chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Demyelination, Feeling hot, Full blood count normal, Hypoaesthesia, Impaired work ability
Clinical narrative: 8/19/19 1600- warm/hot sensation in left leg. 1700 numbess/tingling in left foot. 1900 shower, water felt like fire.  8/20/19-numbness tingling sensation to mid calf. Feels like fire. 0800. Reported at work; where tdap shot was given. Went to ER. Waited for hours. Told if I began to have problems breathing go to the ER. 8/20/19- 1700. Out of work. Numbness/tingling/fire pain now past knee. Went to Urgent Care. ER Doctor didn?t know what to do; said yes it was adverse reaction and prescribed 100 mg Gabapentin. 8/21/19- Numbness/tingling/fire now to left thigh.  8/22/19- Contacted ER Doctor who sent STAT orders to a local Neurologist; no appointments available. Said to follow up with PCP.  8/23/19 0845: PCP appointment, Dr. Dr. did a complete physical and neuro exam and called to the nearest Trauma Center. He sent us straight to the ER. Placed in Trauma 2. 10:30 am Admitted to hospital on NeuroScience unit at 1200 noon. Numbness/tingling/fire now from left foot to lower back. Tingling/numbess beginning in right leg. 8/24/19 Neuro rounds, family attending and residents. Begin treating with high dose IV steroids. All labs are normal. MRI full spinal and brain. shows c3 demyelination, NEW. Ordered a LP. 3 attempts at LP by Dr., unsuccessful. Will continue steroids and wait until Monday 8/26/19 8/26/19 IR did LP. Numbness tingling and fire pain now in both legs toe to hips, and left side to mid back. Still IV steroids 8/27/19- Neuro insisting on doing plasmapheresis. Central line placed. Tingling/numbness/fire in right hand beginning 8/28/19-1st Plasmapheresis 8/30/19- 2nd plasmapheresis 9/1/19- 3rd plasmapheresis; all labs in LP NORMAL 9/3/19- 4th plasmapheresis 9/5/19- 5th plasmapheresis 9/7/19- 6th plasmapheresis 9/9/19- 7th plasmapheresis 9/10/19- central line removed. Transferred to Rehabilitation center. Minimal use of legs. Cant feel pressure. Vistibular system off. Brachial Neuritis. ADEM. Transverse Myelitis. NSHL. 9/11/19- told weeks of inpatient at facility.  Unknown Recovery time frame, if recovery possible.
Age: 33.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Lumbar puncture normal, Magnetic resonance imaging brain abnormal, Magnetic resonance imaging spinal abnormal, Metabolic function test normal, Musculoskeletal disorder
Clinical narrative: 8/19/19 1600- warm/hot sensation in left leg. 1700 numbess/tingling in left foot. 1900 shower, water felt like fire.  8/20/19-numbness tingling sensation to mid calf. Feels like fire. 0800. Reported at work; where tdap shot was given. Went to ER. Waited for hours. Told if I began to have problems breathing go to the ER. 8/20/19- 1700. Out of work. Numbness/tingling/fire pain now past knee. Went to Urgent Care. ER Doctor didn?t know what to do; said yes it was adverse reaction and prescribed 100 mg Gabapentin. 8/21/19- Numbness/tingling/fire now to left thigh.  8/22/19- Contacted ER Doctor who sent STAT orders to a local Neurologist; no appointments available. Said to follow up with PCP.  8/23/19 0845: PCP appointment, Dr. Dr. did a complete physical and neuro exam and called to the nearest Trauma Center. He sent us straight to the ER. Placed in Trauma 2. 10:30 am Admitted to hospital on NeuroScience unit at 1200 noon. Numbness/tingling/fire now from left foot to lower back. Tingling/numbess beginning in right leg. 8/24/19 Neuro rounds, family attending and residents. Begin treating with high dose IV steroids. All labs are normal. MRI full spinal and brain. shows c3 demyelination, NEW. Ordered a LP. 3 attempts at LP by Dr., unsuccessful. Will continue steroids and wait until Monday 8/26/19 8/26/19 IR did LP. Numbness tingling and fire pain now in both legs toe to hips, and left side to mid back. Still IV steroids 8/27/19- Neuro insisting on doing plasmapheresis. Central line placed. Tingling/numbness/fire in right hand beginning 8/28/19-1st Plasmapheresis 8/30/19- 2nd plasmapheresis 9/1/19- 3rd plasmapheresis; all labs in LP NORMAL 9/3/19- 4th plasmapheresis 9/5/19- 5th plasmapheresis 9/7/19- 6th plasmapheresis 9/9/19- 7th plasmapheresis 9/10/19- central line removed. Transferred to Rehabilitation center. Minimal use of legs. Cant feel pressure. Vistibular system off. Brachial Neuritis. ADEM. Transverse Myelitis. NSHL. 9/11/19- told weeks of inpatient at facility.  Unknown Recovery time frame, if recovery possible.
