chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored doses of varivax was administered to one patient; no adverse event; This spontaneous report was received from an administrator, refers to a patient of unknown age. The patient's medical history and concurrent conditions were unknown.  On 11-JUN-2019, the patient was vaccinated with one improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (frequency unknown) lot # R018931, expiry: 02-JUL-2020, subcutaneous for prophylaxis.  The sterile diluent (DILUENT MRK INJ), that was used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored properly. No adverse effect reported. Product quality complaints was not involved.  Temperature or Time frame:   -14-degree C to -10-degree C (-13. 8C) for 6 hours and 38 minutes  -50-degree C to -15-degree C (-14.8C) for 4 minutes  Previous temperature excursion:  -50-degree C to -15-degree C (-14. 7 C) for 7 minutes  -14-degree C to -10-degree C (-13.1 C) for 1 hour and 22 minutes  The report was because of a data logger.  This is one of two reports received from the same reporter.
Sex: M
Vaccine: MENB
Symptoms: Intensive care, Meningitis
Clinical narrative: meningitis; This case was reported by a consumer via interactive digital media and described the occurrence of meningitis in a male patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included food allergy and sensorimotor disorder.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, 3 days after receiving Bexsero, the patient experienced meningitis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the meningitis was unknown.   It was unknown if the reporter considered the meningitis to be related to Bexsero.  Additional case details were provided as follows: The age at vaccination was not reported. The patient had terrible food allergies prior and sensory issues and therefore reporter was feeling that it was not right to give it to him but the physician forced for this vaccination. 3 days after getting the meningitis shot, the patient got meningitis.  The patient was admitted in the intensive care unit for 10 days. The reporter tried to obtain the batch number of the shot but even after three requests, the physician did not report it.  The reporter was wondering about the accuracy of the reported shot related events.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Rash vesicular
Clinical narrative: Shingles like rash; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of nausea (For tolerance to 1st dose please refer case US2019007963 ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a shingles like rash for the 2nd day at the date of reporting. The patient wanted to get detailed information about possible shingles after vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult 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, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed shingles on the 2nd or 3rd day following of Shingrix. It was a short episode that lasted 4 to 5 days. The reporter consented to follow up. The registered pharmacist had no other details.  The registered pharmacist wants to call MD to confirm this.  All information provided to registered pharmacist was from patient.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th April 2019, 7 days after receiving Shingrix, the patient experienced shingles. On 7th June 2019, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated his brother in law received the Shingrix and developed shingles 1 week later. The reporter did not provide any further details on this event.  The reporter asked if it was a live vaccine.  The reporter asked if any new studies have been done on the outcome of having only the first vaccination. The date of birth or medical doctor information was not given.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: injection site  pain; injection site redness; injection site swelling; injection site Itching; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 74-year-old 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 injection site pain, injection site erythema, injection site swelling and injection site itching. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and injection site itching were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and injection site itching to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced severe pain, swelling, redness and itchiness near injection site. The reporter stated that the adverse event may have been reported previously via email by a agent.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Pruritus
Clinical narrative: Patient stated that a very large red and hot patch showed up on her arm shortly after receiving the Shingrix vaccine. this was the second dose of the series and she stated there was no adverse effects from the first dose.  the area was covering her bicep and tricep starting around the injection site and moving down her arm towards her elbow. she also stated having a rash and being very itchy around her waist.  she did not notice any swelling or difficulty breathing. she reported the reaction to the pharmacy on Friday 06/13/19. the rash was slightly smaller per patient but it still was covering part of her bicep and was moving down her arm towards her elbow. Patient did not express any pain or sworeness except for right around the injection site. She had full range of movement with no pain per patient. I advised her to take some Claritin or Benadryl for a possible allergic reaction and to keep an eye on it to ensure it is getting better and not worse.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient stated that a very large red and hot patch showed up on her arm shortly after receiving the Shingrix vaccine. this was the second dose of the series and she stated there was no adverse effects from the first dose.  the area was covering her bicep and tricep starting around the injection site and moving down her arm towards her elbow. she also stated having a rash and being very itchy around her waist.  she did not notice any swelling or difficulty breathing. she reported the reaction to the pharmacy on Friday 06/13/19. the rash was slightly smaller per patient but it still was covering part of her bicep and was moving down her arm towards her elbow. Patient did not express any pain or sworeness except for right around the injection site. She had full range of movement with no pain per patient. I advised her to take some Claritin or Benadryl for a possible allergic reaction and to keep an eye on it to ensure it is getting better and not worse.
