter stated that the patient would go to occupational health for evaluation, and was not aware of any other medical intervention that had been taken.
Age: 71.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Asthenia, Blood culture, Cough, Dyspnoea, Dysuria
Clinical narrative: Per  MD  note  from  11/10/17:  Patient is a 71 year old man with PMH of OSA and PTSD presenting with several weeks of cough  /  shortness of breath. Later developed acute rash and weakness after flu and PNA vaccines. ROS also positive for new dysuria. Objective findings on presentation to the ED included fever and leukocytosis. Evaluation thus far has not suggested UTI or PNA, with ddx including cellulitis vs. adverse reaction to vaccination. Currently on ceftriaxone for possible cellulitis, while blood cx pending. (Blood cultures were all negative).
Age: 71.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Leukocytosis, Pyrexia, Rash, White blood cell count
Clinical narrative: Per  MD  note  from  11/10/17:  Patient is a 71 year old man with PMH of OSA and PTSD presenting with several weeks of cough  /  shortness of breath. Later developed acute rash and weakness after flu and PNA vaccines. ROS also positive for new dysuria. Objective findings on presentation to the ED included fever and leukocytosis. Evaluation thus far has not suggested UTI or PNA, with ddx including cellulitis vs. adverse reaction to vaccination. Currently on ceftriaxone for possible cellulitis, while blood cx pending. (Blood cultures were all negative).
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Paraesthesia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of dizziness in a male patient who received BEXSERO. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, unknown after receivinf BEXSERO, the patient experienced dizziness and tingling of extremity. On an unknown date, theo outcome of the dizziness and tingling of extremity were unknown. It was unknown if the reporter considered the dizziness and tingling of extremity to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient was complaining of tingling in his below his waist in his lower half of his body and legs. The patient also felt dizzy.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pustular, Skin lesion
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of erythematous rash in a 79-year-old male patient who received SHINGRIX. Concomitant products included LIPITOR, SINEMET and verapamil. On 15th February 2018, the patient received SHINGRIX. On 19th February 2018, 4 days after receiving SHINGRIX, the patient experienced erythematous rash, pustular skin eruption and skin lesion. On an unknown date, the outcome of the erythematous rash, pustular skin eruption and skin lesion were unknown. The reporter considered the erythematous rash to be probably related to SHINGRIX. It was unknown if the reporter considered the pustular skin eruption and skin lesion to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's partner who was also a retired physician. On 22nd February 2018, the reporter noticed the rash on the patient but believes it might have started on 19th February 2018 and was full blown by 22nd February 2018. The rash was described as red with pustular lesions appearing mostly on both arms. A few lesions also presented on his back and legs. The rash has mostly resolved but there were a few lesions still present. The vaccine was administered at a doctor's office but the reporter did not want the doctor contacted because they had not told the doctor till the time of reporting.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pruritus
Clinical narrative: Rash on left thigh, redness and raised area, symptoms: itching.
Age: 22.0
Sex: M
Vaccine: ADEN_4_7, FLUC4, HEPA, MMR, MNQ, TDAP, UNK, VARCEL
Symptoms: Unevaluable event
Clinical narrative: See MD note.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Feeling hot, Immediate post-injection reaction, Loss of consciousness, Pallor, Tinnitus
Clinical narrative: Right after vaccine was given, pt. became hot, pale and became unresponsive for less than 30 seconds.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Unresponsive to stimuli
Clinical narrative: Right after vaccine was given, pt. became hot, pale and became unresponsive for less than 30 seconds.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Fall, Peripheral swelling, Pneumonia, Skin warm
Clinical narrative: Patient received the vaccines and states that later that afternoon her arm was swollen, warm, and red to touch. She happened to fall that afternoon requiring a visit to the hospital for a broken wrist and the patient states the hospital told her it was infected. She also stated that when she got to the hospital they diagnosed her with a urinary tract infection and pneumonia. She indicated on our questionnaire that she was not ill and did not have a fever. She stated that the hospital had her on antibiotics for the UTI, pneumonia and her swollen arm.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Urinary tract infection
Clinical narrative: Patient received the vaccines and states that later that afternoon her arm was swollen, warm, and red to touch. She happened to fall that afternoon requiring a visit to the hospital for a broken wrist and the patient states the hospital told her it was infected. She also stated that when she got to the hospital they diagnosed her with a urinary tract infection and pneumonia. She indicated on our questionnaire that she was not ill and did not have a fever. She stated that the hospital had her on antibiotics for the UTI, pneumonia and her swollen arm.
