chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.25
Sex: M
Vaccine: PNC13
Symptoms: Dermatitis infected, Inappropriate schedule of drug administration, Injection site rash, Rash, Rash erythematous
Clinical narrative: This is a spontaneous report from a contactable Physician. A 3.5-month-old male patient received PREVNAR 13 via an unspecified route of administration at single dose in left thigh from 11Nov2016 16:16 for immunization, at Physician office. No other vaccines administered on the same date of the Pfizer suspect. Medical history was none. Concomitant medication included probiotics since the age of 6 weeks for unknown reason. Prior Vaccinations within 4 weeks: PENTACEL, ROTAVIRUS VACCINE, PENTAVALENT VACCINE, all with no adverse effects. The patient started having a rash at the injection site almost a week after administration. It started at injection site and then started traveling. Reporter saw the patient in her office on 21Nove2015 and the rash was scalant like on the lower extremities. Patient had a few rashes on the chest and right shoulder. He had a couple of non-speculated on extremities, patches on chest. Had two or three lesions on the face.  The rash was erythematous, almost fluid filled dome like appearance. Was able to irritate to touch and rub and it would disappear. Clarified as, the fluid fill would recede a little, but would come back again.  Initially, thought it was a bacterial infection but later concluded it was not cause vesicles not that wide. It was atypical for infected dermatitis. The case presented was just weird. Reporter explained the patient should have had the initial vaccine at the age of 2 months, but did not.  Instead it was given at 3 months, a month later. The even rash required a visit to the physician Office. Therapeutic measures were taken as a result of rash was erythematous, rash at injection site: he took of probiotics and all baby products: Johnson and Johnson. Only can use plain Dove soap water to clean.
Age: 0.25
Sex: M
Vaccine: PNC13
Symptoms: Skin irritation, Skin lesion
Clinical narrative: This is a spontaneous report from a contactable Physician. A 3.5-month-old male patient received PREVNAR 13 via an unspecified route of administration at single dose in left thigh from 11Nov2016 16:16 for immunization, at Physician office. No other vaccines administered on the same date of the Pfizer suspect. Medical history was none. Concomitant medication included probiotics since the age of 6 weeks for unknown reason. Prior Vaccinations within 4 weeks: PENTACEL, ROTAVIRUS VACCINE, PENTAVALENT VACCINE, all with no adverse effects. The patient started having a rash at the injection site almost a week after administration. It started at injection site and then started traveling. Reporter saw the patient in her office on 21Nove2015 and the rash was scalant like on the lower extremities. Patient had a few rashes on the chest and right shoulder. He had a couple of non-speculated on extremities, patches on chest. Had two or three lesions on the face.  The rash was erythematous, almost fluid filled dome like appearance. Was able to irritate to touch and rub and it would disappear. Clarified as, the fluid fill would recede a little, but would come back again.  Initially, thought it was a bacterial infection but later concluded it was not cause vesicles not that wide. It was atypical for infected dermatitis. The case presented was just weird. Reporter explained the patient should have had the initial vaccine at the age of 2 months, but did not.  Instead it was given at 3 months, a month later. The even rash required a visit to the physician Office. Therapeutic measures were taken as a result of rash was erythematous, rash at injection site: he took of probiotics and all baby products: Johnson and Johnson. Only can use plain Dove soap water to clean.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 71-year-old female patient received on 21Nov2016 the second dose of PREVNAR 13 (lot R19477, expiration date Jan2018, NDC number 0005197102) at 0.5 ml single dose in the left arm intramuscular for immunization. Concomitant medications and medical history were not reported. First dose of pneumococcal 13-val conj vac (dipht crm197 protein) was administered on 15Apr2015. It was reported that the patient experienced fever within 24 hours of receiving the second dose. Outcome was unknown.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative, who reported similar events for two patients. This is the 1st of 2 reports. A female patient in her late 50's received a single dose of PREVNAR 13 at single dose and the flu vaccine, both in opposite arms on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient's arm became red, hot, and hard the arm where the patient received the Prevnar 13. The adverse events took 2 to 3 weeks for the patient to completely recover. Sender's Comments: Linked Report(s): US-PFIZER INC-2016547364 Same reporter/drug/event, different patient.