chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEPA
Symptoms: Panniculitis lobular, Pruritus, Skin abrasion, Skin hypopigmentation, Skin mass
Clinical narrative: This literature marketed report was received from the authors of the published article. A 4-year-old boy presented with a 1-month history of three soft, pruritic, subcutaneous, 1-cm mobile nodules on the anterior left and right thighs with overlying hypopigmentation, excoriated dermatitis, and moderate xerosis. The patient had a history of persistent cervical lymphadenopathy of the right anterior and lateral neck, eczema on the flanks and upper buttock, and keratosis pilaris on the posterior bilateral arms. Viral studies were unremarkable except for detectible immunoglobulin G antibodies to EpsteinBarr virus indicating a previous infection. The patient's family first observed the nodules after he had received a hepatitis A vaccine (manufacturer unknown) in the left thigh 1 month before. The patient received six vaccinations: three doses of the diphtheria, tetanus, pertussis, polio vaccine  Haemophilus influenzae type b conjugate vaccine and three doses of the pneumococcal vaccine. There was no record of where on the patient these vaccines were administered. His scheduled vaccination program was continued after he and his family moved. A punch biopsy of a nodule on the left anterior thigh was performed for histopathologic examination. A punch biopsy specimen demonstrated lobular panniculitis with a dense infiltrate composed of lymphocytes, histiocytes, plasma cells, numerous eosinophils, and clusters of dendritic Langerhans cells. Stains for microorganisms were unrevealing. The patient underwent patch testing and at 96 hours had a 2+ positive reaction to 2.0% aluminum chloride hexahydrate. In the months after, the patient developed diffuse hypopigmented patches on his trunk and overlying the thigh nodules. The patient was diagnosed with aluminum hypersensitivity. The outcome of events was unknown. The authors considered the events to be related to aluminium salts used as adjuvants in vaccines, including hepatitis A vaccine (manufacturer unknown).
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 44-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of PROQUAD (dose, frequency, route of administration were not reported) lot # N015623 with expiration date: 15-NOV-2018 and a dose of VARIVAX (dose, frequency, route of administration were not reported), lot# N008077 with expiration date: 09-MAR-2019 instead of M-M-R II. The vaccines were reconstituted with sterile diluent (manufacturer unknown). No adverse effects were reported. No causality assessment was provided.
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age and ethnicity received second dose of PREVNAR 13 (batch number requested) via an unspecified route of administration on 25Oct2017 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) on 16Mar2015 and pneumococcal polysaccharide vaccine (PPV23) on 24Mar2016. The patient was vaccinated with pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) on 25Oct2017 and has not been feeling well since (unspecified date in 2017). After she received the vaccination, she went into her patient portal and realized that she had already received the pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) vaccine last 16Mar2015. The patient queried if there was any danger in double dosing. The outcome of the event was unknown. The following information on the batch number has been requested.
