chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. Medical history included a severe reaction to IVP dye once and had difficulty breathing. She also had contact dermatitis and her dermatologist said she may be "allergic to something in the air". The patient's concomitant medications were not reported. The patient previously took TYLENOL. The patient stated that shortly after the vaccine, on an unspecified date, she had a rash, swelling, and pain at the site of injection. She added that 2-3 days later, "broke out in hives" on her hip, leg, toes, arms, wrist and shoulder. She had also taken TYLENOL so she was not sure if it could have been caused by that, although she has taken TYLENOL in the past with no issues. The outcome of the events was unknown. Information on the batch number has been requested.
Sex: M
Vaccine: FLUX, PNC13, TDAP
Symptoms: Blood urine present, Urinary tract infection
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A male patient of an unspecified age PREVNAR 13, influenza vaccine and TDAP, all via an unspecified route of administration from an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. Patient immediately developed a UTI and had blood in his urine. He went to the MD who told him he had an infection. Pharmacist was concerned because she had overheard that another patient had died. Outcome of the events was unknown. Information on the batch number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional. A female patient of an unspecified age received TRUMENBA, (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swelling of arm and fever both on an unspecified date. The outcome of the events was unknown. The following information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Pruritus generalised, Sleep disorder
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received PREVNAR 13, (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for immunization. Medical history included ongoing gluten allergy. The patient's concomitant medications were not reported. On an unspecified date, the patient wanted to know if there are sulfates in pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) formulation as she has a gluten allergy. The patient stated that she had already been vaccinated with the vaccine and since then she has experienced itching all over her body stating legs, arms, back, face and that the itching has woken her up and 3 AM. The outcome of the events was unknown. The following information on the batch number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician (patient's parent). A 18-year-old female patient received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. The patient experienced fever of 101.5 F on an unspecified date with outcome of recovered. The patient underwent lab tests and procedures which included body temperature: 101.5 F.
Sex: M
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 47-year-old male patient received PREVNAR 13 via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient was asthmatic and without spleen. Concomitant medications were not reported. The patient experienced body aches for a day on an unspecified date with outcome of unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Myalgia
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. This pharmacist reported for a female patient receive PREVNAR 13, (lot number and expiration date were not reported) and FLU VACCINE VII; both via an unspecified routes of administration on unspecified dates at single doses for immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient complained of muscle soreness in both arms on an unspecified date, which resolved in 2-3 days. Information on lot number, batch number and expiration date has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13; (batch number unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness and swelling at injection site on an unspecified date after pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) administration. The outcome of redness and swelling at injection site was recovered on an unknown date. No follow-up attempts are possible, information on the batch number could not be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Back pain, Chills, Diarrhoea, Feeling cold, Headache
Clinical narrative: Pt received HPV vaccine in the AM and had onset of headache, nausea, vomiting, diarrhea, chills, fever, body aches, back pain, and a rash at 1100 on the same day. Pt started having diarrhea first at symptom onset and thought they had eaten something very bad. Pt then felt very cold and shivering at 1530. Reported to ED for management of symptoms and was discharged home after being stable during observation.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Pain, Pyrexia, Rash, Vomiting
Clinical narrative: Pt received HPV vaccine in the AM and had onset of headache, nausea, vomiting, diarrhea, chills, fever, body aches, back pain, and a rash at 1100 on the same day. Pt started having diarrhea first at symptom onset and thought they had eaten something very bad. Pt then felt very cold and shivering at 1530. Reported to ED for management of symptoms and was discharged home after being stable during observation.
Age: 36.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: After receiving flu vaccine within fifteen minutes patient developed redness swelling and warm touch on injection site.
Age: 0.08
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction was noted per mother.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site scar, Injection site swelling, Injection site warmth
Clinical narrative: RED SCAR THAT IS WARM TO THE TOUCH, AND SORE AT INJECTION SITE. ALSO PATIENT REPORTED A BUMP AT SITE.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: RED SCAR THAT IS WARM TO THE TOUCH, AND SORE AT INJECTION SITE. ALSO PATIENT REPORTED A BUMP AT SITE.