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal discomfort, Body temperature increased, Diarrhoea, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer. A contactable consumer reported that a 67-year-old male patient received PREVNAR 13, via an unspecified route of administration at single dose on top part of left arm on 21Nov2016 at around 16:00 for immunisation, as pneumonia vaccine at annual wellness visit and administered in doctor's office. Medical history included hiatus hernia and heartburn. PSA was done once year. Concomitant medication included omeprazole (PRILOSEC) 20 mg, 1x/day taking for probably for 15 years and ongoing for hiatal hernia and heartburn.  No history of all previous immunization with the Pfizer vaccine considered as suspect: he had not received before. Had Flu shot 6 weeks before without adverse effect. His 87 year old mother received PREVNAR 13  three weeks before and had diarrhea the next week. On 22Nov2016 at 4:00am he was sick as a dog, was nauseated, had diarrhea and sick to his stomach. He has gone to bathroom multiple times, has limited his liquid intake. Had a 102 temperature. Diarrhea was worse all morning. It was different that when he has a stomach virus, he would go 25 times.  This time he went for two hours without going. Colon would fill with water, and go a huge volume and does it again in two hours.  Nauseated was worse when he woke up this morning, with some improvement. He put ice on his stomach, has not taking anything for it. He called the doctor's office and was told to take Tylenol and drink liquids to call back if it had gotten worse. He took two Tylenol and his Prilosec OTC, this afternoon, he has been able to keep down. He was still having discomfort in stomach, but not as bad.
Age: 7.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative, who reported similar events for two patients. This is the second of two reports. A male patient who was in his late 60's received  a single dose of  PREVNAR 13, on an unspecified date in arm because he was getting a cochlear implant.  The patient medical history and concomitant medications were not reported. On an unspecified date the patient's arm became red, hot, and hard. The adverse events took 2 to 3 weeks for the patient to completely recover.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016547356 Same reporter/drug/event, different patient.
Sex: U
Vaccine: MENB
Symptoms: Diarrhoea, Headache, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age, race and gender received TRUMENBA on an unspecified date at 0.5 ml single for immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fever, vomiting, diarrhoea and headache, all on an unspecified date with unknown outcome. The reporting physician considered the events related to the suspect vaccine.
Sex: U
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age, race and gender received TRUMENBA on an unspecified date at 0.5 ml single for immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fever on an unspecified date with unknown outcome. The reporting physician considered the event related to the suspect vaccine.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, warmth, swelling, tenderness in left upper arm.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, warmth, swelling, tenderness to left upper arm. Ice, but no medicine no treatment.
Age: 70.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Induration, Injection site reaction, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 70-year-old male patient. The patient was allergic to penicillin and had no other pertinent medical history. On 22-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, intramuscularly, lot# M037669, expiry date 09-MAY-2018 (dose was not reported) and with a dose of influenza virus vaccine (unspecified) (formulation, dose and route of administration were not reported). There were no concomitant therapies. It was reported that the patient came into pharmacy on 23-NOV-2016, complaining of an injection site reaction. The pharmacist stated the patient had swelling, redness and induration below the site of injection (onset date unspecified, approximately in November 2016). There were no diagnostic studies performed. The outcome of the events was reported as recovering/resolving. The relatedness between the events and the suspect vaccines was not reported. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Asthenia, Ear infection, Urinary tract infection, Urticaria
Clinical narrative: Urinary Tract Infection and infection in right ear. Treatment: antibiotics for urinary infection and antibiotic oil for ear infection. I got a terrible case of hives from the antibiotics. I had to go to the emergency room 11/23/2016 for a possible ITA and overall weakness in my body. Today I am taking pain pills for overall distress in my body. Before the shots (flu and pneumonia at the same time) I was swimming laps every day and was in excellent health.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain
Clinical narrative: Pain and redness.
Age: 7.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Spoke with mother and stated patient's arm around her flu shot received yesterday is larger, red and hot. No fever but have been giving TYL, Ibuprofen. No drainage. Blood sugars within usual limits, 80's pre dinner tonight.
