chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Flushing, Throat tightness
Clinical narrative: Pt. reports throat tightness and facial flushing after 5th Anthrax dose. Pt. returned to clinic and was given 50 mg BENADRYL medication. VS monitored closely for 45 minutes. Pt. reports symptoms resolved after medication. Pt. educated to call 911 if symptoms returned.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Syncope
Clinical narrative: Fainting after received HPV vaccine MENVEO and TDaP.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Positive swelling and mild redness around the injection site with warmth. Non tender. BENADRYL 7.5 ml given.
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: Nausea, Poor quality sleep, Vomiting
Clinical narrative: Child was squirmy and restless while sleeping. At 2:00AM he woke up saying he was going to throw up. He went back to sleep for 30 minutes then woke up and began vomiting. Child went back to sleep at 3:30AM and slept for the rest of the morning and so far has been fine.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Patient called 2/2/2018 reporting severe pain to arm at injection site and radiating to shoulder and all of the left upper extremity. Pain was mild on day of injection and became increasingly worse (interfering with daily activities), reaching a plateau on 2/1/2018 and then continually decreasing. Client denied any swelling, edema, numbness, tingling, or loss of dexterity to area affected. This nurse reviewed Table 1 of GARDASIL insert regarding severe pain as injection site adverse reactions for her age group and sex. Patient reports some relief of pain with ibuprofen and cold compresses. She declines to seek care of medical provider.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Haemorrhage, Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Within 30-60 minutes of vaccine, patient developed swelling and redness and pruritis of left upper arm, below injection site. Mother reports that immediately after injection, patient had bleeding (more than normal). On exam 1 day later, there is a 11cm x 6.5cm indurated erythematous patch on left deltoid region, with visible injection site superior to patch. Nontender to palpation. No fluctuance. No other skin rashes/hives present. No shortness of breath, trouble swallowing, facial swelling, lip swelling, vomiting. She did have some mild abdominal pain this morning (usual type of pain for her). She has had multiple flu vaccines in the past with no reaction. No other vaccine reactions in the past. Questioning whether injection ended up subcutaneous rather than intramuscular.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Within 30-60 minutes of vaccine, patient developed swelling and redness and pruritis of left upper arm, below injection site. Mother reports that immediately after injection, patient had bleeding (more than normal). On exam 1 day later, there is a 11cm x 6.5cm indurated erythematous patch on left deltoid region, with visible injection site superior to patch. Nontender to palpation. No fluctuance. No other skin rashes/hives present. No shortness of breath, trouble swallowing, facial swelling, lip swelling, vomiting. She did have some mild abdominal pain this morning (usual type of pain for her). She has had multiple flu vaccines in the past with no reaction. No other vaccine reactions in the past. Questioning whether injection ended up subcutaneous rather than intramuscular.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pityriasis, Pruritus, Skin haemorrhage, Skin ulcer, Urticaria
Clinical narrative: Broke out in welts on back, thought to be pityriasis. Very itchy. Given hydroxyzine (can't recall dosage) seemed to help. Had a second outbreak on (approximate) first of Feb 2018. This time not just on back.  It was on basically all over my body. Received hydroxyzine in 25mg -3 times a day and one other medicine, pills. Meds didn't seem to work as itching seem to intensify. Bought over the counter GOLD BOND anti itch and CALADRYL. Helped a little. Itching was so bad I scratched until I bled. Have sores on body. Feb 7, 2018 returned to clinic and received Prednisone 20mg and Acyclovir 800mg to take and see if it helps relieve the itching. Also a cream was prescribed but wasn't in and will be mailed to me.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist, refers to a patient of unknown age and gender. Information on patient's medical history and concurrent conditions was not provided. On 10-JAN-2018, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 PFU, either from lot # N016185, expiration date 31-JUL-2018 or from lot # N021170, expiration date 27-OCT-2018 (dose number and route of administration were not reported) for prophylaxis.  Other suspect therapies included STERILE DILUENT. The pharmacist reported that, on an unknown date, the dose of ZOSTAVAX that was administered to the patient, suffered a data logged temperature excursion from 15°F to 46°F for 4 hours and 45 minutes. He also reported that a previous data logged excursion occurred, on an unknown date, from 15°F to 46°F for 7 hours and 45 minutes. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Nodule, Peripheral swelling
Clinical narrative: This spontaneous report has been received from a physician via company representative referring to a female patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 in the right arm for prophylaxis (strength, dose, route, lot number and expiration date were not provided). On an unknown date, "approximately 4 days after vaccination", the patient's arm was swollen, red and there was a painful knot. The outcome of peripheral swelling, nodule and erythema was unknown. The causality assessment between therapy with GARDASIL 9 and the events was not reported.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Patient had rash reaction in left thigh where PREVNAR was around injection site. Fever unknown etiology.
