chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Cough, Diarrhoea, Headache, Injection site discomfort
Clinical narrative: Started with cough, tickling around injection site, headache, fever, turned into intense vomiting and diahrrea by 3:30AM on 03/05/2015. Chills, fever, nausea, diarrhea, headache and neck ache lingered and are still present.
Age: 23.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Neck pain, Pyrexia, Vomiting
Clinical narrative: Started with cough, tickling around injection site, headache, fever, turned into intense vomiting and diahrrea by 3:30AM on 03/05/2015. Chills, fever, nausea, diarrhea, headache and neck ache lingered and are still present.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza in a female patient who received Influenza vaccine. Concurrent medical conditions included chronic obstructive asthma (with obstructive pulmonary disease). On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced influenza. On an unknown date, the outcome of the influenza was unknown. It was unknown if the reporter considered the influenza to be related to Influenza vaccine. Additional information received: The reporter mentioned that a lot of people have taken the flu shot but still gotten the flu. For example, her sister received the flu shot but still got the flu. No further details were provided.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Rash generalised, Rash pruritic
Clinical narrative: Case number PHEH2015US002081 is an initial spontaneous report received from a consumer on 27 Jan 2015 and a follow up report from the physician received on 19 Feb 2015. This report refers to a 56 years old female patient. She had good overall health. Her concomitant medications were not reported. She was vaccinated with one dose of FLUVIRIN (batch number: 1411901, expiry date: May 2015) at a dose of 0.5 ml intramuscularly in the left deltoid on 30 Oct 2014. It was reported that she experienced rash in early-mid November and she had rash all over on 10 Nov 2014. It sometimes changed location and her back was covered with rash. She stated that the rash itched terribly. Upon follow up, the physician stated that the patient did not report any rash to them, but if she did have any, the physician asked to consider them as an allergic reaction. The outcome of event was reported as condition unchanged. The consumer reported the event as serious (disabling). The causality of the events was not reported. Follow up report from the physician received on 19 Feb 2015: Changed product coding from seasonal influenza vaccine to FLUVIRIN. Added batch number, expiry date, site of vaccination and dose of FLUVIRIN vaccine.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 4 month old patient. The patient was vaccinated with oral, ROTATEQ (dose, lot number not provided, dose 1 on 05-DEC-2014, dose 2 on 12-FEB-2015 two weeks ago and dose 3 on 26-FEB-2015) orally. No adverse effect reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Injection site erythema, Injection site warmth, Peripheral swelling
Clinical narrative: Vaccine administered 2/20/15 (PNEUMOVAX 23). Rash and chills on 2/21/15. Fever (100, with patient's baseline 97-98) on 2/22/15. Seen in the office on 2/23/15 with the arm red, itchy, swollen and warm (puncture site clear, with area of erythema and warmth just distally, measuring 21cmx7cm, with extension to the axilla. Reaction: right arm.
Age: 17.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pruritus, Pyrexia, Rash, Skin warm
Clinical narrative: Vaccine administered 2/20/15 (PNEUMOVAX 23). Rash and chills on 2/21/15. Fever (100, with patient's baseline 97-98) on 2/22/15. Seen in the office on 2/23/15 with the arm red, itchy, swollen and warm (puncture site clear, with area of erythema and warmth just distally, measuring 21cmx7cm, with extension to the axilla. Reaction: right arm.
Age: 64.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chest pain, Confusional state, Dyspnoea, Pyrexia
Clinical narrative: Patient admitted to Hospital on 9/23/14 with admitting diagnosis of chest pain for observation. Confusion, fever and dyspnea.
Age: 0.51
Sex: M
Vaccine: HIBV
Symptoms: Crying
Clinical narrative: Persistent, inconsolable crying lasting > 3 hours within 24 hours of dose, lasting for 48 hours.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Chills, Confusional state, Death, Dyspnoea
Clinical narrative: Hives, swollen glands, chills, difficult breathing, feeling unwell, rash, skin infection, muscle weakness, tiredness, weakness confusion, leg pain and wheezing.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Laboratory test, Lymphadenopathy, Malaise, Muscular weakness
Clinical narrative: Hives, swollen glands, chills, difficult breathing, feeling unwell, rash, skin infection, muscle weakness, tiredness, weakness confusion, leg pain and wheezing.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Rash, Skin infection, Urticaria, Wheezing
Clinical narrative: Hives, swollen glands, chills, difficult breathing, feeling unwell, rash, skin infection, muscle weakness, tiredness, weakness confusion, leg pain and wheezing.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Noted to have red raised warm area with distinct marks from where vaccine administered, pain at site warm to touch tender mother took picture of left arm on phone to show provider.
