chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: This spontaneous report was received from a 62 year old female patient who reported for herself. The patient's concurrent conditions included hypercholesterolemia. She did not have any immunocompromising conditions. There was no history of drug allergies or reactions. In 2003, the patient had received 1 dose of PNEUMOVAX 23. On 14-NOV-2015, the patient was vaccinated with PNEUMOVAX 23 lot # L035686 for pneumonia. The patient also stated that "My doctor gives everyone a dose of PNEUMOVAX 23 every 5 years". Concomitant medications were none. On 14-NOV-2015, in the evening of the same day, she developed a 102 degree fever and her arm down to her elbow got very swollen. The patient's arm also became very inflamed and bright red and she couldn't move the vaccinated arm. Patient also mentioned she had a headache and she got chills and just felt sick. The patient went to an unspecified urgent care facility where she was diagnosed with a cellulitis infection as a result of the vaccination. The patient underwent blood test and flu test on an unknown date in November 2015. The patient received MOTRIN and doxycycline (unknown manufacturer) as treatment in response to the events. The outcome of the events was resolving as the patient stated that she was almost fully recovered. Causality assessment was not provided. The patient required as lot # check for PNEUMOVAX 23. There was no product quality complaint involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood test, Cellulitis, Chills, Erythema, Headache
Clinical narrative: This spontaneous report was received from a 62 year old female patient who reported for herself. The patient's concurrent conditions included hypercholesterolemia. She did not have any immunocompromising conditions. There was no history of drug allergies or reactions. In 2003, the patient had received 1 dose of PNEUMOVAX 23. On 14-NOV-2015, the patient was vaccinated with PNEUMOVAX 23 lot # L035686 for pneumonia. The patient also stated that "My doctor gives everyone a dose of PNEUMOVAX 23 every 5 years". Concomitant medications were none. On 14-NOV-2015, in the evening of the same day, she developed a 102 degree fever and her arm down to her elbow got very swollen. The patient's arm also became very inflamed and bright red and she couldn't move the vaccinated arm. Patient also mentioned she had a headache and she got chills and just felt sick. The patient went to an unspecified urgent care facility where she was diagnosed with a cellulitis infection as a result of the vaccination. The patient underwent blood test and flu test on an unknown date in November 2015. The patient received MOTRIN and doxycycline (unknown manufacturer) as treatment in response to the events. The outcome of the events was resolving as the patient stated that she was almost fully recovered. Causality assessment was not provided. The patient required as lot # check for PNEUMOVAX 23. There was no product quality complaint involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Inflammation, Influenza virus test, Injected limb mobility decreased, Malaise, Peripheral swelling
Clinical narrative: This spontaneous report was received from a 62 year old female patient who reported for herself. The patient's concurrent conditions included hypercholesterolemia. She did not have any immunocompromising conditions. There was no history of drug allergies or reactions. In 2003, the patient had received 1 dose of PNEUMOVAX 23. On 14-NOV-2015, the patient was vaccinated with PNEUMOVAX 23 lot # L035686 for pneumonia. The patient also stated that "My doctor gives everyone a dose of PNEUMOVAX 23 every 5 years". Concomitant medications were none. On 14-NOV-2015, in the evening of the same day, she developed a 102 degree fever and her arm down to her elbow got very swollen. The patient's arm also became very inflamed and bright red and she couldn't move the vaccinated arm. Patient also mentioned she had a headache and she got chills and just felt sick. The patient went to an unspecified urgent care facility where she was diagnosed with a cellulitis infection as a result of the vaccination. The patient underwent blood test and flu test on an unknown date in November 2015. The patient received MOTRIN and doxycycline (unknown manufacturer) as treatment in response to the events. The outcome of the events was resolving as the patient stated that she was almost fully recovered. Causality assessment was not provided. The patient required as lot # check for PNEUMOVAX 23. There was no product quality complaint involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a 62 year old female patient who reported for herself. The patient's concurrent conditions included hypercholesterolemia. She did not have any immunocompromising conditions. There was no history of drug allergies or reactions. In 2003, the patient had received 1 dose of PNEUMOVAX 23. On 14-NOV-2015, the patient was vaccinated with PNEUMOVAX 23 lot # L035686 for pneumonia. The patient also stated that "My doctor gives everyone a dose of PNEUMOVAX 23 every 5 years". Concomitant medications were none. On 14-NOV-2015, in the evening of the same day, she developed a 102 degree fever and her arm down to her elbow got very swollen. The patient's arm also became very inflamed and bright red and she couldn't move the vaccinated arm. Patient also mentioned she had a headache and she got chills and just felt sick. The patient went to an unspecified urgent care facility where she was diagnosed with a cellulitis infection as a result of the vaccination. The patient underwent blood test and flu test on an unknown date in November 2015. The patient received MOTRIN and doxycycline (unknown manufacturer) as treatment in response to the events. The outcome of the events was resolving as the patient stated that she was almost fully recovered. Causality assessment was not provided. The patient required as lot # check for PNEUMOVAX 23. There was no product quality complaint involved. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Deafness transitory, Ear discomfort, Hypoacusis, Otorrhoea
Clinical narrative: I went deaf for half an hour. Strange substance came out of ear. I have regained some hearing but it is muffled with a great deal of pressure.
