chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Chills, Fatigue, Influenza like illness
Clinical narrative: Bad muscle soreness at injection site, chills, general muscle soreness throughout body, fatigue, exaggerated joint soreness in arthritic joints. Somewhat like flu symptoms but without fever or upper respiratory issues.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia
Clinical narrative: Bad muscle soreness at injection site, chills, general muscle soreness throughout body, fatigue, exaggerated joint soreness in arthritic joints. Somewhat like flu symptoms but without fever or upper respiratory issues.
Age: 0.67
Sex: F
Vaccine: PNC13
Symptoms: Cardiac function test normal, Cyanosis, Electroencephalogram normal, Hypotonia, Laboratory test normal
Clinical narrative: 24 hours after recieving the vaccine, the patient had a spontaneous epsiode of limpness / unresponsiveness, cyanosis all over the body, not breathing. This lasted for approximately 2 minutes.  Parents revived the child.
Age: 0.67
Sex: F
Vaccine: PNC13
Symptoms: Neurological examination normal, Posture abnormal, Respiratory arrest, Unresponsive to stimuli
Clinical narrative: 24 hours after recieving the vaccine, the patient had a spontaneous epsiode of limpness / unresponsiveness, cyanosis all over the body, not breathing. This lasted for approximately 2 minutes.  Parents revived the child.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea
Clinical narrative: Severe shivering, nausea.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Extremely sore left arm for several days but also fever, aches for 24 hours. First SHINGRIX vaccine only caused extreme fatigue for first 24 hours. My husband's symptoms were the reverse of mine. He only had extreme fatigue with the 2nd SHINGRIX shot but had fever, aches and fatigue with the first shot. We felt the side effects were perhaps underreported in the general information available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site pain, Injection site pruritus
Clinical narrative: Small blisters (15-20) on various areas of the body face, L finger, abd, legs, L ankle. Started 3 days after injection. Severe itching at sites. No pain. Injection site was sore for 3-4 days, but no visible signs of reaction. New areas still breaking out 6 days out from immunization.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Shortly after injection area became red, swollen and tender. The redness and swelling continued to expand. Area was warm to touch. Upon exam on 07/27/18 the left upper arm had a clearly demarcated, erythematous and warm rash along the entire bicep area extending posteriorly, no streaking.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth, Rash erythematous
Clinical narrative: Shortly after injection area became red, swollen and tender. The redness and swelling continued to expand. Area was warm to touch. Upon exam on 07/27/18 the left upper arm had a clearly demarcated, erythematous and warm rash along the entire bicep area extending posteriorly, no streaking.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Pain, Pyrexia
Clinical narrative: Patient called pharmacy explaining she has a 101.2 fever, body aches and flushing. I explained to patient that this is an adverse effect of the vaccine and is common. She asked that I still report it.
Age: 1.92
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash, Rash pruritic, Rash pustular
Clinical narrative: Mom called and reported itchy rash over child's extremities and torso. Verified by looking at rash-blister like with pustules. Instructed to notify child's PCP, keep away from unvaccinated or immunosuppressed persons. Treat with BENADRYL, CALAMINE LOTION and oatmeal baths for itching.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Patient started feeling ill less than 24 hours after SHINGRIX administration. She is experiencing body aches, headache, fatigue, malaise, nausea, and decreased appetite. Patient will take TYLENOL or ibuprofen and wait another 1-2 days to see if symptoms improve.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient started feeling ill less than 24 hours after SHINGRIX administration. She is experiencing body aches, headache, fatigue, malaise, nausea, and decreased appetite. Patient will take TYLENOL or ibuprofen and wait another 1-2 days to see if symptoms improve.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, PNC13, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient inadvertently received a pediatric Hep A vaccine instead of a pediatric Hep B vaccine. Parents notified, and patient was given the correct Pediatric Hep B vaccine. No adverse reactions reports at this time. Patient's pediatrician, notified.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Hypersensitivity, Urticaria
Clinical narrative: PATIENT STATES SHE DEVELOPED HIVES, SHORTNESS OF BREATH. SHE WENT TO THE HOSPITAL ON 07/29/2018 AND WAS TOLD SHE WAS HAVING AN ALLERGIC REACTION TO SHINGRIX. RECEIVED WRITTEN PRESCRIPTIONS FOR RANTIDINE 150MG, PREDNISONE 20MG, AND TRIAMCINOLONE 0.1% CREAM FOR REACTION.
