chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Throughout the night following the injection, difficulting sleeping due to severe and prolonged shivering (and what appeared to be feverish when no shivering) along with intense pain in left hip, and other pain throughout.  The next morning I was achy all over and felt as if I had the flu but without the "head/nasal" symptoms.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia, Nausea
Clinical narrative: Flu like symptoms - muscle pain, fatigue, nausea, headache
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash
Clinical narrative: Patient developed baseball-sized area swelling around injection site and a rash that provider felt might be shingles on her right forearm.  Prescriber prescribed 7 day course of Valtrex 1gram three time daily and a 10 day course of Keflex 500mg three times daily.  Patient is to follow up with PCP if needed.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Headache, Influenza like illness, Insomnia
Clinical narrative: Woke up in middle of night feeling very achy -- like I had the flu. Sore arm & mild headache also. Great difficulty sleeping.  Felt so bad the next day that I was unable to do anything; just layed on the couch. Took 2 extra strength Tylenol every 6 hours which helped. Went to bed early & slept through the night. Felt much better in the morning; only symptom now is sore arm - red & warm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Pain in extremity, Skin warm
Clinical narrative: Woke up in middle of night feeling very achy -- like I had the flu. Sore arm & mild headache also. Great difficulty sleeping.  Felt so bad the next day that I was unable to do anything; just layed on the couch. Took 2 extra strength Tylenol every 6 hours which helped. Went to bed early & slept through the night. Felt much better in the morning; only symptom now is sore arm - red & warm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Urticaria
Clinical narrative: Upset stomach and hives for 2-3 weeks
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspepsia, Headache, Musculoskeletal stiffness, Vomiting
Clinical narrative: Patient reported extreme vomiting, stiff neck, headache, and heartburn.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Patient reports to a small blister forming on this skin away from the injection site about a week after the vaccine.  About another week later his is having more blister like reactions mainly on the left side of the body.  He describes them as non-painful, fluid filled areas similar to poison ivy.  Patient was not sure if this was related to the vaccine.  He plans to make an appointment with his dermatologist.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: Within minutes after getting the injection, patient developed hives on left arm. Soon after the urticaria spread to the neck and face and patient was becoming increasingly itchy. Patient was given an intramuscular injection of epinephrine and Dexamethasone
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal distension, Abdominal pain, Allergy test, Blood test, Colonoscopy
Clinical narrative: Severe abdominal pain , bloating & constipation.  Became lactose intolerant & gluten intolerant. Chronic headache, pressure, dizziness & brain "zapps" Chronic fatigue
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Constipation, Dizziness, Endoscopy, Fatigue, Feeling abnormal
Clinical narrative: Severe abdominal pain , bloating & constipation.  Became lactose intolerant & gluten intolerant. Chronic headache, pressure, dizziness & brain "zapps" Chronic fatigue
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Gastrointestinal tube insertion, Gluten sensitivity, Head discomfort, Headache, Lactose intolerance
Clinical narrative: Severe abdominal pain , bloating & constipation.  Became lactose intolerant & gluten intolerant. Chronic headache, pressure, dizziness & brain "zapps" Chronic fatigue
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Nuclear magnetic resonance imaging brain, Ultrasound scan, X-ray
Clinical narrative: Severe abdominal pain , bloating & constipation.  Became lactose intolerant & gluten intolerant. Chronic headache, pressure, dizziness & brain "zapps" Chronic fatigue
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Pyrexia, Rash, Rash pruritic
Clinical narrative: Within 18 hours of receiving the vaccine I developed fever, joint pain at multiple locations, raised itchy rash covering my entire trunk and the top of my arms (front and back) - these symptoms lasted for 2-3 days;  additionally,  within 3 days of receiving the vaccine,  I developed a shingles rash at a location where I had had one 2-1/2 years earlier - this rash resolved in about a week.
