chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms
Clinical narrative: Patient reported cramping described as "charlie horses" She said she has had these before but it has been a while. She was unsure if the immunization could have "triggered" this. They resolved over night. She said if they comeback she will contact her doctor.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous, Skin warm
Clinical narrative: Red rash size of tennis ball, sore, warm to touch. Called the next day, took one BENADRYL on 10/01/2018 and rash was smaller and not as sore.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: The patient said there was a huge red circle about 2" in diameter around the injections site and that it was red, puffy, and itchy. She came into the pharmacy on 09/29/2018 to show the pharmacist the red circle that was around the injection site.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swelling, redness right arm. Patient received steroid shot at clinic. Given Prednisone 10mg and AUGMENTIN 875 scripts to be filled.
Age: 42.0
Sex: M
Vaccine: PNC13
Symptoms: Dizziness, Face injury, Injected limb mobility decreased, Laboratory test, Loss of consciousness
Clinical narrative: At 230 pm I received the shot by 600pm on 9/28/2018 my arm became locked into the position that it was in, as the night progress the pain in my arm began to worsen, I awoke at 430am Saturday 9/289/2018 to get pain meds and warm cloth for some pain relief. I was unable to move my arm at all. I woke up at 900am became dizzy and passed out hitting my face and chin on the floor the ambulance was called and I was taken to the hospital. I was given oxycodone and test I was sent home with prescriptions for steroids and lidocaine patches,. as of 10/02/2018 Iam still unable to move my shoulder without excruciating pain.
Age: 42.0
Sex: M
Vaccine: PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: At 230 pm I received the shot by 600pm on 9/28/2018 my arm became locked into the position that it was in, as the night progress the pain in my arm began to worsen, I awoke at 430am Saturday 9/289/2018 to get pain meds and warm cloth for some pain relief. I was unable to move my arm at all. I woke up at 900am became dizzy and passed out hitting my face and chin on the floor the ambulance was called and I was taken to the hospital. I was given oxycodone and test I was sent home with prescriptions for steroids and lidocaine patches,. as of 10/02/2018 Iam still unable to move my shoulder without excruciating pain.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Mobility decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported that on Saturday (day after her vaccination) her arm was sore and couldn't move it as much. Sunday she felt achy all over and she took 2 doses of TYLENOL. Monday her arm started to feel warm and still felt sore and then welts started to appear and the area was red and a little swollen. Tuesday she said some of the welts reduced in size and other started to appear and still had some arm soreness and has stayed pretty much the same in terms of soreness. Patient tried using TYLENOL but didn't help as much, patient cannot take NSAIDS due to her previous ulcers. I recommended to the patient that she seek medical attention if it's still hurting her. She hadn't seen her PCP in over a year.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Urticaria
Clinical narrative: Patient reported that on Saturday (day after her vaccination) her arm was sore and couldn't move it as much. Sunday she felt achy all over and she took 2 doses of TYLENOL. Monday her arm started to feel warm and still felt sore and then welts started to appear and the area was red and a little swollen. Tuesday she said some of the welts reduced in size and other started to appear and still had some arm soreness and has stayed pretty much the same in terms of soreness. Patient tried using TYLENOL but didn't help as much, patient cannot take NSAIDS due to her previous ulcers. I recommended to the patient that she seek medical attention if it's still hurting her. She hadn't seen her PCP in over a year.
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: Dizziness, Urticaria
Clinical narrative: Hives over arms and chest, possible vision component, and dizziness.
Age: 54.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Arthralgia, Blood pressure abnormal, Myalgia, Pain
Clinical narrative: Severe muscle aches and body/joint pain which led the patient to see his physician, physician immediately sent him to the ER to stabilize his blood pressure.