Age: 1.17
Sex: M
Vaccine: DTAP, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Pt given extra dose of varicella. Per CDC immunization hotline, no serious adverse events or complications to look for, only site reaction could be possible.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash
Clinical narrative: Rash over arms, legs, torso and face.
Age: 33.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Maternal exposure before pregnancy, Pregnancy test negative, Pregnancy test urine positive
Clinical narrative: Patient became pregnant less than 4 weeks after receiving the vaccine. She had a negative pregnancy test on 6/4/2018 and 7/6/2018. Received the varicella vaccine on 7/6/2018 and had a positive pregnancy test on 7/30/2018. LMP 06/23/2018
Age: 33.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Patient became pregnant less than 4 weeks after receiving the vaccine. She had a negative pregnancy test on 6/4/2018 and 7/6/2018. Received the varicella vaccine on 7/6/2018 and had a positive pregnancy test on 7/30/2018. LMP 06/23/2018
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: HIVES WHICH STARTED DISTALLY ON BOTH UPPER AND LOWER EXTREMITIES THE FOLLOWING EVENING  07/28/18. INITIALLY SYMPTOMS RESOLVED WITH BENADRYL BUT HIVES RETURNED FOLLOWING DAY.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site discomfort, Injection site swelling
Clinical narrative: Extreme fatigue. Presented 24 hours later, duration was 6 days. Also some discomfort and swelling at the site of the injection.
Age: 37.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site inflammation, Myalgia
Clinical narrative: Fever, chills, nausea, muscle aches/pain, headache, fatigue, inflammation at injection site.
Age: 37.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever, chills, nausea, muscle aches/pain, headache, fatigue, inflammation at injection site.
Age: 24.0
Sex: F
Vaccine: TYP, YF
Symptoms: Cold sweat, Hyperhidrosis, Presyncope, Syncope
Clinical narrative: Patient had a vasovagal reaction due to receiving both the YF and Typhoid vaccines. Patient had described having similar issues previously when she received vaccinations and gave blood. Patient displayed syncope, sweating, cool clammy skin. Orthostatic Vital signs following the reaction were in normal parameters.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies and drug reactions or allergies provided. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD subcutaneously, lot # R001541, 15-JUL-2019 (dose was not reported). It was unknown, if sterile diluent (strength, dose, lot# and expiration date were not reported) used to reconstitute was stored properly. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 43 minutes. There was no previous temperature excursion. Information was received from a data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA013035.
Sex: F
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: This initial spontaneous report was received from the mother of a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date, the patient was vaccinated with GARDASIL 9 (route, dose, and lot # not provided). The mother reported that her daughter experienced seizures after receiving GARDASIL 9 (she did not provide the onset date). The mother requested information on how long the seizures her daughter experienced with GARDASIL 9 were supposed to last and what she could do to reverse the effects. She also stated that it was unacceptable for children to be given GARDASIL 9 while knowing it can cause seizures and that it should be mentioned in the pamphlets and brochures. The mother stated she has contacted her lawyer. The outcome of the seizures was not recovered. Causality assessment was considered related. The mother commented on a potential lawsuit that she saw on television regarding "thousands" of patients who experienced seizures or died after receiving GARDASIL 9 (see case # 1807USA012762). This is one of two reports from the same reporter. Upon internal review, seizures were considered medically significant. The reporter did not provide any contact information or consent to be contacted for follow-up.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies and drug reactions or allergies provided. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD subcutaneously, lot # R001541, 15-JUL-2019 (dose was not reported). It was unknown, if sterile diluent (strength, dose, lot# and expiration date were not reported) used to reconstitute was stored properly. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 43 minutes. There was no previous temperature excursion. Information was received from a data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA010837.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Injection site swelling
Clinical narrative: Initial information received on 23-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves patient who experienced swelling at site, while received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site. The patient developed a non-serious swelling at site following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Final diagnosis was swelling at site. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for swelling at site.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Swelling
