chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Hypersensitivity, Pain in extremity, Pruritus, Rash
Clinical narrative: on 7/15/2020 Pea size hard, warm, skin area to Right arm.  On 7/16/2020, Softball size hot red sore area to back of right arm.   C/O rash, itching to area behind knees to inner thighs under areas of both arms.  Patient saw local PMP and states she was told she was having an adverse allergic reaction to a component of Varicella.  Gave her a prescription with an histamine
Age: 20.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Skin induration, Skin warm
Clinical narrative: on 7/15/2020 Pea size hard, warm, skin area to Right arm.  On 7/16/2020, Softball size hot red sore area to back of right arm.   C/O rash, itching to area behind knees to inner thighs under areas of both arms.  Patient saw local PMP and states she was told she was having an adverse allergic reaction to a component of Varicella.  Gave her a prescription with an histamine
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Myalgia, Pyrexia
Clinical narrative: Myalgia, low grade fever, headache, exhaustion, swelling heat and redness at vaccination site.  Developed several small papules on left arm around vaccine site, inside upper left arm, and on left leg.  Reaction lasted 2+  days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site papule, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Myalgia, low grade fever, headache, exhaustion, swelling heat and redness at vaccination site.  Developed several small papules on left arm around vaccine site, inside upper left arm, and on left leg.  Reaction lasted 2+  days.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Chills, headache, fatigue
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Low grade fever, body aches, tiredness
Age: 50.0
Sex: M
Vaccine: FLUR4, PPV
Symptoms: Asthenia, Dysphonia, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Patient Reports that he has a significantly sore arm after the immunizations. He then developed tingling on his left extremities. He also reports numbness, weakness, a change in his voice and a slight droop
Age: 56.0
Sex: M
Vaccine: FLUN4, PPV, VARZOS
Symptoms: Aphonia, Arthralgia, Feeding disorder, Headache, Malaise
Clinical narrative: LEFT ARM- WELTS ,  HEAD ACHE, COULD NOT EAT, NIGHT SWEATS,JOINTS HURT, LOST VOICE , LOW GRADE FEVER, DID NOT FEEL WELL FOR TWO DAYS. TODAY, 08/12/2020 HE FEELS FINE/NORMAL. OUT IN THE SUN WORKING WITH ANIMALS.  HE STILL FEELS THE WELTS IN LA.
Age: 56.0
Sex: M
Vaccine: FLUN4, PPV, VARZOS
Symptoms: Night sweats, Pyrexia, Urticaria
Clinical narrative: LEFT ARM- WELTS ,  HEAD ACHE, COULD NOT EAT, NIGHT SWEATS,JOINTS HURT, LOST VOICE , LOW GRADE FEVER, DID NOT FEEL WELL FOR TWO DAYS. TODAY, 08/12/2020 HE FEELS FINE/NORMAL. OUT IN THE SUN WORKING WITH ANIMALS.  HE STILL FEELS THE WELTS IN LA.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Muscle spasms
Clinical narrative: PATIENT COMPLAINED OF CRAMPING FINGERS AND COULD NOT LIFT UP HER LEFT THUMB AFTER THE SAME DAY OF VACCINATION
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Cellulitis, Influenza like illness, Malaise, Pruritus, Seborrhoeic keratosis
Clinical narrative: Became very ill that evening and had flu like symptoms for 3 days. I have never received this reaction from the flu vaccination and did not receive a reaction when received in 2019. I did not go back for the shingles booster and also advised by Dr., my doctor at that time. I have developed what I would call an extreme case of pruritus on the arm of the shingles vaccination, so severe it disrupts sleep. I have been applying steroid cream for relief. I also have developed cellulitis. I have never had these issues until after the shingles vaccination. I am a healthy fit 57 year old that takes no prescription medication. I wish I had never received this vaccination. Seborrheic Keratoses Diagnosed by NP and cellulitis on record with NP as well.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Sleep disorder
