chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Stomatitis
Clinical narrative: The injection itself was very painful. The first two days after getting the vaccine, I developed flu like symptoms.......chills, body aches, slight fever. Soreness at the injection site for a week. A few weeks later I developed pus like sores, itching and redness around the left side of my mouth, down the left side of my jaw, neck and in my hairline. It was a weekend when these symptoms developed. Since there was no pain, only itching, I decided to wait until Monday morning to call for appt with my Dr which I got the next day. I was very surprised when she told me I had the shingles. I told her that I had just taken the shingles shot so that I would not get it. She told me to let the pharmacy know that I got the shingles after being given the first dose of the shot. So, I did and they were very surprised as well to see that I had the shingles and told me to report it and to wait closer to the six month before taking the second dosage. Is this common, and is there a chance that I will get it again after taking the second dosage? Should I even take the second dosage? I don't know; you tell me.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Dyspnoea, Eye pain, Fatigue
Clinical narrative: 9/26- could not sleep much at night, very cold. 9/27 (24 hrs after)- difficulty breathing, tachycardia, very dizzy and weak in the legs and whole body. Felt sick. Vomitting occurred 9/28- Headache, muscle aches, tired and cold all day. Not very hungry. Right eye (which is blind- previous condition) has hurt when putting in drops since vaccination.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Insomnia, Muscular weakness, Myalgia
Clinical narrative: 9/26- could not sleep much at night, very cold. 9/27 (24 hrs after)- difficulty breathing, tachycardia, very dizzy and weak in the legs and whole body. Felt sick. Vomitting occurred 9/28- Headache, muscle aches, tired and cold all day. Not very hungry. Right eye (which is blind- previous condition) has hurt when putting in drops since vaccination.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Tachycardia, Vomiting
Clinical narrative: 9/26- could not sleep much at night, very cold. 9/27 (24 hrs after)- difficulty breathing, tachycardia, very dizzy and weak in the legs and whole body. Felt sick. Vomitting occurred 9/28- Headache, muscle aches, tired and cold all day. Not very hungry. Right eye (which is blind- previous condition) has hurt when putting in drops since vaccination.
Age: 82.0
Sex: F
Vaccine: FLU3, PNC13, TDAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Muscle pain, swelling, redness and purple discoloration at site.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Nodule, Pain, Swelling
Clinical narrative: Patient reported on 10/3/18 that she had severe swelling and soreness and that as of today (10/3) the swelling has finally resolved but she now has a knot.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Patient presented w/ 4 inch circular red, warm to the touch rash approx 8 inches on arm. Patient was to follow-up with prescriber.
Age: 7.0
Sex: M
Vaccine: IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Child personal information (date of birth) was entered wrong at the time of registration. Child needed to be updated on vaccines, as a result of wrong age indicated at the system at the time of vaccination he was given one vaccinate not appropriate for his age. He was administered 5 vaccines but only one MCV4 (MENVEO) was not appropriate for his age. After vaccination child was monitored after vaccination without s\s. Explained to sister what happened and recommended in case of emergency to take him to ER>.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site pruritus, Injection site warmth
Clinical narrative: Soreness, hot and itchy at injections site, tiredness, chills, 101.9 fever, flu like symptoms.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Soreness, hot and itchy at injections site, tiredness, chills, 101.9 fever, flu like symptoms.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dysgeusia, Dyspnoea, Erythema, Hyperhidrosis
Clinical narrative: Patient reported bad taste in mouth to husband upon leaving consultation room then seconds later was sitting in waiting room beet red, sweating, grabbing chest and gasping for air.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: Hives warm to the touch surrounding injection site on right thigh. Noticed 30 minutes after injection.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Erythema, Injection site urticaria, Pruritus, Rash macular