Age: 32.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash vesicular
Clinical narrative: Patient received vaccine on 01/24/18 with no adverse reaction. On 02/06, patient noticed a red, warm bump on injection site along with 2 varicella-like bumps on chest and back. RPH advised patient to avoid coming in contact with anyone susceptible to contracting varicella. RPH counselled on use of calamine to help ease itch, along with cold compresses and bath with baking soda for symptom relief.
Age: 32.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Dermatitis allergic, Injection site erythema, Injection site warmth
Clinical narrative: Patient received vaccine on 01/24/18 with no adverse reaction. On 02/06, patient noticed a red, warm bump on injection site along with 2 varicella-like bumps on chest and back. RPH advised patient to avoid coming in contact with anyone susceptible to contracting varicella. RPH counselled on use of calamine to help ease itch, along with cold compresses and bath with baking soda for symptom relief.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: 6cm x 2cm area of local swelling, pain, redness, and heat.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Hypersensitivity, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Allergic reaction to Zoster Vaccine. Pt states the night of the vaccine, he began to experience pain to BUE, stiffness, arms locking up, SOB, and dizziness and it lasted for the next 2 days. States he contacted Triage RN on phone the next day to report it and was told to go to nearest ED, pt states he declined to go to ED due to feeling slightly better and having his wife with him to watch him. Pt states he will not be able to receive the second dose but states he feels great now. Pt denies, SOB, N/V/D, chest pain, pain to BUE, stiffness, dizziness, muscle cramps at this time.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Uterine dilation and curettage
Clinical narrative: Allergic reaction to Zoster Vaccine. Pt states the night of the vaccine, he began to experience pain to BUE, stiffness, arms locking up, SOB, and dizziness and it lasted for the next 2 days. States he contacted Triage RN on phone the next day to report it and was told to go to nearest ED, pt states he declined to go to ED due to feeling slightly better and having his wife with him to watch him. Pt states he will not be able to receive the second dose but states he feels great now. Pt denies, SOB, N/V/D, chest pain, pain to BUE, stiffness, dizziness, muscle cramps at this time.
Age: 0.58
Sex: M
Vaccine: IPV, TDAP
Symptoms: Wrong drug administered
Clinical narrative: I mistakenly took a BOOSTRIX vaccine from our immunization fridge rather than an INFANRIX and inadvertently administered it to my 7 month old patient. Once I realized what I had done I immediately notified the doctor and the mother of the patient. Dr. then notified the Health Dept to speak with one of the immunization nurses there. They together reviewed the prescribing information. Dr. then went and spoke with and reassured the mother of the error and what to watch for in the case of an adverse reaction.
Age: 12.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness, Malaise
Clinical narrative: Patient tensed prior to giving shot. Shot was administered. He was fine. After giving shot, pharmacist was notified that he has passed out during shot administration. Patient wasn't feeling well. Pharmacist asked patient to remain seated. He started passing out. He passed out and came back to. Was given food and drink and sat for 15 minutes. Patient was fine and was able to leave pharmacy unassisted with father.
Age: 1.25
Sex: F
Vaccine: FLU4, MMR
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Within minutes of her first MMR she developed redness and wheals at injection site, total area of involvement was about 6cm. 12.5mg of BENADRYL given.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Rash
Clinical narrative: PATIENT DEVELOPED A RASH ON CHEST AND TRUNK.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Posture abnormal
Clinical narrative: Before shot pt expressed her fear of needle stating she wasn't going to look.. I gave her the shot place the Band Aid.. pt then slumped forward and blacked out for a few second.. she came around  we offered BENADRYL .. her dad came in gave him BENADRYL to go and informed to seek medical attention.