Age: 41.0
Sex: F
Vaccine: FLUR4
Symptoms: Hyperhidrosis, Injection site erythema, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: Swollen lymph nodes under right and left arm, red at site of injection, site of inject warm to touch, site of injection raised, sweating along forehead/back of neck.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pruritus, Rash
Clinical narrative: Pain at site of injection, total body muscle aches and rash with itching.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Fatigue, Malaise, Skin warm
Clinical narrative: Patient describes feeling sick, tiredness, says her arm was hot. Patients also reports having a red mark on the mid upper arm (not at injection site) that she described looks like a strawberry birthmark or a burn. Patient was instructed to consult with physician.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Food allergy, Skin warm
Clinical narrative: Patient requested the pneumococcal vaccine. He reported allergies to onion and raisins. He advised staff today that he had no egg allergy, however, today after redness and warmth same arm as injection developed he reported that he only eats egg whites, he reports allergy to egg yolk. Allergy Package has been updated.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Dry skin, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient stated that 2 to 3 days after receiving flu vaccine her left arm started swelling. Then she started developing patches down whole left arm and palm. At time of PCP visit on 10/02/2018, patient's left arm was red and swollen and she had sporadic dry patches down arm and palm. Provider tending to patient also stated that patient had vesicles in hard pallet of mouth. Patient also stated that she had pain of left arm when moving. Provider does not think symptoms are associated with shingles but patient patient will be treated with acyclovir. Patient has also been referred to dermatologist.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: 9cm x 7cm red, raised area note distal to injection site. Warm to the touch. Tender to the touch-otherwise not painful. No open areas noted. No drainage noted.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Clavicle to elbow swelled, was bright red and hot to the touch.
Age: 79.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Limited ROM (L) arm, severe pain. ER visit suggest cold compress and F/U with PCP if not resolved w/in 1-2 days. Same day care visit- Tx with TORADOL/60mg IM, PO ibuprofen and NORCO. Pt will not take NORCO D/T constipation.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large, raised, red circle around the injection site. Warm to touch.
Age: 49.0
Sex: F
Vaccine: MNQ, TYP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had red, raised area at site of injection which was warm to the touch. Treatment: Levofloxacin 500 mg every day.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia
Clinical narrative: Patient complained of difficulty swallowing after vaccination. Patient denied difficulty breathing; SOB, hives, lightheadedness. Pt refused EPIPEN injection. Pt received 2 pills of diphenhydramine 25 mg. I called 911 and she went to hospital. Patient was conscious. Patient was able to speak, walk, and be alert until ambulance arrived. Patient stated that she's never gotten any reactions from previous flu shots.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Nausea, Pain, Pyrexia, Skin warm
Clinical narrative: Pt started feeling pain all over and skin feeling very hot, felt nauseous. Also felt chills and had a fever that night. By time she reported symptoms already feeling better after taking TYLENOL COLD and FLU. Fever has gone away, contacted PCP.
Age: 81.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Myalgia
Clinical narrative: Myalgia.
Age: 65.0
Sex: M
Vaccine: FLUA3
Symptoms: Pyrexia
Clinical narrative: High fever of unknown determination, patient was admitted to hospital.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Had flu-like symptoms, without fever, for 24 hours.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: 6 cm area of redness to injection site, h/o egg allergy.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Feeling cold, Flushing, Headache, Injection site pain
Clinical narrative: 8 AM administration vaccines. Mild soreness to (L) arm injection site. 4PM nausea, chills, facial flushing, intense body aches 7-11PM especially neck and back. Temp 10PM-11PM-100.6 orally. Fatigue continued and body aches, headaches 9/28-9/30 improving daily.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Nausea, Pain
Clinical narrative: 8 AM administration vaccines. Mild soreness to (L) arm injection site. 4PM nausea, chills, facial flushing, intense body aches 7-11PM especially neck and back. Temp 10PM-11PM-100.6 orally. Fatigue continued and body aches, headaches 9/28-9/30 improving daily.
Age: 77.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Decreased appetite, Nausea, Pain, Rash papular, Swelling
Clinical narrative: Sunday night pain, nausea, poor appetite, swelling, red bumpy skin, sore, painful, not itchy. Aspirin, ice applied.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Axillary pain, Erythema, Peripheral swelling
Clinical narrative: Left arm became swollen and red. Armpit was painful all the way down to her elbow. Pt. went to PCP who told her to take CLARITIN and swelling went down.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Rash, Skin warm
Clinical narrative: Rcd shot 9/18 started 9/19 pain, swelling redness, rash. Worse daily. Went to clinic 9/22. Warm to touch, 3x5 rash, hard.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Rcd shot 9/18 started 9/19 pain, swelling redness, rash. Worse daily. Went to clinic 9/22. Warm to touch, 3x5 rash, hard.