Age: 32.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Persistent hives in arms, chest, and thighs. Symptoms improved with Zyrtec nightly but return the next night until another dose is taken. Never had any reactions or allergies to prior flu shots.
Age: 1.5
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Ear infection, Extra dose administered, Irritability, Pyrexia
Clinical narrative: This medically confirmed spontaneous report (initial receipt 17-Nov-2015) concerns an 18 month-old infant patient. On an unspecified date, the patient received Afluria injection (Influenza virus vaccine polyvalent, batch number not provided) 0.5 mL once via the intramuscular route for the protection against seasonal influenza in the infant. The child patient received a 'double paediatric dose' of 0.5mL of Afluria. On an unspecified date, approximately after a week, the patient experienced a fever, was cranky and had an ear infection. The outcome was unknown. Reporter's Comments: Reporter's comments: The reporter reported the terms 'overdose' and 'off label use', and reported that the fever was possibly due to Afluria or concomitant ear infection. Sender's Comments: Company comments: Seriousness criterion/criteria: Medically significant. Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus vaccine and the Afluria PI, ear infection is unlisted. Fever and feeling cranky (irritability) are listed are listed. Overdose, medication error and product administered to child of inappropriate age are also unlisted.  Causality: Unrelated. Time to onset is approximately 1 week following vaccination. Fever following CSL IVV in a child generally occurs within hours/ same days and unlikely after 72 hours. In this case the ear infection which is not uncommon in children under 5 was the probable cause of fever and irritability. Causality for other events (overdose, medication error and product administered to child of inappropriate age) is unassessable.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site pain, Pain
Clinical narrative: 2:30 PM - Dull soreness at injection site. 3:30 PM - increasing discomfort at injection site. 4:00 - 11:00 PM - discomfort continued to increase and noted with any movement, some shooting pains down arm from deltoid to elbow. 10/27/15 5:00 AM - mild discomfort more typical for flu shots of past years. 10/28/15 - am - Pain resolved.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Rash generalised
Clinical narrative: Slight fever, bumps/rash on entire body, swelling in the arms and hands, pain in the fingers of the arm where vaccine was given.
Age: 68.0
Sex: F
Vaccine: DPP, FLUX, HBHEPB, IPV
Symptoms: Glossodynia, Lip pain, Oral pain
Clinical narrative: Sore mouth, mostly tongue, lips.
Age: 44.0
Sex: F
Vaccine: FLUC3
Symptoms: Pain, Pain in extremity, Sleep disorder, Tenderness
Clinical narrative: Arm started aching a couple hours after receiving the influenza vaccine.  Ibuprofen was taken.  Arm has since been aching with movement.  Feels bruised to the touch. If lying on it at night, pain will wake her up from sleep.  No pain while arm is at rest.