Sex: M
Vaccine: MENB
Symptoms: Seizure
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 19-year-old male patient of an unspecified race and ethnicity received two single doses of TRUMENBA on unspecified dates for immunisation. The patient medical history and concomitant medications were not reported. One month after each dose patient had a seizure. The patient had no prior history of seizures. Outcome was unknown.; Sender's Comments: 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 and Investigators as appropriate.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 68-year-old female patient of an unspecified ethnicity received PREVNAR 13 (batch number requested), via an unspecified route of administration on 19Dec2017 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was administered with pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) on 19Dec2017 and got swelling at injection site which was normal. However, it was also reported that the patient still have redness, swelling and pain in injection site (noted in Dec2017) even after 8 days. The pharmacist was asking what to do. The outcome of the events was not recovered. The information regarding the batch number has been requested.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Blood test, Musculoskeletal stiffness, Pain in extremity, Rheumatoid arthritis
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A 85-year-old female patient of an unknown race/ethnicity received Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) at single dose on 19Sep2017 for immunization. The first day the patient experienced sore arm, the second day she has a stiff neck, and the third day all her joints from where her neck joins her head down to her toes were awful and hurting, and they are still bothering her. The patient was diagnosed with rheumatoid arthritis, and a blood test was done. The patient was in excellent health prior to this shot. The outcome of the events was reported as unknown. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected. Pfizer is Marketing Authorization Holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, X-ray limb
Clinical narrative: Pt. came in for office visit on 11/27/2017 and reported she had pain in her left deltoid region since she received the flu shot 2 weeks prior. I spoke with patient after she saw the Nurse Practitioner and informed her the pain she was describing wasn't the typical pain patients experience from a side effect of the vaccine and I would report to VAERS and someone maybe calling her from VAERS. Pt. returned on 12/5 saying pain was no better shoulder xray performed.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Incorrect vaccines was given, the ped vaccine was given. Patient will need the adult vaccine.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Patient came to the pharmacy ten days after the vaccine had been administered to show a fresh bruise at the site of injection. She said it was not painful or tender.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Borrelia test, Computerised tomogram head, Dysgeusia, Epstein-Barr virus test, Eyelid function disorder
Clinical narrative: Starting on 12/11/17 paralysis developed paralysis of left facial nerve, diagnosed with Bell's palsy. He continued to have symptoms including facial droop, unable to close left eye, severe pain and diminished/altered taste. He was treated with MEDROL dose pack x 5 days with improvement but 2 days following completion of the dose pack, symptoms worsened and he was prescribed prednisone daily again x 5 more days. He also used eye drops and eye covering. Was seen by ENT also on 12/28/2017.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Facial paralysis, Hypogeusia, Laboratory test, Mononucleosis heterophile test, Pain
Clinical narrative: Starting on 12/11/17 paralysis developed paralysis of left facial nerve, diagnosed with Bell's palsy. He continued to have symptoms including facial droop, unable to close left eye, severe pain and diminished/altered taste. He was treated with MEDROL dose pack x 5 days with improvement but 2 days following completion of the dose pack, symptoms worsened and he was prescribed prednisone daily again x 5 more days. He also used eye drops and eye covering. Was seen by ENT also on 12/28/2017.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Red blood cell sedimentation rate
Clinical narrative: Starting on 12/11/17 paralysis developed paralysis of left facial nerve, diagnosed with Bell's palsy. He continued to have symptoms including facial droop, unable to close left eye, severe pain and diminished/altered taste. He was treated with MEDROL dose pack x 5 days with improvement but 2 days following completion of the dose pack, symptoms worsened and he was prescribed prednisone daily again x 5 more days. He also used eye drops and eye covering. Was seen by ENT also on 12/28/2017.
Age: 47.0
Sex: F
Vaccine: ANTH
