chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Ultrasound scan, Urine analysis, Vaccination site pain, White blood cell count increased, X-ray limb
Clinical narrative: Patient reported to medical department approximately 36 hours after Anthrax vaccination. He complained of 6/10 right arm pain and aches around vaccination site and noticed firmness and redness on upper right arm upon waking in AM of 4/12/2020. He took acetaminophen for pain and felt chills and felt warmer despite taking medication. No discharge from the arm and no other complaints. Patient denied any symptoms of chest pain/discomfort, difficulty breathing, cough, nausea/vomiting/diarrhea. Denies GI, MSK, and neurological symptoms. He was alert and oriented x3. Admitted to ICU for treatment and observation. IV placed and infused 2 Liters NS. Given Ceftriaxone 1 gram IV and started on Doxycycline 100mg TAB, given twice a day with meals on Day 1 and 2 with no significant improvement. Started Clindamycin IV in PM of 4/13/2020 and showed good results. 4/14/2020, Day 3, patient improved with resolution of cellulitis. Diagnosis: Cellulitis. Discharged with Clindamycin 150mg capsule, to be taken as 2 capsule every 6 hours, x12 days.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis, Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: On 16-Apr-2020 @8:00PM, approximately 72 hours after patient received anthrax vaccination, he reported to Medical Department with complaint of mild headache and redness to upper right arm, at site of inoculation. Denied fevers and chills or other systemic symptoms. All vital signs were normal. Pain level reported 3-4/10, constant, with "warm" feeling around inoculation site. Physical exam showed erythema of right upper arm, blanching, non-pruritic, rash at the lateral aspect of the arm. No induration, discharge, or crepitus. Showed no ecchymosis. No lesions. Patient has no Hx of MRSA, very low suspicion of MRSA at this time. No purulence or abscess. No fluid collection in the fascial plane. Superficial cobblestones see consistent with cellulitis. DIAGNOSIS: CELLULITIS. PLAN: Patient administered Ceftriaxone 1gm IV for loading. Prescribed Cephalexin 500mg taken by mouth 1 capsule TWICE A DAY for 7 days. Follow-Up Instructions: Patient will be "Sick In Quarters"(Bed Rest) for 24 hours and instructed to return to clinic after for follow-up. Patient verbalized understanding of Rx and Follow-Up instructions.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Pallor, Rash, Staphylococcal infection, Ultrasound scan
Clinical narrative: On 16-Apr-2020 @8:00PM, approximately 72 hours after patient received anthrax vaccination, he reported to Medical Department with complaint of mild headache and redness to upper right arm, at site of inoculation. Denied fevers and chills or other systemic symptoms. All vital signs were normal. Pain level reported 3-4/10, constant, with "warm" feeling around inoculation site. Physical exam showed erythema of right upper arm, blanching, non-pruritic, rash at the lateral aspect of the arm. No induration, discharge, or crepitus. Showed no ecchymosis. No lesions. Patient has no Hx of MRSA, very low suspicion of MRSA at this time. No purulence or abscess. No fluid collection in the fascial plane. Superficial cobblestones see consistent with cellulitis. DIAGNOSIS: CELLULITIS. PLAN: Patient administered Ceftriaxone 1gm IV for loading. Prescribed Cephalexin 500mg taken by mouth 1 capsule TWICE A DAY for 7 days. Follow-Up Instructions: Patient will be "Sick In Quarters"(Bed Rest) for 24 hours and instructed to return to clinic after for follow-up. Patient verbalized understanding of Rx and Follow-Up instructions.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Received Pneumovax 23 in Right deltoid. No symptoms until ~2AM. Pt reports arm (shoulder) doubled in size and pounding and hot to touch. Put ice on shoulder and took ibuprofen. Reports nausea. No fever. Went to an urgent care in morning and received antihistamines and ibuprofen. Arm feeling better.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Gait disturbance, Pain, Rash erythematous, Skin warm
Clinical narrative: On day 1 of injections, Patient reported pain and was favoring his right leg.  Mother noticed a rash developing on day two.  It initially looked like a couple small bug bites... Throughout the day, the rash/redness expanded and there were multiple red bumps that were harder under the skin and painful to the touch. Skin/rash was hot. Took child to clinic to see Dr. who marked for monitoring.  Rash continued to grow into the third day. It went outside of the marked lines.  Mother marked new lines on night three. By the midmorning or early afternoon on day four, the rash started to improve. The doctor had prescribed medicine that we did not give Patient... He seemed to be acting normal other than when we touched it, so we didn't give the medicine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: "every single muscle, bone, and fiber hurts in my body" ,  up and down all night,  Arm is swollen and really sore
Age: 42.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Arthralgia, Back pain, Blood heavy metal normal, Borrelia test negative, Impaired work ability
Clinical narrative: First vaccine given on July 9, 2019, the second vaccine  on Aug 6, , 2019  Lot 1621926.. One week after 1st shot - developed severe back pain. Some relief after treatment.  After 2nd - developed severe back and all over joint pain. No relief to date.  Consulted primary care and chronic pain management doctor.  Prior to pregnancy in January, 2020, took muscle relaxant, a prescription NSAID, glucosamine chondritin, medical grade CBD oil . Tried, low impact cardio, sauna, hot yoga, aquatherapy - minimal relief.  As of January 2020, all medications ceased except for tylenol.  Pain is severe in mornings, and significantly impacts my daily work as Nurse Anesthesist and daily routine.