Clinical narrative: Hives formed around the injection site, had elevated BP, shaking, extreme itching, red blotchy skin.  Was sent to ER for evaluation and treatment. Received IV Benadryl, a dose of oral benadryl and IV fluids.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Hives formed around the injection site, had elevated BP, shaking, extreme itching, red blotchy skin.  Was sent to ER for evaluation and treatment. Received IV Benadryl, a dose of oral benadryl and IV fluids.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Patient received MMR vaccination within seconds after injection was given a lump was noted at injection site approximately 1 inch in diameter. Lump was also noted to be red in appearance but was not warm to the touch. The Medical Provider was called to inspect the site.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Urticaria
Clinical narrative: Redness initiating at site of injection and radiating to front of left arm with 2 red streaks and 2 whelps.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Loss of consciousness, Memory impairment, Skin laceration
Clinical narrative: PATIENT WAS BREATHING FAST BEFORE GIVING THE VACCINES BECAUSE SHE WAS NERVOUS.  WE HAD HER SIT FOR 20 MINUTES AFTER GIVING THE VACCINES AND WHEN SHE STOOD UP TO LEAVE, SHE PASSED OUT AND RECEIVED A SIGNIFICANT LACERATION TO HER FOREHEAD. SHE WAS ONLY OUT FOR A FEW SECONDS BUT DOESN'T REMEMBER FALLING. AFTER STOPPING THE BLEADING AND CHECKING HER VITALS, SHE SAT IN OUR OFFICE FOR ANOTHER 20 MINUTES WAITING FOR HER OTHER PARENT TO ARRIVE AND THEY ESCORTED HER TO THE ER TO HAVE STITCHES OR STAPLES PLACED.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TDAP given to patient on 8/21/2018 and another TDAP given on 10/02/2018, 11 days apart. No reaction noted on date of injection. Patients parent aware of error in vaccine schedule administration. Multiple attempts made to talk to parent but unable to follow up due to parent not accepting phone calls.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Dizziness, Injection site erythema, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Large red area (almost tennis ball area) at injection site. Dizziness, muscle aches, nausea, threw up once. No appetite even this evening. Symptoms have affected daily functioning of patient.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Large red area (almost tennis ball area) at injection site. Dizziness, muscle aches, nausea, threw up once. No appetite even this evening. Symptoms have affected daily functioning of patient.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Cognitive disorder, Decreased appetite, Headache
Clinical narrative: Patient received vaccine on Sunday. On Monday, symptoms developed which included aches in joints and muscles, headache, fever (99.8), swelling, itch and pain at site of injection; some loss of appetite. Cognitive functions were also affected which patient describes as being slow and low in energy. Patient took 1 or 2 ibuprofen 200mg on Monday. Symptoms are getting better as of today when she called me (Wednesday).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Patient received vaccine on Sunday. On Monday, symptoms developed which included aches in joints and muscles, headache, fever (99.8), swelling, itch and pain at site of injection; some loss of appetite. Cognitive functions were also affected which patient describes as being slow and low in energy. Patient took 1 or 2 ibuprofen 200mg on Monday. Symptoms are getting better as of today when she called me (Wednesday).
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: On 10/3/8 at 2pm, the patient came to the pharmacy with an area of redness on her left arm. The area went from the injection sites to about 3" above the brachial artery area. It was about 3" to 4" wide.  The patient stated that the area was warm to the touch and had a little tightness in the bicep muscle.  She first noticed the redness on 10/2/18.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain
Clinical narrative: Pain and aches in left shoulder for ten days after receiving vaccine.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Erythema, Joint range of motion decreased, Swelling
Clinical narrative: Localized swelling, painful ROM, erythema.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: RED AND SWOLLEN UPPER ARM.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Fever 101, chills, body aches, and nausea.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site rash
Clinical narrative: Patient presented with substantial bruising around indicated injection site. Outside of this bruising, patient had red patches of rash skin. No treatment provided.
Age: 53.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Upon injection patient complained of discomfort he described as pressure. Over the afternoon this developed into severe pain. When I spoke with him around 6 this evening he was not getting relief from the pain using topical pain relievers.
Age: 11.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Cold sweat, Dizziness
Clinical narrative: Approximately 10 minutes after receiving the vaccine after using the restroom, the patient reported feeling light headed and clammy. She was laid down and her legs were elevated. She recovered within 10 minutes. She did not lose consciousness.
