chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMR, VARCEL
Symptoms: Urticaria, Vomiting
Clinical narrative: Began violently throwing up, could not keep water down, or any type of fluid or food. Vomited throughout the evening hours until he kept down 4oz of formula at 10:00 AM the following morning 10/29/16. Continued off and on vomiting throughout the day 10/29/16. Awoke 10/30/2016 covered in hives from head to toe. Seen by Pediatrician on 10/30/2016 recommended BENADRYL and/or CLARITIN to control the hives.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Injection site erythema, Skin reaction, Tenderness
Clinical narrative: Note that date/time are approximate. Initially had some shortness of breath, then noticed right arm tender and red on 12/2012. Called on call doctor on 12/12 and was advised to use Benadryl and ice over her arm. Benadryl resolved the shortness of breath that she had experienced. Seen in office 12/14 and still has an erythematous area on right upper arm12 cm x 5 cm in size.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: Swelling at site of vaccine, left thigh, 3 x 4 cm in size.
Age: 37.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized swelling and redness to arm where injection was given.
Age: 26.0
Sex: M
Vaccine: HPV9
Symptoms: Dyskinesia, Muscle rigidity
Clinical narrative: Blood draw started. In the middle of drawing pt's blood at the nursing station, pt started jerking with his eyes close along with rigid arms and fingers that lasted for about 15 seconds. Code blue initiated. Drs. arrived at the scene.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II injection, lot# M002419, expiration date 12-JAN-2018 and lot# M004899, expiration date 27-JAN-2018 (doses and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines had been stored at the temperature of 10.2 degrees Celsius for 1 hour and 9 minutes (date unspecified). A digital data logger was involved. Previous temperature excursions was reported at the temperature of 8.9 degrees Celsius for 1 hour and 8 minutes. Follow-up information has been received on 23-NOV-2016 from the license practical nurse. The reporter was unable to find information for a temperature excursion on 29-SEP-2016 and requested that the Company sends a letter referencing 08-SEP-2016. The vaccines albumins status were rHA (recombinant human albumin). This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA000081: MERCK 1610USA007964:Mfr number.
Sex: U
Vaccine: HEPA
Symptoms: Adverse reaction, Incorrect product storage
Clinical narrative: Information has been received from a medical assistant concerning an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history, relevant laboratory data and concurrent conditions were not informed. On 17-OCT-2016 the patients were vaccinated with incorrect storage VAQTA lot # M018644, expiration date 20-SEP-2017, 0.5 ml administered per intramuscular route for prophylaxis reported as hepatitis A vaccination. Concomitant therapies were not informed. The medical assistant reported that on unspecified dates, the VAQTA had undergone a temperature excursion. It was informed that at the time of the report, the patients had not experienced any adverse reaction and had not been provided any treatment. It was unknown if the patients continued to receive VAQTA. On 12-DEC-2016, a telephone call was placed to the medical assistant who stated that she would research the information and fax the patient identifiers and dates of vaccination. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA010786: MERCK 1610USA011665:Mfr number.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a employee and refers to a female patient of unknown age. Her pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 29-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (exact dose, route of administration, lot # and expiration date were not reported) to prevent a pneumococcal disease. On 30-NOV-2016, she had a reaction. Her arm was red and swollen around the injection site. There was a treatment given for the adverse events. The patient did not seek medical attention. The outcome of the events was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot# and expiry date were not reported). On unknown dates, the patients were late receiving their second and third doses of GARDASIL 9. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: DTPHIB, PPV
Symptoms: Brain oedema
Clinical narrative: This spontaneous report was received from a patient's mother via Pfizer, Inc. and refers to an 18 month old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, at the age of 18 months, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid vaccine and Hib conj vaccine (unspecified carrier), (for all administered vaccines, route and site of administration, dose, lot number and expiration date were not reported). On an unknown date, the patient experienced brain swelling. The outcome of the brain swelling and the relatedness between this event and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid vaccine and Hib conj vaccine (unspecified carrier) were not reported. Upon internal review, the event of brain swelling was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On unknown dates, the patients were vaccinated with M-M-R II lot # L005291, expiry date 17-FEB-2017 (route of administration, dose and dose number were not reported). Temperature was 56 Fahrenheit degrees, for 2 hours, data logger was not involved, 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. Sender's Comments: US-009507513-1612USA007916.