Age: 57.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Acute febrile neutrophilic dermatosis, Biopsy skin abnormal
Clinical narrative: I developed and still have Sweet's Syndrome. Onset 6/1/19 to present.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin ulcer
Clinical narrative: silver dollar size sore
Age: 70.0
Sex: F
Vaccine: TYP
Symptoms: Blister, Erythema, Herpes zoster, Injection site cellulitis, Pruritus
Clinical narrative: Shingrix vaccine given at Pharmacy on July 26. This was the second one. Pt reports no problem with first vaccine. She has a swollen, erythematous area on left deltoid area measuring 6.5x7 cm with cellulitis of injection site. She complains of itching of rt forearm and upper back. Pt has fluid filled vesicles along the T2 dermatone on the underside of rt forearm. No rash noted on back but the intensely itchy area on rt upper back is also along the T2 dermatone. Diagnosis of shingles.
Age: 70.0
Sex: F
Vaccine: TYP
Symptoms: Swelling
Clinical narrative: Shingrix vaccine given at Pharmacy on July 26. This was the second one. Pt reports no problem with first vaccine. She has a swollen, erythematous area on left deltoid area measuring 6.5x7 cm with cellulitis of injection site. She complains of itching of rt forearm and upper back. Pt has fluid filled vesicles along the T2 dermatone on the underside of rt forearm. No rash noted on back but the intensely itchy area on rt upper back is also along the T2 dermatone. Diagnosis of shingles.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Pain in extremity
Clinical narrative: Patient called the pharmacy and said she has experienced severe pain on her arm from the Shingrix shot.  The pain which started on Thursday was so bad that she almost went to the ER.   Now, it has radiated to lymph nodes in her armpit  and  inside of her arm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site rash, Injection site warmth, Insomnia
Clinical narrative: Experienced chills around midnight of the day I got the injection. 2.5" diameter rash surrounding the site of the injection. VERY painful; I woke up every time I rolled over onto  my arm. Sleepless night. Took 2 aspirins twice during the night and throughout the day following. No relief. Injection site is hot to touch. The  chills were gone in the morning and the pain has lessened somewhat at this point but I can hardly stand to touch my upper arm. The needle was painful going in - more so than any other injection I have ever received. I am not looking forward to getting the second shot! I don't need a call from my regular doctor, just feel like my symptoms should be cataloged for others.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia
Clinical narrative: Experienced chills around midnight of the day I got the injection. 2.5" diameter rash surrounding the site of the injection. VERY painful; I woke up every time I rolled over onto  my arm. Sleepless night. Took 2 aspirins twice during the night and throughout the day following. No relief. Injection site is hot to touch. The  chills were gone in the morning and the pain has lessened somewhat at this point but I can hardly stand to touch my upper arm. The needle was painful going in - more so than any other injection I have ever received. I am not looking forward to getting the second shot! I don't need a call from my regular doctor, just feel like my symptoms should be cataloged for others.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: sore arm, headache, fatigue, nausea
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: DEVELOPED A RASH AROUND SITE ABOUT 1 INCH IN RADIUS UPPER LEFT ARM
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Insomnia
Clinical narrative: Patient reported having redness, warmth, extreme pain within 3-4 hours after vaccination. Pain, warmth and redness radiated out from injection site down to patient's elbow. Described pain as being severe enough to interfere with sleep. Patient was seen by his PCP 7/24/19 and prescribed Doxycycline. As of 7/26/19 noted some improvement but described entire bicep as being tender, redness fading, not warm to touch. As of 7/28/19 still improving with little soreness.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, Skin discolouration, Skin warm
Clinical narrative: The patient states that since the morning following her vaccination her left arm has been very hot, swollen, and purple (due to so much swelling). She says that she has had reactions to vaccines or medications in the past, including anaphylaxis, but this is her first dose of this new vaccine. The patient has been using Tylenol and cold compresses for the pain and swelling. A follow up call was made to the patient 7/28/19 (the day after incident reported) but no answer and left voicemail. Patient stated she was going to contact her PCP to find out if the reaction would warrant her to skip final dose of the vaccine.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Patient devoloped red rash approximately 3 in. x 5 in. at site of injection "a day or 2" after immunization. rash was itchy & persisted for 2 weeks from injection date.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Impaired healing, Pain in extremity
Clinical narrative: patient mentioned on July 27 2019 that her arm still hurts sometimes and it took a while for the place of injection to heal
