chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient stated a week after the vaccine her arm presented with swelling, redness, and warm to the touch. Patient decribed as a cellulitis
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Body aches, low grade fever (99.8), chills, headache, 6cm induration @ injection site with redness, warmth, pain and swelling. Sx developed by 2100 day of injection. 24-60hours post injection- continued all Sx as above with development of fatigue, development of sharp, stabbing left lateral torso pain (under lower ribs,) and worsening arm pain (throbbing) and increased area of redness and warmth. 60+ hours post injection -body aches abated, headache abated, side pain lessened in frequency, local arm reaction continued and itching began.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Body aches, low grade fever (99.8), chills, headache, 6cm induration @ injection site with redness, warmth, pain and swelling. Sx developed by 2100 day of injection. 24-60hours post injection- continued all Sx as above with development of fatigue, development of sharp, stabbing left lateral torso pain (under lower ribs,) and worsening arm pain (throbbing) and increased area of redness and warmth. 60+ hours post injection -body aches abated, headache abated, side pain lessened in frequency, local arm reaction continued and itching began.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Body aches, low grade fever (99.8), chills, headache, 6cm induration @ injection site with redness, warmth, pain and swelling. Sx developed by 2100 day of injection. 24-60hours post injection- continued all Sx as above with development of fatigue, development of sharp, stabbing left lateral torso pain (under lower ribs,) and worsening arm pain (throbbing) and increased area of redness and warmth. 60+ hours post injection -body aches abated, headache abated, side pain lessened in frequency, local arm reaction continued and itching began.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Burning sensation, Urticaria
Clinical narrative: 6 hours after receiving the vaccination I experienced severely burning hands and feet. Within 15 minutes I observed hives forming on my torso and arms. I went to the clinic, and by that time hives were all over: arms, chest, torso, abdomen, thighs, hips. They gave me BENADRYL and Methylprednisolone. They prescribed a 6-day MEDROL pack, and advised me to take ranitidine and antihistamines for a month. I still have the sense of anxiety that began the day of the reaction.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: Sore arm with mild or moderate pain, redness and at shot site. I also feel tired, and have muscle pain, headache, shivering, fever (not sure), stomach jitters, loss of appetite. Generally out of sorts, fluish, limiting my usual activities still 24 hours later.   I didn't have a reaction like this to the first vaccination -- or ever before to any vaccination -- only this 2nd shot.  Ibuprofen helps.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Influenza like illness, Injection site erythema, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Sore arm with mild or moderate pain, redness and at shot site. I also feel tired, and have muscle pain, headache, shivering, fever (not sure), stomach jitters, loss of appetite. Generally out of sorts, fluish, limiting my usual activities still 24 hours later.   I didn't have a reaction like this to the first vaccination -- or ever before to any vaccination -- only this 2nd shot.  Ibuprofen helps.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm with mild or moderate pain, redness and at shot site. I also feel tired, and have muscle pain, headache, shivering, fever (not sure), stomach jitters, loss of appetite. Generally out of sorts, fluish, limiting my usual activities still 24 hours later.   I didn't have a reaction like this to the first vaccination -- or ever before to any vaccination -- only this 2nd shot.  Ibuprofen helps.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Acarodermatitis, Pityriasis rosea, Rash
Clinical narrative: about two weeks after my son developed a rash that started behind his neck, the next morning it had spread across his back onto his head and face. about a week later the rash moved to his arms and legs. hes had the rash about three weeks now with no signs of it getting any better. its getting worse.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Coordination abnormal, Injection site pain, Muscular weakness
Clinical narrative: PT SAID AFTER SHE GOT THE INJECTION SHE STARTED WITH INJECTION SITE PAIN THEN GRADUALLY SHE HAS MUSCLE WEAKNESS ON HER LEGS AND ARMS. IN ADDITION SHE HAS LACK OF COORDINATION
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain, Headache, Lip swelling, Oropharyngeal pain, Pyrexia
Clinical narrative: 5hrs  after flu shot got tactile fever.  Then, 24 h  after flu shot got upper lip swelling (lasted 24h), sore throat, HA, abd pain, vomit x 1.  Dx strep in ER and given prednisone for possible "allergic reaction to flu shot"
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Streptococcal infection, Streptococcus test positive, Vomiting
Clinical narrative: 5hrs  after flu shot got tactile fever.  Then, 24 h  after flu shot got upper lip swelling (lasted 24h), sore throat, HA, abd pain, vomit x 1.  Dx strep in ER and given prednisone for possible "allergic reaction to flu shot"
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, fever, and chills for 2 days
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: First symptom was very painful injection site. Within about 6 hours I had a terrible headache and within 12 hours felt achy, low grade fever which lasted the entire next day.