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On unknown dates, the patients were vaccinated with VARIVAX lot # M004326, expiry date 25-JAN-2017 (route of administration, dose and dose number were not reported). Temperature was 56 Fahrenheit degrees, for 2 hours, data logger was not involved, 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. Sender's Comments: US-009507513-1612USA006317.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: This is a spontaneous report obtained from a contactable medical assistant calling on behalf of a physician and from a contactable nurse. A 18-year-old female patient received the first dose of TRUMENBA, (Lot. M74091, Expiration date: 01Jun2017) on 04Aug2016 at 16:50, intramuscular, in left arm, 0.5 ml single, for immunization. Ongoing relevant medical history included ADHD (attention deficit/hyperactivity disorder) from 20Nov2007 and anxiety. Concomitant medications included CONCERTA 54 mg, once daily, from 30Dec2014 (ongoing) for ADHD, oral FOCALIN 10 mg, once daily, from 21Dec2015 (ongoing) for ADHD and oral sertraline 50 mg, once daily, from 02Aug2016 for anxiety. On 04Aug2016 the patient experienced a significant localized reaction with redness and swelling at the injection area. The patient recovered from the events on an unknown date in 2016. The reporting nurse stated that the patient came in for primary care physician to look at and was not admitted to hospital. Events were considered related to meningococcal group b rlp2086 by the reporting medical assistant and by the reporting nurse. Follow-up (08Oct2016): Follow-up attempts are completed.  No further information is expected. Follow-up (06Dec2016): New information from a contactable nurse: suspect vaccine details, events details, causality assessment.
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient experienced welts all over her body on an unspecified date with outcome of unknown.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer reported for himself, via a Pfizer sales representative. A 67-year-old male patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and the patient's concomitant medications were not reported.  He complained of continued arm pain beyond just the injection site. He stated that he had a steroid injection in the same arm a few weeks prior. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a Pfizer Sponsored program, from a contactable pharmacist. An adult female patient (a doctor) of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. Medical history included ongoing latex allergy. The patient's concomitant medications were not reported. The patient's  arm became swollen on an unspecified date. The outcome of the event was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a Company representative. This nurse reported for herself. A 65-year-old female patient received PREVNAR 13, via an unspecified route of administration on an unspecified date in 2016 at 0.5 ml, single for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced arm from her elbow up to her shoulder turned red and was swollen on an unspecified date in 2016 with outcome of recovered.  Also the reporter stated that did not think the vaccine was shaken vigorously prior to administration.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Dizziness, Headache, Influenza, Mobility decreased
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. This 72-year-old female consumer received PREVNAR 1) intramuscular, in left arm, in Oct2016, at single dose, for immunisation. Medical history and concomitant medications were not reported. Shortly after vaccination the consumer could not lift both arms on an unspecified date in 2016 with outcome of recovering, experienced muscle pain in both her arms and shoulders on an unspecified date in 2016 with outcome of not recovered, joint pain everywhere on an unspecified date in 2016 with outcome of not recovered, rash on the back of her neck on an unspecified date in 2016 with outcome of recovering, bad headaches on an unspecified date in 2016 with outcome of not recovered, she was dizzy in Dec2016 with outcome of not recovered, got the flu on an unspecified date in 2016 with outcome of resolved after 2 weeks, she could not even sleep on her sides because of the joint pain on an unspecified date in 2016 with unknown outcome.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. This 72-year-old female consumer received PREVNAR 1) intramuscular, in left arm, in Oct2016, at single dose, for immunisation. Medical history and concomitant medications were not reported. Shortly after vaccination the consumer could not lift both arms on an unspecified date in 2016 with outcome of recovering, experienced muscle pain in both her arms and shoulders on an unspecified date in 2016 with outcome of not recovered, joint pain everywhere on an unspecified date in 2016 with outcome of not recovered, rash on the back of her neck on an unspecified date in 2016 with outcome of recovering, bad headaches on an unspecified date in 2016 with outcome of not recovered, she was dizzy in Dec2016 with outcome of not recovered, got the flu on an unspecified date in 2016 with outcome of resolved after 2 weeks, she could not even sleep on her sides because of the joint pain on an unspecified date in 2016 with unknown outcome.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Bursa injury, Injection site bruising, Musculoskeletal pain
Clinical narrative: Shoulder blade pain. Did not notify provider until 11/4/16. She states the shot burst her bursa sac. Provider could see the bruise where the shot was given and it was not close to the bursa. No pain at the injection site only in her back.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, PPV
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: High pitched cry, irritability, high fever 103 degrees.