Clinical narrative: Became very ill that evening and had flu like symptoms for 3 days. I have never received this reaction from the flu vaccination and did not receive a reaction when received in 2019. I did not go back for the shingles booster and also advised by Dr., my doctor at that time. I have developed what I would call an extreme case of pruritus on the arm of the shingles vaccination, so severe it disrupts sleep. I have been applying steroid cream for relief. I also have developed cellulitis. I have never had these issues until after the shingles vaccination. I am a healthy fit 57 year old that takes no prescription medication. I wish I had never received this vaccination. Seborrheic Keratoses Diagnosed by NP and cellulitis on record with NP as well.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Unevaluable event
Clinical narrative: Patient was evaluated by clinician.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling, Swelling face
Clinical narrative: Per pt she started having swelling over her body including the face about 30 minutes after receiving the vaccine. She took Benadryl and went to the emergency room where they administered more Benadryl and steroids. She was discharged 08/11. Dropped off script for a 4 day course of prednisone at 7:30pm on 08/12.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Fatigue, Pain, Peripheral swelling, Pruritus
Clinical narrative: PATIENT FELT TIRED WITH SWOLLEN, RED ARM THE DAY AFTER VACCINATION. PATIENT TOOK TYLENOL TO RELIEVE PAIN.  4 DAYS AFTER VACCINATION, A SLIGHTLY RAISED, RED, AREA WITH SMALL SCABS OVER (FROM SCRATCHING) WERE VISIBLE ON LEFT ARM. PATIENT WAS ADVISED TO TAKE BENADRYL AND TYLENOL FOR REACTION. OVERALL PATIENT HAS RECOVERED.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Scab
Clinical narrative: PATIENT FELT TIRED WITH SWOLLEN, RED ARM THE DAY AFTER VACCINATION. PATIENT TOOK TYLENOL TO RELIEVE PAIN.  4 DAYS AFTER VACCINATION, A SLIGHTLY RAISED, RED, AREA WITH SMALL SCABS OVER (FROM SCRATCHING) WERE VISIBLE ON LEFT ARM. PATIENT WAS ADVISED TO TAKE BENADRYL AND TYLENOL FOR REACTION. OVERALL PATIENT HAS RECOVERED.
Age: 4.0
Sex: M
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Muscle pain at injection site, fever 102.1, headache, nausea
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Electrocardiogram normal, Fall
Clinical narrative: Patient sat down to receive his flu shot. He has had flu shot without any issue before. Gave him the flu shot. He got up to wait in our wait room.  Mom sat down to get her flu shot and I heard mom yelled out his name. He stood to send a text message and fell right outside our room. I grabbed my smelling salt and EpiPen but he was awake immediately. He muttered "what happened". He laid down for a few min, then slowly sat up. By the time paramedic came, he was able to slowly walk (with mom's help) to the chair. His EKG was normal, BP and HR was normal. They did not take him to the ER due to fear of COVID. He told paramedic he felt fine (no nausea, no dizziness, no pain)  He sat for 15 more min after paramedic left the left the store with mom.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact, Injection site irritation, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: ARM SiTE injected SWELLS & TAPE IRRATES Skin AS SWELLING CONTiues -pain AT SiTE INCREASES. SweLLing MOVES DOWN The ARM TO ELBOW. LARGE Hive COVERS ARM MuscLE & Begin To TAKE Bendryl 25mg EVERy 2HRS. ARM iTches so I Apply itch CREAM CONTIUE TREATMENT FOR 4 days. Swelling &hive SLowly ResoLVE AFTER A week OF TREATMENT.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Pruritus
Clinical narrative: ARM SiTE injected SWELLS & TAPE IRRATES Skin AS SWELLING CONTiues -pain AT SiTE INCREASES. SweLLing MOVES DOWN The ARM TO ELBOW. LARGE Hive COVERS ARM MuscLE & Begin To TAKE Bendryl 25mg EVERy 2HRS. ARM iTches so I Apply itch CREAM CONTIUE TREATMENT FOR 4 days. Swelling &hive SLowly ResoLVE AFTER A week OF TREATMENT.
