chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a nurse prescriber refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 22-SEP-2017, the patient was vaccinated with first dose of GARDASIL 9 (dose, units and frequency not reported) (lot# and expiration date not reported) intramuscularly. On 28-MAR-2018, the patient was vaccinated with second dose of GARDASIL 9 (dose, units and frequency not reported) (lot# and expiration date not reported) intramuscularly and received about half of the second dose in the series for an unspecified reason. No adverse effects reported. No product quality complaint was involved.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concomitant medications, drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II injection in the right deltoid (dose, route of administration lot number and expiration date were not reported). Within 24 hours, the patient was vaccinated with another dose of M-M-R II in the right arm. The doses of the vaccine were reconstituted with sterile diluent (MERCK) (dose, route of administration, lot number and expiration date were not reported). Both doses were given while the patient was an inpatient at the Labor and Delivery unit at the hospital. No adverse events were reported.
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report as received from a consumer (also reported as mother of the patient) refers to a 14 year old female patient. The patient's pertinent medical history included eczema. It was reported that the patient did not have any drug reactions/ allergies and was not taking any medications concomitantly. On an unknown date in July 2017 the patient was vaccinated with first dose in series of GARDASIL 9 (lot number and expiry date unknown) 1 injection in the left arm (route unknown) to avoid Human papillomavirus (HPV). On an unknown date approximately in July 2017 (also reported as a few hours after vaccination) the patient's left arm became slightly swollen, very red, painful and warm to touch. It was reported that the patient did not seek medical attention. Lab diagnostics studies were not performed. It was reported that the arm was treated with cold compress and the patient recovered in 2 days. The outcome of the events was reported as recovered. The relatedness of the event to the therapy with GARDASIL 9 was unknown. There was no product quality complaint reported.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Myalgia
Clinical narrative: Large bruising. Muscle pain from shoulder around to the armpit.
Age: 1.5
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: The site where both vaccines were given became red the next day, and by day 5 post vaccine, the site looked worse, increased redness and swelling. Contacted virtual MD on her computer, due to the fact it was the weekend. Virtual MD diagnosed a cellulitis and put her on antibiotics. Since being on antibiotics, the site is healing well.
Sex: M
Vaccine: VARZOS
Symptoms: Eye pain, Eye pruritus, Facial pain, Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. On 20-APR-2016, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent and severe strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient developed severe and painful itching on his face and within his eyes. Thereafter, he presented to a dermatologist and was diagnosed with shingles on his face and in both eyes. As a direct an proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Upon internal review, shingles in both eyes was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. On 20-APR-2016, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent and severe strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient developed severe and painful itching on his face and within his eyes. Thereafter, he presented to a dermatologist and was diagnosed with shingles on his face and in both eyes. As a direct an proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Upon internal review, shingles in both eyes was determined to be medically significant. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Ear pain, Fatigue, Headache, Lymphadenopathy, Pain in jaw
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program Pfizer, from a contactable consumer reporting for herself. A 54-year-old female patient received PREVNAR 13, via an unspecified route of administration on 13Apr2018 at single dose in her right arm, for immunisation, and Pneumococcal Polysaccharide vaccine, 23-valent, via an unspecified route of administration on 06Apr2018 Injection in her left arm, one dose for immunisation. Medical history included ongoing bundle branch block left, Diagnosed originally about 5 years ago as Left bundle branch block only. Then told her she didn't have it anymore then realized the reason it was on and off was because it was rate dependent, ongoing cardiac failure congestive Mild Congestive heart failure, Started about 2 years ago, sarcoidosis from 2004 and ongoing , craniocerebral injury from 2002 and ongoing result of being hit by a drunk driver, lymphadenopathy from an unknown date and unknown if ongoing Why was the patient taking Concomitant Products Hydrochlorothiazide, Mild Congestive heart failure, lymph nodes are not working great because swelling from sarcoidosis. Concomitant medication included phentermine, prednisone, hydrochlorothiazide. The patient stated received pneumococcal polysaccharide vaccine, 23-valent also mentioned as 'PREVNAR 23' and pneumococcal 13-val conj vac (dipht crm197 protein) within a week of each other, weird pain in ear and jawbone, right around where they connect in front of her ear and up into her neck on 15Apr2018 with outcome of not recovered, really bad headache on 15Apr2018 with outcome of recovering, tired on 15Apr2018 with outcome of not recovered, swelling in lymph nodes in collarbone and left arm on Apr2018 with outcome of recovering , fever on an unspecified date with outcome of recovered.