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Somnolence
Clinical narrative: Sweating, C/O feeling hot and lightheaded, denies CP, denies difficulty breathing, drowsy/loopy but conscious. Hx of syncope/autonomic nerve/jitters pt with blood draws or receipt of injections. Event lasted 6 minutes. Pt monitored by nurse x 15 minutes and BP obtained and WNL. Reviewed S/S adverse reaction with pt.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia, Pain
Clinical narrative: Within 6-7 hours of receiving the vaccine I developed muscle and joint aches and pain and extreme fatigue. I thought I had the flu, since I'd never before had a reaction to any vaccine. The symptoms lasted 12-15 hours.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local reaction at injection site. Treatment-BENADRYL. Arm red and swollen.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Myalgia, Rash
Clinical narrative: Fatigue, muscle soreness, severe chills, headache, rash appearance. Swelling. 4 x 4 demarcation below injection site. Very warm to the touch.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Skin warm, Swelling
Clinical narrative: Fatigue, muscle soreness, severe chills, headache, rash appearance. Swelling. 4 x 4 demarcation below injection site. Very warm to the touch.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: On 9/18, patient came to pharmacy and reported he got red blotchy first on his red side trunk for 1 day then next day right cheek progressed to left cheek and then right upper lip.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Dyspnoea
Clinical narrative: About 1 min after injection, pt had a hard time breathing. I gave her a 0.3mg Epinephrine inj. in her right thigh. After about 1 min w/no relief, I gave her a second inj. of the same thing. 911 was called and they came shortly after Epi injections.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Peripheral swelling
Clinical narrative: Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer or non healthcare professional. This case involves a 39 years old female patient who experienced swelling in feets and legs, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 30-Aug-2018, the patient received a once dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported in the left arm (expiry date, dose, dose in series and route of administration were not reported). On an unknown day, the patient developed a non-serious swelling in feets and legs (peripheral swelling) 20 minutes following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported by the doctor of the patient that everything was fine with her cholesterol, BP and thyroid, only thing different was the flu shot. On an unknown date, the doctor sent the patient to the Emergency Room to find the cause of this swelling. On an unknown date, patient was performed lab work, X ray and will be doing ultrasound next Tuesday to rule out blood clot (result: not reported). Final diagnosis was swelling in feets and legs. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for swelling in feets and legs. Documents held by the sender: none.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Laboratory test, Peripheral swelling, X-ray
Clinical narrative: Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer or non healthcare professional. This case involves a 39 years old female patient who experienced swelling in feets and legs, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 30-Aug-2018, the patient received a once dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported in the left arm (expiry date, dose, dose in series and route of administration were not reported). On an unknown day, the patient developed a non-serious swelling in feets and legs (peripheral swelling) 20 minutes following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported by the doctor of the patient that everything was fine with her cholesterol, BP and thyroid, only thing different was the flu shot. On an unknown date, the doctor sent the patient to the Emergency Room to find the cause of this swelling. On an unknown date, patient was performed lab work, X ray and will be doing ultrasound next Tuesday to rule out blood clot (result: not reported). Final diagnosis was swelling in feets and legs. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for swelling in feets and legs. Documents held by the sender: none.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received SHINGRIX (batch number AS9CM, expiry date 25th April 2020) for prophylaxis. On 6th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 7th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) stated that the events lasted for 2 weeks and got fully resolved in June 2018.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received SHINGRIX (batch number AS9CM, expiry date 25th April 2020) for prophylaxis. On 6th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 7th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) stated that the events lasted for 2 weeks and got fully resolved in June 2018.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Local reaction
Clinical narrative: 2 days ago received meningococcal vaccine to left deltoid has developed localized reaction. Low likelihood of cellulitis. Administered Benadryl 25 mg PO, Rocephin 1g IM, Ibuprofen 600 mg PO.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Mass, Syncope
Clinical narrative: Fainting. Lump still at 6 weeks.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Bradycardia, Dizziness, Dyspnoea, Pruritus
Clinical narrative: Shortness of breath. Light headedness. Itchy skin no hives. Bradycardia.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Malaise, Myalgia, Nausea, Rash macular
Clinical narrative: 9-19-18 sore deltoid muscle. 9-20-18 sore deltoid muscle, malaise, nausea, joint pain even at rest. 9-20-18 - 10-3-18 continue joint pain primarily in hands. 10-3-18 macular rash.
