chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Nausea, Presyncope
Clinical narrative: Within ~1 minutes of receiving this IM Influenza injection (into the R deltoid), patient (employee) became diaphoretic, nauseated and dizzy/light-headed (vasovagal response; near syncope - did not lose consciousness).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash
Clinical narrative: Dull headache, on 3-15 had rash on forehead neck front chest. On 3-16 rash had seemed to clear on neck and forehead and had moved to cheeks. Rash did seem to disappear on 3-17.
Age: 65.0
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Balance disorder, Chills, Hyperhidrosis, Lymphadenopathy, Pain
Clinical narrative: Swollen glands, body aches, disequilibrium , chills, sweats.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Cerebrovascular arteriovenous malformation, Electroencephalogram normal, Generalised tonic-clonic seizure, Nuclear magnetic resonance imaging brain abnormal, Partial seizures
Clinical narrative: Patient had a focal seizure that generalized to a tonic clonic seizure on 3/15/2019 and a second generalized tonic clonic seizure on 3/25/2019. Patient has seen a neurologist and is now taking levetiracetam. No further seizures reported.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Tremor
Clinical narrative: Patient contacted the pharmacy one day after injection (1/12/19) and reported she had headache, chills, shakes, and flu-like symptoms following vaccination. Patient has not returned pharmacy call to complete follow up on outcome.
Age: 1.5
Sex: F
Vaccine: UNK
Symptoms: Abnormal behaviour, Aggression, Pyrexia, Tenderness
Clinical narrative: Fever of 104.4 lasting for 72 hours. Behavior changes, throwing long lasting fits, saying out ouch when touched or needing to get dressed
Sex: M
Vaccine: VARZOS
Symptoms: Pericarditis
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pericarditis in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several weeks after receiving SHINGRIX, the patient experienced pericarditis (serious criteria GSK medically significant). On an unknown date, the outcome of the pericarditis was recovered/resolved. It was unknown if the reporter considered the pericarditis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Several weeks after the 1st injection, the patient had pericarditis which was self-resolved. This case has been linked to case US2019GSK063245, reported by the same reporter for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Acupuncture, Chiropractic, Mobility decreased, Pain in extremity, Tuberculosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cold abscess in a adult patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cold abscess (serious criteria GSK medically significant), pain in arm and mobility decreased. On an unknown date, the outcome of the cold abscess, pain in arm and mobility decreased were unknown. It was unknown if the reporter considered the cold abscess, pain in arm and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of SHINGRIX series in the two part and experienced pain in left arm ever since, trouble lifting and turning. The patient consulted the Primary Care Physician (PCP), and was sent to physical therapy(PT) for an evaluation. The patient had many expensive massages, acupuncture, and chiropractic appointments were not available. Both the physical therapy (PT) and chiro reported that this was not the first patient to have problems with the new vaccine and finally, someone suggested that the patient might have a cold abscess and asked if there was any kind of correlation between the SHINGRIX and abscesses, sterile or non-sterile, and asked if there was any possibility, how it would be treated and would it go away.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 61-year-old female patient who received SHINGRIX (batch number N9CA2, expiry date 2nd July 2021) for prophylaxis. On 11th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was recovered/resolved. It was unknown if the reporter considered the injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX vaccine and had terrible itching in the injection arm for 5 days following the vaccination.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 62-year-old female patient who received SHINGRIX (batch number 4LH35, expiry date 11th September 2021) for prophylaxis. On 30th March 2019, the patient received SHINGRIX. On 31st March 2019, 1 days after receiving SHINGRIX, the patient experienced localized erythema, induration and local swelling. On an unknown date, the outcome of the localized erythema, induration and local swelling were not recovered/not resolved. It was unknown if the reporter considered the localized erythema, induration and local swelling to be related to SHINGRIX. Additional case details were reported as follows: On 30th March 2019 at 7:00 pm the patient received the vaccine in left arm. She woke up Sunday with a red, swollen oval shaped area less than an inch below the injection site. It was also hard to the touch. The patient returned to the pharmacy today as it had not resolved. It was 2 inches in circumference. The reporter gave permission to follow up.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Blood culture negative, Bronchiolitis, C-reactive protein increased, Chest X-ray abnormal, Culture urine negative
Clinical narrative: Patient developed a high fever and possible seizure approximately 2-3 hours after injection. Patient was brought back to our office and temp was 103.7. Patient was given ibuprofen and labs were ordered. We also completed a chest xray and gave a dose of rocephin.  Patient was also brought back in on 4/9/19 for re check and second rocephin dose. Later that day she developed high fever and seizure like activity at home and was advised to go to ER.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Pneumonia viral, Pyrexia