Age: 4.0
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Pt received vaccines on 9/17 - MMRV#1 and PCV13#1. Developed fever and rash on 9/27-9/29, rash worse on 9/29. Parent didn't give medicine and didn't bring pt to see doctor;  symptoms self-resolved. Parent showed pictures of rash -- hives/urticaria like -- rash was diffused from face, periorbital and on body. No more symptoms now. Normal appetite, normal activity level. No other complaints/concerns no travel. Pt is due for more catch up vaccines.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Respiratory arrest, Syncope
Clinical narrative: Patient fainted following administration of ZOSTAVAX immunization. Patient never stopped breathing and seemed to recover after a few minutes. Pt was taken to Emergency Room by ambulance for follow up.
Age: 4.0
Sex: M
Vaccine: FLU4, MMR
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Pain, Swelling
Clinical narrative: Raised, Red, and sore to touch. Redness moved up left leg several inches. Patient refused to walk on leg after taking nap.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: UPPER ARM, BELOW SHOULDER, SWELLED WAY UP AND WAS VERY PAINFUL. THEN BY 10:00 PM IT STARTED SWELLING UP IN THE BICEP OF THE ARM ALSO AND WAS PAINFUL. THE NEXT MORNING IT IS STILL SWOLLEN AND A BIT PAINFUL YET IN BOTH AREAS OF THE ARM.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site discolouration
Clinical narrative: I was notified of issue at sibling visit on 12/12.  Sometime after getting the vaccine mom had noted 6cm of irreg hypopigmentation at site of vaccine.  Only vaccine given at that time.  No inflammation or other issue after vaccine.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-NOV-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M013636, expiration date 15-FEB-2018 (strength, dose, administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported. The vaccine had two temperature excursions one of 29.9 Fahrenheit (F) for 2 hours 30 minutes and the other of 47.7 (F) for 30 minutes; with a data logger involved. Also it was reported no previously temperature excursions. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected because the reporter do not want to be contacted; Sender's Comments: US-009507513-1611USA013515: US-009507513-1612USA000347: US-009507513-1612USA000348: US-009507513-1612USA000349: US-009507513-1612USA000350: US-009507513-1612USA000351.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-NOV-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M013636, expiration date 15-FEB-2018 (strength, dose, administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported. The vaccine had two temperature excursions one of 29.9 Fahrenheit (F) for 2 hours 30 minutes and the other of 47.7 (F) for 30 minutes; with a data logger involved. Also it was reported no previously excursions. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA000346: US-009507513-1612USA000348: US-009507513-1612USA000349: US-009507513-1612USA000350: US-009507513-1612USA000351: US-009507513-1611USA013515.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, intramuscularly (dose, lot number and expiry date were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Irritability, Pyrexia
Clinical narrative: Fever fussy all throught the night. Didn't see the swelling on the leg until this morning 12/15/16 at 5:00 AM.
