chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Injection site pain, Lung infection, Nausea
Clinical narrative: Injection in left arm slight pain. Pain dissipated in two days. Six days after getting shot I woke with very severe pneumonia like symptoms. All my joints, back, neck ache with pain. Constantly running fever (104), eyes hurt. I periodically sweat a lot, then shiver for hours. This has been going on from July 26 to present. On July 29, 2019 I visited my PCP. He stated symptoms were very serious & I needed to go to Emergency room. My wife immediately drove me to emergency  room at Hospital. I was having a hard time standing & walking, I was extremely weak. I was asked by several healthcare persons if I had recently had a flu shot etc. I told them on July 20 I had taken the Shingrix shot none seemed to know anything about Shingrix  (I explained to them what it was for). I told healthcare persons I did not have much of an appetite since getting the Shingrix shot. I told them I felt that if I ate I would vomit. I have been trying to avoid that at all cost. I can only imagine what the pressure if vomiting would be like on my aching head & body. They diagnosed me with pneumonia. I told them that before the shot & after I had not been around large groups of people with the exception of being in grocery store to get the shot. I truly believe that the Shingrix vaccine was the cause of this. I have not been sick in years. Bad diarrhea started on 7/31/2019. Entered emergency room on 7/29/2019 - 6:00 PM Released on 7/30/2019 - 5:00 PM
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pneumonia, Pyrexia
Clinical narrative: Injection in left arm slight pain. Pain dissipated in two days. Six days after getting shot I woke with very severe pneumonia like symptoms. All my joints, back, neck ache with pain. Constantly running fever (104), eyes hurt. I periodically sweat a lot, then shiver for hours. This has been going on from July 26 to present. On July 29, 2019 I visited my PCP. He stated symptoms were very serious & I needed to go to Emergency room. My wife immediately drove me to emergency  room at Hospital. I was having a hard time standing & walking, I was extremely weak. I was asked by several healthcare persons if I had recently had a flu shot etc. I told them on July 20 I had taken the Shingrix shot none seemed to know anything about Shingrix  (I explained to them what it was for). I told healthcare persons I did not have much of an appetite since getting the Shingrix shot. I told them I felt that if I ate I would vomit. I have been trying to avoid that at all cost. I can only imagine what the pressure if vomiting would be like on my aching head & body. They diagnosed me with pneumonia. I told them that before the shot & after I had not been around large groups of people with the exception of being in grocery store to get the shot. I truly believe that the Shingrix vaccine was the cause of this. I have not been sick in years. Bad diarrhea started on 7/31/2019. Entered emergency room on 7/29/2019 - 6:00 PM Released on 7/30/2019 - 5:00 PM
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Bursitis, Cartilage injury, Immediate post-injection reaction, Muscular weakness, Musculoskeletal pain
Clinical narrative: Patient describes severe shoulder pain that began immediately after receiving AVA #4.  Shoulder was 0/10 pain prior to immunization.  Patient indicates that the injection was centered but high, adding that both he and the vaccinator were standing, but the vaccinator was much taller than him.  When first evaluated, patient's pain was 2/10 without movement and up to 8/10 with activity. Pain has increased over the past week because patient's spouse is away for work and he is caring for their 11mo by himself: pain is constant, now 5/10 at the lowest and 6-7/10 with activity. He describes the pain as 'grinding of bones.' Pain significantly disturbs sleep. Patient denies radiation or parasthesias but shoulder is weak compared to L. On exam there is no obvious deformity and pain not reproduced with superficial palpation. Patient is pos for Neer's sign but neg for cross arm.  Patient has been taking Mobic and Tylenol and doing HEP. He was referred for PT (start 15 MAY); had 4 session and received steroid injection on 23 MAY 2019. He has since been lost to followup.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain, Product administered at inappropriate site, Sleep disorder, Tendon disorder
Clinical narrative: Patient describes severe shoulder pain that began immediately after receiving AVA #4.  Shoulder was 0/10 pain prior to immunization.  Patient indicates that the injection was centered but high, adding that both he and the vaccinator were standing, but the vaccinator was much taller than him.  When first evaluated, patient's pain was 2/10 without movement and up to 8/10 with activity. Pain has increased over the past week because patient's spouse is away for work and he is caring for their 11mo by himself: pain is constant, now 5/10 at the lowest and 6-7/10 with activity. He describes the pain as 'grinding of bones.' Pain significantly disturbs sleep. Patient denies radiation or parasthesias but shoulder is weak compared to L. On exam there is no obvious deformity and pain not reproduced with superficial palpation. Patient is pos for Neer's sign but neg for cross arm.  Patient has been taking Mobic and Tylenol and doing HEP. He was referred for PT (start 15 MAY); had 4 session and received steroid injection on 23 MAY 2019. He has since been lost to followup.