Age: 1.31
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Rash, Scab, Varicella post vaccine
Clinical narrative: Father call today 03/05/2015 asking about a follow up flu vaccine for his daughter, then stated his daughter had Chickenpox from the VZV vaccine given on 02/05/2015. Pt recieved both MMR & VZV at seperate sites on 02/05/2015 as well as other vaccines. Father states rash appeared on or about 02/23/2015. A few spots to buttocks, arms, a few spots on chest & back. Between 8- 12 total spots, now starting to crust over. No PCP visit for verification. Also mother of child is pregnant, as been kept seperate from child since rash appeared.
Age: 81.0
Sex: F
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: "High fever". No temp recorded.
Age: 29.0
Sex: M
Vaccine: MMR
Symptoms: Fatigue, Local reaction, Lymphadenopathy, Musculoskeletal stiffness, Rash
Clinical narrative: Client and client's mom called in together to report an adverse reaction to MMR immunization administered on 02/23/2015. Client's mom states client has never had vaccinations before. They reported that client had felt tired for 1-2 days after shot and then got "bumps" on his neck (back and front), and along jawline 2-3 days ago from 03/05/2015. They stated that they were the "size of a pea," "half the size of a penny," and "chick pea" size when asked to describe them. Client stated that one of the seemed to be "hooked to the muscle," that one of them is tender, and "not red at all." When asked if he could count the bumps, client replied "there's several." Client's mom also stated that client had felt a "stiff neck" before the bumps developed. Denied fever since vaccination. Mom stated client's "glands are swollen in the neck" and that his lymph nodes in the armpit were not. Mom further stated the reaction was "localized in the head and neck region." Client has not been to the doctor for this reaction. PHN recommended him to go see a physician about this reaction.
Age: 29.0
Sex: M
Vaccine: MMR
Symptoms: Tenderness
Clinical narrative: Client and client's mom called in together to report an adverse reaction to MMR immunization administered on 02/23/2015. Client's mom states client has never had vaccinations before. They reported that client had felt tired for 1-2 days after shot and then got "bumps" on his neck (back and front), and along jawline 2-3 days ago from 03/05/2015. They stated that they were the "size of a pea," "half the size of a penny," and "chick pea" size when asked to describe them. Client stated that one of the seemed to be "hooked to the muscle," that one of them is tender, and "not red at all." When asked if he could count the bumps, client replied "there's several." Client's mom also stated that client had felt a "stiff neck" before the bumps developed. Denied fever since vaccination. Mom stated client's "glands are swollen in the neck" and that his lymph nodes in the armpit were not. Mom further stated the reaction was "localized in the head and neck region." Client has not been to the doctor for this reaction. PHN recommended him to go see a physician about this reaction.
Age: 25.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Daydreaming, Feeling abnormal, Headache, Nausea
Clinical narrative: General fuzzy/absent-minded feeling, nausea, headache, chills.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test, Neuralgia, Oral disorder, Oral surgery, Rash vesicular
Clinical narrative: Broke out in a rash that looked like some shingle sores and some chicken pox. Lasted about a month but still have some sore occurring now. Levocetirizine & Triamcinolone. Lesions in mouth that Dr thought was cancer but removed and was not cancer. Nerve pain in legs and arms.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema
Clinical narrative: Severe redness around injection site.
Age: 16.0
Sex: M
Vaccine: FLUN4, HPV4, VARCEL
Symptoms: Erythema, Induration, Local reaction, Pain
Clinical narrative: LOCALIZED REDNESS, SORE, HARDENED AREA. ROUND, ORANGE SIZE. HAD FIRST VZV ON 6/27/99, #2 ON 7/15/99, CAIR INDICATED THAT #2 WAS STILL DUE. GIVEN ON 3/1/15.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Pain, Pyrexia
Clinical narrative: Fever 102.5 F, dizziness, chills, body aches.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Fatigue, Pyrexia, Rash
Clinical narrative: 2/23/15 FEVER, JOINT ACHES AND FATIGUE TREATED WITH TYLENOL. 2/24/15 RASH ON LEGS AND FOREARMS. TREATED WITH BENADRYL.  2/27/15 SYMPTOMS RESOLVED.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Genital rash
Clinical narrative: Rash on penis foreskin and tip of penis.