Symptoms: Blood pressure increased, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: A 47 year old female employee reported experiencing sore throat, cold symptoms and elevated blood pressure for a couple of days following immunization with BioThrax. On 26JUL2017 she received a third dose of BioThrax (FAV634) in the left deltoid. Symptoms began on the day of vaccination. Consumer noted that the first two shots did not present these symptoms. She was treated with CHLORASEPTIC SORE THROAT RELIEF SPRAY and ADVIL and experienced some relief. On 08AUG2017, consumer reported that she felt better. On 23AUG2017, she indicated that she was fully recovered on 10AUG2017. No additional information is expected.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal discomfort, Fatigue, Fibromyalgia, Mental disorder, Myalgia
Clinical narrative: A 35 year old reported experiencing chronic fatigue, psychological and sleep disorders, GI distress, fibromyalgia, and muscle pain following immunization with BioThrax. In 2003, when he was 21 years of age prior to going to overseas, he received BioThrax vaccine series. The consumer indicated that his symptoms were persistent. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Sleep disorder
Clinical narrative: A 35 year old reported experiencing chronic fatigue, psychological and sleep disorders, GI distress, fibromyalgia, and muscle pain following immunization with BioThrax. In 2003, when he was 21 years of age prior to going to overseas, he received BioThrax vaccine series. The consumer indicated that his symptoms were persistent. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: ANTH
Symptoms: Arthritis, Pain
Clinical narrative: A 47 year old female consumer reported experiencing severe inflammation in right shoulder joint and painful to lift arm following immunization with BioThrax. On 20APR2016 at 10:00 AM, she received a booster dose of BioThrax (FAV602) intramuscularly in the right arm. Symptoms began 5 days after the day of vaccination. She was treated with naproxen and TYLENOL. Consumer reported that her pain lasted for 6 months. She noted that she was unresponsive to NSAIDS: increasing naproxen dose didn't help and TYLENOL did not relieve her pain. The adverse events were reported to be recovered in OCT2016. Concurrent medical conditions included: hypothyroid (Hashimoto's thyroiditis) (1991), seasonal allergies (2006), and arthritis (2010). Concomitant medications included: SYNTHROID for hypothyroid, loratadine for seasonal allergies and naproxen for arthritis. No additional information is expected.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Blood testosterone decreased, Dyspnoea, Fatigue, Influenza like illness, Lethargy
Clinical narrative: A 25 year old male reported that he received his first dose of BioThrax in 2015 without any untoward effects. He states after receiving the 2nd dose, he experienced flu-like symptoms, nausea, and difficulty breathing. The consumer stated he has felt lethargic and tired in the last year; a blood test conducted within the last 30 days, revealed "low testosterone levels". He has scheduled an appointment to see an endocrinologist regarding the basis for his low testosterone levels. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Nausea
Clinical narrative: A 25 year old male reported that he received his first dose of BioThrax in 2015 without any untoward effects. He states after receiving the 2nd dose, he experienced flu-like symptoms, nausea, and difficulty breathing. The consumer stated he has felt lethargic and tired in the last year; a blood test conducted within the last 30 days, revealed "low testosterone levels". He has scheduled an appointment to see an endocrinologist regarding the basis for his low testosterone levels. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MEN, MENB
Symptoms: Asthenia, Cold sweat, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other health professional via a Pfizer sales representative. A 16-year-old male patient of unspecified race/ethnicity received TRUMENBA (lot# r47584, exp date 31Jul2018), via an unspecified route of administration in the left arm, on 17Aug2017, at 0.5 ml single, for immunisation and MCV4, via an unspecified route of administration in the right arm, on 17Aug2017, at unspecified dose, for immunisation. Relevant medical history included asthma in 2006 at age 5, bronchiolitis in 2006 at age 5, allergy to bees. Concomitant medications included budesonide, SYMBICORT, salbutamol, cetirizine hydrochloride and an unspecified nasal spray. On an unspecified date the patient experienced fever for 3 days, around 101.9 degrees Fahrenheit with outcome of unknown; cold sweats lasting no longer than a week with outcome of recovering, weak and body aches for about 7 days with outcome of unknown, could not perform athletics with outcome of unknown. Therapeutic measures were taken as a result of fever and included treatment with Ibuprofen.