Age: 18.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Cold sweat, Eye movement disorder, Hypotonia, Loss of consciousness, Muscle tightness
Clinical narrative: After receiving the Varicella vaccine, the patient passed out. His eyes rolled to he back of his head, his body went limp, then his arm muscles tensed/seized up. Patient came to quickly and was speaking normally but had cold clammy skin. Patient was advised to remain seated. Within 5 minutes, patient passed out again with similar symptoms as previous. Again, he quickly came to and was speaking and acting normally. Paramedics arrived and patient was found to be stable with no more episodes. Patient was released from care.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effect reported; second dose of PROQUAD was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant therapies, concurrent conditions, and drug reactions/allergies were not provided. The patient was administered a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) on 16-JAN-2015.  On 26-DEC-2017, the patient was administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number and expiration date were unknown) subcutaneously for prophylaxis.  On 12-JUN-2019, the patient did not have his/her vaccination record upon visiting office, at which time a second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number S000620, expiration date 06-JUL-2020) subcutaneously for prophylaxis. Once the patient's vaccination record was obtained, it was discovered that the patient had already received a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (extra dose administered). No adverse effect was reported. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Exposure during pregnancy
Clinical narrative: no adverse effects; received one dose of GARDASIL 9 while pregnant; received one dose of GARDASIL 9 while pregnant; received one dose of GARDASIL 9 while pregnant; This spontaneous prospective pregnancy report was received from an office manager referring to a pregnant female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  The patient became pregnant with last menstrual period (LMP) of 28-NOV-2018.  On 15-MAY-2019, at a gestational period of 24 weeks, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage schedule, route and anatomical location were not reported), lot # R004689, with expiration date on 29-NOV-2020, for prophylaxis (maternal exposure during pregnancy) (vaccine exposure during pregnancy) (product use issue). On an unknown date an unspecified blood work was performed.  The pregnancy outcome was outcome pending and the fetal outcome was unknown. The estimated date of delivery (EDD) was calculated as 04-SEP-2019.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; a patient was administered an improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Concomitant medications included sterile diluent. Information about the patient's pertinent medical history, previous drug reactions and allergies was not provided.  On 16-JUL-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis, lot number R035221 and expiration date 04-DEC-2019 (strength and route of administration was not provided) (product storage error).   No adverse effects were reported.  The temperature of the vaccine administered was reported as from 15-degree Fahrenheit to 46-degree Fahrenheit (29.1-degree Fahrenheit) and the time frame as for 3 hours.  There was no previous temperature excursion. No data logger involved.
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: No adverse effects; An adult patient received a pediatric dose of VAQTA; This spontaneous report has been received from a registered nurse referring to an adult patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On 14-JUN-2019, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated(VAQTA) lot # R034339 with expiration date of  23-NOV-2019 (strength, frequency, dose, route, and anatomical location were not provided) for prophylaxis.
