chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MENB
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site swelling and pain in arm. On an unknown date, the outcome of the injection site swelling and pain in arm were recovered/resolved. It was unknown if the reporter considered the injection site swelling and pain in arm to be related to BEXSERO. Additional information was received as follows: The age at vaccination was not applicable for this report. The demographic details of the patients was not reported. The physician stated that generally she had several patients who had experienced a sore arm / pain and swelling at the injection site for several days. She also said that in her experience the incidence appeared to be greater than other adolescent vaccines (i.e., HPV, MCV4).
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site pain, pain in arm, erythema of extremities, extremities hot feeling of and swelling arm. On an unknown date, the outcome of the injection site pain, pain in arm, erythema of extremities, extremities hot feeling of and swelling arm were recovered/resolved. It was unknown if the reporter considered the injection site pain, pain in arm, erythema of extremities, extremities hot feeling of and swelling arm to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported, but could be 86 or 87 years old. The patient developed pain at the injection site on the first day. The next morning (1 day after vaccination), the patient's arm was painful, red, swollen and hot. The events slowly resolved over the next several days. The reporter agreed to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Feeling cold, Feeling hot
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of erythema of extremities in a female patient who received SHINGRIX for prophylaxis. On 5th August 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 5th August 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On 6th August 2018, the patient experienced feeling cold, shivering, fever and tiredness. In August 2018, the patient experienced erythema of extremities, extremities hot feeling of and swelling arm. On an unknown date, the outcome of the erythema of extremities, extremities hot feeling of and swelling arm were recovering/resolving and the outcome of the feeling cold, shivering, fever and intramuscular formulation administered by other route were unknown and the outcome of the tiredness was not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, extremities hot feeling of, swelling arm, feeling cold, shivering, fever and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On Sunday the SHINGRIX vaccine was administered subcutaneously instead of intramuscularly, which led to inappropriate route of vaccine administration. Twenty four hours after getting the SHINGRIX shot, the patient was freezing shivering in bed then she had a fever of 101.6 and the patient was so tired that she remained in bed for 48 hours. This was her third day and she was tired on the reporting date. In Aug 2018, less than a week after receiving SHINGRIX, the patient's entire upper arm was red hot and swollen and it was just starting to resolve after three days. The patient did call the pharmacist who administered the shot so that she would not continue to administer it incorrectly. The nurse read the pamphlet and apologized and said she would administer it intramuscularly from now on. The patient did not imagine this was just an isolated event since the original shingles shot was given subcutaneously. That route was what medical personnel were used to. The patient thought that, there should be more education or something on the box written over to alert personnel while giving the SHINGRIX injection intramuscularly. The patient was asked if she would have adequate protection with the SHINGRIX booster that was given subcutaneously.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of erythema of extremities in a female patient who received SHINGRIX for prophylaxis. On 5th August 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 5th August 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On 6th August 2018, the patient experienced feeling cold, shivering, fever and tiredness. In August 2018, the patient experienced erythema of extremities, extremities hot feeling of and swelling arm. On an unknown date, the outcome of the erythema of extremities, extremities hot feeling of and swelling arm were recovering/resolving and the outcome of the feeling cold, shivering, fever and intramuscular formulation administered by other route were unknown and the outcome of the tiredness was not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, extremities hot feeling of, swelling arm, feeling cold, shivering, fever and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On Sunday the SHINGRIX vaccine was administered subcutaneously instead of intramuscularly, which led to inappropriate route of vaccine administration. Twenty four hours after getting the SHINGRIX shot, the patient was freezing shivering in bed then she had a fever of 101.6 and the patient was so tired that she remained in bed for 48 hours. This was her third day and she was tired on the reporting date. In Aug 2018, less than a week after receiving SHINGRIX, the patient's entire upper arm was red hot and swollen and it was just starting to resolve after three days. The patient did call the pharmacist who administered the shot so that she would not continue to administer it incorrectly. The nurse read the pamphlet and apologized and said she would administer it intramuscularly from now on. The patient did not imagine this was just an isolated event since the original shingles shot was given subcutaneously. That route was what medical personnel were used to. The patient thought that, there should be more education or something on the box written over to alert personnel while giving the SHINGRIX injection intramuscularly. The patient was asked if she would have adequate protection with the SHINGRIX booster that was given subcutaneously.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of influenza like illness in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza like illness and activities of daily living impaired. On an unknown date, the outcome of the influenza like illness and activities of daily living impaired were unknown. It was unknown if the reporter considered the influenza like illness and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced grade 3 flu like symptoms which limited her activities of daily living for 4 to 5 days.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a 53-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 91 days after receiving 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. Additional details were as follows: The patient's initials and gender were unknown. The age at vaccination was not reported but the patient could be 52 or 53 years old. The patient presented with mild case of shingles 3 to 4 months after 2nd dose of SHINGRIX. The case was not confirmed by Polymerase chain reaction (PCR). This case was considered as a suspected vaccination failure case as the laboratory results were unknown at the time of reporting. The reporter agreed to be followed up.