Age: 78.0
Sex: M
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: Patient came in with significant swelling below his left elbow
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site irritation, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Patient called about 9a and stated that she had some irritation at the injection site. Asked her to come to the pharmacy to be assessed (works here). 1030a-Pt presented with redness at injection site -- pink with a red dote in the center about 3" in diameter on Right Arm. It was warm and firm to the touch compared to the rest of her arm. She reported some stiffness and pain. Told pt if the redness grows or the arm get more painful to return to the pharmacy. 520p - Pt returned to pharmacy. Pt and I agreed that the reaction looked better. Pt still experiencing soreness. Advised that she put ice on the site a few times tonight.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient called about 9a and stated that she had some irritation at the injection site. Asked her to come to the pharmacy to be assessed (works here). 1030a-Pt presented with redness at injection site -- pink with a red dote in the center about 3" in diameter on Right Arm. It was warm and firm to the touch compared to the rest of her arm. She reported some stiffness and pain. Told pt if the redness grows or the arm get more painful to return to the pharmacy. 520p - Pt returned to pharmacy. Pt and I agreed that the reaction looked better. Pt still experiencing soreness. Advised that she put ice on the site a few times tonight.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary mass, Influenza like illness
Clinical narrative: Patient received second SHINGRIX vaccine on 4/8/19. The next morning he experienced flu like symptoms. The second morning he developed a lump the size of a baseball in his arm pit. He went to the doctor and was told to put hot compresses on it and if it did not subside in a few days to return to the clinic. The doctor also advise that he take an over the counter NSAID for the pain and inflammation.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Asthenia, Chills, Decreased appetite, Dizziness
Clinical narrative: Unrelenting chills for nearly 24 hours, extreme weakness, literally couldn't get off the couch - when I did, felt as if I was going to faint, pass out. Unable to eat - absolutely no appetite only had a little clear soup and 1/2 a piece of toast the entire day. I didn't have this reaction after the first shot in January - just a very sore arm - which I also have this time. I know these symptoms can be expected in some patients, but I am reporting this because of the severity - I felt so very sick and weak, unable to walk but a few steps without feeling I was going to pass out. The shot was Tuesday afternoon, it is Thursday - no more chills, but still so weak that I have not gone out of the house and cancelled two appointments.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeding disorder, Gait inability, Malaise, Mobility decreased
Clinical narrative: Unrelenting chills for nearly 24 hours, extreme weakness, literally couldn't get off the couch - when I did, felt as if I was going to faint, pass out. Unable to eat - absolutely no appetite only had a little clear soup and 1/2 a piece of toast the entire day. I didn't have this reaction after the first shot in January - just a very sore arm - which I also have this time. I know these symptoms can be expected in some patients, but I am reporting this because of the severity - I felt so very sick and weak, unable to walk but a few steps without feeling I was going to pass out. The shot was Tuesday afternoon, it is Thursday - no more chills, but still so weak that I have not gone out of the house and cancelled two appointments.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Ear infection, Pruritus, Pyrexia, Rash, Skin disorder
Clinical narrative: 4/10/2019  3:57 PM  Chief complaint: SKIN PROBLEM  HPI: Parents here with concern for measles. Patient is a 12 M female brought by mother and father presenting with progressively worsening rash on face, arms and torso which began yesterday. Had the MMR/varicella vaccine on 3/29, and was treated for ear infection and completed The Amoxil on Monday 4-8  Symptoms:  Sunday-Monday:   Began with fever 103F-105F Tuesday-Wed: Rash: began on face, torso and hands at once, Temp 99F Tuesday And 98.4F today. No Cough, no Coryza , no Conjunctivitis Seems a little itchy, but otherwise normal behavior.  Parents gave Benadryl once this morning.  Additional history: Attends daycare Recommended symptomatic care, and home care until rash resolves. Reviewed recommendations with parents and precautions given RETURN TO CLINIC sooner with concerns.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Myalgia, Pyrexia
Clinical narrative: symptoms started the next morning after shot was administered - muscle pain, headache, loss of energy, low grade fever of 100.6F.  Side effects lasted approx. two days, easing on the 2nd day.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Erythema, Swelling face