Age: 42.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Loss of personal independence in daily activities, Rheumatoid factor negative, Thyroid function test normal
Clinical narrative: First vaccine given on July 9, 2019, the second vaccine  on Aug 6, , 2019  Lot 1621926.. One week after 1st shot - developed severe back pain. Some relief after treatment.  After 2nd - developed severe back and all over joint pain. No relief to date.  Consulted primary care and chronic pain management doctor.  Prior to pregnancy in January, 2020, took muscle relaxant, a prescription NSAID, glucosamine chondritin, medical grade CBD oil . Tried, low impact cardio, sauna, hot yoga, aquatherapy - minimal relief.  As of January 2020, all medications ceased except for tylenol.  Pain is severe in mornings, and significantly impacts my daily work as Nurse Anesthesist and daily routine.
Age: 1.5
Sex: F
Vaccine: HIBV
Symptoms: Cyanosis, Hypotonia, Pyrexia, Respiratory arrest, Seizure
Clinical narrative: Patient began a fever of 101.2 degrees on Friday 4/17/2020 at 2:45 pm and her fever continued until present time. She had a seizure at 5:37 pm on Saturday 4/18/2020 which lasted 2 minutes. She was not breathing for the second minute of the seizure. She turned blue and completely limp. She eventually began to regain her usual color and was breathing on her own. Her fever after the seizure was 102.7.
Age: 1.5
Sex: F
Vaccine: HIBV
Symptoms: Urine analysis normal
Clinical narrative: Patient began a fever of 101.2 degrees on Friday 4/17/2020 at 2:45 pm and her fever continued until present time. She had a seizure at 5:37 pm on Saturday 4/18/2020 which lasted 2 minutes. She was not breathing for the second minute of the seizure. She turned blue and completely limp. She eventually began to regain her usual color and was breathing on her own. Her fever after the seizure was 102.7.
Age: 65.0
Sex: M
Vaccine: FLUA3, PNC13, VARZOS
Symptoms: Acquired diaphragmatic eventration, Chest X-ray, Computerised tomogram, Diaphragmatic paralysis, Dyspnoea
Clinical narrative: Shortness of breath accompanied with right sub-scapular pain started appox 2 days following the vaccinations. Symptoms became progressively worse until admission to the Emergency Room was required. The diagnosis of elevated right hemi-diaphragm was diagnosed during the ER admission.  October 31-Nov 1 2019 an inpatient polysomnography was done which resulted in the diagnosis of sleep apnea related to the paralyzed right diaphragm.    On Nov 20 2019 the Pulmonary physician attributed the paralyzed diaphragm directly to the vaccinations that were given on Nov 1 2018.