Age: 36.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient reported having redness followed by swelling under the arm with a fever. He took some ibuprofen but went to the doctor on Saturday because the swelling didn't go down and received some antibiotics. Patient currently doing better and the swelling subsided.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The patient's underside of her left arm is red and swollen.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Peripheral swelling
Clinical narrative: The patient's underside of her left arm is red and swollen.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: REDNESS SWOLLEN ITCHY PATIENT TOOK BENADRYL.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Bedridden, Chills, Decreased appetite, Dizziness, Injection site induration
Clinical narrative: Dizziness, chills, bedridden for 31 hours, no appetite, hardness and soreness not at injection site but further down arm near elbow.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Dizziness, chills, bedridden for 31 hours, no appetite, hardness and soreness not at injection site but further down arm near elbow.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash papular
Clinical narrative: Papular erythematous rash primarily on trunk, spread to proximal upper extremities and forehead. No fever. Rash is not pruritic or otherwise bothersome to patient.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Arthritis, Chronic fatigue syndrome, Cognitive disorder, Dizziness
Clinical narrative: JOINT PAIN, CFS, INSOMNIA, DIZZINESS, HEADACHES, COGNITIVE MEMORY IMPAIRMENT, NIGHT SWEATS, RASH, IRREGULAR HEART BEAT & ARTHRITIS.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Heart rate irregular, Injection site pain, Insomnia, Night sweats
Clinical narrative: JOINT PAIN, CFS, INSOMNIA, DIZZINESS, HEADACHES, COGNITIVE MEMORY IMPAIRMENT, NIGHT SWEATS, RASH, IRREGULAR HEART BEAT & ARTHRITIS.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Rash
Clinical narrative: JOINT PAIN, CFS, INSOMNIA, DIZZINESS, HEADACHES, COGNITIVE MEMORY IMPAIRMENT, NIGHT SWEATS, RASH, IRREGULAR HEART BEAT & ARTHRITIS.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Heart rate irregular, Insomnia, Night sweats, Rash
Clinical narrative: JOINT PAIN, CFS, INSOMNIA, DIZZINESS, HEADACHES, COGNITIVE MEMORY IMPAIRMENT, NIGHT SWEATS, RASH, IRREGULAR HEART BEAT & ARTHRITIS.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Arthritis, Chronic fatigue syndrome, Cognitive disorder, Dizziness
Clinical narrative: JOINT PAIN, CFS, INSOMNIA, DIZZINESS, HEADACHES, COGNITIVE MEMORY IMPAIRMENT, NIGHT SWEATS, RASH, IRREGULAR HEART BEAT & ARTHRITIS.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Heart rate irregular, Injection site pain, Insomnia, Night sweats
Clinical narrative: JOINT PAIN, CFS, INSOMNIA, DIZZINESS, HEADACHES, COGNITIVE MEMORY IMPAIRMENT, NIGHT SWEATS, RASH, IRREGULAR HEART BEAT & ARTHRITIS.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Rash
Clinical narrative: JOINT PAIN, CFS, INSOMNIA, DIZZINESS, HEADACHES, COGNITIVE MEMORY IMPAIRMENT, NIGHT SWEATS, RASH, IRREGULAR HEART BEAT & ARTHRITIS.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Arthritis, Chronic fatigue syndrome, Cognitive disorder, Dizziness
Clinical narrative: JOINT PAIN, CFS, INSOMNIA, DIZZINESS, HEADACHES, COGNITIVE MEMORY IMPAIRMENT, NIGHT SWEATS, RASH, IRREGULAR HEART BEAT & ARTHRITIS.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Heart rate irregular, Injection site pain, Insomnia, Night sweats
Clinical narrative: JOINT PAIN, CFS, INSOMNIA, DIZZINESS, HEADACHES, COGNITIVE MEMORY IMPAIRMENT, NIGHT SWEATS, RASH, IRREGULAR HEART BEAT & ARTHRITIS.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Rash
Clinical narrative: JOINT PAIN, CFS, INSOMNIA, DIZZINESS, HEADACHES, COGNITIVE MEMORY IMPAIRMENT, NIGHT SWEATS, RASH, IRREGULAR HEART BEAT & ARTHRITIS.
Age: 46.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Arthralgia, Arthritis, Chronic fatigue syndrome, Cognitive disorder, Dizziness
Clinical narrative: JOINT PAIN, CFS, INSOMNIA, DIZZINESS, HEADACHES, COGNITIVE MEMORY IMPAIRMENT, NIGHT SWEATS, RASH, IRREGULAR HEART BEAT & ARTHRITIS.
Age: 46.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Headache, Heart rate irregular, Injection site pain, Insomnia, Night sweats
Clinical narrative: JOINT PAIN, CFS, INSOMNIA, DIZZINESS, HEADACHES, COGNITIVE MEMORY IMPAIRMENT, NIGHT SWEATS, RASH, IRREGULAR HEART BEAT & ARTHRITIS.
