chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Erythema, Induration, Skin discolouration, Skin warm
Clinical narrative: MOM REPORTS REDNESS APPEARED -2 AFTER IMMUNIZATION . TODAY, & 3 DAYS  PT HAS REDNESS SURROUNDING PUNTURE MARKS ON R THIGH EXTENDING -3 X 4 INCHES INDUREATED, SLIGHTLY DARKENED AREAS, THINNING OF SUB Q TISSUE, + WARMTH
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test, Gait disturbance, Injection site pain, Musculoskeletal pain
Clinical narrative: A traveling pain .  Started in my left shoulder and then to my right.  Pain moved to in the inside side of my left foot. Then it moved to my right foot.....back ankle. Then to my right hand making it hard to grip things. Then to my right shoulder and then both shoulders and now staying with my left shoulder. Then pain was back but on top of my left foot making it hard to walk.  The pain moves but is very pin pointed.  Aleve sometimes helps....sometimes.   The pain usually lasts about 2 days.....then a break....then it moves somewhere else.   I have never had anything like this before so I'm thinking it had something to do with the shot.   The pain has slowed down and not as often.  When it does start to hurt it only lasts about 5 hrs.   I have been to my doctor and he referred me to a rheumatology doctor.  Saw him yesterday and he said since its getting better not worse that it probably isn't arthritis.  I didn't want to fill this out until I saw him.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: A traveling pain .  Started in my left shoulder and then to my right.  Pain moved to in the inside side of my left foot. Then it moved to my right foot.....back ankle. Then to my right hand making it hard to grip things. Then to my right shoulder and then both shoulders and now staying with my left shoulder. Then pain was back but on top of my left foot making it hard to walk.  The pain moves but is very pin pointed.  Aleve sometimes helps....sometimes.   The pain usually lasts about 2 days.....then a break....then it moves somewhere else.   I have never had anything like this before so I'm thinking it had something to do with the shot.   The pain has slowed down and not as often.  When it does start to hurt it only lasts about 5 hrs.   I have been to my doctor and he referred me to a rheumatology doctor.  Saw him yesterday and he said since its getting better not worse that it probably isn't arthritis.  I didn't want to fill this out until I saw him.
Age: 13.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 5 X 4 CM CIRCULAR EMTREMATOUS CIRCULAR AREA AT INJECTION SITE.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Headache
Clinical narrative: Headache,fever,chills,nausea,muscle aches,weakness,dizziness, jaw pain,redness,swelling and pain at injection site
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Nausea
Clinical narrative: Headache,fever,chills,nausea,muscle aches,weakness,dizziness, jaw pain,redness,swelling and pain at injection site
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in jaw, Pyrexia
Clinical narrative: Headache,fever,chills,nausea,muscle aches,weakness,dizziness, jaw pain,redness,swelling and pain at injection site
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Full blood count, Swelling
Clinical narrative: REDNESS AND SWELLING MEASURING 13 X 12 WITHOUT TENDERNESS
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: AREA AROUND VACCINATION SITE IS SWOLLEN, PAINFUL, SORE AND ITCHY.  PATIENT ALSO HAS 2 RED, RAISED AREAS A FEW INCHES BELOW THE VACCINATION SITE THAT WERE  NOT THERE YESTERDAY, THE DATE OF THE VACCINATION.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix was administered before patient turned 4.
Age: 1.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered
Clinical narrative: I grabbed an expired varivax out of the VFC freezer without noticing. I put the vaccine in the patients chart and did not receive a warning about the vaccine being expired. I drew up the vaccine and administered it.
Age: 1.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: I grabbed an expired varivax out of the VFC freezer without noticing. I put the vaccine in the patients chart and did not receive a warning about the vaccine being expired. I drew up the vaccine and administered it.
