chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report as received from a consumer refers to herself, a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. The patient reported that she received GARDASIL 9 while she was pregnant in 2016 (date was unspecified)(exposure during pregnancy)(lot # and expiry date were not reported) for prophylaxis. The Last Menstrual Period and Estimated Date of Delivery were unknown. Other suspect therapies included sterile diluent. The patient reported that the nurse inadvertently gave her the vaccine while she was pregnant. The pregnancy outcome and fetal outcome were unknown. No PQC involved. No further AE information provided.
Sex: U
Vaccine: VARCEL
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. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 06-MAR-2018, the patient was vaccinated with an expired dose of VARIVAX subcutaneous, lot# M009766, expiration date 23-FEB-2018, for prophylaxis (strength, dose, frequency were not reported). The vaccine was reconstituted with an Merck sterile diluent, lot # M004656, expiration date 13-AUG-2018. No temperature excursions were involved. No symptoms reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies and concomitant medications were not provided. On 19-MAR-2018, the patient was vaccinated with VARIVAX intramuscularly, for prophylaxis (strength, dose, lot # and expiration date were not reported) which was reconstituted with a Sterile Diluent intramuscularly (strength, dose, lot # and expiration date were not reported). No adverse effects were reported.
Sex: U
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales representative. A patient of unspecified age race/ethnicity and gender received TRUMENBA (Lot S85201, Expiration date Dec2019) via an unspecified route of administration on an unspecified date at 0.5 ml single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hives on abdomine, arms, upper back, chest and upper legs (non-serious) on an unspecified date, one day after receiving the vaccination. The outcome of the event was unknown.
Sex: F
Vaccine: MENB
Symptoms: Erythema, Influenza like illness, Nausea, Pain
Clinical narrative: This is a spontaneous report from a non-contactable health care professional via Pfizer sales representative. A 17-year-old female patient of unspecified race/ethnicity received TRUMENBA via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported. The patient on an unspecified date experienced flu like symptoms for a couple days, redness, aches, nausea. The events were non-serious and took place after use of product. The outcome of the events flu like symptoms, redness, aches, nausea was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: HIBV, PNC13
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: This is a spontaneous report from a contactable Other-HCP via Pfizer sales representative. A patient of unspecified age ethnicity and gender started received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization, HIB vaccine, via an unspecified route of administration on an unspecified date at an unspecified dose for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that pneumococcal 13-val conj vac (dipht crm197 protein) was given with HIB vaccine in same leg. Patient's leg swelled and got Hives. MA said this happened 5 years ago. Now gives vaccines in separate legs. The outcome of the events was unknown.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Pyrexia, Tuberculin test
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales representative. A 17-year-old male patient of an unspecified race/ethnicity received TRUMENBA, first dose, via an unspecified route of administration on  27Feb2017 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced on 27Feb2017 horrible headache very soon after vaccination, and fever of 100. Both events were non-serious. Everything resolved within a few hours and he was able to go to school the next day. The outcome of horrible headache and fever of 100 was recovered on 27Feb2017. The patient also had a ppd test given on 27Feb17, the same day as the first dose of meningococcal group b rlp2086. The patient and the parents are very nervous to get the second dose. The information on the batch/lot number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer representative. A female patient of an unspecified age and ethnicity received PREVNAR 13 on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced redness that was quite excessive after the use of the vaccine, like her whole arm was red and red for a while, like a week or so. The final outcome of the event was unknown. Information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at 0.5 ml, single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swelling at injection site (non-serious) on an unspecified date after use of product. The outcome of the event was unknown. The information on the batch/lot number has been requested
Age: 50.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Body temperature increased, Cellulitis, Erythema, Induration, Injection site erythema
Clinical narrative: 03/06/2018 16:10 Temp 99.3 TYLENOL given 16:21. 03/06/2018 20:20 Temp 100.9 Afebrile after this. MOTRIN given 20:45. 03/07/2018 noted in doctor's rounds right upper arm pain and redness. 03/07/2018 11:42 dx with cellulitis and KEFLEX ordered. Received first dose 11:56. 03/08/2018 09:54 swelling, redness increased, firm tender areas warm to touch. Monitor. 03/09/2018 10:48 erythema receding / fading. Discharged routinely.
