chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13, FLUX
Symptoms: Blood pressure abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 69-year-old female patient received on 04Dec2015 PREVNAR 13 at single dose and influenza vaccine (manufacturer unknown). Medical history included blood pressure (under control). The patient received an influenza vaccine in Sep2015. Concomitant medications were none. On an unspecified date, the patient experienced dehydration, loss of energy, appetite lost and diarrhea. Reactions were described as follows: The patient reported that she really had a hard time on vaccination. She had to go to ER because she had dehydration and they gave her some fluids there. Blood work was performed on an unspecified date at the hospital and on 01Mar2016, results were not available. Blood work was performed since she had dehydration due to a whole week of diarrhea. She had no energy and no appetite. She thinks too many toxins were there in her body at one time. The patient was not experiencing any side effects right now and on 01Mar2016 was the first day when she felt normal.
Age: 87.0
Sex: M
Vaccine: FLUX
Symptoms: Abasia, Asthenia, Back pain, Blood test, Chest X-ray
Clinical narrative: Delirious, fever, sleeping all day, weak. Lost 10 lbs dehydrated. Emergency room after days - hydrated me - chest x-ray - blood work - urine test. Had low grade fever - released me. This lasted a good 2 wks. Then back pain and leg pain - then I couldn't walk.
Age: 87.0
Sex: M
Vaccine: FLUX
Symptoms: Dehydration, Delirium, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Delirious, fever, sleeping all day, weak. Lost 10 lbs dehydrated. Emergency room after days - hydrated me - chest x-ray - blood work - urine test. Had low grade fever - released me. This lasted a good 2 wks. Then back pain and leg pain - then I couldn't walk.
Age: 87.0
Sex: M
Vaccine: FLUX
Symptoms: Urine analysis
Clinical narrative: Delirious, fever, sleeping all day, weak. Lost 10 lbs dehydrated. Emergency room after days - hydrated me - chest x-ray - blood work - urine test. Had low grade fever - released me. This lasted a good 2 wks. Then back pain and leg pain - then I couldn't walk.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site hypersensitivity, Injection site pain, Injection site swelling, Joint range of motion decreased
Clinical narrative: Swelling at site and soreness. It progressed to sensitivity to touch, loss of range of motion without pain, and at this point the pain goes from the shoulder to the fingers. I am unable to sleep on that arm without pain and it is difficult to put that arm into a sleeve or reach for anything without experiencing pain. It also prevents me from doing any needlework that brought me great pleasure.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: Swelling at site and soreness. It progressed to sensitivity to touch, loss of range of motion without pain, and at this point the pain goes from the shoulder to the fingers. I am unable to sleep on that arm without pain and it is difficult to put that arm into a sleeve or reach for anything without experiencing pain. It also prevents me from doing any needlework that brought me great pleasure.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: 10cm X 5 cm redness, itching, induration at the injection site lasting 48 hours.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13, RV5
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: No adverse event reporting a med error. Needed 6 month set of shots and intended to give Pentacel but gave Pediarix and Engerix B. Child ended up getting 2 doses Hep B and no HIB. Error discovered after they left. PC to mother who said she will call and reschedule the HIB later.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Eye pruritus, Vaccination site rash
Clinical narrative: Rash around arm at sight of vaccination, abdominal pain, itchy R eye.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Parotitis
Clinical narrative: Parotitis left side.
Age: 1.05
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL, FLUX
Symptoms: Autopsy, Death
Clinical narrative: Child found deceased.
Age: 1.05
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL, FLUX
Symptoms: Death
Clinical narrative: Child found deceased.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV
Symptoms: Full blood count, Seizure, Unresponsive to stimuli
Clinical narrative: Child was in car seat and began having seizure activity.  Mom pulled in to restaurant down the street and called 911.  Child unresponsive x 5-7 minutes per mom.  EMS arrived for transport to hospital.  No fever reported.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pruritus, Injection site swelling, Skin warm
Clinical narrative: Patient awoke with significant swelling of left upper extremity where vaccines had been administered.  Overlying skin was intensely pruritic.  No associated fever, difficulty breathing or GI symptoms.  Range of motion at shoulder, elbow, wrist, fingers intact.  Strength intact.  Sensation intact.  Pulses palpable.  Capillary refill <2 seconds.  Extremity warm to touch.