Age: 33.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Myelitis transverse, Neurological examination, Paraesthesia, Plasmapheresis, Radiculitis brachial
Clinical narrative: 8/19/19 1600- warm/hot sensation in left leg. 1700 numbess/tingling in left foot. 1900 shower, water felt like fire.  8/20/19-numbness tingling sensation to mid calf. Feels like fire. 0800. Reported at work; where tdap shot was given. Went to ER. Waited for hours. Told if I began to have problems breathing go to the ER. 8/20/19- 1700. Out of work. Numbness/tingling/fire pain now past knee. Went to Urgent Care. ER Doctor didn?t know what to do; said yes it was adverse reaction and prescribed 100 mg Gabapentin. 8/21/19- Numbness/tingling/fire now to left thigh.  8/22/19- Contacted ER Doctor who sent STAT orders to a local Neurologist; no appointments available. Said to follow up with PCP.  8/23/19 0845: PCP appointment, Dr. Dr. did a complete physical and neuro exam and called to the nearest Trauma Center. He sent us straight to the ER. Placed in Trauma 2. 10:30 am Admitted to hospital on NeuroScience unit at 1200 noon. Numbness/tingling/fire now from left foot to lower back. Tingling/numbess beginning in right leg. 8/24/19 Neuro rounds, family attending and residents. Begin treating with high dose IV steroids. All labs are normal. MRI full spinal and brain. shows c3 demyelination, NEW. Ordered a LP. 3 attempts at LP by Dr., unsuccessful. Will continue steroids and wait until Monday 8/26/19 8/26/19 IR did LP. Numbness tingling and fire pain now in both legs toe to hips, and left side to mid back. Still IV steroids 8/27/19- Neuro insisting on doing plasmapheresis. Central line placed. Tingling/numbness/fire in right hand beginning 8/28/19-1st Plasmapheresis 8/30/19- 2nd plasmapheresis 9/1/19- 3rd plasmapheresis; all labs in LP NORMAL 9/3/19- 4th plasmapheresis 9/5/19- 5th plasmapheresis 9/7/19- 6th plasmapheresis 9/9/19- 7th plasmapheresis 9/10/19- central line removed. Transferred to Rehabilitation center. Minimal use of legs. Cant feel pressure. Vistibular system off. Brachial Neuritis. ADEM. Transverse Myelitis. NSHL. 9/11/19- told weeks of inpatient at facility.  Unknown Recovery time frame, if recovery possible.
