chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Reddness at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a elderly male patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 10th September 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved.   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 but it could be 66 years or 67 years. After receiving Shingrix, the patient experienced redness at injection site which lasted for 3 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: injection site redness; Vaccine Administered at Inappropriate Site; This case was reported by a consumer via call center representative and described the occurrence of injection site redness in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th May 2019, the patient received the 2nd dose of Shingrix (subcutaneous). On 7th May 2019, less than a day after receiving Shingrix, the patient experienced injection site redness and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site redness was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   The reporter considered the injection site redness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient received her dose of Shingrix in the fatty tissue near the under part of her right arm, which led to intramuscular formulation administered by other route. Later that day, the patient had a red circle around the injection site the size of a quarter or fifty cent piece.  In the morning of the reporting day, the circle was about the size of a large orange.  The patient asked the pharmacist about the site of the injection as her 1st dose was given in the muscle and was told by the pharmacist that this is where the CDC says it should go, that it would be better absorbed.
Age: 64.0
Sex: F
Vaccine: RAB
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: pain on injection; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Rabies NVS (RabAvert) (batch number SWQG26CA, expiry date 30th June 2022) for prophylaxis.   In March 2019, the patient received RabAvert (intramuscular). In March 2019, immediately after receiving RabAvert, 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 RabAvert.  Additional details were provided as follows: The reporter was a buyer for the hospital. In early March 2019, the patient went to the emergency room (ER) and received a dose of RabAvert. The patient experienced pain on injection and was not able to tolerate receiving the full injection due to the pain. The patient left the ER.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Incorrect route of product administration, Injection site mass
Clinical narrative: Knot at the area of injection; Wrong Route of Administration; This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2F977, expiry date 1st December 2019) for prophylaxis.   On 29th April 2019, the patient received Pediarix (subcutaneous). On 29th April 2019, unknown after receiving Pediarix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site lump to be related to Pediarix.  Additional details were provided as follows: The patient received Pediarix subcutaneously instead of intramuscularly, which led to inappropriate route vaccine administration. The patient experienced a knot at the area of the injection.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Myalgia; This case was reported by a physician via call center representative and described the occurrence of myalgia in a male 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 myalgia. On an unknown date, the outcome of the myalgia was unknown.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported having myalgias from 1st dose of Shingrix. The reporter did not consent to follow up.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Rash generalised
Clinical narrative: Rash started within 2-5 minutes after Pentacel given on right thigh. Rash was also up on trunk and spread to the rest of her body. Nurse was called to the room. Benadryl and steroids given. Rash went away within 30 minutes of meds being given. Patient went home with mom after rash went away.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Dark circles under eyes, Pallor, Skin discolouration
Clinical narrative: Infant received immunizations. Approximately 5 minutes later, while still in office,  Mom was nursing infant when she noted that the baby had fallen asleep and was dusky around his eyes. Physician was alerted and noted that the baby was slightly pale. Vital signs were within normal limits and baby was moving around and responsive. Observation was continued, and app. 10  minutes later, mom reported that he was  "dusky" around his mouth. Physician was alerted again, and baby was noted to be alert, vital signs were normal but physician also noted a very slight dusky color that disappeared within a matter of seconds.  The baby was in no respiratory distress of any type, and would smile when prompted. Baby was observed for approximately one hour after this, and then parent went home. Baby was not pale and was comfortable. Mom reports 24 hours later that baby  is fine, happy and has experienced no further symptoms of any type.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Swelling
Clinical narrative: Large area of localized swelling, pruitis
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Rash, Swelling
Clinical narrative: Patient was seen in ED on 5-15-2019 for a rash and swelling , Patient was given steroid inject and benadryl .
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Headache, Nausea, Pain, Urticaria
Clinical narrative: Patient received trumemba vaccine and approximately 45 minutes to 1 hour later, the  patient reportedly  felt nauseous, broke out in hives all over her body. She had a headache and felt dizzy as well. She reported that she  had pain from her  head all the way down to her groin area. I spoke to her over the phone during this episode. I instructed her to take  50 mg of benadryl and  800 mg  of ibuprofen. Her symptoms resolved in 45 minutes after taking those medications.
