chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, warm to touch and swelling x 2 days -ice/MOTRIN.
Age: 6.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Headache, Nausea, Peripheral coldness, Tremor
Clinical narrative: Spoke with pt. dad. Pt had Hep A and typhoid injections about an hour ago and he is complaining of headache at back of head, nausea, cold hands and shaking arms. I encouraged that they call his physician and seek medical help. Dr. aware.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: PAIN, RED, WARM TO THE TOUCH.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Hypoaesthesia, Tunnel vision
Clinical narrative: Patient waited in clinic for 15 minutes post vaccination. About 15-20 minutes after vaccination pt reported to clinic window complaining of dizziness and tunnel vision. Brought back to clinic room for about 30 minutes with continued dizziness. Started having complaints of numbness in hands.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Pain in left arm immediately after injection. States pain is mild but has persisted.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests, Ear pain, Headache, Hearing aid user, Hypoacusis
Clinical narrative: Started as pain and ringing in right ear, headache, some stiffness and soreness in neck. End results partial loss of hearing in right ear. Did recover some hearing after several months.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain, Nuclear magnetic resonance imaging, Tinnitus
Clinical narrative: Started as pain and ringing in right ear, headache, some stiffness and soreness in neck. End results partial loss of hearing in right ear. Did recover some hearing after several months.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Redness & swelling at injection site x 3 days. Joint pain, myalgia from head to toe, fatigue x 2 weeks.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Rash, Skin mass, Swelling
Clinical narrative: On 3/09/2018 patient was accompanied by mother for immunizations was given dtap+hepb+ipv on the right vastus lateralis, with no complications, on 3/10/2018 mother stated that there was localized rash, erythema and swelling, and palpable lump under the skin which lasted until 3/20/2018. Mother did not bring child in for evaluation until 3/22/2018 and was seen by provider at that time. The exam was normal, without any sign of edema, rash, erythema or lump under skin of right or left upper thigh. All symptoms are based on mother's recall. Child had no reaction to the birth Hep B vaccine.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: Pt received vaccine f/u with primary care provider for a rash that appeared after being vaccinated with the smallpox vaccine. Pt stated that he produced a rash that looked like pimples across his chest with no other concerns or symptoms.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient reports development of the shingles virus in February 2018, approximately 10 months after receiving the vaccine. I explained that the vaccine does not fully prevent the virus, but that if the patient acquires the virus, the symptoms and length of the virus would be less severe. She was concerned that she had seen that the 'previous' shingles vaccine (ZOSTAVAX) had some 'problems' and didn't work.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of upper Left Arm--Measured about 20cm in length and 18cm round--Given Septra antibiotic for 7 days--Patient did not return for follow up appointment and did not answer or return any phone calls when message was left on home phone.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and swelling at injection site began day of vaccination and continuing 3 days later, although they have subsided greatly.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Erythema and swelling at injection site began day of vaccination and continuing 3 days later, although they have subsided greatly.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site reaction, Rash
Clinical narrative: The adverse event that occurred one day after immunization with SHINGRIX included idiopathic erythema and non-itchy red rash on areas of the upper arm, neck, shoulder, and back. After 3 days, post-immunization, the patient's injection site itself was self-limiting where pain and erythema resolved although a rash appeared on areas other than the injection site which included the back, neck, upper arm, and shoulder area. Patient reports that this type of rash occurs with some other immunizations in the past with his medical history. Symptoms of the rash were self-limiting and will seek out medical provider if rash continues or worsens. Based on patient's feedback, he did not feel as though emergency care was required for alleviation of symptoms.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: The adverse event that occurred one day after immunization with SHINGRIX included idiopathic erythema and non-itchy red rash on areas of the upper arm, neck, shoulder, and back. After 3 days, post-immunization, the patient's injection site itself was self-limiting where pain and erythema resolved although a rash appeared on areas other than the injection site which included the back, neck, upper arm, and shoulder area. Patient reports that this type of rash occurs with some other immunizations in the past with his medical history. Symptoms of the rash were self-limiting and will seek out medical provider if rash continues or worsens. Based on patient's feedback, he did not feel as though emergency care was required for alleviation of symptoms.