Clinical narrative: Skin rash and swelling.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: On 7/21/18 in morning- child complained with left deltoid area swollen, red and hot to touch. Mother gave her ibuprofen but it continued to bother her through the day. In the evening the parents took her to the EMS base to ask and see if they could do anything for her at the ER. They told her to do to her doctor. The next day, 7/22/18, mother took child to Urgent Care and they gave her oral steroids. On 7/23/18 grandmother reported to mother that child was fine and her arm was not swollen or red anymore.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Low grade fever, chills, profuse sweating swelling at injection site, redness at injection site & tenderness & warmth at injection site. The initial injection of SHINGRIX I did not have any problem except some swelling and redness at injection site and it was a little warm. The fever & chills & sweating lasted from Friday around 9:P.M. until Sunday morning.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Low grade fever, chills, profuse sweating swelling at injection site, redness at injection site & tenderness & warmth at injection site. The initial injection of SHINGRIX I did not have any problem except some swelling and redness at injection site and it was a little warm. The fever & chills & sweating lasted from Friday around 9:P.M. until Sunday morning.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Diplegia, Rash, Vomiting
Clinical narrative: 1 week after immunization, patient had paralysis in both legs for 2 days. She also had rashes on both arms and legs and was vomiting.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pyrexia
Clinical narrative: Felt tired around 4 pm. Started running 103 degree fever within 12 hours and had severe flu-like symptoms. Patient took Ibuprofen for relief. Symptoms resolved within 24 hours of vaccination.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Alopecia, Bedridden, Influenza like illness, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: High fever and flu like symptoms, bed ridden for 3 days and unable to function.  Hair loss began 3 months after, lost about 60% to 70% of her hair.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Alopecia, Influenza like illness, Pyrexia
Clinical narrative: High fever and flu like symptoms, bed ridden for 3 days and unable to function.  Hair loss began 3 months after, lost about 60% to 70% of her hair.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Alopecia, Bedridden, Blood test normal, Influenza like illness, Malaise
Clinical narrative: High fever and flu like symptoms, bed ridden for 3 days and unable to function.  Hair loss began 3 months after, lost about 60% to 70% of her hair.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Mobility decreased, Pyrexia
Clinical narrative: High fever and flu like symptoms, bed ridden for 3 days and unable to function.  Hair loss began 3 months after, lost about 60% to 70% of her hair.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 25-year-old female patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapies were not reported. On 31-MAY-2018, the patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL 9 (lot number and expiration date not reported) for prophylaxis. The medical assistant reported, that the subject received her second dose (0.5 ml, administered intramuscularly for prophylaxis) of GARDASIL 9 (lot number and expiration date not reported) too early, on 26-JUN-2018. No adverse effects were reported. The outcome of the event was not reported. The causality for the event was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Oral papilloma
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a 14 year old female patient. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was unknown by reporter. On an unknown dates, the patient was vaccinated with 2 doses of GARDASIL 9 (route, lot # and expiration date were not provided), according to schedule, for prophylaxis. Subsequently, on an unknown date,  the patient experienced Human Papilloma Virus (HPV) on the roof of her mouth. It was reported that, on an unknown date, the patient sought medical attention by an office visit. The reporter stated that the patient planned follow up with an unspecified ear, nose and throat doctor for treatment. It was unknown if diagnostic laboratory tests were performed. At the reporting time, the outcome of oral papilloma and the causality between the event and GARDASIL 9 were unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash, Visual impairment
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication.  On or about 23-JUL-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX vaccine, the patient developed a painful rash under her left eye and nerve pain causing throughout the left side of her face, contributing to reduced vision in her left eye. Thereafter, in response to these complaints, the patient presented to her primary care physician/MD at a clinic, and was diagnosed as suffering from shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Upon internal review, the event of Herpes zoster ophthalmicus was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On 30-MAR-2016 the patient was vaccinated with GARDASIL for prophylaxis (dose, route of administration, lot# and expiration date were not reported). On 17-JUL-2017, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). No adverse effect was reported.