Age: 2.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Blood lead normal, Crying, Full blood count normal, Petechiae, Rash
Clinical narrative: Dad noticed small pinpoint rash on child's neck and face approximately 10 minutes after the administration of vaccinations.  Child assessed by nurse at that time.  Child was crying on and off during the administration of vaccines and during assessment.  Bp 110/80, P 120 , afebrile, and respirations normal as well as lung sounds.   Small amount of scattered petechiae seen on nape of neck and face.  No other abnormalities noted.  Child calm and mental status alert.  Concerned parents wished for child to be transported to local hospital for further observation and assessment.  Ambulance transported child and parent to local emergency department where child was treated with oral ?steroid? and ?Benadryl.?  Mom was given a ?Benadryl? prescription upon discharge from ED and instructed to give every 6 hours.   Discharge instructions included seeing child?s MD the next day for further assessment and workup.  Mom stated that MD took a lab test (CBC/lead), which was sent to lab, and stated that child was ?fine.?  Spoke with mom the next day and she stated that lab work came back ?normal? and that the petechial ?rash? was almost all gone.  She had not given child Benadryl at home.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Asthenia, Fatigue, Migraine, Myalgia
Clinical narrative: Severe generalized muscle and joint pain, migraine, weakness, exhaustion.  Symptoms gone within 24 hours of onset.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; patients were administered one dose each of improperly stored Rotateq; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 20-MAR-2019, the patient was vaccinated with one dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ)orally, lot # R016790, expiration date: 20-APR-2020 (also reported as 04-APR-2020, but upon internal validation established as 20-APR-2020). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of above 9 degrees Celsius (8.5 degrees Celsius) for 7 hours 1 minute. Previous excursion was reported as above 9 degrees Celsius (9.6 degrees Celsius) for 33 minutes. Digital data logger was involved.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA008780:
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse affects; improperly stored dose of PROQUAD was administered to a patient; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 24-APR-2019, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R026717, expiration date: 17-MAR-2020 (exact dose, site and route of administration were not reported). It was unknown how the sterile diluent used to reconstitute the administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored. No adverse effects were reported. The vaccines were exposed to a temperature of 70 degree Fahrenheit (F) for a time frame of 2 hours. The digital data logger was involved in recording the temperature details. There was no previous temperature excursion.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: a patient was given a dose of VARIVAX and approximately one week later, the patient was administered a dose of MMR II; No adverse effects were reported; This spontaneous report as received from a registered nurse, via company representative, regarding a child of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On an unspecified date reported as Monday, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) and approximately one week later, as the patient's mom was nervous that everyone was getting measles, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), both for prophyaxis (strength, dose, frequency, route, anatomical location, lot # and expiration date were not provided ).No adverse effects were reported. The reporter wanted to know which of the live vaccines became invalid and if what vaccine they need to repeat.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site haemorrhage, Oropharyngeal pain, Pain in extremity, Peripheral swelling, Pulmonary thrombosis
Clinical narrative: This spontaneous report was received from a 76-year-old male patient referring to himself. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 06-APR-2019, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. The shingles shot nicked a vein and it started to bleed. On an unknown date in 2019, the patient's arm was hurting, blood clot formed and it slowly went into chest. On an unknown date in 2019, the patient was hospitalized for 6 days to suck out the blood clot. While he was hospitalized, they put something in so he could not swallow his tongue so he had a sore throat on an unknown date in 2019. His arm was still puffed out on an unknown date in 2019. The outcome of thrombosis, pain in extremity, venous injury and venous haemorrhage was unknown. The outcome of oropharyngeal pain and peripheral swelling was reported as not recovered. Causality assessment between the events and ZOSTAVAX was not reported. Upon internal review, the events of venous haemorrhage, venous injury and thrombosis were considered to be medically significant.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Thrombosis