Age: 1.58
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Rash, Respiratory rate increased, Tachycardia
Clinical narrative: Rash on face, increased respirations, and tachycardia. Pt given BENADRYL and nebulizer treatment with albuterol. Symptoms resolved after ~1 hour of treatment. Pt sent home.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Injection site rash
Clinical narrative: Patient reported a feeling of rapid heartbeat starting at 5pm 03/20/2018. By 03/21/2018, the feelings of rapid heartbeat had disipated. She noticed a rash approximately 6 inches round at site of injection around 8am 03/21/2018. The rash slowly receded and by 1pm 03/22/2018, the size of rash was 3 inches round. No other symptoms reported.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Musculoskeletal pain
Clinical narrative: Soreness in shoulder.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Injection site hypoaesthesia
Clinical narrative: Patient reported lightheadedness/dizziness and numbness in the arm the vaccine was administered. I monitored her for about 15 minutes and took her blood pressure and heart rate. I advised to visit an urgent care or call EMT if symptoms get worse or any difficulty breathing/swelling of lips or face or chest pain. Patient elected to go home and seek medical help if needed. Her step-father was present at the time of incident.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pain, Peripheral swelling, Pyrexia
Clinical narrative: ALL S&S OCCURED WITHIN 48 HRS OF INJECTION, SWOLLEN ARM, ACHES, CHILLS, FEVER, MALAISE.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Pain
Clinical narrative: PATIENT REPORTED SWEATING AND BODY ACHES.
Age: 1.08
Sex: M
Vaccine: PNC13
Symptoms: Epistaxis, Lethargy, Pyrexia, Streptococcus test negative
Clinical narrative: Fever for 8 days, bloody nose, lethargic.
Age: 35.0
Sex: M
Vaccine: HPV9
Symptoms: Condition aggravated, Middle insomnia, Pain in extremity, Paraesthesia, Tremor
Clinical narrative: Patient started having tremor in left hand about 2 weeks after injection of GARDASIL 9 vaccine. Arm that was injected has been hurting. Tremors in both hands - always had tremor in the right hand; a few days ago, legs started to have tremors - was waking him from sleep. Arm that got injected started feeling tingly. Tremor in the hand if drawing - thumb/index finger. Lifelong slight tremor in right hand. Mother had essential tremor. Seeing Neurologist: Complete Neurological Care.
Sex: F
Vaccine: HEP
Symptoms: Blood corticotrophin decreased, Cortisol decreased, Exercise tolerance decreased, Fatigue
Clinical narrative: After hep b vaccine I had many low incidence side effects. I did not have an allergic reaction. Ever since the shot I have had physical fatigue, low exercise tolerance. I recently have been diagnosed with low cortisol levels. These recent symptoms are the same as I have had all along, but got more severe. I am wondering if there have been others at with cortisol issues after a hep b vaccine. I am not looking for blame, just trying to find ways to feel better.
Age: 59.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Anaphylactic reaction, Angioedema, Hypotension, Lip swelling, Pain in extremity
Clinical narrative: Patient is a 59 yo M with pmh of HTN, OSA, BPH, alcohol abuse, herpes genitalis who presented to the ED today for generalized body rash and lip swelling. Pt received pneumococcal vaccine and Tdap vaccines on 3/22/2017. Noted (R) arm pain yesterday and since this morning acute onset of worsening lip swelling and a circumoral pruritic disseminated body rash. Denies any stridor or shortness of breath. Pt also had presyncopal episode lasting about 5-10 seconds while his vitals were being taken at the ED triage. Symptoms: 1. Anaphylaxis, 2. Angioedema, 3. Skin Rash, 4. Hypotension. Treatment Drugs Used: 1. Epinephrine, 2. Methylprednisolone, 3. Ranitidine.