Age: 1.08
Sex: M
Vaccine: DTAP, FLUX, HIBV, PNC13
Symptoms: Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: Severe hives that persisted for 5 months, red, raised, severely itchy skin.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Nausea, Pallor, Presyncope, Rash
Clinical narrative: Patient had a pre-syncopal event following the event. He felt pale and nauseous; dizzy. Did not pass out. 3-4 days later developed a very dry rash on cheeks of face bilaterally. I do not think the rash is related to the immunization. No hives.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Pallor, Posture abnormal
Clinical narrative: Patient tolerated flu injection well, she was talkative with mom and was able to out of the room unassisted. Mom had to stop at our front desk for future scheduling, a that time patient was found to be sitting in the waiting room chair, slumped back and pale. Nursing staff was readily available to assist patient and mother (patient was still in chair and did not fall nor slip off), a doctor was called out to the waiting room help to assess the patient as well. Pt was instructed to lean forward, take deep breaths, and a cool compress was applied to the nape of her neck. Her BP was checked. Orange juice was provided to the patient as well. Patient felt well enough to walk back to the office room where she was monitored and re-assessed by her doctor. Her BP and pulse was continuously monitored, OJ was provided to drink, and a cool compress was also applied to her forehead. Patient stayed with mother in office room for several minutes. Prior to discharge, pt's doctor re-assessed patient and discharged her. The office placed a follow up call with mother the net day, she was very appreciative of the call. Patient was doing well the following day with no adverse symptoms reported. Mom explained that she forgot too mention to staff that patient had fainted when she was 11 years old after receiving the flu vaccine. This has been noted in the chart for future reference of staff and provider.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Allergy test, Erythema, Pruritus, Skin swelling, Urticaria
Clinical narrative: Adverse Event: Severe swelling of skin, hives, redness, severe itching. Treatment: Topical Steroids, Wet wraps, salt baths, bleach baths.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema
Clinical narrative: Redness at site of injection.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Induration, Mass, Pain
Clinical narrative: Pain, redness swelling hard lump, headache. Swollen down arm and was spreading.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Pain, redness swelling hard lump, headache. Swollen down arm and was spreading.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site for 1 week after injection. Which patient claims to have gotten better with no other residual affects. After few weeks (aprox. 12/27/17) arm soreness reappears and starts to increasingly get worse. Received called on 1/2/18 from patient claiming adverse event and has appointment with MD in upcoming week.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Neck pain, Pain in extremity, Tenderness
Clinical narrative: Patient reported tenderness and pain at site of injection which radiated down the right arm and up to the shoulder and neck. Pain is not sharp and there is no numbness or tingling. Patient can raise arm slightly. The injection site was not red or swollen. Patient was able to work today at her job.
Age: 55.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Feeling hot, Throat irritation, Throat tightness
Clinical narrative: Thirty minutes post vaccination the employee called to report that her throat was scratchy and tight. I advised her to come to the ER to be evaluated for anaphylactic reaction to the vaccines. She also reported a warm feeling that went up her neck when she received the Hepatitis vaccination. She was seen in the ER and given DECADRON 10mg IM x1 injection, and Rx for prednisone 20mg 3 tabs by mouth x5 days, and PEPCID 20mg 1 every 12hours daily x10 days.
Age: 1.08
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Had fever up to 104, widespread scattered  rash-no treatment.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Asthenia, Hypotonia, Pallor, Pyrexia, Respiratory arrest
Clinical narrative: Onset of generalized weakness/ whole body went limp/ febrile/ change of overall color with pallor and stopped breathing/ was given CPR and paramedics were called/ baby was then brought to ER.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Resuscitation
Clinical narrative: Onset of generalized weakness/ whole body went limp/ febrile/ change of overall color with pallor and stopped breathing/ was given CPR and paramedics were called/ baby was then brought to ER.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Drug administered at inappropriate site, Inflammation, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Felt the flu shot was given really high in my shoulder. After, experienced more pain than usual, pain increased each day and I experienced limited mobility and increased weakness. On day 4 went to doctor and started ibuprofen for inflammation. Pain still got worse after that. Hard to even put a shirt on. On day 10, went back to the doctor and they got an MRI later in the day. MRI showed inflammation and fluid build-up so started on a steroid. Shoulder still is hurting even on the steroids and having some weakness and limited mobility. Now waiting to see if the pain goes away when steroid is done. Doctor suggested it may be painful/inflamed due to the shot being given too high and going through the muscle and into the bursa sac. Pain is most severe when shoulder is reached above the head or moved laterally behind or across body.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Oedema, Pain
Clinical narrative: Felt the flu shot was given really high in my shoulder. After, experienced more pain than usual, pain increased each day and I experienced limited mobility and increased weakness. On day 4 went to doctor and started ibuprofen for inflammation. Pain still got worse after that. Hard to even put a shirt on. On day 10, went back to the doctor and they got an MRI later in the day. MRI showed inflammation and fluid build-up so started on a steroid. Shoulder still is hurting even on the steroids and having some weakness and limited mobility. Now waiting to see if the pain goes away when steroid is done. Doctor suggested it may be painful/inflamed due to the shot being given too high and going through the muscle and into the bursa sac. Pain is most severe when shoulder is reached above the head or moved laterally behind or across body.