Age: 50.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Skin warm, Swelling, Tenderness
Clinical narrative: 03/06/2018 16:10 Temp 99.3 TYLENOL given 16:21. 03/06/2018 20:20 Temp 100.9 Afebrile after this. MOTRIN given 20:45. 03/07/2018 noted in doctor's rounds right upper arm pain and redness. 03/07/2018 11:42 dx with cellulitis and KEFLEX ordered. Received first dose 11:56. 03/08/2018 09:54 swelling, redness increased, firm tender areas warm to touch. Monitor. 03/09/2018 10:48 erythema receding / fading. Discharged routinely.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 3/14/18 07:34am in doctor's rounds pt c/o left upper arm tender, swollen, no erythema. Encourage heat and MOTRIN PRN. Elevate. 3/15/18 10:03am per Nurse Practitioner note left upper extremity swollen, tender, mild erythema, warm to touch. Cellulitis s/p pneumonia vaccine. Encourage heat and MOTRIN PRN. Elevate. Worsening redness, heat, and pain today. Start KEFLEX. Follow up with PCP. 3/15/18 Pt discharged routinely.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Fever of 103.2 followed by diffuse maculopapular rash starting on the trunk progressing to the hands and feet.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: Patient stated that he had a rash like chickenpox all over his body that started the next day. It lasted about a week. He reported this to his doctor as well.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Itchy rash on left arm below injection site.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Breath holding, Crying, Cyanosis, Dyspnoea, Hypotonia
Clinical narrative: After patient was given vaccines, pt cried out once and then held breath. Pt lips began turning blue. I left room a got Dr. and we returned 5 seconds later to find patient limp and cyanotic on exam table. Dr roused baby by turning him over at which point he gasped and began crying and his normal color returned. We checked pulse ox which registered at 96%. Injection sites had redness 5 inches in diameter on each thigh. We observed patient for 20 mins in office. There were no additional symptoms and redness had resolved without treatment before patient left the office.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema
Clinical narrative: After patient was given vaccines, pt cried out once and then held breath. Pt lips began turning blue. I left room a got Dr. and we returned 5 seconds later to find patient limp and cyanotic on exam table. Dr roused baby by turning him over at which point he gasped and began crying and his normal color returned. We checked pulse ox which registered at 96%. Injection sites had redness 5 inches in diameter on each thigh. We observed patient for 20 mins in office. There were no additional symptoms and redness had resolved without treatment before patient left the office.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient seen on 11/21/2016, for vaccines KINRIX and MMRV (PROQUAD) given correctly. Patient was seen on 02/02/2017 for CHE and Provider order KINRIX and MMRV repeated dose vaccine error.  Patient is ok no treatment needed, actions taken MA and Provider PNP got retrained in vaccines schedule and protocols for our Health Center.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR
Symptoms: Facial paralysis, Irritability, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Mother reported on 03/20/2018 child did have on the evening of 12/20/2017 facial drooping, red rash all over body. Then on the following days that followed child suffered a fever of 101.4. Mother did also state the child became fussy and and sluggish after receiving the vaccines.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR
Symptoms: Sluggishness
Clinical narrative: Mother reported on 03/20/2018 child did have on the evening of 12/20/2017 facial drooping, red rash all over body. Then on the following days that followed child suffered a fever of 101.4. Mother did also state the child became fussy and and sluggish after receiving the vaccines.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Provider ordered INFANRIX, but LPN gave HAVRIX in error. No adverse reaction identified. Parent made aware when error was found; 5 days later. Parents were notified.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: TRUNK BODY RASH, TREATED WITH A PREDNISONE BURST, OUTCOME UNKNOWN AS OF YET.
Age: 0.58
Sex: F
Vaccine: FLUX
Symptoms: Urticaria, Wheezing
Clinical narrative: Hives, wheezing requiring epi pen dose x 1. Improved with epi pen x 1 and observation for 30-40 min.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient received the vaccination in the afternoon. That night she started experiencing chills and was running a fever of 103. The fever continued for two more days, and then broke. She  took Tylenol and ibuprofen as needed for the pain and fever. Site of injection and beyond was swollen, red, hot to the touch. She went to urgent care on the third night and was given Benadryl, told to take Claritin as well and the area was mapped out on her arm to watch for spreading. Currently it is spreading beyond the lines mapped out, she is going to follow up with urgent care as soon as possible.
Age: 0.17
Sex: F
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No symptoms.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Joint range of motion decreased, Pain, Pyrexia, Rash
Clinical narrative: Severe pain, limited range of motion, rash, redness, warmth, low grade fever, swelling.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Severe pain, limited range of motion, rash, redness, warmth, low grade fever, swelling.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Rash erythematous, Skin warm, Tenderness, Urticaria
Clinical narrative: Large red rash, very warm to the touch, slightly tender. Red hard wheal, approximately 8 inches.
