chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus generalised, Rash generalised, Swelling of eyelid
Clinical narrative: A couple of hours after vaccination the patient removed her non-latex Coverlet bandage and directly underneath her arm was quite red and irritated. The swelling continued in her arm and around bedtime that evening she had chills and uncontrolled shivering but no fever. The next morning ( 9/25/18 ) she states she was itchy all over and throughout the day the itching and swollen red arm worsened. When she woke up on 9/26/2018 she had a severe rash all over her body and the area under both her eyes was swollen and painful to the touch. She saw her PA and PMD later that morning and they told her they believed she had cellulitis in the arm and an allergic reaction to the vaccine. They referred her to the advice of her allergist as to whether or not she should have the booster dose of SHINGRIX, and prescribed her Prednisone 20 mg, 2 tablets once daily for 5 days, but did not prescribe an anti-biotic. They did mark the area on her arm where the reaction was occurring and told the patient to call if the swelling went outside the area. When spoken to today ( 9/27/2018 ) patient stated that she is feeling better and that the swelling on her arm, and the rash, do appear to be diminishing. The area directly under where the bandage was, is still is the most irritated.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Chest discomfort, Dyspnoea, Rash macular, Rash pruritic
Clinical narrative: About 2 hours after receiving a flu vaccine from a multidose vial (Sanofi lot #UJ998AE, exp June 30 2019) early in the am at work on 9/22, she developed pinpoint itchy red spots on her arms. About 15 minutes later, she developed generalized hives, SOB, wheezing, chest heaviness and partial throat closing. Her BP was 180/110.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness, Urticaria, Wheezing
Clinical narrative: About 2 hours after receiving a flu vaccine from a multidose vial (Sanofi lot #UJ998AE, exp June 30 2019) early in the am at work on 9/22, she developed pinpoint itchy red spots on her arms. About 15 minutes later, she developed generalized hives, SOB, wheezing, chest heaviness and partial throat closing. Her BP was 180/110.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Nausea
Clinical narrative: Arm pain, nausea, dizziness, chills, exhaustion, extreme weakness.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain, nausea, dizziness, chills, exhaustion, extreme weakness.
Age: 20.0
Sex: M
Vaccine: FLUC4
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: States he received his flu shot and approximately an hour later he began to feel a "stiffness" in his neck on the right side. He is able to complete flexion/extension and lateral flexion but with "soreness." He denies muscle weakness, tenderness or tingling in his extremities at this time and is afebrile and in no acute distress. Ambulating without difficulty.
Age: 61.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills, Fatigue, Feeling hot, Influenza like illness, Injection site rash
Clinical narrative: I had no adverse affects to my first SHINGRIX vaccine received in June of 2018. The day after my second vaccination I felt like I had the full blown flu. Body aches, chills, fatigue. This got worse as the evening progressed and lasted thru the night. I had teeth chattering chills to throw the sheet off warmth. I had to change my tee shirt in the night when I woke up to a sweat dampened shirt. By late morning the next day I felt fine. I also had a rash and minor swelling at the injection site.
Age: 61.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Injection site swelling, Night sweats, Pain
Clinical narrative: I had no adverse affects to my first SHINGRIX vaccine received in June of 2018. The day after my second vaccination I felt like I had the full blown flu. Body aches, chills, fatigue. This got worse as the evening progressed and lasted thru the night. I had teeth chattering chills to throw the sheet off warmth. I had to change my tee shirt in the night when I woke up to a sweat dampened shirt. By late morning the next day I felt fine. I also had a rash and minor swelling at the injection site.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Headache, Laboratory test
Clinical narrative: Severe headache & BP of 200/105, requiring ER visit.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Skin warm, Tenderness