Age: 29.0
Sex: F
Vaccine: HEPA
Symptoms: Fatigue, Head injury, Nausea, Suture insertion, Syncope
Clinical narrative: I was administered Hepatitis A Vaccine by shot in my right arm, momentarily afterward there were symptoms of nausea, fatigue, and fainting. I had to have immediate stitches given due to head injury. Nausea and fatigue symptoms lasted for a couple days.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Glossodynia, Headache
Clinical narrative: WITHIN 24 HOURS AFTER RECEIVING THE ABOVE IMMUNIZATIONS PATIENT REPORTED FLU LIKE SIGNS AND SYMPTOMS, SORE TONGUE, SORE THROAT, BURNING LIPS, BURNING THROAT, JOINT PAIN, CHILLS, FATIGUE, FEVER, AND HEADACHE.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Influenza like illness, Oral discomfort, Oropharyngeal pain, Pyrexia, Throat irritation
Clinical narrative: WITHIN 24 HOURS AFTER RECEIVING THE ABOVE IMMUNIZATIONS PATIENT REPORTED FLU LIKE SIGNS AND SYMPTOMS, SORE TONGUE, SORE THROAT, BURNING LIPS, BURNING THROAT, JOINT PAIN, CHILLS, FATIGUE, FEVER, AND HEADACHE.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Myalgia
Clinical narrative: Rigors, muscle aches 102 temp.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injection site pain, Loss of personal independence in daily activities, Pain, Tendonitis
Clinical narrative: Severe pain in left shoulder near injection site (high on outer back part of arm) that started within a day of administration. Pain is dull and constant and has progressively gotten worse over the past month plus. Reaching across and above my body with my left arm causes excruciating pain and disrupts my daily activities including work, exercise, sleep and showering/ getting dressed. I was treated for bursitis with a 6-day steroid regimen (Prednisone 5 MG) after a follow up appt with her on 12/5/17. One day 2, the pain ceased but it came back even worse before I had finished the doses. Went back to see Dr.  on 12/11/17 and she told me to "schedule ib profen" 3 times a day for 2 weeks to reduce the inflammation and said it was likely tendonitis. I have been taking the ib profen routinely for pain but it has not helped. The pain has now been going on for almost 2 months.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Cardiac flutter, Erythema multiforme, Injection site swelling, Insomnia, Myalgia
Clinical narrative: Per patient report: My arm was extremely painful that night with swelling about 6 inches around the shot site was hard to sleep and had to put cold packs on it. The next day it was swollen on the outside of the arm down to the elbow. The 3rd day it was swollen on the bicep with about a 1/4 inch raise. Then heart palpitations, fluttering happened throughout the day, sometimes for 14 seconds or longer. The 4th day the swelling disappeared and so did the palpitations. Myalgia, erythema multiform, palpitations and swelling 6 inches around injection site.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Palpitations
Clinical narrative: Per patient report: My arm was extremely painful that night with swelling about 6 inches around the shot site was hard to sleep and had to put cold packs on it. The next day it was swollen on the outside of the arm down to the elbow. The 3rd day it was swollen on the bicep with about a 1/4 inch raise. Then heart palpitations, fluttering happened throughout the day, sometimes for 14 seconds or longer. The 4th day the swelling disappeared and so did the palpitations. Myalgia, erythema multiform, palpitations and swelling 6 inches around injection site.