Age: 20.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Expired product administered
Clinical narrative: GAVE HEP A VACCINE WHICH HAD EXPIRED LAST MONTH.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain, Pruritus, Swelling
Clinical narrative: Zostavax vaccine was given to the patient on 3/11/16 and she had a reaction the day after having soreness, itchiness and a blister appeared. Went to the doctor's office couple of times for a usual appointment and hoping that they will give her an advice what to do or take to relieve the symptoms. But they just ignore her and told her to go back to the pharmacy. She didn't have time to go back until 3/11/16. The blister had busted and it was sore and swollen. Advised her to take Benadryl by mouth, Neosporin bid, cleaning thea area first before applying and applying ice as often as needed. Made a follow up call with her daughter and said it has improved and healing is evident.
Age: 79.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Lethargy, Pain, Syncope
Clinical narrative: Fainted. Sore shoulder, more sore than with previous shots. Arm was sore to raise and move.  Lethargic for day's remainder.
Age: 79.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Lethargy, Musculoskeletal pain, Pain, Pain in extremity, Syncope
Clinical narrative: Fainted. Sore shoulder, more sore than with previous shots. Arm was sore to raise and move.  Lethargic for day's remainder.
Sex: U
Vaccine: MEN
Symptoms: Rhabdomyolysis
Clinical narrative: This case was reported in a literature article and described the occurrence of rhabdomyolysis in a patient who received Meningococcal B vaccine. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Meningococcal B vaccine, the patient experienced rhabdomyolysis (serious criteria GSK medically significant). On an unknown date, the outcome of the rhabdomyolysis was recovered/resolved. The reporter considered the rhabdomyolysis to be possibly related to Meningococcal B vaccine. Additional information was provided: This case was reported in a literature article and described the occurrence of rhabdomyolysis in a patient of unspecified age and gender who was vaccinated with unspecified rMenB (manufacturer unknown). The patient was the part of vaccination campaign held from December 2013 to May 2014. Monitoring for serious adverse events (SAEs) was conducted from receipt of the first dose to 30 days after the second dose. SAEs were collected passively by phone, email, university clinic visits, and local hospital reports, and actively via questionnaires prior to the second dose and electronic surveys 30 days after the second dose. No information on the patient's medical or family history or concurrent condition was provided. No information on patient's concomitant medication was provided. On an unspecified date between December 2013 and May 2014, the patient received either one or two doses of unspecified rMenB vaccine (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date between December 2013 and May 2014, an unknown period after vaccination with unspecified rMenB vaccine, the patient had rhabdomyolysis. Treatment was unknown. The outcome was recovered. The authors commented that the rhabdomyolysis was possibly related to unspecified rMenB. The authors stated that "We described the first use of an unlicensed MenB vaccine to successfully control two institutional outbreaks. Safety monitoring demonstrated no concerning or unexpected patterns of SAEs and supports the sue of rMenB in response to future MenB outbreaks. Until a licensed MenB vaccine is available, prompt multi-agency coordination to facilitate the IND process should be established when a MenB outbreak is suspected." This is 1 of the 2 valid cases in the article. The article is not available for regulatory submission due to copyright restrictions.
Age: 0.2
Sex: F
Vaccine: RV1
Symptoms: Escherichia urinary tract infection, Gastroenteritis
Clinical narrative: This case was reported in a literature article and described the occurrence of gastroenteritis in a 2-month-old female subject who received Rotavirus vaccine. On an unknown date, 5 days after receiving Rotavirus vaccine, the subject developed gastroenteritis. Serious criteria included hospitalization. Additional event(s) included Escherichia urinary tract infection with serious criteria of hospitalization and GSK medically significant. The outcome of gastroenteritis was recovered/resolved. The outcome(s) of the additional event(s) included Escherichia urinary tract infection (recovered/resolved). The investigator considered that there was a reasonable possibility that the gastroenteritis and Escherichia urinary tract infection may have been caused by Rotavirus vaccine. Additional information was provided: This case was reported in a literature article and it described the concurrence of gastroenteritis and urinary infection in a 2-month-old female who had received ROTARIX (GlaxoSmithKline). The patient was deemed to be a healthy infant by the authors and had received the vaccine as part of a clinical study with the following exclusion criteria: significant history of gastrointestinal disease or other serious medical conditions, history of immunodeficiency, known sensitivity to any vaccine components, previous receipt of a rotavirus vaccine, acute illness at the time of or in the previous 48 hours before vaccine administration (axillary temperature higher than 100.2 deg F, more than 3 looser-than normal stools or any episodes of vomiting), participation in another study involving an experimental agent, birth before 37 weeks of gestation, receipt of blood and/or blood products (including immunoglobulin) within 4 weeks before vaccine administration or receipt of any live vaccine within the previous 30 days or an inactivated vaccine within the previous 14 days. No further information on the patient's concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date between March 2011 and September 2013, the patient received a dose of ROTARIX. Dosage unknown; administration route and site unspecified; batch number was not provided. On an unspecified date, 5 days after the vaccination, the patient was admitted to hospital with gastroenteritis. She was also diagnosed with Escherichia coli urinary tract infection. Patient was discharged home after 48 hours. This was a serious case as the patient required hospitalisation. Treatment was unknown. Outcome of the gastroenteritis was recovery without sequelae according to the authors. Outcome of the urinary tract infection was unspecified at the time of reporting. The authors commented that her admission was believed to be associated with the vaccine. The authors concluded that "mixed rotavirus vaccine schedules are safe and non-inferior in immune responses when compared with those in which a single formulation of licensed rotavirus vaccines is administered alone."