Clinical narrative: Patient developed a high fever and possible seizure approximately 2-3 hours after injection. Patient was brought back to our office and temp was 103.7. Patient was given ibuprofen and labs were ordered. We also completed a chest xray and gave a dose of rocephin.  Patient was also brought back in on 4/9/19 for re check and second rocephin dose. Later that day she developed high fever and seizure like activity at home and was advised to go to ER.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Seizure like phenomena, Urine analysis normal, White blood cell count increased
Clinical narrative: Patient developed a high fever and possible seizure approximately 2-3 hours after injection. Patient was brought back to our office and temp was 103.7. Patient was given ibuprofen and labs were ordered. We also completed a chest xray and gave a dose of rocephin.  Patient was also brought back in on 4/9/19 for re check and second rocephin dose. Later that day she developed high fever and seizure like activity at home and was advised to go to ER.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Balance disorder, Cerebral disorder, Cytogenetic analysis, Developmental delay, Developmental regression
Clinical narrative: Left arm very swollen, became erythmatous and warm. Large patch of erythema and swelling over the left arm. DX swelling or mass of limb and Aseptic inflammation from vaccine shot. No treatment. Was told it was rare (1 out of every 1,000 children this would happen to) by pediatrician. My child started stuttering two days after the vaccine, lost his balance and has had brain shrinkage and developmental delays sense the vaccines. Was recently diagnosed with partial focal epilepsy. Problems with muscle tone and stiffness, he cannot speak clearly now and had a full vocabulary and no issues with speaking before the vaccine. So the outcome has been severe developmental regression and balance issues due to muscle tone and neurological issues. Has to wear AFO's and needs to use a wheelchair most of the time do to loss of muscle tone and sensory/balance issues. He had no problems with balance or walking before the vaccine.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Dysphemia, Electromyogram, Fall, Hypotonia, Inflammation
Clinical narrative: Left arm very swollen, became erythmatous and warm. Large patch of erythema and swelling over the left arm. DX swelling or mass of limb and Aseptic inflammation from vaccine shot. No treatment. Was told it was rare (1 out of every 1,000 children this would happen to) by pediatrician. My child started stuttering two days after the vaccine, lost his balance and has had brain shrinkage and developmental delays sense the vaccines. Was recently diagnosed with partial focal epilepsy. Problems with muscle tone and stiffness, he cannot speak clearly now and had a full vocabulary and no issues with speaking before the vaccine. So the outcome has been severe developmental regression and balance issues due to muscle tone and neurological issues. Has to wear AFO's and needs to use a wheelchair most of the time do to loss of muscle tone and sensory/balance issues. He had no problems with balance or walking before the vaccine.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Muscle tone disorder, Musculoskeletal stiffness
Clinical narrative: Left arm very swollen, became erythmatous and warm. Large patch of erythema and swelling over the left arm. DX swelling or mass of limb and Aseptic inflammation from vaccine shot. No treatment. Was told it was rare (1 out of every 1,000 children this would happen to) by pediatrician. My child started stuttering two days after the vaccine, lost his balance and has had brain shrinkage and developmental delays sense the vaccines. Was recently diagnosed with partial focal epilepsy. Problems with muscle tone and stiffness, he cannot speak clearly now and had a full vocabulary and no issues with speaking before the vaccine. So the outcome has been severe developmental regression and balance issues due to muscle tone and neurological issues. Has to wear AFO's and needs to use a wheelchair most of the time do to loss of muscle tone and sensory/balance issues. He had no problems with balance or walking before the vaccine.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Nervous system disorder, Nuclear magnetic resonance imaging, Sensory disturbance, Speech disorder, Wheelchair user
Clinical narrative: Left arm very swollen, became erythmatous and warm. Large patch of erythema and swelling over the left arm. DX swelling or mass of limb and Aseptic inflammation from vaccine shot. No treatment. Was told it was rare (1 out of every 1,000 children this would happen to) by pediatrician. My child started stuttering two days after the vaccine, lost his balance and has had brain shrinkage and developmental delays sense the vaccines. Was recently diagnosed with partial focal epilepsy. Problems with muscle tone and stiffness, he cannot speak clearly now and had a full vocabulary and no issues with speaking before the vaccine. So the outcome has been severe developmental regression and balance issues due to muscle tone and neurological issues. Has to wear AFO's and needs to use a wheelchair most of the time do to loss of muscle tone and sensory/balance issues. He had no problems with balance or walking before the vaccine.