Age: 47.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Pyrexia
Clinical narrative: PATIENT REPORTED SIGNS OF HEADACHE AND FEVER.
Age: 1.0
Sex: F
Vaccine: PNC13, UNK
Symptoms: Crying, Discomfort, Fatigue, Flatulence, Glassy eyes
Clinical narrative: High fever lasting multiple days regardless of TYLENOL or MOTRIN (102.6-105. Hospital had 104.4), different personality-acting different (not her happy self), crying in pain for multiple days, uncomfortable and restless, threw up up once, injection site reaction/lump, just noticed a rash on her back today (3/1/18), gassy and in pain from it from (is still having bowel movements). Glassy eyed, tired/lethargic.
Age: 1.0
Sex: F
Vaccine: PNC13, UNK
Symptoms: Influenza virus test negative, Injection site mass, Lethargy, Pain, Personality change
Clinical narrative: High fever lasting multiple days regardless of TYLENOL or MOTRIN (102.6-105. Hospital had 104.4), different personality-acting different (not her happy self), crying in pain for multiple days, uncomfortable and restless, threw up up once, injection site reaction/lump, just noticed a rash on her back today (3/1/18), gassy and in pain from it from (is still having bowel movements). Glassy eyed, tired/lethargic.
Age: 1.0
Sex: F
Vaccine: PNC13, UNK
Symptoms: Pyrexia, Rash, Restlessness, Vomiting
Clinical narrative: High fever lasting multiple days regardless of TYLENOL or MOTRIN (102.6-105. Hospital had 104.4), different personality-acting different (not her happy self), crying in pain for multiple days, uncomfortable and restless, threw up up once, injection site reaction/lump, just noticed a rash on her back today (3/1/18), gassy and in pain from it from (is still having bowel movements). Glassy eyed, tired/lethargic.
Age: 1.67
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blood electrolytes normal, CSF test normal, Computerised tomogram head normal, Febrile convulsion, Full blood count normal
Clinical narrative: Complex febrile seizure 14 days after administration. MMR and VZV administered separately. Also with viral URI so picture is more complicated.
Age: 1.67
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Viral upper respiratory tract infection
Clinical narrative: Complex febrile seizure 14 days after administration. MMR and VZV administered separately. Also with viral URI so picture is more complicated.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Headache, Injection site urticaria, Musculoskeletal stiffness, Nausea, Pain in extremity
Clinical narrative: Quarter size welts appeared around injection site from elbow to shoulder, sore stiff arm and whole body, headache, shakes, nausea. Welts got worse for 2 days, just starting to subside. Headache still part of time.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Tremor
Clinical narrative: Quarter size welts appeared around injection site from elbow to shoulder, sore stiff arm and whole body, headache, shakes, nausea. Welts got worse for 2 days, just starting to subside. Headache still part of time.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Headache, Hyperhidrosis, Pain in extremity, Rash erythematous, Urticaria
Clinical narrative: Quarter size welts appeared around injection site from elbow to shoulder, sore stiff arm and whole body, headache, shakes, nausea. Welts got worse for 2 days, just starting to subside. Headache still part of time.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Extensive swelling, redness, itchiness and limited elevation of the L arm on vaccine site (MENVEO / FLUARIX) administered on 2/13, reaction started 8 hs after vaccination, peaked on 2/15. Symptoms improved with cold compresses. Today at PE, FROM of the L arm, mild erythema of the external aspect of the L arm, no tenderness, no swelling.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Developed redness and quarter sized fluid filled blister at injection site two days after injection. Prescribed topical Diprolene AF 0.05% cream to apply twice a day.