Age: 46.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Rash
Clinical narrative: JOINT PAIN, CFS, INSOMNIA, DIZZINESS, HEADACHES, COGNITIVE MEMORY IMPAIRMENT, NIGHT SWEATS, RASH, IRREGULAR HEART BEAT & ARTHRITIS.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Insomnia, Saliva altered, Upper-airway cough syndrome
Clinical narrative: Post nasal drip resulting in salty saliva. Sleeplessness.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative referring to a 13 year old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with the 1st dose of GARDASIL 9 (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis. The patient's concomitant medications were not reported. It was reported by the physician, that on an unknown date, 8 months after receiving the first dose, the patient was vaccinated with the 2nd dose of GARDASIL 9 (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis (inappropriate schedule of drug administration). Furthermore, it was reported that, no adverse effects were developed and that no product quality issue was involved. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site scab, Injection site swelling, Injection site warmth
Clinical narrative: A spontaneous report was received on 08JUN2016 with additional information received on 27JUN2016. A 31 year old female employee reported experiencing injection site redness, swelling, and warmth, with feeling of numbness in left arm and shoulder area following immunization with BIOTHRAX. On 07JUN2016 she received a booster dose of BIOTHRAX (FAV602) intramuscularly in the left deltoid. Symptoms began in the evening of the day of vaccination. She was treated with ibuprofen and hydrocortisone cream and experienced some relief. Consumer reported that it took a week before the bump and redness was completely gone. She also reported that there remained a small scab at the injection site for 10 days after the injection. The adverse events were reported to be recovered on 14JUN2016. No additional information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable other hcp. A patient of unspecified age, race and gender received PREVNAR 13, via an unspecified route of administration at single dose on 16Nov2016 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced "redness, warm to touch, swollen and tenderness" at the injection site on an unspecified date with outcome of unknown.
Sex: U
Vaccine: PNC13
Symptoms: Mobility decreased
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative.  A patient of unspecified age, ethnicity and gender received PREVNAR 13; (batch/lot number unknown), via an unspecified route of administration on an unspecified as single dose for immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced limitation of arm movement on an unspecified date. The outcome of limitation of arm movement was unknown. The reporting pharmacist does believe that the limitation of arm movement was due to pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein).
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Malaise
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This report was received via a Pfizer sales representative. A female patient of an unspecified age and ethnicity received the PREVNAR 13, via an unspecified route of administration from an unspecified date to an unspecified date at a single for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified in 2016, the patient experienced red and swollen arm around injection site and felt very ill for few days post vaccination. The clinical outcome of the event, red and swollen arm around injection site and felt very ill, was unknown.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal behaviour, Decreased eye contact, Diarrhoea, Feeling abnormal
Clinical narrative: Parents state about 1-2hrs after vaccines given baby became "spacey" she wouldn't make eye contact, and didn't act herself for almost 3 weeks. She also had diarrhea stools 1-2/day for 4wks and then her stools returned to normal.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Pruritus, Skin irritation, Skin warm
Clinical narrative: Bruising, red, irritation, warm to touch, slightly itchy.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pt stated that on the day she received her injections, her arm was sore, red, and at one point, had swollen to the size of a grapefruit. By the next day, the swelling had subsided, but her arm was still sore and red. She took TYLENOL, rested, and it was suggested that she apply a cold compress to the affected area.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Raised itchy rash to left of site of injection.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Chest pain, Erythema, Injection site erythema, Injection site pain
Clinical narrative: Next day after receiving the PNEUMOCOCCAL POLYSACCHARIDE VACCINE I felt an extreme pain in my left arm, all the way to my hand and fingers. The pain was very strong in my left chest and shoulder, as well as under the left arm. The skin had patches of red on all my left upper side and upper arm. I took some TYLENOL 650 mg to be able to stand and move a little bit. This excruciating pain lasted 48 hours, then eased out.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Next day after receiving the PNEUMOCOCCAL POLYSACCHARIDE VACCINE I felt an extreme pain in my left arm, all the way to my hand and fingers. The pain was very strong in my left chest and shoulder, as well as under the left arm. The skin had patches of red on all my left upper side and upper arm. I took some TYLENOL 650 mg to be able to stand and move a little bit. This excruciating pain lasted 48 hours, then eased out.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash vesicular
Clinical narrative: Arm swelling and open blistering rash.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, erythema, warm to the touch, started MOTRIN, BENADRYL and cool packs.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Dark circles under eyes, Dyspnoea, Lethargy, Mobility decreased, Pain in extremity
Clinical narrative: Difficulty breathing, legs hurt and very hard to lift them to move, paralysis, scab-like sore on side of mouth, dark circles under eyes, fever of 101.3, lethargic.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Paralysis, Pyrexia, Stomatitis
Clinical narrative: Difficulty breathing, legs hurt and very hard to lift them to move, paralysis, scab-like sore on side of mouth, dark circles under eyes, fever of 101.3, lethargic.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus generalised
Clinical narrative: Swelling and redness of inj site, itching in general.