Age: 1.92
Sex: F
Vaccine: HEPA
Symptoms: Ammonia increased, Seizure, Swelling
Clinical narrative: The mother refers that after the vaccine was administered the child started to swell and afterward she had convulsions. After the episode the mother went directly to Dr., who is the pediatrician of the girl and made a referral to a neurologist, Dr., and to a geneticist, Dr.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Areflexia, Ataxia, Dysphagia, Gastrostomy, Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome. Symptoms began 9/20/18. Patient seen in office 9/21/18 and hospitalized at Hospital. He had ataxic gait, weakness of extremities, and areflexia. He was treated with IVIG. He developed swallowing difficulty and G-tube placed. Transferred to another hospital 9/30/18 and undergoing plasmaphoresis.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Immunoglobulin therapy, Muscular weakness, Plasmapheresis
Clinical narrative: Guillain-Barre Syndrome. Symptoms began 9/20/18. Patient seen in office 9/21/18 and hospitalized at Hospital. He had ataxic gait, weakness of extremities, and areflexia. He was treated with IVIG. He developed swallowing difficulty and G-tube placed. Transferred to another hospital 9/30/18 and undergoing plasmaphoresis.
Age: 1.17
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Mother said that the girl developed a fever and rash all over her body.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 12 month old patient of unknown gender. The patient's concomitant therapies pertinent, medical history and drug reactions/allergies were not reported. On 17-SEP-2018 the patient was vaccinated with PROQUAD (route, strength, dose, frequency, batch/lot # and expiration date were not reported) instead of M-M-R II for prophylaxis. On the same date, the patient also vaccinated with VARIVAX (route, strength, dose, frequency, batch/lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Age: 3.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assissance concerning a 3 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 18-SEP-2018, the patient was inadvertently vaccinated with a dose of GARDASIL 9 lot # R008164 as reported, expiry date 12-NOV-2020, for prophylaxis (strength, dose, dosage schedule and anatomical location were not provided) (drug administered to patient of inappropriate age). No adverse effect reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported. In November 2017, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (lot # and expiration date were unspecified). On 21-SEP-2018, the patient went to the reporter's office to receive the second dose of GARDASIL 9, which was a late dose (inappropriate schedule of vaccine administration). No adverse effects reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, 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 pertinent medical history, drug reactions and allergies were not reported.      On 28-SEP-2018, the patient was vaccinated with M-M-R II, intramuscular route (incorrect route of drug administration), lot#: R000556 and expiration date: 08-JAN-2020 (strength, dose and anatomical location were not reported) indicated for prophylaxis, which was reconstituted with sterile diluent(MERCK STERILE DILUENT). No adverse effects reported.
Sex: U
Vaccine: HEP, HIBV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from nurse concerning an unspecified number of patients of unknown age and gender. The patients historical conditions, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored Oka/Merck VARIVAX, reported lot number R007695, expiry date 14-MAR-2020 (strength, dose, route and frequency were not reported), LIQUID PEDVAXHIB, reported lot number N034410, expiry date 01-FEB-2020 (strength, dose, route and frequency were not reported), and RECOMBIVAX HB reported lot number N002914, expiry date 04-NOV-2019 (strength, dose, route and frequency were not reported) all vaccines for prophylaxis. The administered dose of LIQUID PEDVAXHIB and RECOMBIVAX HB, experienced a temperature excursion of 47°F to 77°F (52.7°F) for 2 hours, with a previous temperature excursion of 32°F up to 35°F (33.1°F) for 2 hours and 25 minutes. Regarding Oka/Merck VARIVAX, experienced a temperature excursion of 6°F to 14°F (8.8 °F), for 1 hour, with a previous temperature excursion of 6°F to 14°F (6.3 °F) for 10 minutes. It was not recorded by a data logger. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a Registered Nurse and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 27-SEP-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R011806, expiration date 23-APR-2020, for prophylaxis (dose and route were not reported). The temperature involved was (-7C) for 28 hours. Previous temperature excursion was not reported and a data logger was involved.
Age: 20.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a health professional referring to a 20 year old female patient. The patient had no medical history, concurrent conditions or concomitant medications. On 15-JUN-1999, the patient was vaccinated with the first dose of M-M-R II and the first dose of VARIVAX, on 06-OCT-2003, the patient received the second dose of M-M-R II and on 04-JUN-2007, the patient received the second dose of VARIVAX (Captured in MARRS 1810USA000814). On 01-OCT-2018, the patient was vaccinated with PROQUAD rHA lot number R008206 and expiration date of 16-SEP-2019, subcutaneously, for prophylaxis (dose and anatomical location were not reported). This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1810USA000814.