Age: 1.67
Sex: M
Vaccine: HEPA
Symptoms: Injection site rash, Rash
Clinical narrative: Patient came in on 3/19/2018 complaining of rash on lower abdomen, groin, and thighs. Patient was prescribed Prednisolone 15mg/5mL (2mL daily).
Age: 11.0
Sex: M
Vaccine: HEPA, MEN, TDAP
Symptoms: Erythema, Eye pruritus, Injection site pruritus, Pain, Periorbital oedema
Clinical narrative: Within 1/2 hour of injections pt had red swollen warm bump and was complaining of pain. Began to sporadically complain of itching to site as day progressed. Pain increased and at bedtime was given 320mg tylenol. At 1000 the next day tylenol dose was repeated, while he complained of increased itching and itching had now spread to neck, upper chest and armpits. By 1300 pt was complaining of itching eyes and had developed a rash to itching areas as well as periorbital edema. Benadryl 25mg given. Pediatrics office called.
Age: 11.0
Sex: M
Vaccine: HEPA, MEN, TDAP
Symptoms: Pruritus, Rash pruritic, Skin warm, Swelling
Clinical narrative: Within 1/2 hour of injections pt had red swollen warm bump and was complaining of pain. Began to sporadically complain of itching to site as day progressed. Pain increased and at bedtime was given 320mg tylenol. At 1000 the next day tylenol dose was repeated, while he complained of increased itching and itching had now spread to neck, upper chest and armpits. By 1300 pt was complaining of itching eyes and had developed a rash to itching areas as well as periorbital edema. Benadryl 25mg given. Pediatrics office called.
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain in extremity, Skin reaction, Skin warm
Clinical narrative: Patient complains of pain on R arm. Site of complaint is not at site of injection so not sure if it an injection site reaction. Patient reported event on 3/19/18 on 5th day since receiving vaccination. The area is red and warm to the touch.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient states that today when he was driving his truck, he experienced a sudden, stabbing pain (5/10) in his L upper arm deltoid where the injection was given 2 weeks ago. Patient states that lasted less than a minute or so and now is a very dull, barely noticeable pain (<1/10) in the same location. Patient denies any other problems at this time. Patient has a long sleeve shirt on and has not been able to physically look at his arm to note any changes on the surface of his skin. Patient stated in his VM that he had physically checked his L arm for any signs of skin discoloration, rash, redness and there is no physical sign of a problem. L arm is very slight dull pain in the deltoid. Patient will contact us or office with any further changes or questions.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Back pain, Chills, Injection site pain
Clinical narrative: Fever of 99.9, chills, muscle pain and weakness, joint pain, upset stomach, and the standard soreness at the injection site. Onset was about five or six hours after injection, starting with upset stomach, progressing to chills, fever and pain. Pain in legs and back was really uncomfortable. Took ALEVE to ease the pain, 440 mg over the counter. Pain in muscles and joints remains, but is lessening. I would say this is was a pretty unexpected and painful reaction and I still have to get the second dose.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fever of 99.9, chills, muscle pain and weakness, joint pain, upset stomach, and the standard soreness at the injection site. Onset was about five or six hours after injection, starting with upset stomach, progressing to chills, fever and pain. Pain in legs and back was really uncomfortable. Took ALEVE to ease the pain, 440 mg over the counter. Pain in muscles and joints remains, but is lessening. I would say this is was a pretty unexpected and painful reaction and I still have to get the second dose.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Erythema, Hypertension, Injection site erythema
Clinical narrative: FEVER, RED FACE OR HIGH BLOOD PRESSURE, SEVERE ACHING ALL OVER THE BODY AND JOINTS, LOSS OF APPETITE, SLEEPLESSNESS, SEVERE SWEATING THROUGHOUT THE NIGHT SLEEPING, ACHING ARM, REDNESS AROUND INJECTION SITE, PAIN TO RAISE OR USE THE ARM.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Night sweats, Pain, Pain in extremity, Pyrexia
Clinical narrative: FEVER, RED FACE OR HIGH BLOOD PRESSURE, SEVERE ACHING ALL OVER THE BODY AND JOINTS, LOSS OF APPETITE, SLEEPLESSNESS, SEVERE SWEATING THROUGHOUT THE NIGHT SLEEPING, ACHING ARM, REDNESS AROUND INJECTION SITE, PAIN TO RAISE OR USE THE ARM.