Clinical narrative: TDaP & HPV administered 4/9/19 around 10:30 AM. Approximately 21 hours after vaccination, 4/10/19 at 07:30 AM  she noted mild left sided (only) facial/cheek swelling when getting ready for school. By 12:30 PM, the school reported mild redness and swelling just to the left cheek, but student felt fine. Denied and currently denies any localized reaction at injection site, hives, difficulty breathing, hoarseness, or difficulty swallowing. Mother gave her one dose of BENADRYL that night, and followed up the next day, 4/11/19 where symptoms had improved and she "felt fine". There was no evidence of hives, mild left cheek swelling and erythema noted just to cheek, otherwise negative exam.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: Received vaccine Monday afternoon, all day Tuesday patient reported feeling very sickly with symptoms similar to flu symptoms. She stayed in bed most of the day. Around 3pm on Tuesday (24 hours post inoculation) she began to feel better. Her arm was very sore and red with localized swelling and was hot to the touch. This persisted until today Thursday. She is going to her PCP tomorrow morning to see if she needs an antibiotic.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Received vaccine Monday afternoon, all day Tuesday patient reported feeling very sickly with symptoms similar to flu symptoms. She stayed in bed most of the day. Around 3pm on Tuesday (24 hours post inoculation) she began to feel better. Her arm was very sore and red with localized swelling and was hot to the touch. This persisted until today Thursday. She is going to her PCP tomorrow morning to see if she needs an antibiotic.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Fluid intake reduced, Hypersomnia, Irritability, Pyrexia
Clinical narrative: Vomiting 3 days after vaccine was administered  Low grade fever on the 4th- 7th days  Crabby, no appetite, not drinking, sleeping more than usual Day 8 rash beginning on neck  Day 9 rash covering entire trunk
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Vomiting
Clinical narrative: Vomiting 3 days after vaccine was administered  Low grade fever on the 4th- 7th days  Crabby, no appetite, not drinking, sleeping more than usual Day 8 rash beginning on neck  Day 9 rash covering entire trunk
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Itching at injection site.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Injection site rash, Musculoskeletal pain
Clinical narrative: patient came into pharmacy with complaint of shoulder pain; she also has large rash around the injection site; she also said that there is a burning sensation.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Lip swelling, Pyrexia
Clinical narrative: Fever, shivering, tiredness, swollen lip.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient's wife called and stated that his arm was in significant pain. She stated that the pain was such that he could not lift a full glass of water.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient states arm is swollen, red, and warm to the touch.  Painful when moving/lifiting arm. Started about one hour prior to reporting. No reported difficulties breathing.   Recommended cold/ice pack on arm and taking APAP/Ibuprofen prn to relieve pain and inflammation.  Consulted to seek urgent care if no improvement or worsening symptoms.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Patient states arm is swollen, red, and warm to the touch.  Painful when moving/lifiting arm. Started about one hour prior to reporting. No reported difficulties breathing.   Recommended cold/ice pack on arm and taking APAP/Ibuprofen prn to relieve pain and inflammation.  Consulted to seek urgent care if no improvement or worsening symptoms.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: pt has swelling at the deltoid muscle and warm to the touch.  recommended benadryl and to use a cold compress
Age: 4.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Erythema, Induration, Pain, Peripheral swelling, Pruritus
Clinical narrative: swollen arm, red.  I had it sprouted and very hard.  with itching and pain
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Rash, Rash papular, Skin hyperpigmentation
Clinical narrative: Received vaccine on Saturday. Rash appeared on Monday - on chest,left arm (whole length) Mom took a picture. (papular rash Rash resolved by todays visit (there are hyperpigmented spotty areas on distal forearm and proximal arm anterior aspect.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Hyperhidrosis, Peripheral swelling, Pruritus generalised, Urticaria
Clinical narrative: hives & itching all over + swelling of hands that comes and goes (Right hand worse) - started ~2pm 4/10/19 & got worse. Pt's allergist advised that he take prednisone & benadryl & go to ER if got worse. Pt was able to control the Rxn. w/ benadryl & prednisone but still had some itching & fatigue + sweating after taking.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 4x2 inch Red Itchy Patch at injection site at day 9. She will take some BENADRYL and contact her doctor.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chills, Hyperhidrosis, Injection site pain, Injection site warmth, Malaise
Clinical narrative: Shortly after the immunization she felt ill, had chills and muscle shaking followed by fever to 102. Was given acetaminophen which resolved fever and reduced chills and malaise. Had sweats did not recur. Has warmth and soreness of arms at injection site.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pyrexia, Tremor