Age: 24.0
Sex: M
Vaccine: TYP
Symptoms: Rash
Clinical narrative: Mild skin rash (hand, arm, face).
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Pyrexia
Clinical narrative: Patient called the pharmacy and stated that he felt very sick and had since he received the high dose flu vaccine (FLUZONE HD). He had been feeling sick for about five days and stated he had been running a high fever. He asked that I report it. It is important to note the patient took a course of amoxicillin for ten days starting 11/9/16 for an unknown ailment.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Haematoma, Immune system disorder, Injection site nodule
Clinical narrative: Sub Q nodule felt at the injection site that increased in size over 4 days. No fever or discharge noted.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Asthenia, Back pain, Dyspnoea, Pain, Pain in extremity
Clinical narrative: Patient was having trouble breathing. He felt very weak. Complained of pain in his lower back that kept shooting down his right leg. 911 was called. They just took blood pressure and talked with patient. He refused treatment and drove himself home.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: Malaise and pain all over her body with chills and fever around 100 Fahrenheit.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Altered state of consciousness, Dizziness, Headache
Clinical narrative: Dizzy, almost passed out around Midnight, 11 hours after injection. Called Doctor in am, only had headache. Not seen. No further symptoms.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Experienced rash that expanded down the upper arm, then started to recede on 12/12.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Headache, Vomiting
Clinical narrative: 12-9-16 1530 Clients mother called and spoke to PCA. States client was in for influenza vaccine on 12-9-16 at 11:25AM. States at 3:30pm client started having stomach aches, vomiting, and has a headache. Mother stated client has not eaten or done anything out of the normal. States she has not taken client to the doctor yet. Education provided to take client to PCP or clinic if worried client had a reaction. Educated mother most reactions happen within the first 15 minutes after vaccination. Mother states she is taking client to clinic when clients father gets home. Educated mother would call and check on client before 5 pm today. Mother verbalized understanding. -RN 12-9-16 1641 PCA called clients mother. Mother states she has not taken client to clinic yet. Client still having vomiting, stomach ache and headache. Educated mother will check on client next week per phone call. Mother verbalized understanding. RN 12-13-16 1315 Attempted to contact mother, no answer, message left by PCA to call CHD-RN 12-15-16 1400 Attempted to contact clients mother, no answer, message left by PCA, to contact CHD -RN.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Blood chloride decreased, Decreased appetite, Electrocardiogram normal, Fatigue, Feeling abnormal
Clinical narrative: Child had Flu and MENACTRA on 12/13/2016, felt strange that night, had loss of appetite, fatigue. The next day she developed numbness in hands and feet and hyperventilation. She was taken by ambulance to ED. She was given IV fluids. Cl was 97 low. She improved and was discharged from ED.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Hyperventilation, Hypoaesthesia, Neutrophil percentage increased, Urine analysis normal
Clinical narrative: Child had Flu and MENACTRA on 12/13/2016, felt strange that night, had loss of appetite, fatigue. The next day she developed numbness in hands and feet and hyperventilation. She was taken by ambulance to ED. She was given IV fluids. Cl was 97 low. She improved and was discharged from ED.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: I spoke with patient the morning after administering the vaccine and she reported a small bruise at the injection. Redness/swelling was denied at that time. I advised her to continue to monitor and consult her physician if other symptoms developed. On 12/15/16 she spoke with the Senior Center Director (where clinic was conducted on 12/7/16) and showed her the injection site. The Senior Center Director took a picture of her left upper arm and sent it to me. There was significant bruising noted around the injection and redness that extended from the injection site almost to the elbow. The Senior Center Director advised pt to follow up with her PCP. I spoke with the PCP office who confirmed that patient has an appointment tomorrow (12/16/16). Medical Advisor informed.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Pt complains of arm hurting and loss of strength after receiving the flu shot. Pt stated that the arm still hurts.