Clinical narrative: My arm is still quite sore and the upper arm is painful to the touch and hot.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: Persistent and forceful vomiting after every feeding for over three consecutive days following vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Mobility decreased, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Patient just wanted to give feedback on SHINGRIX series - after first dose on 5/14/18, she had a fever over 101* and flu like symptoms for 2-3 days. She reported a more severe reaction after the second dose on 09/04/2018. Patient stated she got a fever again and had severe joint pain - she said it was the worst in her hands and she felt like they were very difficult to move.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: PATIENT HAD A SHINGLES LIKE OUTBREAK WITH A BLISTERY RASH ASSOCIATED WITH THE INJECTED ARM, IN WHICH AFTER 1 WEEK--SPREAD TO HER LEFT OUTER THIGH. PATIENT WAS GIVEN ACYCLOVIR. HER DR RECOMMENDED THE SHINGRIX DUE TO PAST SHINGLES OUTBREAKS.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Very large red spot slightly lower than injection site. Not on deltoid muscle but around bicep. Has been about 48 hours since vaccine, Patient did report it feeling warm to the touch (pharmacist also agreed), no itching, no pain, no other symptoms, rash was about 3 inches in length.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Mobility decreased, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: The patient stated that she had the 2nd SHINGRIX Vaccine on Monday afternoon (9/10/18), the next day (9/11/18) she felt severe flu-like symptoms throughout her body, and by Friday, when she came to the office she could hardly move, and had a fever of 100.0.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMRV, VARCEL
Symptoms: Eczema, Rash papular
Clinical narrative: I do not recall the exact time of how long after the vaccines my child developed bumps on her arms and legs. It was after the vaccinations done on 11/29/2007. I took her to the doctor on 12/20/2007 and was told that she had Eczema. I was not told that this could be a reaction from the vaccines. Until recently, I was unaware that I could file a report.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Chills, Injection site discomfort, Injection site erythema, Injection site pain
Clinical narrative: 9/20/2018. SHINGRIX Vaccine administer in L deltoid. Mild discomfort and minimal erythema at injection site in the evening. 9/21/2018 Evening-  spreading erythema and markedly increased pain extending distally toward elbow from the site of injection. 9/22/2018 AM awoke with fevers, chills increased pain and worsening of erythema down L arm. Diagnosed with cellulitis. Started on AUGMENTIN for treatment. 9/24/2018 Fevers, chills resolved. Erythema and pain nearly resolved.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 9/20/2018. SHINGRIX Vaccine administer in L deltoid. Mild discomfort and minimal erythema at injection site in the evening. 9/21/2018 Evening-  spreading erythema and markedly increased pain extending distally toward elbow from the site of injection. 9/22/2018 AM awoke with fevers, chills increased pain and worsening of erythema down L arm. Diagnosed with cellulitis. Started on AUGMENTIN for treatment. 9/24/2018 Fevers, chills resolved. Erythema and pain nearly resolved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cold sweat, Crying, Heart rate increased, Injection site pain, Loss of consciousness
Clinical narrative: Patient had brief loss of consciousness when standing from mothers lap. She was out only 5-15 seconds. Neurologically intact. Clammy skin, crying, when asked where did she hurt she pointed to injection sites each time. Mother stated she thinks she hit her head. Hairband removed and scalp inspected, no redness or swelling. Denies head pain. Initial Heart rate 118 at 2:15 and repeat heart rate at 2:36 106. She was given water and able to swallow. She ate lollipop and responded to verbal commands. Stopped crying. Walked to car by herself accompanied by mother and this nurse. Mother given nurse cell #, office # and email for f/u and stated it was okay for nurse to call and check on her later today.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: WARM TO TOUCH, SWELLING, PAIN, BLISTERS, RASH, REDNESS AT SITE.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Headache, fatigue, muscle aching, chills, roaring in ears, nausea, sore red swollen at sight of injection. Started 12 hours after vaccination and lasted 12-14 hours.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Nausea, Tinnitus
Clinical narrative: Headache, fatigue, muscle aching, chills, roaring in ears, nausea, sore red swollen at sight of injection. Started 12 hours after vaccination and lasted 12-14 hours.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 17-year-old female patient. The patient's concurrent conditions, medical history, drug reactions, allergies, and concomitant medications were not reported. On 18-SEP-2018 the patient was vaccinated with GARDASIL 9, intramuscular for prophylaxis (dose, strength, lot number or expiration date not provided). On the same date, the patient passed out shortly after the application. It was reported that the patient sought medical attention for the event, as she was in the physician's office at the time of the event. The patient recovered from the event on an unknown period of time afterward. The causality assessment between the event and the vaccine was not reported. Upon internal review, the event was considered as medically significant.