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program Pfizer, from a contactable consumer reporting for herself. A 54-year-old female patient received PREVNAR 13, via an unspecified route of administration on 13Apr2018 at single dose in her right arm, for immunisation, and Pneumococcal Polysaccharide vaccine, 23-valent, via an unspecified route of administration on 06Apr2018 Injection in her left arm, one dose for immunisation. Medical history included ongoing bundle branch block left, Diagnosed originally about 5 years ago as Left bundle branch block only. Then told her she didn't have it anymore then realized the reason it was on and off was because it was rate dependent, ongoing cardiac failure congestive Mild Congestive heart failure, Started about 2 years ago, sarcoidosis from 2004 and ongoing , craniocerebral injury from 2002 and ongoing result of being hit by a drunk driver, lymphadenopathy from an unknown date and unknown if ongoing Why was the patient taking Concomitant Products Hydrochlorothiazide, Mild Congestive heart failure, lymph nodes are not working great because swelling from sarcoidosis. Concomitant medication included phentermine, prednisone, hydrochlorothiazide. The patient stated received pneumococcal polysaccharide vaccine, 23-valent also mentioned as 'PREVNAR 23' and pneumococcal 13-val conj vac (dipht crm197 protein) within a week of each other, weird pain in ear and jawbone, right around where they connect in front of her ear and up into her neck on 15Apr2018 with outcome of not recovered, really bad headache on 15Apr2018 with outcome of recovering, tired on 15Apr2018 with outcome of not recovered, swelling in lymph nodes in collarbone and left arm on Apr2018 with outcome of recovering , fever on an unspecified date with outcome of recovered.
Sex: F
Vaccine: PNC13
Symptoms: Application site erythema, Application site pruritus, Application site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 79-year-old female patient of an unspecified ethnicity received PREVNAR 13, (lot number and expiration date unknown) via an unspecified route of administration on 12Apr2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Apr2018, the patient stated that she had redness on the application site, with swelling and itchiness. The patient also stated that the red area has the diameter of her palm and has gotten itchier these past few days. The reporter was querying to see if there was any information regarding what to do with this local reaction. The patient has not recovered from the itchiness while the outcome of the events was unknown. The following information on the batch number has been requested.
Sex: M
Vaccine: HPVX, MENB
Symptoms: Headache, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable nurse via a Pfizer sales representative. A male patient of unknown age received on an unknown date a single dose of TRUMENBA and HPV vaccine (manufacturer unknown), both for immunization. Medical history and concomitant medications were not reported. On the same date, in the evening, the patient had a severe headache, body ache and low grade fever. He tried to run in a school track meet and could not due to the way he was feeling. Outcome was not reported. No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Arthralgia, Injected limb mobility decreased, Pain in extremity, Peripheral swelling, Vertigo
Clinical narrative: Arm swelling with pain and couldn't move arm she has used ice and took MOBIC twice daily. She followed with us to check everything was ok. Had Tdap on 4/12/18 in the left arm. By that night she had arm swelling, pain and could not move her arm. Has since put on ice every few hours and took MOBIC twice daily. She feels much better now. She want to make sure there is no other problems. Also has right arm pain that comes and goes. Works in housekeeping. Pain in elbow and forearm and can affect the shoulder at times. Chronic x many years. For her vertigo notes she took medication: difenidol/vontrol.
Age: 22.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Loss of consciousness, Seizure
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of seizure in a 22-year-old male patient who received HAVRIX (batch number TB995, expiry date 25th October 2020). On 9th April 2018, the patient received the 1st dose of HAVRIX .5 ml. On 9th April 2018, immediately after receiving HAVRIX, the patient experienced seizure (serious criteria GSK medically significant) and passed out (serious criteria GSK medically significant). In April 2018, the patient experienced dizziness. In April 2018, the outcome of the seizure and passed out were recovered/resolved. On an unknown date, the outcome of the dizziness was unknown. The reporter considered the seizure, passed out and dizziness to be related to HAVRIX. Additional details were provided as follows: The case was reported by the registered nurse (RN). The patient received HAVRIX in left deltoid. Later on the day of vaccination in the evening, the patient had another seizure and went to the urgent care and they stated that there was no way he could have had two seizures from the HAVRIX vaccine. The patient was also dizzy.