Age: 77.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Insomnia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Yesterday afternoon patient swept leaves. Had a flu shot in left arm, no soreness. Starting yesterday evening the arm was sore, hard to move, throbbing pain. Patient had difficulty sleeping overnight. Arm still sore this morning. Patient denies warmth/redness/swelling. Patient routinely takes APAP 650mg extended release morning and night. Will try NSAID and cold pack and report  back to us in a day or 2.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Within eight days of receiving the first of a two part dosage of SHRINGRIX vaccine I was diagnosed with Guillain-Barré syndrome. I write this on day forty nine of my hospital stay. I will return home tomorrow.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Inflammation
Clinical narrative: PATIENT CALLED THE PHARMACY THE DAY AFTER IN INJECTION. HE SAID HIS ARM WAS VERY INFLAMED AND WONDERED IF THERE WAS AN INTERACTION BETWEEN HIS NEW CANCER DRUG, ERLEADA, AND THE FLU SHOT. OUR SOFTWARE WAS UNABLE TO CHECK INTERACTION OF FLUZONE HD WITH THIS NEW CANCER DRUG. I CALLED THE PATIENT ON 10/3/18 AND HE WAS FINE. HE SAID EVERYTHING HAD RESOLVED WITHIN 24-36 HOURS. HE DID NOT SEEK MEDICAL ATTENTION OR TAKE ANY OTC MEDS.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain, Pyrexia
Clinical narrative: Pt received both FLUZONE HD and PNEUMOVAX 23 in left arm, PNEUMOVAX lower and second of two shots. Reported significant poke pain compared to flu shot. Waited in pharmacy for 15 min, left feeling fine. Called in to pharmacy Monday reported case of Cellulitis that started on Sat (9/29). Went to local Urgent Care on 9/30 received KEFLEX 500 (TID x 7 day). Followed up Wed (10/3) and pt reported improved symptoms and beginning of resolution of fever/erythema.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Injection site pain, Rash pruritic
Clinical narrative: The patient said she had muscle pain at the injection site and had a mild rash on her right arm that was itchy. Her left arm looked unaffected and she did not mention any soreness in that arm. The patient also said she also had some "chills" the night before but that side effect had resolved. I counseled the patient on over the counter items like tylenol and ibuprofen to help with the pain and mentioned she could try benadryl to help with the itching and redness. I told the patient to monitor the rash and if it worsened to contact her doctor.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Chest discomfort, Dyspnoea, Throat tightness
Clinical narrative: Pt called pharmacy at approximately 6:30pm 10/3/18 and reported that after going for a run (time not stated) he felt tightness in his chest and had some trouble breathing (not normal for patient). Pt called again at approximately 6:45pm 10/3/18 and stated that he felt like the chest-tightness had worsened and that his throat felt like it was closing. Pt was advised to seek treatment at an urgent care or emergency room--pt declined. RPh spoke with pt at approximately 7:45pm to follow-up with pt's condition. Pt stated he took "2 allergy pills" and was feeling better. He no longer felt as though his throat was closing and the chest tightness had started to lessen.
Age: 67.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Urticaria
Clinical narrative: She developed full body hives that started on her scalp and progressed down to her entire body. She went to her primary care doctor and was told to take 25mg Benadryl every 4 hours as needed and then a Claritin once daily.
Age: 0.17
Sex: M
Vaccine: DTAP, RV5
Symptoms: Bacterial test negative, Blood test normal, Catheter placement, Culture urine negative, Emotional distress
Clinical narrative: After 3 days, my baby began to sleep for abnormal amounts of time, waking just to eat and low grade fever. Around the 7th day he had a high fever for his age. 101.9 and was unconsolable. We brought him to the ER where they questioned meningitis, he was poked over 4 times to get blood samples. Straight cathed for urine sample. All of which came back negative.
Age: 0.17
Sex: M
Vaccine: DTAP, RV5
Symptoms: Full blood count normal, Hypersomnia, Pyrexia, Urine analysis normal
Clinical narrative: After 3 days, my baby began to sleep for abnormal amounts of time, waking just to eat and low grade fever. Around the 7th day he had a high fever for his age. 101.9 and was unconsolable. We brought him to the ER where they questioned meningitis, he was poked over 4 times to get blood samples. Straight cathed for urine sample. All of which came back negative.
Age: 72.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site pain
Clinical narrative: Patient states he has soreness in his arm from the date he received vaccine up until at least October 1 (prolonged soreness at injection site).
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient said he wanted a PREVNAR. So I gave him a PREVNAR. And when he got home and checked his records. He said he had that one last year and he was supposed to get a PNEUMOVAX. No adverse events have been experienced at this time.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient came into the pharmacy on 10/3/18 with rash on his left elbow region and forearm, that is itchy. Occurring approximately one week ago which would be 9/26/18 per patient. Patient had his second dose of the SHINGRIX vaccination on 9/13/18 on his left arm. Patient was told to be seen by his provider.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site reaction, Pain in extremity, Urticaria
Clinical narrative: My arm hurt worse than when you receive a tetanus shot; it felt like I had been punched and had a bruise. When I looked at where I felt like I had a bruise, I saw raised red welts at the site of the injection (I have a photo) I was also extremely tired and had to go to bed early. The pain in my arm and welts for about a week. It went away gradually. The tiredness went away after about one night. Now I am fine; no issue that I know of.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea
Clinical narrative: Patient experienced nausea (without vomiting) and fatigue for 3 days.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Paraesthesia, Throat tightness
Clinical narrative: Right after patient received FLUZONE HD (1st) and PREVNAR 13 (2nd), she felt tightness in her throat. She immediately took 25mg of Benadryl of her own. She started having different sensation in her face and lips, she injected epinephrine 0.3mg pharmacy provided. Patient stated that she does not feel any difference, and 3 minutes later she received 2nd dose of epinephrine injection since the symptoms got worse. One of the technicians called 911. Patient said that the 2nd dose worked and she started feeling better in her throat. She was able to drink water and waited in her seat until paramedic came in. Paramedic took her and her husband to emergency room.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Patient returned to pharmacy 3 days after receiving FLUARIX vaccine with complaint of silver dollar sized reddened area at injection site that was slightly warm and painful to touch and very itchy according to patient.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Dizziness, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Fever, chills/shivering, sweats, dizziness and nausea.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood urine present, Dysuria, Heart rate increased, Pyrexia
Clinical narrative: The patient first received a fever and then later experienced increased heart rate on the same day. The following day, the patient starting having problem urinating. It started with the patient needing to forced in order to urinate then he later starting having blood in his urine.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy, Injection site vesicles
Clinical narrative: The day after vaccination, the patient developed multiple blisters at the site of the injection. Patient is 20 weeks 5 days pregnant and is due 2/15/2019. Patient weight 202 lbs.