Age: 1.5
Sex: F
Vaccine: DTAP, FLU4, IPV
Symptoms: Abasia, Arthralgia, C-reactive protein increased, Decreased appetite, Joint effusion
Clinical narrative: Bilateral hip pain, refusal to walk. Subjective fevers. decreased appetite.
Age: 1.5
Sex: F
Vaccine: DTAP, FLU4, IPV
Symptoms: Nuclear magnetic resonance imaging abnormal, Osteomyelitis, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Bilateral hip pain, refusal to walk. Subjective fevers. decreased appetite.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Abnormal behaviour
Clinical narrative: Our daughter (patient) became overwhelmed with emotion, both sadness and happiness, uncontrollably sobbing and then laughing. She acted as if she was under the influence of "drugs", and it subsided about one and half hours later, and she appeared to be "crashing" from a high! At bedtime, she had further episodes, and the next night, more sadness at bedtime, but not as intense. To us it seemed like the vaccination effected her "affect" or maybe serotonin. She also had the Flu vaccine at the same time, same arm. She has had flu vaccines before without incident.
Age: 53.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Had redness and swelling in Rt upper arm with aches and fever.  Rt arm measures 1.5 inches larger that LT arm.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Seizure
Clinical narrative: Within 24 hours of receiving the FLUARIX vaccine patient had a brief generalized seizure. She has a known seizure D/O - last seizure was 1yr-prior. Medication levels were not obtained.
Age: 0.58
Sex: U
Vaccine: FLU4
Symptoms: Peripheral coldness, Rash macular
Clinical narrative: Cold leg with diagonal erythematous macules upon awakening morning after vaccine.
Age: 1.33
Sex: F
Vaccine: DTAP, FLU4, HIBV, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever 103.9 48 degrees after imms.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS, FLU3, PNC13, VARZOS
Symptoms: Injection site erythema, Rash macular
Clinical narrative: Patient had a few red splotches on the arm and red at site of injection. Only on right arm.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS, FLU3, PNC13, VARZOS
Symptoms: Hypersensitivity, Injection site bruising, Injection site cellulitis, Injection site erythema, Injection site inflammation
Clinical narrative: Patient had a few red splotches on the arm and red at site of injection. Only on right arm.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS, FLU3, PNC13, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient had a few red splotches on the arm and red at site of injection. Only on right arm.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS, FLU3, PNC13, VARZOS
Symptoms: Rash macular, Skin bacterial infection
Clinical narrative: Patient had a few red splotches on the arm and red at site of injection. Only on right arm.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Haemorrhage, Induration, Pain, Skin warm
Clinical narrative: After vaccine bleeding noted, hard bump and then bruise, hot, sore - 24 hours after ice pack times 15 min. Bruise 1 3/4" X 1 1/2" Bump 1" X 1".
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Blood pressure decreased, Visual impairment
Clinical narrative: Pt stated that he was feeling fine before the shot, but during administration expressed his fear of needles. After administration, walked out of the room and to the end of the aisle and started to feel vision going in and out. Pt tried to lower his body to the ground so would not pass out and then sat down near front register. Manager gave pt water and banana. Pt stated this is not the first time he has experienced this (drop in BP and anxiety setting in). Pt declined ambulance/911. Checked pt's BP at 1:33pm- 108/70 and pulse 84. Pt stated he was feeling fine after sitting and drinking water and eating banana. Pt stated he was ok to drive and leave the store after checking his blood pressure at 1:33pm.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient felt fine immediately after vaccination, walked thru store w/family. At checkout register at front of the store became lightheaded and passed out.
Age: 38.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen and painful left pelvic nodes.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site, unresolved after 1 month of monitoring.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: RED AND SWOLLEN. HOT TO TOUCH.  PAIN SO BAD, HAD TO TAKE A PAIN PILL TO GET SLEEP. SYMPTOMS LASTED 3 DAYS.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Chills, Headache, Injection site warmth
Clinical narrative: 1. Chills, raised temperature and headaches - duration for about six hours then subsided.  Headache continued to next day.  2. Site of injection became warm for about 24 hours.  It was scary.