Age: 1.42
Sex: F
Vaccine: DTAP
Symptoms: Altered state of consciousness, Blood test, Computerised tomogram head, Depressed level of consciousness, Electroencephalogram
Clinical narrative: 1. RECURRENT COMPLEX SEIZURE W/ POSTURING & RESPIRATORY DEPRESSION; 2. FEVER; 3. ALTERED/ DEPRESSED LEVEL OF CONSCIOUSNESS.
Age: 1.42
Sex: F
Vaccine: DTAP
Symptoms: Posturing, Pyrexia, Respiratory depression, Seizure
Clinical narrative: 1. RECURRENT COMPLEX SEIZURE W/ POSTURING & RESPIRATORY DEPRESSION; 2. FEVER; 3. ALTERED/ DEPRESSED LEVEL OF CONSCIOUSNESS.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Ear pain, Ear swelling, Erythema, Pruritus, Swelling
Clinical narrative: Hives, redness, itchiness, swelling, ears swelling/pain. Treated with Hydroxyzine and Prednisone.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Hives, redness, itchiness, swelling, ears swelling/pain. Treated with Hydroxyzine and Prednisone.
Age: 8.0
Sex: F
Vaccine: HEP, HEPA, IPV, UNK
Symptoms: Contusion, Injection site reaction, Local reaction, Rash erythematous, Skin discolouration
Clinical narrative: LOCALIZED REACTION AT 3 OF 4 INJECTION SITES. ONE ON RT ARM, 2 ON LEFT ARM. BRUISED APPEARANCE WITH SMALL RED SLIGHTLY RAISED BUMPS IN DARKENED AREA, APPROXIMATELY THE SIZE OF QUARTERS, STILL PRESENT AFTER 1 MONTH. OCCURED SEVERAL DAYS AFTER INJECTIONS, TREATED WITH NEOSPORIN , ALCOHOL & PEROXIDE-(PARENT REPORT) DR. NOTIFIED
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Severe headache on night one.  Headache persists with decreasing severity but lasting until present (6 days later).  Nausea and vomiting on 5/17 and 5/18
Age: 8.0
Sex: M
Vaccine: FLU4, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: LARGE LOCALIZED REACTION AROUND INJECTION SITE & REDNESS IT WARM TO TOUCH, X 1 DAY, ADVISED TO USE BENADRYL CREAM OR TABLETS
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site nodule, Injection site rash, Joint swelling, Pain in extremity
Clinical narrative: Redness,rash nodule formation at injection site, pain/soreness, swelling in rt arm down to rt knee  Symptoms reported to have resolved 05/23/19
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Peripheral swelling
Clinical narrative: Redness,rash nodule formation at injection site, pain/soreness, swelling in rt arm down to rt knee  Symptoms reported to have resolved 05/23/19
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site scar
Clinical narrative: pain in arm; mark clearly seen; This case was reported by a consumer and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2018, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced injection site pain and injection site scar. On an unknown date, the outcome of the injection site pain and injection site scar were not recovered/not resolved.   The reporter considered the injection site pain and injection site scar to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on the left upper arm. Several days after receiving Shingrix, the patient began suffering from endless pain in the upper arm at the area where the shot was given with mark clearly seen. After 2 weeks, the patient reported to the pharmacist about the pain he was suffering and the pharmacist told that he would report it to regular channels. The patient updated the pharmacist at almost every 10 days and they decided to wait for few weeks in the hope that the pain will go away. The patient stated that, the pain would come and goes every 2 to 3 days, sometimes a sharp pain, sometimes for a few minutes and often for days. Since from 25th March 2019, the pain persisted and the patient was worried a lot. The pain was troubling as the patient had no way to overcome it and there was no known relief. The pain was bothering the daily life of patient.  The patient claimed that, he hold GlaxoSmithKline responsible for this adverse event and also the company must aware of this medical damage but it was hiding from public. The patient requested amicable settlement in the form of medical relief and monetary compensation for this adverse event.   Follow up information received from the consumer on 21st April 2019: The patient requested to assign a physician to examine him so that the complete information about the adverse events the patient was experiencing would be provided to GlaxoSmithKline. Or the patient would seek medical examination or help by himself and would proceed further for lawsuit.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Headache, Injection site erythema
