chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: I gave KINRIX vaccine instead of DTaP. No adverse side effects.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Malaise, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX. On 31st March 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st March 2018, less than a day after receiving SHINGRIX, the patient experienced fever, fatigue, malaise and chills. On 2nd April 2018, the outcome of the fever, fatigue, malaise and chills were recovered/resolved. It was unknown if the reporter considered the fever, fatigue, malaise and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine in right deltoid. The outcome of events was recovered and duration was 2 days. Only partial information was provided. The physician wanted to be transferred to MI.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Injection site pain, Injection site pruritus
Clinical narrative: Swelling pain and itching of the shot site, its Monday and its the same. Beginning the night of the shot, nausea, extreme chills, muscle aches all over, very tired and lethargic, diarehea still on Monday after.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lethargy, Myalgia, Nausea
Clinical narrative: Swelling pain and itching of the shot site, its Monday and its the same. Beginning the night of the shot, nausea, extreme chills, muscle aches all over, very tired and lethargic, diarehea still on Monday after.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary mass, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: PATIENT STATES WAS IN MVA ON 04/02/2018 AND SEEN AT ER DEPT AT LOCAL HOSPITAL. PATIENT STATED SHE RECEIVED A TDAP VACCINE TO RIGHT ARM AROUND 6:00 PM THAT DAY. THE NEXT MORNING (04/03/2018) UPON AWAKENING NOTICED BRIGHT REDNESS TO ARM, PAIN WHEN TOUCHING SITE AND WARM TO TOUCH. PATIENT STATES NOTICED "BALL" UNDER ARM IN ARMPIT AREA THAT DAY AS WELL. PATIENT STATED REDNESS AND PAIN HAVE IMPROVED SINCE THEN.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Bordetella test positive, Cough, Malaise, Pertussis
Clinical narrative: Mother of patient reported an adverse event. Mother reported when patient was 11 years old he received an affected vaccine, DTaP on September 2, 2016 and sometime in December of 2016 patient experienced symptoms of "coughing and coughing". He was sick for 2 to 3 weeks. The doctor was notified and in December of 2016 the patient was tested for Whooping cough and it was positive. No specific treatment was reported. Mother reported patient "did asthma treatments" as he has a history of asthma. Whooping cough resolved sometime in 2017 after "100 days". Mother reported she did not know if her son was currently experiencing any symptoms related to the AE.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a patient who received SHINGRIX. 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 symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. Adverse Event was collected from GlaxoSmithKline employee in Vaccine Inside Sales, call to the Regulatory Authority. The health care professional was not on the line. GlaxoSmithKline employee stated health care professional called and told her that a pharmacist was told by another pharmacist at work that people at church were discussing having flu-like symptoms following administration of SHINGRIX. No vaccine data, no patient data and no other information was available to Regulatory Authority at the reporting time.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Breast pain, Musculoskeletal pain, Pain in extremity, Thinking abnormal
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of back pain in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced back pain, scapula pain, breast pain and leg pain. On an unknown date, the outcome of the back pain, scapula pain, breast pain and leg pain were recovered/resolved. It was unknown if the reporter considered the back pain, scapula pain, breast pain and leg pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that after vaccination, the patient experienced pain in the back, scapula, breast area and the pain ran down her leg. The patient was foggy in thinking. The event lasted for 7 to 8 days. The health care professional called MI for advice on administering the 2nd dose. No additional information was provided.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 69-year-old female patient who received SHINGRIX. Concomitant products included Rifampin, ESTRING, VAGIFEM. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and bone pain. On an unknown date, the outcome of the fever and bone pain were recovered/resolved. It was unknown if the reporter considered the fever and bone pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by an office manager. The prescription was written on 28th December 2017 and sent to the pharmacy but the reporter did not know the specific day it was given. The patient received SHINGRIX in late December 2017 to January 2018. The patient experienced a low grade fever. The symptoms lasted about 1 day. At the time of reporting, the patient was due for her 2nd dose and was wondering if she should get it based upon the previous side effects.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The concurrent conditions, medical history and concomitant medications were unknown. On an unknown date, the patients were vaccinated for prophylaxis with an improperly stored dose of Oka-Merck PROQUAD lot # N029878 and expiration date 22-APR-2019 for prophylaxis. Route of administration, number of previous doses and strength were not reported. The Oka-Merck PROQUAD vaccines were reconstituted with properly stored vials of sterile diluent. No adverse events were reported, however, Oka-Merck PROQUAD vaccines suffered from temperature excursion (stored at 15°F to 46°F) for a period of 49 minutes. Digital data logger was involved. There was no previous temperature excursion.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a child of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On 05-APR-2018, the patient was vaccinated with RECOMBIVAX HB (5/0.5 mcrg/ml) 5 Microgram, once by intramuscular route from lot L048236 that expired on 31-MAR-2018 for prophylaxis. Product did not have a temperature excursion. No adverse effects reported. No product quality complaint was involved.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer sponsored Program, by a contactable consumer (patient's husband). A female patient of an unspecified age and ethnicity received PREVNAR 13) via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pneumonia, PREVENAR 13 didn't work with outcome of unknown. No follow-up attempts possible. No further information expected. Information about batch/lot number cannot be obtained.