Sex: U
Vaccine: HEPA
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site burning in an unspecified number of patients who received HAVRIX for prophylaxis. On an unknown date, the patient received HAVRIX at an unknown dose. On an unknown date, unknown after receiving HAVRIX, the patient experienced injection site burning. On an unknown date, the outcome of the injection site burning was unknown. It was unknown if the reporter considered the injection site burning to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist noted that he had seen some burning at the injection site for HAVRIX in a few patients. The practice area for the pharmacy was in a high Hepatitis A outbreak area, and the pharmacy was giving out more injections of HAVRIX that before. The reporter was from the GlaxoSmithKline outbound vaccines service center. He was notified last night during an outbound sales call to the pharmacist. There was no QA to report. This case has been linked with case US2018143555, reported by same reporter.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received SHINGRIX (batch number ZY3X4, expiry date unknown) for prophylaxis. On 23rd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The pharmacist stated that the patient experienced sore arm with first dose of the SHINGRIX. No further details were provided. This case was linked with US2018144799, reported for same patient.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Grip strength decreased, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 80-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018, 6 hrs after receiving SHINGRIX, the patient experienced feeling cold, shivering, tingling of extremity and grip strength decreased. On an unknown date, the outcome of the feeling cold, shivering, tingling of extremity and grip strength decreased were recovered/resolved. It was unknown if the reporter considered the feeling cold, shivering, tingling of extremity and grip strength decreased to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she received dose of SHINGRIX on left arm around 10:00 AM and around 4:00 PM, she started to experience shivering, tingling of feet and hands and she could not hold anything so she used an electric blanket to stay warm. The patient provided contact details of the physician. This case was linked with US2018144788, reported by the same reporter.
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 an unspecified number of adult patients 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 applicable for this report. The reporter believed that other patient's had received SHINGRIX subcutaneously Instead of intramuscularly, which led to inappropriate route of vaccine administration. This case has been linked with US2018144849 (reported by same reporter for herself).