Age: 63.0
Sex: F
Vaccine: FLUC3
Symptoms: Dysphonia, Palatal swelling, Pharyngeal oedema
Clinical narrative: Employee was vaccinated with Flucelvax (NDC: 62577-0614-01, lot# 174085, exp# 05/2016).  Approximately 1 hour later, employee experienced swollen upper palate progressing to a feeling of throat swelling.  Visual assessment shoed a markedly swollen area along the midline upper palate.  Employee's voice was affected as well, raspy and hoarse.  Benadryl 50 mg PO was given and the employee monitored 1:1 for 2 hours with an EpiPen immediately available.  Her symptoms began to resolve during the 2 hour monitoring and she went home for the day.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Throat irritation
Clinical narrative: Rash and patient described "weird feeling" in throat.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever 103.8F.  Given Tylenol and Ibuprofen at emergency room.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: 3 days after vaccine pt developed Bells Palsy on (L) face.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Angiogram, Diplopia, Laboratory test, Lumbar puncture, Muscular weakness
Clinical narrative: 11/2/15 woke up with diplopia -> seen at eye office - labs and MRI done. Angiogram -> perform for possible AV fistula. 11/3/15 -> weakness of lower extremities -> ED spinal tap perf immed.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: 11/2/15 woke up with diplopia -> seen at eye office - labs and MRI done. Angiogram -> perform for possible AV fistula. 11/3/15 -> weakness of lower extremities -> ED spinal tap perf immed.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Panic attack
Clinical narrative: Patient felt dizzy after the vaccine, she said she was having a panic attack. EMT was contacted but she did not want to go to the hospital. The next day patient's father called and said she'is been really tired.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Hypersomnia, Lip exfoliation, Oral mucosal blistering, Tongue blistering
Clinical narrative: Mouth and tongue blisters - also bottom lip skin peeling off - occurred within 1st 24 hrs. Also chills no fever - slept a lot.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of upper left extremity. Started antibiotics.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Borrelia test, Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: Pt started with numbness and paralysis to the right side of his face on the morning of 11/5/15.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Impaired driving ability, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Arm was sore after shot but it has lasted since the shot.  Arm hurts so much it is hard to drive, and lift, or even lift the arm.  The pain has awoken her from sleeping 12-01-2015.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: Started out with expected soreness.  3 weeks later I have limited movement and it hurts to put weight on that elbow.
Age: 13.0
Sex: F
Vaccine: HPV2
Symptoms: Epilepsy, Hypersensitivity, Swelling, Throat tightness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of epilepsy in a 13-year-old female patient who received CERVARIX. Concomitant products included CERVARIX. In November 2015, the patient received the 2nd dose of CERVARIX. In November 2015, 8 days after receiving CERVARIX, the patient experienced epilepsy (serious criteria GSK medically significant), swelling and throat tightness. On 21st November 2015, the patient experienced allergic reaction. The patient was treated with BENADRYL (nos). On an unknown date, the outcome of the epilepsy, swelling, throat tightness and allergic reaction were unknown. The reporter considered the epilepsy, swelling and throat tightness to be possibly related to CERVARIX. It was unknown if the reporter considered the allergic reaction to be related to CERVARIX. Additional details were provided as follows: The patient received the 1st dose of CERVARIX one month before reporting. Ten days before reporting the patient received the 2nd dose of CERVARIX. Approximately 8 days after 2nd dose CERVARIX (48 hours before reporting), the patient experienced epileptic reaction, swelling and throat tightness. The patient was taken to the emergency room because of the events. The patient was provided with BENADRYL and other medication to stop the reaction. The patient was brought back home and had another allergic reaction on 21st November 2015, approximately 10 days after vaccination. The patient's mother called in to know for how long the medication was going to stay in her body.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Cerebrovascular accident, Pneumonia
Clinical narrative: Patients caretaker reported he was hospitalized the day after with pneumonia and a stroke. Not sure if they are related as history shows pt. tolerated flu shot in the past.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Health care worker refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 05-NOV-2015, the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # K010442 EXP date: 22-JUL-2016) (dose, route, therapy type not reported). No adverse symptoms were reported. This case is one of two reports received from the same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Chills, Fatigue, Guillain-Barre syndrome, Nausea
Clinical narrative: Guillain-Barre Syndrome, shivering, couldn't walk because shivering was too intense, nausea, vomiting, aches, heavy fatigue.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Vomiting
Clinical narrative: Guillain-Barre Syndrome, shivering, couldn't walk because shivering was too intense, nausea, vomiting, aches, heavy fatigue.