Sex: F
Vaccine: HPV4
Symptoms: Premature menopause
Clinical narrative: This spontaneous report was received from a physician concerning a female patient of unknown age. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided. On an unknown date, the patient was vaccinated with GARDASIL (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient experienced premature menopause. At the reporting time, the outcome of premature menopause was unknown. The causality between GARDASIL and premature menopause was not assessed.
Age: 47.0
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 27-Dec-2018 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves a 47 years old male patient who received 0.5 ml of first dose of vaccine PENTACEL (batch number: UI952AAA, expiry date: 17-May-2019) instead of vaccine ACT-HIB (batch number, expiry date, dose, dose in series not reported) (route and site of administration were not reported for both the vaccines) on 21-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR for Immunization. It was case of actual medication error due to Wrong vaccine administered and Inappropriate age at vaccine administration. It was not reported if any adverse event was experienced or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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: F
Vaccine: DTAPIPVHIB, FLUX, PNC13, RVX
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 26-Dec-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a six-months-old female patient who received 0.5 ml of third dose of vaccine PENTACEL (batch number: UI966AAA, expiry date: 7-Jul-2020) via intramuscular route in the right thigh on 26-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE (FLU) for Immunization; ROTAVIRUS VACCINE for Immunization; and PREVNAR for Immunization. It was a case of actual medication error due to incorrect product storage (dose of PENTACEL was invalid due to shipping excursion). Caller stated that they received the shipment of PENTACEL vaccines on 21-Dec-2018 at 11:54 AM and it was in transit from 18-Dec-2018 at 15:39 PM. No adverse event was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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: 0.67
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives developed same afternoon influenza vaccine administered.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Next morning had flu like symptoms that last day and a half. I had similar reaction to first shot.  I participate in class with classmates of similar age. Many of them reported similar reaction to first SHINGRIX shot. My neighbor had yesterday and she is experiencing similar reactions today.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Nausea
Clinical narrative: Profound exhaustion, body aches, headache, nausea, localized redness and pain at injection site.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Profound exhaustion, body aches, headache, nausea, localized redness and pain at injection site.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Myalgia, Nausea, Somnolence
Clinical narrative: 24 hour loss of appetite, nausasia, sleepiness and muscle pain for this shot and the one three months later. Given the badness of the disease, these kinds of symptoms far outweigh the discomfort experienced. The next day all this disappeared as if nothing happened.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal disorder, Pain in extremity, Rash
Clinical narrative: Rash the night of vaccination, then very sore arm that has still not recovered 6 months after vaccination. Pt cannot lift arm normally and it is still sore. Pt saw her PCP and was prescribed ibuprofen and VOLTAREN gel. Pt plans on going to physical therapy to get normal arm function back but has not done so yet.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Muscle fatigue, Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe pain at injection site, traveling down arm and up into shoulder. Muscle fatigue and pain in arm and shoulder for over 6 weeks. As of Dec 31 2018 has become less but comes and goes.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Patient reported flu like symptoms about 12 hours after receiving the shot. She said she had flu symptoms after her first dose and already reported that, and called to tell us that the symptoms occurred this time again after having the second shot. She has fever and chills.
Age: 24.0
Sex: M
Vaccine: ANTH, JEV1, SMALL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site vesicles, Scab
Clinical narrative: Received injection in Apr2018; reportedly had normal blistering reaction that resolved. In Dec2018, started developing pruritus at the site, eventually became well demarcated erythematous patch w/ raised border and crusting. No vesicles/pustules or blister.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, Product administered at inappropriate site, X-ray limb
Clinical narrative: The pharmacist put the flu shot up into my shoulder joint. I have been in pain ever since.