Sex: U
Vaccine: HEP, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 09-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves Infant patient who received a dose of ADACEL lot C55418AA via intramuscular route in unknown administration site of HEPATITIS B VACCINE not produced by Sanofi Pasteur lot number not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant therapies were not reported. This was the case of medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was reported that Infant received ADACEL. Order was written to give hep B but ADACEL was administered. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was not reported if the patient experienced any adverse event. 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. Documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Hypoaesthesia, Injection site erythema, Injection site hypoaesthesia, Injection site pain
Clinical narrative: PATIENT WAS GIVEN 3RD MENINGITIS B SHOT ON 08/14/2018 AS ORDERED BY PHYSICIAN DUE TO NEEDING SURGERY. CLIENT CASE TO PUBLIC HEALTH OFFICE ON 08/16/2018 AND HER LEFT UPPER ARM DOWN TO HER WRIST WAS SWOLLEN, RED, HOT AND SHE STATED IT HURT AND SHE HAD NUMBNESS AND TINGLING THROUGHOUT ENTIRE ARM ONE DAY AFTER VACCINATION.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site paraesthesia, Injection site swelling, Injection site warmth, Pain in extremity, Paraesthesia
Clinical narrative: PATIENT WAS GIVEN 3RD MENINGITIS B SHOT ON 08/14/2018 AS ORDERED BY PHYSICIAN DUE TO NEEDING SURGERY. CLIENT CASE TO PUBLIC HEALTH OFFICE ON 08/16/2018 AND HER LEFT UPPER ARM DOWN TO HER WRIST WAS SWOLLEN, RED, HOT AND SHE STATED IT HURT AND SHE HAD NUMBNESS AND TINGLING THROUGHOUT ENTIRE ARM ONE DAY AFTER VACCINATION.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: PATIENT WAS GIVEN 3RD MENINGITIS B SHOT ON 08/14/2018 AS ORDERED BY PHYSICIAN DUE TO NEEDING SURGERY. CLIENT CASE TO PUBLIC HEALTH OFFICE ON 08/16/2018 AND HER LEFT UPPER ARM DOWN TO HER WRIST WAS SWOLLEN, RED, HOT AND SHE STATED IT HURT AND SHE HAD NUMBNESS AND TINGLING THROUGHOUT ENTIRE ARM ONE DAY AFTER VACCINATION.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise, Nausea, Pyrexia, Tremor
Clinical narrative: 6 hours post injection increasingly severe fever, shaking chills, nausea, malaise lasting about 6 hours. 4 days later another episode of shaking chills lasting 2 hours.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hypoaesthesia, Limb mass, Nodule, Pain, Pain in extremity
Clinical narrative: Patients father, called today 08/20/18 and stated the child had a half dollar sized knot on right arm. Father stated the child complained of numbness in right arm the night of the injection. The father called the child's primary care provider and was told to call the place of administration. The father denies redness or heat at the site. The father states the area is tender to the touch and child still complains of pain when lifting arm
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Tenderness
Clinical narrative: Patients father, called today 08/20/18 and stated the child had a half dollar sized knot on right arm. Father stated the child complained of numbness in right arm the night of the injection. The father called the child's primary care provider and was told to call the place of administration. The father denies redness or heat at the site. The father states the area is tender to the touch and child still complains of pain when lifting arm
Age: 67.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Asthenia, Chills, Pruritus, Skin warm
Clinical narrative: Extremely hot face and ears; Weakness; Short time chills; Itching left neck and shoulder; 8-12 hours.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Vaccine MENACTRA adm. 8/14/2018, (L) deltoid region became red/pink warm. Size 10cm W x 10.5cm long - using ice and ibuprofen, seen in office 8/17/18.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red warm area (R) upper arm approx 4 cm circular. Observed at O.V 8/13/18 for an illness.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Urticaria
Clinical narrative: Two days after administration of 2nd dose of SHINGRIX. Patient experienced hives and swelling. Tx: ranitidine 300 mg twice a day for 10 days; prednisone 10 mg, 20 day course starting 4 tablets and decreasing, triamcinolone cream 0.1%.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Pain, edema and erythema at injection site. Later low-grade fever, myalgia, arthralgia and fatigue for about a week.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Pain, edema and erythema at injection site. Later low-grade fever, myalgia, arthralgia and fatigue for about a week.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Paraesthesia, Pyrexia
Clinical narrative: Pain at injection site, swelling, parasthesia, fever/chills, fatigue - all lasting for 5-7 days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Pain at injection site, swelling, parasthesia, fever/chills, fatigue - all lasting for 5-7 days.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Skin lesion
Clinical narrative: Patient developed redness and swelling at the injection site with other lesions also developing. Patient was prescribed Loratadine and TAGAMET.