Age: 80.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Pruritus, Rash, Urticaria
Clinical narrative: Soreness/puffy at injection site. Lasting approx. five days. Then broke out in a rash in an area 6" down the arm and 4" across. Very itchy. This rash went away for about a week. Then came back with larger welts similar to shingles. This lasted about 10-14 days. Then finally cleared up.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Rash pruritic
Clinical narrative: Localized pruritic rash and mild headache occurred 1 day after injection. OTC remedies for symptomatic relief and instructed to keep rash covered. Instructed to return to clinic or ER if symptoms worsen acutely or don't resolve within 10 days.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Urticaria per the patient's allergist. Can no longer receive flu shot.
Age: 33.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Heart rate increased, Injection site pain
Clinical narrative: Itching, swelling, hives, increased HR (160), BP 173-110, SOB, chest pain. Seen in ED. Given IM EPI, PO BENADRYL, Prednisone, ZANTAC, PEPCID. Transferred to other facility. Given IM BENADRYL. DC'd home. F/U with clinic 12/27/17. Soreness at injection site. Recommended F/L with health care provider.
Age: 33.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Itching, swelling, hives, increased HR (160), BP 173-110, SOB, chest pain. Seen in ED. Given IM EPI, PO BENADRYL, Prednisone, ZANTAC, PEPCID. Transferred to other facility. Given IM BENADRYL. DC'd home. F/U with clinic 12/27/17. Soreness at injection site. Recommended F/L with health care provider.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Eye infection viral, Visual impairment
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of abnormal vision in a 53-year-old female patient who received FLULAVAL Quadrivalent) (batch number 222FX, expiry date 30th April 2018. On 14th November 2017, the patient received FLULAVAL Quadrivalent. On an unknown date, 7 days after receiving FLULAVAL Quadrivalent, the patient experienced abnormal vision and eye infection viral. On an unknown date, the outcome of the abnormal vision and eye infection viral were unknown. It was unknown if the reporter considered the abnormal vision and eye infection viral to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: The patient did not receive no concomitant vaccines, and any other medical or medication history. The patient received FLULAVAL in left deltoid and developed a prism effect in her eye. The reporting nurse was not able to elaborate more about symptom, but stated that the patient visited an ophthalmologist, and the ophthalmologist determined that the patient had a virus in her eye. The reporting nurse stated that it was worth noting that the patient was an emergency room nurse.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, X-ray
Clinical narrative: Whole arm pain syndrome. Started after the shot and lasting 1 mo. Her pharmacy that provided the shot directed her to contact her PCP to report this.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Blood test normal, Musculoskeletal stiffness
Clinical narrative: Pain and soreness in joints (shoulder, hips and hands) began immediately next day after injection. I expected some soreness, but the pain increased day after day and I still am experiencing the pain and stiffness. I have gone to my primary physician, he ran blood tests and found no answers in the bloodwork. My question is, how long will this pain and soreness last? It has now been over two months.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager in charge of vaccine storage and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-DEC-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot # M042504 with expiration date of 30-NOV-2017, for prophylaxis (strength, dose, route and frequency were not reported). No adverse effects were reported in the patient.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-DEC-2017, the patient was inadvertently administered an expired dose of VARIVAX lot # L043622 03-NOV-2017, for prophylaxis (strength, dose, route and frequency were not reported).  Other suspect therapies included sterile diluent (strength, dose, route, frequency, indication, lot/batch # and expiration date were not reported). No adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age or gender. No information was provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies. On 19-DEC-2017, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX subcutaneously (exact dose was not reported; lot # M038864 with the expiration date of 12-DEC-2017) for prophylaxis. The administered dose of ZOSTAVAX was reconstituted with sterile diluent (lot# and expiration date were not reported). No adverse effects were reported.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 19-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in 2013, 4 years ago when the patient was 15 years old, he was vaccinated with the first dose of GARDASIL 9 (dose, frequency, route of administration, lot# and expiration date were not reported). On an unknown date in 2017, the patient came to the office to receive the second dose of GARDASIL 9. It was not reported if the patient was vaccinated with the second dose after 4 years. No adverse effects were reported. The relatedness between the event and therapy with GARDASIL 9 was not reported.