Age: 30.0
Sex: M
Vaccine: FLUC4
Symptoms: Malaise, Vomiting
Clinical narrative: Woke about 7 AM 12/31/2018, after a bit under 3 hours sleep. Felt sick, so went to bathroom, laid on bathroom floor very briefly, and then vomited a large quantity. Before and after that, did and do not feel sick. Went back to sleep. I don't know the cause for sure. I also tried a new restaurant dish, so it could be food poisoning, but I have no other reason to suspect that. I donated platelets on 12/30/2018, the day of the vaccination (donated before the vaccination).
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Vaccine was given at 1 pm on 12/30/18. At around 5 pm I called to check to see how she was doing because she had had issues with a previous vaccine given (flu and pneumo together). At 5 pm she said she had no issues. On 12/31/18 at 9 am she called me to let me know that she had gotten a very bad headache at around 8 pm the previous night and spiked a fever of 100.9 degrees F that was not going down. She also had started to have the injection site become enlarged and painful to the touch- swelled 1-2 inches past injection site with red center. She had been taking TYLENOL and she asked me to call her nephrologist to see about ibuprofen. The nephrologist ok'd her to take ibuprofen max of 800 mg per day for up to five days due to potential complications of stents in her kidneys.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hypersomnia, Injection site erythema, Injection site pain
Clinical narrative: Injection site: Pain, redness, soreness, swelling Systemic: Headache, muscle aches, fever, nausea/vomiting, and fatigue. Patient reports that she slept for 2 days. Treatment: MEDROL dosepak.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Injection site: Pain, redness, soreness, swelling Systemic: Headache, muscle aches, fever, nausea/vomiting, and fatigue. Patient reports that she slept for 2 days. Treatment: MEDROL dosepak.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: Adverse events: Redness, warmth, tenderness, swelling. Pt declined going to urgent care.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Lethargy, Pruritus, Pyrexia
Clinical narrative: Flu like symptoms the day after; lethargy and fever; passed by second day. Redness and itching of extremities and trunk starting about the third day. Now have significant rash on both arms from wrists to just above elbows at five and one half weeks; dense raised rash with acute itching at times. Have done a course of Prednisone and been sporadically taking antihistamines OTC. Now using a cream but nothing seems to help.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Flu like symptoms the day after; lethargy and fever; passed by second day. Redness and itching of extremities and trunk starting about the third day. Now have significant rash on both arms from wrists to just above elbows at five and one half weeks; dense raised rash with acute itching at times. Have done a course of Prednisone and been sporadically taking antihistamines OTC. Now using a cream but nothing seems to help.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure decreased, Fear of injection, Heart rate decreased, Syncope
Clinical narrative: NEEDLE PHOBIC - PATIENT FAINTED AFTER FLU SHOT GIVEN.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Immobile, Influenza like illness, Neck pain, Rash
Clinical narrative: Headache, neck pain resulting in partial immobility, rash/hives, flu-like symptoms. Symptoms were more severe 1 day post-vaccination, but have begun to improve starting day 2 after vaccination. Managed with NSAIDs and rest.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Headache, neck pain resulting in partial immobility, rash/hives, flu-like symptoms. Symptoms were more severe 1 day post-vaccination, but have begun to improve starting day 2 after vaccination. Managed with NSAIDs and rest.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Lethargy, Pyrexia
Clinical narrative: Fever 104 degrees, extreme lethargy.