Age: 67.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Diarrhoea, Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: Diarrhea, Nausea, Sore Arm, Headache and Vomiting.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site bruising, Rash, Rash pruritic
Clinical narrative: She got a bruise around the injection site initially, but then 3 days after vaccination, she developed a rash lower down on the arm. The rash started about the size of a Band-Aid but has spread to the size of a baseball. It itches and burns if scratched. She described it as a minor burn-like rash.
Age: 1.17
Sex: F
Vaccine: DTAPHEPBIP, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash morbilliform
Clinical narrative: 3 days of fever starting 3/18. Followed by full body morbiliform rash that started on 3/19 and progressed from trunk to extremities and face.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Decreased appetite, Frequent bowel movements, Hyperhidrosis
Clinical narrative: FEVER, SLEEPLESSNESS, ACHING ALL OVER THE BODY AND JOINTS, LOSS OF APPETITE, 6 BOWEL MOVEMENTS ONE DAY LONG, SEVERE SWEATS AND COLD CHILLS, ACHING ARM, REDNESS AROUND INJECTION SITE, SWOLLEN, ITCHY, AND PAINFUL TO RAISE OR USE THE ARM.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Insomnia, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: FEVER, SLEEPLESSNESS, ACHING ALL OVER THE BODY AND JOINTS, LOSS OF APPETITE, 6 BOWEL MOVEMENTS ONE DAY LONG, SEVERE SWEATS AND COLD CHILLS, ACHING ARM, REDNESS AROUND INJECTION SITE, SWOLLEN, ITCHY, AND PAINFUL TO RAISE OR USE THE ARM.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: FEVER, SLEEPLESSNESS, ACHING ALL OVER THE BODY AND JOINTS, LOSS OF APPETITE, 6 BOWEL MOVEMENTS ONE DAY LONG, SEVERE SWEATS AND COLD CHILLS, ACHING ARM, REDNESS AROUND INJECTION SITE, SWOLLEN, ITCHY, AND PAINFUL TO RAISE OR USE THE ARM.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Abnormal behaviour, Crying, Irritability, Pyrexia
Clinical narrative: Woke up at two o'clock to find pt with a fever and pulsating soft spot. He was still sleeping. Cooled his body with wet rags and fever diminished. Later that morning I noticed him very fussy and would not roll over or babble like he had been. His voice also changed to a high pitch cry instead of his normal one.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Red, sore arm.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Given Hepatits B shot in am on 01/24/2018, saw raised red dots on both upper arms the next morning while getting dressed. Coming home that night on 01/25/2018, she noticed hives had also gone to upper chest, nothing on breast or stomach area. Red dots also went up into the neck area, and when employee saw that, she went to the ER on 02/02/2018 @ 18:33pm.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Nausea, Pain
Clinical narrative: Sore, red arm, chills, nausea, headache.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Influenza like illness, Suture insertion, Syncope
Clinical narrative: Patient begun having flu like symptoms the evening of getting the vaccine, and had an episode of syncope.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness, Gait disturbance, Mobility decreased, Pain
Clinical narrative: Started Tues evening 3/13/2018 to Wednesday all day. Side effect was mostly on Wednesday all day. Could barely walk, extreme dizziness, couldn't turn head, hurts to sit. Trouble keeping balance.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Injection site erythema, Skin warm, Swelling
Clinical narrative: REDNESS, SWELLING, WARMNESS TO THE TOUCH. REDNESS EQUIVLAVENT TO THE SIZE OF PATIENTS HAND ON HIS LEFT BICEP. PATIENT WAS SEEN IN THE EMERGENCY ROOM. GIVEN ZYRTEC 10MG - 1 TAB EVERYDAY FOR 5 DAYS THEN PRN. CLARITIN 150 MG - 1 TAB BID FOR 5 DAYS.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Impaired work ability, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Sore shoulder for 3 days. Used ice pack which helped pain. Arm was stiff enough to miss work for 1 day. Headache for 2 days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Pain in joints specifically the knees.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, Dyspnoea, Influenza virus test negative, Injection site erythema, Injection site pain
Clinical narrative: Pain & redness at injection site. About 27 hours after injection baby experienced elevated temperature of 100.7 Fahrenheit and labored respirations of 75 respirations per minute. Gave one dose of Tylenol. Rechecked temperature after 30 minutes, decreased respiration rate to 65 labored respirations per minute, temperature of 100.4. Nurse line instructed to bring baby into ER. Temperature and respirations retuned to normal within 1 hour 45 minutes of 1 dose of Tylenol.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Respiratory syncytial virus test negative
Clinical narrative: Pain & redness at injection site. About 27 hours after injection baby experienced elevated temperature of 100.7 Fahrenheit and labored respirations of 75 respirations per minute. Gave one dose of Tylenol. Rechecked temperature after 30 minutes, decreased respiration rate to 65 labored respirations per minute, temperature of 100.4. Nurse line instructed to bring baby into ER. Temperature and respirations retuned to normal within 1 hour 45 minutes of 1 dose of Tylenol.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site induration, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: Arm became extremely inflamed, hot to the touch, and very hard. It was also very itchy.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Chills, Decreased appetite, Ear pain