Age: 71.0
Sex: F
Vaccine: PNC
Symptoms: Allergy to vaccine
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program via a contactable physician.  A 71-year-old female patient received the PREVNAR, via an unspecified route of administration on an unspecified date at a single dose for immunization and lisinopril (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at an unknown dose for an unspecified indication. Medical history included moderate allergy to adhesive tape. The patient's concomitant medications were not reported. On unspecified dates, the patient experienced allergy PREVNAR and lisinopril. The events were further described as: critical for the PREVNAR and mild for lisinopril. The action taken in response to the events for PREVNAR was not applicable and for lisinopril was unknown. The clinical outcome of the events, allergy to PREVNAR and lisinopril, was unknown.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Atypical pneumonia, Chest X-ray normal, Diarrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer reporting on behalf of his mother. A 87-year-old female patient received first dose of PREVNAR 13 at single dose on an unknown date for immunization. Medical history included osteoporosis, atrial fibrillation (about 4 years before this report), pacemaker (about 4 or 5 years before this report, an ablation was done) and ongoing spastic colon (she had all of her life). Concomitant medications included influenza vaccine for immunization within a month. In Oct2016 the patient experienced diarrhea. As treatment the patient received Colestipol and Imodium. She had gotten better from diarrhea, then was diagnosed with walking pneumonia in Nov2016. The patient was prescribed two antibiotics: azithromycin (ZITHROMAX PACK) once a day and a cephalosporin type antibiotic, then she had diarrhea again. The reporter thought that antibiotics were the cause for diarrhea. She was taken off the antibiotics. An X-ray was done on an unspecified date in 2016 that showed that her chest has cleared up.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Rash generalised, Tremor
Clinical narrative: Rash all over upper body, shakiness started 3-4 minutes after vaccines were given.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Flu vaccine given 11/11/16 about 11am to 12pm. That evening patient got severe chills and uncontrolled shivering. About 45 minutes after going to bed in warm water be shivering stopped but felt he had a fever. Was fine next day.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Shooting pain down left arm.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: About 15min after injection patient skin turned red around injection site. Patient had no other reactions.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site erythema, Pruritus, Serum sickness
Clinical narrative: Redness around injection site. Patient states itchiness on other upper arm that evening and resolved without treatment. 2 days following the vaccine she noted pain in her elbow. Initially thought it was from overuse but now feels it is from the administration of the vaccine in that arm. MD today stated he thought it was 'serum sickness'.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Pt left arm is red and swollen in the deltoid region and said it is hard to use his arm.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Guillain-Barre syndrome, Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: Numbness and tingling if fingers/toes, which progressed to numbness to just above knees and elbows in all 4 extremities.  One week after numbness, onset of generalized fatigue and myalgia most prominent in the RUE.  Diagnosed with acute inflammatory demyelinating polyradiculoneuropathy (AIDP) 11/9/16.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Lymph node pain, Lymphadenopathy, Neck pain, Peripheral swelling
Clinical narrative: Patient reports that on 11/23/16 she woke up with a swollen arm and knot at injection site.  States by late PM on 11/23/16 the pain had moved up her neck.  On 11/24/16 noticed swollen lymph node or gland on the right side of neck.  States area very painful to touch on 11/24/16.  Reported all above symptoms to local health department on 11/28/16.  States all symptoms have resolved except for swollen gland in neck which is improving but still tender to touch.  Denies any follow up with PCP; treated self with Ibuprofen and Nyquil at home.  Denied fever or any other symptoms of illness.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Redness and swelling at injection site (L arm), swelling is hard and size of silver dollar. Aching down to mid forearm.
Age: 59.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Arthralgia, Gait disturbance, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Painful swelling at injection site.  About a week later had muscle and joint pain, difficulty walking. Pain down spine into hips.
