chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Local reaction, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: Pt had local reaction over entire tricep. It's hard, welt, swelling, raised, warm. No blisters or other signs of anaphylaxis.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: PATIENT CALLED STATING THAT HE'D NOTICED 2 RED SPOTS ON HIS ARM APPROXIMATELY 2 WEEKS AFTER RECEIVING THE SHINGLE VACCINE. HE SUGGESTED THAT IT MAY BE SHINGLES THAT HE'S CONTRACTED AS A RESULT OF RECEIVING THE VACCINE. I ASKED THE PATIENT IF HE'D POSSIBLY BEEN STUNG OR BITTEN BY AN INSECT OR IF IT'S POSSIBLE THAT HE HAS BEEN IN CONTACT WITH SOMETHING THAT HE'S ALLERGIC TO. HE SAID THAT NEITHER OF MY SUGGESTIONS WERE THE CASE. I INFORMED THE PATIENT TO REPORT TO THE NEAREST ER OR URGENT CARE IF HIS SYMPTOMS PERSIST FOR A PROPER DIAGNOSIS.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Rash
Clinical narrative: Rash other than administration site and bruise other than administration site.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Contusion, Injection site pain, Mobility decreased
Clinical narrative: Right arm. Patient felt pain upon administration. Pain continued to worsen, arm bruised and unable to lift arm. Black and blue from shoulder to elbow. 8/28/17 went to MD told has cellulitis referred to surgeon.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Lymphadenopathy, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Swollen lymph nodes, sore throat, nausea headache, fever, tachycardia.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Tachycardia
Clinical narrative: Swollen lymph nodes, sore throat, nausea headache, fever, tachycardia.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Dysarthria, Dysstasia, Gait disturbance, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Patient's husband said today that she began slurring her words and having muscle weakness around 12-25-16. She is still having difficulty walking, standing, and talking. Her doctor believes that her symptoms may be consistent with Guillain-Barre syndrome even though symptoms began approximately 3 months after vaccination.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Pain, Pain in extremity, Tendon pain
Clinical narrative: Patient describes sore tendons/joints and says whole arm hurts to move for 8 days now. Explained to patient to try NSAIDS and cold ice packs on arm.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling, Lymphadenopathy, Swelling
Clinical narrative: After BEXSERO vaccine 4 hour later came with pain and swelling of the (R) upper arm extended to neck-swelling (R) shoulder. Supraclavicular lymphadenopathy.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Site of injection red and warm to touch.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Patient describes a bump and bruise at injection site. Describes bump as a large lump she can push around. It has not gotten better. Recommended seeking medical care.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Blister, Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Both vaccinations received in right deltoid but patient experienced severe swelling/fluid filled area near elbow with redness, fever, pain. Went to his Dr.'s office for treatment. Steroid shot, diphenhydramine, hydrocortisone cream.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Computerised tomogram normal, Full blood count normal, Mumps antibody test negative, Swelling, Swelling face
Clinical narrative: LT sided facial/neck swelling.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Sore arm, can't move currently. Dr. referral.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Pt called 8/28 of arm soreness, pain and edema asked pt to apply ice packs and take ES TYLENOL, which she did and if no improvement come to the office on 8/29. 8/29/17 C/O pain, edema and stiffness after PNEUMOVAX yesterday did apply ice and take ES TYLENOL. TYLENOL helped pain and ice on 15/off 15 min. Swelling has improved. (L) arm edematous, erythematous, warm and firm to touch surrounding injection site, decreased about 7 inches below inj. site.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity, Swelling
Clinical narrative: Pt called 8/28 of arm soreness, pain and edema asked pt to apply ice packs and take ES TYLENOL, which she did and if no improvement come to the office on 8/29. 8/29/17 C/O pain, edema and stiffness after PNEUMOVAX yesterday did apply ice and take ES TYLENOL. TYLENOL helped pain and ice on 15/off 15 min. Swelling has improved. (L) arm edematous, erythematous, warm and firm to touch surrounding injection site, decreased about 7 inches below inj. site.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Seizure
Clinical narrative: 2 seizures the night following flu shot, fever, chills.
Sex: U
Vaccine: MENB
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of diarrhea in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced diarrhea and vomiting. On an unknown date, the outcome of the diarrhea and vomiting were unknown. It was unknown if the reporter considered the diarrhea and vomiting to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by GlaxoSmithKline representative to Medical Information on behalf of the physician. The patient experienced diarrhea and nausea. The physician did not want to be contacted. No additional information was provided. This case had been linked with US2017130641, reported by same reporter.