Age: 68.0
Sex: F
Vaccine: YF
Symptoms: Dyspnoea, Feeling abnormal, Pyrexia, Throat tightness
Clinical narrative: morning of 7/20 started feeling bad; felt that throat was closing and fever so went to the ED; discharged but then later went back with difficulty of breathing; ED gave IV and PO steroids - pt declined stiffness of neck
Age: 20.0
Sex: F
Vaccine: YF
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Fever of about 102F for ~ 8 hrs then broke at 5 am; then runny nose; felt better after that
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal, Blood bicarbonate decreased, Blood chloride normal
Clinical narrative: 8 hours after receiving vaccines patient had a low grade fever to 100.4 and emesis. Over the next day fevers resolved, some emesis continued but patient started having looser stools. This progressed to copious, frequent watery diarrhea over the next week, ultimately leading to significant dehydration and requiring admission to the hospital for IV hydration.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood creatinine normal, Blood glucose increased, Blood lactic acid, Blood potassium increased, Blood sodium decreased
Clinical narrative: 8 hours after receiving vaccines patient had a low grade fever to 100.4 and emesis. Over the next day fevers resolved, some emesis continued but patient started having looser stools. This progressed to copious, frequent watery diarrhea over the next week, ultimately leading to significant dehydration and requiring admission to the hospital for IV hydration.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood urea increased, Dehydration, Diarrhoea, Frequent bowel movements, Haemoglobin normal
Clinical narrative: 8 hours after receiving vaccines patient had a low grade fever to 100.4 and emesis. Over the next day fevers resolved, some emesis continued but patient started having looser stools. This progressed to copious, frequent watery diarrhea over the next week, ultimately leading to significant dehydration and requiring admission to the hospital for IV hydration.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Infantile spitting up, Platelet count, Polymerase chain reaction positive, Pyrexia, Rotavirus test positive
Clinical narrative: 8 hours after receiving vaccines patient had a low grade fever to 100.4 and emesis. Over the next day fevers resolved, some emesis continued but patient started having looser stools. This progressed to copious, frequent watery diarrhea over the next week, ultimately leading to significant dehydration and requiring admission to the hospital for IV hydration.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Stool analysis, Vomiting, White blood cell count increased
Clinical narrative: 8 hours after receiving vaccines patient had a low grade fever to 100.4 and emesis. Over the next day fevers resolved, some emesis continued but patient started having looser stools. This progressed to copious, frequent watery diarrhea over the next week, ultimately leading to significant dehydration and requiring admission to the hospital for IV hydration.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient got Shingrix vaccination at 230pm on 07/28 at Pharmacy.  Patient went home and stated he was sitting in the sun for a short period of time, and noticed three bumps(possibly hives as described by patient) on both his thumbs and one ankle at approximately 345pm.  Patient took 2 capsules of diphenhydramine 25mg at approximately 4pm.  I followed up with patient an hour later, and the bumps had decreased in size; and hadn't spread.  Patient stated he was feeling fine.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: CSF glucose normal, CSF lymphocyte count increased, CSF monocyte count increased, CSF protein increased, CSF red blood cell count positive
Clinical narrative: Guillain Barre syndrome:  symptoms (paresthesias in hands and feet) started on 7/13/2019.   Symptoms progressed, with paresthesias in hands and both legs up to the mid-thighs, and included difficulty walking due to weakness,   Diagnosis made by lumbar puncture at Medical Center on 7/23/2019.  Patient is being treated with IVIG 0.4 g/kg/day for 5 days (7/24/2019 to 7/28/2019).  Today (7/28/2019), the patient reports 50-60% decrease in paresthesias in hands and legs, but no significant improvement in weakness in his hands and legs with ongoing difficulty walking.  Tomorrow, we will be consulting Neurology for further treatment recommendations.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: CSF white blood cell count negative, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Guillain Barre syndrome:  symptoms (paresthesias in hands and feet) started on 7/13/2019.   Symptoms progressed, with paresthesias in hands and both legs up to the mid-thighs, and included difficulty walking due to weakness,   Diagnosis made by lumbar puncture at Medical Center on 7/23/2019.  Patient is being treated with IVIG 0.4 g/kg/day for 5 days (7/24/2019 to 7/28/2019).  Today (7/28/2019), the patient reports 50-60% decrease in paresthesias in hands and legs, but no significant improvement in weakness in his hands and legs with ongoing difficulty walking.  Tomorrow, we will be consulting Neurology for further treatment recommendations.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Guillain Barre syndrome:  symptoms (paresthesias in hands and feet) started on 7/13/2019.   Symptoms progressed, with paresthesias in hands and both legs up to the mid-thighs, and included difficulty walking due to weakness,   Diagnosis made by lumbar puncture at Medical Center on 7/23/2019.  Patient is being treated with IVIG 0.4 g/kg/day for 5 days (7/24/2019 to 7/28/2019).  Today (7/28/2019), the patient reports 50-60% decrease in paresthesias in hands and legs, but no significant improvement in weakness in his hands and legs with ongoing difficulty walking.  Tomorrow, we will be consulting Neurology for further treatment recommendations.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Hypoaesthesia, Paraesthesia, Pruritus, Sensory loss