Age: 2.0
Sex: M
Vaccine: PNC13, UNK
Symptoms: Injection site swelling, Local reaction
Clinical narrative: Right arm very swollen at injection site. DX localized reaction to immunization. Was told to ice it and give Tylenol.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Blood glucose normal, Immediate post-injection reaction, Presyncope
Clinical narrative: Administered 1st shot in Hepatitis B series, employee had an immediate vasovagal reaction. Was sitting on a therapy bench, and assisted into the laying down position. No injury sustained. Medical team response requested immediately. Monitored Heart rate, blood pressure, pulse ox, blood glucose immediately after incident and continued to monitor for 1 hour. Recovered fully.
Age: 39.0
Sex: M
Vaccine: MMR
Symptoms: Anti-GAD antibody, Blood glucose, Blood magnesium, C-reactive protein increased, Differential white blood cell count
Clinical narrative: Extreme inflammatory response resulting in hyperglycemia and hemolytic anemia requiring  blood transfusion x 2. Pt's symptoms included dizzy, lightheaded, blurred vision, fatigue. See attached hospital and office records.
Age: 39.0
Sex: M
Vaccine: MMR
Symptoms: Dizziness, Fatigue, Full blood count, Glycosylated haemoglobin, Haemolytic anaemia
Clinical narrative: Extreme inflammatory response resulting in hyperglycemia and hemolytic anemia requiring  blood transfusion x 2. Pt's symptoms included dizzy, lightheaded, blurred vision, fatigue. See attached hospital and office records.
Age: 39.0
Sex: M
Vaccine: MMR
Symptoms: Hyperglycaemia, Inflammation, Insulin C-peptide, International normalised ratio, Lipase
Clinical narrative: Extreme inflammatory response resulting in hyperglycemia and hemolytic anemia requiring  blood transfusion x 2. Pt's symptoms included dizzy, lightheaded, blurred vision, fatigue. See attached hospital and office records.
Age: 39.0
Sex: M
Vaccine: MMR
Symptoms: Metabolic function test, Prothrombin time, Red blood cell sedimentation rate, Staphylococcus test, Transfusion
Clinical narrative: Extreme inflammatory response resulting in hyperglycemia and hemolytic anemia requiring  blood transfusion x 2. Pt's symptoms included dizzy, lightheaded, blurred vision, fatigue. See attached hospital and office records.