Age: 52.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Within 30 minutes of getting the flu shot, my arm got very itchy, and there appeared to be a hive, however, the shot was given near my small pox vaccine scar, so it was hard to tell if the hive was there, but a red swelling occurred around the injection site and continued to itch for 2 -3 days. The redness extended down my arm to the elbow from the injection site by the 2nd day. Only antihistamines were used to control itching.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, Swelling, Pain, and Itching surrounding injection site, approximately 5 inches in diameter when reported approx 24 hours post-injection.
Age: 6.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Laboratory test normal, Mononucleosis heterophile test negative, Pharyngitis, Pyrexia, Rash generalised
Clinical narrative: On 9/26 /18--MMR, Flu vaccine given. On 10/1/18  fever started --T max 39 C. Rash started on  10/1/18 all over body then swelling over the face only.
Age: 6.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Streptococcus test, Swelling face
Clinical narrative: On 9/26 /18--MMR, Flu vaccine given. On 10/1/18  fever started --T max 39 C. Rash started on  10/1/18 all over body then swelling over the face only.
Age: 57.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: Patient reported that next morning after receiving vaccines he was very ill. He had chills, low grade fever and body aches and couldn't get out of bed. These symptoms lasted about 2 days.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral, Pruritus generalised, Urticaria
Clinical narrative: Lip tingling, hives on arms, itchy all over, HR 120's.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Flu shot given on 9-5-18. On 10-3-18 patient complained of arm soreness, but no other symptoms. Patient will call MD.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Patient called 09/27/18. To report that she was experiencing hives all over. She stated that a few hours after she got vaccination on 9/24/18, she developed a rash on her shoulder that resolved with BENADRYL. The following dat, the rash returned to her trunk, and arms, and has progressed to hives. We directed her to seek medical care at the nearest urgent care.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: 10cm x 5 1/2cm red area, warm to touch. Pt reports it started on the day after injection and is a little bit achy. Was advised to use heat as she has been applying ice.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Staring, Tremor
Clinical narrative: Mom (Parent) reported that child was noted to be woken from sleep at 3AM post day of vaccine with "Full body shaking, heavy breathing" for about 5 minutes. No loss of weakness, no SOB. Returned to sleep. 9PM next day noted to be "starring". Mom reported event to Immunology office 2 days past vaccine.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chest discomfort, Disturbance in attention, Dizziness, Dyspnoea
Clinical narrative: 10/2/18 Pt reports SOB, palpitations, fatigue, malaise, lack of focus, tingling in hands/face, chest "heaviness". Local site erythema at left deltoid. Vitals stable. 10/3/18 Reports continued fatigue, dizziness, weakness, SOB, headache. Left arm swelling/redness improved.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram normal, Erythema, Fatigue, Fibrin D dimer normal, Headache
Clinical narrative: 10/2/18 Pt reports SOB, palpitations, fatigue, malaise, lack of focus, tingling in hands/face, chest "heaviness". Local site erythema at left deltoid. Vitals stable. 10/3/18 Reports continued fatigue, dizziness, weakness, SOB, headache. Left arm swelling/redness improved.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Malaise, Palpitations, Paraesthesia, Peripheral swelling
Clinical narrative: 10/2/18 Pt reports SOB, palpitations, fatigue, malaise, lack of focus, tingling in hands/face, chest "heaviness". Local site erythema at left deltoid. Vitals stable. 10/3/18 Reports continued fatigue, dizziness, weakness, SOB, headache. Left arm swelling/redness improved.