Age: 65.0
Sex: M
Vaccine: FLUA3, PNC13, VARZOS
Symptoms: Echocardiogram, Musculoskeletal pain, Pulmonary function test, Sleep apnoea syndrome, Sleep study abnormal
Clinical narrative: Shortness of breath accompanied with right sub-scapular pain started appox 2 days following the vaccinations. Symptoms became progressively worse until admission to the Emergency Room was required. The diagnosis of elevated right hemi-diaphragm was diagnosed during the ER admission.  October 31-Nov 1 2019 an inpatient polysomnography was done which resulted in the diagnosis of sleep apnea related to the paralyzed right diaphragm.    On Nov 20 2019 the Pulmonary physician attributed the paralyzed diaphragm directly to the vaccinations that were given on Nov 1 2018.
Age: 65.0
Sex: M
Vaccine: FLUA3, PNC13, VARZOS
Symptoms: Vaccination complication, X-ray
Clinical narrative: Shortness of breath accompanied with right sub-scapular pain started appox 2 days following the vaccinations. Symptoms became progressively worse until admission to the Emergency Room was required. The diagnosis of elevated right hemi-diaphragm was diagnosed during the ER admission.  October 31-Nov 1 2019 an inpatient polysomnography was done which resulted in the diagnosis of sleep apnea related to the paralyzed right diaphragm.    On Nov 20 2019 the Pulmonary physician attributed the paralyzed diaphragm directly to the vaccinations that were given on Nov 1 2018.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Adverse drug reaction, Aphonia, Blister, Chills, Condition aggravated
Clinical narrative: Arms and legs covered in rash, blistering, bleeding. swollen arms and legs (minimal swelling or pain   at injection site). still occurring until present (04/20/2020), Pain, itching, numbness in arms legs,fingers and toes,  Chills with freezing sensations. Hearing loss in right ear.(significant) . Whole body sensation of tingling and with severe itching.. ALL SYMPTOMS CONTINUE AS PER THIS REPORT DATE(04/20/2020) Glaxo Smith Kline was non responsive to my multiple calls, I received the run around when attempting to get answers , Transferred to multiple numbers which after an extended period of waiting were disconnected on their end
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Food intolerance, Hyperhidrosis, Nausea, Productive cough
Clinical narrative: Arms and legs covered in rash, blistering, bleeding. swollen arms and legs (minimal swelling or pain   at injection site). still occurring until present (04/20/2020), Pain, itching, numbness in arms legs,fingers and toes,  Chills with freezing sensations. Hearing loss in right ear.(significant) . Whole body sensation of tingling and with severe itching.. ALL SYMPTOMS CONTINUE AS PER THIS REPORT DATE(04/20/2020) Glaxo Smith Kline was non responsive to my multiple calls, I received the run around when attempting to get answers , Transferred to multiple numbers which after an extended period of waiting were disconnected on their end
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: Arms and legs covered in rash, blistering, bleeding. swollen arms and legs (minimal swelling or pain   at injection site). still occurring until present (04/20/2020), Pain, itching, numbness in arms legs,fingers and toes,  Chills with freezing sensations. Hearing loss in right ear.(significant) . Whole body sensation of tingling and with severe itching.. ALL SYMPTOMS CONTINUE AS PER THIS REPORT DATE(04/20/2020) Glaxo Smith Kline was non responsive to my multiple calls, I received the run around when attempting to get answers , Transferred to multiple numbers which after an extended period of waiting were disconnected on their end
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Chills, Deafness unilateral, Feeling cold, Haemorrhage
Clinical narrative: Arms and legs covered in rash, blistering, bleeding. swollen arms and legs (minimal swelling or pain   at injection site). still occurring until present (04/20/2020), Pain, itching, numbness in arms legs,fingers and toes,  Chills with freezing sensations. Hearing loss in right ear.(significant) . Whole body sensation of tingling and with severe itching.. ALL SYMPTOMS CONTINUE AS PER THIS REPORT DATE(04/20/2020) Glaxo Smith Kline was non responsive to my multiple calls, I received the run around when attempting to get answers , Transferred to multiple numbers which after an extended period of waiting were disconnected on their end
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Injection site pain, Injection site swelling, Pain, Paraesthesia
Clinical narrative: Arms and legs covered in rash, blistering, bleeding. swollen arms and legs (minimal swelling or pain   at injection site). still occurring until present (04/20/2020), Pain, itching, numbness in arms legs,fingers and toes,  Chills with freezing sensations. Hearing loss in right ear.(significant) . Whole body sensation of tingling and with severe itching.. ALL SYMPTOMS CONTINUE AS PER THIS REPORT DATE(04/20/2020) Glaxo Smith Kline was non responsive to my multiple calls, I received the run around when attempting to get answers , Transferred to multiple numbers which after an extended period of waiting were disconnected on their end