Age: 33.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Scan with contrast abnormal, Vestibular disorder
Clinical narrative: 8/19/19 1600- warm/hot sensation in left leg. 1700 numbess/tingling in left foot. 1900 shower, water felt like fire.  8/20/19-numbness tingling sensation to mid calf. Feels like fire. 0800. Reported at work; where tdap shot was given. Went to ER. Waited for hours. Told if I began to have problems breathing go to the ER. 8/20/19- 1700. Out of work. Numbness/tingling/fire pain now past knee. Went to Urgent Care. ER Doctor didn?t know what to do; said yes it was adverse reaction and prescribed 100 mg Gabapentin. 8/21/19- Numbness/tingling/fire now to left thigh.  8/22/19- Contacted ER Doctor who sent STAT orders to a local Neurologist; no appointments available. Said to follow up with PCP.  8/23/19 0845: PCP appointment, Dr. Dr. did a complete physical and neuro exam and called to the nearest Trauma Center. He sent us straight to the ER. Placed in Trauma 2. 10:30 am Admitted to hospital on NeuroScience unit at 1200 noon. Numbness/tingling/fire now from left foot to lower back. Tingling/numbess beginning in right leg. 8/24/19 Neuro rounds, family attending and residents. Begin treating with high dose IV steroids. All labs are normal. MRI full spinal and brain. shows c3 demyelination, NEW. Ordered a LP. 3 attempts at LP by Dr., unsuccessful. Will continue steroids and wait until Monday 8/26/19 8/26/19 IR did LP. Numbness tingling and fire pain now in both legs toe to hips, and left side to mid back. Still IV steroids 8/27/19- Neuro insisting on doing plasmapheresis. Central line placed. Tingling/numbness/fire in right hand beginning 8/28/19-1st Plasmapheresis 8/30/19- 2nd plasmapheresis 9/1/19- 3rd plasmapheresis; all labs in LP NORMAL 9/3/19- 4th plasmapheresis 9/5/19- 5th plasmapheresis 9/7/19- 6th plasmapheresis 9/9/19- 7th plasmapheresis 9/10/19- central line removed. Transferred to Rehabilitation center. Minimal use of legs. Cant feel pressure. Vistibular system off. Brachial Neuritis. ADEM. Transverse Myelitis. NSHL. 9/11/19- told weeks of inpatient at facility.  Unknown Recovery time frame, if recovery possible.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt called approximately 7 hours after receiving vaccine. Said she was experiencing swelling, itching, and redness at the immunization site. Pt has had influenza shots in the past with no history of reactions, however this was the first time she had received the high dose influenza vaccine.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Antinuclear antibody positive, Chills, Feeling cold, Hypoaesthesia, Middle insomnia
Clinical narrative: At 3 am that night I woke up and my legs were suddenly numb. I was shaking uncontrollably , with chill like symptoms. My teeth were chattering. I was cold in a normal temperature room. This went on for 3 hours. Since then I am having different pains and symptoms in my body. ANA tests are coming back positive which I never had before. I now have a possible auto immune disease.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Tremor
Clinical narrative: At 3 am that night I woke up and my legs were suddenly numb. I was shaking uncontrollably , with chill like symptoms. My teeth were chattering. I was cold in a normal temperature room. This went on for 3 hours. Since then I am having different pains and symptoms in my body. ANA tests are coming back positive which I never had before. I now have a possible auto immune disease.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pyrexia, Retching
Clinical narrative: nausea, fever, dry heaves fatigue
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect; The patient had her first dose of GARDASIL 9 on 10-JUL-2019 and is in the office on 13-AUG-2019 to get her second dose of GARDASIL 9; This spontaneous report was received from a nurse referring to a female patient of unknown age. The patient had no concomitant therapies, pertinent medical history or drug reactions or allergies.  On 10-JUL-2019, the patient was vaccinated with her first dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1602283, expiration date 18-AUG-2021, strength, dose and route were not reported) for prophylaxis. On 13-AUG-2019, she got her second dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, strength, dose and route were not reported) (inappropriate schedule of vaccine administered). No adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse effects reported by the Nurse.; pediatric dose of RECOMBIVAX HB vaccine instead of an Adult Dose of RECOMBIV AX HB; This spontaneous report was received from a nurse referring to a patient of unknown age.  Information about concurrent condition, concomitant medication and medical history was not reported.   On unknown dates, the patient was vaccinated with the first and second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. In 2003, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot# 641071/1069L, reported batch number was 1069L, expiration date 01-JUN-2004, strength and dose, route were not provided). The nurse reported that there was a possibility that the patient was administered a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) instead of an adult dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for the third dose of the hepatitis b vaccine (recombinant) (RECOMBIVAX HB) vaccination series (inappropriate dose of vaccine administered). No adverse effects reported by the Nurse.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; a patient was administered her first dose of the three dose series of GARDASIL 9 (lot and expiration unknown) on 8/19/2013 and was administered her second dose of GARDASIL 9 (1602283  8/16/2021) late on 6/18/2019; This spontaneous report was received from a registered nurse referring to a currently 26-year-old female patient. The patient's concurrent conditions, pertinent medical history, concomitant therapies and drug reactions/allergies were not reported.   