Sex: M
Vaccine: PNC13
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program, by a contactable consumer (patient). A currently 68-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sick/ was in hospital sick (hospitalization) with outcome of unknown. The information on the lot number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Hypotension, Pneumonia, Rash
Clinical narrative: This is a spontaneous report from a Pfizer sponsored Program, by a contactable consumer (patient).  A female patient of an unspecified age, race and ethnicity received PREVNAR 13, via an unspecified route of administration, at single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, two weeks after the vaccination, the patient had skin out breaks on her legs. On an unspecified date, one month after the vaccination, the patient was taken by ambulance to hospital with very low blood pressure and chest X-ray showed pneumonia. Clinical outcome of the events was unknown at time of this report. No follow-up attempts possible. No further information expected. Information about batch/lot number cannot be obtained.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Treponema test positive
Clinical narrative: This is a spontaneous report from a contactable physician received via Pfizer sales representative. A 17-year-old male patient of an unspecified ethnicity received the first dose TRUMENBA, at single dose, and second dose of MENACTRA, at unknown dose and frequency; both via an unspecified route of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. The patient received second dose of meningococcal vaccine a/c/y/w conj (dip tox) and first dose of meningococcal group b rlp2086 during an office visit. The physician also ordered an RPR blood test for an unprotected sexual encounter. RPR Blood test was drawn 1 or 2 days later, and test result showed positive for Syphilis, but a repeat RPR showed negative. The physician said the vaccines caused a seroconversion. No adverse events were reported other than anxiety due to an initial positive test result. The outcome of the events was unknown. Information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Death, Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program comScore Quant Concept Testing. A contactable consumer reported for a female patient (his/her mother) of an unspecified age and race who received PREVNAR 13 at single dose on unknown date for immunization via unspecified route. Relevant medical history and concomitant medication were unknown. The patient died of pneumonia. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected. Reported Cause(s) of Death: Died of pneumonia.
Sex: F
Vaccine: PNC13
Symptoms: Limb mass
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's friend) reported that a female patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The consumer stated that pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) had "way too many side effects" and on an unspecified date, the patient who had the vaccine had a huge lump on her arm. The outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: (L) arm swelling/day/fever at night.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Tremor
Clinical narrative: Patient presented to receive his third Anthrax vaccine dose, and after receiving vaccine reported to Immunization technician he is concerned his tremors started after he received his initial Anthrax dose. When questioned he reports he has had a tremor since at least September 2017. He received his first Anthrax dose in April 2017 and his second dose in August 2017. He denies cutaneous, constitutional, and systemic symptoms following his Anthrax doses. He denies prior adverse vaccine reactions. He complains of tremor affecting both hands which he feels is worse on the left side. He denies vision/hearing changes, speech/swallowing issues, and difficulty walking. He denies numbness, tingling, and weakness other than perhaps several occasions where he has dropped a can with his left hand due to "holding it too gently since I was afraid I would crush it."
