chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Client developed redness, warmth, hardness, pain at injection site.  No fever reported.  Redness and pain remained 4 days later.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Injection site cellulitis, Mass, Pain
Clinical narrative: The day following the vaccine, I had a small pink lump which was  sore and warm. I also had a headache and chills. The second day, the pink lump grew larger and was hard and hot to the touch.  I iced it that night but it was larger on the third day (3" x 5").  I went to see my PCP who felt I had developed a cellulitis in the area of the injection and started me on a 10 day course of Augmentin.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm
Clinical narrative: The day following the vaccine, I had a small pink lump which was  sore and warm. I also had a headache and chills. The second day, the pink lump grew larger and was hard and hot to the touch.  I iced it that night but it was larger on the third day (3" x 5").  I went to see my PCP who felt I had developed a cellulitis in the area of the injection and started me on a 10 day course of Augmentin.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: The day following the vaccine, I had a small pink lump which was  sore and warm. I also had a headache and chills. The second day, the pink lump grew larger and was hard and hot to the touch.  I iced it that night but it was larger on the third day (3" x 5").  I went to see my PCP who felt I had developed a cellulitis in the area of the injection and started me on a 10 day course of Augmentin.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Lymphadenopathy, Swelling
Clinical narrative: Swelling of left clavicle, both sides of neck, and left armpit glands appearing 2 days after shot. Fatigue apparent 1 day after shot.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red/Swollen arm, Hot to touch
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Platelet count decreased, Pyrexia, Rash, White blood cell count decreased
Clinical narrative: low white cell count; fever; diarrhea; rash; low platelet count; This spontaneous report as received from a registered nurse refers to a 53-year-old female patient . The patient's concurrent conditions included: anxiety, atrial fibrillation, hypothyroidism, gastrooesophageal reflux disease, hyperchloraemia, hyperinsulinism, hypokalaemia, hypertension and hypersensitivity for the blue dye. The patient's drug allergies included: amoxicillin, metformin, diphenhydramine hydrochloride (BENADRYL) and escitalopram oxalate (LEXAPRO). The patient's concomitant medication included: aspirin, diltiazem, pantoprazole, potassium, cyproheptadine and unspecified thyroid medication.  On 15-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R031679, expiration date 01-NOV-2020, subcutaneous for prevention of measles (exact dose and frequency were not provided). On 27-MAY-2019, the patient had unspecified blood work performed, with the results of low platelet count and low white blood cell count. Additionally, on the same day the patient experienced fever, rash and diarrhea. The patient sought medical attention in primary care on an unknown date, and received treatment for events on an unknown date. The outcome of events was unknown.  The reporter considered pyrexia, platelet count decreased, white blood cell count decreased, rash and diarrhoea to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The Physician reported 11-day old patient received GARDASIL 9 today.; No adverse effects reported.; This spontaneous report was received from a physician referring to an 11 day old patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.      On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. No adverse events were reported.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema multiforme, Rash, Swelling
Clinical narrative: Skin Rash, Erythema Multiform & BUMP
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: & SWOLLEN; RED; WARM; ITCHY DIPHENHYDRAMINE OTC Benadryl PRN MG PRN, CEPHALEXIN 500 MG QID
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, slight swelling, painful to touch at shot site
Age: 56.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Informed by receptionist that patient was requesting to see a nurse due to "hives on his back." I assessed patient in clinic room. He stated, "I got hep. vaccines and another shot on Tuesday. One hour later I started itching really bad to my back." Skin assessment was made. Noted that skin to patient's upper and mid-back was very reddened. Skin was intact. Photo was taken and sent to Dr. via secure mobile app. Dr. gave order to apply Sarna lotion to affected area. Sarna lotion was not readily available at clinic. Eucerin cream was applied until Sarna could be obtained. Director of Clinical Services, RN, was notified.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Enlarged lymph node to left clavicular area with tenderness
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Streptococcus test negative
Clinical narrative: onset of fever and rash 11 days after 1st dose of MMR vaccine
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient has a rash on both of his legs and hit buttocks. The rash started 6/8/19 in the AM.  It is a red lacy rash. It is not raised, not itchy or painful. Benadyl PRN if helps with the rash. Still present on 6/10/19 when evaluated in our office.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chest discomfort, Dyspnoea, Fatigue, Muscle spasms
Clinical narrative: Tightness in chest for two days, better over time, gone by the thirdday Felt like a knotted rope tied around my chest with the knot pressing down on my heart Unable to breath deeply or normally for two days Felt similar to having bronchitis Low fever for several days Fatigue General physical weakness Had to leave work on the second  day after vaccination for fear I would pass out For two day the thumb and index finger were having spasms - not normal behavior