Age: 76.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site rash
Clinical narrative: Patient presented on 7 February 2018 stating she just came from the physician's office with a rash on her arm where she received two shots (PREVNAR 13 and FLUZONE QUAD). Prescriber gave her a steroid ointment and she was satisfied with this. I asked if the physician's office call cost her anything - she said it did not. I refunded the cost of the ointment to her.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Aches/pain within 6 to 8 hours; fever/chills next day.
Age: 14.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Within minutes, she had fatigue, increased injection site soreness. Redness, muscle pain, swelling noted within 10 minutes after TRUMENBA injection.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain
Clinical narrative: Persistent soreness/pain and restriction of movement since day after vaccination. Slight improvement, but no resolution.
Age: 34.0
Sex: M
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: I do not know, I was not the one the pt. reported to. I was advised by my supervisor to fill this out.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Pyrexia, Seizure
Clinical narrative: This is what Mom reported to me on 02-07-2018. On 11-24-2017, the child had a fever of 101 degrees and then had a seizure. They took the child to the emergency room. According to Mom, one of the seizures lasted 45 minutes. Health Center flew the child out to another Hospital. The child stayed at hospital for 3 or 4 nights according to Mom. Mom reports the child was on medication for seizures, but isn't anymore. Mom reports that the child has not had any seizures since this.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: The patient's upper arm got all swollen on the side where she got the vaccine. She said it "swelled up to the size of her thigh". It was sore to the touch and had limited range of motion. She was instructed to watch it, and if it looked like the swelling was getting worse, or if she had fevers, to go see a doctor.  She started feeling worse, and had fevers up to 103 degrees. She went in to the Dr, and was not given an antibiotic, for they felt it was just a strong response to the vaccine. BENADRYL was prescribed, and helped to decrease the swelling and reaction. At the time she saw the MD, the injection site swelling was the size of a baseball, and they marked it with a pen. It didn't get worse, and today when she came to tell me about this, the site looked much better, and was not raised, nor fevered.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Emotional distress, Tinnitus
Clinical narrative: I developed tinnitus approximately 1 hour after having the extra dose flu vaccine for adults 65 at my pharmacy. I had an appointment with ENT today and he stated the vaccine could have contributed to development of the tinnitus. I thought it should be reported as the tinnitus is very distressing and I am now being treated for it.
Sex: F
Vaccine: FLU4
Symptoms: Eye haemorrhage
Clinical narrative: This case was reported by a pharmacist and described the occurrence of broken blood vessel in eye in a female patient who received FLUARIX Quadrivalent. On 15th January 2018, the patient received FLUARIX Quadrivalent. On an unknown date, less than a week after receiving FLUARIX Quadrivalent, the patient experienced broken blood vessel in eye (serious criteria GSK medically significant). On an unknown date, the outcome of the broken blood vessel in eye was unknown. It was unknown if the reporter considered the broken blood vessel in eye to be related to FLUARIX Quadrivalent. Additional details were provided as follows: On 3rd February 2018 at 4:15 pm, the reporter called and stated that the patient had a FLUARIX Quadrivalent that she thought she had an adverse reaction to the flu shot. The flu shot was given to the patient at approximately by noon on that day, by the pharmacist on duty. The patient presented to the pharmacy about 27 hours after the injection and she had a broken blood vessel in her eye. The patient was examined by the pharmacist, the nurse practitioner in the clinic, the doctor in the optometry office and she was told that there was a 99.9 percent chance that broken blood vessel in her eye was not from the flu shot, and there were a million different ways that would have happened, but after spending 3 hours with the patient, she wanted it reported that the flu shot gave her a broken blood vessel in her eye. On 5th February 2018 at 11:54 am, an attempted was made to contact reporter for additional patient information, but reporter was not working that day and employee on duty was not aware of the situation. No additional information was able to be obtained.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse events was given higher dose.