Sex: U
Vaccine: MENB
Symptoms: Headache, Nausea, Pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain, nausea and headache. On an unknown date, the outcome of the pain, nausea and headache were unknown. It was unknown if the reporter considered the pain, nausea and headache to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by GlaxoSmithKline representative to Medical Information on behalf of the healthcare professional. The patient experienced severe soreness, headache and nausea. No additional information was provided. The physician did not want to be contacted. This case was linked with case US2017130642, reported by the same reporter.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Lumbar puncture, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of dizziness in a 19-year-old female patient who received BEXSERO (batch number 156701, expiry date 1st August 2017). On 24th July 2017, the patient received the 1st dose of BEXSERO. On 25th July 2017, 1 days after receiving BEXSERO, the patient experienced dizziness, sore throat, general body pain and fever. The patient was treated with Lorazepam and fentanyl. On an unknown date, the outcome of the dizziness, sore throat, general body pain and fever were recovered/resolved. The reporter considered the dizziness, sore throat, general body pain and fever to be probably related to BEXSERO. Additional details were provided as follows: The patient in the clinic had an anaphylactic reaction to the MenB vaccine. The incident happened a month ago and was not an anaphylactic reaction. On 25th July 2017, the body temperature was recorded as 104F. The patient was treated with Fentanyl and Lorazepam and the symptoms subsided. The patient required emergency room visit and had a spinal tap in the emergency room, but was not hospitalized.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Injection site bruising, Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 19-year-old female patient who received BEXSERO. On 16th August 2017, the patient received the 1st dose of BEXSERO. On 16th August 2017, immediately after receiving BEXSERO, the patient experienced injection site pain. On 17th August 2017, the patient experienced numbness of extremities and injection site bruising. On an unknown date, the outcome of the injection site pain, numbness of extremities and injection site bruising were not recovered/not resolved. The reporter considered the injection site pain, numbness of extremities and injection site bruising to be probably related to BEXSERO. Additional details were provided as follows: The patient received the BEXSERO vaccine in the left upper arm. Less than a day after vaccination, the patient complained of pain at injection site since she had received the injection. On 17th August 2017, 1 day after vaccination, the patient woke up in the morning with numbness in left arm below the elbow and left hand. The patient also had slight bruising at injection site. The reporter did not want the physician to be contacted regarding these events.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Mom noticed a couple of red bumps of patient's belly on Thursday evening, 8/24/17, little round bumps. Then they continued to spread on torso, to back of neck, they were itchy, no fever, no blisters. Woke up Sunday, itching. Mom took her to Walk In Clinic on 8/27. Was told to give her BENADRYL, which helped them. When mom called me on Monday morning 8/28/17, she was going to buy more BENADRYL, and patient had some bumps on her cheeks now.
Sex: M
Vaccine: DTAPIPV
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a male patient who received KINRIX. On an unknown date, the patient received KINRIX (subcutaneous). On an unknown date, unknown after receiving KINRIX, the patient experienced injection site pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site pain to be related to KINRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was a pharmacist who reported event for her son. The patient received KINRIX subcutaneously, which led to inappropriate route of administration. The area where injection occurred hurt the patient a lot. The reporter declined to provide demographics and declined to proceed with safety report.
Age: 36.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Exposure during pregnancy, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: Patient is in her 3rd trimester of pregnancy. The day following receiving the BOOSTRIX vaccine, the patient's arm was sore. As days progressed, she began to experienced pain when moving her arm. She is having difficulty performing normal daily functions due to pain upon mobility.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Muscle tightness
Clinical narrative: Dizzy and clenching of hands/tightening of body after vaccines. Pt did not remember this after vaccines. Alert and oriented, responding to RN questions right after.
Age: 25.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Pain, Soft tissue disorder, Swelling, Ultrasound scan abnormal
Clinical narrative: Pain, swelling; soft tissue fluid collection per ultrasound. Possible abscess. Treated with oral antibiotics x 7 days; TYLENOL; Ibuprofen; NORCO.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: 13x12cm erythematous and essentially indurated swollen area of left upper arm. Slightly warm compared to the side. Itchy. Treatment given - KEFLEX 250 mg/5m twice daily for 5 days can also give BENADRYL and cool compresses.