Clinical narrative: Patient states arm feels numb, no sensation, doesn't feel touch, and itchyness/tingliness that radiates down to both hands.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Pyrexia
Clinical narrative: Developed chills in the evening and over night the first day. Second day fever of 99.7, took ibuprofen 400mg but little relief. Third day 600mg, got some relief but about 6 hours later wearing off. Too another 600mg and plan to take again at bedtime.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: THE DAY AFTER BEING VACCINATED THE INJECTION SITE BECAME SORE AND RED (ABOUT 6-8 INCHES IN AREA)
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Ear discomfort, Insomnia, Pain, Swelling
Clinical narrative: Joint pain and sweeping on both hands. Very painful swelling behind ears neck and jaw. Ear pressure and facial swelling. Difficulty sleeping. Feel swellng in arms and feet, forehead and lower cranial area. Experiencing these symptoms for over two months.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Swelling face
Clinical narrative: Joint pain and sweeping on both hands. Very painful swelling behind ears neck and jaw. Ear pressure and facial swelling. Difficulty sleeping. Feel swellng in arms and feet, forehead and lower cranial area. Experiencing these symptoms for over two months.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Muscular weakness, Myalgia
Clinical narrative: Extreme fatigue, chills, and muscle aches/weakness approximately 22-23 hours after shingles vaccination (this was my 2nd dosage - 1st dosage received approx. 3 months earlier from same pharmacy - only had extreme fatigue with 1st dosage).  Symptoms lasted for approximately 7 hours.
Age: 81.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Rash, Rash pruritic
Clinical narrative: Patient reported deep bruising around inj site. Patient reported full upper body rash within 5 days of vaccine. Rash is itchy and painful, after consulting with PCP patient was given steroids for symptom relief.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Injection site reaction, Malaise, Pyrexia, Rash erythematous
Clinical narrative: fatigue / malaise and fatigue seemed excessive compared to the fever; malaise / malaise and fatigue seemed excessive compared to the fever/generalized malaise; pyrexia / Fever. Was only to 101.; Right deltoid inj site with mild redness/The right lateral deltoid with small erythemato s rash inferior to injection site with no fluctuance or proximal erythema; vaccination reaction/Immune response to vaccine; This report was identified from a line listing obtained on request by the Company from FDA under the Freedom of Information Act (HA # 705738) on 13-DEC-2017. This spontaneous report as received from a physician referred to a 12-year-old male patient. The patient was allergic to amoxicillin.The patient had no medical history, current illnesses and concomitant therapies.On 26-JUL-2017 at 09:00, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly in the right arm, lot # N000326 (expiration date was not reported) for prophylaxis. On 26-JUL-2017 at 20:00, the patient experienced fever, malaise and fatigue. The fever was only to 101 (units not provided). However malaise and fatigue seemed excessive compared to the fever. On the following day, the patient was seen in local Emergency Room (ER), however no workup deemed necessary. The outcome of the events was reported as recovered. The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was unknown.  Follow up information has been received on 15-JUL-2019 from the Physician. The patient is currently 14 year old. The patient's concurrent conditions included asthma exercise induced, anaphylactic reaction to nuts, cough, eczema, rash, wheezing, Sever's apophysitis bilateral with mild lselin's disease and drug hypersensitivity to penicillin and rash with Azithromycin(ZITHROMAX) otherwise a healthy active and overall doing well. The patient received the vaccine with public funds from a private doctor's office/ hospital for routine pediatric vaccine. Concomitant therapies included albuterol and triamcinolone. On 26-JUL-2017, the patient experienced small erythematous rash inferior to injection site with no fluctuance(Injection site erythema) or proximal erythema which was caused by the immune response to the vaccine(vaccination complication). The physician recommend fever control and hydration treatment. Outcome of the events was unknown by the reporter. Causality assessment was not provided by the reporter.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Vaccination complication