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Pneumonia, Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for herself. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history included chronic obstructive pulmonary disease (COPD), asthma, hospitalisation from Feb through Mar and pneumonia. Concomitant medications were not reported. The patient experienced pneumonia on an unspecified date with outcome of recovering. Before vaccination, she was in the hospital from Feb through Mar and they sent her home on steroids and two kinds of antibiotics. Subsequently she had the vaccine shot, but she still came down with it. This was the 2nd time she experienced pneumonia and was worse. She complained of difficulty breathing and a high fever. No follow-up attempts are possible, information about lot number cannot be obtained.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Headache, Laboratory test, Lumbar puncture normal, Neck pain
Clinical narrative: This is a spontaneous report from a contactable nurse. A 16-year-old male patient received TRUMENBA (Lot# T52805, Exp date 31Aug2019), via an unspecified route of administration, on 11Sep2018 afternoon, at single dose, for immunisation and influenza vaccine (unspecified trade name) (Exp Date 30Jun2019, NDC# 49281-418-10, UPC# 349281-418-105), via an unspecified route of administration, on 11Sep2018, at unspecified dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe head and neck ache on 12Sep2018. On 12Sep2018 his mother took him to the emergency room (ER). In the ER he was observed and received fluid. The patient underwent lab tests and procedures which included spinal tap (unknown date): negative. He was hospitalized due to the events on 12Sep2018. On 13Sep2018 he was feeling much better, the diagnosis was side effect from the vaccine. Outcome of the events was recovering. Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine TRUMENBA contributed to the development of the reported events severe head and neck ache. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 64 years and 10 months old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot no UJ010AC and expiration date 22-APR-2019) via unknown route in the left arm on 18-Sep-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due product storage error and vaccine was administered to patient of inappropriate age (it was reported that temp excursions of High dose Flu vaccine occurred and administered to a male patient who was 64 years and 10 months old) without any adverse effects noted. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: Initial unsolicited report received from pharmacist on 19-Sep-2018. This case involves an unknown age and gender patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UI977AC, expiration date: 03-Sep-2019, site of administration: arm and route was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to syringe leak (needle in the arm, pushed on it and stuff came out). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Discomfort, Erythema, Musculoskeletal pain, Peripheral swelling, Sleep disorder
Clinical narrative: Feeling like a heavy weight on the body, Red, hot, swollen arm. The redness spread to 3 areas of the upper arm. They were not connected. Pain in the left shoulder so much so she couldn't sleep and when the doctor touched it she winced and pulled away.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site erythema, Injection site induration
Clinical narrative: Headache, neck, muscle pains for past 3 days. Nauseated for past 3 days, but no vomiting. Diarrhea. Shivers during night after receiving vaccines (09/25/18) with flu-like sxs, but no fever. Looks like mosquito bite: firm, red, tender, and hot to touch lump of 3in on LA where PNEUMOVAX was administered.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site mass, Injection site pain, Injection site warmth, Myalgia, Nausea
Clinical narrative: Headache, neck, muscle pains for past 3 days. Nauseated for past 3 days, but no vomiting. Diarrhea. Shivers during night after receiving vaccines (09/25/18) with flu-like sxs, but no fever. Looks like mosquito bite: firm, red, tender, and hot to touch lump of 3in on LA where PNEUMOVAX was administered.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Neck pain
Clinical narrative: Headache, neck, muscle pains for past 3 days. Nauseated for past 3 days, but no vomiting. Diarrhea. Shivers during night after receiving vaccines (09/25/18) with flu-like sxs, but no fever. Looks like mosquito bite: firm, red, tender, and hot to touch lump of 3in on LA where PNEUMOVAX was administered.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Hot flush, Influenza like illness, Limb discomfort
Clinical narrative: Patient reported flu-like symptoms, including full body aches, chills for several hours at a time, and hot flashes. She has a "large" red spot/bump further down her arm below the injection site that is hot to the touch, and a second spot forming closer to the injection site (between the first spot and the injection site, and to the right). She also reports pain down her arm, and her arm feels heavy/hard to lift. Patient notified pharmacy 2 days after administration of vaccination, pharmacist advised patient to call doctor to be seen for evaluation. Patient was seen by nurse practitioner who diagnosed symptoms as a regular reaction to a vaccination. Patient was prescribed CELEBREX daily for 14 days and betamethasone cream twice daily for 14 days, and told to take BENADRYL OTC for rash. Patient to follow-up with NP if reaction worsens or doesn't get better.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nodule, Pain, Pain in extremity