Age: 70.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Malaise, Mass, Oropharyngeal pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of mass in a 70-year-old female patient who received BOOSTRIX (batch number TB2R2, expiry date 2nd December 2019) for prophylaxis. Co-suspect products included SHINGRIX (batch number B5EK2, expiry date 28th April 2020) and (batch number ZX3YA, expiry date 28th April 2020) for prophylaxis. On 26th April 2018, the patient received BOOSTRIX and the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 27th April 2018, 1 days after receiving BOOSTRIX and SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced mass. On an unknown date, the patient experienced sore throat and feeling unwell. On an unknown date, the outcome of the mass was recovered/resolved and the outcome of the sore throat and feeling unwell were unknown. It was unknown if the reporter considered the mass, sore throat and feeling unwell to be related to BOOSTRIX. It was unknown if the reporter considered the sore throat and feeling unwell to be related to SHINGRIX. Additional information reported as follows: The healthcare professional reported patient received BOOSTRIX on left deltoid and SHINGRIX on right deltoid on the same day. The arm in which the BOOSTRIX was given the patient developed big, huge lumps or bumps. The patient also felt sick for a while and had been experiencing a sore throat. The reported batch number BSEK2 for SHINGRIX did not exist and was updated to B5EK2 as per the sales database.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Headache, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received SHINGRIX for prophylaxis. On 21st July 2018 02:45, the patient received the 1st dose of SHINGRIX. On 21st July 2018, less than a day after receiving SHINGRIX, the patient experienced headache, joint pain, injection site pain, malaise, injection site swelling, injection site erythema, appetite lost and blotchy. The patient was treated with analgesic, nos. On an unknown date, the outcome of the headache, joint pain, injection site pain, malaise, injection site swelling, injection site erythema, appetite lost and blotchy were not recovered/not resolved. It was unknown if the reporter considered the headache, joint pain, injection site pain, malaise, injection site swelling, injection site erythema, appetite lost and blotchy to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received SHINGRIX on the left arm. The patient said she had an area of skin around the injection site that was red, swollen and blotchy. The area was very painful and the patient had been taking medication to help with the pain. The patient was taking the doses of the medication every six hours. The patient stated that she did not feel like eating since the injection.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise, Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received SHINGRIX for prophylaxis. On 21st July 2018 02:45, the patient received the 1st dose of SHINGRIX. On 21st July 2018, less than a day after receiving SHINGRIX, the patient experienced headache, joint pain, injection site pain, malaise, injection site swelling, injection site erythema, appetite lost and blotchy. The patient was treated with analgesic, nos. On an unknown date, the outcome of the headache, joint pain, injection site pain, malaise, injection site swelling, injection site erythema, appetite lost and blotchy were not recovered/not resolved. It was unknown if the reporter considered the headache, joint pain, injection site pain, malaise, injection site swelling, injection site erythema, appetite lost and blotchy to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received SHINGRIX on the left arm. The patient said she had an area of skin around the injection site that was red, swollen and blotchy. The area was very painful and the patient had been taking medication to help with the pain. The patient was taking the doses of the medication every six hours. The patient stated that she did not feel like eating since the injection.
Sex: U
Vaccine: VARZOS
Symptoms: Loss of consciousness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of passed out in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was recovered/resolved. It was unknown if the reporter considered the passed out to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter was a friend of the patient. The reporter reported that the patient passed out after receiving a dose of SHINGRIX vaccine, which was a 2 part series. The patient would not receive the 2nd dose of SHINGRIX vaccine. The reporter provided limited information. The reporter disconnected call before further questions could be addressed regarding the adverse events of the patient. This case was linked with case US2018GSK136348, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had possible outbreak of shingles after 2nd inoculation and needed guidance if this could occurred and asked about treatment. The call was foldered by the fulfillment specialist for a call back to HCP, was not able to reach HCP till the time of reporting. Sender forwarded/send the details to the patient safety with the questions that was posed to MI for assistance. This case was considered as the suspected vaccination failure since the exact time to onset for the event was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of welts in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced welts. On an unknown date, the outcome of the welts was unknown. It was unknown if the reporter considered the welts to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The patient had welts following vaccination only over the entire arm that was injected. The patient's initials, gender and date of birth were unknown. The reporter did not agree to be contacted for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that SHINGRIX may have been administered to a patient subcutaneously, which led to inappropriate route of vaccination. The patient and product details were unavailable.