Age: 12.0
Sex: M
Vaccine: FLUN4, HPV4
Symptoms: Crying, Dysstasia, Eye movement disorder, Fall, Head injury
Clinical narrative: Approximately 60-90 seconds after receiving HPV vaccine patient had an episode of syncope. Patient was standing behind her mother, who was seated, and fell to the floor. Patient's head made an audible "thud" when it hit the floor. It appeared she struck the back of her head. Initially patient's eyes were rolled back and patient was twitching slightly. She then closed her eyes in an apparent loss of consciousness for 20-30 seconds. Patient did not respond to questions or commands during this episode. Approximately 90-120 seconds after start of episode patient became more alert and began sobbing. Emergency Department was called immediately and 2 ED RNs responded. Pt was transferred (wouldn't/couldn't stand) to wheel chair and taken to ED. Patient had received intranasal flu vaccine ~5 minutes prior to HPV. Patient's mother and 1 sibling witnessed event. Father and 2 other siblings were called to room by mother while patient was still on the ground. Patient was examined and observed in the Emergency Department for 4 hours. She was cleared for discharge to home in parents' care. Two or three days after event patient presented to outside hospital with reported altered mental status. Patient was found to have small subdural hematoma and was transferred to another hospital.
Age: 12.0
Sex: M
Vaccine: FLUN4, HPV4
Symptoms: Loss of consciousness, Mental status changes, Muscle twitching, Subdural haematoma, Syncope
Clinical narrative: Approximately 60-90 seconds after receiving HPV vaccine patient had an episode of syncope. Patient was standing behind her mother, who was seated, and fell to the floor. Patient's head made an audible "thud" when it hit the floor. It appeared she struck the back of her head. Initially patient's eyes were rolled back and patient was twitching slightly. She then closed her eyes in an apparent loss of consciousness for 20-30 seconds. Patient did not respond to questions or commands during this episode. Approximately 90-120 seconds after start of episode patient became more alert and began sobbing. Emergency Department was called immediately and 2 ED RNs responded. Pt was transferred (wouldn't/couldn't stand) to wheel chair and taken to ED. Patient had received intranasal flu vaccine ~5 minutes prior to HPV. Patient's mother and 1 sibling witnessed event. Father and 2 other siblings were called to room by mother while patient was still on the ground. Patient was examined and observed in the Emergency Department for 4 hours. She was cleared for discharge to home in parents' care. Two or three days after event patient presented to outside hospital with reported altered mental status. Patient was found to have small subdural hematoma and was transferred to another hospital.
Age: 12.0
Sex: M
Vaccine: FLUN4, HPV4
Symptoms: Unresponsive to stimuli, Wheelchair user
Clinical narrative: Approximately 60-90 seconds after receiving HPV vaccine patient had an episode of syncope. Patient was standing behind her mother, who was seated, and fell to the floor. Patient's head made an audible "thud" when it hit the floor. It appeared she struck the back of her head. Initially patient's eyes were rolled back and patient was twitching slightly. She then closed her eyes in an apparent loss of consciousness for 20-30 seconds. Patient did not respond to questions or commands during this episode. Approximately 90-120 seconds after start of episode patient became more alert and began sobbing. Emergency Department was called immediately and 2 ED RNs responded. Pt was transferred (wouldn't/couldn't stand) to wheel chair and taken to ED. Patient had received intranasal flu vaccine ~5 minutes prior to HPV. Patient's mother and 1 sibling witnessed event. Father and 2 other siblings were called to room by mother while patient was still on the ground. Patient was examined and observed in the Emergency Department for 4 hours. She was cleared for discharge to home in parents' care. Two or three days after event patient presented to outside hospital with reported altered mental status. Patient was found to have small subdural hematoma and was transferred to another hospital.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Syncope
Clinical narrative: Patient felt dizzy and fainted 5 minutes after vaccination with Fluvirin 15-16.  He regained consciousness immediately and was sweating.  BP was ~80-60.  Pt given and ice pack as well as orange juice and wafers for strength and BP resolved to 126/84 within 15 minutes.  No other medical attention was necessary and patient elected to go home shortly after.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Break out in shingle along rear left waist band...never had shingles before.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt received PREVNAR 13 and FLUZONE High Dose same days. Same arm -2 days later arm still red from elbow to shoulder - warm - not painful.
Age: 61.0
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Arthralgia, Erythema, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: On day 6 after immunization, pt experienced swelling tenderness at site of injection. Day 7, pt had redness/swelling alongside length of arm and joint pain on same side elbow.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chest discomfort, Dizziness, Headache, Lymphadenopathy
Clinical narrative: Receive flu shot 11/23/15 - early next morning had pain in chest when taking deep breath - headache - dizziness - no arm pain at injection site, no redness or swelling - presents with upper chest discomfort with deep breath and temp 101.4 - glands swollen.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Painful respiration
Clinical narrative: Receive flu shot 11/23/15 - early next morning had pain in chest when taking deep breath - headache - dizziness - no arm pain at injection site, no redness or swelling - presents with upper chest discomfort with deep breath and temp 101.4 - glands swollen.