Age: 29.0
Sex: M
Vaccine: MENB
Symptoms: Irritable bowel syndrome
Clinical narrative: Patient had symptoms of IBS after vaccine.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Redness on LT deltoid area, itchiness x 2 days.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness on LT deltoid area, itchiness x 2 days.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Injection site erythema, Pain, Pain in extremity, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 77-year-old female patient who received SHINGRIX. The patient's past medical history included neoplasm (spine tumor years ago). Concomitant products included atenolol, atorvastatin, levothyroxine, lisinopril and aspirin (Baby). On 18th January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a month after receiving SHINGRIX, the patient experienced injection site erythema and pain. On 20th January 2018, the patient experienced pain in arm and breast pain. The patient was treated with VICODIN. In January 2018, the outcome of the injection site erythema, pain in arm and breast pain were recovered/resolved. On an unknown date, the outcome of the pain was not recovered/not resolved. The reporter considered the injection site erythema, pain in arm, pain and breast pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she had a red arm which she described as angry on her left upper arm near the injection site. Two days later, she was sore to the touch and had pain under her left breast which was a striking pain like lightening. She had the pain for 4 days and then it resolved. This morning she awoke with the same pain under her right breast and she took VICODIN to help resolve the pain. She had a spine tumor years ago and experienced the same pain and she believed that her nerves were affected. She contacted her neurologist after the pain started under her left breast and they wanted to do an MRI but the pain resolved. The patient believed that her nerves could be weakened or susceptible which was causing the pain but she related the pain to the SHINGRIX vaccine.
Age: 75.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Cold sweat, Retching, Tremor
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of chills in a 75-year-old male patient who received SHINGRIX. Previously administered products included ZOSTAVAX with an associated reaction of headache (experienced severe probable reaction as headache after receiving 10 years before the time of reporting). Concomitant products included PNEUMOVAX. On 31st January 2018 15:00, the patient received SHINGRIX. On 31st January 2018 17:00, 2 hrs after receiving SHINGRIX, the patient experienced chills. On an unknown date, the patient experienced cold sweat and dry heaves. The patient was treated with ZOFRAN. On an unknown date, the outcome of the chills, cold sweat and dry heaves were recovering/resolving. The reporter considered the chills, cold sweat and dry heaves to be probably related to SHINGRIX. Additional details were provided as follows: The reporting healthcare professional was the patient. The patient received SHINGRIX on the left arm and PNEUMOVAX on the right arm concomitantly on the same day. The reporter did not have lot number or expiry date for the SHINGRIX or PNEUMOVAX. The patient experienced shaking chills, dry heaves and cold sweats on standing, hours after receiving a SHINGRIX administration. The patient received ZOFRAN after developing dry heaves in the middle of the night and the symptoms were alleviated the little.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Incorrect route of drug administration, Injection site discomfort
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site discomfort in a 60-year-old female patient who received SHINGRIX. Concomitant products included ADACEL. On 1st February 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 1st February 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In February 2018, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort and intramuscular formulation administered by other route were unknown. The reporter considered the injection site discomfort to be related to SHINGRIX. Additional details were provided as follows: The pharmacist report that he gave the 1st dose of SHINGRIX in the left arm subcutaneously, which led to inappropriate route of vaccination. The patient called yesterday and notified that no issues except usual discomfort at site. The pharmacist reported technicians in the pharmacy remove the vials and place in amber vial in fridge, pharmacist checked the NDC number, but he did not see the box that mentions intramuscular. He stated he was under the pretense this was like ZOSTAVAX and was a live vaccine to be given subcutaneously. The pharmacist was made aware this is a recombinant vaccine and to be given intramuscularly. The pharmacist was not at the location of the vaccination and could not provide lot number and expiration date of SHINGRIX product during time of this call.
Age: 61.0
Sex: F
Vaccine: HEPAB
Symptoms: Abdominal pain upper, Arthralgia, Asthma, Conjunctivitis, Diarrhoea
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pruritus in a adult female patient who received TWINRIX. Concomitant products included DULERA, Montelukast, PROVENTIL Inhaler and Supplement. On an unknown date, the patient received TWINRIX at an unknown dose. On an unknown date, unknown after receiving TWINRIX, the patient experienced pruritus, photosensitivity, conjunctivitis, swollen glands, upper abdominal pain, joint pain, nausea, swallowing difficult, headache, tinnitus, ear pain, asthma, malaise and diarrhea. On an unknown date, the outcome of the pruritus, photosensitivity, conjunctivitis, swollen glands, upper abdominal pain, joint pain, nausea, swallowing difficult, headache, tinnitus, ear pain, asthma, malaise and diarrhea were recovering/resolving. The reporter considered the pruritus, photosensitivity, conjunctivitis, swollen glands, upper abdominal pain, nausea, swallowing difficult, headache, tinnitus, ear pain, asthma, malaise and diarrhea to be possibly related to TWINRIX. The reporter considered the joint pain to be probably related to TWINRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional called and stated she had several adverse events on a patient who received the TWINRIX vaccine. Health care professional wanted to speak to a medical professional and she was filling out the VAERS report. The agent instructed the reporter that adverse event would be filed. Health care professional was anxious to speak to Medical Information to determine if product caused the adverse events, no additional details obtained. Health care professional stated she wanted to be contacted in relation to this adverse events and patient.