Clinical narrative: Patient reported flu-like symptoms, including full body aches, chills for several hours at a time, and hot flashes. She has a "large" red spot/bump further down her arm below the injection site that is hot to the touch, and a second spot forming closer to the injection site (between the first spot and the injection site, and to the right). She also reports pain down her arm, and her arm feels heavy/hard to lift. Patient notified pharmacy 2 days after administration of vaccination, pharmacist advised patient to call doctor to be seen for evaluation. Patient was seen by nurse practitioner who diagnosed symptoms as a regular reaction to a vaccination. Patient was prescribed CELEBREX daily for 14 days and betamethasone cream twice daily for 14 days, and told to take BENADRYL OTC for rash. Patient to follow-up with NP if reaction worsens or doesn't get better.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Herpes zoster, Malaise, Pain
Clinical narrative: 1 day fever and malaise and headache. 2 days malaise and headache. 3 days severe pain in right waist. 4 days severe pain continues. 5 days rash appears on right waist and severe pain continues. 6 days blisters appear on rash with continued severe pain. 7 days rash, pain and blisters persist.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: 1 day fever and malaise and headache. 2 days malaise and headache. 3 days severe pain in right waist. 4 days severe pain continues. 5 days rash appears on right waist and severe pain continues. 6 days blisters appear on rash with continued severe pain. 7 days rash, pain and blisters persist.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus generalised, Swelling, Throat tightness, Urticaria
Clinical narrative: At approximately 345 PM patient complained of itchiness on his body, hives, swelling and tightness in throat. Consulted with provider and administered 2 tabs BENADRYL monitored vitals. Provider re-evaluated and nurse administered hydroxyzine HCI 25 mg/ml. Patients vitals and symptoms were evaluated by provider and released to go home.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Migraine, Nausea, Peripheral swelling
Clinical narrative: Arm swelled, itched, got hot & red. Got a migraine, nausea, & lack of energy. These symptoms lasted 2 days. Swelling & redness increased to 3/4 diameter of arm & lasted 5 days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm
Clinical narrative: Arm swelled, itched, got hot & red. Got a migraine, nausea, & lack of energy. These symptoms lasted 2 days. Swelling & redness increased to 3/4 diameter of arm & lasted 5 days.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Crying, Emotional distress, Hypophagia, Opisthotonus, Pyrexia
Clinical narrative: Child received vaccines 6/27/2018, following day child reduced his PO intake, he slept longer, high pitched crying, arching of the back, none consolable, he developed temperatures of 102.5F and continued with temperatures over the weekend for 3 days. He followed up in his previous PCP office 3d after the imm with fevers, per mom she was told that it was a low grade temp, did not believe it was d/t vaccines, and that it was viral. Did not take child to ER, was monitoring at home, mom thought he would resolve.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Somnolence, Viral infection
Clinical narrative: Child received vaccines 6/27/2018, following day child reduced his PO intake, he slept longer, high pitched crying, arching of the back, none consolable, he developed temperatures of 102.5F and continued with temperatures over the weekend for 3 days. He followed up in his previous PCP office 3d after the imm with fevers, per mom she was told that it was a low grade temp, did not believe it was d/t vaccines, and that it was viral. Did not take child to ER, was monitoring at home, mom thought he would resolve.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site rash
Clinical narrative: Patient experienced a rash at the site of the injection.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Patient stated she noticed a bubble on her arm where she received the vaccine. The area seemed to be raised and dry and has not gone away since receiving the vaccine. The patient said she did not experience any pain.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pain and swelling in left arm and hand which persisted for 2 days. Patient took over the counter diphenhydramine 25 mg. Pain and swelling resolved on 3rd day with no additional consequences.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Flushing, Malaise, Pain, Pyrexia
Clinical narrative: Patient called to report full body achiness, feeling flushed/feverish and shortness of breath on 9/26. Patient said onset of symptoms was a few hours after receiving the High Dose flu shot. She states that she has had the flu vaccines in past years, with no adverse issues, but this time she feels ill with symptoms listed about for about 5 days now.