Sex: U
Vaccine: HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date the patients were vaccinated with GARDASIL 9 lot # R004689 and expiration date 29-NOV-2020 for prophylaxis (dose, frequency and route were not provided). Other suspect therapies included ROTATEQ lot# R002516 and expiration date 13-SEP-2019 for prophylaxis (dose, frequency and route were not provided). No adverse effects were reported. Digital data logger registered a temperature excursion between 0°C to l°C (0.2 C) for 86 hours. There were no previous temperature excursions registered. This case was determined to be non-valid as there was no patient identifier.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding an unknown age patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reaction/allergies were not reported. On 01-OCT-2018, the patient was administered an expired dose of RECOMBIVAX HB lot # N002922 and 30-SEP-2018 expiration date for prophylaxis (strength, frequency and route of administration were not reported). No adverse effects reported.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a health professional referring to 1 year old female patient. The patient had no medical history, concurrent conditions or concomitant medications. On 15-JUN-1999, the patient was vaccinated with the first dose of M-M-R II and the first dose of VARIVAX, on 06-OCT-2003, the patient received the second dose of M-M-R II and on 04-JUN-2007, the patient received the second dose of VARIVAX all of them for prophylaxis (route of administration, anatomical location, lot number and expiration date were not reported). On an unspecified date, an unspecified test was performed and the results showed titres were 0. Nevertheless, the patient did not receive treatment to the aforementioned event. On 01-OCT-2018, the patient was vaccinated with PROQUAD (Captured in MAARS # 1810USA000670). At the time of the report, the outcome of antibody test negative was reported as resolved. Additionally, the reporter did not provide causality assessment between the event and vaccination with M-M-R II and VARIVAX. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1810USA000670.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MENB
Symptoms: Abdominal pain upper, Arthralgia, Blood test, Diarrhoea, Dysphagia
Clinical narrative: 6/15/2016 - within 3 hours - sore and red in injection right arm, couldn't lift, warm to the touch. 2 days of that and also low grade fever and fatigued. Day 5 and 6 after shot: rash that hurt around neck area, low grade fever off and on, headache and body/joint pain. Day 13 post shot: very sore throat, low grade fever, difficulties swallowing, body aches, fatigued again, loose stools and stomach ache.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MENB
Symptoms: Fatigue, Headache, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: 6/15/2016 - within 3 hours - sore and red in injection right arm, couldn't lift, warm to the touch. 2 days of that and also low grade fever and fatigued. Day 5 and 6 after shot: rash that hurt around neck area, low grade fever off and on, headache and body/joint pain. Day 13 post shot: very sore throat, low grade fever, difficulties swallowing, body aches, fatigued again, loose stools and stomach ache.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MENB
Symptoms: Injection site warmth, Oropharyngeal pain, Pain, Pyrexia, Rash
Clinical narrative: 6/15/2016 - within 3 hours - sore and red in injection right arm, couldn't lift, warm to the touch. 2 days of that and also low grade fever and fatigued. Day 5 and 6 after shot: rash that hurt around neck area, low grade fever off and on, headache and body/joint pain. Day 13 post shot: very sore throat, low grade fever, difficulties swallowing, body aches, fatigued again, loose stools and stomach ache.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Bone pain, Chills, Fatigue
Clinical narrative: Began with intense chills, shivering, pain and feeling of heat and pain at injection site and GI upset in early hours of 10/25/1018. Unable to return to sleep due to aforementioned. Chills turned to fever-100.5F,  body aches that felt like they were coming from deep in my bones and joint pain, headache including inability to focus my eyes, fatigue all increasing in intensity during the day. By late night of same day it began to abate. The most serious effects were gone by midnight. Pain and heat it the injection site remained as did the fatigue the next day.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site warmth, Pain, Pyrexia
Clinical narrative: Began with intense chills, shivering, pain and feeling of heat and pain at injection site and GI upset in early hours of 10/25/1018. Unable to return to sleep due to aforementioned. Chills turned to fever-100.5F,  body aches that felt like they were coming from deep in my bones and joint pain, headache including inability to focus my eyes, fatigue all increasing in intensity during the day. By late night of same day it began to abate. The most serious effects were gone by midnight. Pain and heat it the injection site remained as did the fatigue the next day.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Began with intense chills, shivering, pain and feeling of heat and pain at injection site and GI upset in early hours of 10/25/1018. Unable to return to sleep due to aforementioned. Chills turned to fever-100.5F,  body aches that felt like they were coming from deep in my bones and joint pain, headache including inability to focus my eyes, fatigue all increasing in intensity during the day. By late night of same day it began to abate. The most serious effects were gone by midnight. Pain and heat it the injection site remained as did the fatigue the next day.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: 4 days after injection - hives & scalp itching.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Tendon pain, Tendonitis