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site induration, Local reaction, Pruritus
Clinical narrative: Was given a tetanus vaccine routinely at her PCP office 3/11/16 (she believes it was a Tdap, but not completely sure).  Pt presented to occupational health clinic today (not same clinic that she was given the vaccination) with a large local reaction on the left upper arm, ~10cm x 6.5cm erythematous reaction.  Area ~4cm in diameter is firm directly around the injection site. Does not appear infected, +pruritis.  Antihistamine given in clinic, recommended ice pack and continued antihistamine use.  Told to return with any worsening or swelling of arm. Recommended that she contact her PCP to make them aware as well.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Abdominal pain, Arthralgia, Disease complication, Dizziness
Clinical narrative: She had irregular symptoms after receiving the second GARDASIL vaccination. She had recurrent abdominal pain, nausea, dizziness, light-headedness, off and on low grade fevers, etc. I took her back to her pediatrician several times, but he didn't do anything except flu and strep cultures in December and February 1. Then she complained of joint pain as we were leaving his office on February 1. By the time we got home, she couldn't walk and had purpura all over her legs. I called the pediatrician back and he said it was an allergic reaction and to give her BENADRYL. I did but it got worse. I sent them pictures and told them it was blood under the skin, they argued with me over the phone. I hung up and took her to an urgent care. They called an ambulance because they were afraid it was meningitis. The ER diagnosed her with HSP. She had complications and we returned to the ER two days later, then more complications led to us taking her to another ER on 2/8/16. She stayed for 7 days. We are still having complications and seeing a rheumatologist and nephrologist there.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Haemorrhage subcutaneous, Henoch-Schonlein purpura, Hypersensitivity, Influenza virus test, Nausea
Clinical narrative: She had irregular symptoms after receiving the second GARDASIL vaccination. She had recurrent abdominal pain, nausea, dizziness, light-headedness, off and on low grade fevers, etc. I took her back to her pediatrician several times, but he didn't do anything except flu and strep cultures in December and February 1. Then she complained of joint pain as we were leaving his office on February 1. By the time we got home, she couldn't walk and had purpura all over her legs. I called the pediatrician back and he said it was an allergic reaction and to give her BENADRYL. I did but it got worse. I sent them pictures and told them it was blood under the skin, they argued with me over the phone. I hung up and took her to an urgent care. They called an ambulance because they were afraid it was meningitis. The ER diagnosed her with HSP. She had complications and we returned to the ER two days later, then more complications led to us taking her to another ER on 2/8/16. She stayed for 7 days. We are still having complications and seeing a rheumatologist and nephrologist there.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Purpura, Pyrexia, Streptococcus test
Clinical narrative: She had irregular symptoms after receiving the second GARDASIL vaccination. She had recurrent abdominal pain, nausea, dizziness, light-headedness, off and on low grade fevers, etc. I took her back to her pediatrician several times, but he didn't do anything except flu and strep cultures in December and February 1. Then she complained of joint pain as we were leaving his office on February 1. By the time we got home, she couldn't walk and had purpura all over her legs. I called the pediatrician back and he said it was an allergic reaction and to give her BENADRYL. I did but it got worse. I sent them pictures and told them it was blood under the skin, they argued with me over the phone. I hung up and took her to an urgent care. They called an ambulance because they were afraid it was meningitis. The ER diagnosed her with HSP. She had complications and we returned to the ER two days later, then more complications led to us taking her to another ER on 2/8/16. She stayed for 7 days. We are still having complications and seeing a rheumatologist and nephrologist there.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dyskinesia, Fall, Loss of consciousness
Clinical narrative: Approximately 15 min after receiving Menactra and meningococcal B (Trumemba), pt was leaving the clinic area when he fell to the floor and had a brief episode of body jerking. He regained consciousness about 3 min later and was able to state his location and date of birth. EMS arrived and took patient to the Hospital for further evaluation.