Clinical narrative: Nausea; Vomiting; diarrhea; Chills; Headaches; quite debilitating; injection site red; Injection site hot; Injection site rash/raised 8 inch rash at the injection site; This case was reported by a consumer and described the occurrence of nausea in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of no adverse event (received original vaccine at least 10 or more years before the reporting date).   On 16th April 2019, the patient received the 1st dose of Shingrix 1 ml. In April 2019, several hours after receiving Shingrix, the patient experienced papular rash, injection site erythema and injection site warmth. On 16th April 2019, the patient experienced nausea, vomiting, diarrhea, chills, headache and debility. In April 2019, the outcome of the papular rash, injection site erythema and injection site warmth were recovered/resolved. On 21st April 2019, the outcome of the nausea, vomiting, diarrhea, chills, headache and debility were recovered/resolved.   It was unknown if the reporter considered the nausea, vomiting, diarrhea, papular rash, chills, headache, injection site erythema, injection site warmth and debility to be related to Shingrix.  Additional details were reported as follows: The patient was in good health and had never reacted to any vaccines in the past. The patient received Shingrix approximately 4:00 PM the first of the two Shingrix. In the same evening, several hrs after vaccination the patient experienced nausea, vomiting, diarrhea, chills throughout the night, splitting headache similar to a migraine.  The next morning on 17th April 2019, the patient had a hot, red, raised 8 inch rash at the injection site.  The most of these symptoms continued until last evening 5 days which seems to be an extended period of time. The patient also had attached a shot of the reaction site as of the day of reporting. Less than a week after, the symptoms were quite debilitating.  The patient was reporting these results in an abundance of caution and in the interest of further research and study.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth, Nausea, Rash papular, Vomiting
Clinical narrative: Nausea; Vomiting; diarrhea; Chills; Headaches; quite debilitating; injection site red; Injection site hot; Injection site rash/raised 8 inch rash at the injection site; This case was reported by a consumer and described the occurrence of nausea in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of no adverse event (received original vaccine at least 10 or more years before the reporting date).   On 16th April 2019, the patient received the 1st dose of Shingrix 1 ml. In April 2019, several hours after receiving Shingrix, the patient experienced papular rash, injection site erythema and injection site warmth. On 16th April 2019, the patient experienced nausea, vomiting, diarrhea, chills, headache and debility. In April 2019, the outcome of the papular rash, injection site erythema and injection site warmth were recovered/resolved. On 21st April 2019, the outcome of the nausea, vomiting, diarrhea, chills, headache and debility were recovered/resolved.   It was unknown if the reporter considered the nausea, vomiting, diarrhea, papular rash, chills, headache, injection site erythema, injection site warmth and debility to be related to Shingrix.  Additional details were reported as follows: The patient was in good health and had never reacted to any vaccines in the past. The patient received Shingrix approximately 4:00 PM the first of the two Shingrix. In the same evening, several hrs after vaccination the patient experienced nausea, vomiting, diarrhea, chills throughout the night, splitting headache similar to a migraine.  The next morning on 17th April 2019, the patient had a hot, red, raised 8 inch rash at the injection site.  The most of these symptoms continued until last evening 5 days which seems to be an extended period of time. The patient also had attached a shot of the reaction site as of the day of reporting. Less than a week after, the symptoms were quite debilitating.  The patient was reporting these results in an abundance of caution and in the interest of further research and study.
Sex: U
Vaccine: FLU4, PPV
Symptoms: Influenza, Pneumonia, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Co-suspect products included PNEUMOCOCCAL PNEUMONIA VACCINE for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose and PNEUMOCOCCAL PNEUMONIA VACCINE. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant), pneumonia (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure, pneumonia and influenza were unknown. It was unknown if the reporter considered the vaccination failure, pneumonia and influenza to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. After vaccination, the patient experienced flu and also pneumonia. The reporter did not think, the reporter would no more bother. This case was considered as suspected vaccination failure as details regarding time to onset for target disease, time to onset and laboratory confirmation were unknown.