Age: 1.75
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Morning of 08/17 patient presented with right anterior thigh with erythema, warm to touch and slightly indurated area measuring approx. 8cm x 4cm. No discharge from area, patient able to ambulate. Prescribed Keflex.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Hypotension, Nausea, Vomiting
Clinical narrative: Pt became lightheaded, nausea, began vomiting within 6 minutes of receiving vaccine, blood pressure was low. Pt was given water and monitored for 15 minutes after. Pt stated that he felt better.
Age: 29.0
Sex: F
Vaccine: HEPAB
Symptoms: Limb discomfort, Malaise, Migraine, Nausea, Skin tightness
Clinical narrative: Throughout me feeling sick, the migraine and nausea kept more occupied so not sure how often the tight feeling in the upper left area and the heavy left arm was going on. On 8/16/18, I woke up feeling normal and have had no problems so far.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Body aches, tiredness, chills, fever.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Cough, Pyrexia
Clinical narrative: Several blisters on baby's left foot on 8/14, fever and cough developed 8/19.
Age: 1.17
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Otitis media acute, Rash morbilliform, Viral upper respiratory tract infection
Clinical narrative: Morbilliform rash developed after 10 days. Also diagnosed with viral URI and acute right OM.
Age: 56.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Chest X-ray, Electrocardiogram, Laboratory test normal, Pain in extremity, X-ray limb
Clinical narrative: Pt presented to ER with severe (10/10) R arm pain in afternoon. Received SHINGRIX at approx 1200. Within 30 minutes reports ahing in R arm. After 1 hour, reports severe pain. Pt treated with several meds before pain was relieved.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Moderate pain and swelling injection site. Headache. General Malaise.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Feeling cold, Headache
Clinical narrative: Joint aches, chills, headache, received shot 8-9-18 at 4:04 pm and symptoms started at 10:00 pm on same day. Treated with Ibuprofen.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Chills, Discomfort, Drug ineffective
Clinical narrative: Joint aches, chills, headache, received shot 8-9-18 at 4:04 pm and symptoms started at 10:00 pm on same day. Treated with Ibuprofen.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Headache, Insomnia, Mobility decreased, Pain
Clinical narrative: Joint aches, chills, headache, received shot 8-9-18 at 4:04 pm and symptoms started at 10:00 pm on same day. Treated with Ibuprofen.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Joint aches, chills, headache, received shot 8-9-18 at 4:04 pm and symptoms started at 10:00 pm on same day. Treated with Ibuprofen.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Discomfort, Fatigue, Insomnia
Clinical narrative: Joint aches, chills, headache, received shot 8-9-18 at 4:04 pm and symptoms started at 10:00 pm on same day. Treated with Ibuprofen.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Joint aches, chills, headache, received shot 8-9-18 at 4:04 pm and symptoms started at 10:00 pm on same day. Treated with Ibuprofen.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Feeling cold, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized joint pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included ADVIL unknown for drug use for unknown indication. On 9th August 2018, the patient received the 1st dose of SHINGRIX and ADVIL 500 mg at an unknown frequency. In August 2018, less than a day after receiving SHINGRIX and not applicable after starting ADVIL, the patient experienced generalized joint pain, headache, tiredness, mobility decreased, pain in arm, general body pain, chills, sleeplessness, back pain, discomfort and lack of drug effect. The action taken with ADVIL was unknown (Dechallenge was unknown). Rechallenge with ADVIL was unknown. On an unknown date, the outcome of the generalized joint pain, headache, tiredness, mobility decreased, pain in arm, general body pain, chills, sleeplessness, back pain, discomfort and lack of drug effect were unknown. It was unknown if the reporter considered the generalized joint pain, headache, tiredness, mobility decreased, pain in arm, general body pain, chills, sleeplessness, back pain and discomfort to be related to SHINGRIX. It was unknown if the reporter considered the lack of drug effect to be related to ADVIL. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient reported that the night before reporting after getting the vaccine, she started having side effects from it. She experienced joint ache all over her body. She had a severe headache since last night. She had pain that radiated down her arm and down her back. She started taking ADVIL 500mg for the side effects, however she said it was not touching, helping with what she was experiencing. She said that she had taken eight ADVIL pills since the night before reporting. She was tired and was unable to sleep the night before reporting. She said she woke up about 5 times. She could not get comfortable to be able to sleep from the side effects. She had been trying to get some sleep on the day of reporting. The patient stated that she hurt all over and could not move her neck.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Chills, Discomfort, Drug ineffective