On 19-AUG-2013, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency and route of administration not reported; lot # and expiration date unknown) as prophylaxis. Late on 18-JUN-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1602283, expiration date reported as 16-AUG-2021, but upon internal validation established as 18-AUG-2021) (dose, frequency and route of administration not reported) as prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effect; the patient received first dose, second dose and third dose of GARDASIL 9 in August 2018, February 2019 and August 2019 respectively; Information has been received from a pharmacist referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On unknown date in August 2018, the patient was administered the first dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N003703, expiration date: 29-OCT-2019, strength, dose and route were unknown) for prophylaxis. In February 2019, the patient received the second dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N003703, expiration date: 29-OCT-2019, strength, dose and route were unknown). On an unspecified date in August 2019, the patient received the third dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N003703, expiration date: 29-OCT-2019, strength, dose and route were unknown) (inappropriate schedule of vaccine administered). No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient received one dose of improperly stored ROTATEQ; This spontaneous report was received from a healthcare business professional regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.  On 08-AUG-2019, the patient was vaccinated with one dose of improperly stored (product storage error) rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R025713, expiration date: 20-JUN-2020 (dose, unit were not reported) orally for prophylaxis. The vaccine was exposed to 33.9 Fahrenheit degrees (F) for 40 minutes. The previous temperature excursion included: total time and lowest temperature below 36 F (30.3F) for 90 hours and 7 minutes, total time and lowest temperature below 36 F (30.5F) for 1 hours and 45 minutes and total time and lowest temperature below 36 F (35.2F) for 2 hours and 5 minutes. Data logger was involved. No adverse effects were reported
Age: 29.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site indentation
Clinical narrative: a noticeable indentation was seen at the site of the first injection; This spontaneous report has been received from a physician via field representative referring to a 29-year-old female patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 19-JUN-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1602283, expiration date reported as 16-AUG-2021, but upon internal validation established as 18-AUG-2021; dose not reported) intramuscularly for prevent human papillomavirus (HPV).         The patient was seen in the office on 22-AUG-2019 (reported as today) for the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1602283, expiration date reported as 16-AUG-2021, but upon internal validation established as 18-AUG-2021; dose not reported) intramuscularly for prevent human papillomavirus (HPV). On that date, a noticeable indentation was seen at the site of the first injection. The patient was in no pain and there was just a depression (indentation) at the site. There was no treatment given to the patient. There was no lab diagnostics or studies performed. The patient sought medical attention. No product quality complaint (PQC) involved.   The outcome of the event was recovering. The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Product administered to patient of inappropriate age; This spontaneous report as received from a nurse refering to a 19 year old patient (gender unknown). No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 23-AUG-2019, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated(VAQTA),pediatric dose, 0.5 milliliter for prophylaxis (route of administration, lot number and expiration date were not reported) (incorrect dose administered). There was no adverse symtoms reported.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: patient was inadvertently administered the first dose of GARDASIL 9 on 8/27/2019, 2 minutes after her pregnancy test was resulted as positive; This spontaneous report was received from a nurse prescriber referring to a currently 24-year-old female patient, who had no pertinent medical history, drug reactions or allergies or concomitant therapies. Her pregnancy test was performed on 27-AUG-2019 and was resulted as positive.  On 27-AUG-2019, 2 minutes after her pregnancy test was resulted as positive, the patient was inadvertently vaccinated the first dose with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1614897, expiration date 29-SEP-2021, upon internal validation established as 20-SEP-2021, dose not reported) intramuscularly for prophylaxis (vaccine exposure during pregnancy). The last menstrual period (LMP) and estimated date of delivery (EDD) was unknown. The pregnancy outcome was pending. At the reporting time, the outcome of the event was unknown.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Blood creatine phosphokinase, Hypoaesthesia, Paraesthesia, Thyroid function test, Tinnitus