Age: 79.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient skin raised and red at injection site (left arm). Event started about 4 days after receiving vaccine. No fever or pain reported. Warm to the touch as per patient.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Contusion, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red, swelling, hot to the touch, and bruising to Rt arm.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: warm to touch injection site slight fever
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: ReCEiVED 4yr old Boosters ON 8-10-2020. DeVEloped a fever the same night with T.max 101.5 No fever today IN office 8-12-20. INjection site swollen, red & painful. ABEL to move arm well
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose decreased, Fall, Syncope
Clinical narrative: syncopal episode; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID:818959) referring to a 12 year old male patient. The patient's chronic or long-standing health conditions included prematurity, asthma and cerebral palsy. At the time of vaccination, the patient had no illness and no known allergies to medication, food or other products. The patient had not ever had an adverse event following any previous vaccine.  Concomitant therapies included fluticasone propionate(FLONASE), albuterol(ALBUTEROL) and fluticasone propionate(FLOVENT).     On 14-JUN-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vial, 2nd dose in series, in the left arm, intramuscularly (lot # R020200, expiring on 05-MAY-2021).  On the same date, the patient also received diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL), 1st dose in series, in the right arm, intramuscularly, (lot # U6128aa) and meningococcal acyw conj vaccine (crm197) (MENVEO), 1st dose in series, in the left arm, intramuscularly, (lot # AMAA048a).    After the patient got his vaccine, he stood up and fell / syncopal episode (syncope).  The patient's blood pressure was 123/51 (units not provided), oxygen saturation was normal (100%) on RA, blood sugar was 69mg/dL, and an unspecified exam was normal.  The patient was lied down for about 35 minutes and signs rechecked: blood pressure was 119/79 - 112/74 (lying - standing), and was finally sent home, completely recovered from the event.  The agency considered this case as non-serious.  The reporter did not assess the causal relationship between suspect therapies and the patient's events.  As of 11-AUG-2020, all attempts trying to obtain additional information has been unsuccessful. No further information is expected. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R020200; expirationdate: 05-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Blindness unilateral, Blood test normal, Chorioretinitis, Computerised tomogram thorax normal, Laboratory test
Clinical narrative: started losing vision in left eye/was diagnosed with bilateral posterior uveitis; occular sarcoidosis; This spontaneous report was received from the patient's mother via the Agency and refers to a non-pregnant female patient of an unknown age, who was 14 years old at the time of vaccination. The patient had no concomitant medications, concurrent conditions and allergies.  On 01-JUN-2017 at 10:30, 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) intramuscularly, into arm (unspecified) (exact dose, lot# and expiration date were not reported) for prophylaxis. On 01-AUG-2017 at 18:00, the patient started losing vision in the left eye. On 11-SEP-2017, the patient was diagnosed with bilateral posterior uveitis. She had many tests and diagnosis was presumed as ocular sarcoidosis. Lung computerized tomography (CT) was negative, pulmonary functions tests was normal, all sorts of bloodwork for disease, viruses and other issues were all normal. She took prednisone for several month and then was changed to 2000 mg of mycophenolate mofetil (CELLCEP), which was still ongoing at the reporting time. Since 03-JUL-2019 (reported as 7/3/3019), she saw a rheumatologist and retina specialist every 4 months. Next visits were scheduled in August. The patient's vision would not be restored. The events resulted in disability or permanent damage.  The outcome of the event was reported as not recovered. The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  As of 06-AUG-2020, all telephone attempts trying to obtain additional information has been unsuccessful. A message was left requesting a call back.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Ocular sarcoidosis, Pulmonary function test normal, Viral test negative
Clinical narrative: started losing vision in left eye/was diagnosed with bilateral posterior uveitis; occular sarcoidosis; This spontaneous report was received from the patient's mother via the Agency and refers to a non-pregnant female patient of an unknown age, who was 14 years old at the time of vaccination. The patient had no concomitant medications, concurrent conditions and allergies.  On 01-JUN-2017 at 10:30, 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) intramuscularly, into arm (unspecified) (exact dose, lot# and expiration date were not reported) for prophylaxis. On 01-AUG-2017 at 18:00, the patient started losing vision in the left eye. On 11-SEP-2017, the patient was diagnosed with bilateral posterior uveitis. She had many tests and diagnosis was presumed as ocular sarcoidosis. Lung computerized tomography (CT) was negative, pulmonary functions tests was normal, all sorts of bloodwork for disease, viruses and other issues were all normal. She took prednisone for several month and then was changed to 2000 mg of mycophenolate mofetil (CELLCEP), which was still ongoing at the reporting time. Since 03-JUL-2019 (reported as 7/3/3019), she saw a rheumatologist and retina specialist every 4 months. Next visits were scheduled in August. The patient's vision would not be restored. The events resulted in disability or permanent damage.  The outcome of the event was reported as not recovered. The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  As of 06-AUG-2020, all telephone attempts trying to obtain additional information has been unsuccessful. A message was left requesting a call back.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Peripheral swelling, Rash erythematous, Skin warm