Age: 34.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Severe pain in left shoulder and arm.  Limited range of motion of arm.
Age: 78.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chills, Diarrhoea, Dyspnoea, Fatigue, Feeding disorder
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of vaccination failure in a 78-year-old male patient who received Influenza vaccine. Co-suspect products included ADVAIR Diskus inhalation powder for asthma and emphysema. The patient's past medical history included pneumonia. Concurrent medical conditions included arthralgia multiple (airplane flying accident), emphysema (taking ADVAIR) and asthma (taking ADVAIR). Concomitant products included amlodipine, FLONASE, SINGULAIR, NAPROSYN, PROAIR HFA, Aspirin (Baby) and prednisone. In October 2015, the patient received influenza vaccine (intramuscular). In April 2001, the patient started ADVAIR Diskus (inhaled) 1 puff(s) once daily. In October 2015, an unknown time after receiving influenza vaccine and ADVAIR Diskus, the patient experienced underdose. In November 2015, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, shivering, difficulty breathing, weight loss, unable to eat, tiredness, diarrhea and vomiting. ADVAIR Diskus was continued with no change. On an unknown date, the outcome of the vaccination failure and underdose were unknown and the outcome of the influenza, shivering, difficulty breathing, weight loss, unable to eat, diarrhea and vomiting were recovered/resolved and the outcome of the tiredness was not recovered/not resolved. The reporter considered the vaccination failure, influenza, shivering, difficulty breathing, weight loss, unable to eat, tiredness, diarrhea and vomiting to be unrelated to influenza vaccine. The reporter considered the influenza, shivering, difficulty breathing, weight loss, unable to eat, tiredness, diarrhea and vomiting to be unrelated to ADVAIR Diskus. Additional details were received as follows: This case was received from the consumer via the vaccine patient assistance program (GlaxoSmithKline Access). In October 2015, the patient received Flu vaccine (unknown manufacturer). In November 2015 (approximately 30 days after vaccination) and December 2015, the patient experienced the flu, with multiple symptoms. Underdose was also reported as an event, it was not clear whether it corresponded to ADVAIR or Flu vaccine and the exact reason for underdose was also not provided. The patient planned to continue follow-up with his physician on an unknown date. The patient believed that the ADVAIR and flu shot (unknown manufacturer) had nothing to do with him experiencing the flu, including the multiple symptoms as listed above. The patient was transferred from GlaxoSmithKline Access. This case was as suspected vaccination failure since the laboratory confirmation of the flu was not available.
Age: 78.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Influenza, Underdose, Vaccination failure, Vomiting, Weight decreased
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of vaccination failure in a 78-year-old male patient who received Influenza vaccine. Co-suspect products included ADVAIR Diskus inhalation powder for asthma and emphysema. The patient's past medical history included pneumonia. Concurrent medical conditions included arthralgia multiple (airplane flying accident), emphysema (taking ADVAIR) and asthma (taking ADVAIR). Concomitant products included amlodipine, FLONASE, SINGULAIR, NAPROSYN, PROAIR HFA, Aspirin (Baby) and prednisone. In October 2015, the patient received influenza vaccine (intramuscular). In April 2001, the patient started ADVAIR Diskus (inhaled) 1 puff(s) once daily. In October 2015, an unknown time after receiving influenza vaccine and ADVAIR Diskus, the patient experienced underdose. In November 2015, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, shivering, difficulty breathing, weight loss, unable to eat, tiredness, diarrhea and vomiting. ADVAIR Diskus was continued with no change. On an unknown date, the outcome of the vaccination failure and underdose were unknown and the outcome of the influenza, shivering, difficulty breathing, weight loss, unable to eat, diarrhea and vomiting were recovered/resolved and the outcome of the tiredness was not recovered/not resolved. The reporter considered the vaccination failure, influenza, shivering, difficulty breathing, weight loss, unable to eat, tiredness, diarrhea and vomiting to be unrelated to influenza vaccine. The reporter considered the influenza, shivering, difficulty breathing, weight loss, unable to eat, tiredness, diarrhea and vomiting to be unrelated to ADVAIR Diskus. Additional details were received as follows: This case was received from the consumer via the vaccine patient assistance program (GlaxoSmithKline Access). In October 2015, the patient received Flu vaccine (unknown manufacturer). In November 2015 (approximately 30 days after vaccination) and December 2015, the patient experienced the flu, with multiple symptoms. Underdose was also reported as an event, it was not clear whether it corresponded to ADVAIR or Flu vaccine and the exact reason for underdose was also not provided. The patient planned to continue follow-up with his physician on an unknown date. The patient believed that the ADVAIR and flu shot (unknown manufacturer) had nothing to do with him experiencing the flu, including the multiple symptoms as listed above. The patient was transferred from GlaxoSmithKline Access. This case was as suspected vaccination failure since the laboratory confirmation of the flu was not available.