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site rash, Muscle spasms
Clinical narrative: Muscle spasm after injection. Rash over Right Deltoid area within 6 hours of injection despite 25 mg of BENADRYL being taken 1.5 hours prior to injection. Point tenderness over injection site lasting longer than 21 days.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: The pharmacist was in the process of administering my flu shot, while the needle was in my arm an employee opened the door behind him, knocking him forward sending the needle further into my arm than intended. Shocked that this happened, I question the pharmacist how a room designated for vaccines could be accessed with such negligence. He did not offer an explanation but did apologize and told me that the employee would be reprimanded. My arm still tingles and throbs periodically. My shoulder also hurts occasionally. My Dr checked my arm and doesn't see any visible issues, he did not prescribe any medications because I am pregnant. He asked me to do a few exercises to try to relieve the stiffness in my shoulder.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain at injection site reported 24 hours post vaccination. Instructed patient to mark edge of redness and monitor for spreading. 4/7/2018 24 hours after 1st report patient with redness spreading past borders. Instructed to seek medical care. Patient seen in emergency department.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pruritus, Swelling
Clinical narrative: Pt described her side effect to the pharmacy on 4/9 symptoms: swollen, pain at injection site, itchiness.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a 3rd dose of the Hepatitis A vaccine when it was not necessary. Patient's mother was notified. No adverse reactions were reported.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Injection site vesicles, Local reaction
Clinical narrative: Local reaction to include red raised hives from injection site to approx 5 inches down arm to include a blister at end of hives.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site urticaria, Injection site vesicles
Clinical narrative: Local reaction to include red raised hives from injection site to approx 5 inches down arm to include a blister at end of hives.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Injection site vesicles, Local reaction
Clinical narrative: Large red raised hives from injection site to approx 5 inches down arm to include blister at the end of the rash.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site urticaria, Injection site vesicles
Clinical narrative: Large red raised hives from injection site to approx 5 inches down arm to include blister at the end of the rash.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Patient went to Urgent care with rash all over her trunk, arms, and neck on 3/3/2018. She was given SOLU-MEDROL 125 mg IM, Prednisone taper 40 mgx3, 20mg X3 , add cimetidine 400 TID and continue CLARITIN, BENADRYL. F/U with Dr. Cool compresses, tepid bathing and looser clothing.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Computerised tomogram head normal, Computerised tomogram normal, Condition aggravated, Confusional state
Clinical narrative: Note PT has preexisting pain and weak in legs with instability. However within 12-14 hours after the vaccination I experienced increase in instability, weakness, and confusion. I fell three times during the day after the vaccination between approximately 8 AM-6PM. After third fall was too weak to stand. Husband called for ambulance, and I was transported to ED, approximately 6:30 PM. A battery of test were administered: CT Scan of head and cervical spine, MRI, blood tests of urine which were all negative. I remained in the hospital overnight. I was and continue to be back to my normal when I left the hospital.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysstasia, Fall, Gait disturbance, Muscular weakness, Nuclear magnetic resonance imaging normal
Clinical narrative: Note PT has preexisting pain and weak in legs with instability. However within 12-14 hours after the vaccination I experienced increase in instability, weakness, and confusion. I fell three times during the day after the vaccination between approximately 8 AM-6PM. After third fall was too weak to stand. Husband called for ambulance, and I was transported to ED, approximately 6:30 PM. A battery of test were administered: CT Scan of head and cervical spine, MRI, blood tests of urine which were all negative. I remained in the hospital overnight. I was and continue to be back to my normal when I left the hospital.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Urine analysis normal