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: Arms and legs covered in rash, blistering, bleeding. swollen arms and legs (minimal swelling or pain   at injection site). still occurring until present (04/20/2020), Pain, itching, numbness in arms legs,fingers and toes,  Chills with freezing sensations. Hearing loss in right ear.(significant) . Whole body sensation of tingling and with severe itching.. ALL SYMPTOMS CONTINUE AS PER THIS REPORT DATE(04/20/2020) Glaxo Smith Kline was non responsive to my multiple calls, I received the run around when attempting to get answers , Transferred to multiple numbers which after an extended period of waiting were disconnected on their end
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: after 4 hours soreness in arm. after 12 hours aches and fever developed. site of injrction was red. aches and fever persisted for 24 hours. after three days inection  site is still tender and red
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects were reported in the patient; a patient received an expired dose of PROQUAD; The spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 01-APR-2020, the patient received an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (lot # R026719 and expiration date: 17-MAR-2020; dose, strength, frequency and route were unknown) for prophylaxis (expired vaccine used). No additional adverse effects were reported in the patient. No product quality complaint (PQC) reported. The outcome of the events was unknown.
Sex: F
Vaccine: UNK, VARCEL, UNK, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: patient bad a negative pregnancy test on 3/3/2020 and was administered VARN AX on 3/3/2020; This spontaneous report was received from a registered nurse referring to a currently 39-year old female patient. The patient had no pertinent medical history, drug reactions/allergies and concomitant medication.  On 03-MAR-2020, the patient had a negative pregnancy test and was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (intramuscular, lot # S002084, expiration date was reported as 22-JUL-2021, but upon internal validation established as 21-JAN-2021; dose were unknown) for prophylaxis. The reporter did not know if the varicella virus vaccine live (oka/merck) (VARIVAX) administered on 03-MAR-2020 was the patient's first dose. Other suspect therapies included sterile diluent (STERILE DILUENT).    On 26-MAR-2020, the patient took an unspecified type of pregnancy test and the test was positive for pregnancy (vaccine exposure during pregnancy). The last menstrual period (LMP) was estimated to be 12-MAR-2020 and the estimated date of delivery (EDD) was 17-DEC-2020. The pregnancy outcome was pending. The fetal outcome was unknown.
Sex: F
Vaccine: UNK, VARCEL, UNK, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive, Ultrasound antenatal screen normal
Clinical narrative: patient bad a negative pregnancy test on 3/3/2020 and was administered VARN AX on 3/3/2020; This spontaneous report was received from a registered nurse referring to a currently 39-year old female patient. The patient had no pertinent medical history, drug reactions/allergies and concomitant medication.  On 03-MAR-2020, the patient had a negative pregnancy test and was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (intramuscular, lot # S002084, expiration date was reported as 22-JUL-2021, but upon internal validation established as 21-JAN-2021; dose were unknown) for prophylaxis. The reporter did not know if the varicella virus vaccine live (oka/merck) (VARIVAX) administered on 03-MAR-2020 was the patient's first dose. Other suspect therapies included sterile diluent (STERILE DILUENT).    On 26-MAR-2020, the patient took an unspecified type of pregnancy test and the test was positive for pregnancy (vaccine exposure during pregnancy). The last menstrual period (LMP) was estimated to be 12-MAR-2020 and the estimated date of delivery (EDD) was 17-DEC-2020. The pregnancy outcome was pending. The fetal outcome was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; an improperly stored dose of VARIVAX was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions/allergies were not reported.  On 02-APR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number S022755 was verified to be a valid lot number, expiration date reported and established as 02-JUL-2021), for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion -13.4 degrees Celsius for 1 hour 30 minutes (product storage error), as recorded by a data logger. There was no adverse effect reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No known adverse effects.; patient received a dose of VARIVAX and a dose of PROQUAD.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not provided.     On 02-APR-2020, the patient was vaccinated with a dose varicella virus vaccine live (oka/merck) (VARIVAX) (lot number S020965 and expiration date 07-JUL-2021), and with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (lot number  S012470 and expiration date 20-OCT-2020) (overdose), for both vaccines were administered as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported). No additional adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Deafness, Herpes zoster, Rash