Age: 0.75
Sex: U
Vaccine: HEP
Symptoms: Needle issue, No adverse event
Clinical narrative: No adverse effects reported; the needle came apart where it was attached and as a result, it is possible that the patient did not receive full dose.; the needle came apart where it was attached and as a result, it is possible that the patient did not receive full dose.; Information has been received from a registered nurse, referring to a 9 months old infant of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 17-MAY-2019, the patient was vaccinated with third dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (lot # R021372, expiration date: 25-MAY-2021, therapy type: thimerosal free, strength, dose, frequency, route were unknown) for prophylaxis. During administration, the needle came apart where it was attached and as a result, it was possible that the patient did not receive full dose (accidental underdose, product use issue). No product quality issue since determined to be user error in attaching needle to syringe. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Oral administration complication, Underdose, Vomiting projectile
Clinical narrative: projectile vomited immediately afterward and spit up the entire dose; projectile vomited immediately afterward and spit up the entire dose; projectile vomited immediately afterward and spit up the entire dose; This spontaneous report was received from a physician referring to a 2 months old patient of unknown gender. No information was provided regarding the patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.    On 20-JUL-2019, the patient was vaccinated with one dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (dose, frequency, lot# and expiration date were not reported) route was default as oral for prophylaxis. The patient had "projectile vomited" immediately afterward and spit up the entire dose (underdose). The outcome of the events vomiting projectile and infantile spitting up were not reported.        The causality between the suspect vaccine and the events vomiting projectile and infantile spitting up were not reported.
Sex: F
Vaccine: HPV9
Symptoms: Gait disturbance, Muscular weakness, Walking aid user
Clinical narrative: severe muscle weakness in her legs the next day/the patient was not able to walk without assistance; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age, who was the pharmacist's sister. There was no information concerning the patient's pertinent medial history, concomitant medications, concurrent conditions, drug reactions or allergies provided. On an unknown date in approximately 2015 (reported as 3-4 years ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9),intramuscularly (dose, lot# and expiration date were not provided) for prophylaxis.  On an unknown date in approximately 2015, reported as on the next day, the patient developed severe muscle weakness in her legs.The patient sought medical attention and on the same day, she went to an unspecified hospital however it was unknown at the time of call if she was admitted. Reporter stated that the symptoms lasted for four weeks and the patient was not able to walk without assistance however it gradually got better and went away on an unspecified date. The causality assessment was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Balance disorder, Syncope
Clinical narrative: fainted right in front of me; lost her balance; This spontaneous report was received from a pharmacist, and refers to a female patient of unknown age, described as young. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. 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), injection, intramuscularly (exact dose, lot# and expiry date were not reported) for prophylaxis. On an unknown date, after the vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient lost her balance and fainted right in front of the reporter.   At the reporting time, the outcome of the events was not reported, and the causality assessment was not provided.  Upon internal review, the event of syncope was considered to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects were reported; 8 year old patient was inadvertently administered a dose of GARDASIL 9; This spontaneous report was received from a physician via a company representative and refers to an 8 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 17-JUN-2019 (also reported as 17-JUL-2019), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R021636, expiration date 12-MAY-2021, intramuscularly in the patient's upper left arm (dose and frequency were not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient had first GARDASIL 9 ata age 12 and second dose at age 17; This spontaneous report was received from a nurse via a Merck Vaccine Customer Center (MVCC) Representative referring to a 13 years old female patient. The patient's concomitant therapies, concurrent conditions, and drug reactions/ allergies were not provided.  Approximately in 2014, the patient had her first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number, expiration date and route of administration were unknown by the reporter) for prophylaxis at age 12. No product quality complaint (PQC) was involved.  On 26-JUL-2019, the patient was in the office to receive her 2nd dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number, expiration date and route of administration were unknown) for prophylaxis at age 17 (inappropriate schedule of product administration).
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects; the patient received a dose of VARIVAX via the intramuscular route; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information regarding patient's concurrent conditions, medical history, drug allergies or reactions was provided.      On 28-JUL-2019, the patient was vaccinated for prophylaxis with varicella virus vaccine live (oka/merck) (VARIVAX) one dose, intramuscularly, (lot # S002084 and expiration date: 21-JAN-2021) (anatomical location site of administration were not provided) (incorrect route of product administration) and sterile diluent (STERILE DILUENT) (lot number and expiration date were not reported). No adverse effects were reported.
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Pain
Clinical narrative: fatigue; pain; This case was reported by a nurse via sales rep and described the occurrence of fatigue in a 20-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero .5 ml. On an unknown date, unknown after receiving Bexsero, the patient experienced fatigue and pain. On an unknown date, the outcome of the fatigue and pain were recovered/resolved.   It was unknown if the reporter considered the fatigue and pain to be related to Bexsero.  Additional information was provided as follows: The age at vaccination was not reported, however the patient's age group could be adult. The patient received Bexsero and experienced significant fatigue and pain which lasted for one or two days. The reporter agreed to be followed up.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Felt Horrible; This case was reported by a nurse via call center representative and described the occurrence of feels awful in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingrix.  Additional details were received as follows: The age vaccination was not reported. The healthcare professional stated that she felt horrible for a week after the immunization. The healthcare professional submitted as much information as she provided in the email. The reporter did not consent to follow up.