Age: 8.0
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Skin warm
Clinical narrative: Patient developed erythema 7.5 cm x 4 cm around injection site. Skin warm to touch. BENADRYL and Ibuprofen were administered with decrease in symptoms.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N020139 with expiration date 14-FEB-2020, for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. At the time of reporting, the temperature excursion and the time frame were unknown. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1803USA000351: US-009507513-1803USA000352: US-009507513-1803USA000353: US-009507513-1803USA000354: US-009507513-1803USA000355: US-009507513-1803USA000356: US-009507513-1803USA000357: US-009507513-1803USA000358:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 28-FEB-2018, the patient received a properly stored but expired dose of Oka/Merck VARIVAX, subcutaneously for prophylaxis, lot # M009766 and expiration date on 23-FEB-2018 (dose and anatomical location were not reported). No adverse effects were reported for the patient.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse, referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 20-MAR-2017, the patient was vaccinated with her first dose of PNEUMOVAX 23, 0.5 ml for prophylaxis, lot # N000508 and expiration date on 19-OCT-2018 (route of administration and anatomical location were not provided). On 30-NOV-2017, the patient was inadvertently administered a second dose of PNEUMOVAX 23, lot # N022704 and expiration date on 27-FEB-2019. No adverse effects were reported for the patient.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N020139 with expiration date 14-FEB-2020, for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. At the time of reporting, the temperature excursion and the time frame were unknown. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1802USA013755: US-009507513-1803USA000352: US-009507513-1803USA000353: US-009507513-1803USA000354: US-009507513-1803USA000355: US-009507513-1803USA000356: US-009507513-1803USA000357: US-009507513-1803USA000358.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N020139 with expiration date 14-FEB-2020, for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. At the time of reporting, the temperature excursion and the time frame were unknown. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1802USA013755: US-009507513-1803USA000351: US-009507513-1803USA000353: US-009507513-1803USA000354: US-009507513-1803USA000355: US-009507513-1803USA000356: US-009507513-1803USA000357: US-009507513-1803USA000358.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N020139 with expiration date 14-FEB-2020, for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. At the time of reporting, the temperature excursion and the time frame were unknown. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1802USA013755: US-009507513-1803USA000351: US-009507513-1803USA000352: US-009507513-1803USA000354: US-009507513-1803USA000355: US-009507513-1803USA000356: US-009507513-1803USA000357: US-009507513-1803USA000358.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N020139 with expiration date 14-FEB-2020, for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. At the time of reporting, the temperature excursion and the time frame were unknown. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1802USA013755: US-009507513-1803USA000351: US-009507513-1803USA000352: US-009507513-1803USA000353: US-009507513-1803USA000355: US-009507513-1803USA000356: US-009507513-1803USA000357: US-009507513-1803USA000358.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N020139 with expiration date 14-FEB-2020, for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. At the time of reporting, the temperature excursion and the time frame were unknown. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1802USA013755: US-009507513-1803USA000351: US-009507513-1803USA000352: US-009507513-1803USA000353: US-009507513-1803USA000354: US-009507513-1803USA000356: US-009507513-1803USA000357: US-009507513-1803USA000358.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N020139 with expiration date 14-FEB-2020, for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. At the time of reporting, the temperature excursion and the time frame were unknown. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1802USA013755: US-009507513-1803USA000351: US-009507513-1803USA000352: US-009507513-1803USA000353: US-009507513-1803USA000354: US-009507513-1803USA000355: US-009507513-1803USA000357: US-009507513-1803USA000358:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N020139 with expiration date 14-FEB-2020, for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. At the time of reporting, the temperature excursion and the time frame were unknown. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1802USA013755: US-009507513-1803USA000351: US-009507513-1803USA000352: US-009507513-1803USA000353: US-009507513-1803USA000354: US-009507513-1803USA000355: US-009507513-1803USA000356: US-009507513-1803USA000358.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N020139 with expiration date 14-FEB-2020, for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. At the time of reporting, the temperature excursion and the time frame were unknown. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1802USA013755: US-009507513-1803USA000351: US-009507513-1803USA000352: US-009507513-1803USA000353: US-009507513-1803USA000354: US-009507513-1803USA000355: US-009507513-1803USA000356: US-009507513-1803USA000357.