Sex: U
Vaccine: MMR, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect reported; inadvertently administered the second dose of MMR II; This spontaneous report was received from a nurse referring to a patient with unknown vaccination history. Information about concurrent condition, concomitant medication and medical history was not provided.   On 08-MAY-2019 the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, frequency, route were unknown; lot # R031679, expiration date 01-NOV-2020) for prophylaxis along with sterile diluent(STERILE DILUENT). On 31-MAY-2019, the patient was inadvertently administered the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, frequency, route were unknown; lot # R036582, expiration date 17-DEC-2020) for prophylaxis along with sterile diluent(STERILE DILUENT) (Inappropriate dose of vaccine administered). No adverse effect reported. The outcome of the events was unknown. No PQC presented.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Bedridden, Burning sensation, Discomfort
Clinical narrative: severe burning sensation in mid-section (abdomen & hip area); severe burning sensation in mid-section (abdomen & hip area); discomfort eases; stay in bed; This case was reported by a consumer via call center representative and described the occurrence of burning sensation in abdomen in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included burning sensation, discomfort and bedridden. The patient had a Family History of shingles. Previously administered products included Tamoxifen with an associated reaction of burning sensation (received from 1996 to 1997), Fosamax with an associated reaction of discomfort (discontinued on an unknown date), Actonel with an associated reaction of discomfort (discontinued on an unknown date) and bisphosphonates with an associated reaction of discomfort (discontinued on an unknown date).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced burning sensation in abdomen, burning hip, discomfort and bedridden. On an unknown date, the outcome of the burning sensation in abdomen, burning hip, discomfort and bedridden were recovered/resolved.   It was unknown if the reporter considered the burning sensation in abdomen, burning hip, discomfort and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a negative reaction to the 1st shot and had some concerns.  The patient experienced severe burning sensation in the mid-section (abdomen and hip area) which lasted for several days. During that time, the patient became very uncomfortable and had to stay in bed until discomfort eases.  The patient did not considered these events as side effect because the patient reacted similarly to several other drugs and medications received in past.  The patient asked to the primary care physician regarding to have 2nd shot. They both had concerns of having the same effects or possibly worse and lasting longer.  The patient was very aware of the pain of Shingles, since several family members have had Shingles and the patient would like to avoid that experience. Therefore, the patient asked that only 1 Shingrix shot reduce the odds of having Shingles or was the 2nd shot essential to be effective.  The patient would going to receive 2nd shingrix shot shortly.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: hives; itching; This case was reported by a consumer via call center representative and described the occurrence of hives in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included ZOSTAVAX with an associated reaction of urticaria (also had Zostavax when it first came out).   On 28th May 2019, the patient received the 1st dose of Shingrix .5 ml. On 1st June 2019, 4 days after receiving Shingrix, the patient experienced hives and pruritus. On an unknown date, the outcome of the hives and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the hives and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter declined to provided date of birth.  The patient received Shingrix and noticed what appeared to be mosquito bites on her ankles that then spread to her arms and legs. The patient also had one on her forehead. She said some itch, but others did not.  They appear as single hives and not so much in clusters.  The reporter reported that she had a scheduled appointment with her physician in the coming weeks, and planned to discuss when him then.   Did not consent to follow up. The reporter declined to provide health care professional information.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site pain, Injection site swelling
Clinical narrative: inappropriate schedule of vaccine; soreness; swelling; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 1st July 2018, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On an unknown date, the patient experienced incomplete course of vaccination. On 6th July 2018, the outcome of the injection site pain and injection site swelling were recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm and reported that he experienced soreness and swelling at the injection site.  The reporter consented to follow up. Shingrix asymptomatic reported.  The patient reported that he missed his 2nd dose, but planned to get it in the near future, which led to incomplete course of vaccination.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Injection site rash, Irritability, Rash generalised, Rash pruritic, Vaccination complication
Clinical narrative: MOTHER CALLED AM OF 06/08/19 STATED CHILD STARTED WITH RASH ON LEGS LATE IN THE EVENING OF 06/07/19, NO FEVER BUT IRRITABLE. CHILD WOKE AT ABOUT 11 AM 06/08/19 RASH WAS ALL OVER CHILD. CHILD WAS STILL IRRITABLE RASH ON ARMS, LEGS, ABDOMEN AND BACK WAS VERY ITCHY. ENCOURAGE MOTHER TO TAKE CHILD TO PCP. MOTHER NOTIFIED CLINIC AFTER SEEING PCP, APN DIAGNOSED CHILD WITH ADVERSE REACTION TO DTAPACEL PER MOTHER.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Headache, Nodule, Pyrexia
Clinical narrative: FEVER STARTING 48 HOURS AFTER INJECTION; RED, RAISED KNOT DEVELOPED; HEADACHE
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced injection site pain. The patient asked about how long does the injection site hurt. The patient also mention that was the worst shot I have ever got.