Clinical narrative: Shortly after the immunization she felt ill, had chills and muscle shaking followed by fever to 102. Was given acetaminophen which resolved fever and reduced chills and malaise. Had sweats did not recur. Has warmth and soreness of arms at injection site.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dyskinesia, Immediate post-injection reaction, Loss of consciousness, Muscle twitching, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID 694862) regarding a 11 year old female patient. She had no medical history, concurrent condition and concomitant medications. On 15-MAY-2017, the patient was vaccinated with first doses of GARDASIL 9 (lot # M036059, unknown route in the right arm), BOOSTRIX (lot # LZ972, unknown route in the left arm), and MENACTRA (lot # U5416AA, unknown route in the right arm) for prophylaxis. On the same day, after receiving the vaccine, the patient experienced temporary loss of consciousness immediately. There was slight body twitching, jerking and pale coloring. Patient was sitting, no harm or injury occurred. Incident lasted 30 seconds and consciousness was regained. Recovery occurred in a few minutes following that for all the events. No medical intervention other than observation was needed. Child left the building ambulatory. The causality for the events was not provided. The agency considered the events as non-serious. Follow up information was received from a registered nurse (RN) via agency on 25-FEB-2019. The patient was vaccinated on 15-MAY-2017 at 16:00. At the same time, the patient developed the events. No diagnostic lab/test was performed. The Follow up information was received from a non-healthcare professional on 11-APR-2019. The reporter was not able to identify the patient with the provided information in the letter. The reporter was provided the date and time of the vaccination and was going to check if it will aid in identifying the patient.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Fibromyalgia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 80-year-old female patient who received SHINGRIX (batch number A4D72, expiry date 23rd May 2021) for prophylaxis. Concurrent medical conditions included fibromyalgia (has been in remission from fibromyalgia for 14 years). On 19th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th January 2019, less than a day after receiving SHINGRIX, the patient experienced muscle pain and fibromyalgia worsened. On an unknown date, the outcome of the muscle pain and fibromyalgia worsened were not recovered/not resolved. It was unknown if the reporter considered the muscle pain and fibromyalgia worsened to be related to SHINGRIX. Additional details were provided as follows: After vaccination in the evening the patient started to have muscle pain similar to fibromyalgia. The patient described to the reporter that she had been in remission from fibromyalgia for 14 years. The patient called the reporter and described this situation and stated that she was continuing to have the muscle pain and that her fibromyalgia was back. The reporter did not give consent to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Fibromyalgia, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 80-year-old female patient who received SHINGRIX (batch number A4D72, expiry date 23rd May 2021) for prophylaxis. Concurrent medical conditions included fibromyalgia (has been in remission from fibromyalgia for 14 years). On 19th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th January 2019, less than a day after receiving SHINGRIX, the patient experienced muscle pain and fibromyalgia worsened. On an unknown date, the outcome of the muscle pain and fibromyalgia worsened were not recovered/not resolved. It was unknown if the reporter considered the muscle pain and fibromyalgia worsened to be related to SHINGRIX. Additional details were provided as follows: After vaccination in the evening the patient started to have muscle pain similar to fibromyalgia. The patient described to the reporter that she had been in remission from fibromyalgia for 14 years. The patient called the reporter and described this situation and stated that she was continuing to have the muscle pain and that her fibromyalgia was back. The reporter did not give consent to follow up.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Local reaction, Pruritus, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 84-year-old female patient who received SHINGRIX (batch number 2YN4S, expiry date 9th July 2021) for prophylaxis. On 30th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st March 2019, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site itching and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site warmth were recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site itching and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient was administered 1st dose of SHINGRIX vaccine. Next day post vaccination patient experienced 3 inch circle at the injection site associated with redness, itching and warmth. Symptoms were worse by Tuesday and they started to improve by Wednesday. No further details were provided. The reported batch number 2YN45 was corrected to 2YN4S as per sales data sheet.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 84-year-old female patient who received SHINGRIX (batch number 2YN4S, expiry date 9th July 2021) for prophylaxis. On 30th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st March 2019, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site itching and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site warmth were recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site itching and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient was administered 1st dose of SHINGRIX vaccine. Next day post vaccination patient experienced 3 inch circle at the injection site associated with redness, itching and warmth. Symptoms were worse by Tuesday and they started to improve by Wednesday. No further details were provided. The reported batch number 2YN45 was corrected to 2YN4S as per sales data sheet.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP
Symptoms: Injection site reaction, Rash maculo-papular
Clinical narrative: papules; redness; This case was reported by a nurse via call center representative and described the occurrence of injection site papule in a 4-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 924Y3, expiry date 11th August 2019) for prophylaxis.   The patient's past medical history included rash (The patient had a rash with a unknown previous vaccine.). Concomitant products included ROTAVIRUS VACCINE (ROTATEQ VACCINE).   On 28th March 2019, the patient received Pediarix. On an unknown date, less than a week after receiving Pediarix, the patient experienced injection site papule and red rash. On an unknown date, the outcome of the injection site papule was not recovered/not resolved and the outcome of the red rash was recovered/resolved.   It was unknown if the reporter considered the injection site papule and red rash to be related to Pediarix.  Additional details were provided as follows: The patient received dose of Pediarix on the thigh. The patient had papule, which was uniform in shade and color on the upper side of the patient's thigh. The patient had two tiny streaks of redness in a swath on her upper outer side. There was not any drainage nor swollen, but it was odd looking. The patient looked smiley and happy and was eating normal and was also alert.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP
Symptoms: Injection site papule, Injection site reaction, Injection site streaking, Rash erythematous
Clinical narrative: papules; redness; This case was reported by a nurse via call center representative and described the occurrence of injection site papule in a 4-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 924Y3, expiry date 11th August 2019) for prophylaxis.   The patient's past medical history included rash (The patient had a rash with a unknown previous vaccine.). Concomitant products included ROTAVIRUS VACCINE (ROTATEQ VACCINE).   On 28th March 2019, the patient received Pediarix. On an unknown date, less than a week after receiving Pediarix, the patient experienced injection site papule and red rash. On an unknown date, the outcome of the injection site papule was not recovered/not resolved and the outcome of the red rash was recovered/resolved.   It was unknown if the reporter considered the injection site papule and red rash to be related to Pediarix.  Additional details were provided as follows: The patient received dose of Pediarix on the thigh. The patient had papule, which was uniform in shade and color on the upper side of the patient's thigh. The patient had two tiny streaks of redness in a swath on her upper outer side. There was not any drainage nor swollen, but it was odd looking. The patient looked smiley and happy and was eating normal and was also alert.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Product administered at inappropriate site, Rash erythematous
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a 76-year-old female patient who received SHINGRIX (batch number GL2HR, expiry date 23rd May 2021) for prophylaxis. On 2nd April 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced rash and intramuscular formulation administered by other route. On an unknown date, the outcome of the rash and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional case details were provided as follows: The patient received the dose of SHINGRIX and experienced a rash in the mid-upper arm region. The reporter stated when the patient came in to the pharmacy they examined the injection site and believed it was possible that the administering pharmacist did not administer the vaccine into the patient's deltoid muscle, which led to inappropriate route of administration. The reporter stated that it was documented as being administered intramuscularly in the left arm, but again did not believe the vaccine fully was given into the deltoid. The reporter stated she believed at least part of the dose did not make it into the muscle. The reporter attempted to confirm if reporter believes vaccination was completed below the deltoid or subcutaneously, reporter was unable to confirm. When probed reporter stated that did not thought that it would had been administered at 45 degree angle (for subcutaneous administration) but was not sure it went into the muscle.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration, Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a 76-year-old female patient who received SHINGRIX (batch number GL2HR, expiry date 23rd May 2021) for prophylaxis. On 2nd April 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced rash and intramuscular formulation administered by other route. On an unknown date, the outcome of the rash and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional case details were provided as follows: The patient received the dose of SHINGRIX and experienced a rash in the mid-upper arm region. The reporter stated when the patient came in to the pharmacy they examined the injection site and believed it was possible that the administering pharmacist did not administer the vaccine into the patient's deltoid muscle, which led to inappropriate route of administration. The reporter stated that it was documented as being administered intramuscularly in the left arm, but again did not believe the vaccine fully was given into the deltoid. The reporter stated she believed at least part of the dose did not make it into the muscle. The reporter attempted to confirm if reporter believes vaccination was completed below the deltoid or subcutaneously, reporter was unable to confirm. When probed reporter stated that did not thought that it would had been administered at 45 degree angle (for subcutaneous administration) but was not sure it went into the muscle.