Clinical narrative: shakes and quivers in her arms and legs; numbness and tingling in her left arm that eventually traveled to her entire left side of her body; numbness and tingling in her left arm that eventually traveled to her entire left side of her body; buzzing in her head; This spontaneous report was received from a nurse (patient's aunt) and refers to a 23-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-JUN-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, lot # and expiration date were not reported) for HPV prevention. On 20-JUN-2019, the patient experienced numbness and tingling in her left arm that eventually traveled to her entire left side of her body and buzzing in her head. On unknown date in July 2019 (reported as one month ago), she starting having shakes and quivers in her arms and legs. On an unspecified date, the patient sought medical attention and was sent to an unspecified neurologist, who ordered unspecified blood tests (reported as "blood work", thyroid and creatine phosphokinase (CPK)) (results not provided) and unspecified magnesium supplements, that did not help. The neurologist sent the patient to outpatient physical therapy 3 times a week for the last 2 weeks, without any improvement. The outcome of numbness and tingling in left arm that eventually traveled to entire left side of the body and buzzing in head was reported as eventually improved on an unknown date in 2019. The outcome of tremor was reported as not recovered/not resolved. There was no causality assessment provided by the reporter.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Tremor
Clinical narrative: shakes and quivers in her arms and legs; numbness and tingling in her left arm that eventually traveled to her entire left side of her body; numbness and tingling in her left arm that eventually traveled to her entire left side of her body; buzzing in her head; This spontaneous report was received from a nurse (patient's aunt) and refers to a 23-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-JUN-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, lot # and expiration date were not reported) for HPV prevention. On 20-JUN-2019, the patient experienced numbness and tingling in her left arm that eventually traveled to her entire left side of her body and buzzing in her head. On unknown date in July 2019 (reported as one month ago), she starting having shakes and quivers in her arms and legs. On an unspecified date, the patient sought medical attention and was sent to an unspecified neurologist, who ordered unspecified blood tests (reported as "blood work", thyroid and creatine phosphokinase (CPK)) (results not provided) and unspecified magnesium supplements, that did not help. The neurologist sent the patient to outpatient physical therapy 3 times a week for the last 2 weeks, without any improvement. The outcome of numbness and tingling in left arm that eventually traveled to entire left side of the body and buzzing in head was reported as eventually improved on an unknown date in 2019. The outcome of tremor was reported as not recovered/not resolved. There was no causality assessment provided by the reporter.
Sex: U
Vaccine: HEPA, HIBV, MMRV, RV5, VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored vaccines were inadvertently administered to unspecified patients; This spontaneous report was received from a medical assistant referring to unspecified patients of unknown age and gender. Information about the patients' concurrent conditions, pertinent medical history, previous drug reactions or allergies and concomitant medications was not provided.  On unspecified dates in 2019 (reported as between May 2019 and August 2019), the patients were inadvertently vaccinated with improperly stored vaccines as haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) one dose, for prophylaxis, lot number R021078 and expiration date 12-JUN-2021 (strength, route of administration and anatomical location were not provided); rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot number R028189 and expiration date 06-JUN-2020 (strength, route of administration and anatomical location were not provided); hepatitis a vaccine, inactivated (VAQTA) for prophylaxis, lot number S002459 and expiration date 15-MAY-2020 (strength, route of administration and anatomical location were not provided); measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) for prophylaxis, lot number R030799 and expiration date 22-APR-2020 (strength, route of administration and anatomical location were not provided) and varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis, lot number S002736 and expiration date 28-JAN-2021 (strength, route of administration and anatomical location were not provided) (product storage error).  It was reported that on an unknown date, the vaccines haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and hepatitis a vaccine, inactivated (VAQTA) were exposed to a temperature excursion of 52.5 degrees Fahrenheit (F) for 4 hours and 40 minutes. There was no previous temperature excursion reported. The call was placed because of a digital data logger.  It was reported that on an unknown date, the vaccines measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) and varicella virus vaccine live (Oka/Merck) (VARIVAX) were exposed to a temperature excursion of 9.9 F for 57 minutes. There was a previous temperature excursion of 28.9 F for 5 hours and 30 minutes. The call was placed because of a digital data logger.  This is a non-valid case because there were no patients identifiers.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; one dose of GARDASIL 9 that had expired was inadvertently administered to the patient on 8/21/2019; This spontaneous report was received from a nurse prescriber via company representative, referring to a patient of unknown gender and age. The patient's concurrent condition, pertinent medical history, concomitant therapy and drug reactions/allergies were not reported.  On 21-AUG-2019, the patient was inadvertently vaccinated with one dose of expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, frequency and route of administration not reported) (lot #: M037770, expiration date: 01-JUN-2019) (expired product administered) for prophylaxis. No adverse effects were reported.