Clinical narrative: Warm, red rashes', swelling at shot site and down arm.  Swollen and painful
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Warm, red rashes', swelling at shot site and down arm.  Swollen and painful
Sex: U
Vaccine: VARCEL
Symptoms: Cellulitis, Local reaction
Clinical narrative: 2-3 patients return to the office 7-10 days after administration of VARIVAX due to a local reaction. The doctor ended up diagnosing each of those patients with cellulitis; This spontaneous report was received from a registered nurse, referring to 2 or 3 child patients between the ages of 1 to 5-years-old and unknown gender. Information regarding the patients' pertinent medical history, concomitant therapies, and previous drug reactions or allergies were unknown by the reporter.   On an unknown dates since February 2020 (reported as "over the past 6 months"), the patients were vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), administered subcutaneously (dose, vaccination scheme frequency, anatomical site of vaccination, lot number and expiration date were unknown by the reporter) as prevention of varicella.  Since February 2020 (reported as "within the past 6 months"), the reporter stated that the patients returned to the office 7 to 10 days after administration of varicella virus vaccine live (oka/merck) (VARIVAX) due to a local reaction. Subsequently, the doctor ended up diagnosing each of those patients with cellulitis and treated them with cephalexin (KEFLEX). The patients did not have any disability or incapacity due to the events, no overdose occurred, no laboratory tests were performed neither were hospitalized.  At the time of reporting, it was reported that every patients had recovered from cellulitis on an unknown dates in 2020. The causal relationship between the above-mentioned event and the varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.  Upon internal review, the event cellulitis was considered to be medically significant.  This was one of two reports received from the same reporter.  As of 06-AUG-2020, a telephone attempt trying to obtain additional information has been unsuccessful.; Sender's Comments:  US-009507513-2008USA003129:
Sex: U
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Local reaction
Clinical narrative: 2-3 patients return to the office 7-10 days after administration of VARIVAX due to a local reaction. The doctor ended up diagnosing each of those patients with cellulitis / one patient had a reaction on the leg after the 2nd dose of VARIVAX; This spontaneous report was received from a registered nurse, referring to a child patient of unknown gender with approximately 5-years-old. Information regarding the patient's pertinent medical history, concomitant therapies, and previous drug reactions or allergies were unknown by the reporter.   On an unknown date in 2020 (reported as "over the past 6 months"), the patient was vaccinated with the second dose of  varicella virus vaccine live (oka/merck) (VARIVAX), administered subcutaneously (dose, vaccination scheme frequency, anatomical site of vaccination, lot number and expiration date were unknown by the reporter) as prevention of varicella.  On an unknown date in 2020 (reported as "within the past 6 months"), the reporter stated that the patient returned to the office 7 to 10 days after administration of varicella virus vaccine live (oka/merck) (VARIVAX) due to a local reaction. Subsequently, the doctor ended up diagnosing the patient with cellulitis and prescribed cephalexin (KEFLEX). Additionally, the registered nurse reported that the patient had this reaction on the leg. The patient did not have any disability or incapacity due to the events, no overdose occurred, no laboratory tests were performed neither were hospitalized.  At the time of reporting, it was reported that patient had recovered from cellulitis on an unknown date in 2020. The causal relationship between the above-mentioned event and the varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.  Upon internal review, cellulitis was considered a medically significant event.  This was one of two reports received from the same reporter.  As of 06-AUG-2020, a telephone attempt trying to obtain additional information has been unsuccessful.; Sender's Comments:  US-009507513-2008USA001706:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 31-MAY-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; MMR II was administered to a patient that was improperly stored.; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 05-AUG-2020, the patient received one improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) as prophylaxis (formulation, strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported, lot number S015427 which has been verified to be valid, expiration date reported; and validated as 20-MAY-2021). The vaccine was exposed to a temperature and excursion of -4.1 degrees Celsius (C) during 45 minutes (product storage error), as recorded by the data logger. There was no previous temperature excursion. No additional adverse event was reported.