Age: 59.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Presyncope, Rash generalised, Rash pruritic
Clinical narrative: Patient is a 59 yo M with pmh of HTN, OSA, BPH, alcohol abuse, herpes genitalis who presented to the ED today for generalized body rash and lip swelling. Pt received pneumococcal vaccine and Tdap vaccines on 3/22/2017. Noted (R) arm pain yesterday and since this morning acute onset of worsening lip swelling and a circumoral pruritic disseminated body rash. Denies any stridor or shortness of breath. Pt also had presyncopal episode lasting about 5-10 seconds while his vitals were being taken at the ED triage. Symptoms: 1. Anaphylaxis, 2. Angioedema, 3. Skin Rash, 4. Hypotension. Treatment Drugs Used: 1. Epinephrine, 2. Methylprednisolone, 3. Ranitidine.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Generalised erythema, Immediate post-injection reaction, Injection site erythema, Injection site haematoma, Injection site pain
Clinical narrative: Gave MMRV SQ in (L) tricep-hematoma formed immediately with sm amt bldg. marked erythema noted at injection site. Gave KINRIX (R) deltoid with same reaction. Gave Hep A (L) anterior thigh with no reaction.  Used 25-g x 5/8 inch needle. Presented with generalized erythema and rash on arms, face, back, and torso. Post vaccination today was seen for kindergarten boosters prior to above sx. Mother denies any previous reactions. Vital signs stable here - wt. 20 kg, HR-80 RR-18 O2 sats-99% R/A. No sign of anaphylaxis - no respiratory distress, tongue edema, difficulty swallowing. Skin warm to touch immediately at arm injection sites. Skin "blotchy" with diffuse rash noted. This 5 yr old youngster is very fair skinned - Blue eyes and blonde haired. Because of the concern for anaphylaxis, we recommended an eval at ED. Patient was stable to transfer via private car. ED record - given Rx for the following: Ranitidine 105 BID, BENADRYL 12.5 mg TID x 3 days, Prednisolone 21 mg BID x 3 days, Epinephrine 0.15 mg IM x 1 PRN anaphylaxis (EPIPEN auto-injector). Update 3/22/18 - Mother sent child to school today. Patient c/o (L) arm and shoulder pain this A.M. The patient is a 5 y/o M who presented to the ED w/ a c/o a rash that began around 3:15 pm. Mother reports that pt had vaccine shots around 3:15 and began to develop a rash throughout his arms, face, back and legs. Pt denies any trouble breathing, throat tightness, abd pain, or diarrhea. There are no further complaints.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site rash, Injection site warmth, Rash, Rash macular
Clinical narrative: Gave MMRV SQ in (L) tricep-hematoma formed immediately with sm amt bldg. marked erythema noted at injection site. Gave KINRIX (R) deltoid with same reaction. Gave Hep A (L) anterior thigh with no reaction.  Used 25-g x 5/8 inch needle. Presented with generalized erythema and rash on arms, face, back, and torso. Post vaccination today was seen for kindergarten boosters prior to above sx. Mother denies any previous reactions. Vital signs stable here - wt. 20 kg, HR-80 RR-18 O2 sats-99% R/A. No sign of anaphylaxis - no respiratory distress, tongue edema, difficulty swallowing. Skin warm to touch immediately at arm injection sites. Skin "blotchy" with diffuse rash noted. This 5 yr old youngster is very fair skinned - Blue eyes and blonde haired. Because of the concern for anaphylaxis, we recommended an eval at ED. Patient was stable to transfer via private car. ED record - given Rx for the following: Ranitidine 105 BID, BENADRYL 12.5 mg TID x 3 days, Prednisolone 21 mg BID x 3 days, Epinephrine 0.15 mg IM x 1 PRN anaphylaxis (EPIPEN auto-injector). Update 3/22/18 - Mother sent child to school today. Patient c/o (L) arm and shoulder pain this A.M. The patient is a 5 y/o M who presented to the ED w/ a c/o a rash that began around 3:15 pm. Mother reports that pt had vaccine shots around 3:15 and began to develop a rash throughout his arms, face, back and legs. Pt denies any trouble breathing, throat tightness, abd pain, or diarrhea. There are no further complaints.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test normal, Syncope, Vertigo
Clinical narrative: I had immunization SHINGRIX inj in pharmacy. Within 1/2 hour my daughter had me in the ER. The official diagnosis was syncope. I was sent home. On Monday morning the 19th of Feb. I knew something was wrong. Contacted my daughter and as soon as she saw me called 911. I was rushed to the ER and the diagnosis was Vertigo. I am still taking meclizine for it. My PCP of 14 years was informed. Her response was suspicious based on the proximity to the immunization.