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; one patient received an improperly stored VARIVAX; This spontaneous report was received from a nurse, concerning to a 5-years-old patient of unknown gender. The patient's medical history, concurrent conditions and past drug allergies or reactions were not reported.  On 12-AUG-2019 and on 13-AUG-2019, varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccine experienced two temperature excursions. On 04-SEP-2019, the patient received an improperly stored dose (product storage error) of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, schedule, anatomical site of injection, route of administration were not reported). Lot numbers R006221 and R029517 have been verified to be a valid lot of numbers for varicella virus vaccine live (Oka/Merck) with expiration dates on 29-FEB-2020 and on 14-OCT-2020 (reported as " 14/2020) respectively. It was reported that the vaccine was reconstituted with properly stored sterile diluent.  The reporter did not have the specific lot and expiration date administered to the patient, but it was one of two listed above.    The administered dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced a temperature of -14 degrees Celsius to -10 degrees Celsius (-11.91 degrees Celsius) for 8 hours as recorded by a data logger. There was no adverse effect reported.  No product quality complaint was involved.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects were reported; she received tbe first dose of GARDASIL 9 in October of 2018 and tbe second dose in June of 2019; This spontaneous report was received from a female patient of unknown age referring to herself. No information regarding her pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On an unknown date in October 2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date in June 2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, exact dose, route of administration, lot # and expiration date were not reported) for the same indication. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse effect; inadverently administered a dose of varivax by intramuscular injection instead of subcutaneous; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender.   No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications.  On 06-SEP-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S015459, expiry date: 20-MAY-2021) strength, dosage information and anatomical locations were unknown inadvertently administered by intramuscular injection instead of subcutaneous injection for prophylaxis (incorrect route of product administration). The outcome of incorrect route of product administration and no adverse event was unknown. No adverse effects were reported. No additional information provided.
Age: 47.0
Sex: M
Vaccine: DT, TD
Symptoms: Rash, Urticaria
Clinical narrative: Hives & rash
Age: 47.0
Sex: M
Vaccine: DT, TD
Symptoms: Urticaria
Clinical narrative: Hives & rash
Age: 47.0
Sex: M
Vaccine: DT, TD
Symptoms: Rash, Urticaria
Clinical narrative: diffuse hives, beginning on chest/back, then arms. legs, face. approx 24 horus
Age: 47.0
Sex: M
Vaccine: DT, TD
Symptoms: Urticaria
Clinical narrative: diffuse hives, beginning on chest/back, then arms. legs, face. approx 24 horus
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Body aches, awakened with shivering. Tiredess persisting into the day.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Allergy to vaccine, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, and pain in the area of her right upper arm around the lateral deltoid where she was given a Tdap on 9/5/19. Meloxicam and doxycycline given for oral treatment. Tdap vaccine added to patients allergies.
Age: 70.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: Both arms were slightly sore at the site of the injections.  At 9:00 PM I began to be chilly, that turned to chills and shaking.  Took my temperature 99.8, it kept going up to 100.6 when I took one 650mg tablet of Acetaminophen.  I also had a slight headache and was very tired.   Fever broke around 12:30 AM.  When I got up on 9/11/19, my temperature was 99.4 and my headache was a little worse.  Took a second 650mg tablet of Acetaminophen.
Age: 70.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Tremor
Clinical narrative: Both arms were slightly sore at the site of the injections.  At 9:00 PM I began to be chilly, that turned to chills and shaking.  Took my temperature 99.8, it kept going up to 100.6 when I took one 650mg tablet of Acetaminophen.  I also had a slight headache and was very tired.   Fever broke around 12:30 AM.  When I got up on 9/11/19, my temperature was 99.4 and my headache was a little worse.  Took a second 650mg tablet of Acetaminophen.
Age: 45.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Injection site pain, Insomnia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: The initial shot hurt more than I can remember and my arm was very sore for the rest of day and night.  The soreness never really went away and instead became increasingly debilitating.  Without significant pain, I cannot dress myself, put on seat belt, pick up my children, sleep, exercise etc.  I have no strong reflex and am concerned if I fall, I will not be able to save myself.  I have been to the Dr., and tried advil but nothing is helping to ease the pain.  It is AWFUL.
Age: 45.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Injection site pain, Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: The initial shot hurt more than I can remember and my arm was very sore for the rest of day and night.  The soreness never really went away and instead became increasingly debilitating.  Without significant pain, I cannot dress myself, put on seat belt, pick up my children, sleep, exercise etc.  I have no strong reflex and am concerned if I fall, I will not be able to save myself.  I have been to the Dr., and tried advil but nothing is helping to ease the pain.  It is AWFUL.