Age: 38.0
Sex: U
Vaccine: FLU3, HEP, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: 3-22-16 PC from Pt: Pt began experiencing swelling and pain in (R) shoulder 3 days following TDaP vaccination.  Pain is not relieved with current pain medications. Instructed pt: to use cold compress and/or warm as comfort measure, check for fever and warmth at injection site, return to clinic for evaluations, report to PCP.
Age: 15.0
Sex: F
Vaccine: HPV9, IPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: NONE YET.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV
Symptoms: Accidental exposure to product
Clinical narrative: Patient was given a full dose flu shot by accident.  Patient mom notified.  I checked with pharmacy said she should be fine.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient received flu shot on January 27, 2016. He alleges that he experienced pain the day after and actually experiences pain and having hard time moving arm.
Age: 54.0
Sex: F
Vaccine: HEP, HEPA, IPV, TYP, VARZOS
Symptoms: Erythema, Pain, Pruritus, Pyrexia
Clinical narrative: Pain, itching, feverish 3 inch X1.5" oblong dark red spot with pink fringe of another inch. Still present but smaller.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Pallor, Pharyngeal oedema
Clinical narrative: Patient c/o throat swelling, became pale, light headed. Reports throat problem lasted 5 minutes.  Faintness for half an hour.  Vitals within normal limits, laid down for half an hour. Offered Benadryl and prednisone which patient declined.  She was to take oral Benadryl and Zantac as soon as she got home.  Mother in attendance and verbalized understanding.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Erythema, Induration, Injection site swelling, Pain in extremity
Clinical narrative: WITHIN 2 DAYS, HIS ARM WAS REALLY SORE, RED IN COLOR, WARM TO THE TOUCH, SWOLLEN.  HE HAD AN INDURATION THE SIZE OF A GOLF BALL.  SOFT TISSUE SWELLING 2-3 INCHES ABOVE THE INJECTION SITE ALL THE WAY DOWN TO HIS ELBOW.  LOW GRADE FEVER 2 DAYS POST VACCINATION.  VACATIONED 2 DAYS POST VACCINATION.  HE SAW A PHYSICIAN THERE.  PHYSICIAN GAVE HIM KEFLEX AND A PROBIOTIC.  HE PUT ICE AT THE INJ SITE FOR A FEW DAYS, THEN SWITCHED TO TAKING A WARM SHOWER.  NOTHING HELPED HIS PAIN.  HE IS NOW BACK TO NORMAL WITH NO LINGERING SIDE EFFECTS.  NOTE: THE INJECTION WAS GIVEN IN THE OUTER ASPECT OF THE TRICEPS NOT IN THE DELTOID REGION AS RECOMMENDED BY THE ACIP.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: WITHIN 2 DAYS, HIS ARM WAS REALLY SORE, RED IN COLOR, WARM TO THE TOUCH, SWOLLEN.  HE HAD AN INDURATION THE SIZE OF A GOLF BALL.  SOFT TISSUE SWELLING 2-3 INCHES ABOVE THE INJECTION SITE ALL THE WAY DOWN TO HIS ELBOW.  LOW GRADE FEVER 2 DAYS POST VACCINATION.  VACATIONED 2 DAYS POST VACCINATION.  HE SAW A PHYSICIAN THERE.  PHYSICIAN GAVE HIM KEFLEX AND A PROBIOTIC.  HE PUT ICE AT THE INJ SITE FOR A FEW DAYS, THEN SWITCHED TO TAKING A WARM SHOWER.  NOTHING HELPED HIS PAIN.  HE IS NOW BACK TO NORMAL WITH NO LINGERING SIDE EFFECTS.  NOTE: THE INJECTION WAS GIVEN IN THE OUTER ASPECT OF THE TRICEPS NOT IN THE DELTOID REGION AS RECOMMENDED BY THE ACIP.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hives in a 54-year-old female patient who received Seasonal Influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced hives and rash. On an unknown date, the outcome of the hives and rash were unknown. It was unknown if the reporter considered the hives and rash to be related to Seasonal Influenza vaccine. Additional details were received as follows: This case has been linked with case US2015GSK180049, reported for the same patient for the events experienced after ENGERIX B adult and BOOSTRIX.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema multiforme, Rash generalised, Skin swelling
Clinical narrative: Red raised swelling of the skin, taken to ER said it was a mild reaction on 3/10/2016 he had a full blown rash head to toe which Dr.s finally call in erythema multiforme diagnosed 3/13/16 after 4 different Dr.s.