Clinical narrative: painful and debilitating rashes and shingles across her body, was diagnosed with herpes zoster; loss of hearing; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On 15-MAR-2019, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) at medical center, for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Approximately 10 days after receiving the vaccine, patient suffered painful and debilitating rashes and shingles across her body, was diagnosed with herpes zoster, and subsequently developed loss of hearing. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in the physical injuries identified above and limitations not present prior to using the vaccine. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of loss of hearing and herpes zoster was unknown. The lawyer considered loss of hearing and herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     Upon internal review, loss of hearing was considered to be medically significant.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improperly stored PROQUAD was inadvertently administered; Information has been received from a medical assistant concerning to a 11 year old male patient. No medical history nor concurrent conditions were reported. On 31-OCT-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot No. S012536, exp. date 20-OCT-2020) (rHA) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse event was reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA015996:
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Improperly stored VARIVAX was inadvertently administered; Information has been received from a medical assistant concerning to a 12 month old female patient. No concurrent conditions, medical history nor concomitant medications were reported. On 21-OCT-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Lot No. S015459, exp. date 20-MAY-2020) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse event was reported.      This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA015996:
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events; Improperly stored VARIVAX was inadvertently administered; This report was received from a medical assistant concerning to a 7 year old male patient. No medical history nor concurrent conditions medications were reported. On 21-OCT-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Lot No. S015459, exp. date 20-MAY-2020) for prophylaxis. The vaccine was reconstituted with properly stored diluent. No adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA015996:
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improperly stored PROQUAD was inadvertently administered; Information has been received from a medical assistant concerning to a 5 year old female patient. No medical history, concurrent conditions nor concomitant medications were reported. On 19-OCT-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot No. S012536,exp. date 20-OCT-2020) (rHA) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse event was reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA015996:
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improperly stored PROQUAD was inadvertently administered; Information has been received from a medical assistant concerning to a 4 year old female patient. No medical history nor concurrent conditions were reported. On 21-OCT-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot No. S012536, exp. date 20-OCT-2020) (rHA) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse event was reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA015996:
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improperly stored PROQUAD was inadvertently administered; Information has been received from a medical assistant concerning to a 4 year old male patient. No medical history, concurrent conditions nor concomitant medications were reported. On 22-OCT-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot No. S012536,exp. date 20-OCT-2020) (rHA) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse event was reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA015996:
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Headache, Incorrect route of product administration, Skin warm
Clinical narrative: Redness; is also warm to touch; , more subcutaneous than muscle; have joint pain/ Pain in elbow; and headache; This case was reported by a nurse via call center representative and described the occurrence of joint pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (received 1st dose on 29th November 2019, refer case US2020019106).   On 31st January 2020, the patient received the 2nd dose of Shingrix (subcutaneous). On 31st January 2020, less than a day after receiving Shingrix, the patient experienced joint pain, headache and intramuscular formulation administered by other route. On 2nd February 2020, the patient experienced erythema and skin warm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the joint pain and erythema were not recovered/not resolved and the outcome of the headache and skin warm were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the joint pain, headache, erythema and skin warm to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient's wife. The reporter believed that the vaccine was given too low and too anterior on the arm, which led to intramuscular formulation administered by other route. The band aid was low on the anterior part of his arm, more subcutaneous than muscle.  The reporter called pharmacy to inform them but by paperwork it notes the vaccine was given IM. After the vaccination, the patient began to have joint pain and headache.  