Clinical narrative: Severe tendon pain in hips.....diagnosed as tendonitis by MD.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Dysphagia, Ear pain, Head discomfort, Injection site bruising
Clinical narrative: Fever up to 102.3, pain in left side of abdomen, feeling of stabbing pain in both ears, pressure in head/headache, funny feeling swallowing in throat, small bruise at injection site.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: Fever up to 102.3, pain in left side of abdomen, feeling of stabbing pain in both ears, pressure in head/headache, funny feeling swallowing in throat, small bruise at injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthritis, Chills, Decreased appetite, Frequent bowel movements
Clinical narrative: 9/22 rash, warmth and pain at injection site, lasting 3 days. 9/23 beginning of malaise, myalgia (not localized), lasting 10+ days. 9/23 loss of appetite, lasting 10 days. 9/25 abdominal cramping and frequent bowel movement without diarrhea, lasting 3 days. 9/27 onset of fever and chills, lasting 2 days. Max temperature 100 degrees. Slight feverish episodes for an additional 2 days. 9/29 onset of nighttime inflammation of joints of hands, wrists and feet lasting 4+ days. Inability to completely close fingers into a fist upon awakening, with improvement as the patient worked her hands. Steroids prescribed. 9/29 onset of mild to moderate morning headaches, lasting 4+ days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site rash, Injection site warmth, Malaise
Clinical narrative: 9/22 rash, warmth and pain at injection site, lasting 3 days. 9/23 beginning of malaise, myalgia (not localized), lasting 10+ days. 9/23 loss of appetite, lasting 10 days. 9/25 abdominal cramping and frequent bowel movement without diarrhea, lasting 3 days. 9/27 onset of fever and chills, lasting 2 days. Max temperature 100 degrees. Slight feverish episodes for an additional 2 days. 9/29 onset of nighttime inflammation of joints of hands, wrists and feet lasting 4+ days. Inability to completely close fingers into a fist upon awakening, with improvement as the patient worked her hands. Steroids prescribed. 9/29 onset of mild to moderate morning headaches, lasting 4+ days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: 9/22 rash, warmth and pain at injection site, lasting 3 days. 9/23 beginning of malaise, myalgia (not localized), lasting 10+ days. 9/23 loss of appetite, lasting 10 days. 9/25 abdominal cramping and frequent bowel movement without diarrhea, lasting 3 days. 9/27 onset of fever and chills, lasting 2 days. Max temperature 100 degrees. Slight feverish episodes for an additional 2 days. 9/29 onset of nighttime inflammation of joints of hands, wrists and feet lasting 4+ days. Inability to completely close fingers into a fist upon awakening, with improvement as the patient worked her hands. Steroids prescribed. 9/29 onset of mild to moderate morning headaches, lasting 4+ days.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Exposure during pregnancy, Pruritus, Tenderness, Urticaria
Clinical narrative: Pt was seen for her first OB appointment with Dr. Pt stated about an hour after she left the office after receiving her flu vaccine, she developed hives across her feet. Pt stated they continued to spread and this am she is covered all over her body in hives. Pt reports to itching, redness and tenderness. Pt denies shortness of breath, difficulty breathing or swelling. Pt was instructed to take oral Benadryl 25mg 1 tablet by mouth every 6 hours as needed.  Pt denies previous reactions to flu vaccines and denies any known allergies to foods or medications. Pt has an estimated due date of 4/18/2019.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site swelling, Myalgia, Pain, Peripheral swelling
Clinical narrative: Swelling across arm, spreading from injection site across and down multiple inches. Warmness, and muscle aches, unable to move arm without pain. Color was dark red.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Swelling across arm, spreading from injection site across and down multiple inches. Warmness, and muscle aches, unable to move arm without pain. Color was dark red.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Injection site pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: More pain during injection than usual, shoulder more sore than usual immediately after injection, shooting excruciating pain down arm while sleeping 7 hours later, pain reduced to sore arm 12 hours after injection.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Peripheral swelling, Pruritus, Rash
Clinical narrative: Headache, insomnia, severe rash over bilateral upper extremities- itchy, raised.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pruritus, Urticaria