Age: 59.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Spinal pain
Clinical narrative: Painful swelling at injection site.  About a week later had muscle and joint pain, difficulty walking. Pain down spine into hips.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Hives at injection site, itchy.  Has been a recurring event since the injection.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Moderate pain of shoulder at rest, severe pain when arm raised or sleeping on that side.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthralgia, Diarrhoea, Injection site erythema, Injection site pain
Clinical narrative: Injection site swollen painful red for one week. Diarrhea abdominal pain for 10 days let up currently beginning 11/27/16 diarrhea abdominal pain nausea vomiting (severe joint pain for couple days which has let up).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Vomiting
Clinical narrative: Injection site swollen painful red for one week. Diarrhea abdominal pain for 10 days let up currently beginning 11/27/16 diarrhea abdominal pain nausea vomiting (severe joint pain for couple days which has let up).
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient had no adverse events when shot was given. Came to pharmacy on 11/28/16. Said she has had numbness, tingling in the hand, and shoulder was sore. An exact time course for all these events is unknown patient said the numbness in hand was improving.  Manufacturer was contacted on 11/28/16. Patient was advised to see a physician by manufacturer, per recommendations Facts and Comparisons, and pharmacy. The manufacturer said they was going to submit a report as well.
Sex: U
Vaccine: PNC13
Symptoms: Cerebrovascular accident
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A patient of unspecified age ethnicity and gender received pneumococcal PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced mild stroke on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
Age: 52.0
Sex: M
Vaccine: TYP
Symptoms: Joint swelling, Pruritus, Rash
Clinical narrative: Itching on palms and soles of feet, rash on hands with swelling at joints.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Bursitis, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: I felt soreness in my left shoulder, approximately 8:00 a.m. on the morning of October 12th, 2016.  I also felt a pain in the elbow (felt like on the bone), almost like I had bumped it, but I noticed that it hurt to lift objects or use my arm.  These symptoms lasted for weeks (and still persist).  I thought that they would go away.  I have trouble sleeping and using my left arm.  I finally told the nurse at the Health Dept. (on 11/22/2016) when I had an appointment for the 2nd dose of my immunization (Hep B) and she sounded surprised.  I told her everything that happened and when I noticed it.  I told her that I had an appointment to see my primary care physician on that same day.  I told my doctor the same thing and upon questioning and X-rays he determined that I had bursitis and tendonitis.  He prescribed a medication (either Prednisone or Baclofen).
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Tendonitis, Weight bearing difficulty, X-ray limb abnormal
Clinical narrative: I felt soreness in my left shoulder, approximately 8:00 a.m. on the morning of October 12th, 2016.  I also felt a pain in the elbow (felt like on the bone), almost like I had bumped it, but I noticed that it hurt to lift objects or use my arm.  These symptoms lasted for weeks (and still persist).  I thought that they would go away.  I have trouble sleeping and using my left arm.  I finally told the nurse at the Health Dept. (on 11/22/2016) when I had an appointment for the 2nd dose of my immunization (Hep B) and she sounded surprised.  I told her everything that happened and when I noticed it.  I told her that I had an appointment to see my primary care physician on that same day.  I told my doctor the same thing and upon questioning and X-rays he determined that I had bursitis and tendonitis.  He prescribed a medication (either Prednisone or Baclofen).