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain upper, Condition aggravated, Decreased appetite, Interchange of vaccine products, Muscular weakness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stomach cramps in a female patient who received RABAVERT. Co-suspect products included Rabies Vaccine, IMOVAX RABBIA. The patient's past medical history included automobile accident (16 years ago, the patient had a car accident). Concurrent medical conditions included muscle pain (experienced pain from a previous car accident 16 years before reporting date) and muscle weakness. On an unknown date, the patient received the 1st dose of RABAVERT and the 2nd dose of IMOVAX RABBIA. On an unknown date, 1 day after receiving RABAVERT, the patient experienced stomach cramps, appetite lost, muscle weakness, muscle pain, fever, condition aggravated and interchange of vaccine products. On an unknown date, the outcome of the stomach cramps, appetite lost, muscle weakness, muscle pain, fever, condition aggravated and interchange of vaccine products were unknown. It was unknown if the reporter considered the stomach cramps, appetite lost, muscle weakness, muscle pain, fever and condition aggravated to be related to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. The reporter declined to provide further limited demographic information beyond her first name and initial of her last name. The patient received one shot of RABAVERT in the emergency room (ER) around midnight. The next day, the patient had stomach cramps. The next shot, the patient received was another manufacturer's product IMOVAX, thus leading to interchange of vaccine products. She then had severe muscle pain and weakness on her left side, which she described as an exacerbation of pain from the previous car accident. Later, the patient had a low grade fever with loss of appetite. The patient said that she already had contacted the manufacturer of IMOVAX and was told that she should continue receiving IMOVAX instead of further RABAVERT injections. The reporter stated that she was calling to find out if the symptoms she was experiencing were due to RABAVERT or rabies as well as to inquiry if GlaxoSmithKline (GSK) recommended that she should continue with RABAVERT versus IMOVAX because most of her symptoms started after receiving IMOVAX. The reporter was provided a medical disclaimer and healthcare referral, and the call was placed on hold to further research for her product side effect inquiry. No further related details were provided.
Sex: F
Vaccine: RAB
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stomach cramps in a female patient who received RABAVERT. Co-suspect products included Rabies Vaccine, IMOVAX RABBIA. The patient's past medical history included automobile accident (16 years ago, the patient had a car accident). Concurrent medical conditions included muscle pain (experienced pain from a previous car accident 16 years before reporting date) and muscle weakness. On an unknown date, the patient received the 1st dose of RABAVERT and the 2nd dose of IMOVAX RABBIA. On an unknown date, 1 day after receiving RABAVERT, the patient experienced stomach cramps, appetite lost, muscle weakness, muscle pain, fever, condition aggravated and interchange of vaccine products. On an unknown date, the outcome of the stomach cramps, appetite lost, muscle weakness, muscle pain, fever, condition aggravated and interchange of vaccine products were unknown. It was unknown if the reporter considered the stomach cramps, appetite lost, muscle weakness, muscle pain, fever and condition aggravated to be related to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. The reporter declined to provide further limited demographic information beyond her first name and initial of her last name. The patient received one shot of RABAVERT in the emergency room (ER) around midnight. The next day, the patient had stomach cramps. The next shot, the patient received was another manufacturer's product IMOVAX, thus leading to interchange of vaccine products. She then had severe muscle pain and weakness on her left side, which she described as an exacerbation of pain from the previous car accident. Later, the patient had a low grade fever with loss of appetite. The patient said that she already had contacted the manufacturer of IMOVAX and was told that she should continue receiving IMOVAX instead of further RABAVERT injections. The reporter stated that she was calling to find out if the symptoms she was experiencing were due to RABAVERT or rabies as well as to inquiry if GlaxoSmithKline (GSK) recommended that she should continue with RABAVERT versus IMOVAX because most of her symptoms started after receiving IMOVAX. The reporter was provided a medical disclaimer and healthcare referral, and the call was placed on hold to further research for her product side effect inquiry. No further related details were provided.