Age: 39.0
Sex: M
Vaccine: MMR
Symptoms: Troponin T, Urine analysis, Vision blurred
Clinical narrative: Extreme inflammatory response resulting in hyperglycemia and hemolytic anemia requiring  blood transfusion x 2. Pt's symptoms included dizzy, lightheaded, blurred vision, fatigue. See attached hospital and office records.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Pruritus
Clinical narrative: Shingles reaggravating, mainly up the back and shoulders; itching; Inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 88-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles, pruritus and incomplete course of vaccination. On an unknown date, the outcome of the shingles and pruritus were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles and pruritus to be related to Shingles vaccine.  Additional case details were provided as follows: The age at vaccination was not reported for 1st dose and not applicable for 2nd dose. The patient received dose of the shingles vaccine about a year and a half before day of reporting and after few months experienced shingles. Till the time of reporting, the patient did not receive the 2nd dose of shingles, which led to incomplete course of vaccination. The patient thought that it was the Shingrix, but patient was not sure. The patient stated that she just kept putting it off for the second dose. After the vaccination the patient had shingles, and they all came back to her. The patient currently stated that they were not real bad, but they were aggravating, mainly up the back and shoulders. The patient took aloe vera daily and uses a backscratcher for the itching, but the patient was tired of it. The patient consented for follow up.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Visual impairment
Clinical narrative: After receiving HPV, patient felt lightheaded and was seeing white. Per DO, pt said she was seeing white and purple. Placed in Trendelenburg position and color improved. States she had some tingling in her arms after last HPV injection. Blood pressure taken (100/60 supine) was given some apple juice. BP rechecked and again 100/60 and feeling fine. Discharged home.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Severe shivering muscle ache subjective fever.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Red, hard, raised, hot, painful swelling at injection site. Circumference size of a golf ball. Raised swelling of about 1/4 inch depth. Started evening of vaccine and only slightly better (as fear as color and heat) 48 hours later. Stiffness and pain in arm. 48 hours after vaccine, diarrhea onset.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Injection site warmth, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Red, hard, raised, hot, painful swelling at injection site. Circumference size of a golf ball. Raised swelling of about 1/4 inch depth. Started evening of vaccine and only slightly better (as fear as color and heat) 48 hours later. Stiffness and pain in arm. 48 hours after vaccine, diarrhea onset.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Chest X-ray, Peripheral swelling, Pruritus, Rash, Skin tightness
Clinical narrative: A few hours after the vaccine, my hands began to itch tremendously which was followed by a rash starting on my hands and moved down my arms. Then, my hands began to swell and become very tight. The rash spread down my legs and onto my feet. I went to the emergency room and was given a Benadryl and a prescription for Prednisone. As of 1 day on the steroid, the rash seems to have returned, but not as severe.
Sex: U
Vaccine: VARZOS
Symptoms: Dyspnoea, Fatigue, Hypoaesthesia, Paraesthesia, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of numbness in a adult patient who received SHINGRIX for prophylaxis. On 28th December 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced numbness, tingling, difficulty breathing, sleepiness and tiredness. On an unknown date, the outcome of the numbness, tingling, difficulty breathing, sleepiness and tiredness were unknown. It was unknown if the reporter considered the numbness, tingling, difficulty breathing, sleepiness and tiredness to be related to SHINGRIX. Additional case details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and experienced severe reaction numbness in hands and feet, tingling in head, severe breathing issues, tired to the point of falling asleep in the car. The patient has been given the consent for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Oedema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of edema in a adult patient who received SHINGRIX for prophylaxis. On 29th March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced feeling bad. On an unknown date, the patient experienced edema and headache. In March 2019, the outcome of the feeling bad was recovered/resolved. On an unknown date, the outcome of the edema and headache were unknown. It was unknown if the reporter considered the edema, headache and feeling bad to be related to SHINGRIX. Additional case details were provided as follows: The age at vaccination was not reported. The patient received the dose of SHINGRIX on Friday and had experienced edema headaches and felt so bad the entire weekend. The patient left the chat before providing any additional information due to the connection lost.