Age: 73.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Facial paralysis, Inappropriate schedule of product administration
Clinical narrative: Drug dose administration interval too short; Bells Palsy/ Facial drooping; This case was reported by a pharmacist via call center representative and described the occurrence of bell's palsy in a 74-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   On 8th February 2019, the patient received the 2nd dose of Twinrix. On an unknown date, the patient received the 3rd dose of Twinrix. On 1st June 2019, 113 days after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the bell's palsy and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the bell's palsy to be related to Twinrix.  Additional details were provided as follows: The patient came in for third dose of Twinrix, when they noticed facial drooping. The patient received 3rd dose of Twinrix earlier than recommended interval, which led to the shortening of vaccination schedule.  The reporter reported developing Bells Palsy 4 month after receiving 2nd dose of Twinrix. The reporter consented to follow up. The reporter did not have lot number or expiration date at this location.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Herpes oesophagitis, Herpes ophthalmic, Herpes zoster, Herpes zoster oticus
Clinical narrative: Suspected vaccination failure; herpes outbreaks; eyes herpes; herpes on throat; herpes on ear; patches over skin; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 10th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster, herpes ophthalmic (serious criteria GSK medically significant), herpes esophagitis (serious criteria GSK medically significant), herpes zoster oticus (serious criteria GSK medically significant) and patchy rash. On an unknown date, the outcome of the vaccination failure, herpes zoster, herpes ophthalmic, herpes esophagitis, herpes zoster oticus and patchy rash were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster, herpes ophthalmic, herpes esophagitis, herpes zoster oticus and patchy rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported for the 1st dose. The patient had experienced constant and recurring herpes outbreaks since the second dose, occurring in the eyes, throat, ears and patches over skin.   The reporter reported that this event has necessitated patient be seen by his primary care doctor and they have been running blood tests to investigate. The reporter consented to follow up. This case was considered as suspected vaccination failure as time to onset for the event and laboratory confirmation were unknown.      Lab Comments: Lab test performed on unknown date
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; herpes outbreaks; eyes herpes; herpes on throat; herpes on ear; patches over skin; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 10th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster, herpes ophthalmic (serious criteria GSK medically significant), herpes esophagitis (serious criteria GSK medically significant), herpes zoster oticus (serious criteria GSK medically significant) and patchy rash. On an unknown date, the outcome of the vaccination failure, herpes zoster, herpes ophthalmic, herpes esophagitis, herpes zoster oticus and patchy rash were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster, herpes ophthalmic, herpes esophagitis, herpes zoster oticus and patchy rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported for the 1st dose. The patient had experienced constant and recurring herpes outbreaks since the second dose, occurring in the eyes, throat, ears and patches over skin.   The reporter reported that this event has necessitated patient be seen by his primary care doctor and they have been running blood tests to investigate. The reporter consented to follow up. This case was considered as suspected vaccination failure as time to onset for the event and laboratory confirmation were unknown.      Lab Comments: Lab test performed on unknown date
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Syncope; This case was reported by a physician via call center representative and described the occurrence of syncope in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th July 2019, the patient received the 1st dose of Shingrix. On 19th July 2019, 1 days after receiving Shingrix, the patient experienced syncope (serious criteria GSK medically significant). On an unknown date, the outcome of the syncope was recovered/resolved.   It was unknown if the reporter considered the syncope to be related to Shingrix.  Additional details were provided as follows: The patient had a syncopal episode 1 day after immunization.