Clinical narrative: fatigue / malaise and fatigue seemed excessive compared to the fever; malaise / malaise and fatigue seemed excessive compared to the fever/generalized malaise; pyrexia / Fever. Was only to 101.; Right deltoid inj site with mild redness/The right lateral deltoid with small erythemato s rash inferior to injection site with no fluctuance or proximal erythema; vaccination reaction/Immune response to vaccine; This report was identified from a line listing obtained on request by the Company from FDA under the Freedom of Information Act (HA # 705738) on 13-DEC-2017. This spontaneous report as received from a physician referred to a 12-year-old male patient. The patient was allergic to amoxicillin.The patient had no medical history, current illnesses and concomitant therapies.On 26-JUL-2017 at 09:00, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly in the right arm, lot # N000326 (expiration date was not reported) for prophylaxis. On 26-JUL-2017 at 20:00, the patient experienced fever, malaise and fatigue. The fever was only to 101 (units not provided). However malaise and fatigue seemed excessive compared to the fever. On the following day, the patient was seen in local Emergency Room (ER), however no workup deemed necessary. The outcome of the events was reported as recovered. The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was unknown.  Follow up information has been received on 15-JUL-2019 from the Physician. The patient is currently 14 year old. The patient's concurrent conditions included asthma exercise induced, anaphylactic reaction to nuts, cough, eczema, rash, wheezing, Sever's apophysitis bilateral with mild lselin's disease and drug hypersensitivity to penicillin and rash with Azithromycin(ZITHROMAX) otherwise a healthy active and overall doing well. The patient received the vaccine with public funds from a private doctor's office/ hospital for routine pediatric vaccine. Concomitant therapies included albuterol and triamcinolone. On 26-JUL-2017, the patient experienced small erythematous rash inferior to injection site with no fluctuance(Injection site erythema) or proximal erythema which was caused by the immune response to the vaccine(vaccination complication). The physician recommend fever control and hydration treatment. Outcome of the events was unknown by the reporter. Causality assessment was not provided by the reporter.
Age: 17.0
Sex: M
Vaccine: FLU3, HEPA, HPV9, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: syncope; This report was identified from a line listing obtained on request by the Company from the Food and Drugs Administration (FDA) (HA# 736458) under the Freedom of Information Act and refers to a 17-year-old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.   On 25-JAN-2018, 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 # N020353, expiration date: 28-APR-2020) intramuscularly in the right arm; the third dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N021721, expiration date: 10-AUG-2019), intramuscularly in the left arm; the third dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) (lot # U5833AA, expiration date not reported), intramuscularly in the left arm; the second dose of influenza virus split virion 3v vaccine inactivated (FLUARIX) (lot # 5LR3F, expiration date not reported), intramuscularly in right arm and the second dose of hepatitis A virus vaccine inactivated (HAVRIX) (lot # NB7R9, expiration date not reported), intramuscularly in the left arm; all for prophylaxis.   On the same day, the patient experienced syncope. After vaccine administration, he had a period of syncope lasting 20-30 seconds. His head was put between his knees and he came to. The outcome of syncope was reported as recovered on an unspecified date in 2018.  The causality between the event and the suspect vaccines was not reported.  Follow up information has been received from FDA on 15-APR-2019. On 25-JAN-2018 at 09:00, 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)(previously reported as second dose), the second dose of varicella virus vaccine live (oka/merck) (VARIVAX)(previously reported as third dose), the second dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA)(previously reported as third dose), the first dose of influenza virus split virion 3v vaccine inactivated (FLUARIX) (previously reported as second dose) and the first dose of hepatitis A virus vaccine inactivated (HAVRIX)(previously reported as second dose).  As of 26-JUL-2019, all telephone attempts to obtain follow-up information have been unsuccessful.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Allergy to vaccine, Antinuclear antibody, Biopsy skin, C-reactive protein, Full blood count