Age: 67.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Chills, Diarrhoea, Joint swelling, Vomiting
Clinical narrative: Shots given on 11/3/15, had vomiting and diarrhea and chills that evening. The next day felt fine. On Nov. 5th, he developed swelling in his wrists and knees. Dr. saw patient in the office on 11/20/15. Patient given Prednisone.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Anaphylactic reaction, Throat tightness
Clinical narrative: S/sx if anaphylaxis within 15-30 min after injection. Pt states throat closing off on drive home. Took BENADRYL and iced arm. Lasted for several days.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: Allergic reaction to the flu shot. Two days after the shot he noticed itchiness in bilateral antecubital fossae. Rash appeared on neck, bacck, chest, groin.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypersensitivity, Throat tightness
Clinical narrative: 48 hrs after injection patient experienced difficulty breathing (closing of throat). No rash. No dizziness. Was treated at walk in clinic.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate irregular, Malaise, Palpitations, Vaccine positive rechallenge
Clinical narrative: Developed malaise and palpitations, and a feeling of "irregular heart beat". Experienced these same sxs after receiving 2014's influenza vaccination. She was given only 1/2 dose this year and still had the same sxs. Underwent a cardiac workup in early 2015 which showed atrial and ventricular ectopy (PVCs and PAcs) for which cause is unknown and usually harmless. When she received the influenza vaccine, however, the sxs greatly increased. Possible myocarditis? According to myocarditis definition one may not have chest pain but have palpitations only.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # K025004, expiration date 22-JUL-2017) and (lot # L002867, expiration date 11-NOV-2017), doses, routes and anatomical locations were not provided. No concomitant medications were reported. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Pruritus, Rash, Scab
Clinical narrative: Pt received vaccine on 11-9-15. Severe swelling, red and hot x 10 days. Itching and "bumps" thereafter. 12/1/15-> red and scabbed and "hurts way down in the arm" and "hurts to lay down on it at night".
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Pt received vaccine on 11-9-15. Severe swelling, red and hot x 10 days. Itching and "bumps" thereafter. 12/1/15-> red and scabbed and "hurts way down in the arm" and "hurts to lay down on it at night".
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 16 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 15-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K007828 expiration date 02-MAR-2017. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a health professional referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, these patients were vaccinated with doses of improperly stored oral, ROTATEQ (lot # reported as 1020859, expiration date: 19-JAN-2017, strength and dose unknown) orally. There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Lymphadenitis, Lymphadenopathy, Tenderness, Ultrasound scan, X-ray
Clinical narrative: Enlarged "left supvraclavicular and infraclavicular adenopathy. Given the reported rapid development and tenderness, the findings likely reflect reactive adenitis."
Age: 59.0
Sex: M
Vaccine: FLUC3
Symptoms: Erythema, Local reaction
Clinical narrative: Patient contacted primary care provider on 11/17/15 and stated that he had a local reaction of redness after receiving his Flu shot on 11/10/15. Patient also stated he has had redness before from bandaids.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema multiforme, Local reaction, Skin swelling
Clinical narrative: Swelling on skin area; Localized reaction to deltoid area, began 24 hours after vaccination and is still present 48 hours post-vaccination. Appears to be improving. Erythema multiform.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 years old patient of unknown gender. Concurrent conditions and medical history were not reported. On 30-SEP-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L027634 and expiration date 21-JAN-2017, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 14 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 30-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L011846 and expiration are 16-JUN-2017) (dose and route of administration were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. Concurrent conditions and medical history were not reported. On 18-SEP-2015, the patient was vaccinated with an improperly stored PROQUAD (Merck) (lot number L010142 expiration date 24-SEP-2016, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: FLU4
Symptoms: Bursitis, Musculoskeletal pain, Neuritis, Nuclear magnetic resonance imaging
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a patient who received FLUARIX QUADRIVALENT (batch number 7994K, expiry date 16th June 2016). On 7th October 2015, the patient received FLUARIX QUADRIVALENT .5 ml. In October 2015, 7 days after receiving FLUARIX QUADRIVALENT, the patient experienced shoulder pain. On an unknown date, the patient experienced neuritis and bursitis. On an unknown date, the outcome of the shoulder pain, neuritis and bursitis were unknown. It was unknown if the reporter considered the shoulder pain, neuritis and bursitis to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: This case was reported by a nurse to a pharmacist. There were 5 employees who received FLUARIX QUADRIVALENT, and experienced increasing pain at the shoulder, one week later after vaccination. Among the 5 employees 2 patients were female and the genders of the other 3 patients were unknown. One of the patients was treated at the emergency room. Other patients were seen by their primary care physician and diagnosed with possible bursitis or neuritis. The patients were underwent Nuclear magnetic resonance, but it was unknown that, who amongst 5 patients underwent had the test and what are the outcomes. It was reported that, according to one physician the cause of the event was maladministration, but the nature of maladministration was not certain. The reporter stated that, she provided all the information she had available.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site induration, Injection site rash, Urticaria
Clinical narrative: Almost immediately after administration of Kinrix, patient developed rash inferior to site about 6 cm almost down to elbow with some induration and hives on his back.  No respiratory involvement.  Patient was examined by the MD and administered PO Benadryl.  Monitored for 20 mins at which time rash resolved and hives mostly resolved.