Age: 61.0
Sex: F
Vaccine: HEPAB
Symptoms: Dysphagia, Ear pain, Headache, Lymphadenopathy, Malaise
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pruritus in a adult female patient who received TWINRIX. Concomitant products included DULERA, Montelukast, PROVENTIL Inhaler and Supplement. On an unknown date, the patient received TWINRIX at an unknown dose. On an unknown date, unknown after receiving TWINRIX, the patient experienced pruritus, photosensitivity, conjunctivitis, swollen glands, upper abdominal pain, joint pain, nausea, swallowing difficult, headache, tinnitus, ear pain, asthma, malaise and diarrhea. On an unknown date, the outcome of the pruritus, photosensitivity, conjunctivitis, swollen glands, upper abdominal pain, joint pain, nausea, swallowing difficult, headache, tinnitus, ear pain, asthma, malaise and diarrhea were recovering/resolving. The reporter considered the pruritus, photosensitivity, conjunctivitis, swollen glands, upper abdominal pain, nausea, swallowing difficult, headache, tinnitus, ear pain, asthma, malaise and diarrhea to be possibly related to TWINRIX. The reporter considered the joint pain to be probably related to TWINRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional called and stated she had several adverse events on a patient who received the TWINRIX vaccine. Health care professional wanted to speak to a medical professional and she was filling out the VAERS report. The agent instructed the reporter that adverse event would be filed. Health care professional was anxious to speak to Medical Information to determine if product caused the adverse events, no additional details obtained. Health care professional stated she wanted to be contacted in relation to this adverse events and patient.
Age: 61.0
Sex: F
Vaccine: HEPAB
Symptoms: Nausea, Photosensitivity reaction, Pruritus, Tinnitus
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pruritus in a adult female patient who received TWINRIX. Concomitant products included DULERA, Montelukast, PROVENTIL Inhaler and Supplement. On an unknown date, the patient received TWINRIX at an unknown dose. On an unknown date, unknown after receiving TWINRIX, the patient experienced pruritus, photosensitivity, conjunctivitis, swollen glands, upper abdominal pain, joint pain, nausea, swallowing difficult, headache, tinnitus, ear pain, asthma, malaise and diarrhea. On an unknown date, the outcome of the pruritus, photosensitivity, conjunctivitis, swollen glands, upper abdominal pain, joint pain, nausea, swallowing difficult, headache, tinnitus, ear pain, asthma, malaise and diarrhea were recovering/resolving. The reporter considered the pruritus, photosensitivity, conjunctivitis, swollen glands, upper abdominal pain, nausea, swallowing difficult, headache, tinnitus, ear pain, asthma, malaise and diarrhea to be possibly related to TWINRIX. The reporter considered the joint pain to be probably related to TWINRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional called and stated she had several adverse events on a patient who received the TWINRIX vaccine. Health care professional wanted to speak to a medical professional and she was filling out the VAERS report. The agent instructed the reporter that adverse event would be filed. Health care professional was anxious to speak to Medical Information to determine if product caused the adverse events, no additional details obtained. Health care professional stated she wanted to be contacted in relation to this adverse events and patient.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Impaired work ability, Injection site pain, Neck pain
Clinical narrative: Initial unsolicited report received from a physician (patient-himself) on 18-Dec-2017. This case involves a 38-year-old male patient who was vaccinated with a 0.1 ml of dose of FLUZONE QUADRIVALENT ID injection once via intradermally (Batch number: UIS904AA, expiry date, dose in series were not reported) on the right arm on 17-Nov-2017. The patient's medical history was not reported and concomitant medications included Prednisone. On an unknown date, following vaccination, the patient had developed muscle pain, which radiating to right elbow and right side of neck. Also reported the patient was right handed, hard to work with the pain. Also there was intervenation required to prevent permanent impairment/damage. Lab investigations and corrective treatments