Sex: U
Vaccine: PNC13
Symptoms: Dyspnoea, Malaise, Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer reporting for her/himself. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date in 2015, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient was very sick the week before report and went to the doctor, then to the emergency room at the hospital because she/he couldn't breathe. The patient was diagnosed with pneumonia. Outcome of the event was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Rash erythematous
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 67-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced redness and swelling site reaction on an unspecified date. She returned a week later due to red rash across back and arms. Therapeutic measures were taken as a result of the events and included treatment with topical steroids. Outcome of the events was unknown. No follow-up attempts are possible, information about lot number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia, Therapy non-responder
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her daughter. This 7-year-old female patient of an unspecified race/ethnicity received PREVNAR 13 at single dose on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The reporter stated that an immunologist saw her daughter and thought the she did not respond to PREVNAR 13, so there was a possible lack of efficacy. The patient experienced recurrent pneumonia on an unspecified date after the vaccination. Outcome was unknown. The information on the lot number has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Chest discomfort, Dyskinesia, Dyspnoea, Injection site pain, Pain in extremity
Clinical narrative: Patient reported severe stabbing pains down left arm to fingers and into shoulder, reported shortness of breath, reported chest feeling hot. BP was 120/78, heart rate was 99, O2 sat was 98%. Patient reported symptom onset at 1120 AM. Patient was given 600 mg Ibuprofen and 25 mg BENADRYL both by mouth. Mother was notified and asked to pick child up. Mother was instructed of concerning signs and symptoms to monitor patient for at home and when to seek emergency care if needed. Mom later reported taking patient to the emergency room for jerking. Mom said ATIVAN was given at ER and mom gave patient ZANAFLEX when she returned home. Mom made follow up appointment with PCP and a religious exemption/medical exemption was completed by PCP.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site warmth
Clinical narrative: Patient experienced redness and warmth at and immediately around the injection site starting 02/27/2018. Patient presented to pharmacist on 02/28/2018 with redness and warmth that started at the injection site and extended distally to approximately 2-3 inches from the elbow in a 2-3 inch wide band. Patient was counseled to take cetirizine 10mg and follow up with PCP if reaction worsens or does not improve.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Pain, Swelling
Clinical narrative: Pt c/o pain/burning approx 10 minutes after receiving vaccine. Pt noted increased pain/burning/redness/swelling of area and returned to clinic for eval. Area noted to have swelling, redness, measures 4.5"x3". Pt's has no reports of breathing difficulty. Vital signs WNL, BP 127/89, HR 87, O2 sat 99% on room air. Pt given 25mg liquid benadryl orally, pt given ice pack to hold over area.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Injection site erythema, Limb discomfort, Onychalgia
Clinical narrative: On 2/27/2018 she received the SHINGRIX vaccine in the left upper arm. The patient states that shortly thereafter, she did develop some discomfort in the arm. On 2/28, the patient states that she experienced joint pains in association with her nails and hair also hurting. She had no fevers or chills and no difficulty breathing. Then, on 3/1/2018 she states that the arthralgias resolved but she developed redness in the left upper arm. The tenderness does persist in the form of burning. She has had no fevers or chills and complains of no numbness or tingling in the lower extremities or hands currently.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Tenderness
Clinical narrative: On 2/27/2018 she received the SHINGRIX vaccine in the left upper arm. The patient states that shortly thereafter, she did develop some discomfort in the arm. On 2/28, the patient states that she experienced joint pains in association with her nails and hair also hurting. She had no fevers or chills and no difficulty breathing. Then, on 3/1/2018 she states that the arthralgias resolved but she developed redness in the left upper arm. The tenderness does persist in the form of burning. She has had no fevers or chills and complains of no numbness or tingling in the lower extremities or hands currently.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Drooling, Fatigue, Heart rate increased, Lethargy, Posture abnormal
Clinical narrative: Within 15 minutes of vaccines, became very tired, lethargic and appeared slumped over, drooling some, unresponsive except to painful stimuli. With painful stimuli, would withdraw, open eyes slightly, say brief phrase, like "no", but then appear to go back to sleep. After about 5 minutes seemed more lucid, sitting up, looking around, but then had another 3-5 min episode similar to above. After second episode, remained normal thereafter. Was observed in ED. She did develop onset of fever around same time as symptoms, initially low grade 100.3, then rose to 101. 3.  Ibuprofen given and no further sx once fever resolved. No hives, oropharyngeal swelling, seizure like movements. BP was normal. HR was elevated to 160s during event.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Unresponsive to stimuli