Clinical narrative: Muscle pain, fatigue, itchy and welts on arms legs and face.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Dizziness starting around 4 PM on the day that I had the vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Nausea, Pain
Clinical narrative: Woke up feeling achy and nauseous. Checked temperature, 100.2 F.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Injection site pain, Injection site ulcer, Malaise
Clinical narrative: Fever, malaise, body aches, diarrhea, leg cramps, severe pain at site of injection, superficial ulceration at site of injection, itching on left arm, redness. Treatment: Tylenol for pain, wound care with bacitracin/bandaid, Benadryl for itching, comfort care such as rest, fluids and position of comfort for the arm.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Pain, Pruritus, Pyrexia, Wound treatment
Clinical narrative: Fever, malaise, body aches, diarrhea, leg cramps, severe pain at site of injection, superficial ulceration at site of injection, itching on left arm, redness. Treatment: Tylenol for pain, wound care with bacitracin/bandaid, Benadryl for itching, comfort care such as rest, fluids and position of comfort for the arm.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Parents purchased vaccine from the Pharmacy. A family member administered the vaccine, which was expired. The expiration date was 19 Jan 18. Health Department was noticed by School Nurse that they received a child's vaccine on a hand written note and were told the family member had administered the vaccine at home. She wanted to know if it was acceptable. The father also provided the school with a picture of the empty vial. The information was sent to agency. It was noted and verified that the vaccine was expired. The agency recommended that child be revaccinated in 8 weeks and that the local HD submit a VAERS report.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Dizziness, Feeling jittery, Loss of consciousness, Pallor
Clinical narrative: Patient had never received flu vaccine prior to today and had never had a previous reaction to a vaccine before. Patient instructed to stay in my location for 15 minutes after injection per policy. Patient administered vaccine at 7:42am in right arm and walked over to an area behind my work table to sit on a couch (about 10 feet). Patient fainted/passed out at 7:48 am while seated on couch. No injury occurred at any time. Patient reports feeling "like he was falling asleep really fast" and had a head rush prior to fainting. Upon becoming aware of his surroundings, he remained jittery and had feelings of anxiety. He reported no issues with breathing or constriction of airway. Patient had very little to eat for breakfast one hour prior and so we gave his a little orange juice orally at 7:55am. At 8:00 am patient vomited x2 while still seated. Heart rate was steady at 68 bpm and respiratory rate of 16. Lips were pale as was skin. Patient's hands were shaking but he was talking and describing his symptoms. At 8:15 am, patient laid down with his legs elevated on the couch. He felt this made him feel worse again and so he sat back up at 8:25 am. Patient continued to improve over the course of the next 40 minutes and reported feeling 90% or better and could return to work. He was advised to remain with another person for the duration of his day if he was able to stay at work. If he felt like he needed to go home, he was instructed to only go home if he was with another person and to have that person drive him. I will follow-up with him in the afternoon.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope, Tremor, Vomiting
Clinical narrative: Patient had never received flu vaccine prior to today and had never had a previous reaction to a vaccine before. Patient instructed to stay in my location for 15 minutes after injection per policy. Patient administered vaccine at 7:42am in right arm and walked over to an area behind my work table to sit on a couch (about 10 feet). Patient fainted/passed out at 7:48 am while seated on couch. No injury occurred at any time. Patient reports feeling "like he was falling asleep really fast" and had a head rush prior to fainting. Upon becoming aware of his surroundings, he remained jittery and had feelings of anxiety. He reported no issues with breathing or constriction of airway. Patient had very little to eat for breakfast one hour prior and so we gave his a little orange juice orally at 7:55am. At 8:00 am patient vomited x2 while still seated. Heart rate was steady at 68 bpm and respiratory rate of 16. Lips were pale as was skin. Patient's hands were shaking but he was talking and describing his symptoms. At 8:15 am, patient laid down with his legs elevated on the couch. He felt this made him feel worse again and so he sat back up at 8:25 am. Patient continued to improve over the course of the next 40 minutes and reported feeling 90% or better and could return to work. He was advised to remain with another person for the duration of his day if he was able to stay at work. If he felt like he needed to go home, he was instructed to only go home if he was with another person and to have that person drive him. I will follow-up with him in the afternoon.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Anion gap decreased, Asthenia, Basophil count decreased, Basophil percentage decreased