Sex: U
Vaccine: FLUX
Symptoms: Asthma, Chronic obstructive pulmonary disease, Dyspnoea
Clinical narrative: Asthma; copd; struggle with my breathing; This case was reported by a consumer via media and described the occurrence of asthma in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, less than a month after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced asthma, chronic obstructive pulmonary disease and difficulty breathing. On an unknown date, the outcome of the asthma, chronic obstructive pulmonary disease and difficulty breathing were unknown.   It was unknown if the reporter considered the asthma, chronic obstructive pulmonary disease and difficulty breathing to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The reporter was a carer for the elderly person. The patient walked to all calls about 3 months before the reporting date. The reporter had the new flu jab 3 in 1 within 2 weeks and started to struggle with breathing and had been diagnosed with COPD (chronic obstructive pulmonary disease) or Asthma had anyone else had the same sort of reaction to the shot. The patient was always being very fit working 50 to 60 hours per week without any problem.
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Previously administered products included ZOSTAVAX. Concurrent medical conditions included allergy to antibiotic (Sulfa antibiotics), drug hypersensitivity (to neomycin) and iodine allergy. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a sore arm after receiving a flu vaccine (unknown manufacturer). This case has been linked with US2019087226, reported by same reporter for the same patient. It was unknown whether VAERS information reported for Flu vaccine or not.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Gait disturbance, Pain, Rash
Clinical narrative: rash on her shoulder; severe diarrhea; body aches from head to neck; weak; could hardly walk; This case was reported by a consumer via call center representative and described the occurrence of rash in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced rash, diarrhea, general body pain, weakness and walking difficulty. The patient was treated with valaciclovir hydrochloride (Valtrex) and topical steroid nos (Steroid Ointment Nos). On an unknown date, the outcome of the rash, diarrhea and weakness were not recovered/not resolved and the outcome of the general body pain was recovering/resolving and the outcome of the walking difficulty was unknown.   The reporter considered the rash to be related to Shingrix. It was unknown if the reporter considered the diarrhea, general body pain, weakness and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient had Shingrix and a few days later she started having symptoms and her symptoms really got worse about a week after.  Her symptoms were rash on her shoulder the size of baseball. She visited her dermatologist and was prescribed a steroid ointment. Her dermatologist also put her on Valtrex as a precautionary method, since they were not sure why she was reacting that way to the vaccine.  Patient also experienced severe diarrhea. The diarrhea comes and goes. She still had it until yesterday at least and she lost 7 pounds. Patient also experienced all over aching or body aches from her head, neck, all the way down her body.  The pain was so severe she couldn't get out of bed and could hardly walk due to the pain.  Patient is not having the pain as severely  anymore but said she is still very weak and doesn't feel completely well. The reporter did not consent to follow-up. There is a discrepancy with respect to the outcome of the events rash, diarrhea and weakness In Argus core the outcome is reported as not recovered for these events, however in provided source document it is recovering/resoling. The outcome for these event is retain as per reported.      Lab Comments: Lab test performed on an unknown date
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Weight decreased
Clinical narrative: rash on her shoulder; severe diarrhea; body aches from head to neck; weak; could hardly walk; This case was reported by a consumer via call center representative and described the occurrence of rash in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced rash, diarrhea, general body pain, weakness and walking difficulty. The patient was treated with valaciclovir hydrochloride (Valtrex) and topical steroid nos (Steroid Ointment Nos). On an unknown date, the outcome of the rash, diarrhea and weakness were not recovered/not resolved and the outcome of the general body pain was recovering/resolving and the outcome of the walking difficulty was unknown.   The reporter considered the rash to be related to Shingrix. It was unknown if the reporter considered the diarrhea, general body pain, weakness and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient had Shingrix and a few days later she started having symptoms and her symptoms really got worse about a week after.  Her symptoms were rash on her shoulder the size of baseball. She visited her dermatologist and was prescribed a steroid ointment. Her dermatologist also put her on Valtrex as a precautionary method, since they were not sure why she was reacting that way to the vaccine.  Patient also experienced severe diarrhea. The diarrhea comes and goes. She still had it until yesterday at least and she lost 7 pounds. Patient also experienced all over aching or body aches from her head, neck, all the way down her body.  The pain was so severe she couldn't get out of bed and could hardly walk due to the pain.  Patient is not having the pain as severely  anymore but said she is still very weak and doesn't feel completely well. The reporter did not consent to follow-up. There is a discrepancy with respect to the outcome of the events rash, diarrhea and weakness In Argus core the outcome is reported as not recovered for these events, however in provided source document it is recovering/resoling. The outcome for these event is retain as per reported.      Lab Comments: Lab test performed on an unknown date