Sex: U
Vaccine: VARZOS
Symptoms: Loss of consciousness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of passed out in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was recovered/resolved. It was unknown if the reporter considered the passed out to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter was a friend of the patient. The reporter reported that the patient passed out after receiving a dose of SHINGRIX vaccine, which was a 2 part series. The patient would not receive the 2nd dose of SHINGRIX vaccine. The reporter provided limited information. The reporter disconnected call before further questions could be addressed regarding the adverse events of the patient. This case was linked with case US2018132473, reported by the same reporter.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Swelling face
Clinical narrative: This is a spontaneous report from a non-contactable nurse via Pfizer sales representative. A 17-year-old female patient received the first dose of TRUMENBA (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at 0.5 ml, single for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced facial redness and swelling 2 days after receiving the first dose of meningococcal group b rlp2086. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: M
Vaccine: MENB
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Gastroenteritis viral, Injection site pain
Clinical narrative: This is a spontaneous report from a non-contactable nurse via a Pfizer sales representative. A 19-year-old male patient received TRUMENBA (lot number and expiration date not reported), via an unspecified route of administration on 25Jul2018 03:00 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On 26Jul2018 at 07:00, the patient experienced stomach pain which increased every-time he bent over, accompanied by diarrhea, nausea, and severe chills. It was reported that the house was not air-conditioned except for one room, patient laid on floor covered with 3 blankets from chills but temperature showed no fever. Also on the same day, 26Jul2018, the patient had pain at the injection site and stomach bug. Nurse believed that the patient had stomach bug and it's just coincidental he received meningococcal group b rlp2086 dose day before. The patient has shown improvement since the morning and was feeling better. Outcome of all the events was recovering. No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Nausea
Clinical narrative: This is a spontaneous report from a non-contactable nurse via a Pfizer sales representative. A 19-year-old male patient received TRUMENBA (lot number and expiration date not reported), via an unspecified route of administration on 25Jul2018 03:00 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On 26Jul2018 at 07:00, the patient experienced stomach pain which increased every-time he bent over, accompanied by diarrhea, nausea, and severe chills. It was reported that the house was not air-conditioned except for one room, patient laid on floor covered with 3 blankets from chills but temperature showed no fever. Also on the same day, 26Jul2018, the patient had pain at the injection site and stomach bug. Nurse believed that the patient had stomach bug and it's just coincidental he received meningococcal group b rlp2086 dose day before. The patient has shown improvement since the morning and was feeling better. Outcome of all the events was recovering. No follow up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Dose given 8 days early. No patient problems.
Age: 71.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Ear pain, Injection site pain, Swelling face
Clinical narrative: Patient's son reported starting 7/29/2018 client developed swelling on face towards mouth and jaw and up towards right ear, some pain at right ear and pain at injection site. Denied rash or any respiratory symptoms. Patient was referred to be evaluated with a PCP or urgent care for symptoms and emergency room precautions were given if symptoms change or worsen. Spoke to client's son 7/31/2018, was seen at Hospital and given MEDROL dose pack and symptoms are improving.
Age: 79.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site pruritus, Injection site scab
Clinical narrative: Developed itching, scabbing, and darkened area at site of injection immediately post-administration. Reaction still present post-2 weeks from administration; symptoms improved but still present. Recommended to not receive any more tetanus shots.