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fevers, injection site redness, swelling, pain.  Appearance like cellulitis.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Choking, Crying, Dyskinesia, Erythema, Respiratory arrest
Clinical narrative: After his shot he became inconsolable. Screaming and crying almost non stop for days. I called his GI and we thought it was silent reflux so we got reflux meds took first dose about 5pm on the 5th. On October 5th about 7pm he stopped breathing while awake, 3 hours after eating. Looked like he was choking his face turned red and he was waving his arms. I flipped him face down and was patting his back. It took about 1 minute to get him breathing again. He coughed up spit when he started breathing.  For over a month after he would stop breathing one or more times a day while awake. Haven't noticed any while sleeping. The reflux medication isnt helping this problem so his GI has us adding rice to his formula, but that isnt helping either.  As of this week 11/26/16 he has started only doing it a couple times a week instead of every day.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Screaming
Clinical narrative: After his shot he became inconsolable. Screaming and crying almost non stop for days. I called his GI and we thought it was silent reflux so we got reflux meds took first dose about 5pm on the 5th. On October 5th about 7pm he stopped breathing while awake, 3 hours after eating. Looked like he was choking his face turned red and he was waving his arms. I flipped him face down and was patting his back. It took about 1 minute to get him breathing again. He coughed up spit when he started breathing.  For over a month after he would stop breathing one or more times a day while awake. Haven't noticed any while sleeping. The reflux medication isnt helping this problem so his GI has us adding rice to his formula, but that isnt helping either.  As of this week 11/26/16 he has started only doing it a couple times a week instead of every day.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Flushing, Immediate post-injection reaction, Palpitations
Clinical narrative: PATIENT COMPLAINED FEELING WARM, FLUSHING FACE PALPITATIONS AND DIZZY IMMEDIATELY AFTER RECEIVING VACCINATION.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: RIGHT ARM, SWOLLEN, WARM, RED FROM SHOULDER TO ELBOW; PT WITH LOW GRADE FEVER.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: LEFT ARM VACCINE SITE RED, SWOLLEN, AND WARM.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Hypoaesthesia, Insomnia, Peripheral swelling
Clinical narrative: I started having pain in the same r-elbow on the same arm of injection, then two days later in the right wrist causing it hard to sleep at night. Then a couple days later my left index knuckle swelled. My pinky knuckle swelled and know I am having some numbness in my right hand. I have a doctors appt. scheduled for Dec. 5
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chills, Dyspnoea, Inflammation, Influenza like illness
Clinical narrative: A half hour after receiving the vaccine, I couldn't move my neck. It was stiff, my glands in my neck and armpits were completely inflamed. I had flu-like symptoms that night around midnight. Nauseous, chills, fever, swollen glands, trouble breathing for the next 3 days. Immediate care- 11/25/16.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: A half hour after receiving the vaccine, I couldn't move my neck. It was stiff, my glands in my neck and armpits were completely inflamed. I had flu-like symptoms that night around midnight. Nauseous, chills, fever, swollen glands, trouble breathing for the next 3 days. Immediate care- 11/25/16.
Age: 1.08
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Found out today that wrong diluent was used. No adverse effects reported.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Injection site erythema, Injection site swelling, Scab
Clinical narrative: Red and swollen around injection site. Formed blister that popped and scabbed over. Patient applying Melaluca oil.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Discomfort, Full blood count abnormal, Mobility decreased, Pain
Clinical narrative: Location: left arm pain. Quality: heaviness. Severity: worsening. Duration: present <1 month; started yesterday at 3pm. Timing: constant. Context: had pneumonia shot last week and arm started hurting yesterday; coughing, body pain, hurts to move left arm; pain all over; not sure what is going on; feels feverish; felt fine after shot on Friday and Saturday; 3pm yesterday started with body aches, left arm pain and hard to move; feels Had.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Location: left arm pain. Quality: heaviness. Severity: worsening. Duration: present <1 month; started yesterday at 3pm. Timing: constant. Context: had pneumonia shot last week and arm started hurting yesterday; coughing, body pain, hurts to move left arm; pain all over; not sure what is going on; feels feverish; felt fine after shot on Friday and Saturday; 3pm yesterday started with body aches, left arm pain and hard to move; feels Had.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Myalgia
Clinical narrative: Patient came to pharmacy and said she has muscle pain from flu shot. She has been experiencing discomfort since after the shot. We asked that patient contact her provider and she said she will call tomorrow.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site bruising
Clinical narrative: BRUISING ON RT ARM WHERE VACCINATION WAS ADMINISTERED.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Within 60 seconds my heart started racing and my breathing became mildly labored. Had to go home and take a nebulizer treatment to reduce symptoms.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm, Tenderness
Clinical narrative: Wide area redness in the arm with very hot feel to it. Also pain in the arm with high sensitivity to the touch.