Sex: M
Vaccine: VARZOS
Symptoms: Asthma, Condition aggravated
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of asthma aggravated in a adult male patient who received SHINGRIX (batch number C523T, expiry date unknown). Concurrent medical conditions included asthma. On 13th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 14th April 2018, 1 days after receiving SHINGRIX, the patient experienced asthma aggravated (serious criteria other: as per reporter). The patient was treated with prednisone. On an unknown date, the outcome of the asthma aggravated was unknown. It was unknown if the reporter considered the asthma aggravated to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left deltoid. The patient started having trouble with his asthma and started taking Prednisone. The patient took 40 mg prednisone for 5 days. The reporter spoke with the patient and the patient stated he was better but the pharmacist did not know if that meant his condition had improved or resolved.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown. It was unknown if the reporter considered the muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional (HCP) was cold transferred to medical information. The HCP did not provide me with any details about the patient, the patient's experience or vaccine lot or expiration date.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient required emergency room visit. The patient received the first dose of SHINGRIX on left deltoid and developed swelling and redness at the injection site and encompassed half the length of her arm and persisted for 5-7 days. The patient had this examined by a physician (not the reporter) and no treatment was prescribed.
Age: 43.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient is only 43 years old and got SHINGRIX vaccine.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Vertigo
Clinical narrative: Lightheaded and dizziness for nearly 2 weeks now! Symptoms appear when walking. Today, April 24th, nearly two weeks after vaccination, my lightheadedness is the worst it has been and is very troubling. I have not experienced vertigo symptoms ever before this vaccination and have never had issues after other vaccinations before either.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Aspiration bursa, Bursal fluid accumulation
Clinical narrative: Bursa of left elbow - 13 cc fluid removed on 4/24/2018. Cardiac rehab personnel suspected enlargement sac at elbow was from injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Tenderness
Clinical narrative: Patient contacted our facility today, 4-24-18, stating that she had tenderness and pain under her armpit near her breast that is potentially an affected lymph node. The vaccination was given on 4-22-18. There is limited information regarding adverse events involving lymph nodes in the product information. Patient will seek medical care if condition worsens or does not improve.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Back pain, Fatigue, Impaired work ability
Clinical narrative: Severe pain all over body. Muscles ached, joints were on fire and everything hurt. Lower back by kidneys was very sore and painful. Hurt to lay on back, laid on side of body. This pain continued from 4/23/18 at 2:30 am until 10:00 am on 4/24/18. The vaccination site (upper left arm) was severely painful and could barely lift it. Vaccination given at 3:30 pm on 4/22/18 and severe body pain started at 2:30 am on 4/23/18 until 7:30 pm 4/23/18. Weak, tired and lethargic from 2:30 am 4/23/18 through 4/24/18 1:30 pm. Missed two days of work because of this.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Lethargy, Myalgia, Pain, Vaccination site pain
Clinical narrative: Severe pain all over body. Muscles ached, joints were on fire and everything hurt. Lower back by kidneys was very sore and painful. Hurt to lay on back, laid on side of body. This pain continued from 4/23/18 at 2:30 am until 10:00 am on 4/24/18. The vaccination site (upper left arm) was severely painful and could barely lift it. Vaccination given at 3:30 pm on 4/22/18 and severe body pain started at 2:30 am on 4/23/18 until 7:30 pm 4/23/18. Weak, tired and lethargic from 2:30 am 4/23/18 through 4/24/18 1:30 pm. Missed two days of work because of this.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Body temperature increased, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: Headaches, malaise, loss of energy and enthusiasm, significant fatigue yet inability to stay asleep or nap, fuzzy mentality, loss of appetite (I've lost 5 pounds), periodic temperature (one degree above normal), skin and muscles "tingly". Symptoms have been present since vaccination. It is now about 5 weeks later. Still feeling lousy, still missing partial days of work, still not going to the gym (used to go 3-4 days/wk). For me, I would evaluate taking this vaccine as an overall bad idea. I've been miserable since. My Dr (who suggested the vaccine) says I am a rare case, and should "wait it out".