Age: 1.0
Sex: F
Vaccine: MMRV, PNC13
Symptoms: Rash maculo-papular
Clinical narrative: Child developed maculopapular rash after MMR/Varicella.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a 26 year old female patient. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 30-JUL-2018, the patient was vaccinated with a second dose of GARDASIL 9 lot # N028092 with expiration date on 28-MAY-2020 for prophylaxis (dose and route were not reported), an unspecified number of months from November 2017.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. On 27-JUL-2018, the patient was vaccinated with improperly stored VARIVAX, by subcutaneous route, lot # N031002 with expiration date on 03-NOV-2019, or lot # N031004 with expiration date on 13-NOV-2019, for prophylaxis (dose and anatomical location were not reported). The reporter specified that, the sterile diluent (DILUENT MRK) used for reconstitution of VARIVAX, was properly stored. The dose VARIVAX was exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14 °F (5.5 °F) during a time frame of 24 minutes, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Initial information received on 25-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case is linked to case 2018SA206110. This case involves a 17 years old female patient who was exposed to vaccine MENACTRA while pregnant, patient was seven weeks pregnant. The date of last menstrual period was reported as 26-May-2018. The estimated due date is 02-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines given. On 18-Jul-2018, the patient received a 0.5 ml third dose of suspect MENACTRA (lot U5948AB, frequency once, expiry date 03 July 2019) in the left deltoid, Patient had previously received MENACTRA in May 2012 and then again in Dec 2017 but it was found that Dec 2017 dose invalid due to excursion affecting vaccine. It was an actual medication error due to vaccine exposure during pregnancy, Extra dose administered and Incorrect product storage. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
Age: 27.0
Sex: U
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Initial information received on 24-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA205710, 2018SA207528 and 2018SA207544, related case from same reporter with same vaccine. This case involves a 27 years old patient who was administered expired 0.5 ml dose of TENIVAC lot U5280AA, expiry date 16 Mar 2018 via intramuscular route in the left deltoid on 02-Jun-2018. The patients past medical history and family history were not provided. No other vaccines were administered concomitantly. It was reported that patient was vaccinated with TENIVAC on 02 Jun 2018, which expired on 16 Mar 2018. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. List of documents held by sender- none.
Age: 42.0
Sex: U
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Initial information received on 24-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA205710, 2018SA207505 and 2018SA207528. This case involves a 41 years old patient who experienced expired  TENIVACthat was administered, while he/she received vaccine TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-May-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U5280AA, expiry date-16-Mar-2018 via intramuscular route in the right deltoid. It was a case of actual medication error due to expired vaccine used. 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: 30.0
Sex: U
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Initial unsolicited report received from a nurse on 24-Jul-2018. This case involves an adult patient (age and gender not reported) who was vaccinated with an expired dose of 0.5 ml TENIVAC batch number: U5280AA, expiry date: 16-Mar-2018 via intramuscular route in the right deltoid on 30-Mar-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. It was unknown whether the patient had any harm or not. 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. List of documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Red rash on neck and chest.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Immediate post-injection reaction, Pallor, Vomiting
Clinical narrative: Patient received HPV vaccination and immediately felt faint, lost all color in his face, was clammy and began vomiting. This episode lasted nearly 25 minutes before he felt ok to leave the clinic. Patient was given apple juice.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Confusional state, Disorganised speech, Disorientation, Gait inability, Hyperhidrosis
Clinical narrative: Immediately after vaccines were administered patient passed out for a short duration of time (under 1 minute), then became diaphoretic with nausea and attempts at vomiting. Blood pressure was approximately 80/50, with episodes of intermittent confusion with garbled speech. Unable to walk with assistance, or sit upright in a chair. Cold pack applied to nape of neck, along with O2 as a comfort measure. Refused juice drink due to complaints of nausea. EMS called to transport patient to ER for evaluation and treatment. Patient not sure where he was, or what city he lived in.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Immediate post-injection reaction, Loss of consciousness, Nausea, Posture abnormal, Retching
Clinical narrative: Immediately after vaccines were administered patient passed out for a short duration of time (under 1 minute), then became diaphoretic with nausea and attempts at vomiting. Blood pressure was approximately 80/50, with episodes of intermittent confusion with garbled speech. Unable to walk with assistance, or sit upright in a chair. Cold pack applied to nape of neck, along with O2 as a comfort measure. Refused juice drink due to complaints of nausea. EMS called to transport patient to ER for evaluation and treatment. Patient not sure where he was, or what city he lived in.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fall
Clinical narrative: Patient got her 2nd SHINGRIX vaccine---she did not want to wait after the vaccine--she said she felt fine and did not have a problem with the first. She left but upon walking home, felt dizzy and fell.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dizziness, Dyspnoea, Eyelid oedema, Joint stiffness
Clinical narrative: Dizzy, shortness of breath, muscle ache, stiff joints, puffy eyes, coughing, fever. Started 15 min after vaccine, used inhaler, ZYRTEC, BENADRYL, Ibuprofen, nose spray. Ongoing at this time.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Dizzy, shortness of breath, muscle ache, stiff joints, puffy eyes, coughing, fever. Started 15 min after vaccine, used inhaler, ZYRTEC, BENADRYL, Ibuprofen, nose spray. Ongoing at this time.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Burning sensation, Dyspnoea, Hypoaesthesia, Pain in extremity, Vomiting
Clinical narrative: SHE HAD PAIN, BURNING, AND NUMBNESS IN RIGHT ARM, VOMITED THREE TIMES, AND HAD DIFFICULTY BREATHING.