Sex: M
Vaccine: MEN, MENB
Symptoms: Chills, Decreased appetite, Injection site pain, Pain, Pyrexia
Clinical narrative: The patient experienced fever of 101 degrees; Chills; Body aches; Loss of appetite; Pain at the injection site; This is a spontaneous report from a contactable nurse (patient's mother) via a Pfizer sales representative. A 16-year-old male patient received meningococcal group b rlp2086 (TRUMENBA) and meningococcal vaccine a/c/y/w (manufacturer unknown), via an unspecified route of administration in arm on an unspecified date at a single dose for immunization. Medical history included ongoing asthma and patient has been taking medication for symptom control. The patient's concomitant medications were not reported. The patient was administered both meningococcal group b rlp2086 and meningococcal vaccine a/c/y/w at the same time in separate arms. The patient experienced fever of 101 degrees, chills, body aches, loss of appetite and pain at the injection site on an unknown date. Patient was otherwise normal and healthy. The events resolved on an unknown date after approximately 48 hours.  Information on the batch number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Injection site paraesthesia
Clinical narrative: Tingling of left arm where shot was given, closing of eyes (possible fainting); Tingling of left arm where shot was given, closing of eyes (possible fainting); This is a spontaneous report from a contactable nurse via Pfizer sales representative.   A 17-year-old female patient received the first dose of meningococcal group b rlp2086 (TRUMENBA) on an unspecified date at single doses for immunisation . The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced tingling of left arm where shot was given and closing of eyes (possible fainting); patient stayed for a few minutes and left without further complications. Events were reported as non serious. Final outcome of the events was reported as unknown.Information on the batch number has been requested.; Sender's Comments: Based on the information currently available, a contributory role of TRUMENBA towards the occurrence of events tingling of left arm where shot was given and closing of eyes (possible fainting) cannot be fully excluded.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever- highest of 103
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection sites
Age: 47.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Pain
Clinical narrative: Pain when injecting; pain in shoulder/arm thereafter; hurts especially when lifting arm above shoulder level, ie. Taking off shirt
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Contusion, Full blood count, Petechiae, Platelet count decreased
Clinical narrative: Platelet level of 9,000 after going to doctor for severe bruising and petichia.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEPAB, MMRV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, throwing up
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Influenza like illness, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: one day after - fever of 101.2, body aches (flu-like symptoms), light headed two days after - red rash on arm at site of injection  - itchy/hot/painful
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain, Pyrexia, Rash erythematous
Clinical narrative: one day after - fever of 101.2, body aches (flu-like symptoms), light headed two days after - red rash on arm at site of injection  - itchy/hot/painful
Age: 12.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Dizziness, Pyrexia, Vomiting
Clinical narrative: GRANDMOTHER OF CHILD CALLED HEALTH DEPT VIA PHONE . STATES CHILD HAD VACCINES AT CLINIC ON 7/30/2019. REPORTS CHILD WITH FEVER 102.00 SINCE 5 AM ON 7/31/2019. CHILD COMPLAINS OF VOMITING AND DIZZINESS. AT 8 AM GRANDMOTHER REPORTS CHILD HAS FEVER OF 102.00. ASKED HOW TO PROCEED. ADVISED GRANDMOTHER CHILD COULD BE HAVING ADVERSE REACTION TO VACCINES. NEEDS TO FOLLOW UP WITH CHILD PEDIATRICIAN AND OR EMERGENCY ROOM FOR MONITORING ASAP NOW. GRANDMOTHER VERBALIZED UNDERSTANDING. WILL FOLLOW UP ABOUT MONITORING TOOK DOWN PHONE NUMBER.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient and Mom came into our clinic today. Patient's left arm is warm to touch and minimally swollen.  Gave patient an ice pack to apply at home and instructed Mom to follow up with Clinic if further reactions occur.  Also gave Mom my contact information if any further questions.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Lethargy, Pain in extremity, Pyrexia
Clinical narrative: fever of 102.4 starting aprox 12 hours after injection, lasting about 8 hours. Accompanied by 8/10 headache. sore arm. lethargy for 24hours
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Memory impairment, Pain in extremity
Clinical narrative: The patient states the patient had extreme fatigue and barely remembered a 48 hour period for which she was hospitalized.  She also had extreme arm pain.