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized joint pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included ADVIL unknown for drug use for unknown indication. On 9th August 2018, the patient received the 1st dose of SHINGRIX and ADVIL 500 mg at an unknown frequency. In August 2018, less than a day after receiving SHINGRIX and not applicable after starting ADVIL, the patient experienced generalized joint pain, headache, tiredness, mobility decreased, pain in arm, general body pain, chills, sleeplessness, back pain, discomfort and lack of drug effect. The action taken with ADVIL was unknown (Dechallenge was unknown). Rechallenge with ADVIL was unknown. On an unknown date, the outcome of the generalized joint pain, headache, tiredness, mobility decreased, pain in arm, general body pain, chills, sleeplessness, back pain, discomfort and lack of drug effect were unknown. It was unknown if the reporter considered the generalized joint pain, headache, tiredness, mobility decreased, pain in arm, general body pain, chills, sleeplessness, back pain and discomfort to be related to SHINGRIX. It was unknown if the reporter considered the lack of drug effect to be related to ADVIL. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient reported that the night before reporting after getting the vaccine, she started having side effects from it. She experienced joint ache all over her body. She had a severe headache since last night. She had pain that radiated down her arm and down her back. She started taking ADVIL 500mg for the side effects, however she said it was not touching, helping with what she was experiencing. She said that she had taken eight ADVIL pills since the night before reporting. She was tired and was unable to sleep the night before reporting. She said she woke up about 5 times. She could not get comfortable to be able to sleep from the side effects. She had been trying to get some sleep on the day of reporting. The patient stated that she hurt all over and could not move her neck.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Headache, Insomnia, Mobility decreased, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized joint pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included ADVIL unknown for drug use for unknown indication. On 9th August 2018, the patient received the 1st dose of SHINGRIX and ADVIL 500 mg at an unknown frequency. In August 2018, less than a day after receiving SHINGRIX and not applicable after starting ADVIL, the patient experienced generalized joint pain, headache, tiredness, mobility decreased, pain in arm, general body pain, chills, sleeplessness, back pain, discomfort and lack of drug effect. The action taken with ADVIL was unknown (Dechallenge was unknown). Rechallenge with ADVIL was unknown. On an unknown date, the outcome of the generalized joint pain, headache, tiredness, mobility decreased, pain in arm, general body pain, chills, sleeplessness, back pain, discomfort and lack of drug effect were unknown. It was unknown if the reporter considered the generalized joint pain, headache, tiredness, mobility decreased, pain in arm, general body pain, chills, sleeplessness, back pain and discomfort to be related to SHINGRIX. It was unknown if the reporter considered the lack of drug effect to be related to ADVIL. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient reported that the night before reporting after getting the vaccine, she started having side effects from it. She experienced joint ache all over her body. She had a severe headache since last night. She had pain that radiated down her arm and down her back. She started taking ADVIL 500mg for the side effects, however she said it was not touching, helping with what she was experiencing. She said that she had taken eight ADVIL pills since the night before reporting. She was tired and was unable to sleep the night before reporting. She said she woke up about 5 times. She could not get comfortable to be able to sleep from the side effects. She had been trying to get some sleep on the day of reporting. The patient stated that she hurt all over and could not move her neck.