Age: 54.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Shoulder pain and pain shooting down the arm (left arm).
Age: 54.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Shoulder pain and pain shooting down the arm (left arm).
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: 24 hours after injection, shoulder, triceps, mid upper arm swollen and pink, mildly tender.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: Patient has bruising at injection site.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Abdominal pain, Chills, Diarrhoea, Fatigue, Hyperhidrosis
Clinical narrative: Left arm pain to fingers, fatigue, myalgias, chills, sweats and diarrhea, abdominal pain, swelling and redness at site of injection. Feverx2d.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Left arm pain to fingers, fatigue, myalgias, chills, sweats and diarrhea, abdominal pain, swelling and redness at site of injection. Feverx2d.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: On 12/15/2016, the patient's mother came to report that since the flu vaccine, the patient has been having severe pain in her upper arm/shoulder and cannot lift her arm above a 90 degree angle. The patient is out of the country for several months. RPh recommended she go to a clinic where she is for evaluation.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Local reaction injection site measuring 5x5 in diameter, red, swollen. Pt personal MD did evaluate.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Headache, Pain, Pruritus, Swelling
Clinical narrative: Headache, achy, itchy, red, swollen area. Took ibuprofen, CORTAID cream and BENADRYL.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus
Clinical narrative: Received PREVNAR 13 vaccine on 12-9-16 had mild discomfort at the injection site. This improved over 2-3 days. On 12-15-16, patient noted his right deltoid region to be red and itchy.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Chills, Diarrhoea, Headache
Clinical narrative: Injection site: Swelling, itching for 1 week. Headache, chills, diarrhea, upset stomach, joint and/or muscle aches for 6-7 days. No treatment given/sought by patient.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: Injection site: Swelling, itching for 1 week. Headache, chills, diarrhea, upset stomach, joint and/or muscle aches for 6-7 days. No treatment given/sought by patient.
Age: 0.5
Sex: F
Vaccine: DTAP, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: Possible four minutes of unresponsive, eyes open. No movement. No GTC. Concerning for seizure.
Age: 1.33
Sex: F
Vaccine: VARCEL
Symptoms: Ataxia, Gait disturbance
Clinical narrative: 8 days later presented with unsteady gait. Neurologist diagnosed ataxia S/P varicella.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: The nurse conducting the flu clinic gave me the shot in the upper/top joint area of my left shoulder. My left shoulder has been in pain since-range of motion affected.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient is still experiencing pain in deltoid (left). He has difficulty moving his arm.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV4, MNQ
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Peripheral swelling, Skin warm
Clinical narrative: Tender swelling involving the right arm (deltoid area) extending down to the lower arm below the Right elbow joint. Warm to touch with reduced range of motion at the elbow joint.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV4, MNQ
Symptoms: Tenderness
Clinical narrative: Tender swelling involving the right arm (deltoid area) extending down to the lower arm below the Right elbow joint. Warm to touch with reduced range of motion at the elbow joint.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Flu vaccine given on Tuesday 12/6/16. Parent called on Thursday 12/8/16 at 9AM. Area on RVL where vaccine administered red, swollen, warm to touch. Exam in clinic on 12/8/16 Right anterior thigh erythematous warm to touch, 3 inches in size-no other rashes noted.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Muscle disorder
Clinical narrative: Shot was given at top of shoulder to high - my Dr said shot should have been lower and now my muscle has been affected - next looking at physical therapy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: (R) deltoid: skin erythematous, edematous, firm, warm to touch. Treated with ice, steroid cream, oral antibiotic.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fluid retention, Oedema, Peripheral swelling
Clinical narrative: Patient received on 12/12/16 2 vaccines PNEUMOVAX 23 and FLUZONE HD. She explained that the same day her deltoid began to swell and she started using ice for hours. She said that it feel like water retention on her arm and by 12/15/16 water started to go down her forearm. She came on 12/15 and arm still a little swollen but not pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of Left thigh Cephalexin prescribed on 12-9-16.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Mobility decreased, Pain in extremity, Skin warm, X-ray