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than an hour after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that the pharmacist asked about how fast after giving Shingrix can it cause a headache as the pharmacist had a patient that reports having a headache within 15 minutes, so a pretty sudden onset.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Nausea, Oropharyngeal pain, Saliva altered, Saliva analysis
Clinical narrative: sore throat; white saliva; sticky saliva; white tongue; nausea; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th May 2019, the patient received the 1st dose of Shingrix. On 30th May 2019, immediately after receiving Shingrix, the patient experienced nausea. On 3rd June 2019, the patient experienced sore throat, saliva discoloration, saliva viscid and tongue white. On an unknown date, the outcome of the nausea, sore throat, saliva discoloration, saliva viscid and tongue white were not recovered/not resolved.   It was unknown if the reporter considered the nausea, sore throat, saliva discoloration, saliva viscid and tongue white to be related to Shingrix.  Additional details were provided as follows: The reporter was the spouse of the patient. Right after the shot, a few hours later, the patient started having nausea. The site of the shot was never red, nor swollen, nothing. The patient did have nausea for 3 days. The nausea came and went. The patient experienced a horrible sore throat. All the saliva was white and sticky and his tongue was white like a fungus. He was being to two doctors and have sent sample of saliva to the lab and waiting on results.  The patient said that she read online that an ingredient in the Shingrix comes from a tree from a jungle. She read that ingredient might affect the lining of the mouth.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Saliva discolouration, Tongue discolouration
Clinical narrative: sore throat; white saliva; sticky saliva; white tongue; nausea; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th May 2019, the patient received the 1st dose of Shingrix. On 30th May 2019, immediately after receiving Shingrix, the patient experienced nausea. On 3rd June 2019, the patient experienced sore throat, saliva discoloration, saliva viscid and tongue white. On an unknown date, the outcome of the nausea, sore throat, saliva discoloration, saliva viscid and tongue white were not recovered/not resolved.   It was unknown if the reporter considered the nausea, sore throat, saliva discoloration, saliva viscid and tongue white to be related to Shingrix.  Additional details were provided as follows: The reporter was the spouse of the patient. Right after the shot, a few hours later, the patient started having nausea. The site of the shot was never red, nor swollen, nothing. The patient did have nausea for 3 days. The nausea came and went. The patient experienced a horrible sore throat. All the saliva was white and sticky and his tongue was white like a fungus. He was being to two doctors and have sent sample of saliva to the lab and waiting on results.  The patient said that she read online that an ingredient in the Shingrix comes from a tree from a jungle. She read that ingredient might affect the lining of the mouth.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Headache began the evening after injection; felt feverish for the next 2 nights and had nausea and vomiting for 24 hours.  Got prescription for Zofran which helped reduce nausea and stopped the vomiting.  Also took Tylenol Arthritis 2 tabs every 8 hours for headache and arm pain.  Arm did not show any redness or swelling at injection site, but pain radiated from the area.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Headache began the evening after injection; felt feverish for the next 2 nights and had nausea and vomiting for 24 hours.  Got prescription for Zofran which helped reduce nausea and stopped the vomiting.  Also took Tylenol Arthritis 2 tabs every 8 hours for headache and arm pain.  Arm did not show any redness or swelling at injection site, but pain radiated from the area.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Rash erythematous, Rash generalised, Rash pruritic, Rash pustular, Scab
Clinical narrative: Patient experienced red bumps over majority of body. Pt stated that bumps were itchy.   Bumps left small pustules which left scabs a few days after presentation.   Pt followed protocol and was seen in the ER over the weekend.  No actions taken by ER, followed up with PCM 17 Jun 2019.  Symptoms resolved and pt was not instructed to take any additional medications.  Possible unknown skin condition cited as cause for reaction.  Pt denied any history of skin conditions during screening for Smallpox vaccine.  Member given permanent exemption from future Smallpox vaccines.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site urticaria, Injection site warmth
Clinical narrative: right deltoid region with small erythematous skin and induration, warmth on palpation left deltoid region with a large, 3 1/2" x 5" erythematous skin and induration, warmth on palpation, large urticarial blotch.