Clinical narrative: After receiving flu shot, I got in car to drive home, and began to have some facial numbness, tingling, increased weakness. I turned back around and had 4 episodes of diarrhea. I then went to ER and was evaluated and treated as possible adverse reaction vs allergic reaction to flu shot. Had further episodes of diarrhea. Tachycardic upon ER evaluation and continued tachycardia. Treated with IM BENADRYL and sent home. Have continued to have upset stomach, diarrhea, facial numbness/tingling, tachycardia.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose increased, Blood potassium normal
Clinical narrative: After receiving flu shot, I got in car to drive home, and began to have some facial numbness, tingling, increased weakness. I turned back around and had 4 episodes of diarrhea. I then went to ER and was evaluated and treated as possible adverse reaction vs allergic reaction to flu shot. Had further episodes of diarrhea. Tachycardic upon ER evaluation and continued tachycardia. Treated with IM BENADRYL and sent home. Have continued to have upset stomach, diarrhea, facial numbness/tingling, tachycardia.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Blood sodium normal, Blood urea nitrogen/creatinine ratio, Blood urea normal, Carbon dioxide normal, Diarrhoea
Clinical narrative: After receiving flu shot, I got in car to drive home, and began to have some facial numbness, tingling, increased weakness. I turned back around and had 4 episodes of diarrhea. I then went to ER and was evaluated and treated as possible adverse reaction vs allergic reaction to flu shot. Had further episodes of diarrhea. Tachycardic upon ER evaluation and continued tachycardia. Treated with IM BENADRYL and sent home. Have continued to have upset stomach, diarrhea, facial numbness/tingling, tachycardia.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Eosinophil count decreased, Eosinophil percentage decreased, Haematocrit normal, Haemoglobin normal, Hypoaesthesia
Clinical narrative: After receiving flu shot, I got in car to drive home, and began to have some facial numbness, tingling, increased weakness. I turned back around and had 4 episodes of diarrhea. I then went to ER and was evaluated and treated as possible adverse reaction vs allergic reaction to flu shot. Had further episodes of diarrhea. Tachycardic upon ER evaluation and continued tachycardia. Treated with IM BENADRYL and sent home. Have continued to have upset stomach, diarrhea, facial numbness/tingling, tachycardia.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphocyte count normal, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume normal
Clinical narrative: After receiving flu shot, I got in car to drive home, and began to have some facial numbness, tingling, increased weakness. I turned back around and had 4 episodes of diarrhea. I then went to ER and was evaluated and treated as possible adverse reaction vs allergic reaction to flu shot. Had further episodes of diarrhea. Tachycardic upon ER evaluation and continued tachycardia. Treated with IM BENADRYL and sent home. Have continued to have upset stomach, diarrhea, facial numbness/tingling, tachycardia.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Mean platelet volume normal, Monocyte count normal, Monocyte percentage, Neutrophil count increased, Neutrophil percentage increased
Clinical narrative: After receiving flu shot, I got in car to drive home, and began to have some facial numbness, tingling, increased weakness. I turned back around and had 4 episodes of diarrhea. I then went to ER and was evaluated and treated as possible adverse reaction vs allergic reaction to flu shot. Had further episodes of diarrhea. Tachycardic upon ER evaluation and continued tachycardia. Treated with IM BENADRYL and sent home. Have continued to have upset stomach, diarrhea, facial numbness/tingling, tachycardia.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Platelet count normal, Red blood cell count normal, Red cell distribution width normal, Tachycardia
Clinical narrative: After receiving flu shot, I got in car to drive home, and began to have some facial numbness, tingling, increased weakness. I turned back around and had 4 episodes of diarrhea. I then went to ER and was evaluated and treated as possible adverse reaction vs allergic reaction to flu shot. Had further episodes of diarrhea. Tachycardic upon ER evaluation and continued tachycardia. Treated with IM BENADRYL and sent home. Have continued to have upset stomach, diarrhea, facial numbness/tingling, tachycardia.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: White blood cell count normal
Clinical narrative: After receiving flu shot, I got in car to drive home, and began to have some facial numbness, tingling, increased weakness. I turned back around and had 4 episodes of diarrhea. I then went to ER and was evaluated and treated as possible adverse reaction vs allergic reaction to flu shot. Had further episodes of diarrhea. Tachycardic upon ER evaluation and continued tachycardia. Treated with IM BENADRYL and sent home. Have continued to have upset stomach, diarrhea, facial numbness/tingling, tachycardia.
Age: 1.08
Sex: M
Vaccine: FLU4, MMRV, VARCEL
Symptoms: Decreased appetite, Irritability, Pyrexia
Clinical narrative: Febrile 100.0-103.0, decreased appetite, irritability.