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Malaise, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 4th February 2019, the patient received the 1st dose of SHINGRIX. On 4th February 2019, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, chills, muscle pain and general malaise. On 6th February 2019, the outcome of the influenza-like symptoms, fever, chills, muscle pain and general malaise were resolved with sequelae. It was unknown if the reporter considered the influenza-like symptoms, fever, chills, muscle pain and general malaise to be related to SHINGRIX. Additional details were reported as follows: On 4th February 2019, the patient had SHINGRIX vaccine on late afternoon. The patient said that very same night of vaccination she started having symptoms. The symptoms lasted for about 2 days. The reporter did not consent to follow-up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema, Urticaria
Clinical narrative: Urticarial rash with patches of angioedema onset 3/28/2019 required treatment 3/31/2019 with Prednisone and BENADRYL, with duration of urticarial rash until 4/10/2019 with slow resolution on prednisone taper down to 5 mg daily. Location neck, anterior chest and breast, abdomen, waistline, gluteal and anterior thighs. No respiratory symptoms and no mucous membrane involvement.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, UNK
Symptoms: Injection site swelling, Vaccination complication
Clinical narrative: L leg swollen, but no fever , patient's mom  sent to patient to hospital  urgent care same day night , the provider said it is vaccine reaction.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, UNK
Symptoms: Unevaluable event
Clinical narrative: L leg swollen, but no fever , patient's mom  sent to patient to hospital  urgent care same day night , the provider said it is vaccine reaction.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, UNK
Symptoms: Injection site swelling, Vaccination complication
Clinical narrative: Follow up with urgent care, cetirizine 1mg twice a day and decamethason 2 dozes
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, UNK
Symptoms: Unevaluable event
Clinical narrative: Follow up with urgent care, cetirizine 1mg twice a day and decamethason 2 dozes
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Dermatitis atopic, Dermatitis contact, Vaccination site papule, Vaccination site reaction
Clinical narrative: After removing bandaid, noticed a papular eruption that looked like (to my visual inspection) like atopic vs contact dermatitis However, it centered around the vaccine sites.   given triamcinalone cream; reportedly resolved.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Pain, Pyrexia
Clinical narrative: Redness at injection site, low grade fever, body aches, limp at injection site.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Next morning, got more sore at site of the injection. Vaccination site was hot, red (size of a little bigger than silver dollar), swollen and sore. Took Ibuprofen a couple of times but did not help. Did not call doctor or vaccine administrator since pharmacist warned her that everyone that had received the vaccine at the site so far had reported getting the problems. Patient wants vaccine manufacturer to know what is going on so that they will tweak it especially because she still needs to get the 2nd dose. In terms of recovery, the adverse events are about the same still.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Muscle spasms
Clinical narrative: Severe fatigue (7/10), Headache (5/10), Muscle Cramps (4-6/10). Rapid onset. Consistent duration for ~ 6 hours.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: RIGHT THIGH BECAME RED, SWOLLEN AND PAINFUL  TREATMENT: LESS LIKELY TO BE INFECTION BUT WILL TREAT IN CASE SINCE HE IS TENDER, ESPECIALLY ON THE RIGHT THIGH ZYRTEC DAILY AND IF NEEDED BENADRYL AT BEDTIME FOR ITCHING CEPHALEXIN SUSPENSION RECONSTITUTED, 250MG/5ML, 12 ml, ORALLY, EVERY 12 HRS, 7 DAYS, 168 ml, refills 0
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Muscular weakness, Myalgia, Neuralgia
Clinical narrative: Severe chills first night of getting injection. Very severe muscle and nerve ending body pain. Starting 2 hours after injection through whole body and continuing today still. More so this past week during the night and easing during the day. Ongoing muscle weakness during the day.
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: A patient was administered improperly stored Recombivax; no adverse effects reported; This spontaneous report was received from a registered nurse and refers to a male patient of an unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot number R028528, expiration date 04-JUN-2021 (dose, route, lot number and expiration date were not reported) for prophylaxis.         The total time and highest temperature was above 47 degrees F (57.2 degrees F) for 6 hours. A data logger was involved.