Age: 90.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 90 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-OCT-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 67 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-MAR-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 68.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 69 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-MAR-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Sex: M
Vaccine: ANTH
Symptoms: Autoimmune disorder, General physical health deterioration, Malaise
Clinical narrative: Received a spontaneous report via email on 31JAN2017 from a consumer. A male reported that he went from a healthy vibrant person to a sick patient that spend most of his time seeing doctors who can't tell what is wrong exactly. He states he has been diagnosed with an autoimmune following his anthrax vaccines and deployment in 2013. He also noted that he has always been active playing basketball and training for Jiu-Jitsu tournaments but that year his health quickly declined and he has not recovered. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 19-Dec-2017. This case involves a 74 years old female patient, who was vaccinated once with a 0.5 ml dose of FLUZONE HD(batch number: UI808AA, expiry date: 28-Feb-2018, dose in series and route of administration was not reported) in left deltoid on 09-Nov-2017. Previous medication included vaccine FLUVIRIN. Patient's medication history and concomitant medications were not reported. On an unknown date, after receiving the vaccination, the patient experienced limited left arm movement. On an unknown date, patient was seen by her primary provider. Lab data were not reported. Corrective treatment included 10 physical therapy sessions ordered by patient's primary provider. Event outcome was reported as recovering. List of documents held by sender: none.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: H1N1 influenza, Hypoaesthesia, Syncope, Vaccination failure
Clinical narrative: Initial unsolicited report received from a nurse (patient herself) on 20-Dec-2017. This case involves a female patient (age not reported), who was vaccinated once with 0.5 ml HINI INFLUENZA VACCINE via intramuscular route (batch number: UP013AA; expiry date: 15-SEP-2010, dose in series and site of administration not reported) on 29-Oct-2009. Patient's medical history and concomitant medications were not reported. On an unknown date, few weeks following the vaccination, patient developed "progression of symptoms, numbness face and arms, blood pressure 200/100, fainted twice" seen in ER (emergency room) and diagnosed with H1N1 viral syndrome. On an unknown date, patient got hospitalized. It was also a case of suspected vaccination failure. Other lab test was not reported. Corrective treatment was not reported. On an unknown date, patient recovered from the events. No information reported on hospital discharge. Documents held by sender: none. Sender's Comments: The time to onset is few weeks post vaccination which needs further clarification. No PCR/serology results confirming the diagnosis was reported. No medical history, tolerance to previous vaccinations and condition at the time of vaccination were reported. Additional information regarding the same is required to completely assess the case. Based upon reported information te role of the vaccine can not be assessed.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Loss of consciousness, Nasopharyngitis
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 67-year-old male patient with diabetes mellitus, lipidaemia and anaemia. Concomitant therapies included aspirin (ASPIRIN). On 21-DEC-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N010105 with an expiration date 15-NOV-2018 , 0.5 ml, intramuscularly for routine vaccination (anatomical location was not reported). On an unknown date in December 2017, also reported as "an unspecified time after receiving PNEUMOVAX 23", the patient developed cold-like symptoms, was very weak and passed out. The patient did not receive any treatment for the events. There was no laboratory test performed. At the reporting time, the patient, was scheduled for the consultation, in regards to the reported reactions. Product quality complaint was not reported. The outcome of the events was unknown. Causality assessment was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a pharmacist, concerning unspecified child patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with a dose of VARIVAX (dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient was diagnosed with chicken pox. The outcome of chicken pox was unknown. The causal relationship between the adverse event and the therapy was not assessed. This is one of two report received from the same reporter. Sender's Comments: US-009507513-1712USA000896.
Age: 73.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 74 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-AUG-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Age: 74.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 74 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-OCT-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 66 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-NOV-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Age: 69.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 69 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-OCT-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA000166.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 66 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-NOV-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Age: 68.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 68 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-APR-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 75.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 75 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-NOV-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 68 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-MAY-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 73.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 73 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-NOV-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Age: 53.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 54 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUL-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Age: 86.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 87 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-APR-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.