Age: 44.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Activities of daily living impaired, Chills, Cold sweat, Feeling cold, Hyperhidrosis
Clinical narrative: "I woke up shivering, cold at 0200. I had no pain; just cold and sweating. My breathing was normal. I waited for a little bit and called my doctor. He told me to go to urgent care but they were closed so he said to go to the emergency room. They monitored me for an hour and put in an IV of normal saline. I felt better.  They did not give me any medications. They recommended I take ibuprofen when I got home.  They took my temperature but I don't know what it was. In the morning I feel body ache, so I took ibuprofen. After that I felt fine, but then I started shivering again, cold, clammy. I never had any pain. I did repeat ibuprofen after I took my temperature in my arm pit and it read 98. I fell asleep. Then on Sunday I was better than Saturday but not quite all right. I stayed home from work on Monday. I didn't take any ibuprofen after Saturday. I went to my primary on Monday for something else and discussed reaction with her. She said I was fine. I want to get the next dose in the series in a month. I'll be fine.
Age: 44.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain
Clinical narrative: "I woke up shivering, cold at 0200. I had no pain; just cold and sweating. My breathing was normal. I waited for a little bit and called my doctor. He told me to go to urgent care but they were closed so he said to go to the emergency room. They monitored me for an hour and put in an IV of normal saline. I felt better.  They did not give me any medications. They recommended I take ibuprofen when I got home.  They took my temperature but I don't know what it was. In the morning I feel body ache, so I took ibuprofen. After that I felt fine, but then I started shivering again, cold, clammy. I never had any pain. I did repeat ibuprofen after I took my temperature in my arm pit and it read 98. I fell asleep. Then on Sunday I was better than Saturday but not quite all right. I stayed home from work on Monday. I didn't take any ibuprofen after Saturday. I went to my primary on Monday for something else and discussed reaction with her. She said I was fine. I want to get the next dose in the series in a month. I'll be fine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives within 30 minutes of giving vaccines.
Age: 68.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Nuclear magnetic resonance imaging, Pain in extremity, Periarthritis, Synovitis
Clinical narrative: Pain in arm, frozen shoulder, bicep synovitis Left arm. Tx PT, can't take anti inflammatory meds, Pain and immobility continues.
Age: 68.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: X-ray
Clinical narrative: Pain in arm, frozen shoulder, bicep synovitis Left arm. Tx PT, can't take anti inflammatory meds, Pain and immobility continues.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Pain in elbow, radiating to upper arm down to fingers.  Worsens with certain movements and uses.  Persistent ache with sharp pain occurring with and after use.
Age: 73.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: REDNESS AT INJECTION SITE--SORENESS--SWELLING--HURT LIKE H___.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Fatigue, Joint instability, Musculoskeletal pain, Nodule
Clinical narrative: Pain and swelling began to occur a few days after vaccine at base of middle finger in knuckles on left hand, and right shoulder pain intensified.  Pain and swelling subsequently also occurred in same area on right hand.  On 11/13/2014 nodules were noticed on both thumbs on joints under fingernails and at base. Since that time pain has intensified and traveled to many other joints -- to feet and some larger joints.  Joint weakness where there was none prior--I was able exercise vigorously---running 15-25 miles per week with no joint pain and engaging in high intensity exercise classes 3 times per week. Within weeks of receiving the shot I grow fatigued easily, have half the energy I used to have, and sense joint weakness and instability in many joints.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Peripheral swelling, Rheumatoid arthritis, Rheumatoid factor negative
Clinical narrative: Pain and swelling began to occur a few days after vaccine at base of middle finger in knuckles on left hand, and right shoulder pain intensified.  Pain and swelling subsequently also occurred in same area on right hand.  On 11/13/2014 nodules were noticed on both thumbs on joints under fingernails and at base. Since that time pain has intensified and traveled to many other joints -- to feet and some larger joints.  Joint weakness where there was none prior--I was able exercise vigorously---running 15-25 miles per week with no joint pain and engaging in high intensity exercise classes 3 times per week. Within weeks of receiving the shot I grow fatigued easily, have half the energy I used to have, and sense joint weakness and instability in many joints.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: On 10/9/2012 a 48 year old female was administered an inactivated influenza vaccine (Multiple dose vials, Novartis (FLUVIRIN), Lot# 1205901, Exp - 06/30/2013) in occupational health. Per pt report, roughly 45 minutes to an hour after the administration she experienced pruritus from her ears to her throat and a rash on her back. She returned to occupational health and was given 50mg of diphenhydramine which resolved her pruritus. She had an influenza vaccine administered in the previous year, 2011, without adverse effect. She was directed to not receive an influenza vaccine again this year in 2013.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of sickness in a 68-year-old female patient who received Influenza vaccine. Co-suspect products included BREO ELLIPTA inhalation powder for chronic obstructive pulmonary disease. Concurrent medical conditions included chronic obstructive pulmonary disease. On 7th October 2014, the patient received Influenza vaccine. On 1st April 2014, the patient started BREO ELLIPTA (unknown) 100/25 ug at an unknown dose at unknown dosing. On 7th October 2014, less than a day after receiving Influenza vaccine and 189 days after starting BREO ELLIPTA, the patient experienced sickness. The action taken with BREO ELLIPTA was unknown. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Influenza vaccine and BREO ELLIPTA.