Age: 0.33
Sex: M
Vaccine: DTAP, DTAPHEPBIP, HIBV, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events at appointment time.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity
Clinical narrative: Redness on arm and pain.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Rash
Clinical narrative: Patient had rash after injection. patient contacted oncologist and was told not to get second shot.  Reporting pharmacist found out about reaction after contacting patient for second shot.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Electromyogram, Electromyogram abnormal, Musculoskeletal discomfort, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: During the first few days after the injection, I notice a little more muscle shoulder discomfort than usual, causing me to avoid sleeping on that left shoulder. Discomfort appeared to lessen except when pressing on the injection area. The shoulder pain and stiffness progressively became severe during July, when I began to take ADVIL and TYLENOL nightly and daily during the last week of July. During the first week of August, I used my electric massager for 8 hour sittings at a time when that became ineffective. I began a daily and nightly ice pack regime. When the pain failed to lessen, I visited Urgent Care. August 9, 2018 X-ray taken, prescribed pain medication, given ointment for frost bite condition on left shoulder. Referred for physical therapy. On August 10, 2018, I met PT at Physical Therapy. Began physical therapy sessions, attending 2 sessions per week. As of 11/28/2018 attended 28 sessions, currently the PT sessions are suspended. On September 13, 2018, I began message therapy session 1 per week, 9 therapy session ended November 8, 2018. I continue to do PT task daily, the regime takes 30 minutes to complete.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Nerve conduction studies abnormal, Nuclear magnetic resonance imaging, Rotator cuff syndrome, Vaccination complication
Clinical narrative: During the first few days after the injection, I notice a little more muscle shoulder discomfort than usual, causing me to avoid sleeping on that left shoulder. Discomfort appeared to lessen except when pressing on the injection area. The shoulder pain and stiffness progressively became severe during July, when I began to take ADVIL and TYLENOL nightly and daily during the last week of July. During the first week of August, I used my electric massager for 8 hour sittings at a time when that became ineffective. I began a daily and nightly ice pack regime. When the pain failed to lessen, I visited Urgent Care. August 9, 2018 X-ray taken, prescribed pain medication, given ointment for frost bite condition on left shoulder. Referred for physical therapy. On August 10, 2018, I met PT at Physical Therapy. Began physical therapy sessions, attending 2 sessions per week. As of 11/28/2018 attended 28 sessions, currently the PT sessions are suspended. On September 13, 2018, I began message therapy session 1 per week, 9 therapy session ended November 8, 2018. I continue to do PT task daily, the regime takes 30 minutes to complete.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site joint pain
Clinical narrative: Severe pain Lt. shoulder area, very localized at left shoulder joint. Unable to extend arm forward, or lift to the side. Took an ibuprofen tablet once on 10/30/18. Pain subsided after 4 days -  seemed to be relieved after one week.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Apathy, Arthralgia, Asthenia, Injection site erythema, Injection site pain
Clinical narrative: Much joint pain/aching, lack of energy, listlessness, lack of motivation, night sweats. Joint pains/aching strongest for 36 hours after onset; rest of symptoms persisted for 48 hours. Used Tylenol q8h (something I rarely take - maybe once a year, some years not at all). Redness, swelling, hot to touch, painful to slightest touch, and itching starts approximately 3 inches below injection site in a somewhat oval shape - 2 inches wide and 3 inches long. Itching is most severe in a 1 inch tail at bottom right of oval.  (This report is being filed approximately 91 hours after injection, and arm symptoms remain.) This was my second SHINGRIX shot. After the first shot, I had arm soreness at site of injection but none of the other symptoms.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Listless, Night sweats