Age: 8.0
Sex: F
Vaccine: DT
Symptoms: Abdominal pain, Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Spiked a 103.5 fever within one hour, nausea, vomiting, diarrhea, abdominal cramps
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia, Somnolence
Clinical narrative: Extreme pain at injection site to half way down arm as well as under arm.  Entire body in extreme pain. Very Sleepy. Fever of 100.9  Took Ibprofen which barely touched the pain, slept.  I'm still having symptoms on 6/17/19, but not as bad as first two days.
Age: 1.25
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: I noticed that Medical Assistant gave menactrea which is not in shot schedule for 15 mo. old. I questioned lady and she said she pulled up state Shots online tracking system and it said child was overdue for menactra so she gave vaccine. I called Dr. and then I called CDC and spoke with  agent who said no reason to believe it would be harmful. The vaccine is to be given 9 mos-55 years but children only get if they are high risk. I then called the immunization coordinator at State Shots and spoke with Agent.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: pain, heat and swelling at injection site - as well as blisters and whelps around the site for about two inches all the way around
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: pain, heat and swelling at injection site - as well as blisters and whelps around the site for about two inches all the way around
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient Did not have any reactions
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site irritation, Administration site swelling, Injection site erythema
Clinical narrative: RED AND SWOLLEN SKIN IRRITATION AT SITE OF ADMINISTRATION
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The patient had swelling and redness at the immunization site and kept spreading. Ice pack and Benadryl was applied to the site of injection and patient was monitored.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Tender red and swollen left upper arm not just around injection site. Tender and swollen lymph nodes left axilla. Low grade fever of 100.4 with myalgias , arthralgias, fatigue , and headache . Took extra strength Tylenol to treat symptom of fever, Symptoms lasted three days.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Lymph node pain, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Tender red and swollen left upper arm not just around injection site. Tender and swollen lymph nodes left axilla. Low grade fever of 100.4 with myalgias , arthralgias, fatigue , and headache . Took extra strength Tylenol to treat symptom of fever, Symptoms lasted three days.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Anti-cyclic citrullinated peptide antibody, Antinuclear antibody, Bursitis, C-reactive protein, Full blood count
Clinical narrative: Both injections were given too high on the left shoulder on 11/26/2018. Patient experienced immediate severe pain, 10/10. The pain has lessened over time, but he continues to have sharp pain in the left shoulder up to 5/10. He saw his PCP on 12/7/2018 and was referred to Ortho. He saw the orthopedic surgeon on 1/3/2019 when plain films were negative and he was treated with Meloxicam. He did not have improvement, so returned to his PCP on 5/16/2019. MRI was ordered and showed mild to moderate diffuse thickening of the subacromial subdeltoid bursa, that may represent infectious/inflammatory bursitis. Reactive versus possible. Mild erosive changes in the lateral aspect of the greater tuberosity. Possible mild tendinosis or low-grade interstitial tearing in the anterior infraspinatus tendon. The supraspinatous and subscapularis tendons are intact. No articular or bursal sided rotator cuff tear. He started Physical Therapy for left shoulder impingement/bursitis on 6/11/2019. He was referred back to the orthopedic surgeon on 6/12/2019 and markers of inflammation were collected.   He will see the orthopedic surgeon again, and physical therapy will continue.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Immediate post-injection reaction, Injection site pain, Nuclear magnetic resonance imaging abnormal, Product administered at inappropriate site, Red blood cell sedimentation rate
Clinical narrative: Both injections were given too high on the left shoulder on 11/26/2018. Patient experienced immediate severe pain, 10/10. The pain has lessened over time, but he continues to have sharp pain in the left shoulder up to 5/10. He saw his PCP on 12/7/2018 and was referred to Ortho. He saw the orthopedic surgeon on 1/3/2019 when plain films were negative and he was treated with Meloxicam. He did not have improvement, so returned to his PCP on 5/16/2019. MRI was ordered and showed mild to moderate diffuse thickening of the subacromial subdeltoid bursa, that may represent infectious/inflammatory bursitis. Reactive versus possible. Mild erosive changes in the lateral aspect of the greater tuberosity. Possible mild tendinosis or low-grade interstitial tearing in the anterior infraspinatus tendon. The supraspinatous and subscapularis tendons are intact. No articular or bursal sided rotator cuff tear. He started Physical Therapy for left shoulder impingement/bursitis on 6/11/2019. He was referred back to the orthopedic surgeon on 6/12/2019 and markers of inflammation were collected.   He will see the orthopedic surgeon again, and physical therapy will continue.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Rheumatoid factor, Rotator cuff syndrome, X-ray limb normal