Clinical narrative: This spontaneous report was received from a 76-year-old male patient referring to himself. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 06-APR-2019, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. The shingles shot nicked a vein and it started to bleed. On an unknown date in 2019, the patient's arm was hurting, blood clot formed and it slowly went into chest. On an unknown date in 2019, the patient was hospitalized for 6 days to suck out the blood clot. While he was hospitalized, they put something in so he could not swallow his tongue so he had a sore throat on an unknown date in 2019. His arm was still puffed out on an unknown date in 2019. The outcome of thrombosis, pain in extremity, venous injury and venous haemorrhage was unknown. The outcome of oropharyngeal pain and peripheral swelling was reported as not recovered. Causality assessment between the events and ZOSTAVAX was not reported. Upon internal review, the events of venous haemorrhage, venous injury and thrombosis were considered to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; a patient was administered an improperly stored dose of ROTATEQ; This spontaneous report was received from a medical assistant, regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 08-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally, lot # R029815 with expiration date 18-JUN-2020, for prophylaxis (strength, dose and frequency were not provided). The dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) underwent a temperature excursion below 36°F (32.5°F) during 1 hour as recorded by a data logger. No adverse effect was reported.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: Complaining of Injection site pain; This spontaneous report was received from a medical assistant regarding to a non-pregnant female patient of unknown age. The patient had no pertinent medical history, no drug reactions/allergies and no concomitant medicines. On 01-MAY-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R027577; expiration date: 23-JUN-2021) via intramuscular route for prevention of human papillomavirus (HPV). On an unknown date in May 2019, the patient went to reporter's office with complaint of injection site pain (vaccination site pain). It was reported that the patient sought medical attention and no treatment was given for the event. There was no hospitalization and the event was not life threatening. No product quality complaint involved. The outcome of event was reported as recovering. The reporter's causality assessment was not reported.  This is one of the two reports from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of rheumatoid arthritis aggravated in a adult patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced rheumatoid arthritis aggravated (serious criteria GSK medically significant), fever, pain, muscle soreness, injection site swelling, influenza like illness, difficulty sleeping, injection site erythema and injection site warmth. The patient was treated with TYLENOL and BENADRYL. On an unknown date, the outcome of the rheumatoid arthritis aggravated, fever, pain, muscle soreness, injection site swelling, influenza like illness, difficulty sleeping, injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the rheumatoid arthritis aggravated, fever, pain, muscle soreness, injection site swelling, influenza like illness, difficulty sleeping, injection site erythema and injection site warmth 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 was selected as adult as per vaccine indication. The patient complained of generalized, all over feverish achy feeling, muscle soreness, swollen at site and flu like symptoms with injection site reactions. The reporter reported upon programme called back that, the patient reported that she thought it might have worsened her rheumatoid arthritis, and could not sleep. The reporter reported no reports of adverse experience prior to this lot. Shortage was mentioned. The nurse gave the 4th patient TYLENOL and BENADRYL to alleviate symptoms. No additional details were provided. The nurse stated that, due to workload she was unable to provide requested data but can supply at a later time. This case was 1 of the 4 cases, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Insomnia, Myalgia, Pain, Pyrexia, Rheumatoid arthritis
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of rheumatoid arthritis aggravated in a adult patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced rheumatoid arthritis aggravated (serious criteria GSK medically significant), fever, pain, muscle soreness, injection site swelling, influenza like illness, difficulty sleeping, injection site erythema and injection site warmth. The patient was treated with TYLENOL and BENADRYL. On an unknown date, the outcome of the rheumatoid arthritis aggravated, fever, pain, muscle soreness, injection site swelling, influenza like illness, difficulty sleeping, injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the rheumatoid arthritis aggravated, fever, pain, muscle soreness, injection site swelling, influenza like illness, difficulty sleeping, injection site erythema and injection site warmth 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 was selected as adult as per vaccine indication. The patient complained of generalized, all over feverish achy feeling, muscle soreness, swollen at site and flu like symptoms with injection site reactions. The reporter reported upon programme called back that, the patient reported that she thought it might have worsened her rheumatoid arthritis, and could not sleep. The reporter reported no reports of adverse experience prior to this lot. Shortage was mentioned. The nurse gave the 4th patient TYLENOL and BENADRYL to alleviate symptoms. No additional details were provided. The nurse stated that, due to workload she was unable to provide requested data but can supply at a later time. This case was 1 of the 4 cases, reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash
Clinical narrative: shingles; Rash/ pain in rash; burning in the rash; This case was reported by a physician via sales rep and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number BF4J5, expiry date 5th July 2021) for prophylaxis.   On 21st March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 2nd April 2019, 12 days after receiving Shingrix, the patient experienced shingles, painful rash and burning sensation. On an unknown date, the outcome of the shingles, painful rash and burning sensation were unknown.   It was unknown if the reporter considered the shingles, painful rash and burning sensation to be related to Shingrix.  Additional details were provided as follows: On 2nd April 2019, the patient developed a rash and saw the physician on 8th April 2019 complaining of pain and burning in the rash. The rash was described by the physician as one dermatome, right sided T10-11 and diagnosed as shingles. The patient had not followed up with the reporter, so she does not know if the rash has resolved. Emergency room visit was required.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Palpitations, Pyrexia
Clinical narrative: heart palpitations; low grade fever; nausea; This case was reported by a pharmacist via call center representative and described the occurrence of palpitation in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number DK9L5, expiry date 4th September 2021) for prophylaxis.   On 4th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 5th May 2019, 1 days after receiving Shingrix, the patient experienced palpitation, low grade fever and nausea. On an unknown date, the outcome of the palpitation, low grade fever and nausea were recovered/resolved.   It was unknown if the reporter considered the palpitation, low grade fever and nausea to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that palpitations developed later in the day than the other symptoms. The patient visited the emergency room for the palpitations, but the physicians were not able to determine a cause. As of 8th May 2019, the patient's symptoms were completely resolved, but it was not certain when exactly the patient's symptoms resolved. The pharmacist stated that she was uncertain about causality, but that the patient seems to think that her symptoms were caused by the Shingrix. The reporter consented to follow up. Emergency visit was Required. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose increased
Clinical narrative: Increase blood sugar; This case was reported by a consumer via call center representative and described the occurrence of blood sugar increased in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2019, the patient received the 1st dose of Shingrix. On 6th May 2019, less than a day after receiving Shingrix, the patient experienced blood sugar increased. On an unknown date, the outcome of the blood sugar increased was not recovered/not resolved.   It was unknown if the reporter considered the blood sugar increased to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. On 6th May 2019 (Monday), the patient received the Shingrix vaccine and Since then his blood sugar numbers had been going up.  On 6th May 2019, the patient's blood sugar numbers had been going up. They were normally between 140-150's  On 9th May 2019, the patient's blood sugar numbers were between 230 to 300. The patient would like to know if this was a side effect of the Shingrix vaccines.  No additional information were provided.      Lab Comments: On 6th May 2019, the patient's blood sugar numbers had been going up. They were normally between 140-150's  On 9th May 2019, the patient's blood sugar numbers were between 230 to 300.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: redness around the injection site; This is a spontaneous report from a contactable pharmacist.  A patient of unspecified age and gender received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced redness around the injection site on an unspecified date.  The outcome of the event was unknown.  Information on the batch number has been requested.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: Extreme muscle pain. Ongoing for one week. Difficultly lifting right arm.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass
Clinical narrative: 2.5 inch lump on left arm and 0.5 inches tall, toward the inside of the upper arm (not exactly at the injection site, higher up). Lump is hard, not red or warm or itchy or painful. Started 5/16 in the evening.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Headache, Myalgia
Clinical narrative: Weakness, chills, loss of appetite, muscle ache, headache.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Mobility decreased, Pyrexia
Clinical narrative: Fever, fatigue, inability to get out of bed x 3 days
Age: 59.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Dx:Cellulitis Left upper Arm Rx; Bactrim DS 800-160  tablet Q 12 hours X 10 days
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: muscle aches and fever
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Myalgia, Pyrexia
Clinical narrative: muscle aches and fever
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, chills, shivering, headache, muscle pain.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Incorrect product formulation administered
Clinical narrative: A nurse gave Hib component of pentacel without the diluent that is provided in  the same box.  I emailed CDC and spoke with manufacturer and came to the  understanding  that this dose is invalid.  MD was notified and we are trying to get a hold of parents to let them know and re-vaccinate patient.  No signs of reaction have been reported to clinic at this time.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Rotavirus test positive