Age: 0.59
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a physician via a field representative referring to a 2 year old male patient. On 26-OCT-2012, the patient was vaccinated with the first dose of ROTATEQ (lot# H015649, expiration date unknown), 2 ml, orally. On 07-JAN-2013 and 05-MAR-2013, the patient was respectively vaccinated with the second (lot#:H016904, expiration date unknown) and third (lot#: H019649, expiration date unknown) dose of ROTATEQ 2 ml, orally. On approximately 15-JAN-2015, the patient experienced vomiting and diarrhea. After 1 week of vomiting and diarrhea, on 22-JAN-2015, the patient's mother called the office to seek medical attention. The patient visited the office and performed a lab test on an unknown date in 2015 which showed positive for rotavirus on an unspecified date in 2015. Fluids and other unspecified treatments had been given for the events. The outcome of the events was reported as recovered/resolved. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Influenza virus test negative, Myalgia, Pain, Pyrexia
Clinical narrative: 24 hours after injection, patient developed low grade fever, body aches, muscle pain and headache. Still present after 1 wk. Rapid Flu test done and is negative.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 66-year-old female patient who received FLULAVAL (batch number JL7X5, expiry date June 2015). Previously administered products included FLULAVAL (lot: XJ595, exp: June 2014 no reaction). Concomitant products included PNEUMOVAX. On 23rd January 2015 15:40, the patient received FLULAVAL (intramuscular) .5 ml. On 23rd January 2015, an unknown time after receiving FLULAVAL, the patient experienced injection site swelling, injection site inflammation, injection site pain and injection site warmth. On 24th January 2015, the patient experienced wheals and pruritus. On 27th January 2015, the patient experienced injection site wheal and injection site erythema. On 25th January 2015, the outcome of the injection site swelling, injection site inflammation, injection site pain, injection site erythema. On 25th January 2015, the outcome of the injection site swelling, injection site inflammation, injection site pain, wheals, pruritus and injection site warmth were recovered/resolved. On an unknown date, the outcome of the injection site wheal was unknown and the outcome of the injection site erythema was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site inflammation, injection site pain, injection site wheal, wheals, pruritus, injection site erythema and injection site warmth to be related to FLULAVAL. Additional information: Patient received a FLULAVAL injection on 23-JAN-2015 at around 3:40 pm. That same evening when she got home she noticed that it was: really swollen at the injection site, hot to the touch at the injection site, inflamed at the injection site and soared at the injection site. By Saturday 24-JAN-2015 the injection site had welts around the injection site, welts to the back of her arm, welts close to her armpit, welts started itching. It lasted through Sunday 25-JAN-2015. Today 27-JAN-2015 the patient noticed a triangular pink shape area like the size of a quarter next to the injection site as well diamond size welts around the injection site. Patient received the FLULAVAL in the lower arm and patient stated that all side effects happened around that injection site, and not where the PNEUMOVAX was injected.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Pruritus, Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 66-year-old female patient who received FLULAVAL (batch number JL7X5, expiry date June 2015). Previously administered products included FLULAVAL (lot: XJ595, exp: June 2014 no reaction). Concomitant products included PNEUMOVAX. On 23rd January 2015 15:40, the patient received FLULAVAL (intramuscular) .5 ml. On 23rd January 2015, an unknown time after receiving FLULAVAL, the patient experienced injection site swelling, injection site inflammation, injection site pain and injection site warmth. On 24th January 2015, the patient experienced wheals and pruritus. On 27th January 2015, the patient experienced injection site wheal and injection site erythema. On 25th January 2015, the outcome of the injection site swelling, injection site inflammation, injection site pain, injection site erythema. On 25th January 2015, the outcome of the injection site swelling, injection site inflammation, injection site pain, wheals, pruritus and injection site warmth were recovered/resolved. On an unknown date, the outcome of the injection site wheal was unknown and the outcome of the injection site erythema was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site inflammation, injection site pain, injection site wheal, wheals, pruritus, injection site erythema and injection site warmth to be related to FLULAVAL. Additional information: Patient received a FLULAVAL injection on 23-JAN-2015 at around 3:40 pm. That same evening when she got home she noticed that it was: really swollen at the injection site, hot to the touch at the injection site, inflamed at the injection site and soared at the injection site. By Saturday 24-JAN-2015 the injection site had welts around the injection site, welts to the back of her arm, welts close to her armpit, welts started itching. It lasted through Sunday 25-JAN-2015. Today 27-JAN-2015 the patient noticed a triangular pink shape area like the size of a quarter next to the injection site as well diamond size welts around the injection site. Patient received the FLULAVAL in the lower arm and patient stated that all side effects happened around that injection site, and not where the PNEUMOVAX was injected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant refers to multiple patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored ROTATEQ (dose, route, lot number and indication were not reported). No adverse effects reported. No product quality complaint. This is one of several reports from the same reporter. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: 24 hrs after admin. of Tdap she reports severe arm pain. 48 hrs after upper arm became swollen, red, and warm. 72 hrs she presents to medical provider for eval with continued swelling and redness but now reports pruritis. 96 hrs she reports all improving after taking BENADRYL that night.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site pain, Mobility decreased, Muscular weakness, Neck pain, Pain in extremity
Clinical narrative: 2/4 Right arm pain about 3 hours after receiving PPSV -23 shot in that arm, "feverish" a few hours later; no redness or bruising at site; 2/10 seen in ER with pain in right shoulder and neck, limited movement and weakness in right arm, and history of intermittent fever; Rx diazepam; referred to orthopedist for possible phys. therapy; Pt. reported ER dx was "reaction to vaccine".