Clinical narrative: Both injections were given too high on the left shoulder on 11/26/2018. Patient experienced immediate severe pain, 10/10. The pain has lessened over time, but he continues to have sharp pain in the left shoulder up to 5/10. He saw his PCP on 12/7/2018 and was referred to Ortho. He saw the orthopedic surgeon on 1/3/2019 when plain films were negative and he was treated with Meloxicam. He did not have improvement, so returned to his PCP on 5/16/2019. MRI was ordered and showed mild to moderate diffuse thickening of the subacromial subdeltoid bursa, that may represent infectious/inflammatory bursitis. Reactive versus possible. Mild erosive changes in the lateral aspect of the greater tuberosity. Possible mild tendinosis or low-grade interstitial tearing in the anterior infraspinatus tendon. The supraspinatous and subscapularis tendons are intact. No articular or bursal sided rotator cuff tear. He started Physical Therapy for left shoulder impingement/bursitis on 6/11/2019. He was referred back to the orthopedic surgeon on 6/12/2019 and markers of inflammation were collected.   He will see the orthopedic surgeon again, and physical therapy will continue.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Insomnia, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: fever, myalgia, insomnia, arm pain, swelling, redness.  Took benadryl, and alternated taking ibuprofen & tylenol.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: fever, myalgia, insomnia, arm pain, swelling, redness.  Took benadryl, and alternated taking ibuprofen & tylenol.
Age: 85.0
Sex: U
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 94 years old patient (pt) of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 30-SEP-2010, the pt was prescribed and administered with the zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) by a healthcare provider at a health systems, for the long-term prevention of shingles and zoster-related conditions. On an unknown date, pt suffered herpes zoster resulting from the vaccination. Pt was treated by a healthcare provider at the health systems. The outcome of the event was unknown. The event was considered to be related to the zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; Inadvertently administered an improperly stored dose of PROQUAD; This spontaneous report was received from a Registered Nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On 10-JUN-2019, an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (lot No R020814, expiration date on 16-JAN-2020) was inadvertently administered to the patient for prophylaxis (strength, dose number, anatomical location and route of administration were not reported). The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (PROQUAD) was reconstituted with properly stored sterile diluent. There was no adverse effect reported.  The storage temperature was of 12.5 degrees Fahrenheit (°F) for a time frame of 2 hours 4 minutes without a previous temperature excursion and was called because a digital data logger
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no known adverse effects; an administered dose of VARIVAX underwent a temperature excursion prior to being administered; an administered dose of VARIVAX underwent a temperature excursion prior to being administered; This spontaneous report as received from a nurse refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  Since 07-JUN-2019, a dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot # R030611, expiration date: 23-OCT-2020, underwent a temperature excursion of 1.0 degree Celsius for 72 hours. On 11-JUN-2019, the improperly stored dose was administered to patient subcutaneously for prophylaxis (frequency and exact dosage were not provided). The call was made because of digital data logger, there were no previous temperature excursion. There were no adverse effects reported. The outcome of product storage error, poor quality product administered and no adverse event was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: fainted; This spontaneous report as received from a pharmacist via a company representative refers to a young female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date ,reported as several years ago, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot# and expiration date were not reported) for prophylaxis.  On an unknown date, the patient fainted. The outcome of the event was unknown, also reported as the patient was "fine".  The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.   Upon internal review, the event of faint was considered to be medically significant.