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized joint pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included ADVIL unknown for drug use for unknown indication. On 9th August 2018, the patient received the 1st dose of SHINGRIX and ADVIL 500 mg at an unknown frequency. In August 2018, less than a day after receiving SHINGRIX and not applicable after starting ADVIL, the patient experienced generalized joint pain, headache, tiredness, mobility decreased, pain in arm, general body pain, chills, sleeplessness, back pain, discomfort and lack of drug effect. The action taken with ADVIL was unknown (Dechallenge was unknown). Rechallenge with ADVIL was unknown. On an unknown date, the outcome of the generalized joint pain, headache, tiredness, mobility decreased, pain in arm, general body pain, chills, sleeplessness, back pain, discomfort and lack of drug effect were unknown. It was unknown if the reporter considered the generalized joint pain, headache, tiredness, mobility decreased, pain in arm, general body pain, chills, sleeplessness, back pain and discomfort to be related to SHINGRIX. It was unknown if the reporter considered the lack of drug effect to be related to ADVIL. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient reported that the night before reporting after getting the vaccine, she started having side effects from it. She experienced joint ache all over her body. She had a severe headache since last night. She had pain that radiated down her arm and down her back. She started taking ADVIL 500mg for the side effects, however she said it was not touching, helping with what she was experiencing. She said that she had taken eight ADVIL pills since the night before reporting. She was tired and was unable to sleep the night before reporting. She said she woke up about 5 times. She could not get comfortable to be able to sleep from the side effects. She had been trying to get some sleep on the day of reporting. The patient stated that she hurt all over and could not move her neck.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Discomfort, Fatigue, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized joint pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included ADVIL unknown for drug use for unknown indication. On 9th August 2018, the patient received the 1st dose of SHINGRIX and ADVIL 500 mg at an unknown frequency. In August 2018, less than a day after receiving SHINGRIX and not applicable after starting ADVIL, the patient experienced generalized joint pain, headache, tiredness, mobility decreased, pain in arm, general body pain, chills, sleeplessness, back pain, discomfort and lack of drug effect. The action taken with ADVIL was unknown (Dechallenge was unknown). Rechallenge with ADVIL was unknown. On an unknown date, the outcome of the generalized joint pain, headache, tiredness, mobility decreased, pain in arm, general body pain, chills, sleeplessness, back pain, discomfort and lack of drug effect were unknown. It was unknown if the reporter considered the generalized joint pain, headache, tiredness, mobility decreased, pain in arm, general body pain, chills, sleeplessness, back pain and discomfort to be related to SHINGRIX. It was unknown if the reporter considered the lack of drug effect to be related to ADVIL. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient reported that the night before reporting after getting the vaccine, she started having side effects from it. She experienced joint ache all over her body. She had a severe headache since last night. She had pain that radiated down her arm and down her back. She started taking ADVIL 500mg for the side effects, however she said it was not touching, helping with what she was experiencing. She said that she had taken eight ADVIL pills since the night before reporting. She was tired and was unable to sleep the night before reporting. She said she woke up about 5 times. She could not get comfortable to be able to sleep from the side effects. She had been trying to get some sleep on the day of reporting. The patient stated that she hurt all over and could not move her neck.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized joint pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included ADVIL unknown for drug use for unknown indication. On 9th August 2018, the patient received the 1st dose of SHINGRIX and ADVIL 500 mg at an unknown frequency. In August 2018, less than a day after receiving SHINGRIX and not applicable after starting ADVIL, the patient experienced generalized joint pain, headache, tiredness, mobility decreased, pain in arm, general body pain, chills, sleeplessness, back pain, discomfort and lack of drug effect. The action taken with ADVIL was unknown (Dechallenge was unknown). Rechallenge with ADVIL was unknown. On an unknown date, the outcome of the generalized joint pain, headache, tiredness, mobility decreased, pain in arm, general body pain, chills, sleeplessness, back pain, discomfort and lack of drug effect were unknown. It was unknown if the reporter considered the generalized joint pain, headache, tiredness, mobility decreased, pain in arm, general body pain, chills, sleeplessness, back pain and discomfort to be related to SHINGRIX. It was unknown if the reporter considered the lack of drug effect to be related to ADVIL. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient reported that the night before reporting after getting the vaccine, she started having side effects from it. She experienced joint ache all over her body. She had a severe headache since last night. She had pain that radiated down her arm and down her back. She started taking ADVIL 500mg for the side effects, however she said it was not touching, helping with what she was experiencing. She said that she had taken eight ADVIL pills since the night before reporting. She was tired and was unable to sleep the night before reporting. She said she woke up about 5 times. She could not get comfortable to be able to sleep from the side effects. She had been trying to get some sleep on the day of reporting. The patient stated that she hurt all over and could not move her neck.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Diffuse pink macular papular rash 4 days after MMR/V given. Afebrile. Observation done. Self resolved after 5 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and licensed practical nurse referring to a 4-year old male patient. The patient has 2 brothers and a sister. The patient's medical history and concurrent conditions were not reported. Concomitant medication included a sterile diluent (manufacturer unknown) which was properly stored. Historical drugs included measles virus vaccine live (Enders-Edmonston), mumps virus vaccine live (Jeryl Lynn), rubella virus vaccine live (HPV-77) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid. On 01-AUG-2018, the patient was vaccinated with improperly stored PROQUAD (lot: R002935; expiry date: 29-JUL-2019) subcutaneously in right thigh and KINRIX (lot: 95FR9) in his left thigh intramuscularly (incorrect product storage). The temperature excursion occurred as a result of digital data logger. The vaccines were exposed to -14°C to -10°C for 5 hours. No adverse events reported. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA007589:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Ear pain, Headache, Herpes zoster, Influenza like illness
Clinical narrative: Next day patient experienced headache, flu-like symptoms, pain and hot red rash on arm where injection received. Two weeks later she broke out in a "shingles" like rash with burning on her arms and neck. She had ear pain which she was examined for and told it was a nerve pain.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Neuralgia
Clinical narrative: Next day patient experienced headache, flu-like symptoms, pain and hot red rash on arm where injection received. Two weeks later she broke out in a "shingles" like rash with burning on her arms and neck. She had ear pain which she was examined for and told it was a nerve pain.
Age: 18.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Order was given by FNP-BC I gave the immunization per protocol. It was double checked by RN.I and FNP-BC were unaware that this vaccine was not to be given over the age of 13 years or older. This was reported to the Dept of health, CDC guidelines states it was given off label and her immunization does count. No Need to re vaccinate.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea, Erythema, Rash
Clinical narrative: Call from parent; reported mild diarrhea and facial redness/rash on face(cheeks) which started 8/17/2018. Temp 98.6; No recent history of illness or fever; No localized reaction at injection sites.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Hot flush, Hyperhidrosis, Muscle spasms
Clinical narrative: Patient complained of a hot flash type feeling, sweating, back pain, and back muscle spasms.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Acne, Injection site scab, Skin lesion
Clinical narrative: 6 days after vaccination, patient noted widespread pimples on chest and upper back. No itching or pain. No lesions elsewhere. No fever, resp, cardiac, or systemic symptoms. He has a hx of acne and tried acne face wash on back and chest, with no real change in "pimples". [PHOTOS available] Contacted on 20 Aug 2018 and most lesions resolved, but a few remaining on his left shoulder. Smallpox vaccination site now forming a scab.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Swelling
Clinical narrative: Redness, swelling, inflammation.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Limb discomfort, Musculoskeletal stiffness, Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: PT is complaining of severe arm soreness however after seeing MD was moved to therapy for severe arm stiffness where a diagnosis of possible nerve damage was identified.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Pallor, Syncope