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: 2/4 Right arm pain about 3 hours after receiving PPSV -23 shot in that arm, "feverish" a few hours later; no redness or bruising at site; 2/10 seen in ER with pain in right shoulder and neck, limited movement and weakness in right arm, and history of intermittent fever; Rx diazepam; referred to orthopedist for possible phys. therapy; Pt. reported ER dx was "reaction to vaccine".
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Grip strength decreased, Injected limb mobility decreased, Injection site pain, Muscle tightness, Muscular weakness
Clinical narrative: 2/4 Right arm pain about 3 hours after receiving PPSV -23 shot in that arm, "feverish" a few hours later; no redness or bruising at site; 2/10 seen in ER with pain in right shoulder and neck, limited movement and weakness in right arm, and history of intermittent fever; Rx diazepam; referred to orthopedist for possible phys. therapy; Pt. reported ER dx was "reaction to vaccine".
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Neck pain, Pyrexia
Clinical narrative: 2/4 Right arm pain about 3 hours after receiving PPSV -23 shot in that arm, "feverish" a few hours later; no redness or bruising at site; 2/10 seen in ER with pain in right shoulder and neck, limited movement and weakness in right arm, and history of intermittent fever; Rx diazepam; referred to orthopedist for possible phys. therapy; Pt. reported ER dx was "reaction to vaccine".
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Pt complains of pain at injection site. Cannot lift arm without pain -> this is now 2 months later after immunization.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Vaccination site cellulitis, Vaccination site erythema
Clinical narrative: Erythema and cellulitis at site of vaccine, on KEFLEX and mupirocin. Rt deltoid.
Age: 32.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Nausea, Pyrexia, Rash, Swelling
Clinical narrative: Rash, swelling, red, tender, fever, nausea and vomit.
Age: 32.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Tenderness, Vomiting
Clinical narrative: Rash, swelling, red, tender, fever, nausea and vomit.
Age: 22.0
Sex: F
Vaccine: MMR, MNQ, TDAP
Symptoms: Erythema, Rash
Clinical narrative: 3/2/15- MMR, Tdap, Meningococcal administered. 3/3/15- Patient started present with a rash. Neck bilateral arms, hands and face. Erythema, raised, borderline. 3/5/15- Rash still present, no resolution. Patient sent to Urgent Care.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a physician via a company representative on 05-FEB-2015 referring to a 7 year old female patient. Concurrent condition and medical history were not reported. On 13-MAR-2008, the patient was vaccinated with the first dose of ROTATEQ (lot# 59682/1733U, expiration date 04-AUG-2009, dose 2ml) orally. On 15-MAY-2008 and 15-JUL-2008, the patient were vaccinated with the second and the third dose of ROTATEQ (batch#/lot# 60379/0144X, expiration date 03-OCT-2009, dose 2ml) orally. On 28-JAN-2015, the patient experienced vomiting, diarrhea, a low grade fever and tested positive for rotavirus. On 30-JAN-2015, the patient sought for medical attention by office visit. Fluids and other unspecified treatments were given for the adverse events. The outcome of the events was reported as recovered/resolved on an unknown date in 2015. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Register Nurse refers to a patient of unknown age and gender. Concurrent or medical conditions were not reported. On an unknown date, the patient was vaccinated post supported temperature excursion with VARIVAX (Merck) 0.5 ml, subcutaneous, lot # reported as K000794 with expiration date 30-JUN-2015 and lot #K010339 expiration date 22-JUL-2016. No adverse effects noted. Lot number K000794 is an invalid lot number for VARIVAX (Merck). This is one of several reports received from the same source. 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 practice nurse refers to a multiple unspecified patients of unknown age and gender. No information regarding concurrent condition and medical history was reported. On an unknown date the multiple unspecified patients were vaccinated with M-M-R II (strength, dose, unit, lot number, expiry date and route were unknown) which was stored improperly. No concomitant therapy was reported. No adverse event was reported. The outcome of event was unknown. No further informaiton was provided. This is one of several reports received from the same source. Additional information is not expected.