Clinical narrative: CHILD RECEIVED 3 ROTAVIRUS VACCINES ON SCHEDULE AND POSITIVE FOR ROTAVIRUS 5/15/19. JUST WANTED TO BE MADE AWARE OF POSITIVE ROTAVIRUS AFTER  COMPLETE VACCINATION
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Moderate  pain and swelling  pain in right shoulder at injection site.   Extreme tiredness, Fever (100), chills,  headache
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Moderate  pain and swelling  pain in right shoulder at injection site.   Extreme tiredness, Fever (100), chills,  headache
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: I got the first vaccination on Jan. 31, and the second one on May 16. Both times, I have come down with fever and shivering, between 99-100 degrees. The first time it began a couple of hours after the shot and lasted two days, and was debilitating. The second time began about 12 or 13 hours later, and is not quite as bad as the first time but I still need to leave work.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Swelling
Clinical narrative: Red spotted rash, approximately 3"x1.5". Itching and swelling noticed during the first night. Itching continued for a day and a half. Swelling still ongoing. Redness of rash diminished, but still evident, after 2 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: She states she started having itching on the left upper arm and the some redness the size of a quarter by 10:00 pm on 5/13/19.   She took a Benadryl to see if it would help.  On 5/14/19 she had redness that extended 2 cm x 2.5 cm on the left upper arm, raised and warm to the touch with severe itching.  She was advised to use a cool rag over the area,  continue taking Benadryl as needed and use an anti itch creme as needed.    As of 5/17/19 she stats the redness is getting better and the itching has subsided some.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Injection site swelling, Pain
Clinical narrative: Shivering, weakness, extreme pain in arm, swelling at site.  aches, tiredness.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Shivering, weakness, extreme pain in arm, swelling at site.  aches, tiredness.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Urticaria
Clinical narrative: Patient states she had hives and cold chills (cold chills went away) but just currently "feels bad". She stated that she had no issues with breathing and will contact the pharmacy if symptoms worsen.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Interchange of vaccine products
Clinical narrative: Kinrix given for the fourth dose of DTaP and the third dose of IPV, which is incorrect.  The patient has not reported and symptoms.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: Fever throughout the night, muscle aches over entire body, moderate plus soreness in L deltoid injection site
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Myalgia, Pain
Clinical narrative: Received my Flu shot as part of the hiring process for a new job.  Approximately 30 mins after the injection I started to experience arm (muscle) pain.  I did not thing much of it until the next day when I could not raise my arm without excruciating pain.  I did talk with my primary care physician about it but of course once you receive the shot there isn't anything you can do about it.  Now, 5 months later I am still having pain and decreased ROM.  I am told that I must receive the flu shot every year for my job but I'm very apprehensive to get another one.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injected limb mobility decreased, Injection site inflammation, Injection site pain, Musculoskeletal pain
Clinical narrative: received vaccine left deltoid 5/21/2018. Experienced very sore shoulder and flu-like symptoms. initial shoulder pain post vaccine lasted about 2 weeks, flu symptoms resolved in about 7 days. 7/18 started to develop left pain shoulder, became chronic in nature. finally saw orthopedic specialist, for inflammation 3/19 and attended PT without relief. Returned to Orthopedic doctor 5/19 and was diagnosed with frozen shoulder -adhesive capsulitis . Correlation between initial vaccination and start of inflammation leading to condition. Physical therapy continues to improve ROM of L shoulder.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Periarthritis
Clinical narrative: received vaccine left deltoid 5/21/2018. Experienced very sore shoulder and flu-like symptoms. initial shoulder pain post vaccine lasted about 2 weeks, flu symptoms resolved in about 7 days. 7/18 started to develop left pain shoulder, became chronic in nature. finally saw orthopedic specialist, for inflammation 3/19 and attended PT without relief. Returned to Orthopedic doctor 5/19 and was diagnosed with frozen shoulder -adhesive capsulitis . Correlation between initial vaccination and start of inflammation leading to condition. Physical therapy continues to improve ROM of L shoulder.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Fatigue, Influenza like illness, Insomnia, Nervousness
Clinical narrative: heavy body aches, extreme fatigue for 24 hours; followed by 24 hours of feeling really, really good, followed by 48 hours of anxiety or extreme nervousness and insomnia, followed by flu-like symptoms lasting a week (though may be a subsequent virus, feels like an onset of original side effects)
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: heavy body aches, extreme fatigue for 24 hours; followed by 24 hours of feeling really, really good, followed by 48 hours of anxiety or extreme nervousness and insomnia, followed by flu-like symptoms lasting a week (though may be a subsequent virus, feels like an onset of original side effects)