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Bartonella test, Blood aluminium increased, Blood test, Borrelia test
Clinical narrative: lyme disease (rash and anxiety); high level of aluminium in her blood stream which damaged her mitochondria and thinned the cell walls; bartonella (rash, insomnia and anxiety); high level of aluminium in her blood stream which damaged her mitochondria and thinned the cell walls; high level of aluminium in her blood stream which damaged her mitochondria and thinned the cell walls; This spontaneous report was received from a company representative who read about the event in a non-fiction book. The author spoke about her daughter of an unknown age. The patient's pertinent medical history included irritable bowel syndrome with constipation. Her drug reactions or allergies and concomitant therapy were not reported.  On an unknown date, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot# and expiry date were not reported), for prevention of human papillomavirus (HPV).        On an unknown date, the patient experienced rash, insomnia and anxiety. The doctors could not figure out what was wrong with her. On an unknown date, they eventually diagnosed her with Lyme disease and Bartonella. On an unknown date, she had a high level of aluminium in her blood stream which damaged her mitochondria and thinned the cell walls. On unknown dates, the patient had centers for disease control and prevention (CDC) lyme screening test, Western blot test, enzyme-linked immunosorbent assay (ELISA) test, specialized Bartonella test and cellular blood test performed, however no results were provided. On unknown dates, she was treated with amoxicillin, azithromycin, herbs and unspecified intravenous medication for the events. It was unknown, if the patient was hospitalized due to the events. The outcome of the events was unknown. The relatedness between the events and the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided by the reporter, however the author reported the doctors believed the papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine caused an increase of aluminium in the patient's blood stream.  Upon internal review, the event of Lyme disease and mitochondrial toxicity were considered to be medically significant.
Sex: F
Vaccine: HPV4
Symptoms: Cat scratch disease, Immunology test, Insomnia, Lyme disease, Mitochondrial toxicity
Clinical narrative: lyme disease (rash and anxiety); high level of aluminium in her blood stream which damaged her mitochondria and thinned the cell walls; bartonella (rash, insomnia and anxiety); high level of aluminium in her blood stream which damaged her mitochondria and thinned the cell walls; high level of aluminium in her blood stream which damaged her mitochondria and thinned the cell walls; This spontaneous report was received from a company representative who read about the event in a non-fiction book. The author spoke about her daughter of an unknown age. The patient's pertinent medical history included irritable bowel syndrome with constipation. Her drug reactions or allergies and concomitant therapy were not reported.  On an unknown date, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot# and expiry date were not reported), for prevention of human papillomavirus (HPV).        On an unknown date, the patient experienced rash, insomnia and anxiety. The doctors could not figure out what was wrong with her. On an unknown date, they eventually diagnosed her with Lyme disease and Bartonella. On an unknown date, she had a high level of aluminium in her blood stream which damaged her mitochondria and thinned the cell walls. On unknown dates, the patient had centers for disease control and prevention (CDC) lyme screening test, Western blot test, enzyme-linked immunosorbent assay (ELISA) test, specialized Bartonella test and cellular blood test performed, however no results were provided. On unknown dates, she was treated with amoxicillin, azithromycin, herbs and unspecified intravenous medication for the events. It was unknown, if the patient was hospitalized due to the events. The outcome of the events was unknown. The relatedness between the events and the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided by the reporter, however the author reported the doctors believed the papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine caused an increase of aluminium in the patient's blood stream.  Upon internal review, the event of Lyme disease and mitochondrial toxicity were considered to be medically significant.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: lyme disease (rash and anxiety); high level of aluminium in her blood stream which damaged her mitochondria and thinned the cell walls; bartonella (rash, insomnia and anxiety); high level of aluminium in her blood stream which damaged her mitochondria and thinned the cell walls; high level of aluminium in her blood stream which damaged her mitochondria and thinned the cell walls; This spontaneous report was received from a company representative who read about the event in a non-fiction book. The author spoke about her daughter of an unknown age. The patient's pertinent medical history included irritable bowel syndrome with constipation. Her drug reactions or allergies and concomitant therapy were not reported.  On an unknown date, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot# and expiry date were not reported), for prevention of human papillomavirus (HPV).        