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Impaired work ability, Insomnia, Loss of personal independence in daily activities, Malaise
Clinical narrative: Headaches, malaise, loss of energy and enthusiasm, significant fatigue yet inability to stay asleep or nap, fuzzy mentality, loss of appetite (I've lost 5 pounds), periodic temperature (one degree above normal), skin and muscles "tingly". Symptoms have been present since vaccination. It is now about 5 weeks later. Still feeling lousy, still missing partial days of work, still not going to the gym (used to go 3-4 days/wk). For me, I would evaluate taking this vaccine as an overall bad idea. I've been miserable since. My Dr (who suggested the vaccine) says I am a rare case, and should "wait it out".
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia
Clinical narrative: Headaches, malaise, loss of energy and enthusiasm, significant fatigue yet inability to stay asleep or nap, fuzzy mentality, loss of appetite (I've lost 5 pounds), periodic temperature (one degree above normal), skin and muscles "tingly". Symptoms have been present since vaccination. It is now about 5 weeks later. Still feeling lousy, still missing partial days of work, still not going to the gym (used to go 3-4 days/wk). For me, I would evaluate taking this vaccine as an overall bad idea. I've been miserable since. My Dr (who suggested the vaccine) says I am a rare case, and should "wait it out".
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Fatigue, Feeling abnormal, Formication, Insomnia
Clinical narrative: Headaches, malaise, loss of energy and enthusiasm, significant fatigue yet inability to stay asleep or nap, fuzzy mentality, loss of appetite (I've lost 5 pounds), periodic temperature (one degree above normal), skin and muscles "tingly". Symptoms have been present since vaccination. It is now about 5 weeks later. Still feeling lousy, still missing partial days of work, still not going to the gym (used to go 3-4 days/wk). For me, I would evaluate taking this vaccine as an overall bad idea. I've been miserable since. My Dr (who suggested the vaccine) says I am a rare case, and should "wait it out".
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Paraesthesia, Urinary retention
Clinical narrative: Headaches, malaise, loss of energy and enthusiasm, significant fatigue yet inability to stay asleep or nap, fuzzy mentality, loss of appetite (I've lost 5 pounds), periodic temperature (one degree above normal), skin and muscles "tingly". Symptoms have been present since vaccination. It is now about 5 weeks later. Still feeling lousy, still missing partial days of work, still not going to the gym (used to go 3-4 days/wk). For me, I would evaluate taking this vaccine as an overall bad idea. I've been miserable since. My Dr (who suggested the vaccine) says I am a rare case, and should "wait it out".
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Pain, Photophobia, Pyrexia, Rash generalised
Clinical narrative: Reported having body aches, fever, headaches, light sensitivity on 4/20/18. Developed a couple of rash with fever on 4/21/18. On 4/22/18, had rash all over the face and the body, seen by personal provider, and diagnosed with chickenpox on 4/24/18.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Reported having body aches, fever, headaches, light sensitivity on 4/20/18. Developed a couple of rash with fever on 4/21/18. On 4/22/18, had rash all over the face and the body, seen by personal provider, and diagnosed with chickenpox on 4/24/18.
Age: 1.83
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptoms as of yet.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash vesicular
Clinical narrative: Chickenpox like lesions, itchy, round marks.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (MRK INJ) was properly stored. On 17-APR-2018, the patient was vaccinated with improperly stored VARIVAX (dose, units and frequency not reported) (lot # N027619 and expiration date: 04-OCT-2019) subcutaneously at a temperature from -9 degree Celsius (C) to 8 C for 2 hours. There was no previous temperature excursion to the vaccine. Digital data logger was involved. No product quality complaint was involved.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Acne, Rash
Clinical narrative: Information has been received from a 46 year old female patient with a mental (social) disability and no known drug allergies. On an unspecified date in May 2017, the patient started therapy with ZEPATIER (genotype, lot number, dosage, and frequency not reported) for hepatitis C virus. There was no concomitant medication. The patient started developing a rash and then acne breakouts on her face and arms after two days of starting the ZEPATIER. The ZEPATIER was successful in curing her hepatitis C, but the patient stated she was still having acne breakouts on her arms and face. The patient stated it disappears and then reappears in the same areas. The patient sought medical attention and reported unspecified treatment. It also reappeared after receiving an "unspecified Hep B vaccine" (thimerosal content, lot number, dosage, and route of administration unknown) in approximately January 2018 (reported as three months ago). The patient never had acne and breakouts prior to receiving ZEPATIER therapy. No further symptoms were reported. Therapy with ZEPATIER was continued. The outcome of the rash is unknown. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives on face.