Age: 66.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Abscess, Abscess drainage, Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Local reaction of redness and hurting at the site of injection in left arm where flu shot was given. Treatment sought on 03/22/2018. Doctor lanced the abscess on 03/22/2018.
Sex: U
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site burning in an unspecified number of patients who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, immediately after receiving BEXSERO, the patient experienced injection site burning. On an unknown date, the outcome of the injection site burning was unknown. It was unknown if the reporter considered the injection site burning to be related to BEXSERO. Additional details were reported as follows: The age at vaccination of the patients was not reported. The patients who received doses of BEXSERO, experienced burning sensation at injection site during administration. The Vaccine Service Center Inside sales representative reported the information on behalf of the healthcare professional after he hung up. The healthcare professional was no longer on the phone at the time of adverse event report. No further information was reported.
Age: 3.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Drug administered to patient of inappropriate age, Injection site pain, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 3-year-old male patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020). On 15th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced general body pain, injection site pain and chills. On 15th March 2018, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the general body pain, injection site pain, chills and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the general body pain, injection site pain and chills to be related to SHINGRIX. Additional details were reported as follows: The 3 years old patient received SHINGRIX, which led to inappropriate age at vaccine administration. No additional information was provided.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise, Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 66-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 8th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 8th March 2018, 10 hrs after receiving SHINGRIX, the patient experienced chills. On 9th March 2018, the patient experienced malaise and myalgia. In March 2018, the patient experienced fever. On 9th March 2018, the outcome of the chills was recovered/resolved. On 12th March 2018, the outcome of the malaise and myalgia were recovered/resolved. On an unknown date, the outcome of the fever was unknown. The reporter considered the chills, malaise, myalgia and fever to be related to SHINGRIX. Additional information was received as follows: The health care professional who himself a patient reported that about ten hours after administration of dose of SHINGRIX, he experienced chills overnight for four to five hours. The patient also experienced myalgia and malaise, which he noticed in the next morning and it, lasted for about 3 days. After conversation with call center representative, caller mentioned that the patient also experienced a fever after receiving SHINGRIX. No additional information was obtained. The reporter was certain this was due to the vaccine.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 56-year-old male patient who received SHINGRIX. On 16th March 2018, the patient received SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling and blister. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and blister were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and blister to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient presented to the provider due to pain, redness, and swelling in the left arm. The patient also reported that blisters appeared on the left hand and left foot. It was not known how soon symptoms developed after receiving SHINGRIX. The nurse practitioner was the reporter. She was rushed during the report, and had the patient in an exam room. She was calling for guidance.
Age: 67.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site reaction, Vision blurred
Clinical narrative: Blurred vision and injection site reaction.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Eye swelling, Peripheral swelling, Pyrexia
Clinical narrative: Pt had redness, swelling of arm on which vaccine given as well as periorbital swelling. Fever to 102F. Self-resolved.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Conjunctivitis, Cough, Decreased appetite, Headache, Pain
Clinical narrative: Aches/fever/headache/cough/little appetite/wheezing/conjunctivitis.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Wheezing