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: The patient developed an unspecified rash in an unspecified area; This spontaneous report was received from a registered nurse and refers to a 1-year old male patient. No information was provided regarding patient's medical history, concurrent conditions, allergies or concomitant medications.  On 07-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin(rHA), subcutaneous for prophylaxis (reported as routine injection) (lot # N027779 with expiration date on 08-AUG-2019, dose and frequency were not reported).  On the same date, the patient developed an unspecified rash in an unspecified area after the vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was administered. It was reported that patient's parents called the physician office on 10-MAY-2019 and it was also reported that patient received treatment for the adverse event.  The outcome of unspecified rash in an unspecified area was not recovered at the moment of this report.  The relatedness between the event rash and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administration was unknown.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling
Clinical narrative: Vaccine Administered at Inappropriate Site; Injection site redness; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 42PT4, expiry date 5th October 2019) for prophylaxis.   On an unknown date, the patient received Boostrix (intradermal). On an unknown date, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not reported but it could be 66 years or 67 years. The health care professional reported that a Boostrix dose was inadvertently administered via the intradermal route, which led to the intramuscular formulation administered by other route. The intended vaccination was a tuberculosis skin test however Boostrix was mistakenly used instead.   Follow up information was received from nurse on 26th April 2019: The patient's demographics were updated. On 4th April 2019, the patient received 0.5ml of Boostrix intradermally. The patient notified that as per GSK and CDC, Boostrix given intradermally could not be determined to be effective and would have to be administered intramuscularly at a later date. After receiving intradermal Boostrix the patient denied discomfort, but was advised that the injection site area could become reddened or puffy. On 5th April 2019, the reporting manager called the patient for follow up via an interpreter registered nurse. The patient had no swelling, pain, no fever. Less than a day after receiving Boostrix, the patient's injection site was slightly reddened in arm area of size of a quarter. The patient's family advised to call back if any worsening of area, fever, other discomfort. On 10th April 2019, the patient's daughter called the clinic and stated that the patient's site was normal with no further complaints or concerns. The intended vaccination was a Tdap vaccines however Boostrix was mistakenly administered intradermally instead of intramuscularly. It was unknown if the reporter considered the injection site erythema to be related to Boostrix. This case was medication error with adverse event. The VAERS details were updated.
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Joint injection, Musculoskeletal disorder, Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: Received vaccination at 3;30 pm and by 8 pm had intense pain in left knee.  15 minutes later left knee would not bear my weight and was forced to use crutches.  Saw MD next day and received a shot in knee.  By that evening my left hand had swollen up and was painful enough that i could not use it.  Had MRI on left knee on May13th which showed no problems with knee whatsoever.  Received shot for swelling in hand and as of this writing it is still somewhat swollen but am able to use it with little to no pain.
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Peripheral swelling, Walking aid user, Weight bearing difficulty, X-ray limb
Clinical narrative: Received vaccination at 3;30 pm and by 8 pm had intense pain in left knee.  15 minutes later left knee would not bear my weight and was forced to use crutches.  Saw MD next day and received a shot in knee.  By that evening my left hand had swollen up and was painful enough that i could not use it.  Had MRI on left knee on May13th which showed no problems with knee whatsoever.  Received shot for swelling in hand and as of this writing it is still somewhat swollen but am able to use it with little to no pain.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, RV1
Symptoms: Blood thyroid stimulating hormone normal, Culture stool negative, Diarrhoea, Full blood count normal, Metabolic function test normal
Clinical narrative: Diarrhea a few hours after the vaccinations were given, that continued for 7 days and required hospitalization. Additionally had some emesis and weight loss. No fevers.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, RV1
Symptoms: Occult blood positive, Rotavirus test negative, Urine analysis normal, Vomiting, Weight decreased
Clinical narrative: Diarrhea a few hours after the vaccinations were given, that continued for 7 days and required hospitalization. Additionally had some emesis and weight loss. No fevers.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Headache, Injection site pain, Pyrexia, Rash
Clinical narrative: 104.4 fever, headache, slight rash, pain at injection site