On 1st February 2020, these issues continued. On 2nd February 2020, the patient's left elbow hurt really bad and on the day of reporting, it continued to be really sore.  The reporter also noted the area of redness was marked on 2nd February 2020 and on the day of reporting it was even larger.  The reporter stated it was also warm to touch. The reporter was encouraged to have her husband notify his physician. The reporter consented to follow up. This case has been linked with case US2020019097, reported for same reporter.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Redness; is also warm to touch; , more subcutaneous than muscle; have joint pain/ Pain in elbow; and headache; This case was reported by a nurse via call center representative and described the occurrence of joint pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (received 1st dose on 29th November 2019, refer case US2020019106).   On 31st January 2020, the patient received the 2nd dose of Shingrix (subcutaneous). On 31st January 2020, less than a day after receiving Shingrix, the patient experienced joint pain, headache and intramuscular formulation administered by other route. On 2nd February 2020, the patient experienced erythema and skin warm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the joint pain and erythema were not recovered/not resolved and the outcome of the headache and skin warm were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the joint pain, headache, erythema and skin warm to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient's wife. The reporter believed that the vaccine was given too low and too anterior on the arm, which led to intramuscular formulation administered by other route. The band aid was low on the anterior part of his arm, more subcutaneous than muscle.  The reporter called pharmacy to inform them but by paperwork it notes the vaccine was given IM. After the vaccination, the patient began to have joint pain and headache.  On 1st February 2020, these issues continued. On 2nd February 2020, the patient's left elbow hurt really bad and on the day of reporting, it continued to be really sore.  The reporter also noted the area of redness was marked on 2nd February 2020 and on the day of reporting it was even larger.  The reporter stated it was also warm to touch. The reporter was encouraged to have her husband notify his physician. The reporter consented to follow up. This case has been linked with case US2020019097, reported for same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Psoriasis
Clinical narrative: located many comments and a group of women who have all had the exact break out; This case was reported by a consumer and described the occurrence of psoriasis in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced psoriasis. On an unknown date, the outcome of the psoriasis was unknown.   It was unknown if the reporter considered the psoriasis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. While perusing the internet, the reporter located many comments and a group of women who have all had the exact break out psoriasis. This case has been linked to US2020AMR038938, reported by the same reporter.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: CSF test normal, Computerised tomogram head normal, Dyskinesia, Electroencephalogram abnormal, Endotracheal intubation
Clinical narrative: Developed fever to 102.4 approximately 6 hours after vaccination. The next morning, was noted to be lethargic with seizure-like jerking of extremities. Admitted to our hospital, initial EEG was not consistent with seizures, but continued to have altered mental status. On 3/28/20, developed EEG-confirmed status epilepticus requiring intubation and 3 anti-epileptic medications to break seizures. Ultimately extubated on 3/30 and has continued to show steady improvement each day thereafter with no further seizures witnessed. Is now receiving inpatient rehabilitation.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Lethargy, Leukoencephalopathy, Magnetic resonance imaging brain abnormal, Mental status changes, Pyrexia
Clinical narrative: Developed fever to 102.4 approximately 6 hours after vaccination. The next morning, was noted to be lethargic with seizure-like jerking of extremities. Admitted to our hospital, initial EEG was not consistent with seizures, but continued to have altered mental status. On 3/28/20, developed EEG-confirmed status epilepticus requiring intubation and 3 anti-epileptic medications to break seizures. Ultimately extubated on 3/30 and has continued to show steady improvement each day thereafter with no further seizures witnessed. Is now receiving inpatient rehabilitation.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Seizure, Seizure like phenomena, Status epilepticus
Clinical narrative: Developed fever to 102.4 approximately 6 hours after vaccination. The next morning, was noted to be lethargic with seizure-like jerking of extremities. Admitted to our hospital, initial EEG was not consistent with seizures, but continued to have altered mental status. On 3/28/20, developed EEG-confirmed status epilepticus requiring intubation and 3 anti-epileptic medications to break seizures. Ultimately extubated on 3/30 and has continued to show steady improvement each day thereafter with no further seizures witnessed. Is now receiving inpatient rehabilitation.