Clinical narrative: By 7:30 p.m. I had a splitting headache which remains even with TYLENOL. This morning at 5:00 a.m. awoke with Chills, low grade fever, swollen glands in lower throat, pain in all muscles and joints. Redness at injection site and pain. My arthritic joints in my hands are swollen. Decrease in appetite and extreme fatigue. Tonight my teeth ache and I have a stuffy nose now as well. My ears are sore as well. After 24 plus hours I am the same with these symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Joint swelling
Clinical narrative: By 7:30 p.m. I had a splitting headache which remains even with TYLENOL. This morning at 5:00 a.m. awoke with Chills, low grade fever, swollen glands in lower throat, pain in all muscles and joints. Redness at injection site and pain. My arthritic joints in my hands are swollen. Decrease in appetite and extreme fatigue. Tonight my teeth ache and I have a stuffy nose now as well. My ears are sore as well. After 24 plus hours I am the same with these symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Myalgia, Nasal congestion, Pyrexia, Toothache
Clinical narrative: By 7:30 p.m. I had a splitting headache which remains even with TYLENOL. This morning at 5:00 a.m. awoke with Chills, low grade fever, swollen glands in lower throat, pain in all muscles and joints. Redness at injection site and pain. My arthritic joints in my hands are swollen. Decrease in appetite and extreme fatigue. Tonight my teeth ache and I have a stuffy nose now as well. My ears are sore as well. After 24 plus hours I am the same with these symptoms.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Circumstance or information capable of leading to medication error, Immediate post-injection reaction, Injection site swelling
Clinical narrative: Mother was present in room with minor patient. Patient was informed that she will be receiving 2 vaccine in one arm and 1 in the other arm. After administering 2 vaccines. Patient was informed that the last vaccine MCV4 would be administered into the other arm. Patient requested that the vaccine be administrated into the same arm because she was afraid. Honoring the patient's requests, when administering the MCV4 the patient move arm and tighten muscle causing a small soft raised tissue to appear immediately after administration.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haematochezia, Intussusception, Surgery
Clinical narrative: Mother called office and reported pt received ROTATEQ in January, Feb 18 pt presented in ED for blood in stool, transferred to hospital and had surgery same day for intussusception. Mom is wanting VAERS info to report adverse event.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Emotional distress, Haemoglobin normal, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative
Clinical narrative: Called into the clinic on 12/20/2017. The patient had been running fevers for 2 days and fussy. Little stuffy nose. Very fussy and hard to console. Was seen in this clinic on 12/20/17-mom reports high pitched screams. Fevers up to 101.0.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Irritability, Nasal congestion, Platelet count decreased, Pyrexia, Screaming
Clinical narrative: Called into the clinic on 12/20/2017. The patient had been running fevers for 2 days and fussy. Little stuffy nose. Very fussy and hard to console. Was seen in this clinic on 12/20/17-mom reports high pitched screams. Fevers up to 101.0.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Urine analysis normal, White blood cell count normal
Clinical narrative: Called into the clinic on 12/20/2017. The patient had been running fevers for 2 days and fussy. Little stuffy nose. Very fussy and hard to console. Was seen in this clinic on 12/20/17-mom reports high pitched screams. Fevers up to 101.0.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Erythema and swelling with wheal and flare at injection site. Applied ice to the injection site for 20 minutes. Injection site improving.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Lethargy, Staring
Clinical narrative: Per parents she had a blank look less than 1 hr after shots, was not making any noises. "Mentally not there" would not say words. Lethargic x 10-12 days after the shots. She would eat but would not cry for a bottle. No fever. Lasted about 2 weeks. No treatment parent just said something today about it.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 53-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 7th March 2018, the patient received the 1st dose of SHINGRIX. On 12th March 2018, 5 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: This case was reported by pharmacy intern. The patient developed a Shingles outbreak. The batch number reported for SHINGRIX (324KL), did not exist and was updated to 3Z4KL, as per sale database. The health care provider had limited information.