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Fatigue, Lymphadenopathy, Mobility decreased, Musculoskeletal pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cold in a 53-year-old female patient who received FLUARIX Quadrivalent (batch number XN54L, expiry date 7th June 2018. On 18th August 2017, the patient received FLUARIX Quadrivalent .5 ml. On 18th August 2017, less than a day after receiving FLUARIX Quadrivalent, the patient experienced cold, shoulder pain, unable to swallow, swollen glands, fatigue and mobility decreased. In August 2017, the outcome of the cold, shoulder pain, unable to swallow, fatigue and mobility decreased were recovered/resolved and the outcome of the swollen glands was recovering/resolving. The reporter considered the cold, shoulder pain, unable to swallow, swollen glands, fatigue and mobility decreased to be related to FLUARIX Quadrivalent. Additional details were provided as follows: This case was not previously reported to anyone. The patient received FLUARIX Quadrivalent vaccine in left deltoid. The patient experienced some side effects. The patient was feeling cold and she was fatigued after receiving the vaccine. The patient was tired and she could not swallow. She had a swollen gland and her shoulder was sore and could not move her arm. The patient was feeling better at the time of reporting, but she had a little swollen gland but not as bad as before. The patient was taking other medications, however, the reporter did not want to provided the medication names. The reporter suggested that we could contact and had provided contact details for the same.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Nasopharyngitis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cold in a 53-year-old female patient who received FLUARIX Quadrivalent (batch number XN54L, expiry date 7th June 2018. On 18th August 2017, the patient received FLUARIX Quadrivalent .5 ml. On 18th August 2017, less than a day after receiving FLUARIX Quadrivalent, the patient experienced cold, shoulder pain, unable to swallow, swollen glands, fatigue and mobility decreased. In August 2017, the outcome of the cold, shoulder pain, unable to swallow, fatigue and mobility decreased were recovered/resolved and the outcome of the swollen glands was recovering/resolving. The reporter considered the cold, shoulder pain, unable to swallow, swollen glands, fatigue and mobility decreased to be related to FLUARIX Quadrivalent. Additional details were provided as follows: This case was not previously reported to anyone. The patient received FLUARIX Quadrivalent vaccine in left deltoid. The patient experienced some side effects. The patient was feeling cold and she was fatigued after receiving the vaccine. The patient was tired and she could not swallow. She had a swollen gland and her shoulder was sore and could not move her arm. The patient was feeling better at the time of reporting, but she had a little swollen gland but not as bad as before. The patient was taking other medications, however, the reporter did not want to provided the medication names. The reporter suggested that we could contact and had provided contact details for the same.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Inflammation, Pyrexia
Clinical narrative: Cellulitis like Rx - redness - increased fever - inflammation.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Dizziness, Headache, Pain, Vomiting
Clinical narrative: Dizziness, headache, vomiting, chills/body aches (in sequence) symptoms started within 1/2 hr of injection.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Muscle aches (myalgia), fever, headache. Seen in ER 8/23/17, IV fluids, TORADOL; TYLENOL. Dschgd 8/23/17 PM.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Burning sensation, Dizziness, Syncope
Clinical narrative: HPV was administered first on left arm. MENVEO was administered next, pt complained of burning in the arm. Nurse advised to move arm. After moving arm, pt had dizziness, then fainting spell for less than 1 min. Doctor gave juice and monitored patient's BP and heart rate for the next 30 mins. Patient resumed normal mented status and exam in 5 minutes. BP went up with fluids and did not complain of any dizziness.
Age: 0.33
Sex: F
Vaccine: HIBV, DTAPHEPBIP, HIBV
Symptoms: Injection site discolouration
Clinical narrative: A black mark was left at injection site after giving HIBERIX.
Age: 0.17
Sex: M
Vaccine: HIBV, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration, Injection site discolouration
Clinical narrative: A black mark was left at injection site after giving HIBERIX.
Age: 0.17
Sex: M
Vaccine: HIBV, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site discolouration
Clinical narrative: A black mark was left at injection site after giving HIBERIX.
Age: 0.33
Sex: F
Vaccine: HIBV, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Immediate post-injection reaction, Injection site discolouration
Clinical narrative: A black mark was left at injection site after giving HIBERIX.
Age: 0.33
Sex: F
Vaccine: HIBV, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site discolouration
Clinical narrative: A black mark was left at injection site after giving HIBERIX.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Syncope
Clinical narrative: Given HPV shot patient was anxious about having shots states hates needles; I give the shot about 2 minutes he was pale. I ask him to lay down and he passed out for about 2 minutes. I call the nurses for assistant patient recovery.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Given HPV shot patient was anxious about having shots states hates needles; I give the shot about 2 minutes he was pale. I ask him to lay down and he passed out for about 2 minutes. I call the nurses for assistant patient recovery.
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received PNEUMOVAX-23 and has developed very large, red, painful welt. Patient does not report having any kind of reaction to vaccines like this in the past.