Clinical narrative: Aches/fever/headache/cough/little appetite/wheezing/conjunctivitis.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of joint pain in a 72-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 31st January 2020). On 9th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a week after receiving SHINGRIX, the patient experienced joint pain, chills, vomiting and fever. The patient was treated with TYLENOL. On an unknown date, the outcome of the joint pain, chills, vomiting and fever were recovered/resolved. The reporter considered the joint pain, chills, vomiting and fever to be related to SHINGRIX. Additional details were provided as follows: The patient called physician's office for reporting symptoms that she felt after receiving first dose of vaccine. The healthcare provider advised patient to take TYLENOL.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of joint pain in a 72-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 31st January 2020). On 9th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a week after receiving SHINGRIX, the patient experienced joint pain, chills, vomiting and fever. The patient was treated with TYLENOL. On an unknown date, the outcome of the joint pain, chills, vomiting and fever were recovered/resolved. The reporter considered the joint pain, chills, vomiting and fever to be related to SHINGRIX. Additional details were provided as follows: The patient called physician's office for reporting symptoms that she felt after receiving first dose of vaccine. The healthcare provider advised patient to take TYLENOL.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Skin warm, Tenderness
Clinical narrative: Pain at the time of injection, and within 24 hours had warmth, tenderness, erythema of the upper arm.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Bacterial test, Chlamydia test, Exposure during pregnancy, HIV test, Hepatitis B virus test
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse and refers to a 25 year old female patient who had a history of abnormal Papanicolaou (PAP) smears. No information regarding her other pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 23-FEB-2018, she was vaccinated with a dose of GARDASIL 9 injection, 1 dose, intramuscular, lot # N021733 (also reported as M040146), expiration date 01-FEB-2020 (also reported as 26-DEC-2017) for prevention of HPV. Later on that date, after the vaccination, a urine pregnancy test was administered to the patient, with the result: positive, as "a faint line was present on the pregnancy test, indicating that the patient was pregnant." The date of last menstrual period (LMP) was reported as 23-JAN-2018, and estimated delivery date (EDD) was calculated as 30-OCT-2018. The patient sought medical attention via a physician visit. No treatment was given for the event. On an unknown date, chlamydia and gonorrhea test, HIV test, hepatitis B (Hep B) test, hepatitis C (Hep C) test and rapid plasma reagin test for syphilis (RPR) were performed (results not provided). At the time of the report, the pregnancy outcome was pending.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Hepatitis C virus test, Pregnancy test urine positive, Treponema test
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse and refers to a 25 year old female patient who had a history of abnormal Papanicolaou (PAP) smears. No information regarding her other pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 23-FEB-2018, she was vaccinated with a dose of GARDASIL 9 injection, 1 dose, intramuscular, lot # N021733 (also reported as M040146), expiration date 01-FEB-2020 (also reported as 26-DEC-2017) for prevention of HPV. Later on that date, after the vaccination, a urine pregnancy test was administered to the patient, with the result: positive, as "a faint line was present on the pregnancy test, indicating that the patient was pregnant." The date of last menstrual period (LMP) was reported as 23-JAN-2018, and estimated delivery date (EDD) was calculated as 30-OCT-2018. The patient sought medical attention via a physician visit. No treatment was given for the event. On an unknown date, chlamydia and gonorrhea test, HIV test, hepatitis B (Hep B) test, hepatitis C (Hep C) test and rapid plasma reagin test for syphilis (RPR) were performed (results not provided). At the time of the report, the pregnancy outcome was pending.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from medical assistant and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On an unknown date, the patient was vaccinated with an improperly stored VARIVAX 0.5 ml, lot # N022856 with an expiration date 23-AUG-2019, subcutaneously for prophylaxis (anatomical location was not reported). No adverse effect was reported. Administered doses of experienced the temperature excursion form 15 degrees Fahrenheit to 46 degrees Fahrenheit (max temperature 25.4 degrees Fahrenheit) for 20 minutes and form 6 degree Fahrenheit to 14 degrees Fahrenheit for 12 hours. There was no previous temperature excursion. Digital data logger was involved. This is one of two reports received form the same reporter.; Sender's Comments: US-009507513-1803USA009870:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified date in March 2018, reported as between the 8-MAR-2018 until 14-MAR-2018, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB injection, lot # M022077, expiration date 10-MAR-2019 (also reported as 10-MAY-2019) for prophylaxis (route and anatomical location were not provided). The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F during 55 minutes as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported.; Sender's Comments: US-009507513-1803USA009619: US-009507513-1803USA009620: US-009507513-1803USA009621: US-009507513-1803USA009622: US-009507513-1803USA009623: US-009507513-1803USA009624:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a 6 month old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient was vaccinated with the first dose of ROTATEQ, oral for prophylaxis (dose, lot number and expiration date were not reported). The nurse reported it was thought to be the patient's third dose of ROTATEQ and it was realized after it was given that it was the patient's first dose of ROTATEQ. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: Choking, Oral administration complication