Age: 25.0
Sex: F
Vaccine: FLU4, HPV9, TD
Symptoms: Dizziness, Pharyngeal oedema, Pyrexia
Clinical narrative: Pt received flu shot, TD and HVP on 09/25/18. Pt called on 09/26/18 reports she had feverish, swelling in her throat, and dizziness. She took IBU and her symptoms resolved. Reports he had a cold last week.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU4, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 82.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Gait disturbance, Haematochezia
Clinical narrative: Felt like there was no control over whole body. No control walking. Bloody stool.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: She received a dose of PNEUMOVAX 23 (dose #1) on 24 September and 24 hours later complained of onset of local pain and swelling at the vaccination site on her right shoulder. Over the past 48 hours she notes increased redness, swelling, and tenderness affecting her shoulder and upper arm. For the past 48 hours she has complained of fever (99.9 F), chills, headache, fatigue, malaise, and muscle and joint aches. She denies generalized cutaneous, lip/tongue/oral/laryngeal, pulmonary, GI/GU, and cardiovascular symptoms. She has been taking ZYRTEC and MOTRIN.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Myalgia, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: She received a dose of PNEUMOVAX 23 (dose #1) on 24 September and 24 hours later complained of onset of local pain and swelling at the vaccination site on her right shoulder. Over the past 48 hours she notes increased redness, swelling, and tenderness affecting her shoulder and upper arm. For the past 48 hours she has complained of fever (99.9 F), chills, headache, fatigue, malaise, and muscle and joint aches. She denies generalized cutaneous, lip/tongue/oral/laryngeal, pulmonary, GI/GU, and cardiovascular symptoms. She has been taking ZYRTEC and MOTRIN.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Chills, Headache, Malaise, Pain in extremity
Clinical narrative: Hours after the vaccine was given patient stated she had so much pain in my whole arm/under arm. She also feel really sick with chills, fever, and a headache and also hurts to touch any part of my body.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Tenderness
Clinical narrative: Hours after the vaccine was given patient stated she had so much pain in my whole arm/under arm. She also feel really sick with chills, fever, and a headache and also hurts to touch any part of my body.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Neck pain
Clinical narrative: Approx 12 hrs post vaccination patient started with symptoms of sharp pain in arms travelling up into her neck. Also shooting, stabbing pains in legs, Left ankle, and back. Pain described as debilitating, lasting approx 12 hrs. Also C/O chills, fever, body aches during same time frame.   She also had a rash on her arm, not at vaccination site, that was itchy and very painful to touch(shingles-like rash) which resolved after 1 day. No further symptoms.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Rash, Rash pruritic
Clinical narrative: Approx 12 hrs post vaccination patient started with symptoms of sharp pain in arms travelling up into her neck. Also shooting, stabbing pains in legs, Left ankle, and back. Pain described as debilitating, lasting approx 12 hrs. Also C/O chills, fever, body aches during same time frame.   She also had a rash on her arm, not at vaccination site, that was itchy and very painful to touch(shingles-like rash) which resolved after 1 day. No further symptoms.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Tenderness
Clinical narrative: Approx 12 hrs post vaccination patient started with symptoms of sharp pain in arms travelling up into her neck. Also shooting, stabbing pains in legs, Left ankle, and back. Pain described as debilitating, lasting approx 12 hrs. Also C/O chills, fever, body aches during same time frame.   She also had a rash on her arm, not at vaccination site, that was itchy and very painful to touch(shingles-like rash) which resolved after 1 day. No further symptoms.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Neuropathy peripheral
Clinical narrative: Significant increase in peripheral neuropathy bilat feet, hands, peri oral. Had to use albuterol inhaler in the middle of the night.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: As soon as I injected the patient his injection site swelled up and it formed a lump. It lasted 10-15 minutes in which the patient didnt feel any pain but the site continued to stay swollen. He left. During the 10-15 minutes that he stayed at the pharmacy under supervision of myself and the other pharmacist, we iced the injection site to help the swelling go down.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling jittery, Immediate post-injection reaction, Injection site erythema, Injection site haemorrhage, Injection site pruritus
Clinical narrative: Weal immediately formed at site of injection. Patient also bled from site of injection requiring cotton ball affixed in place with bandage. Had patient sit in chair for further observation. Patient started to have redness on skin expand from site of injection. Patient started to itch at injection site. About 3-4 minutes patient was itching left arm and top of head. Pharmacist administered 2 x 25mg diphenhydramine tablets at that time. Pharmacist continued to observe patient and repeatedly asked if there was any itching in throat or trouble swallowing. Patient indicated that she started to itch in throat and could feel it start to swell. Pharmacist at that time administered in left leg mid-line of femur, epinephrine auto-injector 0.3mg and had 911 called. Patient started to feel the effects of the 2x25mg diphenhydramine, drowsiness and reduction of weal/redness at injection site. Also at the same time, patient did begin to feel the effects of the epinephrine, ie jitterness and no futher swelling in throat.  Paramedics came and transported patient to hospital.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria, Pharyngeal oedema, Somnolence, Throat irritation