Clinical narrative: On 11/8/2016 administer after couple days throbbing pain in arm/aching arm with warmth over week pain increase and patient took Ibuprofen. Two weeks later she said she was not able to raise arm and went to ER-room. They referred her to orthopedic MD which is had appt on 12/5/2016 and due to inflammation told to come back on 12/19/2016.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Fever 100 degrees F on first night - Pt took MOTRIN. Fevers gone by the next AM. Soreness/pain that was controlled well W/MOTRIN. Pt stopped taking med after 2nd day.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Skin ulcer, Swelling, Urinary incontinence, Vomiting
Clinical narrative: Pt. described as "sores" from head to toe, finally clearing now. Severe vomiting/nausea for 5 days post injection. Swelling, could not urinate for 2 days.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Round, raised, pain around injection site.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at site of injection.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling at the injection site and hot to touch. This resolved after 2-3 days, but mother took a long time to get back to us after multiple attempts.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: 17cmx10cm area of redness, warmth and induration. Treated at urgent care with cephalexin.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Fall, Fatigue, Generalised tonic-clonic seizure, Head injury, Syncope
Clinical narrative: Patient fainted, fell off exam table and hit head, then had tonic-clonic seizure lasting approximately 10 seconds. Post seizure exam showed stable vital signs and neurologic state with the exception of reporting feeling tired postictally.
Age: 16.0
Sex: F
Vaccine: HEP, HPV4, IPV, MMR, TD, VARCEL
Symptoms: Cough, Hypersensitivity
Clinical narrative: Pt's. school nurse reported to a staff that patient had some allergic reaction, coughing a lot. She was sent home with father, RN told father if getting worse to take child to ER 12/13/16. Back to school 12/13/16.
Age: 57.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site reaction, Orthopoxvirus test positive, Post vaccination autoinoculation, Pyrexia, Skin lesion
Clinical narrative: Initial unsolicited report received from literature on 01-DEC-2016. This case involves a 57-year-old male patient who was vaccinated with a dose of ACAM2000 (batch number: VV04-003-A, expiry date, dose in series, dose, route and site of administration was not reported) on 22 Jan 2016. The patient's medical history revealed that, the patient had no ocular, oral, nasal, or genital lesions. Also reported that, the patient had no immunosuppression, heart disease, or history or presence of eczema. Concomitant medications were not reported. On 03 Feb 2016, 12 days (reported as 11 days) following the vaccination, the patient had experienced fever of 101 Degree Celsius (38 degree Celsius) and three lesions near the inoculation site. On 04 Feb 2016, 13 days following the vaccination, the patient had numerous lesions surrounding the inoculation site and 20-30 lesions on his contralateral arm, abdomen and back. Relevant laboratory data showed that DNA for both orthopoxvirus and nonvariola orthopoxvirus was detected from the patient's specimens. Corrective treatment includes vaccination site bandaging and hand hygiene, cleaning communal spaces (e.g., shower and sinks) with bleach, doing own laundry and refraining from gym use until all lesions resolved. Outcome of the patient was not reported. Upon internal review, the company decided to consider the event serious because of important medical event post vaccination autoinoculation. List of documents held by sender: none. Sender's Comments: Patient was vaccinated with ACAM2000 vaccine, 11 days after patient had lesion at inoculation site and fever which expected, on 14th day patient had 20-30 lesions on his contralateral arm, abdomen, and back which might be due autoinoculation. Based on available information the role of vaccine is likely considering the culture report from the lesion.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Erythema, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: 61 yo female with PMH CAD, Acute MI, Gastric Ulcer, Prediabetes, OA, SOB, Ptosis of R eyelid, pulmonary emphysema, GERD, Iron deficiency anemia. Patient reports to outpatient provider for appointment and received influenza and PNEUMOVAX vaccines and both were delivered IM into the L deltoid. The patient had no contraindications to injection. Within an hour of the combination injection, the patient developed significant swelling, redness, and pain spreading down the L arm and persisted for several days. She did not report anaphylactic symptoms and her arm pain and swelling improved with symptomatic management.