Age: 82.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, Herpes zoster, Inappropriate schedule of product administration, Sensitive skin
Clinical narrative: Circumstance or information capable of leading to a medication error; Extra dose administered; Drug dose administration interval too long; shingles; sensitivity around his waist; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   In February 2018, the patient received the 1st dose of Shingrix. In November 2018, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 3rd dose of Shingrix. In October 2018, 244 days after receiving Shingrix and not applicable after receiving Shingrix and Shingrix, the patient experienced shingles and sensitive skin. In November 2018, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced circumstance or information capable of leading to medication error and extra dose administered. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the sensitive skin, drug dose administration interval too long, circumstance or information capable of leading to medication error and extra dose administered were unknown.   It was unknown if the reporter considered the shingles and sensitive skin to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Prior to the 2nd dose, in October 2018, less than a year after receiving Shingrix, the patient developed a sensitivity around his waist that was later diagnosed as an isolated mild case of shingles with no rash.  The patient received the 2nd dose in November of 2018 later then the recommended schedule, which led to the lengthening of the vaccination schedule. The patient was working with his physician to get a 3rd dose of Shingrix, which led to the circumstance or information capable of leading to a medication error and extra dose administered. There is a discrepancy with respect to outcome of the event mild case of shingles. As per reported in the structural field it is not recovered; however, as per source document it is recovering/resolving. Retain not recovered as per the structural field.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain in extremity, Pruritus
Clinical narrative: painful blisters on hand; itchy hand; painful hands; This case was reported by a other health professional via call center representative and described the occurrence of blister in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th May 2019, the patient received the 1st dose of Shingrix. On 11th May 2019, less than a day after receiving Shingrix, the patient experienced blister, itching both hands and pain in hand. On an unknown date, the outcome of the blister, itching both hands and pain in hand were not recovered/not resolved.   It was unknown if the reporter considered the blister, itching both hands and pain in hand to be related to Shingrix.  Additional details were reported as follows: The healthcare professional reported that the patient received Shingrix at their pharmacy in the right arm.  On 12th May 2019, the patient woke up to painful, itchy blisters on their right hand.  On 13th May 2019, in the morning patient woke up to painful, itchy blisters on both hands.  The healthcare professional would like to know if MI had treatment options and recommendation on receiving the 2nd dose in 6 months.  The healthcare professional was unaware of the healthcare professional that administered the vaccine. The healthcare professional did not have lot number or expiry date. The outcome reported for all AES in the structured field of database is recovering instead of Not Recovered/Not Resolved (outcome uploaded in database)
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Myalgia, Pain, Pyrexia
Clinical narrative: fever; chills; body aches; joint pain overall; muscle pain overall; This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2019, the patient received the 2nd dose of Shingrix. On 11th May 2019, 5 days after receiving Shingrix, the patient experienced fever, chills, general body pain, joint pain and muscle pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was not recovered/not resolved and the outcome of the chills, general body pain, joint pain and muscle pain were unknown.   It was unknown if the reporter considered the fever, chills, general body pain, joint pain and muscle pain to be related to Shingrix.  Additional details were provided as follows: The reporter reported that he received Shingrix last Monday, and on Saturday and Sunday he began to experience, fever and body temperature was recorded as 101 degree F, chills that required him to stay under the covers, body aches and overall joint and muscle soreness.  The patient took Tylenol for the fever, which resolved but it was back again at the time of reporting. The patient referred to his physician.