Clinical narrative: antinuclear antibody; biopsy skin; c-reactive protein; full blood count; metabolic function test; rash over arms; rash papular; urticaria; rash trunk; This report was identified from a line listing obtained on request by the Company from  the Food and Drug Administration (FDA) (HA# 740616) under the Freedom of Information Act referring to a 14 year old female patient. The patient's medical history and current illness were not reported. The patient had no other medications. On 20-FEB-2017, the patient was vaccinated in the left arm with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot number: M032780, intramuscularly, for prophylaxis (strength, dosage schedule and expiration date were not reported). The patient had a papular rash on UE and trunk that developed 8 hives after HPV vaccine given. The patient did not have any itchiness to the sites. The patient had been referred to allergy and dermatology for further testing. At the time of the report, the patient had the rash. Laboratory results were reported as complete blood count (CBC), "CMP", C-reactive protein (CRP) and antinuclear antibody (ANA) direct (05-APR-2017) the results not provided and the patient had skin biopsy (21-MAR-2018) the results not provided. The outcome of the events was not resolved. The causality assessment was not provided.  Lot number M032780 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).  Follow up information has been received from the FDA on 23-MAY-2019 refers to a patient. The patient's concurrent conditions included drug allergy to quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) and historical vaccine included quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). On 20-FEB-2017 at 17:00, 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) at the physician's office urgent care or hospital. On 23-FEB-2017 at 13:35, the patient experienced the events.  Follow up information was received from a nurse on 01-JUL-2019. The nurse provided the correct lot and expiration for the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The correct lot number was M034780 with expiration date 15-APR-2019. She explained that she had no further information to share regarding this report. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Metabolic function test, Rash, Rash papular, Urticaria
Clinical narrative: antinuclear antibody; biopsy skin; c-reactive protein; full blood count; metabolic function test; rash over arms; rash papular; urticaria; rash trunk; This report was identified from a line listing obtained on request by the Company from  the Food and Drug Administration (FDA) (HA# 740616) under the Freedom of Information Act referring to a 14 year old female patient. The patient's medical history and current illness were not reported. The patient had no other medications. On 20-FEB-2017, the patient was vaccinated in the left arm with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot number: M032780, intramuscularly, for prophylaxis (strength, dosage schedule and expiration date were not reported). The patient had a papular rash on UE and trunk that developed 8 hives after HPV vaccine given. The patient did not have any itchiness to the sites. The patient had been referred to allergy and dermatology for further testing. At the time of the report, the patient had the rash. Laboratory results were reported as complete blood count (CBC), "CMP", C-reactive protein (CRP) and antinuclear antibody (ANA) direct (05-APR-2017) the results not provided and the patient had skin biopsy (21-MAR-2018) the results not provided. The outcome of the events was not resolved. The causality assessment was not provided.  Lot number M032780 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).  Follow up information has been received from the FDA on 23-MAY-2019 refers to a patient. The patient's concurrent conditions included drug allergy to quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) and historical vaccine included quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). On 20-FEB-2017 at 17:00, 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) at the physician's office urgent care or hospital. On 23-FEB-2017 at 13:35, the patient experienced the events.  Follow up information was received from a nurse on 01-JUL-2019. The nurse provided the correct lot and expiration for the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The correct lot number was M034780 with expiration date 15-APR-2019. She explained that she had no further information to share regarding this report. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain, Pain in extremity, Tenderness
Clinical narrative: Pain in upper arm below area of injection.  Contacted pharmacy for advice...  Pharmacy suggested taking ibprobin for several days.  If no results see physician.  Saw physician on 05/29/19.  My temp. was 37.6, bp 120/84, heart rate 78.  The physician advised taking  ibuprofen 600mg every 6-8 hours.  Ibuprofen was taken for 5 weeks with no change.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, X-ray limb normal
Clinical narrative: Pain in upper arm below area of injection.  Contacted pharmacy for advice...  Pharmacy suggested taking ibprobin for several days.  If no results see physician.  Saw physician on 05/29/19.  My temp. was 37.6, bp 120/84, heart rate 78.  The physician advised taking  ibuprofen 600mg every 6-8 hours.  Ibuprofen was taken for 5 weeks with no change.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: It started swelling, hurting, and itching, eventually expanding to an area about 4 inches square; it was raised, red, warm to the touch, and painful when touched. Now, two days later, the symptoms are receding, but it still itches.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: It started swelling, hurting, and itching, eventually expanding to an area about 4 inches square; it was raised, red, warm to the touch, and painful when touched. Now, two days later, the symptoms are receding, but it still itches.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site reaction, Injection site vesicles, Rash erythematous