Age: 4.0
Sex: U
Vaccine: FLU4
Symptoms: Hypersensitivity, Injection site swelling
Clinical narrative: Per dad possible allergic reaction to flu shot, arm (Lt) swollen.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Gave patient 0.25 Influenza vaccine (should have been 0.5-I called mom and she bought patient back on the same day for additional 0.25 dose.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient has pain in the right arm, started two days after vaccine was given. Patient has right arm tenderness of the upper 1/3 of (R) lateral right arm. Has pain on pressure and arm elevation. ALEVE twice daily for 1 week, to call office it gets worse.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Gave patient 0.25 Influenza vaccine (should have been 0.5 - I called mom and she brought patient back on the same day for additional 0.25 dose.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling of left thigh. DX cellulitis. Resolving since starting Clindamycin.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Two inches below the site of Vaccination/Injection had swelling, redness, hard and painful. Planning to see Dr. on 11/29/16.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 17-Nov-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23, lot # L022795, expiration date 05-NOV-2016, (dose number, route and anatomical location of administration were unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial report was received from a medical assistant concerning unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA, , lot number M009377 with expiration date 17-JUN-2017, lot number L009445 with expiration date 01-JUN-2017 and lot number L023936 with expiration date 15-MAR-2017 (dose, strength, route of administration and anatomical location were not reported. According to reporter, the vaccine experienced temperature excursion of up to 45.5 F for 362 hours and 12 minutes. No adverse effects were reported in any patients. This is one of several reported from the same source (1611USA012962 and 1611USA007125). Additional information is not expected since reporter did not give consent for follow up.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional referring to a 61 year old patient of unknown gender. Information about the patent's medical history, concurrent conditions and concomitant medication was not reported. On 08-NOV-2016, the patient was vaccinated with an expire dose of ZOSTAVAX 19400 "PFU" lot # L027322 with an expiration date 21-OCT-2016 (concentration, dose and route of administration were not provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial report was received from a medical assistant concerning unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored M-M-R II, lot number L024265 with expiration date 01-JUL-2017 (dose, strength, route of administration and anatomical location were not reported. According to reporter, the vaccine experienced temperature excursion of up to 45.5 F for 362 hours and 12 minutes. No adverse effects were reported in any patients. This is one of several reports from the same source (1611USA007125 and 1611USA012963). Additional information is not expected since reporter did not give consent for follow up.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M021428, expiration date 29-OCT-2017, dose and dose number were not provided) subcutaneously. There was no store information provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a office manager concerning an approximately 3 or 14 years old male patient. The patient's pertinent medical history, drug reactions, allergies and concurrent conditions were not informed. On an unknown date, the patient was vaccinated with GARDASIL (lot #, expiration date and dosage were not provided). administered per intramuscular route. Concomitant therapies were not informed. On unspecified date, the patient's arm became sore after receiving GARDASIL. The outcome of sore arm was unknown at the time of the report. The causal relationship between sore arm and GARDASIL was not reported. No product quality complaint (PQC) was involved. Additional information is not expected as no consent for follow up was given.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Extra dose 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 unknown date, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (dose, dose number, route, anatomical place of vaccination, lot# and expiration date were not provided). After administration it was discovered that an unspecified flu shot and a pneumococcal vaccine (manufacturer unknown) was received 2 to 3 weeks before. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # L040459, expiry date: 06-APR-2017 and lot # K010215, expiry date: 05-MAY-2017, (strength, dose and route were not reported), which underwent temperature excursions of 46.5 Fahrenheit degrees for 30 minutes and 30.8 Fahrenheit degrees for 108 hours on unspecified dates. No previous temperature excursions were reported. Data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy student referring to an unspecific number of patients, of unknown age and gender. Medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M026317 (expiration date 11-JAN-2018), (route, dose and frequency were not reported). The vaccine was exposed to temperature of -2.1 C, during 4 hours, 6 cycles. The call was because of data logger. No previous temperature excursions and no adverse effects were reported. There was no Product Quality Complain (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician referring a 65 year old male patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 08-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # L035687 and expiration date: 16-FEB-2017, intramuscular. (Dose was not reported). On an unspecified date in November 2016, the patient experienced injection site swelling, injection site pain and injection site erythema. At the time of reporting the outcome of injection site swelling, injection site pain and injection site erythema was unknown. There was not a product quality complaint (PQC) involved. The causality assessment between injection site swelling, injection site pain and injection site erythema and PNEUMOVAX 23 was unknown. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: On 11/15/2016 pt received PREVNAR 13 vaccination. On 11/27/16 pt returned to say her left arm has been painful every since.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash. Seen in ER. Mom called our office next day said she was given BENADRYL and steroids PEDIAPRED.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient received Tdap in (L) arm, MENACTRA in (R) arm. Approximately 5min later while waiting in exam room pt stood up to walk towards father and briefly lost consciousness. Father lowered him to the floor. Immediately alert and coherent afterward.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 74 year old female patient referring to herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The patient did not have any drug allergies. In May 2008, the patient was vaccinated with a dose of ZOSTAVAX (route of administration, lot number and expiration date were not provided). On 21-AUG-2016 the patient was diagnosed with shingles. She contacted her physician and he provided treatment with VALTREX. No laboratory diagnostic studies were performed. At the time of the report, the patient was not recovered from shingles. There was not product quality complaint involved. The causal relationship between shingles and ZOSTAVAX was unknown by the reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to multiple unspecified of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unspecified dates, the patients were vaccinated with a dose of improperly stored (Wistar RA 27-3) M-M-R II with lot number M010426 and expiration date of 01-MAR-2018 (strength, route of administration and dose were unknown), which was stored at 35 Fahrenheit degrees for 1 hour and 47.5 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of two cases from the same reporter. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 6 month old patient. On 31-OCT-2016, the patient was vaccinated with improperly stored ROTATEQ. The physician reported two patients were vaccinated with VAQTA. No adverse effects. Additional information was received from the physician who phoned to provide lot numbers. The physician stated that the Hepatitis A vaccines in question are not MSD products. The physician reported that the administered dose of ROTATEQ came from either lot # M005733 expiration 01-OCT-2017 or lot number M018957 expiration 22-NOV-2017. The temperature was reported a 1 degree centigrade and time frame of 60 hours. No further information was provided. Additional information has been requested.
Age: 88.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a physician concerning an 88 year old patient of unknown gender. The patient's medical history, current conditions, drug reactions/allergies and concomitant therapies were unknown by the reporter. On 10-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # M037669, expiration date: 09-MAY-2018. (dose was not reported), route of administration reported as injection. On 11-NOV-2016, the patient called the physician's office to inform that she was experiencing "Redness, swelling and warmth at the injection site". The patient sought medical attention by calling at the physician's office. The patient received an unspecified treatment for the events. It was unknown by the reporter if lab diagnostics studies were performed to the patient. At the reporting time, the outcome of the events was unknown. The reporter did not provide the causality between PNEUMOVAX 23 and the events. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial report was received from a medical assistant concerning unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9, lot number reported as L040459 with expiration date 06-APR-2017 (dose, strength, route of administration and anatomical location were not reported). According to reporter, the vaccine experienced temperature excursion of up to 45.5 F for 362 hours and 12 minutes. No adverse effects were reported in any patients. This is one of several reports from the same source (1611USA012963 and 1611USA012962). Additional information is not expected since reporter did not give consent for follow up.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Blood creatinine normal, C-reactive protein increased, Carbon dioxide decreased, Chest X-ray normal, Chills
Clinical narrative: Approximately 2 days following PNEUMOVAX, patient developed fevers, chills, cough, wheezing. Seen in office 11/21- labs done. Tx'd with nebs and prescribed certain labs resulted 11/22 - CRP 120.9, CO2 15 Cr 1.08. Pt referred to ER. CO2 improving. Pt tx'd with nebs. to f/u in office.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Pyrexia, Wheezing
Clinical narrative: Approximately 2 days following PNEUMOVAX, patient developed fevers, chills, cough, wheezing. Seen in office 11/21- labs done. Tx'd with nebs and prescribed certain labs resulted 11/22 - CRP 120.9, CO2 15 Cr 1.08. Pt referred to ER. CO2 improving. Pt tx'd with nebs. to f/u in office.