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Adenovirus test, Blood test, Enterovirus test, Influenza virus test, Malaise
Clinical narrative: Vaccinated at 12 mo. phe. 2/22/18 with PCV13, Hep A, MMR, Varicella. Seen here 3/6/18 fever x 3d. Cough, wide spread rash x 1d. Also seen at ER 3/4 URI/conjunctivitis. Sent to ER 3/6 to R/O measles.
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Measles, Viral test
Clinical narrative: Vaccinated at 12 mo. phe. 2/22/18 with PCV13, Hep A, MMR, Varicella. Seen here 3/6/18 fever x 3d. Cough, wide spread rash x 1d. Also seen at ER 3/4 URI/conjunctivitis. Sent to ER 3/6 to R/O measles.
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Adenovirus test, Arthralgia, Conjunctivitis, Contusion, Cough
Clinical narrative: Vaccinated at 12 mo. phe. 2/22/18 with PCV13, Hep A, MMR, Varicella. Seen here 3/6/18 fever x 3d. Cough, wide spread rash x 1d. Also seen at ER 3/4 URI/conjunctivitis. Sent to ER 3/6 to R/O measles.
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Dehydration, Diarrhoea, Enterovirus test, Eye swelling
Clinical narrative: Vaccinated at 12 mo. phe. 2/22/18 with PCV13, Hep A, MMR, Varicella. Seen here 3/6/18 fever x 3d. Cough, wide spread rash x 1d. Also seen at ER 3/4 URI/conjunctivitis. Sent to ER 3/6 to R/O measles.
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Full blood count, Haematology test, Heart rate increased, Influenza virus test, Joint stiffness
Clinical narrative: Vaccinated at 12 mo. phe. 2/22/18 with PCV13, Hep A, MMR, Varicella. Seen here 3/6/18 fever x 3d. Cough, wide spread rash x 1d. Also seen at ER 3/4 URI/conjunctivitis. Sent to ER 3/6 to R/O measles.
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Laboratory test, Lethargy, Measles, Mouth ulceration, Photophobia
Clinical narrative: Vaccinated at 12 mo. phe. 2/22/18 with PCV13, Hep A, MMR, Varicella. Seen here 3/6/18 fever x 3d. Cough, wide spread rash x 1d. Also seen at ER 3/4 URI/conjunctivitis. Sent to ER 3/6 to R/O measles.
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Rhinorrhoea, Viral test, Vomiting
Clinical narrative: Vaccinated at 12 mo. phe. 2/22/18 with PCV13, Hep A, MMR, Varicella. Seen here 3/6/18 fever x 3d. Cough, wide spread rash x 1d. Also seen at ER 3/4 URI/conjunctivitis. Sent to ER 3/6 to R/O measles.
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Conjunctivitis, Cough, Measles post vaccine, Morbillivirus test positive, Pyrexia
Clinical narrative: Vaccinated at 12 mo. phe. 2/22/18 with PCV13, Hep A, MMR, Varicella. Seen here 3/6/18 fever x 3d. Cough, wide spread rash x 1d. Also seen at ER 3/4 URI/conjunctivitis. Sent to ER 3/6 to R/O measles.
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Upper respiratory tract infection
Clinical narrative: Vaccinated at 12 mo. phe. 2/22/18 with PCV13, Hep A, MMR, Varicella. Seen here 3/6/18 fever x 3d. Cough, wide spread rash x 1d. Also seen at ER 3/4 URI/conjunctivitis. Sent to ER 3/6 to R/O measles.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Swelling
Clinical narrative: Patient presented to the clinic two days post vaccination. Redness at injection equivalent to the size of the Patient's palm. Not tender to the touch, no fever, so swelling, or any other symptoms. Pt. advised to take diphenhydramine or cetirizine and monitor. If swelling continues to return to the clinic.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concomitant medication and drug reactions/allergies were not provided. On 19-APR-2012, the patient was vaccinated with an unidentified Merck HPV vaccine, lot # reported as V1229AA (which was not valid for GARDASIL or GARDASIL 9) for prophylaxis (frequency, route, anatomical location and expiration date were not provided) at the age of 14 years. Then, on 11-OCT-2013, the patient was vaccinated with an unidentified Merck HPV vaccine, lot # reported as VH021608 (which was not valid for GARDASIL or GARDASIL 9) for prophylaxis (frequency, route, anatomical location and expiration date were not provided) at the age of 15 years. Later, on 07-AUG-2015, the patient was vaccinated with an unidentified Merck HPV vaccine, lot # reported as VK026246 (which was not valid for GARDASIL or GARDASIL 9) for prophylaxis (frequency, route, anatomical location and expiration date were not provided) at the age of 17 years. Additionally, on 31-JUL-2017, at the age of 19 years, the patient received first dose of GARDASIL 9 injection, intramuscularly, lot # N004798, expiration date 31-OCT-2019 for prophylaxis (frequency and anatomical location were not provided). On 24-OCT-2017, the patient received second dose of GARDASIL 9 injection, intramuscularly, lot # N017832, expiration date 16-NOV-2019 for prophylaxis (frequency and anatomical location were not provided). No adverse effects were reported.