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: The Ipol reached 66.2 degrees Fahrenheit for unknown time; Initial information received on 05-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves two children of an unknown demographics who were vaccinated with a dose of IPV (VERO) [IPOL] (lot: N1G51, expiry date was not reported via unknown route in unknown administration site on 04-Apr-2019.  Past vaccination included both children had 4 IPV's before their 4th birthday as part of other vaccines like Pentacel.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error due to incorrect product storage. It was reported that the refrigerator didn't alarm and IPOL reached to the starting temp was 43 degrees F and went up to 66.2 degrees F over 3 and 1/2 window for unknown time.   It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: patient was administered the diluent without reconstituting it with the Hib (Pentacel Vaccine); Initial information received on 05-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old male patient who received the diluent without reconstituting it with the HIB of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE [PENTACEL] lot UJ100AA, expiry date: 13-Jun-2020, via unknown route in the left vastus lateralis on 05-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was not reported if the patient experienced any adverse event was occurred.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: patient received the diluent containing DTaP-IPV and not the Act HIB component of Pentacel; Initial information received on 05-Apr-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 2 months old female patient who was vaccinated with 0.5 mL of diluent containing DTaP-IPV and not the Act HIB component of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (frequency once) (DTaP-IPV diluent U6327AA expiry 19-Sep-2020 and HIB powder lot UJ097AA expiry 19-Sep-2020) via intramuscular in the left leg on 05-Apr-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  It is an actual medication error case due to inappropriate reconstitution technique. It was reported that the patient received DTaP-IPV, but not the ActHIB.   Treatment Act HIB would be administered separately.  It was not reported that the patient had any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: IPOl being administered to a patient after the temperature excursion; Initial information received on 08-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves seven patients of unknown demographics who was vaccinated with a dose of IPV (VERO) [IPOL] (Batch number: N1K931M and expiry date: 18-Nov-2019) (dose, dose in series, route and site of administration were not reported) on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  It was a case of actual medication error due to incorrect product storage.  It was unknown if any adverse event occurred or not following the vaccination.  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 the sender: none.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: I have been getting fever blisters about every other week since getting the vaccine. I never had one before. My doctor gave me Rx of valacyclovir HCL (1 gram).
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Vaccination site rash
Clinical narrative: Patient has developed rash right arm on vaccine area. Patient parents was asked to come back to office, to check on patient was getting better patient got KEFLEX 250mg for rash.
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Dyspepsia, Headache, Induration, Injection site erythema
Clinical narrative: Left Arm swollen , red from injection site to elbow and above and around arm. left arm sore to touch and hot Chills, head ache digustion problems. left arm hard to touch
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Left Arm swollen , red from injection site to elbow and above and around arm. left arm sore to touch and hot Chills, head ache digustion problems. left arm hard to touch
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Pain in extremity
Clinical narrative: Patient was at the doctor's office for a physical at 11am and Blood Pressure was 120/70 with a 60 pulse. About 2 hours after receiving the vaccine, the arm became very sore. Patient has been taking ½ dose of Losartan for about 5-6 years to maintain normal levels. However, the blood pressure was at 150/90 with an 85 pulse. The doctor's office was closed already so patient called doctor office the next morning. Patient directed to start taking full dose of Losartan. Patient reports arm hurt for about 6 days. On 3/6 patient had follow-up appointment with doctor for another matter. Doctor mentioned that it is possible that problems were vaccine related and recommended to continue taking full dose of medication.  It has been 1 month and even with full dose of medication the systolic blood pressure still is high--130-137. Patient takes BP readings about 3 times a day. Patient has follow-up appointment with doctor in mid-May. Wife received the same vaccine on the same day and her arm was sore for a couple of days.
Age: 1.17
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Cough, Diarrhoea, Extra dose administered
Clinical narrative: Double dose of varicella was given. No treatment at the time, provider notified of double. Patient came in on 4/10 for diarrhea and cough.