Age: 1.33
Sex: F
Vaccine: DTAPHEPBIP, MMR, PNC13, VARCEL
Symptoms: Crying, Staring, Unresponsive to stimuli
Clinical narrative: The patient stopped crying, froze and had a staring spell for one second and then became responsive again and started crying. The patient was observed closely and was back to normal immediately after vaccination. Patient was well when she left the rooms. Her parents confirmed 24 hours later, with a follow up phone call, that she was doing well and showed no signs of adverse effect.
Age: 68.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Chills, Hyperhidrosis, Musculoskeletal stiffness, Myalgia
Clinical narrative: Next day developed chills, diaphoresis, stabbing pain in fingers and toes, joint pains in shoulders and hips, pain at prior surgical scars/sites, generalized muscular pain and stiffness. Fever.
Age: 68.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Pain in extremity, Procedural pain, Pyrexia
Clinical narrative: Next day developed chills, diaphoresis, stabbing pain in fingers and toes, joint pains in shoulders and hips, pain at prior surgical scars/sites, generalized muscular pain and stiffness. Fever.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site abscess
Clinical narrative: Local skin abscess at flu vaccine injection site. Treated with warm compresses and topical antibiotic ointment.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Pain
Clinical narrative: Pt states chills for 2-3 hours and body pain all day.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Fever (103 degrees); extreme shivers; night sweats (needed to change nightshirt and bedclothes); foul odor in urine and perspiration; no appetite; nausea; muscle pain; sore arm; extreme fatigue; light headedness; no energy. Lasted until Sep 17, 2018.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Night sweats, Pain in extremity, Pyrexia
Clinical narrative: Fever (103 degrees); extreme shivers; night sweats (needed to change nightshirt and bedclothes); foul odor in urine and perspiration; no appetite; nausea; muscle pain; sore arm; extreme fatigue; light headedness; no energy. Lasted until Sep 17, 2018.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin odour abnormal, Urine odour abnormal
Clinical narrative: Fever (103 degrees); extreme shivers; night sweats (needed to change nightshirt and bedclothes); foul odor in urine and perspiration; no appetite; nausea; muscle pain; sore arm; extreme fatigue; light headedness; no energy. Lasted until Sep 17, 2018.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Swelling, Tenderness
Clinical narrative: Noticed tenderness (pain) and swelling under left axilla on 9/25. Entire chain of lymph nodes swollen from under left axilla into the left upper quad of the breast. Used MOTRIN and heat to control pain. Swelling decreased by 9/28.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: Had immunization on Friday 9/28/18; woke up 9/30/18, unable to lift arm, Pain with ROM.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Localized hives Lt delt.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Angiogram, C-reactive protein increased, Chest X-ray, Chest pain, Echocardiogram
Clinical narrative: Pt developed 9/10 substernal CP 9/30/18. Pain worse lying down and on deep inspiration. Eval at PCP 10/1/18 noted EKG change 1mm ST elevation. To ED via EMS. Seen by cardiology. Dx acute idiopathic pleuropericarditis. Treated with NSAIDS.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram ST segment elevation, Painful respiration, Pleuropericarditis, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Pt developed 9/10 substernal CP 9/30/18. Pain worse lying down and on deep inspiration. Eval at PCP 10/1/18 noted EKG change 1mm ST elevation. To ED via EMS. Seen by cardiology. Dx acute idiopathic pleuropericarditis. Treated with NSAIDS.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain, Pain in extremity
Clinical narrative: I had a reaction for my first shot and reported it in July 2018 to Vaers. That shot was on 1/16/18 and also in left arm. (Lot number 9NJ59) I had all over body severe aches, fever of 101, teeth chattering, headache, dizzy for 24  hours. Second shot was 10/02/18. (lot  number bR3z4) This time I had all over body severe aches, fever of 101, headache, dizzy and is lasting longer. Today is day 3 for feeling really bad.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Chills, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: I had a reaction for my first shot and reported it in July 2018 to Vaers. That shot was on 1/16/18 and also in left arm. (Lot number 9NJ59) I had all over body severe aches, fever of 101, teeth chattering, headache, dizzy for 24  hours. Second shot was 10/02/18. (lot  number bR3z4) This time I had all over body severe aches, fever of 101, headache, dizzy and is lasting longer. Today is day 3 for feeling really bad.