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 68 year old female patient. The patient had no medical history, concurrent conditions, drug, allergy history or concomitant medications to be reported. On 05-MAR-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N013541, expiry date 23-JAN-2019 in the left deltoid for pneumonia. On 07-MAR-2018, two days later, the patient red rash on her left inner elbow and on an unspecified area on her abdomen. The patient developed the same type of rash on the unspecified injection site arm and an unspecified area of the abdomen after receiving ZOSTAVAX (lot# and expiry date not reported) and PREVNAR 13 on an unknown date in 2016. The patient was given a treatment at unspecified Urgent Care. Diagnostic and laboratory tests were not provided. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX 23 and ZOSTAVAX was not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified date, "less than 10" patients were vaccinated with improperly stored doses of ROTATEQ oral liquid, orally, lot # N000193, expiration date 20-OCT-2018 and lot # N013989 (unknown expiration date) both for prophylaxis (frequency, route and anatomical location were not provided). The mentioned doses were under a temperature excursion in the range between 32°F to 35°F (35°F) during 24 hours as recorded by a digital data logger. No adverse effect reported.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and unknown gender. No information regarding the patient's concurrent condition, medical history and concomitant medications was reported. On an unspecified date in June 2015, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 12-MAR-2018, the patient was vaccinated with additional dose of ZOSTAVAX injection, subcutaneous, lot#: N025565, expiration date: 13-DEC-2018, (exact dose, anatomical location were not provided). No adverse event was reported.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Necrotising retinitis, Photopsia, Rash generalised, Retinal detachment, Vitreous floaters
Clinical narrative: This spontaneous report was received from a 63 year old male patient referring on himself. The patient reported that he had nasal surgery for his sinus and Lasik eye surgery on both of his eyes, on approximately 2003 (reported as "about 15 years ago"). The patient's concurrent conditions were not provided. The patient's concomitant medications included vitamin D, mineral over the counter Aspirin and pregabalin (LYRICA). On approximately 2013 (reported as "about 5 years ago") the patient was vaccinated with (ZOSTAVAX for prevention of shingles (strength, lot # and expiration date were not provided). Three weeks after he received the vaccination he broke out in a rash all over his body, he said it was like shingles, but it was not shingles, it was everywhere.. The physician at that time sent the patient to an Allergist and a Dermatologist, but there was no resolution to the cause of the rash; therefore the patient was placed on a regimen of steroids (unspecified names and dosages) and then on a regimen on antihistamines (unspecified names and dosages) multiple times. Each time toward the end of the treatment the rash would come back. Also on approximately January 2017 (reported as " for the past 4 months"), the patient had floaters in his vision and flashes of light that are to the right side of his vision area. It was like he had a retinal detachment or acute necrotizing retinitis. The patient also stated that he had not seen any eye doctor about this yet, but would be scheduling an appointment soon. At the time of the report, the patient had not recovered from the events.  The causal assessment between the events and ZOSTAVAX was not reported. Upon internal review the acute necrotiziting retinitis and retinal detachment were considered medically significant.
Age: 27.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 27 year old patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date in February 2018, the patient was vaccinated with GARDASIL 9 (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. No adverse effects were reported (Drug use in unapproved age group).
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Administration site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 33 year old female patient. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. Unspecified blood work performed on 16-MAR-2018 revealed that the patient was not immune to M-M-R II. On 19-MAR-2018, the patient was vaccinated with M-M-R II (dosing details, lot # and expiry date unknown) intramuscularly for routine vaccination (incorrect route of drug administration). On 19-MAR-2018, the patient experienced soreness at the administration site on her right upper arm. The outcome of the event was unknown. No treatment was provided for the event. Causality assessment was not provided by the reporter. Product quality complaint (PQC) was not involved.