Age: 45.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Injection site pain, Insomnia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: patient said she had the regular injection site pain following the vaccination but a couple of days after she started having a debilitating feeling in her arm. she describes it as a "dead" arm and that she has weakness and pain. she says that if she fell, she wont be able to catch her self with her dead arm, has a hard time pulling up her pants or doing every day things. she says the pain is worse at night when she lays down to sleep and that if she tries to roll over or move, she has to physically grab her dead arm to move it. she did see her doctor and she claims they have no idea what is causing it and that the vaccine was not up too high and was injected in the right area.
Age: 45.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Injection site pain, Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: patient said she had the regular injection site pain following the vaccination but a couple of days after she started having a debilitating feeling in her arm. she describes it as a "dead" arm and that she has weakness and pain. she says that if she fell, she wont be able to catch her self with her dead arm, has a hard time pulling up her pants or doing every day things. she says the pain is worse at night when she lays down to sleep and that if she tries to roll over or move, she has to physically grab her dead arm to move it. she did see her doctor and she claims they have no idea what is causing it and that the vaccine was not up too high and was injected in the right area.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: complaint of pain and weakness in legs, Admitted to inpatient facility, still undergoing treatment.
Age: 29.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Last menstrual period approx. 4-26-19, + home pregnancy test "early June."  She was given Varivax, MMR, Tdap on 6-6-19 as required for entry into nursing school.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse affects; an expired dose of GARDASIL 9 was administered; This spontaneous report was received from a health care worker, referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant therapy and drug reactions/allergies were not reported.  On 08-AUG-2019, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency and route of administration not reported) (lot #: M041990, expiration date: 28-JUN-2019) (expired product administered) for prophylaxis. No adverse effects were reported. No product quality issue was involved.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Cyst, Headache, Injection site pain, Lip swelling
Clinical narrative: The patient is a 72-year-old female who received a Shingrix vaccine on August 29, 2019. This was administered in her left upper extremity at the pharmacy. Following day patient complained of nausea headaches and arthralgias. She also had pain at the injection site without erythema or edema. Later that evening patient developed diffuse hives, cyst and swelling involving "my lips my tongue in the top of my throat." Patient presented to the Emergency room where she was treated with IV Benadryl and corticosteroids. Patient was discharged on oral prednisone and Benadryl. The hives increased later that day and the patient returned to the Emergency Room. However she did not wait to be seen due to long wait time. I spoke with the patient on the morning of September 1st. I increased her prednisone dose 60 mg that day and we tapered by 10 mg daily. Patient took 20 mg of prednisone this morning. Since that time patient denies recurrent hives. Patient states "overall I fell okay now."
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pharyngeal swelling, Swollen tongue, Urticaria
Clinical narrative: The patient is a 72-year-old female who received a Shingrix vaccine on August 29, 2019. This was administered in her left upper extremity at the pharmacy. Following day patient complained of nausea headaches and arthralgias. She also had pain at the injection site without erythema or edema. Later that evening patient developed diffuse hives, cyst and swelling involving "my lips my tongue in the top of my throat." Patient presented to the Emergency room where she was treated with IV Benadryl and corticosteroids. Patient was discharged on oral prednisone and Benadryl. The hives increased later that day and the patient returned to the Emergency Room. However she did not wait to be seen due to long wait time. I spoke with the patient on the morning of September 1st. I increased her prednisone dose 60 mg that day and we tapered by 10 mg daily. Patient took 20 mg of prednisone this morning. Since that time patient denies recurrent hives. Patient states "overall I fell okay now."