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: I had a reaction for my first shot and reported it in July 2018 to Vaers. That shot was on 1/16/18 and also in left arm. (Lot number 9NJ59) I had all over body severe aches, fever of 101, teeth chattering, headache, dizzy for 24  hours. Second shot was 10/02/18. (lot  number bR3z4) This time I had all over body severe aches, fever of 101, headache, dizzy and is lasting longer. Today is day 3 for feeling really bad.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: I had a reaction for my first shot and reported it in July 2018 to Vaers. That shot was on 1/16/18 and also in left arm. (Lot number 9NJ59) I had all over body severe aches, fever of 101, teeth chattering, headache, dizzy for 24  hours. Second shot was 10/02/18. (lot  number bR3z4) This time I had all over body severe aches, fever of 101, headache, dizzy and is lasting longer. Today is day 3 for feeling really bad.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Seizure
Clinical narrative: Flu shot received Friday, Sept. 28th around 5pm. Dizzy spell followed by fainting and accompanied by seizure on Saturday, Sept. 29th around 12pm. Was sent to ER for CT, EKG, and blood work which were all normal. Doctor believes it was reaction to flu shot.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood test normal, Computerised tomogram normal, Dizziness, Electrocardiogram normal, Seizure
Clinical narrative: Flu shot received Friday, Sept. 28th around 5pm. Dizzy spell followed by fainting and accompanied by seizure on Saturday, Sept. 29th around 12pm. Was sent to ER for CT, EKG, and blood work which were all normal. Doctor believes it was reaction to flu shot.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Syncope, Vaccination complication
Clinical narrative: Flu shot received Friday, Sept. 28th around 5pm. Dizzy spell followed by fainting and accompanied by seizure on Saturday, Sept. 29th around 12pm. Was sent to ER for CT, EKG, and blood work which were all normal. Doctor believes it was reaction to flu shot.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Sleep disorder, Weight bearing difficulty
Clinical narrative: Patient complains of significant pain in left arm after receiving SHINGRIX 2 months later. Patient describes pain as dull, muscle soreness but a significant pain that makes her hesitate to get second dose, and compares pain to shingles episode. Patient received shot at doctor's office, but came to Walgreens to file complaint with pharmacist. Patient has had follow up with doctor's office and states that no resolution or cause has been found.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Patient complains of significant pain in left arm after receiving SHINGRIX 2 months later. Patient describes pain as dull, muscle soreness but a significant pain that makes her hesitate to get second dose, and compares pain to shingles episode. Patient received shot at doctor's office, but came to Walgreens to file complaint with pharmacist. Patient has had follow up with doctor's office and states that no resolution or cause has been found.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: She noticed a small welt form at injection site the morning after the vaccine. By afternoon, another much larger welt (about 1/3 to 1/2 the outer upper arm) developed. It is painful and warm to the touch. The patient is going to go in and have her doctor look at it.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, swelling, warmth and tenderness below injection site spreading down the bicep.
Age: 74.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, swelling, warmth and tenderness below injection site spreading down the bicep.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Cerebral haemorrhage, Coma, Laboratory test
Clinical narrative: Coma, brain bleeds.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle twitching
Clinical narrative: Patient came back at about 5 PM complaining that her arm was twitching right by her underarm. She said she doesn't know exactly when it started, but it has gone on for quite some time after the flu shot was administered.
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Severe Flu like symptoms lasting longer than three days. Fever, chills, muscle and joint soreness. Today is the 4th day of the symptoms, still running low grade fever.
Age: 13.0
Sex: M
Vaccine: HEP, HPV9, MNQ, VARCEL
Symptoms: Dizziness, Head injury, Hyporesponsive to stimuli, Loss of consciousness, Pallor
Clinical narrative: Patient got up and walked to the waiting room where he got very dizzy and passed out. He struck the back of his head and was minimally responsive for a few minutes. After coming to, he was sitting in a chair and got very dizzy and pale. EMS was called and evaluated him and felt he could go home. He has scheduled follow up with his PCP.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Mild random phantom itching on torso, neck - it feels like I have chicken pox.