Clinical narrative: Weal immediately formed at site of injection. Patient also bled from site of injection requiring cotton ball affixed in place with bandage. Had patient sit in chair for further observation. Patient started to have redness on skin expand from site of injection. Patient started to itch at injection site. About 3-4 minutes patient was itching left arm and top of head. Pharmacist administered 2 x 25mg diphenhydramine tablets at that time. Pharmacist continued to observe patient and repeatedly asked if there was any itching in throat or trouble swallowing. Patient indicated that she started to itch in throat and could feel it start to swell. Pharmacist at that time administered in left leg mid-line of femur, epinephrine auto-injector 0.3mg and had 911 called. Patient started to feel the effects of the 2x25mg diphenhydramine, drowsiness and reduction of weal/redness at injection site. Also at the same time, patient did begin to feel the effects of the epinephrine, ie jitterness and no futher swelling in throat.  Paramedics came and transported patient to hospital.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Dizziness, Headache, Hyperaesthesia
Clinical narrative: Approx 32 hrs post vaccination patient had symptoms of backache, headache, body aches, dizziness, skin sensitivity, shivering, chills. She stated she was "groaning in pain all night long". Pain was radiating up arms into neck and jaw. She took baby aspirin and extra strength Tylenol q 4-6 hours. Called MD and they stated these were normal symptoms and she did not need to be seen. Symptoms lasted another 1 1/2 days and resolved.  She stated she "felt fine" by day 3 post vaccination.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Approx 32 hrs post vaccination patient had symptoms of backache, headache, body aches, dizziness, skin sensitivity, shivering, chills. She stated she was "groaning in pain all night long". Pain was radiating up arms into neck and jaw. She took baby aspirin and extra strength Tylenol q 4-6 hours. Called MD and they stated these were normal symptoms and she did not need to be seen. Symptoms lasted another 1 1/2 days and resolved.  She stated she "felt fine" by day 3 post vaccination.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient reported swelling, itching and redness in left arm starting 2 days after vaccination. Patient was referred to her physician for evaluation and treatment. Unknown whether patient will be asked to make an appointment for evaluation or to watch and wait.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blood test, Generalised erythema, Oedema peripheral, Rash, Rash erythematous
Clinical narrative: Widespread erythma over entire body (except head). Rash was not raised or bumpy-looked like a severe sunburn. Edema and rash in both lower legs.
Age: 47.0
Sex: F
Vaccine: FLUR4
Symptoms: Dysphonia, Peripheral swelling, Throat irritation
Clinical narrative: 2 hours post injection  moderate swelling from shoulder to mid arm, throat felt "funny". Took Benadryl 25 mg q 6 hours for 18-24 hours. Reported hoarse voice by someone else.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue
Clinical narrative: The patient says she was in bed the next day with fatigue and chills.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient had redness under injection jsite. Patient stated it was hot to touch and very sore still 7 days later. Will follow up with primary care doctor.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash, Tremor
Clinical narrative: PATIENT REPORTED UNABLE TO STOP SHAKING. PT ALSO GOT A RASH. PATIENT WENT TO THE HOSPITAL.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Lethargy
Clinical narrative: Pt describes feeling lethargic, tired.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Hypotension, Loss of consciousness, Presyncope
Clinical narrative: Began to passout, vasovagal response, laid on floor, ambulance was called, and they came and took her BP, and said it was still low. She sat outside in ambulance, until her husband came to pick her up, then she went home and laid on couch. After 1st injection patient then explained that she has vasovagal responses to injections.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Headache, Peripheral swelling, Rash
Clinical narrative: My upper arm developed a rash, swelling, pain I also had a headache, stomach ache and fatigue for 3 days.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient did not remember she already recieved the flu shot last week...she forgot and the pharmacist who administered the vaccine asked her and she said no.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Discomfort, Rash erythematous
Clinical narrative: Left Arm 2-3" red rash. Discomfort started last night. Rash better this AM but wanted us to now.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site mass
Clinical narrative: Patient presented at 9 month well child check with lump on leg. Mom noticed this lump about 6 hours after the vaccines were given at 6 month well child check, but did not report until 9 month well child check. Mom did notice any other symptoms. Patient is to be scheduled for ultrasound of lump.
Age: 55.0
Sex: M
Vaccine: YF
Symptoms: Dizziness, Headache, Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: Light-headed feeling, mid-grade fever, mild headache, muscle pain, swelling of the hands and feet, extreme rash all over my body.