On an unknown date, the patient experienced rash, insomnia and anxiety. The doctors could not figure out what was wrong with her. On an unknown date, they eventually diagnosed her with Lyme disease and Bartonella. On an unknown date, she had a high level of aluminium in her blood stream which damaged her mitochondria and thinned the cell walls. On unknown dates, the patient had centers for disease control and prevention (CDC) lyme screening test, Western blot test, enzyme-linked immunosorbent assay (ELISA) test, specialized Bartonella test and cellular blood test performed, however no results were provided. On unknown dates, she was treated with amoxicillin, azithromycin, herbs and unspecified intravenous medication for the events. It was unknown, if the patient was hospitalized due to the events. The outcome of the events was unknown. The relatedness between the events and the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided by the reporter, however the author reported the doctors believed the papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine caused an increase of aluminium in the patient's blood stream.  Upon internal review, the event of Lyme disease and mitochondrial toxicity were considered to be medically significant.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored temperature excursion; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 03-AUG-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), dose/frequency reported as 1, lot# S020160, expiration date 30-JUN-2021 ,for prophylaxis (strength and route were not reported) and varicella virus vaccine live (Oka/Merck)(VARIVAX) dose/frequency reported as 1, lot# S038175, expiration date 26-NOV-2021, for prophylaxis (strength and route were not reported).    The temperature excursion was of -50 Fahrenheit degrees (°F), time frame -6°F to 14 °F (10°F) for 1 hour and 15 minutes; 15°C to 46°F (44.8°F) for 1 hour and 30 minutes; 47°F to 77°F (50°F) for 2 hours and 30 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: the male patient, approximately the age of one (1) years old did not show any signs or symptoms; Medical Assistant called to ask if there are any issues or problems if PROQUAD and VARIVAX were administered to a 1 year old at the same time and date; This spontaneous report was received from a medical assistant referring to a male patient of approximately 1-year-old. The patient's concurrent conditions, medical history, concomitant medications, and drug reactions/allergies were not reported.  On 10-AUG-2020, the patient was vaccinated with 0.5 mL varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously (lot # T002844, expiration date 23-JAN-2022) and with 0.5 mL measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) subcutaneously ((lot # S031705, expiration date 06-APR-2021) as vaccination. The reporter called to ask if there was any issue or problems if both vaccines were administered at the same time and date. It was stated the patient did not show any signs or symptoms for excessive vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Mild flu-like symptoms; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Physician was self-reporting that she recently finished the Shingrix series.  After receiving Shingrix, the patient experienced mild flu-like symptoms for a day or two. The reporter did not consent to follow up. For the tolerance of 2nd dose, refer linked case US2020154060.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020154060:same patient, 2nd dose
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: body aching; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient complained of body aching after receiving Shingrix.  The aching lasted 24 to 48 hours. The reporter consent to follow up. This case has been linked with case US2020154014, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020154014:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Diarrhoea, Feeling abnormal, Immediate post-injection reaction, Insomnia
Clinical narrative: feels lousy / does not feel right; doesn't get a lot of sleep; not hungry; severe diarrhea; had a fever; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 23rd July 2020, immediately after receiving Shingrix, the patient experienced fever. On 5th August 2020, the patient experienced diarrhea. On an unknown date, the patient experienced feeling bad, insomnia and decreased appetite. On an unknown date, the outcome of the feeling bad was not recovered/not resolved and the outcome of the insomnia, decreased appetite and diarrhea were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the feeling bad, insomnia, decreased appetite, diarrhea and fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient still feels lousy. The patient doesn't get a lot of sleep, she's not hungry and she does not feel right. For a couple of days she will start to feel better then the bad feeling comes back again.  The patient had a fever right after the injection and that has gone away.  On 5th August 2020 she had severe diarrhea, 22 episodes of diarrhea that day. Shingrix administered by pharmacist   The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: feels lousy / does not feel right; doesn't get a lot of sleep; not hungry; severe diarrhea; had a fever; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 23rd July 2020, immediately after receiving Shingrix, the patient experienced fever. On 5th August 2020, the patient experienced diarrhea. On an unknown date, the patient experienced feeling bad, insomnia and decreased appetite. On an unknown date, the outcome of the feeling bad was not recovered/not resolved and the outcome of the insomnia, decreased appetite and diarrhea were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the feeling bad, insomnia, decreased appetite, diarrhea and fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient still feels lousy. The patient doesn't get a lot of sleep, she's not hungry and she does not feel right. For a couple of days she will start to feel better then the bad feeling comes back again.  The patient had a fever right after the injection and that has gone away.  On 5th August 2020 she had severe diarrhea, 22 episodes of diarrhea that day. Shingrix administered by pharmacist   The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Vaccine positive rechallenge