Age: 19.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Anxiety, Cold sweat, Hyperventilation, Malaise, Nausea
Clinical narrative: MOTHER CALLED TUES 4/24/18 9:50 AM TO REPORT THAT MONDAY 4/23/18 AROUND 9 AM SON FELT NAUSEATED, COLD SWEAT, HYPERVENTILATING, ANXIETY, NOT FEELING WELL, SHE THINKS IT WAS POSSIBLY FROM SHOT ON FRI, DID NOT GO TO DR; SHE JUST MONITORED HIM AT HOME. SHE REPORTS HE IS BETTER NOW.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, Chest X-ray normal, Grunting, Hypotonic-hyporesponsive episode, Influenza B virus test positive
Clinical narrative: Patient was taken to the hospital after a seizure-like episode on the night he received vaccines. This episode involved grunting, turning pale. Patient was admitted to hospital for observation, where he was found to have a temperature of 100.7. He was later diagnosed with influenza type B and started on TAMIFLU. Patient was discharged from the hospital the next day, with no more fever of seizure-like episodes. His PCP feels that his symptoms were consistent with a hypotonic-hyporesponsive episode following vaccines.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pallor, Pyrexia, Respiratory syncytial virus test negative, Seizure like phenomena, White blood cell count increased
Clinical narrative: Patient was taken to the hospital after a seizure-like episode on the night he received vaccines. This episode involved grunting, turning pale. Patient was admitted to hospital for observation, where he was found to have a temperature of 100.7. He was later diagnosed with influenza type B and started on TAMIFLU. Patient was discharged from the hospital the next day, with no more fever of seizure-like episodes. His PCP feels that his symptoms were consistent with a hypotonic-hyporesponsive episode following vaccines.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Hallucination
Clinical narrative: Pt woke up at midnight, roughly 12 hours after receiving KINRIX and PROQUAD and was hallucinating, saying there were bees all over him and in his bed. mom reports no fever, no rash, pt was awake and alert.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Painful injection reported by patient. Patient presented back to the clinic 3 days later reporting continuous pain with difficulty sleeping at night. Difficulty moving right arm. No obvious redness or swelling noted by provider. Treatment with FLEXERIL, LODINE, TYLENOL.
Age: 20.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Asthenia, Discomfort, Injected limb mobility decreased, Injection site reaction, Muscular weakness
Clinical narrative: A few hours after vaccine receipt, patient noticed decreasing sensation and weakness progressing distally to her injection sites of right arm. The following day, patient sought medical evaluation. Reported pressure sensation from distal deltoid to tips of fingers of right arm. On exam, she could minimally flex her wrist (less than 5 degrees) and had difficulty wiggling her fingers. Elbow flexion and extension and full shoulder ROM retained. Decreased pin prick sensation. No reaction to scratching arm with sharp end of reflex hammer in right arm. (Pulled away when same thing done on left arm). Right arm strength decreased compared to left arm, especially strength of right wrist and fingers. Prescribed Ibuprofen. No systemic symptoms reported. No pain at injection sites. No redness, swelling, warmth or tenderness surrounding injection sites. No previous reports of vaccine adverse reactions. Patient returned to clinic for evaluation on 17 Apr 2018. She took Ibuprofen for next few days. She reported return of strength and sensation on 14 April. By 17 Apr 2018, exam back to baseline.