Clinical narrative: Much joint pain/aching, lack of energy, listlessness, lack of motivation, night sweats. Joint pains/aching strongest for 36 hours after onset; rest of symptoms persisted for 48 hours. Used Tylenol q8h (something I rarely take - maybe once a year, some years not at all). Redness, swelling, hot to touch, painful to slightest touch, and itching starts approximately 3 inches below injection site in a somewhat oval shape - 2 inches wide and 3 inches long. Itching is most severe in a 1 inch tail at bottom right of oval.  (This report is being filed approximately 91 hours after injection, and arm symptoms remain.) This was my second SHINGRIX shot. After the first shot, I had arm soreness at site of injection but none of the other symptoms.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Headache, Fever, Chills, Body Aches, Nausea lasting Over 48 hours.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Site is swollen, red and warm to the touch. Patient has complain of pain.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Fatigue, Influenza like illness, Injection site erythema
Clinical narrative: FLU LIKE: CHILLS ACHE ALL OVER; STRONG PAIN, WEAKNESS, TIRED, REDNESS AND SWELLING  AT INJECTION, UPPER ARM. FOR 3 DAYS, THEN TODAY, 4TH DAY, WOKE UP WITH SWELLING OF MY LIPS AND BLISTER LIKE  SORES ON MY LIPS AND ALL AROUND MOUTH AREA.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Lip blister, Lip swelling, Pain
Clinical narrative: FLU LIKE: CHILLS ACHE ALL OVER; STRONG PAIN, WEAKNESS, TIRED, REDNESS AND SWELLING  AT INJECTION, UPPER ARM. FOR 3 DAYS, THEN TODAY, 4TH DAY, WOKE UP WITH SWELLING OF MY LIPS AND BLISTER LIKE  SORES ON MY LIPS AND ALL AROUND MOUTH AREA.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blister, Chills, Influenza like illness, Injection site erythema
Clinical narrative: FLU LIKE: CHILLS ACHE ALL OVER; STRONG PAIN, WEAKNESS, TIRED, REDNESS AND SWELLING  AT INJECTION, UPPER ARM. FOR 3 DAYS, THEN TODAY, 4TH DAY, WOKE UP WITH SWELLING OF MY LIPS AND BLISTER LIKE  SORES ON MY LIPS AND ALL AROUND MOUTH AREA.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Lethargy, Lip swelling, Oral herpes, Pain
Clinical narrative: FLU LIKE: CHILLS ACHE ALL OVER; STRONG PAIN, WEAKNESS, TIRED, REDNESS AND SWELLING  AT INJECTION, UPPER ARM. FOR 3 DAYS, THEN TODAY, 4TH DAY, WOKE UP WITH SWELLING OF MY LIPS AND BLISTER LIKE  SORES ON MY LIPS AND ALL AROUND MOUTH AREA.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular
Clinical narrative: FLU LIKE: CHILLS ACHE ALL OVER; STRONG PAIN, WEAKNESS, TIRED, REDNESS AND SWELLING  AT INJECTION, UPPER ARM. FOR 3 DAYS, THEN TODAY, 4TH DAY, WOKE UP WITH SWELLING OF MY LIPS AND BLISTER LIKE  SORES ON MY LIPS AND ALL AROUND MOUTH AREA.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: On the day after the 2nd dose, I had a fever of 100.4 for the entire day.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Macule, Rash papular
Clinical narrative: Rash: On 12/26 she developed a red spot near the MMRV injection site, on her proximal, anterior thigh, about 1 x 2 cm, red, slightly raised/bumpy. She also developed scattered red macules and papules on her trunk and extremities. She is not itchy, fussy or febrile; she has no symptoms of URI; she is eating, drinking, and sleeping well.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthralgia, Dizziness, Fatigue, Headache
Clinical narrative: Bad headache, nausea, abdominal pain, low fever (99.4 degrees F), major joint and muscle aches all over, extreme fatigue, dizziness. Symptoms were acute for 24 hours and then improved. Still experiencing mild symptoms 40 hours after shot.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Bad headache, nausea, abdominal pain, low fever (99.4 degrees F), major joint and muscle aches all over, extreme fatigue, dizziness. Symptoms were acute for 24 hours and then improved. Still experiencing mild symptoms 40 hours after shot.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Soreness at site and in shoulder of injected arm.