Age: 0.67
Sex: F
Vaccine: HIBV
Symptoms: Crying, Ear swelling, Erythema, Erythema of eyelid, Eyelid oedema
Clinical narrative: Severe rash on stomach, back, head, underarms, legs, swollen eye lids, red puffy eye lids and ears, very red inter-ear, pulling at both ears, cranky, fussy, crying non-stop.
Age: 0.67
Sex: F
Vaccine: HIBV
Symptoms: Irritability, Ocular hyperaemia, Rash
Clinical narrative: Severe rash on stomach, back, head, underarms, legs, swollen eye lids, red puffy eye lids and ears, very red inter-ear, pulling at both ears, cranky, fussy, crying non-stop.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Joint range of motion decreased, Myalgia
Clinical narrative: Left deltoid - chronic muscle aching, moderate weakness, reduced range of motion upper arm.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site movement impairment, Injection site pain, Injection site reaction, Muscular weakness
Clinical narrative: Left deltoid - chronic muscle aching, moderate weakness, reduced range of motion upper arm.
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Nuclear magnetic resonance imaging, Pain, X-ray
Clinical narrative: Pain still persists after being administered 9/14/15.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Bronchial hyperreactivity, Flushing, Hypersensitivity, Laboratory test
Clinical narrative: Began to notice a type of flush on neck, chest, shoulders, increased skin itchiness, edginess - moodiness, anxiousness to personality. A couple weeks or so before 12/10/12, this was noticed - it felt like allergic reactions (like I've had with certain antibiotics, but not on any meds at that time). On and after Dec. 10th, 2012, severe type flushing, itchiness, prickly sensations, reactive airway still have symptoms of this chronically, waxes and wanes.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Mast cell activation syndrome, Mood altered, Paraesthesia, Pruritus
Clinical narrative: Began to notice a type of flush on neck, chest, shoulders, increased skin itchiness, edginess - moodiness, anxiousness to personality. A couple weeks or so before 12/10/12, this was noticed - it felt like allergic reactions (like I've had with certain antibiotics, but not on any meds at that time). On and after Dec. 10th, 2012, severe type flushing, itchiness, prickly sensations, reactive airway still have symptoms of this chronically, waxes and wanes.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Pyrexia, Rash
Clinical narrative: Rash on lower abdomen, left and right leg with fevers.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Pt got dizzy and fainted approximately 5 mins after administration of GARDASIL/TDAP/MENACTRA.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Pruritus, Swelling face
Clinical narrative: Received vaccine 3/12/16. On 3/13/16 patient had swelling in face and lips/itching on face and under neck. Recommended she take BENADRYL and keep a check on herself.