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Malaise, Pyrexia
Clinical narrative: fever; feeling sick; feeling cold; tired; This case was reported by a consumer and described the occurrence of fever in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced fever, feeling unwell, feeling cold and tiredness. On an unknown date, the outcome of the fever, feeling unwell, feeling cold and tiredness were unknown.   It was unknown if the reporter considered the fever, feeling unwell, feeling cold and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient experienced feeling of sick, cold, feverish and tried. The patient asked how long do the side effects last.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness at injection site; This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness 3 to 4 cm at site of injection. The reporter did not agree to to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: big round red rash near the injection site; injection site red rash; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th May 2019, the patient received the 1st dose of Shingrix. On 31st May 2019, 2 days after receiving Shingrix, the patient experienced injection site erythema and injection site rash. On an unknown date, the outcome of the injection site erythema and injection site rash were unknown.   It was unknown if the reporter considered the injection site erythema and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. On the 3rd day, the patient developed a big round red rash near the injection site. On the 4th day, the patient developed another big round red rash not far from the first rash. The patient asked could this be shingles. The patient asked, what did this rash represent, was this also a side effect as well, should he be concern, what should he do, would this happen with his second shot. The patient thought this new shot did not have a live virus.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Adverse drug reaction, Discomfort, Fatigue, Herpes zoster
Clinical narrative: Vaccination failure; Shingles; Rash on the back of his right shoulder; Some Discomfort; This case was reported by a physician via call center representative and described the occurrence of vaccination failure in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. On 11th April 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix and 56 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and discomfort. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, rash and discomfort were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix. It was unknown if the reporter considered the discomfort to be related to Shingrix.  Additional details were provided as follows: The reporter indicated that approximately eight weeks after receiving the second dose of the Shingrix vaccine, the patient developed a rash on the back of his right shoulder with some discomfort. The patient was started on the generic formulation of Valtrex 1 gram every 8 hours, and he took this for four days.   The patient stopped the product on the day of reporting because it upset his stomach, it made him feel fatigued, and caused him to not think clearly.  The event rash has resolved and there was no discomfort at the time of reporting. The reporter did not consent to follow-up. The reporter would not provide any additional information  The reporter wanted to speak with someone in Medical Information.  The manufacturer of the generic formulation of Valtrex and he was counseled to contact the manufacturer to let them know his experience while on the product.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Mental impairment, Rash, Vaccination failure
Clinical narrative: Vaccination failure; Shingles; Rash on the back of his right shoulder; Some Discomfort; This case was reported by a physician via call center representative and described the occurrence of vaccination failure in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. On 11th April 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix and 56 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and discomfort. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, rash and discomfort were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix. It was unknown if the reporter considered the discomfort to be related to Shingrix.  Additional details were provided as follows: The reporter indicated that approximately eight weeks after receiving the second dose of the Shingrix vaccine, the patient developed a rash on the back of his right shoulder with some discomfort. The patient was started on the generic formulation of Valtrex 1 gram every 8 hours, and he took this for four days.   The patient stopped the product on the day of reporting because it upset his stomach, it made him feel fatigued, and caused him to not think clearly.  The event rash has resolved and there was no discomfort at the time of reporting. The reporter did not consent to follow-up. The reporter would not provide any additional information  The reporter wanted to speak with someone in Medical Information.  The manufacturer of the generic formulation of Valtrex and he was counseled to contact the manufacturer to let them know his experience while on the product.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Diarrhoea, Fatigue, Hypersomnia, Injected limb mobility decreased