were not reported. Outcome of all the events were not recovered. List of documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood blister, Injection site extravasation, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 71-year-old female patient. The patient did not have any pertinent medical history, concomitant therapies and drug reactions or allergies. On 18-JAN-2018, the patient was vaccinated with a dose of PNEUMOVAX23, lot# N030111 and expiration date: 21-APR-2019 (also reported as: 19-APR-2019) (dose and route of administration were not reported). On 18-JAN-2018, the patient experienced pain and swelling at the injection site. On 22-JAN-2018, the patient experienced a large clear lump at the injection site with clear liquid coming out. No treatment was given for the events and no lab diagnostics were performed. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX23 was not reported.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site discharge, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 71-year-old female patient. The patient did not have any pertinent medical history, concomitant therapies and drug reactions or allergies. On 18-JAN-2018, the patient was vaccinated with a dose of PNEUMOVAX23, lot# N030111 and expiration date: 21-APR-2019 (also reported as: 19-APR-2019) (dose and route of administration were not reported). On 18-JAN-2018, the patient experienced pain and swelling at the injection site. On 22-JAN-2018, the patient experienced a large clear lump at the injection site with clear liquid coming out. No treatment was given for the events and no lab diagnostics were performed. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX23 was not reported.
Age: 65.0
Sex: F
Vaccine: FLU3, TDAP, FLU3
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient reported pain in left arm (hurting all the up her clavicle). She could not tolerate cold packs on it so is using heat on it and taking ibuprofen. She consulted with her OB/Gyn who said it will take time and had her husband ask his orthopedic dr friend about it and he also said...give it time. I followed up with her today and she reports, still painful.
Age: 65.0
Sex: F
Vaccine: FLU3, TDAP, FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient reported pain in left arm (hurting all the up her clavicle). She could not tolerate cold packs on it so is using heat on it and taking ibuprofen. She consulted with her OB/Gyn who said it will take time and had her husband ask his orthopedic dr friend about it and he also said...give it time. I followed up with her today and she reports, still painful.
Age: 26.0
Sex: M
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: CD4 lymphocytes abnormal
Clinical narrative: Flu like symptoms (bodyaches, headaches, fatigue, runny nose, fever) that lasted for less than 1 week.
Age: 26.0
Sex: M
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Fatigue, HIV test positive, Headache, Influenza like illness, Laboratory test
Clinical narrative: Flu like symptoms (bodyaches, headaches, fatigue, runny nose, fever) that lasted for less than 1 week.
Age: 26.0
Sex: M
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Pain, Pyrexia, Rhinorrhoea, Urine analysis
Clinical narrative: Flu like symptoms (bodyaches, headaches, fatigue, runny nose, fever) that lasted for less than 1 week.
Age: 26.0
Sex: M
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Acquired immunodeficiency syndrome, CD4 lymphocytes decreased, Immunology test, Immunology test abnormal, Rash generalised
Clinical narrative: Flu like symptoms (bodyaches, headaches, fatigue, runny nose, fever) that lasted for less than 1 week.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Dizziness, Exposure during pregnancy, Pyrexia, Ultrasound antenatal screen normal
Clinical narrative: Per the patient, she reported went home and within hours she states she was vomiting, had diarrhea, felt light headed and was having fevers. She reports she was advised to go to the ER. Per ER note, Pt was instructed to continue drinking fluids, and given 500 ml of saline.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Per the patient, she reported went home and within hours she states she was vomiting, had diarrhea, felt light headed and was having fevers. She reports she was advised to go to the ER. Per ER note, Pt was instructed to continue drinking fluids, and given 500 ml of saline.