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: rash spread to his entire body and face on 4/5/2020; The patient "developed a rash on the back and stomach on 4/4/2020; This spontaneous report was received from a consumer referring to his 12 months old son. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 25-MAR-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route, batch/lot# and expiration date were unknown) for prophylaxis; varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency, route, batch/lot# and expiration date were unknown) for prophylaxis and hepatitis a vaccine, inactivated (manufacturer unknown) (strength, dose, frequency, route, batch/lot# and expiration date were unknown) for prophylaxis.  On 04-APR-2020, the patient developed a rash on the back and stomach. On 05-APR-2020, rash spread to the patient's entire body and face. A phone call had been placed to the physician to seek medical attention. The outcome of the events was not recovered. The causality assessment was not provided.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse symptoms were reported; Nurse reported the same patient received second dose ofGARDASIL 9 on unspecified date in 8/2017; This spontaneous report was received from a nurse referring to a male patient over the age of 18. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.   On an unspecified date in July 2016 the patient received dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route, indication, lot # and expiration date were not reported) for prophylaxis. On an unspecified date in August 2017 the patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route, indication, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). No adverse symptoms were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; received one dose of improperly stored VARIVAX; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. Information about concomitant medications, pertinent medical history and drug reactions or allergies was not provided. On 15-APR-2020, the patient was vaccinated with one dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot number: S002393, expiration date: 23-JAN-2021 (strength, dose, vaccination scheme and route of administration were not provided) as prophylaxis. Sterile diluent (STERILE DILUENT) which was used to reconstitute the vaccine had been properly stored. The administered dose of vaccine experienced a temperature excursion of -12.5 degrees Celsius (C) for 15 minutes. The vaccine also experienced previous temperature excursion of -13.5 degrees C for 18 minutes. Digital data logger was involved. No additional adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia
Clinical narrative: was experiencing numbness in her face; This spontaneous report as received from a nurse prescriber via a company representative refers to a non-pregnant female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On 15-APR-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route of administration, lot number and expiration date were not reported) as routine vaccination. On the same date, the patient contacted the physician office and informed that she experienced numbness in her face. The outcome of the event was not reported.  The relatedness between numbness in the patient's face and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling abnormal, Insomnia, Migraine, Myalgia
Clinical narrative: LOUD buzzing in head, faintness, dizzyness, all over muscle aches, too many migraines in one month, unable to sleep because of restlessness in entire body. The night of the injection, it was like I could literally feel my blood surging through my body and the whole room was spinning. These symptoms have persisted in one way or another since Jan 29th and I can not get peace!
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Restlessness, Syncope, Tinnitus, Vertigo
Clinical narrative: LOUD buzzing in head, faintness, dizzyness, all over muscle aches, too many migraines in one month, unable to sleep because of restlessness in entire body. The night of the injection, it was like I could literally feel my blood surging through my body and the whole room was spinning. These symptoms have persisted in one way or another since Jan 29th and I can not get peace!
Age: 17.0
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Infanrix administered to a 17 year old patient in error; This case was reported by a nurse via sales rep and described the occurrence of adult use of a child product in a 17-year-old patient who received DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient received Infanrix at an unknown dose. On an unknown date, unknown after receiving Infanrix, the patient experienced adult use of a child product. On an unknown date, the outcome of the adult use of a child product was unknown.  Additional details were received as follows: The reporter stated that the Infanrix administered to patient in error, instead of Boostrix, which led to adult use of a child product. The reporter asked dose the patient need to be revaccinated with Boostrix.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Skin warm
Clinical narrative: red and hot to the touch
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Ear pain, Gingival pain, Headache, Increased upper airway secretion, Myalgia
Clinical narrative: Patient called and states Friday early evening hours she had a terrible headache, fullness in her throat,  ear pain,  muscle pain, gum pain and then Saturday morning woke up with blisters in her mouth.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Oral mucosal blistering
Clinical narrative: Patient called and states Friday early evening hours she had a terrible headache, fullness in her throat,  ear pain,  muscle pain, gum pain and then Saturday morning woke up with blisters in her mouth.