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Site of shot upper left arm very sore.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Headache, Injection site reaction, Pain
Clinical narrative: Patient came to pharmacy and reported: Headache, body ache, fever, lightheadedness, and redness on arm due to injection side reaction. She said has been in bed for 4 days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient came to pharmacy and reported: Headache, body ache, fever, lightheadedness, and redness on arm due to injection side reaction. She said has been in bed for 4 days.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache
Clinical narrative: Woke up with headache and dizziness that lasted approx 14 hrs.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; Information has been received from a pharmacist via a sales representative, referring to two female patients of unknown age. Information about medical history, concurrent condition and concomitant therapy was unknown.   On unknown dates, the patients were vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, strength, route, lot# and expiration date were unknown) for prophylaxis.         On unknown dates, the patients experienced pain in arm. Pain lasted for about 1 week and then subsided in both patients. The causality assessment was not provided by the reporter.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Inflammation
Clinical narrative: The pharmacist told employee that he experienced redness and inflammation after receiving PNEUMOVAX injection on unspecified date.; The pharmacist told employee that he experienced redness and inflammation after receiving PNEUMOVAX injection on unspecified date.; This spontaneous report was received from a male pharmacist of unknown age via a company representative referring to himself. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was unknown.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, route, lot # and expiration date were) for prophylaxis. On an unspecified date, the patient experienced redness and inflammation after receiving pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). The patient took some ibuprofen and recovered after few days. It was unknown if the patient sought medical attention or performed any lab diagnostics/studies. The causality between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: Incorrect product storage; No adverse effects reported; This non-valid spontaneous report was received from a nurse, concerning 3 unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions or allergies were not provided.  On an unknown date, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023501 with expiration date 16-AUG-2020; and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R008031, expiration date 18-MAR-2020 (strength, anatomical location or route of administration were not provided), both for prophylaxis;  which were concomitantly administered with a properly stored sterile diluent (MERCK STERILE DILUENT).   Regarding varicella virus vaccine live (oka/merck) (VARIVAX) the storage temperature was reported as  15 degree Fahrenheit (°F) to 46°F (-9 degree Celsius (°C) to 8°C) for 6 hours 15 minutes, 6°F to 14°F (-14°C to -10°C) for 9 hours 50 minutes and 47°F to 77°F (9°C to 25°C) for 9 hours.  Regarding rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) the storage temperature was reported as above 47°F/9°C (16.2C) time frame 9 hours.  No previous excursions were reported. The temperature excursions were detected by a data logger
Age: 20.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Chills, Erythema, Impaired work ability, Pain
Clinical narrative: Chickenpox in a Vaccinated Adult; Chickenpox in a Vaccinated Adult; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 37-year-old male patient.  At age 20, the patient was vaccinated with two doses of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis.  The patient presented with a pruritic rash, chills, and body aches for three days. He was afebrile and had scattered vesicles on an erythematous base, on his trunk and extremities. He reported never having chickenpox. He worked at a nursing home where a resident had recently developed shingles. Vesicular fluid polymerase chain reaction (PCR) testing was positive for varicella zoster, consistent with chickenpox. The patient developed chickenpox almost two decades after being vaccinated. The patient was treated with a 7-day course of valacyclovir and was advised to stay home from work for two weeks.  The outcome of the events was unknown. The authors considered the events to be related to varicella virus vaccine live (oka/merck) (VARIVAX).  A copy of the published article is attached as further documentation of the patient's experience.