Age: 55.0
Sex: M
Vaccine: YF
Symptoms: Rash generalised
Clinical narrative: Light-headed feeling, mid-grade fever, mild headache, muscle pain, swelling of the hands and feet, extreme rash all over my body.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness
Clinical narrative: Headache, shivers, flu like symptoms. Took ibuprofen and TYLENOL.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Autism spectrum disorder, Decreased eye contact, Hair metal test abnormal, Immediate post-injection reaction, Injection site swelling
Clinical narrative: Swelling and rash were immediate, then fever for 3 days then child was never the same, no eye contact moderate to severe autism diagnosis followed, recently test results have shown off the chart high aluminum poisoning.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Insomnia, Metal poisoning, Pyrexia, Rash, Swelling
Clinical narrative: Swelling and rash were immediate, then fever for 3 days then child was never the same, no eye contact moderate to severe autism diagnosis followed, recently test results have shown off the chart high aluminum poisoning.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV
Symptoms: Erythema, Injection site bruising, Skin warm, Swelling
Clinical narrative: Redness, swelling, slightly warm to touch approx. 15x8 cm. Also noted a bruise to injection site. Pt's mother stated pt was fine after vaccines were administered but in the morning she noticed some redness to the area. After school, the redness had spread and was swollen. Pt's mother brought pt to clinic on 9/27/18 at 5:00pm to be seen by RN and provider.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Swelling
Clinical narrative: Patient reported back to the pharmacy with right arm pain and inability to move it. Pharmacist examined patient's arm, did not see any swelling or bruising. Pharmacist suggested ibuprofen and ice or heat to help relieve the pain. I called the patient the next day and and she reported swelling and was using heat and taking tramadol. I told her to use ice to relieve the swelling. She said it felt better than the day before.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Chills, Dry mouth, Erythema, Insomnia
Clinical narrative: Dry mouth, Back pain, stuffy nose, fever, chills, sore arm (painful, red, feels like knot in arm), trouble sleeping.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Nasal congestion, Nodule, Pain in extremity, Pyrexia
Clinical narrative: Dry mouth, Back pain, stuffy nose, fever, chills, sore arm (painful, red, feels like knot in arm), trouble sleeping.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site pain, Pain, Pain in extremity
Clinical narrative: L arm pain and bruise lasting 3 weeks. No swelling. Still has pain in arm at injection site whenever she moves it.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt received flu shot @ 9 am in clinic, returned to Day care where he developed tactile fever (parent and daycare worker did not take temp) and vomiting after lunch around 1pm. No tests have been done, will continue to monitor pt.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Patient state that she had a rash on her arm and was itching. Patient was instructed to take a benadryl and if rash got worse to report to ER.
Age: 33.0
Sex: F
Vaccine: YF
Symptoms: Headache, Injection site erythema, Injection site pruritus
Clinical narrative: Received the yellow fever vaccine on 9/21/2018. Noticed redness around the injection site the evening of 9/21/2018. The area of erythema did spread over the next 3 days. Notice area of redness started to decrease on 9/25/2018. The morning of 9/27/2018 noticed area of redness started to spread again and become very pruritic. No fever or pain. She started taking BENADRYL at night on 9/23/2018. Admits to a mild headache on 9/22/2018 and 9/23/2018. Given CLARITIN 10mg QD and hydrocortisone cream 1% to area TID; monitor for temperature.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms, Pain
Clinical narrative: Patient got cramps and aches all over the body after getting the shot. He laid down and rested. Cramps and aches were gone after 3-4 hours.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Patient received the first dose of the SHINGRIX vaccine on 04/19/2018, administered by the pharmacist on duty. The patient experienced pain in the muscle of the upper left arm (deltoid) after receiving the vaccine. The pain continued for several weeks and the patient went in for testing (MRI) to determine if there was any damage. Patient can move her arm but complains of pain in the area surrounding the injection site. The results of the MRI were not available at the time of this report. The patient received the second dose of SHINGRIX on 08/20/2018 and did not have any issues after the second dose.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Limb discomfort
Clinical narrative: Swelling, redness at injection site, tender to touch, arm discomfort.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site reaction, Injection site warmth, Rash pruritic
Clinical narrative: Patient reports a warm, itchy rash on left upper arm that began quickly after immunization and was still present 2 days later when reported. Patient states that it has not increased in size and is localized to left arm where she asked to receive both vaccines. Additionally, patient reports no systemic symptoms such as difficulty breathing or swelling.
Age: 53.0
Sex: F
Vaccine: FLUR4
Symptoms: Mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: Patient received the vaccination high in the arm almost to the shoulder. Patient currently has limited mobility with pain. She was seen by her prescriber MD who has prescribed ibuprofen for pain relief and has told the patient to use hot compress at the site of injection.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Low grade fever and overall body ache.