Clinical narrative: Pt presented with what appeared to be a red rash with small clustered blister-like lesions in the shape of the previously applied bandage.  Site was assessed by SMO and PCM and dermatologist.  Telfa bandage with paper tape was applied to site.  Pt received Benadryl, Claritin and Naproxen for management of localized symptoms, pt denies ALL other symptoms.  Pt f/u in clinic daily for site assessments.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site reaction, Injection site vesicles, Skin lesion, Vaccination complication
Clinical narrative: Pt reports to clinic after noting two satellite blister-like lesions about 1cm left of inoculation site.  Two additional red raised lesions are noted abt 2-3 inches away from inoculation site.  IHD, PCM, Derm, SMO, Imms provider were all notified.  Satellite lesions will be treated like inoculation site.  Daily monitoring at clinic to ensure lesions do not spread.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Electromyogram, Facial paralysis, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: On 5/26/19 patient developed tingling and numbness in lips, fingers, hands and feet. On June 1 patient developed weakness and pain in lower extremities  On June 4  she saw her primary care physician who ordered an MRI  of head. MRI was negative.  On June 7 she went to ED at (hospital) because she could hardly walk and was in extreme pain. She was given a pain injection and sent home. On June 8 she developed right-sided mouth droopy.  She went back to ED on June 9 and was admitted.A CT scan was done on June 9 and was negative.  An MRI was done on June 11.  Lumbar puncture and EMG were done on June 12. Dr, a neurologist, diagnosed her with Bell's Palsy and Guillian-Barre Syndrome.  In the hospital she was treated with prednisone, gabapentin, and IVIG infusions given on 6/12 thru 6/16.  She was released from hospital on 6/17.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Immunoglobulin therapy, Injection site pain, Lumbar puncture
Clinical narrative: On 5/26/19 patient developed tingling and numbness in lips, fingers, hands and feet. On June 1 patient developed weakness and pain in lower extremities  On June 4  she saw her primary care physician who ordered an MRI  of head. MRI was negative.  On June 7 she went to ED at (hospital) because she could hardly walk and was in extreme pain. She was given a pain injection and sent home. On June 8 she developed right-sided mouth droopy.  She went back to ED on June 9 and was admitted.A CT scan was done on June 9 and was negative.  An MRI was done on June 11.  Lumbar puncture and EMG were done on June 12. Dr, a neurologist, diagnosed her with Bell's Palsy and Guillian-Barre Syndrome.  In the hospital she was treated with prednisone, gabapentin, and IVIG infusions given on 6/12 thru 6/16.  She was released from hospital on 6/17.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging brain normal, Pain in extremity, Paraesthesia oral
Clinical narrative: On 5/26/19 patient developed tingling and numbness in lips, fingers, hands and feet. On June 1 patient developed weakness and pain in lower extremities  On June 4  she saw her primary care physician who ordered an MRI  of head. MRI was negative.  On June 7 she went to ED at (hospital) because she could hardly walk and was in extreme pain. She was given a pain injection and sent home. On June 8 she developed right-sided mouth droopy.  She went back to ED on June 9 and was admitted.A CT scan was done on June 9 and was negative.  An MRI was done on June 11.  Lumbar puncture and EMG were done on June 12. Dr, a neurologist, diagnosed her with Bell's Palsy and Guillian-Barre Syndrome.  In the hospital she was treated with prednisone, gabapentin, and IVIG infusions given on 6/12 thru 6/16.  She was released from hospital on 6/17.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Immediate post-injection reaction, Presyncope
Clinical narrative: Patient almost fainted today. She became light-headed and dizzy immediately after vaccine administration, but no loss of consciousness occurred. Patient verbally and clearly declined code white/EMS that was offered by pharmacist. She stayed coherent and was back to normal within less than one minute. Of note, she had history of fainting with flu shots previously, although no incidents since age 13 (over 5 years) and was confident in receiving vaccination. Patient also divulged she had not eaten recently that day.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Irritability, Measles post vaccine, Pyrexia, Rash
Clinical narrative: High fever, irritability, followed by measles rash - started on chest and back and spread to face, arms, legs
Age: 0.17
Sex: M
Vaccine: HIBV, PPV
Symptoms: Eczema, Immediate post-injection reaction, Screaming
Clinical narrative: Immediately following vaccination, high pitch screaming for 4 days and the start of all body eczema
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Pt developed SEVERE right-sided BELL'S Palsy