Clinical narrative: Note PT has preexisting pain and weak in legs with instability. However within 12-14 hours after the vaccination I experienced increase in instability, weakness, and confusion. I fell three times during the day after the vaccination between approximately 8 AM-6PM. After third fall was too weak to stand. Husband called for ambulance, and I was transported to ED, approximately 6:30 PM. A battery of test were administered: CT Scan of head and cervical spine, MRI, blood tests of urine which were all negative. I remained in the hospital overnight. I was and continue to be back to my normal when I left the hospital.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Patient developed fever of 101.5. Swelling at injection site.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions or allergies reported. On 26-MAR-2018, the patient was vaccinated with improperly stored dose of ZOSTAVAX 19400 PFU (lot # N013278, expiry date 26-JUL-2018), subcutaneously which was reconstituted with properly stored STERILE DILUENT as prophylaxis. The patient was stored at a temperature of -9 degree Celsius to 8 degree Celsius, (6 degree Celsius) for a time frame of 7 days. No previous temperature excursions reported. There was a digital data logger involved. No adverse event was reported. Product quality complaint (PQC) was not involved.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an 8 week old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. In approximately September 2017, reported as "24-SEP-2017", (conflicting information because the patient was reported had been born on 27-SEP-2017), 25-OCT-2017 and 28-NOV-2017, the patient was administered the first, second and third doses, respectively, of RECOMBIVAX HB, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PATIENT CLAIMED TO HAVE BAD RED, SWOLLEN REACTION AT SITE OF INJECTION.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site warmth, Myalgia, Pain in extremity
Clinical narrative: Approximately 2 in rash on arm, warm, pain @ injection site, muscle pain in leg, fever/chills. Leg pain & fever/ chills resolved with ibuprofen.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Approximately 2 in rash on arm, warm, pain @ injection site, muscle pain in leg, fever/chills. Leg pain & fever/ chills resolved with ibuprofen.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rectal haemorrhage, Vaginal haemorrhage
Clinical narrative: PT EXPERIENCED RECTAL AND VAGINAL BLEEDING STARTING THE DAY AFTER THE IMMUNIZATION AND LASTING FOR 24 HOURS.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Rectal haemorrhage, Vaginal haemorrhage
Clinical narrative: PT EXPERIENCED RECTAL AND VAGINAL BLEEDING STARTING THE DAY AFTER THE IMMUNIZATION AND LASTING FOR 24 HOURS.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, IPV, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient received, PENTACEL, ROTATEQ, Hep B and IPOL which should have been PREVNAR. I located the error after looking into the patient's chart at the vaccine record. I reported it to Dr. This happened on a Thursday and the patient had a follow up visit with us the next Thursday. Dr. and myself talked with the mother and told her of the mistake. There were no issues with the patient, no local reaction, no fever. The patient was given the PREVNAR and is now UTD. I wrote up the incident and the employee who made the mistake was counseled. Two MA's must check the vaccine prior to giving now.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Myalgia, Neuralgia, Pain in extremity
Clinical narrative: Arm was sore immediately after administration, at some point experienced limited range of motion - difficulty reaching back, muscle/nerve twinges.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Limb discomfort, Movement disorder, Pain in extremity
Clinical narrative: Arm was sore immediately after administration, at some point experienced limited range of motion - difficulty reaching back, muscle/nerve twinges.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Haemorrhage, Peripheral swelling
Clinical narrative: Patient reported to the pharmacy (a week after receiving the vaccine) that she experienced severe bruising, bleeding and swelling of her arm after receiving this vaccine and was still swollen and brusied. She was applying ice to her arm and this was helping with the pain, swelling and bruising.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Insomnia
Clinical narrative: Extreme pain at injection site; severe headache; severe chills and shivering or tremors; all over aching/pain; extreme fatigue; interfered with daily activities and sleep. Took 2 over-the-counter ALEVE pills around 8AM the day after the injection. Relief experienced within a few hours and normal activities resumed early afternoon. 2 more ALEVE pills taken around 9PM the day after injection and side affects no longer experienced.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Pain, Tremor
Clinical narrative: Extreme pain at injection site; severe headache; severe chills and shivering or tremors; all over aching/pain; extreme fatigue; interfered with daily activities and sleep. Took 2 over-the-counter ALEVE pills around 8AM the day after the injection. Relief experienced within a few hours and normal activities resumed early afternoon. 2 more ALEVE pills taken around 9PM the day after injection and side affects no longer experienced.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Headache, Injection site erythema, Injection site reaction
Clinical narrative: Patient complained of Headache, Chills and Joint aches, also had a 2 inch diameter red welt at injection site .
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Patient complained of Headache, Chills and Joint aches, also had a 2 inch diameter red welt at injection site .
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Erythema, Eye pain, Fatigue
Clinical narrative: Patient complained of Headache, Chills and Joint aches, also had a 2 inch diameter red welt at injection site .
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Swelling
Clinical narrative: Patient complained of Headache, Chills and Joint aches, also had a 2 inch diameter red welt at injection site .