Age: 80.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT GOT FLU SHOT HERE WITH NO ADVERSE EFFECTS, BUT WE RECEIVED A NOTICE FROM THE PRIMARY DOCTOR THAT THEY HAD ALREADY ADMINISTERED A FLU SHOT IN SEPTEMBER, IT WAS NOT IN STATE REGISTRY; PT ACTUALLY EXPERIENCED NO ADVERSE EFFECTS.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Bursitis, Injection site reaction
Clinical narrative: Inflamed bursa in left shoulder. Treatment so far has included anti-inflammatory and icing for a over a week, a cortisone shot on November 19th, and physically therapy started on December 24th.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Ear pain, Labyrinthitis, Migraine, Nausea
Clinical narrative: I do not know the type of flu shot that I received. Approximately one week following the flu shot, I started to experience ear ringing. The ear ringing continued and eventually progressed to severe episodes of vertigo leading to nausea and vomiting on December 2, 2018. Vertigo, ear pain and migraines continued, and an MRI was performed on December 21. The MRI did not show anything abnormal (no masses or fluid buildup). My ENT concluded that my labyrinthitis caused by a virus, however I had no other illnesses around the time that the issues began. I continue with vestibular migraines, dizziness and ear pain.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging normal, Tinnitus, Vertigo, Vestibular migraine, Viral infection
Clinical narrative: I do not know the type of flu shot that I received. Approximately one week following the flu shot, I started to experience ear ringing. The ear ringing continued and eventually progressed to severe episodes of vertigo leading to nausea and vomiting on December 2, 2018. Vertigo, ear pain and migraines continued, and an MRI was performed on December 21. The MRI did not show anything abnormal (no masses or fluid buildup). My ENT concluded that my labyrinthitis caused by a virus, however I had no other illnesses around the time that the issues began. I continue with vestibular migraines, dizziness and ear pain.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: I do not know the type of flu shot that I received. Approximately one week following the flu shot, I started to experience ear ringing. The ear ringing continued and eventually progressed to severe episodes of vertigo leading to nausea and vomiting on December 2, 2018. Vertigo, ear pain and migraines continued, and an MRI was performed on December 21. The MRI did not show anything abnormal (no masses or fluid buildup). My ENT concluded that my labyrinthitis caused by a virus, however I had no other illnesses around the time that the issues began. I continue with vestibular migraines, dizziness and ear pain.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Tremor
Clinical narrative: Uncontrollable shivering/tremors for 20-30 mins following shower despite warming efforts (blankets, warming pad). House was normal indoor temperature (approx 70F).
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash generalised, Rash macular
Clinical narrative: Vaccines received 12/20/2018, Fever developed on 12/30/2018 and lasted two days and then rash developed on 1/1/2019, started on face and spread down body including soles of feet, macular rash, no vesicles and no papules and non-urticarial. No Koplik spots, no conjuncitivitis, no cough and no coryza.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Urticaria
Clinical narrative: Patient developed welts on her arm and had a burning pain the day after her immunization. The symptoms resolved on there own about 24 hours after they appeared.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Peripheral swelling, Pyrexia
Clinical narrative: SWOLLEN RED ARM, FEVER, FLU LIKE SYMPTOMS.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Extreme muscle pain all over. Headache Chills and fever.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cardiac monitoring normal, Chills, Electrocardiogram normal, Fall, Head injury
Clinical narrative: Chills, severe pain in the shoulder and had difficulty moving the arm where a shot was given around 7 PM. Around 2:30 AM on way to the bathroom, passed out, fell, and hit head on hard tile floor. Was unconscious till my husband woke me up and got me off the floor.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of consciousness
Clinical narrative: Chills, severe pain in the shoulder and had difficulty moving the arm where a shot was given around 7 PM. Around 2:30 AM on way to the bathroom, passed out, fell, and hit head on hard tile floor. Was unconscious till my husband woke me up and got me off the floor.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Rash, Skin discolouration
Clinical narrative: Arm turned red and developed a rash that lasted several days. The arm is still discolored as of Dec. 28, 2018 and has a general feeling of malaise in that arm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Chills, shivering, nausea, diarrhea, dizziness, tiredness. Stomach upset lasted a few hours. Chills and shivering lasted over 24 hours. Dizziness and tiredness was about 48 hours.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Chills, shivering, nausea, diarrhea, dizziness, tiredness. Stomach upset lasted a few hours. Chills and shivering lasted over 24 hours. Dizziness and tiredness was about 48 hours.