Age: 33.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist referring to an unspecified patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unspecified date, the patient may have received an improperly stored dose of VARIVAX (lot # N015475, expiration date 18-MAY-2019; dose and route of administration were not reported) for prophylaxis (product storage error). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 36 hours. Data logger was not involved. There were no previous excursions reported. Follow up information has been received from the pharmacist on 07-FEB-2018 referring the 33 years old male patient. On 03-JAN-2018, the patient was vaccinated with the first dose of VARIVAX vial subcutaneously in left side (location was not provided), which was reconstituted with sterile diluent (manufacturer unknown). On the same day, the patient also received the first dose of BOOSTRIX (0.5 ml, lot# TB2R2; expiration date unknown) intramuscularly in left side (location was not provided) for prophylaxis. The sterile diluent (manufacturer unknown) had been out from fridge nearly 3 days before being used for vaccination. The reporter had been confirmed the product was good at room temperature for 7 days.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse, referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 15-JAN-2018, the patient was vaccinated with the first dose of properly stored but expired GARDASIL 9 for prophylaxis, lot # reported as L036302 and expiration date on 20-DEC-2017 (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. No product quality complaint was involved.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding an unspecified patient of unknown demographics. Information on pertinent medical history and concomitant medications were not reported. On 18-JAN-2018, the patient received improperly stored VARIVAX lot# N020016 with expiry date of 17-JUL-2019 for prophylaxis. The patient also received a properly stored sterile diluent  lot# M037020 with expiry date of 02-MAY-2019. Temperature: -14 C to -10 C. Timeframe: 10 minutes. There was a previous temperature excursion. -14 C to -10 C for 327 minutes. The call was because of data logger. No adverse effect was reported. Follow up information has been received on 30-JAN-2018 from the registered nurse (R.N) referring to a 13 months old female patient in regards to the letter received. The registered nurse stated that this patient did not experience any adverse events. The request for information was reviewed with the registered nurse in light of vaccine storage events. At the time of report, the registered nurse was able to inform regarding the patient who received VARIVAX Lot N020016 was a female. The registered nurse had no further information. The registered nurse would not be sending back the form. Additional information was not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse, referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history drug reactions or concurrent conditions. On 19-JAN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N012619, expiration date 21-APR-2019) (dose, frequency and route of administration were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 6 to 14 degrees Fahrenheit for 30 minutes, as recorded by a data logger. The vaccine was reconstituted with a sterile diluent (manufacturer unknown) which was properly stored. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. On 31-JAN-2018, a call was received from the nurse, who stated that the patient had no adverse experience from receiving improperly stored vaccine dose. Nurse reported that physician would complete the form and he would place ''not applicable" for adverse event related questions on the form. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Local reaction, Product administered at inappropriate site
Clinical narrative: This spontaneous report was received from a registered nurse refers to a non-pregnant female patient of unknown age. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. In approximately November 2017 (reported as "about 2 months ago"), the patient was vaccinated with a dose of M-M-R II (dose, lot #, expiration date and route were not reported) for routine vaccination. The vaccine was reconstituted with sterile diluent (lot # and expiration date were not reported) and administered in the abdomen because the patient reported that she got an unspecified "flu shot the week before and her arm was hurting". In 2017 (reported as "about 3 weeks later"), the patient experienced "localized red reaction on the abdomen"(erythema and injection site reaction). The patient sought medical attention came back to the clinic and unspecified treatment was given. On unknown date, the patient recovered from erythema and injection site reaction.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # N012840, expiration date 28-JAN-2019, for prophylaxis) (strength, dose, route and frequency were not reported). The temperature excursion was of 47°F to 77°F (54.9 F), during 15 hours. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from an unknown reporter via company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapy were not reported. On an unknown dates, the patient was vaccinated with a first and second dose of GARDASIL (dose, lot #, expiration date and route were not reported) for prophylaxis. Later on unknown date, the patient received one dose of GARDASIL 9 (dose, lot #, expiration date and route were not reported) for prophylaxis. No adverse effects were reported.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 14 year old female patient. The patient had no pre-existing physician diagnosed allergies, birth defects and medical conditions. The patient had no illness at the time of the vaccination. The patient had no concomitant medication. On the morning of 07-NOV-2017, the clinic refrigerator had a temperature excursions of 39/48 degrees Fahrenheit (F). Temperature was short lived as believed by clinic staff but was unsure on the length of time of the excursions. The patient went to clinic for examination. On 07-NOV-2017, the patient was vaccinated with first dose of improperly stored dose of GARDASIL 9 (dose and unit not reported) (lot # M040412, expiry date: 30-JUN-2019) intramuscularly for prophylaxis at public health clinic/hospital with private funds. The patient did not receive any prescription drug treatment. The patient tolerated immunization well. No adverse event or complications were noted. It was reported that possibly a temperature excursions occurred as a result of reading from a Digital Data Logger. The reporting nurse stated that the state representative was notified on 22-DEC-2017 and the manufacturer was notified on 04-JAN-2018 who stated it should be ok.