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site, pt refused appointment to look at area therefore we were not able to see exact reaction only patient report.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Fever, Chills, Nausea, body aches.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Patient developed cellulitis (diagnosed by primary care provider) on left arm with a raised red area approximately 2 x 4" in size near injection site.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swelling, rash and itchiness. Warm to touch.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Per patient report, entire left side of body became numb 48 hours after vaccine was administered. Patient has refused to seek medical attention for symptoms.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, VARZOS
Symptoms: Contusion, Erythema, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: These facts were reported to pharmacy by patient on 4/6/2018. PNEUMOVAX was administered to patient at around 3 pm on 4/2/2018. That evening, patient's arm began to get very swollen at injection sight. The swelling spread to his entire Right upper arm. On Tuesday the arm was still swollen and the patient developed a fever. On Wednesday, the patients whole arm turned red and was still swollen. He sought treatment at an urgent care center, where he received steroids and antibiotics to help the reaction subside. On Monday, when he reported to pharmacy, the redness had subsided and swelling had gone down in his arm, but now he had a large bruise slightly larger than 2 quarters on his forearm that he thought was also from the vaccine.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, VARZOS
Symptoms: Cellulitis, Erythema, Injection site cellulitis, Swelling
Clinical narrative: These facts were reported to pharmacy by patient on 4/6/2018. PNEUMOVAX was administered to patient at around 3 pm on 4/2/2018. That evening, patient's arm began to get very swollen at injection sight. The swelling spread to his entire Right upper arm. On Tuesday the arm was still swollen and the patient developed a fever. On Wednesday, the patients whole arm turned red and was still swollen. He sought treatment at an urgent care center, where he received steroids and antibiotics to help the reaction subside. On Monday, when he reported to pharmacy, the redness had subsided and swelling had gone down in his arm, but now he had a large bruise slightly larger than 2 quarters on his forearm that he thought was also from the vaccine.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Pt. had Redness about 3 inches, swelling, warmth and pain at site of injection. Also had headache, muscle pain, tiredness, fever, dizziness, and started at night of injection. Pt. took some ibuprofen, not helping.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Pyrexia
Clinical narrative: Pt. had Redness about 3 inches, swelling, warmth and pain at site of injection. Also had headache, muscle pain, tiredness, fever, dizziness, and started at night of injection. Pt. took some ibuprofen, not helping.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis L arm.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Injection site pain, Injection site swelling, Injection site warmth, Lip swelling
Clinical narrative: At 4 hours post injection my right upper arm swelled to double its size, at 6 hours it was very hot and painful and at 8 hours my lips swelled and my ulnar nerve was compressed by the edema and the 4th and 5th digits on the right hand tingled. I also was slightly short of breathe and had some wheezing.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Nerve compression, Oedema, Paraesthesia, Wheezing
Clinical narrative: At 4 hours post injection my right upper arm swelled to double its size, at 6 hours it was very hot and painful and at 8 hours my lips swelled and my ulnar nerve was compressed by the edema and the 4th and 5th digits on the right hand tingled. I also was slightly short of breathe and had some wheezing.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, tender and hot and pain about 3 inches long and 1 inch wide at site of injection
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dyskinesia, Syncope
Clinical narrative: Patient had syncope with some brief muscle jerks. Had recurrence of syncope or near syncope over a 20 minute period after the vaccination.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Body temperature increased, Dyskinesia, Electroencephalogram normal, Irritability, Staring
Clinical narrative: Got PENTACEL Friday, 3/23, Sat, 3/24 - Very fussy, Tmax 100.3, vomited x 1 Sat night. Sunday 3/25, Possible seizure activity including extending arms and short staring spells, went to hospital, admitted overnight for observation.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Vomiting
Clinical narrative: Got PENTACEL Friday, 3/23, Sat, 3/24 - Very fussy, Tmax 100.3, vomited x 1 Sat night. Sunday 3/25, Possible seizure activity including extending arms and short staring spells, went to hospital, admitted overnight for observation.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in an unspecified number of patients who received SHINGRIX. 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 fever and pain. On an unknown date, the outcome of the fever and pain were unknown. It was unknown if the reporter considered the fever and pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The physician stated that patients that were administered the SHINGRIX vaccines experienced light fever and aches.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX. In January 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid and developed at the injection site a hot, red, swollen painful area that lasted for about 4 to 5 days and completely resolved. The batch number was not provided.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Malaise, Myalgia