Age: 75.0
Sex: M
Vaccine: DTP, PPV
Symptoms: Cold sweat, Feeling abnormal, Pruritus, Rash macular, Urticaria
Clinical narrative: Red blotches on right arm. No itching or swelling noted, patient also stated he didn't feel right and felt clammy. Urticaria Pruritus
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Blood chloride increased, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal
Clinical narrative: Nursing note from 12/4/11 at 2:40pm - Pt notified writer at this time that her left arm has an area of redness, swelling and tenderness. Site is at left deltoid and pt reports she had received a pneumonia vaccine to this location 12/3/2011. Site is erythemic, swollen and tender to touch. Dr immediately notified and one-time order given for Ibuprofen 400mg PO which was administered to the pt. ADR reported on 12/13/11 by primary care nurse practitioner: band like rash 6cm around area of injection.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Blood urea decreased, Carbon dioxide normal, Haematocrit decreased, Haemoglobin normal, Injection site erythema
Clinical narrative: Nursing note from 12/4/11 at 2:40pm - Pt notified writer at this time that her left arm has an area of redness, swelling and tenderness. Site is at left deltoid and pt reports she had received a pneumonia vaccine to this location 12/3/2011. Site is erythemic, swollen and tender to touch. Dr immediately notified and one-time order given for Ibuprofen 400mg PO which was administered to the pt. ADR reported on 12/13/11 by primary care nurse practitioner: band like rash 6cm around area of injection.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling, Lymphocyte percentage decreased, Mean cell volume normal, Neutrophil percentage increased
Clinical narrative: Nursing note from 12/4/11 at 2:40pm - Pt notified writer at this time that her left arm has an area of redness, swelling and tenderness. Site is at left deltoid and pt reports she had received a pneumonia vaccine to this location 12/3/2011. Site is erythemic, swollen and tender to touch. Dr immediately notified and one-time order given for Ibuprofen 400mg PO which was administered to the pt. ADR reported on 12/13/11 by primary care nurse practitioner: band like rash 6cm around area of injection.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Platelet count normal, White blood cell count decreased
Clinical narrative: Nursing note from 12/4/11 at 2:40pm - Pt notified writer at this time that her left arm has an area of redness, swelling and tenderness. Site is at left deltoid and pt reports she had received a pneumonia vaccine to this location 12/3/2011. Site is erythemic, swollen and tender to touch. Dr immediately notified and one-time order given for Ibuprofen 400mg PO which was administered to the pt. ADR reported on 12/13/11 by primary care nurse practitioner: band like rash 6cm around area of injection.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant refers to multiple patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, route, lot number and indication were not reported). No adverse effects reported. No product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Uritcaria Pruritus
Age: 71.0
Sex: M
Vaccine: HEP
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood albumin decreased, Blood bilirubin normal, Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a published literature article. Introduction: Hepatitis B virus (HBV) vaccination could produce a transiently detectable level of hepatitis B surface antigen (HBsAg), which might be misdiagnosed as prior exposure to HBV. This phenomenon was not widely recognized by gastroenterologists, leading to unnecessary testing. A 71-year-old male with end-stage renal disease on peritoneal dialysis was referred to the hepatology clinic for further investigation when routine evaluation for kidney transplant showed positive HBsAg. He received the Hepatitis B vaccine (manufacturer unknown) (lot #, dose, route not reported) 5 days prior to his positive blood test, He had history of blood transfusion in 1988, but no history of tattoos, Intravenous Drug User (IVDU), or other risk factors for acquiring  HBV infection. No previous history of liver disease, and his HBsAg was negative one year prior to his presentation to the reporter's clinic. He was asymptomatic and denied abdominal pain, jaundice, fever, change in urine or stool color, or nausea/vomiting. On examination, vital signs were stable with no other findings except the presence of left-sided abdominal wall peritoneal dialysis catheter in place. Initial blood tests (5 days post-vaccination) showed positive HBsAg, but HBcAb and HBsAb were negative. International normalised ration (INR), total bilirubin, Aspartate aminotransferase (AST), and Alanine aminotransferase (ALT) were within normal limits. Albumin was low; 2.9 (due to chronic kidney disease). Repeat testing for HBsAg, HBsAb, hepatitis BE antigen, and hepatitis B DNA (28 days post vaccination), all returned negative. The positive HBsAg could be a transient phenomenon related to recent Hepatitis B vaccine (manufacturer unknown) vaccination (usually within 14 days post vaccine). Caution should be exercised when interpreting HBsAg seropositivity within 4 weeks of HBV immunization. Our case highlighted the importance of clinical awareness of recent HBV vaccination as the cause of false positive HBsAg test. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive, Hepatitis C antibody negative, International normalised ratio normal