Age: 20.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Sensory loss
Clinical narrative: A few hours after vaccine receipt, patient noticed decreasing sensation and weakness progressing distally to her injection sites of right arm. The following day, patient sought medical evaluation. Reported pressure sensation from distal deltoid to tips of fingers of right arm. On exam, she could minimally flex her wrist (less than 5 degrees) and had difficulty wiggling her fingers. Elbow flexion and extension and full shoulder ROM retained. Decreased pin prick sensation. No reaction to scratching arm with sharp end of reflex hammer in right arm. (Pulled away when same thing done on left arm). Right arm strength decreased compared to left arm, especially strength of right wrist and fingers. Prescribed Ibuprofen. No systemic symptoms reported. No pain at injection sites. No redness, swelling, warmth or tenderness surrounding injection sites. No previous reports of vaccine adverse reactions. Patient returned to clinic for evaluation on 17 Apr 2018. She took Ibuprofen for next few days. She reported return of strength and sensation on 14 April. By 17 Apr 2018, exam back to baseline.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Redness discovered the same afternoon (started out as about 2 inches x 2 inches) with some warmth and soreness the first few days. 4th day became itchy. Redness spread to about 10 cm x 12 cm. No induration. Redness is blanching.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Patient has experienced soreness day after and fever 101 in the afternoon on April 17th, 2018.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Nausea, Pain
Clinical narrative: FRIDAY NIGHT PAIN. SATURDAY BRIGHT RED/PAIN AT INJECTION SITE ABOUT THE SIZE OF A BASEBALL. SUNDAY STILL EXPERIENCING REDNESS AS WELL AS NAUSEA MOST THE DAY. MONDAY REDNESS FROM THE SHOULDER TO THE ELBOW. TUESDAY MORNING BLACK/BLUE ON ARM WITH REDNESS MOVING TO CHEST.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: FRIDAY NIGHT PAIN. SATURDAY BRIGHT RED/PAIN AT INJECTION SITE ABOUT THE SIZE OF A BASEBALL. SUNDAY STILL EXPERIENCING REDNESS AS WELL AS NAUSEA MOST THE DAY. MONDAY REDNESS FROM THE SHOULDER TO THE ELBOW. TUESDAY MORNING BLACK/BLUE ON ARM WITH REDNESS MOVING TO CHEST.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Paraesthesia
Clinical narrative: Approximately 24 hours after the injection, I developed chills that lasted 10 hours. I had a fever of 101.6 F. I had a headache, tiredness, soreness at the injection site, and tingling in the fingers of the right hand like they were going to sleep. The chills and the headache were the worse. Now, three days after the injection, my only remaining symptom is soreness at the injection site (upper left arm).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Approximately 24 hours after the injection, I developed chills that lasted 10 hours. I had a fever of 101.6 F. I had a headache, tiredness, soreness at the injection site, and tingling in the fingers of the right hand like they were going to sleep. The chills and the headache were the worse. Now, three days after the injection, my only remaining symptom is soreness at the injection site (upper left arm).
Age: 51.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Headache, Injection site pain, Neck pain, Pyrexia
Clinical narrative: Per patient's husband, patient had headaches, fever, injection site pain, and neck pain.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient has redness and swelling at the injection site.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The patient described after 30 minutes that he began to feel warm, red and swollen by the injection site and down to his arm. The symptoms lasted for 3 days, and completely gone by 4-24-18.
Age: 47.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness, and warm to the touch. Pt was given BENADRYL and advised to return tomorrow for re-exam to determine further treatment.
Age: 62.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Dysarthria, Erythema, Grip strength decreased, Hypersensitivity, Hypotension
Clinical narrative: Patient stated that: her arms were red the day of the injections and she did not feel well. On 4/23/2018 the patient stated that she experienced slurred speech and could not hold onto things (she said she dropped two coffee cups). She called her doctor and told them who thought she was having a stroke and told her to go to the hospital. There she had low BP, but no other signs of stroke. Her arms were more red and swollen at this time. The doctor informed her she was having an allergic reaction.
Age: 62.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Malaise, Peripheral swelling
Clinical narrative: Patient stated that: her arms were red the day of the injections and she did not feel well. On 4/23/2018 the patient stated that she experienced slurred speech and could not hold onto things (she said she dropped two coffee cups). She called her doctor and told them who thought she was having a stroke and told her to go to the hospital. There she had low BP, but no other signs of stroke. Her arms were more red and swollen at this time. The doctor informed her she was having an allergic reaction.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 4/23/18 - patient felt "beat up" after getting the vaccine. 4/23/18 - Injection site is sore, red, and warm.