Age: 58.0
Sex: M
Vaccine: TTOX, VARZOS
Symptoms: Bone pain, Headache, Influenza like illness
Clinical narrative: HEADACHE; bones are aching; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of headache in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TETANUS VACCINE for prophylaxis.   On 13th May 2019, the patient received the 1st dose of Shingrix and TETANUS VACCINE. On 14th May 2019, 1 days after receiving Shingrix, the patient experienced headache, bone pain and influenza-like symptoms. On an unknown date, the outcome of the headache, bone pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the headache, bone pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: On the reporting date, in the morning, the patient experienced headache, his bones were aching and he had flu like symptoms. The reporter did not consent to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Rash on arm/ Back; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number N9CA2, expiry date 2nd July 2021) for prophylaxis.   On 17th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and has rash on chest, arms and back.  The reporter gathered patient information.
Sex: U
Vaccine: PNC13
Symptoms: Apnoea, Pyrexia, Seizure
Clinical narrative: seizure; apnea; high fever; This is a spontaneous report from a non-contactable nurse. A patient of unspecified age and gender received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had high fever, seizure and apnea. The reporter requested that the pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) be tested for contamination. The reporter was asking how the product should be stored. The outcome of high fever, seizure and apnea was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: A causal association between administration of PREVENAR 13 and the onset of seizure and apnea cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product.
Sex: U
Vaccine: MENB
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a contactable physician (Pediatrics) via Pfizer sales representative.   A patient of unspecified age and gender received the 1st dose of meningococcal group b rlp2086 (TRUMENBA) via an unspecified route of administration at single dose on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced rash on an unspecified date with outcome of unknown.   The reporter queried If a patient developed a rash after a first meningococcal group b rlp2086 vaccination would it be considered ok to administer the 2nd shot six months later.  Information on the lot/batch number has been requested
Age: 100.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Fatigue, Lethargy, Malaise, Mobility decreased
Clinical narrative: Pain affected arm; could not move her arm; Nausea and vomiting; Nausea and vomiting; Lethargy; Fatigue malaise; Fatigue malaise; Weakness; This is a spontaneous report from a contactable nurse who reported for her mother. A 100-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date unknown), via an unspecified route of administration at the arm on 15May2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain affected arm, could not move her arm, nausea and vomiting, lethargy, fatigue malaise, weakness. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 100.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: Pain affected arm; could not move her arm; Nausea and vomiting; Nausea and vomiting; Lethargy; Fatigue malaise; Fatigue malaise; Weakness; This is a spontaneous report from a contactable nurse who reported for her mother. A 100-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date unknown), via an unspecified route of administration at the arm on 15May2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain affected arm, could not move her arm, nausea and vomiting, lethargy, fatigue malaise, weakness. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Burning sensation, Erythema, Inflammation, Malaise
Clinical narrative: Hurt really bad/stung really bad/little sore; It really burned; He wake up and the area was completely red; A little bit of bump there like the serum had not spread, visibly swollen, protrusion of the inflammation; A little bit of bump there like the serum had not spread, visibly swollen, protrusion of the inflammation; A little bit of bump there like the serum had not spread, visibly swollen, protrusion of the inflammation; Really sleepy; He did not feel good like, he had no energy; He did not feel good like, he had no energy; His arm hurt really bad; This is a spontaneous report from a contactable consumer (patient).   A 50-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date, at single dose, for immunization. Relevant medical history included blood pressure high. Concomitant medications included lisinopril from an unspecified date, once daily (25-20 mg, one time a day), for blood pressure high. On an unspecified date, the patient experienced pain ("hurt really bad/stung really bad/little sore"), burning sensation ("it really burned"), redness ("he wake up and the area was completely red"), mass, swelling, inflammation ("a little bit of bump there like the serum had not spread, visibly swollen, protrusion of the inflammation"), sleepy, feeling unwell, energy decreased ("he did not feel good like, he had no energy") and pain in arm ("his arm hurt really bad"). Clinical outcome of the adverse events was unknown at time of this report.  The information on the lot number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Mass, Pain, Pain in extremity, Somnolence, Swelling