Clinical narrative: Mild flu-like symptoms; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (received 1st dose on an unknown date. For the tolerance of 1st dose, refer linked case US2020AMR157702).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experianced mild flu-like symptoms for a day or two. The reporter did not consent to follow up. This case was linked with case US2020AMR157702, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR157702:same patient, 1st dose
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Severe redness at site of injection (huge red spot the size of a hand); felt warm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 86-year-old female patient who received Herpes zoster (Shingrix) (batch number K735H, expiry date 15th September 2022) for prophylaxis.   On 7th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient had developed a huge red spot at the site of injection. The red spot was the size of a hand and it felt warm.  The reporter was consented to follow up.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue, Vaccine positive rechallenge
Clinical narrative: liquid portion of the DTap-IPV was administered alone and not mixed with the ActHib portion/No AE; Initial information was received on 31-Jul-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a 35 months old female patient who on 14-Jul-2020 received 0.5 ml dose of only the liquid portion of the Dtap-IPV alone of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Box: lot U6218AA and DTAP-IPV Vial lot: UJ016AAA and expiry date for both was 26-Oct-2020) via intramuscular route in the right deltoid for prophylactic vaccination and it was not mixed with the ActHib portion (product preparation issue)   The patient's medical history, past  medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  It was a case of an actual medication error case due to inappropriate reconstitution technique.  Case details: A medical office reporting a medication error with Pentacel described as the liquid portion of the DTap-IPV was administered alone and not mixed with the ActHib portion. The office reported that the error was found because they have a remaining dose of ActHIB that has not been administered.   At the time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was administered to patient after a temperature excursion of minus 1.25 degree Celcius, no AE; Initial information was received on 03-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2020SA203126, 2020SA202350, 2020SA202831, 2020SA202832, 2020SA202232, 2020SA203422, 2020SA203423 and 2020SA207050 (same reporter).  This case involves a 15 month old female patient who was vaccinated with a 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number KG4M7 and expiration date 06-Feb-2022) via an unknown route in the left arm for prophylactic vaccination on 31-Jul-2020 after a temperature excursion of minus 1.25 degree Celsius (product storage error).  The patient's medical history, past vaccination and family history were not provided.  The patient was concomitantly vaccinated with a dose of PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) on 31-Jul-2020 for prophylactic vaccination.   This was an actual medication error case due to product storage error temperature too low.  It was reported that, the refrigerator got too cold many times due to possible batteries issues, got to frozen temperatures several times, with a minimum of minus 1.25 degree Celsius.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: pentacel vaccine was administered to a patient after a temperature excursion of minus 1.25 degree Celsius, no AE; Initial information was received on 03-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2020SA203233, 2020SA203126, 2020SA203423, 2020SA202232, 2020SA202831, 2020SA202832, 2020SA203422 and 2020SA207050 (same reporter).  This case involves a 4 month old female patient who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] after a temperature excursion of minus 1.25 degree Celsius (Product storage error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) injection for prophylactic vaccination.  On 30-Jun-2020, the patient received a 0.5 ml one time dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ026ABA, expiry date: 24-Apr-2021) via unknown route in the left thigh for prophylactic vaccination.  This was a case of an actual medication error case due to product storage error temperature too low.  It was reported that, the refrigerator got too cold many times due to possible battery issue. The vaccine got frozen temperature several times, with a minimum of minus 1.25 degree Celsius.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was administered to patient after a temperature excursion of minus 1.25 degree Celsius, no AE; Initial information was received on 03-Aug-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case is linked to cases 2020SA203233, 2020SA202232, 2020SA202350, 2020SA202831, 2020SA202832, 2020SA203422, 2020SA203423 and 2020SA207050 (same reporter).  This case involves an 11 year old male patient who was vaccinated with a 0.5 ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number and other dosing details were not reported) in the right arm on 28-Jul-2020 for prophylactic vaccination after a temperature excursion.  The patient's medical history, past treatment, vaccination and family history were not provided.  The patient did not receive any other vaccine at the same visit.  This was a case of an actual medication error case due to product storage error temperature too low.  It was reported that, the refrigerator got too cold many times due to possible batteries issues, got to frozen temperatures several times, with a minimum of minus 1.25 degrees Celsius.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.