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative referred to one or two infant patients of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, one or two patients were vaccinated with ROTATEQ vial (strength, dose, lot # and expiry date were not reported) orally for prevention of rotavirus gastroenteritis. The reporter reported that one or two patients choked (medically significant) while taking ROTATEQ in the nurse practitioner's office. The patient(s) did not spit out the ROTATEQ. The patient(s) sought medical attention for the event. It was unknown if treatment was given for the event or if lab diagnostics or studies were performed. The outcome of choking was recovered/resolved. The causality assessment between the event choking and ROTATEQ was not reported. No further information was reported. There was no product quality complaint (PQC) reported. Upon internal review, the event choking was considered to be serious due to medically significant.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified date in March 2018, reported as between the 8-MAR-2018 until 14-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, lot # N010497, expiration date 15-JAN-2020, for prophylaxis (route and anatomical location were not provided). The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F during 55 minutes as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. Sender's Comments: US-009507513-1803USA006513; US-009507513-1803USA009620; US-009507513-1803USA009621; US-009507513-1803USA009622; US-009507513-1803USA009623; US-009507513-1803USA009624.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified date in March 2018, reported as between the 8-MAR-2018 until 14-MAR-2018, the patient was vaccinated with and improperly stored dose of GARDASIL 9 injection, lot # N010497, expiration date 15-JAN-2020, for prophylaxis (route and anatomical location were not provided). The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F during 55 minutes as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. Sender's Comments: US-009507513-1803USA006513: US-009507513-1803USA009619: US-009507513-1803USA009621: US-009507513-1803USA009622: US-009507513-1803USA009623: US-009507513-1803USA009624.
Sex: U
Vaccine: HEP, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified date in March 2018, reported as between the 8-MAR-2018 until 14-MAR-2018, the patient was vaccinated with and improperly stored dose of GARDASIL 9 injection,  lot # N010497, expiration date 15-JAN-2020 and also, the patient the patient was vaccinated with and improperly stored dose of RECOMBIVAX HB injection, lot # M022077 expiration date 10-MAR-2019 (also reported as 10-MAY-2019) both for prophylaxis (route and anatomical location were not provided). The administered doses of the vaccines experienced a temperature excursion in the range between 47°F to 77°F during 55 minutes as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. Sender's Comments: US-009507513-1803USA006513; US-009507513-1803USA009619; US-009507513-1803USA009620; US-009507513-1803USA009622; US-009507513-1803USA009623; US-009507513-1803USA009624.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified date in March 2018, reported as between the 8-MAR-2018 until 14-MAR-2018, the patient was vaccinated with and improperly stored dose of GARDASIL 9 injection, lot # N010497, expiration date 15-JAN-2020, for prophylaxis (route and anatomical location were not provided). The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F during 55 minutes as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. Sender's Comments: US-009507513-1803USA006513: US-009507513-1803USA009619: US-009507513-1803USA009620: US-009507513-1803USA009621: US-009507513-1803USA009623: US-009507513-1803USA009624.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified date in March 2018, reported as between the 8-MAR-2018 until 14-MAR-2018, the patient was vaccinated with and improperly stored dose of GARDASIL 9 injection, lot # N010497, expiration date 15-JAN-2020, for prophylaxis (route and anatomical location were not provided). The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F during 55 minutes as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. Sender's Comments: US-009507513-1803USA006513; US-009507513-1803USA009619; US-009507513-1803USA009620; US-009507513-1803USA009621; US-009507513-1803USA009622; US-009507513-1803USA009624.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified date in March 2018, reported as between the 8-MAR-2018 until 14-MAR-2018, the patient was vaccinated with and improperly stored dose of RECOMBIVAX HB injection, lot # M022077 expiration date 10-MAR-2019 (also reported as 10-MAY-2019) for prophylaxis (route and anatomical location were not provided). The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F during 55 minutes as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported.; Sender's Comments:  US-009507513-1803USA006513: US-009507513-1803USA009619: US-009507513-1803USA009620: US-009507513-1803USA009621: US-009507513-1803USA009622: US-009507513-1803USA009623:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that on 20-MAR-2018, the patient was administered a dose of VARIVAX (lot: N025931, Expiry date: 19-SEP-2019) which was improperly stored (product storage error). No adverse effects reported. The vaccine was exposed to 15F to 46F (39F) for 24 hours & 30minutes. There was no previous temperature excursion. There was no involvement of digital data logger. No PQC was involved.