Clinical narrative: Redness/swelling (L) deltoid (80mm x 110mm), fever 100.5 F, shivering, general malaise, muscle pain.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Redness/swelling (L) deltoid (80mm x 110mm), fever 100.5 F, shivering, general malaise, muscle pain.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult male patient who received SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. The reporter considered the injection site erythema and injection site swelling to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left arm deltoid (closer to the triceps muscle). The healthcare professional did not have the lot number and expiration date of the SHINGRIX available. The time of symptom development was not reported to the healthcare professional. The patient presented to the pharmacy on the third day after vaccination. This case has been linked with US2018057887, reported by same reporter for same events. There had been no further follow-up with the patient at this point.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient received Tdap on 4-5-18 in left deltoid. On 4-6-18 pt. had swelling, warm to touch, and pain in left arm. She had diarrhea, stomach cramping, and fever on 4-7-18. Patient was seen in clinic today, 4-9-18 and to start BENADRYL and ice the left arm.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Skin warm
Clinical narrative: Patient received Tdap on 4-5-18 in left deltoid. On 4-6-18 pt. had swelling, warm to touch, and pain in left arm. She had diarrhea, stomach cramping, and fever on 4-7-18. Patient was seen in clinic today, 4-9-18 and to start BENADRYL and ice the left arm.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse event in a male patient who received SHINGRIX. On 3rd April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient suffered from severe side effects after vaccination. The patient wondered if one do had the side effects on the first shot, would they be more likely to have it again on the second shot.
Age: 0.33
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None. Pt. was given a KINRIX combo vaccine for a 4 month well child. KINRIX is not given at age less than 4-6 years old.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema
Clinical narrative: Patient received SHINGRIX on March 23, 2018 and developed redness and blisters 5" beneath site of injection.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Started day after injections 8 cm x 7 cm in size left deltoid area, red, swollen and hot to the touch! Recommended, cool compresses/TYLENOL.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Immobile, Muscular weakness
Clinical narrative: Patient has pre-existing Parkinson's disease on carbidopa/levodopa. Following first dose of SHINGRIX developed significant acute leg weakness, immobility which improved without specific treatment over several days.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. The reporter considered the injection site erythema and injection site swelling to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left arm deltoid (closer to the triceps muscle). The healthcare professional did not have the lot number and expiration date of the SHINGRIX available. The time of symptom development was not reported to the healthcare professional. The patient presented to the pharmacy on the third day after vaccination. This case has been linked with US2018057886, reported by same reporter for same events. There had been no further follow-up with the patient at this point.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Headache, Mobility decreased, Musculoskeletal pain, Neuralgia
Clinical narrative: Rash, red skin color - came and gone twice. Complaint: feels nerve pain, tremendous pain. On-going. MD says nerve damage - reports headache due to pain - reports shoulder pain. Cannot bend elbow - chronic pain since administered - feels like needle attack, chronic.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Rash, red skin color - came and gone twice. Complaint: feels nerve pain, tremendous pain. On-going. MD says nerve damage - reports headache due to pain - reports shoulder pain. Cannot bend elbow - chronic pain since administered - feels like needle attack, chronic.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination site cellulitis
Clinical narrative: Cellulitis around vaccine site, in otherwise well appearing child will began oral KEFLEX. Patient will schedule follow up visit in 2 days.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Angioedema, Injection site pain, Lip swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of angioedema in a 77-year-old male patient who received SHINGRIX (batch number unknown, expiry date 28th April 2020). Concomitant products included Acetaminophen, Atorvastatin, gabapentin, ibuprofen, Lidocaine, Metformin, SILVADENE, lisinopril, cyclobenzaprine and glipizide. On 19th March 2018 14:09, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th March 2018, 1 days after receiving SHINGRIX, the patient experienced angioedema (serious criteria GSK medically significant). On 26th March 2018, the outcome of the angioedema was recovered/resolved. The reporter considered the angioedema to be almost certainly related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient experienced angioedema on his lips.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Angioedema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of angioedema in a 77-year-old male patient who received SHINGRIX (batch number unknown, expiry date 28th April 2020). Concomitant products included Acetaminophen, Atorvastatin, gabapentin, ibuprofen, Lidocaine, Metformin, SILVADENE, lisinopril, cyclobenzaprine and glipizide. On 19th March 2018 14:09, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th March 2018, 1 days after receiving SHINGRIX, the patient experienced angioedema (serious criteria GSK medically significant). On 26th March 2018, the outcome of the angioedema was recovered/resolved. The reporter considered the angioedema to be almost certainly related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient experienced angioedema on his lips.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Pruritus, Rash
Clinical narrative: Generalized rash, dark urine and diarrhea of light grey coloration.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood potassium decreased, Chromaturia, Diarrhoea, Hepatic enzyme increased, Rash generalised
Clinical narrative: Generalized rash, dark urine and diarrhea of light grey coloration.