Age: 72.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Contusion, Erythema, Pyrexia, Rash
Clinical narrative: Patient reported chills and fever the evening after receiving vaccines. Her right inner arm developed severe bruising and rash/discoloration (red). The bruise/discoloration is still present at 3 days post vaccination. The arm was hot to the touch as well. No mobility issues. The patient took ALLEGRA and TYLENOL for the pain and allergy and will continue these OTCs until it resolves. Pharmacist will call patient's PCP tomorrow to inform of the adverse effect and to follow up with patient.
Age: 72.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Skin warm
Clinical narrative: Patient reported chills and fever the evening after receiving vaccines. Her right inner arm developed severe bruising and rash/discoloration (red). The bruise/discoloration is still present at 3 days post vaccination. The arm was hot to the touch as well. No mobility issues. The patient took ALLEGRA and TYLENOL for the pain and allergy and will continue these OTCs until it resolves. Pharmacist will call patient's PCP tomorrow to inform of the adverse effect and to follow up with patient.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site inflammation, Injection site pruritus, Rash erythematous
Clinical narrative: Patient had inflammation at the injection site, as well as pruritus. On the opposite side forearm, patient had a red rash that was about 3 cm in diameter. Both of this happened the day after the vaccine was given and the rash is improving since then. Was given diphenhydramine to help with itching and rash. Was told if not improving, to return to clinic in no longer than a week. Was given ER precautions.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: Patient called day after immunization, complaining of sore arm, fatigue, myalgia, and chills.  Patient had not yet tried anything for relief. Patient was advised to take acetaminophen (patient cannot take NSAIDs) for flu-like symptoms, can use a cold compress on injections site, and use of diphenhydramine if necessary. Advised patient to follow up with physician if symptoms do not get better/resolve/worsen.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Formication, Photophobia
Clinical narrative: PATIENT REPORTS SENSATION OF BUGS CRAWLING ON SKIN AND LIGHT SENSITIVITY STARTING THE DAY AFTER VACCINATION AND CONTINUING FOR 2 DAYS.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Angioedema, Asthenia, Fatigue, Hypersensitivity, Lip swelling
Clinical narrative: Patient developed an allergic reaction shortly after receiving vaccines. Within 3-5 minutes after vaccines were given pt started sneezing. Pt then complained to mom of her throat "hurting and itchy". A CMA immediately evaluated patient and reported swelling of upper lip and red splotchy rash on pt's torso. I was then notified and observed patient noting severe swelling of lips and cheeks, blood-shot eyes, and patient complained of tiredness and became weak. An appropriate dose of BENADRYL was given after which patient vomited and lost bladder control and urinated.   Diffuse urticaria as well as angioedema. Supervising physician contacted who recommended epinephrine shot, DECADRON, as well as an ambulance transport to ER. 0.15 ml IM injection of 1 mg/ml epinephrine given prior to EMT arriving. No DECADRON given. Pt was assessed by EMT and taken to hospital for evaluation.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Ocular hyperaemia, Oropharyngeal pain, Rash, Rash erythematous, Rash macular
Clinical narrative: Patient developed an allergic reaction shortly after receiving vaccines. Within 3-5 minutes after vaccines were given pt started sneezing. Pt then complained to mom of her throat "hurting and itchy". A CMA immediately evaluated patient and reported swelling of upper lip and red splotchy rash on pt's torso. I was then notified and observed patient noting severe swelling of lips and cheeks, blood-shot eyes, and patient complained of tiredness and became weak. An appropriate dose of BENADRYL was given after which patient vomited and lost bladder control and urinated.   Diffuse urticaria as well as angioedema. Supervising physician contacted who recommended epinephrine shot, DECADRON, as well as an ambulance transport to ER. 0.15 ml IM injection of 1 mg/ml epinephrine given prior to EMT arriving. No DECADRON given. Pt was assessed by EMT and taken to hospital for evaluation.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Sneezing, Swelling face, Throat irritation, Urinary incontinence, Urticaria
Clinical narrative: Patient developed an allergic reaction shortly after receiving vaccines. Within 3-5 minutes after vaccines were given pt started sneezing. Pt then complained to mom of her throat "hurting and itchy". A CMA immediately evaluated patient and reported swelling of upper lip and red splotchy rash on pt's torso. I was then notified and observed patient noting severe swelling of lips and cheeks, blood-shot eyes, and patient complained of tiredness and became weak. An appropriate dose of BENADRYL was given after which patient vomited and lost bladder control and urinated.   Diffuse urticaria as well as angioedema. Supervising physician contacted who recommended epinephrine shot, DECADRON, as well as an ambulance transport to ER. 0.15 ml IM injection of 1 mg/ml epinephrine given prior to EMT arriving. No DECADRON given. Pt was assessed by EMT and taken to hospital for evaluation.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Vomiting