Age: 0.92
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a female patient currently 11 years of age. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 03-APR-2007 (reported as 12 days before she turned one year old), the patient was vaccinated with an unspecified dose of VAQTA (dose, frequency, route, lot # and expiry date were not reported) at an unspecified location for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. The patient concurrent condition and medical history were not reported. On an unknown date the patient was mistakenly vaccinated with SHINGRIX when he should have been vaccinated with VARIVAX. No adverse symptoms reported. No product compliant reported.
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical student refers to a 03 months old male patient. Patient's concurrent conditions, medical history, concomitant medications were not reported. On 23-JAN-2018 the patient was vaccinated with improperly stored RECOMBIVAX HB (dose and route unknown) lot # N002202 expiration date 04-NOV-2019 for prophylaxis (Product storage error). The temperature was 53.2 F, time frame was 5 hours and 57 minutes. It was reported that there was no previous temperature excursion. This case is linked to the case 1802USA001357 (same reporter link).
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On 02-FEB-2018, the patient received both PROQUAD, subcutaneously (dose, lot# and expiration date were not reported) and M-M-R II (dose, route of administration, lot# and expiration date were not reported). Concomitant therapies included sterile diluent. No adverse effect was reported.
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a patient's friend husband referring to a 37 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, dose, route, lot # and expiration date were not reported). The reporter could not confirm how many doses, in the GARDASIL 9 series, the patient was administered. No adverse event was reported.
Age: 0.92
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Reaction on Rt thigh from injection site, it is about a quarter of redness and swelling and hard to the touch. Started on 2/6/18 overnight. No fevers. No drainage or pus from injection site.
Age: 51.0
Sex: F
Vaccine: RV5
Symptoms: Exposure via eye contact, Eye irrigation, Eye irritation, HIV test, Hepatitis C virus test
Clinical narrative: Immediately after administering the ROTATEQ vaccine to a 2 month old baby the child coughed and some of the ROTATEQ vaccine that was still remaining in the childs mouth was splashed into Patient (nurse-self) right eye.  Irritation was felt as well as blurry vision as the liquid was covering the patient's contact lens. Within 5 minutes eye was flushed with saline and report made. Protocol followed and ED visit for assessment was done @ hospital.
Age: 51.0
Sex: F
Vaccine: RV5
Symptoms: Liver function test, Vision blurred
Clinical narrative: Immediately after administering the ROTATEQ vaccine to a 2 month old baby the child coughed and some of the ROTATEQ vaccine that was still remaining in the childs mouth was splashed into Patient (nurse-self) right eye.  Irritation was felt as well as blurry vision as the liquid was covering the patient's contact lens. Within 5 minutes eye was flushed with saline and report made. Protocol followed and ED visit for assessment was done @ hospital.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Differential white blood cell count normal, Full blood count normal, Influenza virus test negative, Pyrexia, Rash generalised
Clinical narrative: Two days after the vaccination, patient had persistent fever of (104).  On the third day, had seizure due to fever. On day fifth, patient had generalized rash. Mild and moderate reactions.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Seizure, Stool analysis normal, Urine analysis normal
Clinical narrative: Two days after the vaccination, patient had persistent fever of (104).  On the third day, had seizure due to fever. On day fifth, patient had generalized rash. Mild and moderate reactions.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Differential white blood cell count normal, Influenza virus test negative, Pyrexia, Rash generalised, Seizure
Clinical narrative: Two days after the vaccination, patient had persistent fever of (104).  On the third day, had seizure due to fever. On day fifth, patient had generalized rash. Mild and moderate reactions.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Stool analysis normal, Urine analysis normal, White blood cell count normal
Clinical narrative: Two days after the vaccination, patient had persistent fever of (104).  On the third day, had seizure due to fever. On day fifth, patient had generalized rash. Mild and moderate reactions.