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain, Urticaria
Clinical narrative: Patient received PNEUMOVAX-23 and has developed very large, red, painful welt. Patient does not report having any kind of reaction to vaccines like this in the past.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram, Laboratory test, Lumbar puncture, Myelitis transverse, Nuclear magnetic resonance imaging brain
Clinical narrative: Caused Transverse Myelitis.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Nuclear magnetic resonance imaging spinal, Nuclear magnetic resonance imaging thoracic
Clinical narrative: Caused Transverse Myelitis.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, MMR
Symptoms: Erythema, Joint swelling
Clinical narrative: MOTHER REPORTED THAT CHILD EXPERIENCED SEVERE REDNESS AND SWELLING IN LEFT ARM THAT BEGAN THE DAY OF RECEIVING VACCINES. THE REACTION RESOLVED OVER A THREE DAY PERIOD. MOTHER TREATED CHILD WITH IBUPROFEN AND DIPHENHYDRAMINE.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Beginning sometime in June 2017, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L045117, expiration date 16-OCT-2018, lot # L048236, expiration date 31-MAR-2018) for prophylaxis. The vaccines were improperly stored in 1.3 degrees Celsius for 117 hours. There was no previous temperature excursion. No data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA012808: US-009507513-1708USA012809:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored dose of ROTATEQ lot # M045545 and lot number M041770 for prophylaxis. No adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. In August 2017 the patient was vaccinated with an expired dose of ZOSTAVAX lot # M020921, expiration date 18-JUL-2017, for prophylaxis. No adverse effects reported.
Age: 0.25
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a other health professional refers to two 3 month old patients. On 23-APR-2001, those patients were vaccinated with M-M-R II for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PNC
Symptoms: Contraindication to vaccination
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old male patient with cardiac disorder, diabetes mellitus, blood disorder and Guillain-Barre syndrome. On 06-OCT-2009, the immunocompromised patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously in the left arm, lot # M041086 with expiration date on 03-JAN-2018. Other suspect therapies included PREVNAR on 07-AUG-2015, 0.5 ml, intramuscularly in the left arm, lot # UI837AA with expiration date on 30-JUN-2018 and on 05-NOV-2015, 0.5 ml, intramuscularly in the right arm, lot # R73811 with expiration date in May 2018.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of an unknown age. On 25-AUG-2017, the patient was vaccinated with ZOSTAVAX lot # M023687, subcutaneous for prophylaxis. Concomitant therapies included sterile diluent. On 25-AUG-2017, the patient experienced expired product administered. No adverse effects were reported. The outcome of expired product administered and no adverse event was unknown.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Injury, Nasal injury, Tooth loss
Clinical narrative: This spontaneous report as received from a physician refers to a 11 year old female patient. On JUL-2017 the patient was vaccinated with GARDASIL 9 for prophylaxis. Other suspect therapies included MENACTRA and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid. On JUL-2017 the patient experienced fall, tooth loss and nasal injury. The outcome of fall, tooth loss and nasal injury is unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. On an unknown date the patient experienced herpes zoster. The outcome of herpes zoster is unknown.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a patient of unknown demographics. The patient's medical history was not reported. On an unknown date in 2014, the patient was vaccinated with GARDASIL (Strength, dose, frequency, route, anatomical location, lot/batch # and expiration date were not reported) for prophylaxis. On 22-JUL-2016, the patient was vaccinated with GARDASIL 9, intramuscularly for prophylaxis (Inappropriate schedule of drug administration). There were no adverse effects reported. There was no product quality complaint involved.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old patient. On 26-JUL-2017, the patient was vaccinated with ZOSTAVAX lot # M039452 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On 26-JUL-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date, the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX.    Additional information is not expected.; Sender's Comments: US-009507513-1708USA012397: US-009507513-1708USA012398: US-009507513-1708USA012396: US-009507513-1708USA012399: US-009507513-1707USA007162: US-009507513-1708USA012395:
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old patient. On 02-AUG-2017, the patient was vaccinated with ZOSTAVAX lot # M039452 for prophylaxis. Concomitant therapies included sterile diluent. On 02-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date, the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. Additional information is not expected. Sender's Comments: US-009507513-1708USA012397: US-009507513-1708USA012398: US-009507513-1708USA012396: US-009507513-1708USA012399: US-009507513-1708USA012394: US-009507513-1707USA007162.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old patient. On 02-AUG-2017, the patient was vaccinated with ZOSTAVAX lot # M039452 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On 02-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date, the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX.    Additional information is not expected.; Sender's Comments: US-009507513-1708USA012397: US-009507513-1708USA012398: US-009507513-1707USA007162: US-009507513-1708USA012399: US-009507513-1708USA012394: US-009507513-1708USA012395:
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old patient. On 14-AUG-2017, the patient was vaccinated with ZOSTAVAX lot # M032141 for prophylaxis. Concomitant therapies included sterile diluent. On 14-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date, the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. Additional information is not expected. Sender's Comments: US-009507513-1707USA007162: US-009507513-1708USA012398: US-009507513-1708USA012396: US-009507513-1708USA012399: US-009507513-1708USA012394: US-009507513-1708USA012395.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old patient. On 16-AUG-2017, the patient was vaccinated with ZOSTAVAX lot # M032141 for prophylaxis. Concomitant therapies included sterile diluent. On 16-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date, the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. Additional information is not expected. Sender's Comments: US-009507513-1708USA012397: US-009507513-1707USA007162: US-009507513-1708USA012396: US-009507513-1708USA012399: US-009507513-1708USA012394: US-009507513-1708USA012395.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old patient. On 19-AUG-2017, the patient was vaccinated with ZOSTAVAX lot # M039452 for prophylaxis. Concomitant therapies included sterile diluent. On 19-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date, the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. Additional information is not expected. Sender's Comments: US-009507513-1708USA012397: US-009507513-1708USA012398: US-009507513-1708USA012396: US-009507513-1707USA007162: US-009507513-1708USA012394: US-009507513-1708USA012395.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD lot # M042497, expiration date 14-APR-2017, for prophylaxis. Concomitant therapies included sterile diluent (MRK). Sender's Comments: US-009507513-1707USA004856.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 13-OCT-2015 the patient was vaccinated with M-M-R II lot # L009213 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to M-M-R II. Sender's Comments: US-009507513-1708USA002370: US-009507513-1708USA002371: US-009507513-1708USA002372: US-009507513-1708USA002373: US-009507513-1708USA002369: US-009507513-1708USA000870.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 dose 4 for prophylaxis. On an unknown date the patient experienced extra dose administered and no adverse event. The outcome of extra dose administered and no adverse event is unknown. The reporter considered extra dose administered and no adverse event to be not related to GARDASIL 9.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a physician referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (lot# M024681 with expiration date of 20-JAN-2018, strength, dosage, frequency and route unspecified) for prophylaxis. No adverse effects were reported. It was reported that temperature was from -14 to -10 degree C and time frame was 6 hours. There was previous temperature excursion which was from -14 to -10 degree C for 30 hours.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Beginning sometime in June 2017, the patients were vaccinated with improperly stored ROTATEQ (lot # M035452, expiration date 04-APR-2018, lot # M041815, expiration date 28-JUN-2018) orally for prophylaxis. The vaccines were improperly stored in 1.3 degrees Celsius for 117 hours. There was no previous temperature excursion. No data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA012809: US-009507513-1708USA001216.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Beginning sometime in June 2017, the patients were vaccinated with improperly stored GARDASIL 9 (lot # reported as M026306, expiration date 30-APR-2018, lot # M041212, expiration date 21-JUN-2019, lot # M040412, expiration date 30-JUN-2019) for prophylaxis. The vaccines were improperly stored in 1.3 degrees Celsius for 117 hours. There was no previous temperature excursion. No data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA012808: US-009507513-1708USA001216.
Age: 76.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Injection site swelling, Palpitations, Vaccination site pain
Clinical narrative: Severe Pain in left shoulder at vaccine site: Upper left arm swollen greatly (balloon size), Heart palpitations and some shortness of breath.
Age: 76.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site rash, Injection site reaction
Clinical narrative: Severe Pain in left shoulder at vaccine site: Upper left arm swollen greatly (balloon size), Heart palpitations and some shortness of breath.