Age: 58.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Borrelia test negative, Headache, Influenza like illness, Nuclear magnetic resonance imaging brain normal
Clinical narrative: The day after I received the flu vaccine, I began having flu-like symptoms with bad headaches. The other symptoms disappeared after a few days, but I had a following 3.5 months of relentless headache thereafter.
Age: 58.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Headache
Clinical narrative: The day after I received the flu vaccine, I began having flu-like symptoms with bad headaches. The other symptoms disappeared after a few days, but I had a following 3.5 months of relentless headache thereafter.
Age: 58.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Borrelia test negative, Headache, Influenza like illness, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Headaches.
Age: 58.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Headache
Clinical narrative: Headaches.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to an unspecified patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 13-MAR-2018, the patient was vaccinated with VAQTA lot number reported as M039209 with expiration date of 11-MAR-2018, (strength, dose and anatomical location were not provided) for prophylaxis (expired product administered). No adverse events were reported. Follow up information has been received from the nurse on 29-MAR-2018. The patient's birth weight was updated, and the patient had no brothers and sisters. On 13-MAR-2018, the patient was vaccinated with the second dose of VAQTA intramuscularly. Error was noted after the administration. The patient's parent was contacted several times beginning on 15-MAR-2018 with messages left, and finally spoke with the patient's mom on 29-MAR-2018. All vaccine boxes had expiration date written visibly on front, nurses checked expiration date before administration, vaccine expirations being checked weekly and documented.
Age: 45.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 45-year-old patient of an unknown gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 15-MAR-2018, the patient was vaccinated with a dose of PROQUAD injection, subcutaneously, lot # N02061 (not valid), expiration date 22-JAN-2019 (dose was not reported), for prophylaxis. PROQUAD was reconstituted with a sterile diluent (manufacturer unknown). No adverse effects reported.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 9 year old male patient. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On 16-MAR-2018, the patient was inadvertently vaccinated with expired VAQTA (0.5 ml, intramuscular, lot # M033611, expiration date 02-MAR-2018) for prophylaxis. No adverse effects reported.
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, and refers to a 60 year old female patient. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 02-APR-2018, the patient was vaccinated with an expired dose of VAQTA (lot # M031806 with an expiration date in 30-MAR-2018), for prophylaxis, (dose, frequency and route were not provided). Furthermore, it was also reported that the expired dose of VAQTA had no temperature excursions prior to being administered No adverse effects were reported and no product quality complaint (PQC) was involved.
Age: 49.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a nurse refers to a 49 year old female patient. Information on patient's pertinent medical history, concomitant medication and drug reactions/allergies were reported as none. On approximately 21-MAR-2018 (reported as about 12 days ago), the patient was vaccinated with VARIVAX injection (strength, dose, frequency, lot # and expiration date were not reported) for prophylaxis. The administered dose of VARIVAX was reconstituted with sterile diluent (manufacturer unknown) (lot# and expiry date were not reported). On an unknown date in 2018, the patient experienced rash on trunk which was spreading (rash), low grade fever (pyrexia) and feeling aches (pain). No treatment was given to treat the adverse events. On 02-APR-2018, the patient sought medical attention at office of physician. The lab diagnostics/studies was not performed. The outcome of rash, pain and pyrexia was reported as not recovered. The causality was not reported for the events. There was no product quality complaint (PQC) reported.