Age: 1.42
Sex: F
Vaccine: MMR, MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered an MMR vaccine which had been expired for 4 days. Date of administration 4-14-2020, expiration date on vaccine 4-10-2020.  Also called the manufacturer, Merck, spoke to staff. Staff stated that the vaccine still should have enough potency & that the patient should not need an additional dose unless the provider thought otherwise. The provider also believes that the vaccine that was administered should be good given the fact that it was only 4 days expired. The patient's mother was informed of the situation and states that her daughter is perfectly fine and did not experience any adverse reactions what-so-ever.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Biopsy bone abnormal, Blood culture negative, Culture negative, Inflammation, Injection site movement impairment
Clinical narrative: Presented to ED on 2/28/20 with decreased left leg movement and tenderness x 4 weeks, first noticed after receiving Hep B vaccine. Discovered to have osteomyelitis of left tibia on MRI. Started on ceftriaxone and clindamycin. Finished 4 weeks of IV antibiotics through central line. Recovered and moving well afterwards.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Injection site pain, Injection site reaction, Magnetic resonance imaging abnormal, Osteomyelitis
Clinical narrative: Presented to ED on 2/28/20 with decreased left leg movement and tenderness x 4 weeks, first noticed after receiving Hep B vaccine. Discovered to have osteomyelitis of left tibia on MRI. Started on ceftriaxone and clindamycin. Finished 4 weeks of IV antibiotics through central line. Recovered and moving well afterwards.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Blood culture, Blood lactic acid, Chills, Computerised tomogram head, Culture urine
Clinical narrative: Experienced chills, fever (104.5) and severe tremors.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Full blood count, Metabolic function test, Pyrexia, Tremor, Urine analysis
Clinical narrative: Experienced chills, fever (104.5) and severe tremors.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Dyspnoea, Injection site urticaria
Clinical narrative: Hives at location of injections, grandmother and mom states baby had SOB Had reactions to Hep A, MMR, & Varicella
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient reported severe redness, heat and pain in arm, her dr told her to go to ER for treatment, patient confirmed she was treated with antibiotics for cellulitis  infection.
Age: 73.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Blood test, Chest X-ray, Cough, Culture, Erythema
Clinical narrative: 1.) Redness 2.) Itching 3.) Warm to touch. 4.) Severe coughing 5.) Thick mucus coughing at the back of my throat - to constant clearing & hard to get out. stress incontinent increased I am sending you this form regarding my experience of receiving a vaccine of (1.) Prevnar (2.) Boostrix of TDAP syringe which I develop all the symptoms of having whooping cough at thick mucus coating behind my throat & experiencing until this time. I had been suffering fr this vaccine. I would like to have this be resolved of my experience coughing & with so much mucus coming out when I cough constantly.
Age: 73.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Pertussis, Pruritus, Secretion discharge, Skin warm, Stress urinary incontinence
Clinical narrative: 1.) Redness 2.) Itching 3.) Warm to touch. 4.) Severe coughing 5.) Thick mucus coughing at the back of my throat - to constant clearing & hard to get out. stress incontinent increased I am sending you this form regarding my experience of receiving a vaccine of (1.) Prevnar (2.) Boostrix of TDAP syringe which I develop all the symptoms of having whooping cough at thick mucus coating behind my throat & experiencing until this time. I had been suffering fr this vaccine. I would like to have this be resolved of my experience coughing & with so much mucus coming out when I cough constantly.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Paranasal sinus hypersecretion
Clinical narrative: sinus started running .. has not stopped
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Spinal compression fracture, X-ray abnormal
Clinical narrative: Injection was 10/ 18.  The next morning around 8:30 I went to the kitchen to fix my breakfast.  I was standing at the counter.  Next thing I knew I was stretched out on the floor (at 90 deg from where I'd been standing) in severe pain.  There was no warning; one second everything was normal and the next I was aware I was on the floor.  I have never fainted before.  Xrays revealed a severe compression fracture of T8.  It is now over 6 months later.  I still have significant pain when standing, sitting in a straight-back chair, or walking more than 25 minutes on a flat course.
Age: 25.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cold sweat, Dyskinesia, Electrocardiogram normal, Hypoaesthesia, Nausea
Clinical narrative: 25 yo F new hire in our outpatient clinic.  Minutes  s/p MMR and varicella injection LVN administering reports patient slouched back in chair and head went back in spastic movements (10-20 sec) then patient leaned forward, pale and clammy, able to talk, breath, RR 30, Pulse 50s/60s.  LVN called for help. Unable to get BP due to distance from wall equipment. Clinic NP (me)  walk in and witnessed similar episode repeat of head back/spastic movements, then patient sat forward, was pale, c/o nausea and numb hands., Had dry heaves. EMS called/arrived within 5 min. No known Hx of cardiac hx, seizures, DM, Pregnancy, recent illness. Stated no hx of vaccine reactions or issues with injections or blooddraws.  EMS stated EKG normal. Patient left via Gurney with EMS. Reportedly declined going to hospital via ambulance and was driven by roommate in private car to ED.   Assessment includes s/p seizure episode vs. Cardiogenic syncopal episode/vasovagal.