Age: 85.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Rash
Clinical narrative: Delayed rash to lower legs and headache.
Age: 87.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cyanosis, Peripheral swelling, Skin discolouration
Clinical narrative: Patient said that about 1 week after she received Prevnar 13 in her right arm, her arm became "swollen" and "black and blue". She said the reaction lasted for approximately 2 weeks. She has had no additional problems since the reaction resolved.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Antinuclear antibody, Arthralgia, Asthenia, Blood thyroid stimulating hormone, Dizziness
Clinical narrative: Severe weakness dizziness joint pain body ache muscle weak. After four days went to MD. Today my joints and muscle remain weak and painful.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test, Muscular weakness, Myalgia, Pain
Clinical narrative: Severe weakness dizziness joint pain body ache muscle weak. After four days went to MD. Today my joints and muscle remain weak and painful.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Musculoskeletal pain, Pain
Clinical narrative: Shoulder pain, can't comfortably lift arm, very sore.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Rash on the arm where the vaccine was administered. It apparently persisted over a week.  No treatment advice was requested from our office. The patient's wife reported that he did not treat himself or seek attention elsewhere.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Injection site bruising, Pain
Clinical narrative: 24 hrs later, severe bruising at injection site, very fatigued, slight headache, no fever. 48 hrs later - severe body aches - continued fatigue. 72 hrs later - body aches and fatigue.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity
Clinical narrative: Numbness/soreness in arm. Weakness in arm.
Age: 11.0
Sex: M
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Adenovirus test, Culture stool negative, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Decreased appetite, fatigue, watery diarrhea onset 48 hr. after vaccines. 12-24 hr after vaccines given, developed induration with erythema at injection site of Tdap - (L) deltoid. Dr feels GI symptoms may be unrelated.
Age: 11.0
Sex: M
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Parasite stool test negative, Viral test negative
Clinical narrative: Decreased appetite, fatigue, watery diarrhea onset 48 hr. after vaccines. 12-24 hr after vaccines given, developed induration with erythema at injection site of Tdap - (L) deltoid. Dr feels GI symptoms may be unrelated.
Age: 1.18
Sex: F
Vaccine: IPV, MMR
Symptoms: Retching, Vomiting
Clinical narrative: Gagging, vomiting.