Age: 21.0
Sex: M
Vaccine: CHOL
Symptoms: Haematochezia
Clinical narrative: This spontaneous case report was received from a nurse on 25-Jun-2018. The report describes a 21-year-old adult male consumer who suspected blood in stool following the intake of VAXCHORA (lot number: 7000009 and expiry date: 28-Feb-2019) for cholera prevention. The consumer took VAXCHORA on 25-Jun-2018. Subsequently, on the same day, he suspected blood in his stool. The nurse reported that the consumer had a formed stool, and the water (in the toilet) was pink-tinged. The nurse stated that the consumer confirmed that had never happened before. The consumer did not have any medical conditions (specifically no history of GI conditions), chronic medications, vitamins, or supplements. The consumer did not report any history of constipation, straining, or fissures. Also, the consumer denied drinking any red beverage, such as GATORADE. He also denied eating anything that was red. The consumer was a vegetarian. The nurse stated that she had spoken with the consumer, and he was feeling fine. The event got resolved on the same day and did not happen again. Blood was found only once in the stool. The consumer neither received any treatment nor had any laboratory tests or blood work done regarding this event as it had resolved. The action taken with VAXCHORA with respect to the event suspected blood in stool was not applicable. The clinical outcome of the event suspected blood in stool was resolved. Sender's Comments: Company comment: In this case, a 21-years-old male consumer had taken VAXCHORA in the morning and on the same day he reported that there was blood in his stool. He said that he had formed stool and the water (in the toilet) was tinged pink. The patient denied having any medical conditions, specifically no history of any GI conditions. He was not taking any chronic medications, vitamins or any supplements. The event occurred only once and resolved on its own without the patient receiving any treatment for the same. Moreover, there was no laboratory tests done to conclude that it was blood in stool. The common etiologies of blood in stool are conditions like constipation, anal fissure, hemorrhoids, colonic polyp, etc. and any GI condition was ruled out in this case. Also, the colour was noticed as tinged pink which is not in line with the usual colour of blood in stool. Based on the available information, it could not be confirmed if the patient actually experienced blood in stool or it was just an incidental finding. Also, in view of the fact that this was a single isolated episode which resolved without any treatment, the causal association of the event with VAXCHORA is assessed as unlikely related.
Sex: F
Vaccine: CHOL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A spontaneous case report was received from a pharmacist on 27-Jun-2018 for two consumers. Based on the information obtained from the pharmacist, two individual case safety reports PVX201806-000641 (PVX2018-2075; female) and PVX201806-000642 (PVX2018-2091, male) were created and cross-linked in the database. This case report describes a female consumer who "took VAXCHORA inspite of being among an unapproved age group to take it". The consumer was receiving VAXCHORA for cholera prophylaxis. It was reported that the consumer administered VAXCHORA but she was over the age of 64 years and under 81 years of age. The action taken with VAXCHORA with respect to event "took VAXCHORA inspite of being among an unapproved age group to take it" was not applicable. The clinical outcome of the event "took VAXCHORA inspite of being among an unapproved age group to take it" was unknown.; Sender's Comments: The causality of the event "took VAXCHORA inspite of being among an unapproved age group to take it" was considered as not applicable.
Sex: M
Vaccine: CHOL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A spontaneous case report was received from a pharmacist on 27-Jun-2018 for two consumers. Based on the information obtained from the pharmacist, two individual case safety reports PVX201806-000641 (PVX2018-2075; female) and PVX201806-000642 (PVX2018-2091, male) were created and cross-linked in the database. This case report describes a male consumer who "took VAXCHORA in spite of being among an unapproved age group to take it". The consumer was receiving VAXCHORA for cholera prophylaxis. It was reported that the consumer administered VAXCHORA but she was over the age of 64 years and under 81 years of age. The action taken with VAXCHORA with respect to event "took VAXCHORA in spite of being among an unapproved age group to take it" was not applicable. The clinical outcome of the event "took VAXCHORA in spite of being among an unapproved age group to take it" was unknown. Sender's Comments: Company's Comment: The causality of the event "took VAXCHORA in spite of being among an unapproved age group to take it" was considered as not applicable.
Sex: U
Vaccine: CHOL
Symptoms: Expired product administered
Clinical narrative: This spontaneous case report was received from a pharmacist (PVX2018-2319) on 19-Jul-2018. The report describes consumer who "administered an expired product". The consumer was receiving VAXCHORA (expiry date: Feb 2018) for an unknown indication. It was reported that the consumer took dose of expired VAXCHORA on 13-Jul-2018. The action taken with VIVOTIF with respect to the event "administered an expired product" was not applicable. The clinical outcome of the event "administered an expired product" was unknown. Sender's Comments: Company's Comment: The causality of the event "administered an expired product" was considered as not applicable.
Age: 57.0
Sex: M
Vaccine: CHOL
Symptoms: Expired product administered
Clinical narrative: This spontaneous case report was received from an other healthcare professional on 21-Aug-2018. The report describes a 57-year-old male consumer who "took expired dose of VAXCHORA". The consumer was receiving oral VAXCHORA (lot number: 7000004 and expiry date: 28-May-2018) for cholera prophylaxis. It was reported that the consumer took an expired dose of VAXCHORA on 17-Aug-2018. The action taken with VAXCHORA with respect to the event "took expired dose of VAXCHORA" was not applicable. The clinical outcome of the event "took expired dose of VAXCHORA" was unknown. Sender's Comments: Company's Comment: The causality of the event "took expired dose of VAXCHORA" was considered as not applicable.