Age: 1.08
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Per county health dept.NO adverse reactions or events should occur.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Loss of personal independence in daily activities, Pain in extremity, X-ray limb normal
Clinical narrative: She had soreness in the area of immunization, but a ew days later developed elbow pain that then migrated to her left forearm and wrist. She is still having left forearm and wrist pain 1.5 months later. She reports that the pain is limiting her activity.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; one patient received one dose of improperly stored MMR II; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 26-JUL-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R028526, expiration date 04-OCT-2020, albumin status rHA (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of above 47 (47.1) degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: VARZOS
Symptoms: Chest pain
Clinical narrative: discomfort/ discomfort below breast bone; This case was reported by a other health professional via interactive digital media and described the occurrence of sternal pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th July 2019, the patient received Shingrix. On 22nd July 2019, 4 days after receiving Shingrix, the patient experienced sternal pain. On an unknown date, the outcome of the sternal pain was unknown.   It was unknown if the reporter considered the sternal pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient had Shingrix shot 4 days ago and the patient experienced lot of discomfort below breast bone. The patient asked if this be a reaction to the shot? The case has been linked to the cases US2019AMR135418 and US2019AMR135404, reported by same reporter.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Felt achy; Low grade fever; Headache; This case was reported by a consumer and described the occurrence of pain in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received Shingrix. On 22nd July 2019, 13 days after receiving Shingrix, the patient experienced pain, low grade fever and headache. On an unknown date, the outcome of the pain, low grade fever and headache were unknown.   It was unknown if the reporter considered the pain, low grade fever and headache to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. 2 weeks ago from the reporting date, the patient received Shingrix. The day before the reporting date, the patient felt achy, had a low grade fever and headache. The patient was fine tidy and was curious and asked could that had been from the vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Pyrexia, Rash
Clinical narrative: leg rash; fever; fatigue; no appetite; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date 11th September 2020) for prophylaxis.   On 6th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th May 2019, 3 days after receiving Shingrix, the patient experienced fever, fatigue and appetite absent. On 11th May 2019, the patient experienced rash. On an unknown date, the outcome of the fever, fatigue, appetite absent and rash were recovered/resolved.   It was unknown if the reporter considered the fever, fatigue, appetite absent and rash to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix in left arm. Five days after the vaccination, the patient developed a rash on her leg. The patient was unsure that how long these symptoms lasted, but that they were all resolved at the time of reporting. The reporter consented to follow up.  In the source document, the outcome of events was reported as recovered/resolved with sequel, while it was reported as recovered/resolved.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Headache, Paranasal sinus hypersecretion, Product storage error
Clinical narrative: fever; headache; shivers; coughing; sinus draining; product storage error; 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 24th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 24th July 2019, less than a day after receiving Shingrix, the patient experienced fever, headache, shivers, cough, nasal sinus drainage and incorrect storage of drug. On 25th July 2019, the outcome of the fever, headache, shivers, cough and nasal sinus drainage were recovered/resolved. On an unknown date, the outcome of the incorrect storage of drug was unknown.   It was unknown if the reporter considered the fever, headache, shivers, cough and nasal sinus drainage to be related to Shingrix.  Additional details were reported as follows: The patient received vaccine stored at temperatures outside storage recommendations, which led to incorrect storage of vaccine. That he would need to be vaccinated again.  The patient had fever, shivers, headache, coughing, and sinus draining that lasted throughout the night and resolved around 4:30 am of next day of vaccination. The reporter consented to follow up.  Consumer did not have vaccine information for this adverse event.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; headache; shivers; coughing; sinus draining; product storage error; 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 24th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 24th July 2019, less than a day after receiving Shingrix, the patient experienced fever, headache, shivers, cough, nasal sinus drainage and incorrect storage of drug. On 25th July 2019, the outcome of the fever, headache, shivers, cough and nasal sinus drainage were recovered/resolved. On an unknown date, the outcome of the incorrect storage of drug was unknown.   It was unknown if the reporter considered the fever, headache, shivers, cough and nasal sinus drainage to be related to Shingrix.  Additional details were reported as follows: The patient received vaccine stored at temperatures outside storage recommendations, which led to incorrect storage of vaccine. That he would need to be vaccinated again.  The patient had fever, shivers, headache, coughing, and sinus draining that lasted throughout the night and resolved around 4:30 am of next day of vaccination. The reporter consented to follow up.  Consumer did not have vaccine information for this adverse event.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Impaired work ability, Myalgia, Poor quality sleep