Age: 45.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site rash, Musculoskeletal pain, Peripheral swelling
Clinical narrative: Received DTaP after exposure to HIV at work. Two weeks following shot (Rt) arm became swollen, painful elbow pain, shoulder pain, quarter sized red rash around injection site. Rash gone, shoulder/elbow still sore, improving.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Movement disorder, Paraesthesia, X-ray
Clinical narrative: Patient came in complaining of symptoms or poor arm movement, tingling and use of arm compared to prior shot. MD gave x-ray.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Ultrasound scan, X-ray
Clinical narrative: Patient came in complaining of symptoms or poor arm movement, tingling and use of arm compared to prior shot. MD gave x-ray.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hypersensitivity, Injection site erythema, Nasal discomfort
Clinical narrative: Headache, chills, half dollar red spot at injection site - 3 days. Allergy like symptoms, runny nose - 2 days. Sore in nose - 5 days. No treatment necessary.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: Headache, chills, half dollar red spot at injection site - 3 days. Allergy like symptoms, runny nose - 2 days. Sore in nose - 5 days. No treatment necessary.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Arthralgia, Neck pain, Rash pruritic, Streptococcus test negative
Clinical narrative: Fine, itchy rash 2 days after vaccine, rash was localed on upper chest and arms and neck and joint pain in shoulder.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Dyspnoea
Clinical narrative: Pt had his pharmacist call while he was there to pick up rx pt said he was experiencing SOB 45 minutes, after he received the PREVANR 13 vx, Dr was gone so dr advised pt to go to the ER for help.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse (LPN) concerning multiple unspecified patients of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On unspecified dates, the patients received doses of improperly stored VAQTA (lot # 015460 with expire date 20-JUL-2017 or L002717 with expire date of 02-JUN-2017, dose and route not reported). The vaccines has been exposed to temperature of 48.4 F for 50 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On unknown dates the patients were vaccinated with doses of VARIVAX (Merck) (dose and route not reported, lot number K011804 with expiration date 21-AUG-2016 and lot number reported as L042265 with expiration date 26-OCT-2017) that were improperly stored (temperature: -1C and time frame: 4 hours). It was reported that there was a previous temperature excursion (-6.7C for 2.5 hours). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for follow up.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates the patient was vaccinated with improperly stored GARDASIL (lot # L008560 with expiration date 15-JUN-2017, lot # L019297 with expiration date 18-AUG-2017, lot # reported as L043213 with expiration date 28-AUG-2017, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unknown dates the patients were vaccinated with doses of PROQUAD (Merck) (dose and route not reported, lot number L008353 with expiration date 11-SEP-2016) that were improperly stored (temperature: -1C and time frame: 4 hours). It was reported that there was a previous temperature excursion (-6.7C for 2.5 hours). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for follow up.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a nurse via a company representative referring to a patient of unknown age and gender. On 17-AUG-2015 the patient received one dose of GARDASIL (dose, route and lot# were not reported), dose two was then administered on 25-NOV-2015 at which time GARDASIL 9 (dose, route and lot# were not reported) was used (interchange of vaccine products), and the patient then received a final dose on 10-MAR-2016 at which time GARDASIL (dose, route and lot# were not reported) was used. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates the patient was vaccinated with improperly stored GARDASIL 9 (lot # reported as K011562 with expiration date 08-APR-2017, lot # reported as K010215 with expiration date 05-MAY-2017, lot # reported as K007828 with expiration date 02-MAR-2017, lot # reported as L040459 with expiration date 16-APR-2017, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse (LPN) concerning multiple unspecified patients of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On unspecified dates, the patients received doses of improperly stored RECOMBIVAX HB (lot # J013394 with expire date of 25-AUG=2016, L010595 with expire date of 12-NOV-2016, or L025738 with expire date of 14-AUG-2017, dose and route not reported). The vaccines had been exposed to temperature of 48.4 F for 50 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On unknown dates the patients were vaccinated with doses of ZOSTAVAX (dose and route not reported, lot number reported as L039094 with expiration date 08-JAN-2017) that were improperly stored (temperature: -1C and time frame: 4 hours). It was reported that there was a previous temperature excursion (-6.7C or 2.5 hours). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for follow up.
Sex: M
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 01-MAR-2016 the patient was vaccinated with GARDASIL 9 (lot number: L014415, expiry date: 25-JUL-207), dose 3. The patient was previously vaccinated with GARDASIL dose 1 (lot number: K004546, expiry: 11-AUG-2016) on 15-AUG-2014 and Dose 2 (lot number: K004546, expiry: 11-AUG-2016) on 31-OCT-201. The patient received first 2 doses of GARDASIL and completed series with third dose as GARDASIL 9. No adverse effects were reported. No product quality complaint was reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MMR, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse (R.N.) refers to two patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 10-MAR-2016 the patients were vaccinated with improperly stored GARDASIL 9 (lot # L018351, expiration date 11-AUG-2017, dose and route were not reported). The vaccines were in 8.9 Celsius degree for 15 minutes as well as 1.0 Celsius degree for 10 minutes without any previous temperature excursion. Concomitant drug was not reported. No adverse effect was reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Pain in extremity
Clinical narrative: This spontaneous report was received from a 68 year old female patient who was reporting on herself. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 12-FEB-2016, the patient was vaccinated with a pneumococcal vaccine (23-valent) (manufacturer unknown) in the right arm, dose, route of administration and lot # was not reported). On 12-FEB-2016 (3 hours after the patient received pneumococcal vaccine, (23-valent) (manufacturer unknown), the patient could not move her right arm. The patient reported that she could not reach over to the passenger side of her car to retrieve her cell phone from her handbag and could not raise her right arm. On 15-FEB-2016 (reported as after 3 days), the movement in the patient's right arm came back. The patient reported that her right arm was still a little sore, but she could "maneuver". The patient sought medical attention via going back to the pharmacy with questions and did not receive any treatment for the adverse events. The outcome of the event "could not move her right arm" was recovered/resolved (on 15-FEB-2016). The outcome of the event "whole right arm was red" was unknown. The outcome of the event "arm was still a little sore" was not recovered/not resolved. The relatedness between the events and the therapy with pneumococcal vaccine, (23-valen) (manufacturer unknown) was not provided. Additional information is not expected as no contact details were provided.