Age: 20.0
Sex: M
Vaccine: VARCEL
Symptoms: Polymerase chain reaction positive, Rash pruritic, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Chickenpox in a Vaccinated Adult; Chickenpox in a Vaccinated Adult; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 37-year-old male patient.  At age 20, the patient was vaccinated with two doses of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis.  The patient presented with a pruritic rash, chills, and body aches for three days. He was afebrile and had scattered vesicles on an erythematous base, on his trunk and extremities. He reported never having chickenpox. He worked at a nursing home where a resident had recently developed shingles. Vesicular fluid polymerase chain reaction (PCR) testing was positive for varicella zoster, consistent with chickenpox. The patient developed chickenpox almost two decades after being vaccinated. The patient was treated with a 7-day course of valacyclovir and was advised to stay home from work for two weeks.  The outcome of the events was unknown. The authors considered the events to be related to varicella virus vaccine live (oka/merck) (VARIVAX).  A copy of the published article is attached as further documentation of the patient's experience.
Sex: M
Vaccine: RVX
Symptoms: Intestinal obstruction, Intussusception
Clinical narrative: This literature marketed report has been received from the author of a published literature article and refers to a 4-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in Summer 2018 (reported as "last summer"), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) orally (dose, lot# and expiration date were not provided) for prophylaxis. On an unknown date, the patient developed intussusception, an intestinal obstruction after receiving the vaccine. The consumer reported that her son's intestines fold in on itself and the patient almost died. The outcome of the event was unknown. The author considered the event to be related to the suspect vaccine. Upon internal review, the event of intussusception was considered to be medically significant and life-threatening.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Dermatitis contact, Influenza, Measles post vaccine, Otitis media, Pyrexia
Clinical narrative: Information has been received from a physician referring to a 1 years old female patient. The patient's concomitant medications included montelukast, cetirizine hydrochloride (ZYRTEC), a daily multivitamin, two topical steroids for atopic dermatitis, clobetasol propionate (also reported as clabetesol) and fluocinolone acetonide (DERMA-SMOOTHE) /FS TOPICAL OIL. Her current condition included atopic dermatitis. The patient was allergic to milk, dust and dogs. Her historical drugs and historical conditions were not reported. On 05-FEB-2015, the patient was vaccinated with M-M-R II (dose, lot number and expiration date were unknown), subcutaneously for prophylaxis. On an unknown date in 2015, the physician reported that the patient's mother believed the patient developed a mild case of the measles, including a fever lasting 5 to 7 days after receiving the M-M-R II and developed a rash (reported as the patient had atopic dermatitis and easily developed a rash). On 11-MAR-2015, the patient came to medical practice and was diagnosed with fever, contact dermatitis, otitis media and influenza. There were no lab diagnostics or studies performed. The physician reported the patient had fully recovered from all reported symptoms. The causality assessment between the events and M-M-R II was not reported. Upon internal review, measles was determined to medically significant.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Information has been received from a physician referring to a 1 years old female patient. The patient's concomitant medications included montelukast, cetirizine hydrochloride (ZYRTEC), a daily multivitamin, two topical steroids for atopic dermatitis, clobetasol propionate (also reported as clabetesol) and fluocinolone acetonide (DERMA-SMOOTHE) /FS TOPICAL OIL. Her current condition included atopic dermatitis. The patient was allergic to milk, dust and dogs. Her historical drugs and historical conditions were not reported. On 05-FEB-2015, the patient was vaccinated with M-M-R II (dose, lot number and expiration date were unknown), subcutaneously for prophylaxis. On an unknown date in 2015, the physician reported that the patient's mother believed the patient developed a mild case of the measles, including a fever lasting 5 to 7 days after receiving the M-M-R II and developed a rash (reported as the patient had atopic dermatitis and easily developed a rash). On 11-MAR-2015, the patient came to medical practice and was diagnosed with fever, contact dermatitis, otitis media and influenza. There were no lab diagnostics or studies performed. The physician reported the patient had fully recovered from all reported symptoms. The causality assessment between the events and M-M-R II was not reported. Upon internal review, measles was determined to medically significant.