Age: 24.0
Sex: M
Vaccine: FLU4, JEV1, SMALL
Symptoms: Biopsy skin, Eczema, Full blood count normal, Generalised vaccinia, HIV test negative
Clinical narrative: 24 YO otherwise healthy male presented to clinic on 29 NOV 2018 for a chief complaint of a diffuse rash without systemic symptoms. Rash first appeared approximately 10 days after vaccine administration of smallpox, JEV, and influenza. He had undergone routine screening prior to vaccination. He had no prior history of atopic dermatitis, no personal or family history of autoimmune disorders, and he had been previously vaccinated for varicella as a child. He had a diffuse pustular rash throughout the torso and extremities. The case, including pictures, was discussed with Dermatology on 29 NOV who believed this was likely generalized vaccinia. CBC, HIV, and Treponema pallidum were unremarkable. Punch biopsies obtained were nonspecific (spongiotic dermatitis) viral cultures obtained after the patient had recovered was negative for orthopox viruses, but was inconclusive for generalized vaccinia. After presentation on 29 NOV the patient was placed on quarters for two weeks, treated with ZYRTEC, and fully recovered; however, he does have post inflammatory hyperpigmentation and he ultimately may have scarring in the future.
Age: 24.0
Sex: M
Vaccine: FLU4, JEV1, SMALL
Symptoms: Post inflammatory pigmentation change, Rash, Rash pustular, Treponema test negative, Viral test negative
Clinical narrative: 24 YO otherwise healthy male presented to clinic on 29 NOV 2018 for a chief complaint of a diffuse rash without systemic symptoms. Rash first appeared approximately 10 days after vaccine administration of smallpox, JEV, and influenza. He had undergone routine screening prior to vaccination. He had no prior history of atopic dermatitis, no personal or family history of autoimmune disorders, and he had been previously vaccinated for varicella as a child. He had a diffuse pustular rash throughout the torso and extremities. The case, including pictures, was discussed with Dermatology on 29 NOV who believed this was likely generalized vaccinia. CBC, HIV, and Treponema pallidum were unremarkable. Punch biopsies obtained were nonspecific (spongiotic dermatitis) viral cultures obtained after the patient had recovered was negative for orthopox viruses, but was inconclusive for generalized vaccinia. After presentation on 29 NOV the patient was placed on quarters for two weeks, treated with ZYRTEC, and fully recovered; however, he does have post inflammatory hyperpigmentation and he ultimately may have scarring in the future.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site pain, Myalgia
Clinical narrative: Fever, chills, muscle aches, extreme headache, flu-like symptoms. Also soreness in arm at site of shot.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, chills, muscle aches, extreme headache, flu-like symptoms. Also soreness in arm at site of shot.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient started developing pain, redness, swelling and itching at the injection site. Arm started feeling numb as patient was a little nauseous.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Patient started developing pain, redness, swelling and itching at the injection site. Arm started feeling numb as patient was a little nauseous.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site irritation, Injection site rash, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67-year-old female patient. The patient's pertinent medical history, concomitant medications or drug reactions and allergies were reported as none. On 29-NOV-2018 the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (also reported as vaccination) (lot number: R022232; expiration date: 16-APR-2020) (dose and route of administration were not reported). By the following day, on 30-NOV-2018, she had developed a swollen arm, and the inside of her arm, opposite of the injection site was red, irritated, and the rash was growing in size. The patient sought medical attention by contacting the pharmacist. She received unspecified treatment for the adverse event. No laboratories or studies were performed and there was no intervention to prevent serious criteria. At the time of reporting, the patient had not recovered from the events. The causal relationship between the events and PNEUMOVAX 23 was not reported.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness, Dizziness
Clinical narrative: Pt received SHINGRIX vaccine on 5-1-18 and beginning 6-9-18 pt began having dizziness, and pt progressively got worse and ended with hearing loss.