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported; inadvertently administered an expired dose of VARIVAX; Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant medication included sterile diluent (Merck manufactured). Information about concurrent condition, drug reactions/allergies and medical history was not provided.  The reporter reported that on 27-JUN-2019, the patient was inadvertently administered an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # was N019127, expiration date was 22-JUN-2019, strength, dose and route were not reported) for prophylaxis (Expired product administered). No adverse effect was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 59-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 01-JUL-2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the events herpes zoster was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 68-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 09-SEP-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the events herpes zoster was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the events herpes zoster was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 59 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 01-AUG-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: not adverse event; Patient was vaccinated with a dose of Gardasil 9 prepared two days before; Patient was vaccinated with a dose of Gardasil 9 prepared two days before; This non-valid spontaneous report was received form a nurse and concerning a patient of unknown age and gender. There was no information provided about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or medical history.  On 08-JUL-2019, an unknown patient was to be administrated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), however the mother of the patient refused the vaccine after the needle was already attached to the syringe.  On 10-JUL-2019 (also reported as two days after), an unknown patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly for prophylaxis (strength, dosage schedule, anatomical site, lot number and expiration date were not reported). This dose of the vaccine was the one which had the needle attached to the syringe (wrong technique in product usage process/Product preparation issue). No adverse effects were reported.   The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the events was not reported.    This case was considered non-valid due to the lack of patient identifiers.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; The patient was vaccinated with a first dose ofGARDASIL 9 on 10/4/2016. He received the second dose of GARDASIL 9 on 7/17/2019.; This spontaneous report was received from a nurse concerning a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 04-OCT-2016, 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) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).   On 17-JUL-2019, the patient was administered the second dose of of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported) (inappropriate schedule of product administration). No adverse symptoms reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No known adverse effects; The patient received a dose of VARIVAX via the intramuscular route in error; This spontaneous report was received from a pharmacist referring  to a patient of unknown age and gender. No information regarding patient's concurrent conditions, medical history, drug allergies or reactions was provided.       On 17-JUL-2019, the patient was vaccinated in with varicella virus vaccine live (oka/merck) (VARIVAX) one dose, intramuscularly, lot # N022995, expiration date 23-AUG-2019, for prophylaxis (strength, and anatomical site of administration  were not provided) in error (incorrect route of product administration).  No adverse events were reported.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse effect reported; On 17-JUL-2019, the patient was administered properly stored PROQUAD instead of M-M-R II; On 17-JUL-2019, the patient was administered properly stored PROQUAD instead of M-M-R II; This spontaneous report was received from a medical assistant referring to a 55 year old-female patient. No information regarding patient's concurrent conditions, medical history, drug allergies or reactions were provided.       On 17-JUL-2019 , the patient was erroneously vaccinated  with  properly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R020814, expiration date 16-JAN-2020 for prophylaxis (strength, dose, frequency, and route of administration were not provided) (product administered to patient of inappropriate age) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered ).  Properly stored sterile diluent used, and  no adverse effects were reported.     ,
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; patient was administered an improperly stored PROQUAD; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history or drug reactions/allergies. Concomitant therapies included sterile diluent.      On 08-JUL-2019, the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, frequency and route were not reported, lot # was S003170, expiration date was 30-JUL-2020) for prophylaxis (product storage error). The sterile diluent that was used to econstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was properly stored. No adverse effects were reported.  There was no previous temperature excursion. The temperature and time frame was 15 Fahrenheit (F) to 46 F for 3 hours. It was not call because of a data logger.