Age: 0.67
Sex: F
Vaccine: HIBV
Symptoms: Injection site bruising, Injection site induration, Injection site nodule, Vomiting
Clinical narrative: Mother reports patient experienced episode of vomiting x 1 one hour after receiving injection. At the same time she observed bruising to the injection site and a hard knot under the skin. The  bruising has resolved but a palpable, mobile 1 cm nodule still remains at the injection site with dimpling around the edges 26 days post-injection.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site induration
Clinical narrative: Induration at injection site, Redness and the provider prescribed diphenhydramine 25mg capsule take q4h as needed.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Client received pediatric dose of Hepatitis A; rather than adult dose of Hepatitis A. on 04-09-2019. Client notified of pediatric administration on 04-10-2019 and referred back to office for adult dose of Hep A to be administered in 6 months.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Cardiac monitoring, Chest X-ray, Echocardiogram, Electrocardiogram
Clinical narrative: Later on in the day, arm really hurt as expected; it hurt for about 10 days. There was pain at site of injection and a red band 2 x 1 inch below site. The pain was bearable but definitely achy; did not take any medications. Within that week vomited for about 30 minutes, which was very strange. Patient went to scheduled appointment with endocrinologist on 1/14. Patient went back on 1/17 to receive results; labs were clear. Patient reports that heart started pounding and there were vibrations in torsothey were strong so it was scary. On 1/22 patient went to pulmonologist because she thought symptoms were related to lung condition and got an  EKG; doctor commented that they looked like heart palpitations and to follow-up with a cardiologist. Patient had scheduled an appointment with cardiologist for 2/8; however, on 1/30 she was feeling so bad with palpitations and vibrations that called cardiologist and was encouraged to go to the ER. The labs/tests (EKG, blood work, sonogram, chest x-ray) showed palpitations so patient was referred to follow-up with cardiologist. On 2/8 patient went to cardiologist and got an EKG and heart monitor for 8 days. Patient has allergy to adhesive on pads so could not use heart monitor for longer. On 2/21 also patient was sent for an Echocardiogram. On 3/6 patient reviewed results with doctor and told that palpitations/vibrations were not heart related. On 3/7 went to follow-up with PCP for palpitations/vibrations and provided a referral to neurologist. On 3/18 went to see neurologist and was scheduled 2 MRIs (cervical and thoracic) on 3/21. On 3/26 patient received results, per neurologist, she did not see any connection to vibrations. On 3/28 patient went back to the primary and she mentioned that she thought it was related to the vaccination. Doctor did not provide any other treatment/test; patient told to give it a few weeks. In the last week patient reports having vibration for 4 daysthey come and go even at night. Vibrations not as strong but still there. Vibrations come even when patient is at rest (sitting down)-- not doing anything physical; it is not something that she you could control.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Nuclear magnetic resonance imaging neck, Nuclear magnetic resonance imaging thoracic normal, Palpitations
Clinical narrative: Later on in the day, arm really hurt as expected; it hurt for about 10 days. There was pain at site of injection and a red band 2 x 1 inch below site. The pain was bearable but definitely achy; did not take any medications. Within that week vomited for about 30 minutes, which was very strange. Patient went to scheduled appointment with endocrinologist on 1/14. Patient went back on 1/17 to receive results; labs were clear. Patient reports that heart started pounding and there were vibrations in torsothey were strong so it was scary. On 1/22 patient went to pulmonologist because she thought symptoms were related to lung condition and got an  EKG; doctor commented that they looked like heart palpitations and to follow-up with a cardiologist. Patient had scheduled an appointment with cardiologist for 2/8; however, on 1/30 she was feeling so bad with palpitations and vibrations that called cardiologist and was encouraged to go to the ER. The labs/tests (EKG, blood work, sonogram, chest x-ray) showed palpitations so patient was referred to follow-up with cardiologist. On 2/8 patient went to cardiologist and got an EKG and heart monitor for 8 days. Patient has allergy to adhesive on pads so could not use heart monitor for longer. On 2/21 also patient was sent for an Echocardiogram. On 3/6 patient reviewed results with doctor and told that palpitations/vibrations were not heart related. On 3/7 went to follow-up with PCP for palpitations/vibrations and provided a referral to neurologist. On 3/18 went to see neurologist and was scheduled 2 MRIs (cervical and thoracic) on 3/21. On 3/26 patient received results, per neurologist, she did not see any connection to vibrations. On 3/28 patient went back to the primary and she mentioned that she thought it was related to the vaccination. Doctor did not provide any other treatment/test; patient told to give it a few weeks. In the last week patient reports having vibration for 4 daysthey come and go even at night. Vibrations not as strong but still there. Vibrations come even when patient is at rest (sitting down)-- not doing anything physical; it is not something that she you could control.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound scan, Vibratory sense increased, Vomiting