Clinical narrative: Information has been received from a published literature article. Introduction: Hepatitis B virus (HBV) vaccination could produce a transiently detectable level of hepatitis B surface antigen (HBsAg), which might be misdiagnosed as prior exposure to HBV. This phenomenon was not widely recognized by gastroenterologists, leading to unnecessary testing. A 71-year-old male with end-stage renal disease on peritoneal dialysis was referred to the hepatology clinic for further investigation when routine evaluation for kidney transplant showed positive HBsAg. He received the Hepatitis B vaccine (manufacturer unknown) (lot #, dose, route not reported) 5 days prior to his positive blood test, He had history of blood transfusion in 1988, but no history of tattoos, Intravenous Drug User (IVDU), or other risk factors for acquiring  HBV infection. No previous history of liver disease, and his HBsAg was negative one year prior to his presentation to the reporter's clinic. He was asymptomatic and denied abdominal pain, jaundice, fever, change in urine or stool color, or nausea/vomiting. On examination, vital signs were stable with no other findings except the presence of left-sided abdominal wall peritoneal dialysis catheter in place. Initial blood tests (5 days post-vaccination) showed positive HBsAg, but HBcAb and HBsAb were negative. International normalised ration (INR), total bilirubin, Aspartate aminotransferase (AST), and Alanine aminotransferase (ALT) were within normal limits. Albumin was low; 2.9 (due to chronic kidney disease). Repeat testing for HBsAg, HBsAb, hepatitis BE antigen, and hepatitis B DNA (28 days post vaccination), all returned negative. The positive HBsAg could be a transient phenomenon related to recent Hepatitis B vaccine (manufacturer unknown) vaccination (usually within 14 days post vaccine). Caution should be exercised when interpreting HBsAg seropositivity within 4 weeks of HBV immunization. Our case highlighted the importance of clinical awareness of recent HBV vaccination as the cause of false positive HBsAg test. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practice nurse refers to a multiple unspecified patients of unknown age and gender. No information regarding concurrent condition and medical history was reported. On an unknown date, the multiple unspecified patients were vaccinated with GARDASIL injection (strength, dose, unit, lot number, expiry date and route were unknown) which was stored improperly. No concomitant therapy was reported. No adverse event was reported. The outcome of event was unknown. No further information was provided. This is one of several reports received from the same source. Additional information is not expected.
Age: 37.0
Sex: F
Vaccine: HEPAB, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Next day, (12/18/14) had a red, tender, swollen site, approx. 1" diameter. Site used TYLENOL 3 and Ibuprofen alternately. By Friday (12/19) the redness and swelling was a large rectangle extending down to her elbow. It hurt quite a lot and couldn't extend her arm. By Sunday (12/21) it was half this size, then in two work days and it was gone.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropod sting, Lip injury, Pain, Rash
Clinical narrative: On 2/27/15, patient reported rash/bumps on left back of scalp. Reported that she got poked by a cat's claw in the lip on 2/26/15 (center of lip) and stung by a wasp, also shortly after receiving the vaccine. On 3/25/15, saw her MD for rash/bumps on scalp and was diagnosed with possible cellulitis/folliculitis and prescribed BACTRIM DS ( one BID x 10 days). Patient called MD on 3/4/15 and reported to her MD that the rash/bumps were now painful and asked to be put on VALTREX 1 gm BID as she had not gotten better and thinks she may have shingles. She still currently has symptoms. Currently being treated by physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to an unspecified number of patients, of unknown age and gender. Medical history and concurrent conditions were not reported. The Licensed practical nurse informed that on an unspecified date, approximately 150 doses of VARIVVAX (Merck) (route, dosage and lot# were not reported), were improperly stored and were administered to unspecified number of patients. No adverse effects reported. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Blistering at injection site, fever, pain at injection site, swelling at and around the injection site, swelling at and around the injection site.