Clinical narrative: Hurt really bad/stung really bad/little sore; It really burned; He wake up and the area was completely red; A little bit of bump there like the serum had not spread, visibly swollen, protrusion of the inflammation; A little bit of bump there like the serum had not spread, visibly swollen, protrusion of the inflammation; A little bit of bump there like the serum had not spread, visibly swollen, protrusion of the inflammation; Really sleepy; He did not feel good like, he had no energy; He did not feel good like, he had no energy; His arm hurt really bad; This is a spontaneous report from a contactable consumer (patient).   A 50-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date, at single dose, for immunization. Relevant medical history included blood pressure high. Concomitant medications included lisinopril from an unspecified date, once daily (25-20 mg, one time a day), for blood pressure high. On an unspecified date, the patient experienced pain ("hurt really bad/stung really bad/little sore"), burning sensation ("it really burned"), redness ("he wake up and the area was completely red"), mass, swelling, inflammation ("a little bit of bump there like the serum had not spread, visibly swollen, protrusion of the inflammation"), sleepy, feeling unwell, energy decreased ("he did not feel good like, he had no energy") and pain in arm ("his arm hurt really bad"). Clinical outcome of the adverse events was unknown at time of this report.  The information on the lot number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: Swelling at site; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), lot number and expiration date were not reported, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced swelling at site on an unspecified date. The outcome of the event swelling at site was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 18.0
Sex: M
Vaccine: SMALL
Symptoms: Urticaria
Clinical narrative: Hives presented 24 APR 2019.
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: HIVE, ERYTHEMA AND ITCHY.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site haemorrhage, Injection site swelling, Injection site warmth
Clinical narrative: A subtle swelling in the RT lower deltoid area w/ 2 small ecchymosis areas. He doesn't seem to be bothered while I palpate the area and  is active and playful in the exam room. Shoulder and elbow FROM. Pulses nl. Area feels slightly warm .
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: FEVER 101 F FOR 4 DAYS THEN RASH, ITCHY & RAISED BUMPS
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient returned to pharmacy on 5/22/19 complaining of extreme pain, swelling, and erythema at the injection site. Patient reports dizziness, forgetfullness, memory lapses, and confusion in the 72 hours following the injection. Patient has treated the injection site with topical ice packs. Approximately 24 post-injection, the patient developed a mild fever that she treated with ibuprofen 400mg. On 5/22/19, a warm red circle approximately 4 inches by 3 inches in size can be seen on the back part of the arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Memory impairment, Pyrexia
Clinical narrative: Patient returned to pharmacy on 5/22/19 complaining of extreme pain, swelling, and erythema at the injection site. Patient reports dizziness, forgetfullness, memory lapses, and confusion in the 72 hours following the injection. Patient has treated the injection site with topical ice packs. Approximately 24 post-injection, the patient developed a mild fever that she treated with ibuprofen 400mg. On 5/22/19, a warm red circle approximately 4 inches by 3 inches in size can be seen on the back part of the arm.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pain
Clinical narrative: Pain and swelling, fever, muscle and joint pain, chills and headache.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: Pain and swelling, fever, muscle and joint pain, chills and headache.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Hypoaesthesia, Neck pain, Nuclear magnetic resonance imaging normal, Pain
Clinical narrative: DAY 1 - SORENESS - 10-29-07 DAY 2 - SORE & SWOLLEN DAY 3 - TINGLING & NUMB & PAIN TO NECK DAY 4 - DISCOLORATION, RED BLOTCHES TO ARM, HA DAY 5 - CIRC. PROBLEMS TO ARM WENT TO ER. HAD MRI  DONE. - IS DOING BETTER 11/6/07
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Rash macular, Skin discolouration, Swelling
Clinical narrative: DAY 1 - SORENESS - 10-29-07 DAY 2 - SORE & SWOLLEN DAY 3 - TINGLING & NUMB & PAIN TO NECK DAY 4 - DISCOLORATION, RED BLOTCHES TO ARM, HA DAY 5 - CIRC. PROBLEMS TO ARM WENT TO ER. HAD MRI  DONE. - IS DOING BETTER 11/6/07