Sex: F
Vaccine: FLU4, PPV
Symptoms: Alopecia
Clinical narrative: This spontaneous report was received from a 71-year-old female patient regarding herself. The patient's concurrent conditions included drug reaction/allergy to sulfacetamide sodium (+) sulfadiazine (+) sulfamethazine. She has no medical history and was not taking any concomitant medication. On 11-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 by injection to "avoid pneumococcal" (dose, strength, anatomical location, lot # and expiration date were not reported), and, with FLUZONE (dose, indication for use, strength, route of administration, lot # and expiration date were not reported). In approximately September 2018 (reported as "2-3 days or a week after vaccination"), her hair began to come out "in clumps"; she also stated that she had no medical history of hair loss and said she had long thick hair prior to vaccination. The patient sought medical attention, but no treatment was given for the event a no laboratory diagnostic studies were performed. At the reporting time, the patient had not recovered from the alopecia, as her hair continued to come out when she combs it or wipes it. The causality assessment between PNEUMOVAX 23, FLUZONE and hair loss was not reported.
Age: 17.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Fainted/Passed Out a few minutes after administration of injection. Lost consciousness for less than 1 minute. 911 called. Determined patient had adverse vasovagal syncope after injection. Would like procedure for all flu shot providers to include sitting for 10 minutes following injection to prevent avoidable potential fall and further injury.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu-like. Low-grade fever 99.3. Chills. All over body aches.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 30-NOV-2018, the patient was vaccinated with an expired dose of VARIVAX (dose and route were not provided) lot# M046929 expiration date 28-NOV-2018, for prophylaxis. No adverse effect was reported. Lot# M046929 is not valid for VARIVAX.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 19-DEC-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, a family nurse practitioner, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 16-JUL-2007, the patient's healthcare provider at a physician's office administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 03-NOV-2016, the patient was treated by a family nurse practitioner at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; and a diminished quality of life. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 19-DEC-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 22-APR-2008, a healthcare provider at a clinic administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 18-NOV-2016, the patient was treated by a physician at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages.The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Gait inability, Mobility decreased, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a consumer referring to a female patient of unknown age referring to herself. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date in November 2018, the patient was vaccinated with a dose of PNEUMOVAX 23, reported as she got "a booster shot" vaccination; (lot number, expiration date and route of administration were not provided) as prophylaxis. The patient reported that on an unspecified date in 2018, after her booster shot of PNEUMOVAX 23 (reported as "the next day"), her arm hurt really bad. A few days later, every joint in her body hurt, and about one week after, she felt severe pain, that she could not get out of bed or walk. The outcome of the patient was unknown. No additional information was given. The causality assessment between PNEUMOVAX 23 and the events was not reported.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse prescriber referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history or concurrent conditions were not reported. On 18-DEC-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R007693 (expiration date: 14-MAR-2020), subcutaneously for prophylaxis, which was reconstituted with a properly stored STERILE DILUENT. No adverse effects were reported. The vaccine was exposed to a temperature excursion of 21 Fahrenheit degrees (15 to 45 Fahrenheit degrees) for a timeframe of 8 hours. It was found because of a digital data logger and there were no previous excursions. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1812USA012971.
Age: 1.67
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse prescriber referring to a 20-month-old patient of unknown gender. The patient's pertinent medical history or concurrent conditions were not reported. On 12-DEC-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R007693 (expiration date: 14-MAR-2020), subcutaneously for prophylaxis, which was reconstituted with a properly stored STERILE DILUENT. No adverse effects were reported. The vaccine was exposed to a temperature excursion of 21 Fahrenheit degrees (15 to 45 Fahrenheit degrees) for a timeframe of 8 hours. It was found because of a digital data logger and there were no previous excursions. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1812USA012876.