Clinical narrative: Within 15 minutes of vaccines, became very tired, lethargic and appeared slumped over, drooling some, unresponsive except to painful stimuli. With painful stimuli, would withdraw, open eyes slightly, say brief phrase, like "no", but then appear to go back to sleep. After about 5 minutes seemed more lucid, sitting up, looking around, but then had another 3-5 min episode similar to above. After second episode, remained normal thereafter. Was observed in ED. She did develop onset of fever around same time as symptoms, initially low grade 100.3, then rose to 101. 3.  Ibuprofen given and no further sx once fever resolved. No hives, oropharyngeal swelling, seizure like movements. BP was normal. HR was elevated to 160s during event.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site and traveling down her arm.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Injection site erythema, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: Patient presented with swollen, hardened, fevered red rash around where the vaccination was given.  Patient was advised to apply warm, moist heat at 20 minute intervals to the injection site. patient was also given some amoxicillin clavulante 875 bid for 10 days. Patient was just seen today (03-01-2018) so we are unsure of outcome to treatment.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Patient presented with swollen, hardened, fevered red rash around where the vaccination was given.  Patient was advised to apply warm, moist heat at 20 minute intervals to the injection site. patient was also given some amoxicillin clavulante 875 bid for 10 days. Patient was just seen today (03-01-2018) so we are unsure of outcome to treatment.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Blood culture negative, Debridement, Injection site abscess, Injection site cellulitis
Clinical narrative: Positive cellulitis and deep abscess developed after administration. Was initially treated with IV antibiotics without success, went on to have surgical debridement of the abscess.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Hypersensitivity, Injection site erythema, Injection site pain
Clinical narrative: Patient saw RN, for redness, warmth, and fevers since getting PCV 23 vaccine. First noticed redness and tenderness at site the following day after receiving vaccine in pharmacy along with fever. Redness progressively got worse. Patient took Tylenol. provider diagnosed her with allergic reaction and cellulitis and prescribed cephalexin 500mg.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Patient saw RN, for redness, warmth, and fevers since getting PCV 23 vaccine. First noticed redness and tenderness at site the following day after receiving vaccine in pharmacy along with fever. Redness progressively got worse. Patient took Tylenol. provider diagnosed her with allergic reaction and cellulitis and prescribed cephalexin 500mg.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Formication, Pain, Pruritus
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 19-Feb-2018. This case involves a 66-year-old female patient, who was vaccinated with 0.5 ml single dose of FLUZONE QIV (batch number, expiration date, dose series and site of administration were not reported), intramuscularly on 26-Oct-2017. The patient developed food allergies and was allergic past to multiple medications such as penicillin, RELAFEN, ULTRAM, VICODIN, PERCOCET and MS CONTIN. The patient medical history includes osteoarthritis, osteopenia, fibromyalgia and sleep apnea, asthma and gastroesophageal reflux disease. The patient's concomitant medication was not reported. On an unknown date, few days post vaccination the patient developed pain, itching, feeling as if bugs were crawling over her body, widespread over the body. The symptoms came and gone, but have not ceased. Patient's lab test and corrective treatment was not reported. At the time of report, outcome of events was not recovered. List of documents held by sender: none.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Myalgia
Clinical narrative: Initial unsolicited report received from pharmacist on 20 Feb 2018. This case involves female patient who was vaccinated with 0.5 ml dose of FLUZONE HD (batch number: UI845AA, expiry date was not reported) intramuscularly in left deltoid on 30 Jan 2018. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination patient had experienced swelling, erythema, pain at injection site of left arm with pain radiating 2 to 3 inches down left arm, also experiencing myalgia, and malaise. Laboratory investigation and corrective treatment were not reported. Patient was not recovered from events. Documents held by sender: none.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial unsolicited report received from pharmacist on 20 Feb 2018. This case involves female patient who was vaccinated with 0.5 ml dose of FLUZONE HD (batch number: UI845AA, expiry date was not reported) intramuscularly in left deltoid on 30 Jan 2018. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination patient had experienced swelling, erythema, pain at injection site of left arm with pain radiating 2 to 3 inches down left arm, also experiencing myalgia, and malaise. Laboratory investigation and corrective treatment were not reported. Patient was not recovered from events. Documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Muscular weakness, Myalgia, Nausea
Clinical narrative: Muscle pain,/weakness, nausea, increased pain at injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Electrocardiogram, Electrocardiogram ambulatory, Heart rate increased, Loss of consciousness
Clinical narrative: Muscle pain,/weakness, nausea, increased pain at injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Syncope, Ventricular extrasystoles
Clinical narrative: Muscle pain,/weakness, nausea, increased pain at injection site.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Injection site pain, Myalgia, Nausea
Clinical narrative: Muscle pain/weakness, nausea, increased pain at injection site. Refused E.R. visit per spouse.
Age: 30.0
Sex: M
Vaccine: ANTH, MMR, TYP
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Severe headache, fever, body aches, chills, fatigue.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Oedema, Oedema peripheral, Pain, Rash erythematous
Clinical narrative: Severe worsening pain. Severe edema spreading Arm twice the size. Severe red rash spreading over the past 24 hours since receiving vaccine.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm, Tongue ulceration
Clinical narrative: The patient has a red spot on the left arm that is sore and warm to the touch and she had sores on her tongue that went away. She is treating the sore spot with ice and ibuprofen. I will contact her doctor when the office is open tomorrow since it is now closed.