Age: 6.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: Large local reaction to Pneumococcal 23 treated with BENADRYL and ibuprofen and ice pack. No sign of anaphylaxis.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient with chronic obstructive pulmonary disease and pulmonary fibrosis. On 12-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # K014834, expiration date: 14-DEC-2015, 0.65 ml, subcutaneous. The patient was also on therapy with triamcinolone prior to ZOSTAVAX. On 27-JAN-2015, the patient developed a non-painful red itchy rash on her scalp that latter migrated to her abdomen. The outcome of the red and itchy rash was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to an unspecified patients, of unknown age and gender. Medical history and concurrent conditions were not reported. The Licensed practical nurse informed that on an unspecified date, approximately 40 doses of ZOSTAVAX (route, dosage and lot# were not reported), were improperly stored and were administered to unspecified patients. No adverse effects reported. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Muscle twitching, Seizure, Syncope
Clinical narrative: Patient was given TDAP, HEP A, VZV, MCV4 and HPV4 vaccines. Approximately 30 seconds after receiving last vaccine (HPV4), he experienced syncope with 5-10 seconds of seizure activity consisting of generalized twitching. He regained full consciousness in approximately one minute. BP was 114/63. Rested 20 min. and felt fine. Advised parent to F/U with MD.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Injection site erythema, Pain, Pruritus, Scab
Clinical narrative: 2/20/15: DTaP to left arm. 2/21/15: Injection site pink, with increase in intensity over the next several days. 2/25/15 (evening): ulcerated area noted, with large area of erythema some itching earlier in the day, with some soreness, and report of pain if asked directly. 2/26/15 (after 2 doses KEFLEX): healed approximately 3 mm healed ulcer, with 8x7cm zone of demarcation with surrounding small crusts and no redness, warmth, tenderness induration or fluctuance.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Ulcer
Clinical narrative: 2/20/15: DTaP to left arm. 2/21/15: Injection site pink, with increase in intensity over the next several days. 2/25/15 (evening): ulcerated area noted, with large area of erythema some itching earlier in the day, with some soreness, and report of pain if asked directly. 2/26/15 (after 2 doses KEFLEX): healed approximately 3 mm healed ulcer, with 8x7cm zone of demarcation with surrounding small crusts and no redness, warmth, tenderness induration or fluctuance.
Age: 68.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema
Clinical narrative: Patient stated he also forgot to take Band Aid off for two days after getting injection, and that area became reddened 1 hour after injection.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant refers to multiple patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored VAQTA (dose, route, lot number and indication were not reported). No adverse effects reported. No product quality complaint involved. This is one of several reports from the same reporter. 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 Medical Assistant refers to multiple patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored GARDASIL (dose, route, lot number and indication were not reported). No adverse effects reported. No product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: Nursing attempted to call patient back, but could not reach, she was instructed if symptoms worsened to report to urgent care. She never did go in to urgent care, but did return call to describe symptoms. Assuming symptoms resolved as no further documentation is noted about the incident. Nausea, vomiting and pain all over body.
Age: 90.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Oropharyngeal pain
Clinical narrative: Sore throat and sore arm at injection site.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal pain
Clinical narrative: On 11/13/2013 a 64 year old male was administered inactivated pneumococcal vaccine (single dose vial, Merck and Co (PNEUMOVAX 23), lot# J010332, exp: 01/14/2015) in the clinic. Later that night he noticed his whole shoulder was swollen, red, and painful. The next day he was seen in clinic and the nurse documented that his left arm from shoulder to antecubital region was red, hot to the touch, slightly swollen on the inner aspect of the arm, on and below the bicep. Patient denied fever, shortness of breath, and trouble breathing. Ice packs were applied in clinic and PCP wrote a prescription for prednisone. Patient was instructed to apply ice packs at home and take medication. Patient verbalized understanding and was told to return to clinic if symptoms get worse.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Pruritus, Urticaria
Clinical narrative: Patient was given pneumococcal vaccine in right deltoid. Within 5 minutes he developed sever itching and redness at the injection site. Redness spread to upper arm, neck and face. Denies SOB/tongue or throat swelling. Patient was given 50mg oral diphenhydramine and observed in clinic. Symptoms began to resolve in 30 minutes. Urticaria Pruritus and Erythema (redness)
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Neck pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: 66 YO female with PMH significant for T2DM received PNEUMOVAX 23 vaccine on (L) deltoid from clinic on 8/11/14. That evening, pt began to experience increased swelling in (L) arm with warmth, tenderness, limited movement, and reported neck/arm pain of 4/10. Pt took 1 APAP 325mg tablet that night and another dose the next morning but symptoms did not improve. Pt contacted the clinic on 8/12/14 and PCP instructed pt to apply warm compress 20-30 mins 4-6x/day and NSAID as directed per OTC label. Pt came to clinic for evaluation: no further information about symptom resolution.