Age: 77.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 12.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effect.  Patient given DTAP and TDAP on same date.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Blepharospasm, Ear pain, Facial pain, Headache, Malaise
Clinical narrative: Patient's mother called PHO on 11/24/15 to report her daughter had signs and symptoms of Bell's palsy after receiving influenza injection on 11/20/2015. Mother states on 11/21/15 her daughter felt sick in the morning, c/o of Pain around the jaw (R) side and pain behind her ear on the right side of face, stuffy nose and headache. On 11/22/15 patient c/o eye twitching which was getting progressively worse throughout the day. On 11/23/15, when patient woke up her mother noticed facial droop and difficulty making facial expressions on the right side of her face. Patient had difficulty smiling on the right side of face. On 11/24/15, patient's mother took her to PCP, and she was told these symptoms were not r/t influenza injection. Patient was referred to EENT. Patient was given steroids, eye re-wetting drops for right eye, and instructions for facial and massage exercises. Patient will f/u with Dr. next week. PHN spoke with mother on 12/1/15 and symptoms have not improved.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Nasal congestion, Pain in jaw, VIIth nerve paralysis
Clinical narrative: Patient's mother called PHO on 11/24/15 to report her daughter had signs and symptoms of Bell's palsy after receiving influenza injection on 11/20/2015. Mother states on 11/21/15 her daughter felt sick in the morning, c/o of Pain around the jaw (R) side and pain behind her ear on the right side of face, stuffy nose and headache. On 11/22/15 patient c/o eye twitching which was getting progressively worse throughout the day. On 11/23/15, when patient woke up her mother noticed facial droop and difficulty making facial expressions on the right side of her face. Patient had difficulty smiling on the right side of face. On 11/24/15, patient's mother took her to PCP, and she was told these symptoms were not r/t influenza injection. Patient was referred to EENT. Patient was given steroids, eye re-wetting drops for right eye, and instructions for facial and massage exercises. Patient will f/u with Dr. next week. PHN spoke with mother on 12/1/15 and symptoms have not improved.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injection site pain
Clinical narrative: Pain and tenderness at site of injection, improved over the following several days but did not resolve. Presented for f/u appointment 12/1/15, dx with bursitis of right shoulder.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Limb discomfort, Pain in extremity
Clinical narrative: Patient had discomfort/pain in arm following flu vaccine.  After 11 days & still having pain, she went to her doctor and was told the vaccine was given too high in shoulder.  She was then given a cortisone shot.  After one month, patient said she is still experiences discomfort in her shoulder.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Shingles Vaccine gave me a mild case of Facial Shingle.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypoaesthesia, Injection site pain
Clinical narrative: Patient reports "numbness" and pain at injection site 2 months after administration.
Age: 60.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain
Clinical narrative: Right upper arm was painful.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache
Clinical narrative: Patient recommended to remain seated for 15 minutes after administration of vaccination. Immediately after administering and for a few minutes following she stated she feels fine, however about 15 minutes post-administration she stated feeling dizzy and with a headache. She was recommended to remain seated longer, asked if she were diabetic, she stated no; she did say she hadn't eaten lunch, we asked if she'd like something to drink, and she requested orange juice so we provided this; we f/u with guest in an hour to check on how she's doing and stated her symptoms subsided and she's doing well.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Choking, Cough, Ear pain, Nerve injury
Clinical narrative: Coughed and choked most of night after shot. Ears started hurting, and I started chilling off an on for 24 hrs.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo, Vestibular disorder
Clinical narrative: Coughed and choked most of night after shot. Ears started hurting, and I started chilling off an on for 24 hrs.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: First I felt feverish. By the end of the day, my right arm where I was shot was throbbing. This type pain has continued. Today is Dec 1 and my arm still pains. I have never had this type reaction from a flu shot before.
Age: 24.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Swelling, red lump at injection site, tenderness.
Sex: U
Vaccine: FLU3
Symptoms: Chills, Headache, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a patient who received FLUARIX. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced chills, headache, fever, general body pain, nasal stuffiness and sore throat. On an unknown date, the outcome of the chills, headache, fever, general body pain, nasal stuffiness and sore throat were unknown. It was unknown if the reporter considered the chills, headache, fever, general body pain, nasal stuffiness and sore throat to be related to FLUARIX. Additional details provided were as follows: The patient received an Influenza vaccine (unspecified season). The patient experienced chills which throw up shakes, headache, fever, body aches (body pain) stuffy head (nasal stuffiness) and sore throat.
Sex: U
Vaccine: FLU3
Symptoms: Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a patient who received FLUARIX. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced chills, headache, fever, general body pain, nasal stuffiness and sore throat. On an unknown date, the outcome of the chills, headache, fever, general body pain, nasal stuffiness and sore throat were unknown. It was unknown if the reporter considered the chills, headache, fever, general body pain, nasal stuffiness and sore throat to be related to FLUARIX. Additional details provided were as follows: The patient received an Influenza vaccine (unspecified season). The patient experienced chills which throw up shakes, headache, fever, body aches (body pain) stuffy head (nasal stuffiness) and sore throat.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling in left deltoid area. Slight redness and warm to touch. Ice applied, ibuprofen and BENADRYL given PO.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: (L) shoulder pain, sharp burning posterior after 2nd flu shot accidentally.