Clinical narrative: Started to have chills, shivering, muscle pain, headaches and restless sleeping. Had to take next day off from work
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: redness, warmth, swelling and tenderness to right upper extremity - started within 12 hours of injection (that evening)
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue
Clinical narrative: About 9 hours after the injection, I got the chills.  I was It was warm in our house but I felt the need to be under multiple blankets.  The next day,  I was light-headed and felt tired.  I went home from work and slept for about 10 hours.   The following day I felt fine.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Crying, Fatigue, Gait disturbance, Headache
Clinical narrative: Fatigue, SEVERE joint pain, muscle aches and mild headache and nausea.  Was up crying during the night (Sunday night - day of injection) with joint pain and had difficulty walking.  Took a sick day at work on Monday - laid in bed all day Monday only getting up to eat once and go to the restroom. Symptoms were improved on Tuesday but remained.  Wednesday, again improved but mildly lingering.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Myalgia, Nausea
Clinical narrative: Fatigue, SEVERE joint pain, muscle aches and mild headache and nausea.  Was up crying during the night (Sunday night - day of injection) with joint pain and had difficulty walking.  Took a sick day at work on Monday - laid in bed all day Monday only getting up to eat once and go to the restroom. Symptoms were improved on Tuesday but remained.  Wednesday, again improved but mildly lingering.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Patient turned pale and passed out after getting the vaccines. We began to apply cool cloths to neck and forehead. Gave the patient a bottle of Gatorade to drink.  His color began to return and he reported feeling fine.  We observed him in our office for approximately 30 minutes.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Rash, Urticaria
Clinical narrative: Severe pain in left arm 10 hours after injection. Rash and hives 17 hours after injection. 75% better 24 hours after injection.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT PRESENTED TO PHARMACY ON 7/31/19 AFTER RECEIVING 2ND SHINGRIX DOSE ON 7/29/19 WITH RED, SWOLLEN, HOT TO TOUCH RASH THE SIZER OF A SOFTBALL ON HER LEFT ARM (RIGHT ABOVE ELBOW)
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Headache, Musculoskeletal pain
Clinical narrative: Headache, shivering, fever, upset stomach, diarrhea, shoulder extremely sore.  Took some aspirin for the headache and went to bed for the rest of the day and night. Feeling a little better morning of 7/31/2019, still have a slight headache and shoulder is still very sore to touch or move.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Tenderness
Clinical narrative: Headache, shivering, fever, upset stomach, diarrhea, shoulder extremely sore.  Took some aspirin for the headache and went to bed for the rest of the day and night. Feeling a little better morning of 7/31/2019, still have a slight headache and shoulder is still very sore to touch or move.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Woke in the night feeling like the flu -- fever, body aches, headache. It's now near 12 noon the next day, took ibuprofen for headache & fever, symptoms subsiding. Fever was 99.7
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Nodule, Skin warm, Swelling
Clinical narrative: Pt's mom called after hours answering service & was transferred to Dr. on 7/25/19 for possible Reaction to Kinrix Vaccine. Size of Redness was size of mom's hand Approx with a hard knot under it. Was told to use ice pack & told to give ibuprofen for swelling. Update: Mom reports resolution of warmth, redness and swelling by 7-26-19.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: PT STATED THAT A FEW DAYS AFTER THE VACCINE (2ND DOSE) SHE HAD A FEW PIMPLE-LIKE RASHES THAT DISSAPPEARED IN A FEW DAYS. THEN A FEW DAYS AFTER THAT, SHE DEVELOPED A LARGER AREA OF PIMPLE-LIKE RASHES THAT ITCHED BUT DID NOT BURN. SHE APPLIED ICE TO THE RASH BUT DID NOT RESOLVE THE ITCHING. THAT IS WHEN SHE CALLED THE PHARMACY. SHE WAS ACTUALLY AFRAID THAT SHE WAS BREAKING OUT IN SHINGLES. I TOLD HER WE HAD NOT HEARD OF PEOPLE GETTING SHINGLES AFTER RECEIVING THE VACCINE SINCE THIS IS NOT A LIVE VACCINE. I INFORMED HER THAT I WOULD CONTACT OUR IMMUNIZATION DEPARTMENT AT CORPORATE TO FIND OUT IF THEY HAD HEARD OF PATIENTS GETTING SHINGLES AFTER RECEIVING THE VACCINE. SHE WAS ADVISED TO TAKE SOME BENADRYL TO HELP WITH ITCHING UNTIL WE HEARD BACK FROM CORPORATE. IMMUNIZATION DEPARTMENT RESPONDED THAT THE RASH DESCRIBED BY THE PATIENT WAS NOT CONSISTENT WITH CLINICAL TRIAL ADVERSE EVENTS DESCRIBED IN PACKAGE INSERT AND RECOMMENDED THAT THE PATIENT BE REFERRED TO HER PHYSICIAN FOR EVALUATION AND DIAGNOSIS. PATIENT WAS ADVISED TO SEE HER PHYSICIAN TO HAVE THE RASH EVALUATED. WE HAVE NOT HEARD FROM PATIENT REGARDING THE OUTCOME Patient has not returned our calls regarding the final outcome of MD visit.