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No known adverse effects; a patient received an expired dose of M-M-R II; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 13-MAY-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # N013868 with expiration date 04-MAY-2019, subcutaneously, albumin status recombinant Human albumin (rHA) (exact dose, dose number, site and route of administration was not reported). There was no known adverse effects.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Patient was given HIB diluent and not powder
Age: 66.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain
Clinical narrative: Pain at injection site (primarily right arm), flu-like body aches, chills; symptoms grew worse over a 12-hour period, and then gradually lessened over the next 12 hours and were non-significant after 24 hours  Did NOT experience headaches, upset stomach, or dizziness
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Malaise, Pyrexia
Clinical narrative: Patient called to report lump size of a half dollar at injection site and fever and feeling of malaise
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling cold, Tremor
Clinical narrative: patient woke at 11pm the day vaccine was given states he was cold + shaking, lasted a minute.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Rash maculo-papular
Clinical narrative: Diffuse maculopapular rash onset chest and spreading outwardly
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Father called to report that for 20 seconds patient held arms above his head and had hives that disappeared quickly ten days after receiving vaccine. Episode was brief.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain, Pyrexia, Vomiting
Clinical narrative: severe abdominal pain; Vomiting; fever over 102; This case was reported by a physician via sales rep and described the occurrence of abdominal pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 3 days after receiving Shingrix, the patient experienced abdominal pain, vomiting and fever. On an unknown date, the outcome of the abdominal pain, vomiting and fever were unknown.   It was unknown if the reporter considered the abdominal pain, vomiting and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that all reported to VAERS and at least two of the three directly to GSK as well. The patient who was also one of their pediatricians had severe abdominal pain and vomiting 2 days afterwards, after having fever over 102 the day after the vaccination.  The reporter has asked her to also report this.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature increased, Feeling abnormal, Headache, Nausea, Pain in extremity
Clinical narrative: upper arm hurt; plain lousy; Headache; queasy stomach; minor/elevated temp; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in January 2019, refer case US2019GSK086392).   On 7th May 2019 20:00, the patient received the 2nd dose of Shingrix. In May 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, feeling bad, headache, queasy and body temperature increased. The patient was treated with acetylsalicylic acid (Aspirin). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, feeling bad, headache, queasy and body temperature increased were unknown.   It was unknown if the reporter considered the pain in arm, feeling bad, headache, queasy and body temperature increased to be related to Shingrix.  Additional details were provided as follows: The patient didn't know if the actually had chicken pox or the measles. The patient was an adult at the time in married student housing during grad school. The patient had the follow up vaccination and reported that the patient had normal activity after vaccination except upper arm hurt, feel just plain lousy with headache (not migraine) and queasy stomach. The patient asked about the events lasts 2 to 3 days. This was worse than first dose. The patient also had minor elevated temperature. The patient took 81 mg Aspirin.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: upper arm hurt; plain lousy; Headache; queasy stomach; minor/elevated temp; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in January 2019, refer case US2019GSK086392).   On 7th May 2019 20:00, the patient received the 2nd dose of Shingrix. In May 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, feeling bad, headache, queasy and body temperature increased. The patient was treated with acetylsalicylic acid (Aspirin). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, feeling bad, headache, queasy and body temperature increased were unknown.   It was unknown if the reporter considered the pain in arm, feeling bad, headache, queasy and body temperature increased to be related to Shingrix.  Additional details were provided as follows: The patient didn't know if the actually had chicken pox or the measles. The patient was an adult at the time in married student housing during grad school. The patient had the follow up vaccination and reported that the patient had normal activity after vaccination except upper arm hurt, feel just plain lousy with headache (not migraine) and queasy stomach. The patient asked about the events lasts 2 to 3 days. This was worse than first dose. The patient also had minor elevated temperature. The patient took 81 mg Aspirin.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: upper arm hurt; feel a lot lousier than with the first dose; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm and feeling bad. On an unknown date, the outcome of the pain in arm and feeling bad were unknown.   It was unknown if the reporter considered the pain in arm and feeling bad to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient experienced upper arm hurt and felt a lousier with the first dose of Shingrix. The case has been linked with the case US2019AMR084199, reported by same reporter for same patient.