Sex: F
Vaccine: IPV, RAB
Symptoms: Dysphagia, Muscle twitching, Nasopharyngitis, Oropharyngeal pain, Throat irritation
Clinical narrative: Initial unsolicited report received from a consumer on 11-FEB-2018. This case involves a female patient (age not reported) who was vaccinated with IMOGAM (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 08-Feb-2018. Patient's medical history was reported as none. Concomitant medications included IMOVAX on 05-Feb-2018 and 08-Feb-2018. On an unknown date following the vaccination patient experienced "twitching in her butt" and she has cold symptoms like a scratchy sore throat that makes it hard to swallow. It was also reported that after hours patient received adverse event on 11-Feb-2018. Other laboratory data and corrective treatment was not reported. The outcome of the event was reported as unknown. Follow-up information received from a physician on 12-Mar-2018. It was reported that IMOGAM was administered with second dose of IMOVAX and received the full IMOGAM dose divided to both thighs. It was also a case of actual medication error due to inappropriate schedule of vaccine administered and wrong technique in product usage process. List of documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Musculoskeletal stiffness, Swollen tongue
Clinical narrative: Initial unsolicited report received from a Health care professional on 08-Mar-2018. This case involves a 16-year-old female patient, who was vaccinated once with 0.5 ml single booster dose of MENACTRA via intramuscular route (batch number - U5839AA, expiry date, site not reported) on 26-Feb-2018. Patient had no allergies and no medical history. Patient's concomitant medications were not reported. On an unknown date, following vaccination patient had stiff neck, back headache and a swollen tongue due to which mom took her to the urgent care on 28-Feb-2018. It was also reported they did not know what testing was performed in the urgent care of what the treatment plan at discharge. Patient also had MENACTRA at 11 to 12 years old and had no issues. Lab test and corrective treatment was not reported. Patient was recovered from the events as symptoms have all resolved at this point. Documents held by sender: none. Sender's Comments: Patient developed Stiff neck, tension headache and swollen tongue after vaccination. Time to onset is compatible with the role of vaccine. However additional information, including but not limited to, the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, medical history, previous similar episodes as well as allergy testing to identify the culprit allergen are needed to further assess this case. Moreover, as two vaccines were administered concomitantly, the role of each component cannot be assessed separately.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm, Swelling
Clinical narrative: Patient presented to office 3/19/18 with swelling of the left arm for the past 2-3 days. He received ADACEL and MENACTRA at this site on 3/16/18. Within 24 hours parent noticed some swelling to the area. The swelling continued to increase over the next 24-48 hours and he also reported having pain along with the swelling on 3/18/19. No fever, cough, runny nose, congestion. No tingling, numbness, weakness in the arm, no other rashes or difficulty breathing or wheezing. There is an area of erythema roughly 3x3", the central part of erythema has a form swelling, which is tender to palpation, hot. Good peripheral pulses and sensations in the arm. Patient advised to apply warm compresses and was started on Cephalexin 500mg twice a day for 7 days. Patient is to follow up in 2-3 days.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Tenderness
Clinical narrative: Patient presented to office 3/19/18 with swelling of the left arm for the past 2-3 days. He received ADACEL and MENACTRA at this site on 3/16/18. Within 24 hours parent noticed some swelling to the area. The swelling continued to increase over the next 24-48 hours and he also reported having pain along with the swelling on 3/18/19. No fever, cough, runny nose, congestion. No tingling, numbness, weakness in the arm, no other rashes or difficulty breathing or wheezing. There is an area of erythema roughly 3x3", the central part of erythema has a form swelling, which is tender to palpation, hot. Good peripheral pulses and sensations in the arm. Patient advised to apply warm compresses and was started on Cephalexin 500mg twice a day for 7 days. Patient is to follow up in 2-3 days.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Local swelling and erythema with itching.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Erythema multiforme, Rash, Rash erythematous, Skin lesion
Clinical narrative: Within a few hours of receiving Hep B vaccine 1, patient noted circular red raised dry rash/lesions, approximately 1/2-3/4 inch in diameter, on bilateral hands. Spread up to wrists and forearms over the next 2 days, then began to resolve. Probable Erythema Multiforme.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions and allergies was unknown. Concomitant therapy included sterile diluent. On an unknown date, the patient was inadvertently vaccinated with one dose of PROQUAD intramuscularly (units and frequency were unknown) (lot # M047303 and expiration date 29-MAY-2018) and one dose of VARIVAX (units and frequency were unknown) (lot # N019127 and expiration date 22-JUN-2019) at the same visit. The nurse practitioner reported the PROQUAD was checked by four different people who did not notice the varicella on the label because the writing wraps around the label and she thinks varicella should be printed underneath the measles. No adverse effects were reported. There was no product quality compliant reported. Lot number [M047303] has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live].