Age: 27.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 27 years old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with GARDASIL injection (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Additional information is not expected as a healthcare worker declined to participate in adverse event collection process.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Pain, Skin ulcer
Clinical narrative: This spontaneous report was received fro a 53 year old female patient, who was reporting on herself. The patient was in remission of breast cancer and had allergies to BENADRYL, VALIUM, ZOLOFT, TAXOL and NEUPOGEN. On 19-FEB-2016, the patient was vaccinated with a dose of ZOSTAVAX, lot # L028280, expiration date: 28-OCT-2016, 0.65 ml, subcutaneously for shingles prevention. There was no concomitant medication. On 03-MAR-2016, the patient developed shingles. She sought medical attention and went to the emergency room (ER) on 03-MAR-2016 was prescribed with VALTREX to treat her shingles outbreak. She was then released from the ER on the same day, hence she was not admitted to the hospital. The patient also mentioned that she felt very tired and she got sores around her "lower middle section" area of her body and she felt pain on an unknown date in 2016. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HEPAB
Symptoms: Pharyngeal oedema, Urticaria
Clinical narrative: TWINRIX #1 given IM Rt deltoid on 3/7/16. Client states on 3/10/16 she developed hives to entire body and throat began to swell shut. Reports that she went to ER for evaluation.
Age: 58.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Ptn states pain in left arm. Pain disappeared however now large red/purple (itchy) raised area at injection site and spreading. Advised to seek medical attention.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. Since 01-FEB-2016, the patients were vaccinated with ROTATEQ (dose, route and site not reported) with lot numbers: lot # L000433 and expiration date 09-JUL-2016 or lot# L013202 and expiration date 27-JAN-2017 or lot# L013206 and expiration date 29-JAN-2017 that was exposed to 31.2 F temperature, outside of the recommended range during one hour. There were no adverse events reported. It was reported that the ROTATEQ vaccine did not experienced previous temperature excursion. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient had red round rash area on arm where vaccine was administered - measured 2.9 x 1.7.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse and refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 17-FEB-2016, the patient was inadvertently vaccinated with GARDASIL 9 (dose, route of administration, lot number and expiry date were not reported). Concomitant therapy was not reported. At the time of vaccination, the patient was unaware of her pregnancy, but the patient was about 4 to 5 weeks gestation (last menstrual period (LMP); 13-JAN-2016 and estimated date of delivery (EDD): 19-OCT-2016). Pregnancy was discovered via unspecified method, an unspecified amount of time after receiving GARDASIL 9 (on an unknown date in 2016). No adverse effect was reported. The patient's outcome was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Alpha 1 foetoprotein normal, Anaemia of pregnancy, Chlamydial infection, Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse and refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 17-FEB-2016, the patient was inadvertently vaccinated with GARDASIL 9 (dose, route of administration, lot number and expiry date were not reported). Concomitant therapy was not reported. At the time of vaccination, the patient was unaware of her pregnancy, but the patient was about 4 to 5 weeks gestation (last menstrual period (LMP); 13-JAN-2016 and estimated date of delivery (EDD): 19-OCT-2016). Pregnancy was discovered via unspecified method, an unspecified amount of time after receiving GARDASIL 9 (on an unknown date in 2016). No adverse effect was reported. The patient's outcome was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pregnancy test negative, Ultrasound abdomen normal, Vaginal infection
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse and refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 17-FEB-2016, the patient was inadvertently vaccinated with GARDASIL 9 (dose, route of administration, lot number and expiry date were not reported). Concomitant therapy was not reported. At the time of vaccination, the patient was unaware of her pregnancy, but the patient was about 4 to 5 weeks gestation (last menstrual period (LMP); 13-JAN-2016 and estimated date of delivery (EDD): 19-OCT-2016). Pregnancy was discovered via unspecified method, an unspecified amount of time after receiving GARDASIL 9 (on an unknown date in 2016). No adverse effect was reported. The patient's outcome was not reported. Additional information has been requested.