Sex: F
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: This spontaneous report has been received from an unspecified source via a company representative referring to "a couple" of patients of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patients were vaccinated with GARDASIL 9 (strength, dose, frequency, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patients developed headache, which lasted for 2 days. The outcome of headache was reported as resolved. The causality assessment was not provided. Follow up information has been received from the medical assistant on 02-OCT-2018. The primary reporter reported that, the 2 patients were teenage girls. The reporter further mentioned, "When it came time for the patients to get their second dose, the mothers for the girls didn't want the patients getting anymore doses due to the really bad headaches that lasted one to two days." The reporter had no knowledge of the dates it occurred or treatments or any further patient specifics. Upon receipt of follow-up information it was determined that this case is now valid as the patient identifier was received.
Age: 0.25
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a nurse referring to a 3 month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On 05-SEP-2018, the patient was inadvertently administered GARDASIL 9 (dose, frequency and routewere unknown; lot # N035957; expiration date 10-OCT-2020 ) for prophylaxis(Inappropriate age at vaccine administration). No adverse effects reported.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: This spontaneous report was received from a pharmacist via poison and drug center regarding a currently 26-year-old male patient. Information on the patient's relevant medical history, concomitant medications, concurrent condition and past drug history were unknown by the reporter. On an unknown date in 2009, the patient was vaccinated with the first dose of GARDASIL 9 via unknown route of administration with lot # R008165, expiry date 12-NOV-2018 for prophylaxis (strength, dose, frequency were not provided). It was reported that the patient never received the full series of GARDASIL 9 and only received one dose in 2009. On 17-SEP-2018, the patient was vaccinated with the second dose of GARDASIL 9 via unknown route of administration for prophylaxis (strength, dose, frequency, batch/lot # and expiration dates were not provided) (inappropriate schedule of drug administration). As of 17-SEP-2018, the patient continues on the GARDASIL 9.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-SEP-2018, the patient was vaccinated with GARDASIL 9, intramuscularly (formulation, dose, dose number, frequency, site of administration, lot # and expiration date were not reported) and experienced pain with the injection and she was being able to feel the shot and it was painful. The outcome of the events and the relatedness between the events and GARDASIL 9 were not reported.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist referring to a 71 years old male patient. Information about medical history, concurrent condition and concomitant therapy was not reported. On an unspecified date in 2014, the patient received a dose of PNEUMOVAX 23 (strength, dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unspecified date in August 2018, the patient received a dose of PNEUMOVAX 23 (lot # reported as R00692, expiration date 09-SEP-2019; in right arm, strength, dose and route of administration were not reported) for prophylaxis (inappropriate schedule of vaccine administered). On unspecified date in August 2018 (reported as the next day), the patient experienced pyrexia and injection site pain in his right arm. On unknown date in 2018, the patient contacted an unspecified physician regarding pyrexia and injection site pain and the physician told the patient to "rest for a few days". The patient reported he "could not get out of bed for 3 or 4 days". Some unspecified treatment was given for the evnets. At the reporting time, the patient was recovered from the events on an unspecified date in 2018. The causality between the events and PNEUMOVAX 23 was not provided. The reporter considered the events as disability due to the patient couldn't get out of bed for 3 or 4 days.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician via company representative concerning a 15 year old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions /allergies were not reported.    On 16-FEB-2018, the patient was vaccinated with a dose of GARDASIL 9 for prophylaxis (strength, dose, dosage schedule, route of administration, anatomical location, lot # and expiry date were not provided). The patient became pregnant with a last menstrual period (LMP) of 23-DEC-2017 and  estimated date of delivery (EDD) of 29-SEP-2018 (exposure during pregnancy). The physician reported that the patient was 8 weeks pregnant when she went to her medical office, and the patient was pregnant whe she received GARDASIL 9. No further details regarding the patient's pregnancy were provided. The pregnancy outcome was pending and the fetal outcome was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Injection site extravasation, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse, via a company representative, referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, previous drug reactions and allergies and concomitant medication was not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 injection, one dosage form (DF), on an unspecified arm, for prophylaxis (dose number, frequency, route of administration, lot number and expiration date was not provided). The nurse stated that, after the patient was administered the dose of GARDASIL 9, when pulling the needle out of the patient's arm, a few drops leaked out and dripped on the patient's unspecified arm, resulting in possible topical exposure and a possible partial dose. No adverse effects or symptoms were reported.