Clinical narrative: Later on in the day, arm really hurt as expected; it hurt for about 10 days. There was pain at site of injection and a red band 2 x 1 inch below site. The pain was bearable but definitely achy; did not take any medications. Within that week vomited for about 30 minutes, which was very strange. Patient went to scheduled appointment with endocrinologist on 1/14. Patient went back on 1/17 to receive results; labs were clear. Patient reports that heart started pounding and there were vibrations in torsothey were strong so it was scary. On 1/22 patient went to pulmonologist because she thought symptoms were related to lung condition and got an  EKG; doctor commented that they looked like heart palpitations and to follow-up with a cardiologist. Patient had scheduled an appointment with cardiologist for 2/8; however, on 1/30 she was feeling so bad with palpitations and vibrations that called cardiologist and was encouraged to go to the ER. The labs/tests (EKG, blood work, sonogram, chest x-ray) showed palpitations so patient was referred to follow-up with cardiologist. On 2/8 patient went to cardiologist and got an EKG and heart monitor for 8 days. Patient has allergy to adhesive on pads so could not use heart monitor for longer. On 2/21 also patient was sent for an Echocardiogram. On 3/6 patient reviewed results with doctor and told that palpitations/vibrations were not heart related. On 3/7 went to follow-up with PCP for palpitations/vibrations and provided a referral to neurologist. On 3/18 went to see neurologist and was scheduled 2 MRIs (cervical and thoracic) on 3/21. On 3/26 patient received results, per neurologist, she did not see any connection to vibrations. On 3/28 patient went back to the primary and she mentioned that she thought it was related to the vaccination. Doctor did not provide any other treatment/test; patient told to give it a few weeks. In the last week patient reports having vibration for 4 daysthey come and go even at night. Vibrations not as strong but still there. Vibrations come even when patient is at rest (sitting down)-- not doing anything physical; it is not something that she you could control.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling
Clinical narrative: Mother called stating school nurse had reported a swelling at injection site on left arm. School nurse advised taking child to PCP for assessment. Mother had not seen child yet, unaware of any other S/Sx.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Right arm is warm, tender, and red at injection site. Lightheaded.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Paraesthesia oral
Clinical narrative: TINGLING OF LIPS WITHIN 24 HOURS AND THEN SWOLLEN UPPER AND BOTTOM LIPS.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Meningococcal Conjugate given Men B was needed
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported in the patient; patient received an expired dose of Vaqta; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender.  The patient's medical history, concomitant medications, and concurrent conditions were not reported.  On 05-APR-2019, the patient received an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscularly, lot # R006209 and expiration date 16-MAR-2019, for prophylaxis (frequency and anatomical location were not provided) (expired product administered).       No adverse effects were reported in the patient, at the time of this report..
Sex: F
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report as received from a physician via company representative regarding a 14-year-old female patient. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dosing details, frequency, route of administration, anatomical site, lot number and expiration date were not provided) for prophylaxis. It was reported that on an unspecified date, also reported as after receipt the vaccine, the patient was diagnosed with non-HPV warts on her hands and feet. The physician stated that the patient was a swimmer and was exposed to chlorine.  At the time of the report, the patient was not recovered from non-HPV warts on her hands and feet.  No treatment was given for this event, it was unknown if laboratory or studies were performed. There was any intervention to prevent serious criteria. The causality between the event and the therapy with GARDASIL 9 was unknown.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored doses of VARIVAX and PROQUAD; This spontaneous report was received from an administrator referring to patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 28-MAR-2019 or 31-MAR-2019 or 02-APR-2019 or 03-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot# R023736 with expiration date on 20-AUG-2020 or measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot numbers R008697 and R000551, for prophylaxis (dose and routes of administration). The administered doses of the vaccines experienced temperature excursion -12.85 degrees Celsius for 15 minutes. There was no adverse effect reported.  This call was because of a data logger and there was not previous temperature excursion.   No product quality complaint was involved.   Lot number R008697 and R000551 are invalid lot numbers for  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) .  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1904USA003556:Original Case : 1904USA003556 US-009507513-1904USA004743:Original Case : 1904USA003556 US-009507513-1904USA004744:Original Case : 1904USA003556 US-009507513-1904USA004739:Original Case : 1904USA003556 US-009507513-1904USA004740: US-009507513-1904USA004742:
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient experienced swelling and redness of arm that continued to worsen days after vaccination, with swelling down to the elbow. Patient also reports itching on the arm of the vaccine.