Age: 72.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Pt reported low grade fever and overall body ache.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Death, Echocardiogram, Electrocardiogram, Electroencephalogram
Clinical narrative: My mother mother, was diagnosed with Guillain-Barre syndrome. She was in the hospital for two weeks, and then in another hospital before she was diagnosed. She was in respiratory failure from August 10th and never recovered. She was in a third hospital for acute illness when she passed away. We had the breathing tube removed when we realized there was no hope of a recovery. The only different medicine she had had was the new vaccine for shingles. She had the first dose on April 25th, 2018 and never had the second dose. I had read that flu vaccines could cause Guillain-Barre, usually closer to the time of the vaccine. But given how Guillain-Barre is so rare and the shingle vaccine is so new, I wondered if there was a connection. The beginning symptoms of Guillain-Barre seem harder to decipher with an elderly patient that already had trouble walking and that already had neuropathy. It took many tests and many doctors, in 2 different hospitals, almost 3 weeks to confirm the diagnosis. Even with plasmapheresis, there was no significant change in her condition.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Guillain-Barre syndrome, Lumbar puncture, Mechanical ventilation, Nerve conduction studies
Clinical narrative: My mother mother, was diagnosed with Guillain-Barre syndrome. She was in the hospital for two weeks, and then in another hospital before she was diagnosed. She was in respiratory failure from August 10th and never recovered. She was in a third hospital for acute illness when she passed away. We had the breathing tube removed when we realized there was no hope of a recovery. The only different medicine she had had was the new vaccine for shingles. She had the first dose on April 25th, 2018 and never had the second dose. I had read that flu vaccines could cause Guillain-Barre, usually closer to the time of the vaccine. But given how Guillain-Barre is so rare and the shingle vaccine is so new, I wondered if there was a connection. The beginning symptoms of Guillain-Barre seem harder to decipher with an elderly patient that already had trouble walking and that already had neuropathy. It took many tests and many doctors, in 2 different hospitals, almost 3 weeks to confirm the diagnosis. Even with plasmapheresis, there was no significant change in her condition.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging, Plasmapheresis, Respiratory failure
Clinical narrative: My mother mother, was diagnosed with Guillain-Barre syndrome. She was in the hospital for two weeks, and then in another hospital before she was diagnosed. She was in respiratory failure from August 10th and never recovered. She was in a third hospital for acute illness when she passed away. We had the breathing tube removed when we realized there was no hope of a recovery. The only different medicine she had had was the new vaccine for shingles. She had the first dose on April 25th, 2018 and never had the second dose. I had read that flu vaccines could cause Guillain-Barre, usually closer to the time of the vaccine. But given how Guillain-Barre is so rare and the shingle vaccine is so new, I wondered if there was a connection. The beginning symptoms of Guillain-Barre seem harder to decipher with an elderly patient that already had trouble walking and that already had neuropathy. It took many tests and many doctors, in 2 different hospitals, almost 3 weeks to confirm the diagnosis. Even with plasmapheresis, there was no significant change in her condition.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Red, swollen, welt on left high noticed the day after flu shot was administered. Pt here with mom, LT sore and red after flu shot. Pt got a small red welt on her leg after the flu vaccine-it was on her left leg. Dad kept her home from school yesterday and took her to the fair to walk it off. Now they need a note for school. Today the welt is almost gone.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Blood albumin decreased, Blood culture negative, Chest X-ray abnormal, Culture negative, Culture throat negative
Clinical narrative: Received HPV vaccine on 8/13/18. Develop headache on 9/16/18, fever on 9/17/18, vaginal ulcers on 9/19/18. Seen on 9/18/18 - diagnosed with pneumonia by chest x-ray - started Augmentin. Seen on 9/19/18 for vaginal ulcers. Admitted to the hospital 9/21/18 - 9/23/18 for pneumonia and vaginal ulcers, and poor PO intake. She was diagnosed with mycoplasma pneumonia and Lipschutz ulcers. Had follow up on 9/26/18 - all symptoms were improving. Also complained of right shoulder pain during the illness. (Vaccine given in left shoulder and pneumonia was in left upper lung.)
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Cytomegalovirus test negative, Eosinophil count decreased, Epstein-Barr virus antibody negative, Full blood count normal, Headache
Clinical narrative: Received HPV vaccine on 8/13/18. Develop headache on 9/16/18, fever on 9/17/18, vaginal ulcers on 9/19/18. Seen on 9/18/18 - diagnosed with pneumonia by chest x-ray - started Augmentin. Seen on 9/19/18 for vaginal ulcers. Admitted to the hospital 9/21/18 - 9/23/18 for pneumonia and vaginal ulcers, and poor PO intake. She was diagnosed with mycoplasma pneumonia and Lipschutz ulcers. Had follow up on 9/26/18 - all symptoms were improving. Also complained of right shoulder pain during the illness. (Vaccine given in left shoulder and pneumonia was in left upper lung.)