Age: 1.58
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema multiforme, Rash generalised, Urticaria
Clinical narrative: Erythema multiforme minor. Started with what thought to be hives on 7/28 seen in urgent care and told to start Benadryl. Continued with full body EM rash with target lesions. Placed on steroids and Benadryl.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Father states child's tight became red and welted, almost the size of patient's fist.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Circumstance or information capable of leading to medication error, Crying, Heart rate decreased, Pallor, Skin warm
Clinical narrative: Pt. was in clinic to receive her 4 y/o vaccines, she was not very happy about it and resisted quite a bit so mother had to hold down her top half and I secured her legs and gave the vaccines, the patient cried during but was quick to get up and let me give her a lollipop and some stickers which ended the tears. Patient was talking and cutting up with her sister who was also present while mother was getting all of her copies together and then they left to go and complete pts school registration process. A few minutes later the school nurse who was participating in the school registration event came and asked me to come check on the patient because she felt her color was "not right" and her lips were very pale. Pt. was sitting up at a table with her head down on her arms when I arrived, she talked to me but her skin color was very pale and her lips in fact had no color either. Mother carried patient to the nurses office where we laid her down and I elevated her feet and put cool wet towels on her forehead, because she felt very warm. After approx. 2 minutes the patients lip color started to return and shortly after that he color was just about back to normal. Pt. denied any pain or difficulty breathing, and her pulse ox was 99%, the school nurse took her other vitals (which I didn't get before we left) and stated other than her pulse being a little low they were normal. Pt never lost consciousness and was able to talk to me throughout the whole process, and her pulse rate also increased after a few minutes. Pt sucked on her lollipop and finished it as we sat together and also started playing with her sister again before they were discharged.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: PATIENT FAINTED FOLLOWING TDAP INJECTION. APPROXIMATELY 5-10 MINUTES AFTER VACCINE ADMINISTERED, PATIENT TOLD HIS MOTHER HE WAS FEELING "LIGHTHEADED".  CHILD BECAME UNRESPONSIVE WHICH LASTED MOMENTARILY. NURSE ASSISTED CHILD TO LAYING POSITION. PULSE AND RESPIRATIONS CONTINUED. CHILD OPENED HIS EYES AND WAS ABLE TO SPEAK. BLOOD PRESSURE 102/64  WHILE LYING DOWN. PATIENT STATED HE WAS ABLE TO SIT UP AND THAT HE FELT BETTER. GAVE THE CHILD SOME WATER AND ALLOWED HIM TO SIT IN CLINIC ROOM. BLOOD PRESSURE WAS RE-CHECKED PRIOR TO THE CHILD GOING TO THE LOBBY WAS 110/68. DENIED ANY LIGHTHEADEDNESS OR NAUSEA. CHILD ABLE TO WALK TO LOBBY. INSTRUCTED MOTHER TO REMAIN IN LOBBY WITH CHILD 20 MINUTES.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Started off as a localized reaction where the injection was given then the redness and pain started radiating towards the elbow.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Coma scale abnormal, Posturing, Unresponsive to stimuli
Clinical narrative: VACCINE GIVEN AT 12:00 WITH IN 5 MINS PATIENT BECAME UNRESPONSIVE WITH GCS OF 3 AND POSTURING. EMS WAS CALLED AND PT AIRLIFTED TO ER. THE VACCINE WAS GIVEN TO 2 OTHER SIBLINGS AND ALL 3 SIBLINGS HAD AN ADVERSE  REACTION.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Muscle twitching, Pallor
Clinical narrative: VACCINE GIVEN AT 12:00 WITH IN 5 MINS PATIENT BECAME UNRESPONSIVE WITH GCS OF 3 AND POSTURING. EMS WAS CALLED AND PT AIRLIFTED TO ER. THE VACCINE WAS GIVEN TO 2 OTHER SIBLINGS AND ALL 3 SIBLINGS HAD AN ADVERSE  REACTION.