Clinical narrative: Information has been received from a nurse via a company representative referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date in 2017, the patient was vaccinated with a dose of GARDASIL 9 (dose, route, lot# and expiration date were not reported) for prophylaxis. After that the patient fainted 15 minutes. The outcome of the event was recovered. The causality was not provided. Upon receipt of follow-up information it was determined that this case is now valid because patient identifiers were received. Follow up information was received on 09-AUG-2018. This spontaneous report concerns a 17 year old male patient. It was reported that the patient did not have any pre-existing physician diagnosed allergies, birth defects and medical conditions. It was also reported that the patient did not have any illness at the time of vaccination. On 08-AUG-2017, the patient was vaccinated with first dose of GARDASIL 9 (lot# N009173 and expiry date 20-NOV-2019) intramuscularly in the right arm and second dose of MENACTRA (lot# U5823AB and expiry date unknown) intramuscularly in the left arm for prophylaxis. It was reported that the patient was vaccinated at a private doctor's office/hospital and the vaccine was purchased with private funds. On approximately 08-AUG-2017 after the vaccines were given the patient was requested to sit in the waiting room for 15 minutes and the patient became pale and fainted while sitting. It was reported that the patient was helped to the exam room and reclined with feet elevated but the patient continued to feel weak and was not well for a period of time. It was reported that prescription drug treatment was not required for the events. It was reported that the patient was discharged without further incident approximately 30 minutes later. It was reported that a temperature excursion did not occur as a result of a reading from a digital data logger. The outcome of the events was reported as recovered. The causality was not provided.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects were reported; received doses of VARIVAX and MMR II following a temperature excursion; This spontaneous report was received from a medical assistant and refers to a currently 4-year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously, lot # N026073 with expiration date on 20-SEP-2019 (dose and site of administration were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ( recombinant Human albumin) (M-M-R II) subcutaneously, lot # N023150 with expiration date on 24-AUG-2019, and lot # N011005 with expiration date on 05-APR-2019 (dose and site of administration were not reported) for prophylaxis. Administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion of 8.3 degrees Celsius for 1 hour 23 minutes. Administered doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) experienced the temperature excursion of 9.5 degrees Celsius for 1 hour 36 minutes. Data logger was involved. There were no previous excursions reported. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA004564: US-009507513-1808USA004565: US-009507513-1808USA004566:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2018, reported as on an unspecified date since 09-JUL-2018, the patient was vaccinated with improperly stored dose of PEDVAXHIB (lot # N024570 with expiration date: 01-MAY-2020) or (lot# N024571 with expiration date: 01-MAY-2020) intramuscularly (dose and frequency were not reported) for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature excursion of 47 to 77 degrees Fahrenheit (F) (57 degrees Fahrenheit (F)) for 14 hours. There was no previous temperature excursion. A digital data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1808USA007409: US-009507513-1808USA007410: US-009507513-1808USA007412: US-009507513-1808USA007413: US-009507513-1808USA007414: US-009507513-1808USA007408: US-009507513-1808USA007407: US-009507513-1808USA007406: US-009507513-1808USA007411.
Sex: F
Vaccine: HPV9
Symptoms: Agglutination test, Blood pressure fluctuation, Blood test, Electroencephalogram, Epilepsy
Clinical narrative: This spontaneous report was received from a consumer and refers to a 11-year-old female patient. The patient's concurrent conditions included attention deficit/hyperactivity disorder (ADHD). The patient did not have any drug reactions or allergies. On 12-AUG-2016, the patient was vaccinated with GARDASIL 9 injection dose 1 (dosage, frequency, route of administration, lot validation and expiration date were not provided) for prophylaxis. Subsequently, she received the second dose of GARDASIL 9 on an unspecified date. Concomitant therapies included ADHD medicine (unspecified). The mother reported that at some point after receiving her first dose of GARDASIL 9, her daughter "started to experience issues of falling down (date and time not specified)". The mother reported that her daughter sought medical attention and was diagnosed with epilepsy on 18-SEP-2016. The mother also reported that her daughter was subsequently been put on 6 different unspecified epilepsy medications that have made the condition worse. The mother also reported that her daughter had also developed blood pressure issues as well as kidney issues. The patient received treatment for the events. On an unspecified date, electroencephalogram, magnetic resonance imaging, capillary agglutination test scan, 3 rounds of blood work were performed (results not provided). The outcome of epilepsy, renal disorder, blood pressure fluctuation and fall was reported as not resolved at the time of the report. The action taken was not applicable. The causality between the events and the suspect vaccine was not provided. Upon internal review, epilepsy and epilepsy aggravation were considered to be medically significant.