Sex: F
Vaccine: PNC13
Symptoms: Impaired work ability, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist, reporting for herself, via Pfizer Sales Representative. A 65-year-old female patient received PREVNAR 13, on an unspecified date at single dose for immunisation. The patient medical history was and concomitant medications were not reported. On an unspecified date, after pneumococcal 13-val conj vaccination, the patient's arm swelled up and was very painful and patient  could not work the next day. Outcome of the events was unknown. Information on the batch number has been requested
Age: 1.42
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: (L) thigh red, swollen, 4x6 cm, the injection site it is the middle region. Rash was first noticed the AM of 1/11/18. No fever, vomiting, diarrhea, difficulty breathing or swallowing. Given sample of ZYRTEC.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling, Vaccination complication
Clinical narrative: Delayed reaction a few days after administration. According to patient's care-giver - non-localized swelling, fever. Patient ended up in emergency room.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received an adult dose of Hep A (1.0 ml). Mom was informed. On 3/23/18 I called mom to follow-up. She said there was no issues more than normal. Patient didn't complain of arm soreness more than usual.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Had a pretty strong reaction for about 4 days: fever and chills, very sore and hot arm, fatigue.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Patient had the sore arm mild fever and chills, fatigue.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Burning sensation, Fatigue, Headache, Influenza like illness
Clinical narrative: Flu like symptoms. Fever, burning up, pins and needles, aching muscles, pains in stomach, headache. Rested after burning feeling lessened. Just tired and achy the next morning. Symptoms we're experienced from approximately 9 pm until 4 am.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Paraesthesia, Pyrexia
Clinical narrative: Flu like symptoms. Fever, burning up, pins and needles, aching muscles, pains in stomach, headache. Rested after burning feeling lessened. Just tired and achy the next morning. Symptoms we're experienced from approximately 9 pm until 4 am.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Conjunctival hyperaemia, Conjunctivitis bacterial, Fatigue, Tonsillar hypertrophy, Urticaria
Clinical narrative: Later that evening pt. developed moderate conj. injection in both eyes - seen in office 2/12/18. Dx'd with bacterial conj. Tx with tobramycin eye drops. On 2/23/18, he developed hives, went to ER was treated. On 3/5/18 developed swollen tonsils and fatigue, was seen in ER.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm pain, states hurts so bad he can't lift his arm. Denied redness or swelling. Recommended to take 800mg ibuprofen every 8 hours as needed for pain. Pain was resolved by 3/16/18.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Laboratory test, Mobility decreased, Pain
Clinical narrative: Patient stated she could not move her arm 11/14/17. Stated she has fever and chills, but did not have a thermometer to know what her temperature was. Stated pain better with MOBIC. Pain reduced to 6/10 from 10/10. States she had some redness around the site. Stated she was "sick in bed" for 3 days before symptoms resolved. However, symptoms started 11/14 and were resolved by 11/16 when she came in for lab work.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Patient stated she could not move her arm 11/14/17. Stated she has fever and chills, but did not have a thermometer to know what her temperature was. Stated pain better with MOBIC. Pain reduced to 6/10 from 10/10. States she had some redness around the site. Stated she was "sick in bed" for 3 days before symptoms resolved. However, symptoms started 11/14 and were resolved by 11/16 when she came in for lab work.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in a male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. The reporter considered the pain to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient at conference mentioned that they received 1st dose of SHINGRIX and experienced pain that lasted about 5 to 7 days.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Full body rash.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional and refers to a pediatric patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-MAR-2018, the patient was inadvertently vaccinated with a dose of VAQTA injection, lot # N016805, expiry date 04-SEP-2018, intramuscularly (exact dose was not reported) for prophylaxis. No adverse effects were reported.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Crying, Emotional distress, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 3/14/18 - Mom called to report swelling, pain and warmth on LA where received Flu and BEXSERO vaccine. Continued till 3/18 when mom reports area is much better. Mom concerned B/C pt. also extremely emotional for few days. Crying for no reason and mom read online this could be d/t BEXSERO vaccine. Sx have since resolved.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Redness, itching, swelling, to right arm.