Clinical narrative: Patient developed an allergic reaction shortly after receiving vaccines. Within 3-5 minutes after vaccines were given pt started sneezing. Pt then complained to mom of her throat "hurting and itchy". A CMA immediately evaluated patient and reported swelling of upper lip and red splotchy rash on pt's torso. I was then notified and observed patient noting severe swelling of lips and cheeks, blood-shot eyes, and patient complained of tiredness and became weak. An appropriate dose of BENADRYL was given after which patient vomited and lost bladder control and urinated.   Diffuse urticaria as well as angioedema. Supervising physician contacted who recommended epinephrine shot, DECADRON, as well as an ambulance transport to ER. 0.15 ml IM injection of 1 mg/ml epinephrine given prior to EMT arriving. No DECADRON given. Pt was assessed by EMT and taken to hospital for evaluation.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The pharmacist refused to provide any information as she was not the person who spoke to the patient. The healthcare professional refused to provide the actual adverse event.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash papular, Rash vesicular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 57-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date unknown). The patient's past medical history included shingles (dates of previous outbreak unknown). On 26th March 2018 13:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 4th April 2018, 9 days after receiving SHINGRIX, the patient experienced shingles, vesicular rash and papular rash. On an unknown date, the outcome of the shingles, vesicular rash and papular rash were not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. The reporter considered the vesicular rash and papular rash to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced small bumps on the opposite arm of vaccination. By the next day, on 5th April 2018, the bumps also appeared on the ankle on the injection side. Within approximately 5 days from appearance, the bumps were raised and fluid filled. The patient had not visited a physician or other medical professional and no diagnosis had been made at this time. The patient, who had experienced a prior case of Shingles, felt that this might be a recurrence of Shingles. The healthcare professional was unable to provide the expiration date of SHINGRIX, as their system automatically defaults to one year after the administration date. The report lot number VY3X4) for SHINGRIX did not exist and was updated to ZY3X4, according to sales database. This case has been linked to US2018063409, reported by the same reporter.
Age: 71.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Asthenia, Chills, Injection site cellulitis, Pyrexia
Clinical narrative: Chills, high fever, cellulitis around injection site. Pt went to hospital with high fever and weakness. Was given course of antibiotic upon release.
Sex: U
Vaccine: DTAP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a patient who received dTpa vaccine. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, 1 day after receiving dTpa vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that he heard from other pharmacists that patients have complained about pain, with TDaP (did not specify BOOSTRIX), at the injection site the day after vaccination. This case has been linked with case US2018062444, reported by same reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date unknown). The patient's past medical history included viral infection. Previously administered products included Valacyclovir (The patient received 2 courses during the previous year). On 5th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 5th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and injection site swelling. In April 2018, the patient experienced welts. The patient was treated with BENADRYL. On 8th April 2018, the outcome of the injection site erythema and injection site pain were recovered/resolved. In April 2018, the outcome of the injection site swelling was recovered/resolved. On an unknown date, the outcome of the welts was unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling and welts to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional was unable to provide the expiration date of SHINGRIX as their system automatically default this to 1 year after the administration date. The patient received SHINGRIX in arm and on the same day developed redness, swelling and soreness at the injection site. This got better after approximately 2 days. As per the healthcare professional, by day 5 to 6 following the injection, the patient reported developing welts over the whole injection arm. The batch number of SHINGRIX was updated from VY3X4 to ZY3X4, as per sales data sheet. This case has been linked with case US2018063410, reported by same reporter.