Age: 29.0
Sex: M
Vaccine: HEP, IPV, MNQ, TYP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient complained of local reaction to vaccine administered on 4/2/19.  Patient reported he didn't know which vaccine was given but that he was told  by the MA that it was a powder and that it could not be given in the muscle. The vaccine was administered SQ to left upper arm.  The site was warm to touch with redness and swelling noted.  Patient reported tenderness at site.   Patient was seen in clinic by Provider.   Patient was advised to apply warm cloth to the area, watch for abscess and fever, and to follow up in symptoms persist.  Patient was prescribed mupirocin to apply to the area.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Injection site bruising, Injection site reaction, Rash erythematous
Clinical narrative: AFTER VACCINE WAS GIVEN THERE WAS A BRUISE AT THE SITE. ABOUT 24 HOURS LATER THERE WAS A RED, RAISED RASH AREA ABOUT 4 CM IN DIAMETER. DTAP & VARIVAX WERE GIVEN IN THE RIGHT THIGH
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Scar, Skin lesion
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 14-JAN-2014, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not specified) for its intended purpose: the prevention of shingles. As a direct result of the vaccine, patient suffered from a Shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. The patient did not have a Shingles outbreak until 01-NOV-2014. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations, scaring and seriousness of his condition and continues to suffer and endure the expenses of life long medications. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Shingles outbreak and scarring were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: The patient experienced redness and swelling with Pneumovax; The patient experienced redness and swelling with Pneumovax; This spontaneous report was received from a nurse regarding a female patient of unknown age and gender. Information on patient's concurrent conditions, medical history and concomitant medications were not reported. On 11-OCT-2010, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, anatomical location, route, lot# and expiry date were not reported) for prophylaxis. On an unknown date, the patient experienced redness (erythema) and swelling with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). It was reported that no other vaccination were given at this time of injection with prepping 13.The outcome of the events was unknown.The causality assessment was related.
Sex: U
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: experienced pain in the arm after receiving the GARDASIL 9 vaccine; This spontaneous report was received from a pharmacist, via a company representative and refers to a 16 year old patient of unknown gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).         On an unknown date, the patient experienced pain in the arm after receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccine (pain in extremity). It was unknown if the patient received any treatment for the event.       The outcome of pain in extremity was reported as resolved at the reporting time and lasted for 1 week.      the causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the event was unknown.      This is one of the 2 reports received form the same source.; Sender's Comments:  US-009507513-1905USA010476:
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects were reported; Inadvertently administered a dose of MMR II via intramuscular route rather than the recommended subcutaneous route; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergy/ drug reaction and concomitant medications were not reported. On 19-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R031629, route: intramuscular (strength, formulation, dose/ frequency was unknown) for prophylaxis. The patient inadvertently administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) via the intramuscular route rather than the recommended subcutaneous route (incorrect route of product administration). On an unknown date, the patient experienced no adverse event. The outcome of incorrect route of product administration and no adverse event was unknown. The reporter considered incorrect route of product administration and no adverse event to be not assessed to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II).
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 73 year old male patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. In April 2017, when the pt was 71 years old, he was vaccinated with zoster vaccine live (ZOSTAVAX) for long term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced herpes zoster resulting from zoster vaccine live (ZOSTAVAX) use. The pt received treatment from a healthcare provider at the facility. The pt claimed damages as result of injuries, loss of consortium and services and economic losses. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).