Age: 1.83
Sex: M
Vaccine: HIBV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizure for @ 3 minutes. Took to hospital via ambulance, fever at hospital 101.5. Given motrin and sent home. No fever thereafter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Joint swelling, Pain, Rash, Swelling
Clinical narrative: SHE STATES THAT SHE HAD MASSIVE SWELLING STARTING WITHIN 24 HOURS OF GETTING THE VACCINE. AND WAS SORE FOR 3 DAYS STRAIGHT. HER LEFT WRIST STARTED TO SWELL STARTING ON DAY 3. ON DAY 6 HER RIGHT WRIST, KNEES, ANKLES STARTED TO SWELL TO THE POINT SHE COULD NOT BEND. SHE ALSO DEVELOPED A RASH ON HER STOMACH.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Full blood count, Immediate post-injection reaction, Loss of consciousness, Metabolic function test, Syncope
Clinical narrative: The patient experienced an immediate brief loss of consciousness upon injection. She was able to answer questions from the nurse immediately after, but she had lost bladder control during the syncopal event. She had not been aware of losing bladder control until after it had occurred. Vitals remained stable throughout her time in the clinic with exception of intermittent tachycardia. She was placed in supine position after and then she proceeded to vomit several times. About one hour later, the patient experienced syncope again for about 30 seconds. She vomited again after the second LOC. She was given two doses of ZOFRAN 4mg SL tabs. We were unable to start an IV in the patient, but after the vomiting had ceased the patient was able to sip fluids. She was kept in our clinic for about an hour after the last syncopal event, and was sent home with significant other. She follow up the next day and was completely improved. Denies any history of seizure-type activity. The patient's mother informed her that she had a vomiting reaction to flu vaccination several years ago.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Tachycardia, Urinary incontinence, Urine analysis, Vomiting
Clinical narrative: The patient experienced an immediate brief loss of consciousness upon injection. She was able to answer questions from the nurse immediately after, but she had lost bladder control during the syncopal event. She had not been aware of losing bladder control until after it had occurred. Vitals remained stable throughout her time in the clinic with exception of intermittent tachycardia. She was placed in supine position after and then she proceeded to vomit several times. About one hour later, the patient experienced syncope again for about 30 seconds. She vomited again after the second LOC. She was given two doses of ZOFRAN 4mg SL tabs. We were unable to start an IV in the patient, but after the vomiting had ceased the patient was able to sip fluids. She was kept in our clinic for about an hour after the last syncopal event, and was sent home with significant other. She follow up the next day and was completely improved. Denies any history of seizure-type activity. The patient's mother informed her that she had a vomiting reaction to flu vaccination several years ago.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Horrible Headache, chills and 102 degree fever.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Laryngeal oedema, Laryngoscopy abnormal, Muscle spasms, Myositis, Tenderness
Clinical narrative: Developed a myositis in my quadricep muscle 24 hrs after the injection. I also developed tenderness and spasm on my Masseter muscles which resolved quickly. However I also developed edema of my supra-glottis requiring treatment with Prednisone.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Laryngeal oedema, Muscle spasms, Myositis
Clinical narrative: Developed a myositis in my quadricep muscle 24 hrs after the injection. I also developed tenderness and spasm on my Masseter muscles which resolved quickly. However I also developed edema of my supra-glottis requiring treatment with Prednisone.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Dizziness, Head injury, Loss of consciousness
Clinical narrative: Dizziness, patient passed out and hit her head, causing, a contusion.
Age: 1.08
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2018-03-21.
Age: 23.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Infection
Clinical narrative: Infection following immunization, initial encounter on 2018-03-21.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC13, RV5
Symptoms: Extra dose administered
Clinical narrative: PEDIARIX and PENTACEL given at same time.
Age: 23.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Infection
Clinical narrative: Infection following immunization, initial encounter on 2018-03-21.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Peripheral swelling, Pruritus, Skin warm, Vaccination complication
Clinical narrative: Patient's whole entire upper arm swelled as a reaction to the shot. It was swollen, itchy and hot to the touch.