Sex: U
Vaccine: FLU4
Symptoms: Bursitis, Musculoskeletal pain, Neuritis, Nuclear magnetic resonance imaging
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a patient who received FLUARIX QUADRIVALENT (batch number 7994K, expiry date 16th June 2016). On 7th October 2015, the patient received FLUARIX QUADRIVALENT .5 ml. In October 2015, 7 days after receiving FLUARIX QUADRIVALENT, the patient experienced shoulder pain. On an unknown date, the patient experienced neuritis and bursitis. On an unknown date, the outcome of the shoulder pain, neuritis and bursitis were unknown. It was unknown if the reporter considered the shoulder pain, neuritis and bursitis to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: This case was reported by a nurse to a pharmacist. There were 5 employees who received FLUARIX QUADRIVALENT, and experienced increasing pain at the shoulder, one week later after vaccination. Among the 5 employees 2 patients were female and the genders of the other 3 patients were unknown. One of the patients was treated at the emergency room. Other patients were seen by their primary care physician and diagnosed with possible bursitis or neuritis. The patients were underwent Nuclear magnetic resonance, but it was unknown that, who amongst 5 patients underwent had the test and what are the outcomes. It was reported that, according to one physician the cause of the events was maladministration, but the nature of maladministration was not certain. The reporter stated that, she provided all the information she had available.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Pain, Pyrexia
Clinical narrative: 3 days of fever to 102 degrees. Redness spreading through left shoulder. Soreness remaining after 2 months.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 08-AUG-2015, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot # L006545 expiration date -23-OCT-2016. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: UNK
Symptoms: Drug administered at inappropriate site, Periarthritis
Clinical narrative: Shot to high up by shoulder got frozen shoulder. Care of Dr.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash vesicular
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding a female patient of unknown age. No medical history and concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) to prevent shingles. Concomitant medications were not reported. On an unknown date, the patient developed an unspecified rash that "resembled shingles" at the injection site which travelled down to the unspecified arm. It was not known if the patient sought medical attention or received treatment. The outcome of the events was unknown. No product quality complaint was reported. Causality assessment was not provided. This is one of the two report from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site of injection - left deltoid - is sore to touch. No redness or erythema noted but some swelling noted, when compared to rt deltoid. Afebrile 97 degrees.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt presents with less than 1 day history of left upper arm redness, warmth, pain, following HPV #2 vaccination that pt had received one day prior.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Dyskinesia, Electroencephalogram normal, Eye movement disorder, Irritability
Clinical narrative: Patient with extreme fussiness, inconsolable crying, jerky movements in arms, eyes going back and forth episodes lasted 15-20 seconds and had 7-8 episodes. Vomiting.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Patient with extreme fussiness, inconsolable crying, jerky movements in arms, eyes going back and forth episodes lasted 15-20 seconds and had 7-8 episodes. Vomiting.
Age: 1.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Abscess, Injection site induration, Ultrasound scan abnormal
Clinical narrative: 3 vaccines given in the left lateral thigh, developing an induration that is 20 x 22 mm and fluctuant. Shots were given in an area less than 1.5 x 1.5 inches. Had similar reaction last July ending in a sterile abscess that was drained.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: Administered MMRV instead of varicella.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site reaction, Local swelling, Pyrexia
Clinical narrative: Injection site reaction: pt. had an aprox. 3"-8" area on her underarm which was red, slightly puffy, and firm compared to surrounding area. Pt. States she also felt feverish. Vaccine admin. on 11/3/15, reaction started 11/5-11/6. Pt. stopped by pharm no showed me on 11/8/15.
Sex: F
Vaccine: PNC13
Symptoms: Rash, Rash pruritic, Vaccination site reaction
Clinical narrative: Rash, itchy started on site of vaccination and moved to scalp, waistline and top of thighs.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain
Clinical narrative: Red painful area 2 inch in diameter, at injection site - suggested hydrocortisone cream. Headache.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: 1 week from vaccination pt woke with small red rash near injection site. Started cold compress, ibuprofen, ZYRTEC. Redness spread to elbow with "heat" in at as well as bright color. Pt saw MD on 11/30, symptoms had already decreased, no other meds prescribed. Continuing to improve.
Age: 49.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site discolouration, Injection site pain, Injection site warmth
Clinical narrative: Patient called stated adult PCV13 was given on 11-23-15, warm to touch, black spot at injection site, slightly painful.