Age: 17.0
Sex: M
Vaccine: UNK
Symptoms: Chills
Clinical narrative: YOUTH COMPLAINT OF CHILLS, ONE TIME DOSE OF TYLENOL 650 MG ADMINISTERED BY RN. NO OTHER COMPLAINTS
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Headache, Inflammation, Pyrexia
Clinical narrative: Patient developed redness, inflammation from shoulder down to elbow.  Also complained of fever, chills and headache.  I believe it to be cellulitis.   Making appt with MD
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cough, Sneezing, Swelling of eyelid
Clinical narrative: PATIENT STARTED HAVING SNEEZING, COUGHING AND THEN SWELLING OF BOTH EYE LIDS.  PATIENT WAS ADMINISTERED BENADRYL 7ML  X1 AND EPINEPHRINE 1:1000 INJECTION.  PARAMEDICS CALLED AND TRANSPORTED TO THE HOSPITAL.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Insomnia
Clinical narrative: Shivering 8PM to 4AM, couldn't sleep, pounding headache 2AM to 6AM.  All symptoms resolved by 9AM
Age: 1.17
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site macule
Clinical narrative: Approximately 5 minutes after administration of vaccine patient was observed to have small red indurations that were in close proximetry to both injections sites. Varicella site greater than MMR site. Areas of redness rapidly increased in size with several macular areas of approximately 1 cm at varicalle site and 1/2 cm at MMR site. Patient was alert and playing with no SOB or other observable problem.  Patient was given 12.5mg of benadryl and redness and macula resolved after approximately 10 minutes. Patients lungs reamined clear and patient was discharged with no symptoms of reaction after 40 minutes of observation.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Shingrix vaccine was administered at the same time as the pneumococcal vaccine, therefore doubling ,maybe, any adverse effect,
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, TD
Symptoms: Abdominal discomfort, Asthenia, Chills, Dizziness, Pyrexia
Clinical narrative: FEVER OF 102.0, CHILLS, DIZZINESS, WEAKNESS, STOMACH UPSET
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Back pain, Chills, Dizziness, Feeding disorder, Gait inability
Clinical narrative: 8pm on july 22 patient began with severe headache dizziness lightheadedness and neck and back pain she also had severe pain in her left arm. Around 10pm she started running a fever of 103.5 we gave motrin and this did bring the fever down to 101.8 for about an hour then back up again. She was shaking, had chills very bad and had gotten to the point that we had to carry her back and forth to use the bathroom because she was unable to walk on her own from the dizziness, shaking and headache. The following morning symptoms continued and she remained in bed curled up in a ball all day as light and sound became unbearable as well.,she couldn't bare to even be out in the living room around either. She was unable to eat and continued with symptoms until around 2am on 7/25/2019 when her fever finally broke and she has since remained fever free. She continued over the next few days from the 25th with mild dizziness, headache and neck and back pain.  All symptoms I talked to the Doctors about but they fall under the Normal reactions as i saw on the sheet that came home after vaccines and on the cdc sight. But my daughter was unable to live any life during this time and that is not normal to me