Sex: M
Vaccine: PPV
Symptoms: Anaphylactic shock, Cardio-respiratory arrest, Death, Dyspnoea, Immediate post-injection reaction
Clinical narrative: Information has been received from the authors of the article and refers to a 50 year old male patient. The patient's past medical history included past anaphylaxis, allergies to angiotensin-converting enzyme inhibitors (unspecified), hypertension, and renal cell carcinoma. The patient's concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of pneumococcal polysaccharide vaccine (manufacturer unknown) for prophylaxis (dose number and route were unspecified). Immediately after vaccination, the patient experienced respiratory difficulty, seizure, and cardiorespiratory arrest. Subsequently, the patient died. The cause of death was reported as anaphylactic shock. It was unknown if an autopsy was performed. The authors considered anaphylactic shock to be related to pneumococcal polysaccharide vaccine (manufacturer unknown).
Sex: M
Vaccine: PPV
Symptoms: Seizure
Clinical narrative: Information has been received from the authors of the article and refers to a 50 year old male patient. The patient's past medical history included past anaphylaxis, allergies to angiotensin-converting enzyme inhibitors (unspecified), hypertension, and renal cell carcinoma. The patient's concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of pneumococcal polysaccharide vaccine (manufacturer unknown) for prophylaxis (dose number and route were unspecified). Immediately after vaccination, the patient experienced respiratory difficulty, seizure, and cardiorespiratory arrest. Subsequently, the patient died. The cause of death was reported as anaphylactic shock. It was unknown if an autopsy was performed. The authors considered anaphylactic shock to be related to pneumococcal polysaccharide vaccine (manufacturer unknown).
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: patient was inadvertently given an extra dose of VARIVAX. Patient was given an unspecified dose of PROQUAD and an unspecified dose VARIVAX; patient was inadvertently given an extra dose of VARIVAX. Patient was given an unspecified dose of PROQUAD and an unspecified dose VARIVAX; This spontaneous report was received from a medical assistant referring to a 12 month old male patient. The patient had not pertinent medical history, drug reactions/allergies or concurrent conditions. The patient's concomitant medications included sterile diluent(MERCK STERILE DILUENT).          On 09-APR-2019, the patient was vaccinated with an unspecified dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) recombinant Human albumin (rHA) lot # R015738 with expiration date 02-DEC-2019, subcutaneously, for prophylaxis (strength and anatomical location were not reported). On the same date, the patient was inadvertently vaccinated with an unspecified dose of varicella virus vaccine live (oka/merck)(VARIVAX), for prophylaxis (strength, route of administration, lot # and expiration date were not reported). No treatment was given to the patient and no laboratory diagnostic test was performed. It was stated that this was not a product confusion.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Immediate post-injection reaction, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On 1st April 2019, immediately after receiving SHINGRIX, the patient experienced chills, fever, muscle soreness and headache. On an unknown date, the patient experienced injection site pain and pruritus. On an unknown date, the outcome of the chills, fever and muscle soreness were unknown and the outcome of the headache, injection site pain and pruritus were recovering/resolving. It was unknown if the reporter considered the chills, fever, muscle soreness, headache, injection site pain and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and day before reporting, the second the patient had chills, fever and body temperature was recorded as 101.6 and headache and sore muscles. The next day patient woke up with headache and soreness at the injection site and kind of itchiness. The patient felt slightly better. The reporter asked were all these normal side effects of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On 1st April 2019, immediately after receiving SHINGRIX, the patient experienced chills, fever, muscle soreness and headache. On an unknown date, the patient experienced injection site pain and pruritus. On an unknown date, the outcome of the chills, fever and muscle soreness were unknown and the outcome of the headache, injection site pain and pruritus were recovering/resolving. It was unknown if the reporter considered the chills, fever, muscle soreness, headache, injection site pain and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and day before reporting, the second the patient had chills, fever and body temperature was recorded as 101.6 and headache and sore muscles. The next day patient woke up with headache and soreness at the injection site and kind of itchiness. The patient felt slightly better. The reporter asked were all these normal side effects of SHINGRIX.