Age: 1.33
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Local reaction, Pyrexia
Clinical narrative: 9/10/19: Seen and diagnosed with local reaction 9/11/19: (+) extension of area with fever dx'd with cellulitis
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: injection site swelling, soreness, tenderness, injection site erythema
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Influenza like illness, Pain, Pyrexia
Clinical narrative: Fever 101.7, flu like symptoms (extreme body aches and weakness) for 6 hours, fever broke after taking Tylenol
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Loss of personal independence in daily activities, Musculoskeletal pain, Myalgia, Nausea
Clinical narrative: MUSCLE ACHES, CHILLS, NAUSEA, PAIN IN ARM - RADIATING TO NECK AND SHOULDER AREAS. RESULTED IN SICK LEAVE FROM WORK AND A PHONE CONSULT WITH PHYSICIAN'S OFFICE. PATIENT TO REPORT TO CLINIC OR HOSPITAL IF SYMPTOMS WORSEN OR RASH DEVELOPS.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: MUSCLE ACHES, CHILLS, NAUSEA, PAIN IN ARM - RADIATING TO NECK AND SHOULDER AREAS. RESULTED IN SICK LEAVE FROM WORK AND A PHONE CONSULT WITH PHYSICIAN'S OFFICE. PATIENT TO REPORT TO CLINIC OR HOSPITAL IF SYMPTOMS WORSEN OR RASH DEVELOPS.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Localized fluid filled blisters (several) at injection site that appeared after administration of varicella iz. given on 8/29/19
Age: 19.0
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse effects; 19-year-old patient who received GARDASIL 9 this week after patient was administered complete HPV series ofGARDASIL (quadrivalent) in the past (on unspecififed dates); This spontaneous report was received from a nurse via company representative referring to a 19-year-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies and drug reactions/allergies were not reported.  On an unspecified date in August 2019 (reported as this week), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  (strength, dose, frequency and route of administration were not reported; lot# and expiration date were unknown by the reporter) for prophylaxis, after the patient completed the series of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) in the past (on unspecified dates) (inappropriate schedule of product administration). No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Menstruation irregular, Nausea, Weight increased
Clinical narrative: a lot of weight gain; anxiety; nause; This spontaneous report has been received from an office manager via company representative referring to a current 21-year-old female patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy information was not provided.      On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscularly for prophylaxis (also reported as vaccination) (strength, dose, frequency, lot # and expiration date were not reported) as a teenager. It was unknown if the patient received treatment for the event. It was unknown whether laboratory diagnostics were performed.         On an unknown date, the patient experienced a lot of weight gain, anxiety, nausea, and she now only had 4 periods per year. The outcome of all events was not reported. The causality between all events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse affects; patient received their third dose of GARDASIL 9 sooner that what is recommended; This spontaneous report was received from a nurse practitioner 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 an unknown date, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R017624, expiration date 17-MAR-2021, dose and route not reported) for prophylaxis. The patient received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) sooner than what was recommended (Inappropriate schedule of product administration) (onset date was reported as 27-AUG-2019). No adverse effects were reported.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Syringe issue
Clinical narrative: it was noticed that the first syringe was empty.; it was noticed that the first syringe was empty.; This spontaneous report was received from the patient's mother referring to her daughter of a 13 years old female patient. Information about pertinent medical history, concurrent condition, concomitant medication and drug reaction/allergy was not provided.  On 29-AUG-2019, the patient came to receive her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose detail, route, lot # and expiration date were not reported) for prophylaxis. On the same day, after the nurse stuck the patient, it was noticed that the first syringe was empty (product quality issue and circumstance or information capable of leading to medication error). The nurse got another syringe and administered second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The outcome of the event was unknown. The causality was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient received unspecified dose of ROTATEQ that was improperly stored; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided.     On 22-AUG-2019, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S009940, expiration date 04-OCT-2020) (dose was not reported) orally for prophylaxis. Excursions occurred on 13-AUG-2019 and 14-AUG-2019. The vaccine underwent excursion of 34.7 Fahrenheit degrees for 3 hours and 2 minutes and 34.1 Fahrenheit degrees for 4 hours and 33 minutes. No adverse effects were reported. Data logger was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: post herpetic neuralgia; Herpes Zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot number and expiry date were not provided) for routine health maintenance and the prevention of shingles. On an unknown date, the patient suffered a painful rash. As a result of these symptoms, he presented to a medical provider and was diagnosed with herpes zoster and postherpetic neuralgia. Thereafter, the patient continued to suffer the effects of herpes zoster and post herpetic neuralgia. As a result, he suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms and diagnoses resulted in physical limitations not present prior to using the vaccine. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt suffered severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). The events were considered to be disabling.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness; Swelling; Itchy; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43E4T, expiry date 1st October 2021) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, less than 6 months after receiving Boostrix, the patient experienced injection site erythema, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site itching to be related to Boostrix.  Additional details were provided as follows: The health care professional reported that the patient had redness, swelling and itching at the site of Injection with Boostrix.  The reporter consented to follow up. The batch number was updated from 43E47 to 43E4T as per sales data sheet. This was one of the 6 cases, reported by the same reporter.