Clinical narrative: I had the first shot of the Shingles vaccine June 14 and I have to say it packs a wallop-literally. Besides being the most painful injection I ever had-and I could not lift my arm afterwards, I became somewhat sick within a few hours. Tired and achy and I had a hard time sleeping that night. Saturday morning I had diarrhea, fatigue and anxiety. I did begin to feel better during the day but feel asleep on the couch Saturday afternoon not to awaken for almost 14 hours. I am feeling better but was wondering if this is unusual as I still have shot #2 to get.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Malaise, Pain
Clinical narrative: I had the first shot of the Shingles vaccine June 14 and I have to say it packs a wallop-literally. Besides being the most painful injection I ever had-and I could not lift my arm afterwards, I became somewhat sick within a few hours. Tired and achy and I had a hard time sleeping that night. Saturday morning I had diarrhea, fatigue and anxiety. I did begin to feel better during the day but feel asleep on the couch Saturday afternoon not to awaken for almost 14 hours. I am feeling better but was wondering if this is unusual as I still have shot #2 to get.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Rash
Clinical narrative: Patient developed injection site related rash which spread from site of injection to patient's back. ER stated this a common injection site reaction and would treat appropriately
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Injection site pain, Injection site reaction, Skin tightness
Clinical narrative: 1) Arm felt tight around shot injection site for one Day. Muscle slightly painful Nothing unusual 2) Sat AM I woke up in AM. so dizzy that I fell back in bed when I tried to get up. Rested & tried again. Could not walk without help of furniture & walls! I was flat on my back the first Day & got up a few times only I was flat on my back most of 2nd Day - got up some. I could get up and site up for half of 3rd day - got up more felt almost back to normal 4th Day, but could not exercise at all. Since I started feeling better beginning in afternoon of second day, I did not contact my doctor until Monday, since she would have not been available. I contacted & talked with my dr's assistant on Monday. She talked with Doctor, who asked if my reaction might have been a coincidence. The only time I have had dizziness was different brand name for my high blood pressure medication. I have not changed or increased any medication, however, recently. My main question to my doctor was and is still on my mind: Should I get the 2nd shot of this medication? What could happen to me then?
Sex: F
Vaccine: VARZOS
Symptoms: Walking aid user
Clinical narrative: 1) Arm felt tight around shot injection site for one Day. Muscle slightly painful Nothing unusual 2) Sat AM I woke up in AM. so dizzy that I fell back in bed when I tried to get up. Rested & tried again. Could not walk without help of furniture & walls! I was flat on my back the first Day & got up a few times only I was flat on my back most of 2nd Day - got up some. I could get up and site up for half of 3rd day - got up more felt almost back to normal 4th Day, but could not exercise at all. Since I started feeling better beginning in afternoon of second day, I did not contact my doctor until Monday, since she would have not been available. I contacted & talked with my dr's assistant on Monday. She talked with Doctor, who asked if my reaction might have been a coincidence. The only time I have had dizziness was different brand name for my high blood pressure medication. I have not changed or increased any medication, however, recently. My main question to my doctor was and is still on my mind: Should I get the 2nd shot of this medication? What could happen to me then?
Age: 15.0
Sex: M
Vaccine: FLUN3, HPV9
Symptoms: Blood test, Burning sensation, Neurological examination, Nuclear magnetic resonance imaging, Tremor
Clinical narrative: Last shot administered 6/9/16. Symptoms started in July 2016. Started w/burinig sensation in feet/heels. Moved throughout body to shoulders, toes, fingertips, etc. Hands began to tremor/shake. Tremors occur in hands consistently throughout the day and are 30sec - 2min in duration.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia
Clinical narrative: Prolonged fever and irratability after 12 month vaccines/MMR. Fever the day of vaccines up to 104.1.