Age: 76.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Musculoskeletal stiffness, Pain, Palpitations
Clinical narrative: Severe Pain in left shoulder at vaccine site: Upper left arm swollen greatly (balloon size), Heart palpitations and some shortness of breath.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Decreased appetite, Diarrhoea, Emotional disorder, Haematochezia, Injection site erythema
Clinical narrative: 4 month vaccines 6/16, Started with fussiness that evening, 6/17 with bouts of being inconsolable, Started with vomiting and diarrhea, Sunday and today more consolable, Decreased appetite. diarrhea, vomiting, red swollen legs and bloody stool.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Injection site swelling, Irritability, Vomiting
Clinical narrative: 4 month vaccines 6/16, Started with fussiness that evening, 6/17 with bouts of being inconsolable, Started with vomiting and diarrhea, Sunday and today more consolable, Decreased appetite. diarrhea, vomiting, red swollen legs and bloody stool.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On multiple unspecified date the patients were vaccinated with improperly stored ROTATEQ (lot M041181 expiry date 31-MAY-2018) (lot N004812 expiry date 04-OCT-2018) for prophylaxis. No adverse effects reported with any patients. The vaccine was exposed to temperature of 0°C to 1°C for a time frame of 35 minutes. Previous temperature excursion was reported (0°C to 1°C for 2 hours and 6 minutes). The call because of a data logger. No PQC involved. No further information provided. This is one of the several reports linked via same reporter link. Lot number N004812 has been verified to be a valid lot number for ROTATEQ. Sender's Comments: US-009507513-1708USA008410: US-009507513-1708USA008708: US-009507513-1708USA008708: US-009507513-1708USA008710.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 3 patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M041990 and expiration date 28-SEP-2019 (dose, frequency and route of administration were not reported) for prophylaxis. There were no adverse symptoms reported. Administered doses of vaccine experienced the temperature excursion from 9 to 25 degrees Celsius for 1 hour and 31 minutes. Data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown demographics. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 18-AUG-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # N002204 with expiration date on 19-JAN-2019 (dose and route of administration were not reported). There was no adverse effect reported. The administered dose of the vaccine experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 2 hours and a previous excursion of 6 to 14 degrees Fahrenheit for 7 hours and 36 minutes. Data logger was involved in recording of the temperature excursions. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA010661.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown demographics. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 21-AUG-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # N002204 with expiration date on 19-JAN-2019 (dose and route of administration were not reported). There was no adverse effect reported. The administered dose of the vaccine experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 2 hours and a previous excursion of 6 to 14 degrees Fahrenheit for 7 hours and 36 minutes. Data logger was involved in recording of the temperature excursions. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA010464.
Age: 57.0
Sex: F
Vaccine: HEP, HEPA, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 25-AUG-2017, the patient was vaccinated with M-M-R II lot # L028273, expiry date 28-JUL-2017 for prophylaxis. Concomitant therapies included sterile diluent. On 25-AUG-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date, the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to M-M-R II. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in August 2017, the patients were vaccinated with PROQUAD (recombinant human albumin (rHA)) lot # M037012, expiration date 21-FEB-2018, subcutaneously. Concomitant therapies included sterile diluent. On an unknown date in August 2017, the patients experienced incorrect product storage. Additional information has been requested. Sender's Comments: US-009507513-1708USA012836: US-009507513-1708USA012835.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in August 2017, the patients were vaccinated with VARIVAX lot # M009768, expiration date 24-MAR-2019. Concomitant therapies included sterile diluent. On an unknown date in August 2017, the patients experienced incorrect product storage. Additional information has been requested. Sender's Comments: US-009507513-1708USA012778.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in August 2017, the patients were vaccinated with ZOSTAVAX lot # N016185, expiration date 31-JUL-2018. Concomitant therapies included sterile diluent. On an unknown date in August 2017, the patients experienced incorrect product storage. Additional information has been requested. Sender's Comments: US-009507513-1708USA012778.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-08-26.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient developed hives to his face, trunk and arms 30 minutes after receiving MMR, VARIVAX, QUADRACEL. Patient returned to our office and oral Benadryl 12.5mg was administered. Patient did not have any breathing issues or oral swelling. Patient was given a subsequent dose of Benadryl at home. After speaking with patients mother on 8/30/17 hives have resolved. No swelling or itching reported. Patient was not treated at any other medical facility for the above reaction.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Haematoma, Pruritus, Rash, Rash erythematous
Clinical narrative: Patient reports itching and circular swollen rash began the day after the injection. Rash persisted and grew - by 8/28/17, rash had become an erythematous ring measuring 6 inches in diameter with a central hematoma where the skin was unraised. Patient was rx Amoxicillin 250mg PO, 1 capsule q8h and Hydroxizine 10mg PO, 1 capsule q8h.