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Tightness in chest for two days, better over time, gone by the thirdday Felt like a knotted rope tied around my chest with the knot pressing down on my heart Unable to breath deeply or normally for two days Felt similar to having bronchitis Low fever for several days Fatigue General physical weakness Had to leave work on the second  day after vaccination for fear I would pass out For two day the thumb and index finger were having spasms - not normal behavior
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Blood culture negative, Body temperature increased, Electroencephalogram normal, Encephalopathy, Endotracheal intubation
Clinical narrative: at 830 PM on 05/30/2019 child had prolonged complex febrile seizure with status epilepticus, requiring Ativan, Intubation at uRGENT care.  Transferred by helicopter to Hospital.  Extubated 6/2/19, room air 6/3/2019, discharged home 06/06/2019, Sepsis work up done including LP,Blood Culture, MRI, EEG, all negatives, IV antibiotics given for presumed aspiration pneumonia until cultures negative.  Etiology of prolonged complex febrile seizure, status epilepticus, encephalopathy, hypoventilation, unknown.  childs temp was 102.6, no previous, fever, no family history of febrile seizures, Child seen today, and PE is completely normal
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Febrile convulsion, Hypoventilation, Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Status epilepticus
Clinical narrative: at 830 PM on 05/30/2019 child had prolonged complex febrile seizure with status epilepticus, requiring Ativan, Intubation at uRGENT care.  Transferred by helicopter to Hospital.  Extubated 6/2/19, room air 6/3/2019, discharged home 06/06/2019, Sepsis work up done including LP,Blood Culture, MRI, EEG, all negatives, IV antibiotics given for presumed aspiration pneumonia until cultures negative.  Etiology of prolonged complex febrile seizure, status epilepticus, encephalopathy, hypoventilation, unknown.  childs temp was 102.6, no previous, fever, no family history of febrile seizures, Child seen today, and PE is completely normal
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect; Second dose of product administered at earlier than recommended time; This spontaneous report as received from a physician assistant refers to an 18-year-old patient of unknown age. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On 26-DEC-2018, the patient was vaccinated with the first dose of an unspecified hepatitis a vaccine (exact dose, route of administration, injection site, lot# and expiration date were not reported) for prophylaxis. On 16-MAY-2019 in an office, at earlier than recommended time from the first dose, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscularly (IM) for prophylaxis (exact dose, injection site, lot# and expiration date were not reported). There was no adverse effect reported.
Age: 78.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: large sore spot; This case was reported by a consumer via call center representative and described the occurrence of painful rash in a 78-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2019, the patient received the 2nd dose of Shingrix. On 21st May 2019, 5 days after receiving Shingrix, the patient experienced painful rash. On an unknown date, the outcome of the painful rash was unknown.   It was unknown if the reporter considered the painful rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine in the arm. The patient had Shingrix and noticed a large sore spot on buttock 2-3 days ago the day of reporting. The reporter asked could that be a reaction and what should we do for it.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Immediate post-injection reaction, Injected limb mobility decreased, Injection site discolouration, Injection site inflammation
Clinical narrative: pain; inflammation; sick to stomach; yellow in center; hard to move arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th May 2019, the patient received Shingrix (intramuscular). On 29th May 2019, immediately after receiving Shingrix, the patient experienced injection site pain, injection site inflammation, upset stomach, injection site discoloration and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, injection site inflammation, upset stomach, injection site discoloration and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site inflammation, upset stomach, injection site discoloration and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: It was reported that right away after vaccination the patient developed pain and inflammation in her arm and was sick to her stomach.  The inflamed area looked yellow in the center and she had difficulty moving her arm. The reporter had consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain; inflammation; sick to stomach; yellow in center; hard to move arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th May 2019, the patient received Shingrix (intramuscular). On 29th May 2019, immediately after receiving Shingrix, the patient experienced injection site pain, injection site inflammation, upset stomach, injection site discoloration and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, injection site inflammation, upset stomach, injection site discoloration and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site inflammation, upset stomach, injection site discoloration and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: It was reported that right away after vaccination the patient developed pain and inflammation in her arm and was sick to her stomach.  The inflamed area looked yellow in the center and she had difficulty moving her arm. The reporter had consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Pain, redness, swelling, rash at the injection site lasting 3 days (and continuing) Headache ( for 1 day) Body and muscle aches (severe for 1 day, 50% improvement on 2nd day, gone on 3rd day)  Feeling tired very for 2 days Nauseated and vomiting after meals on 2nd day Pins and needles in feet and hands (severe for 1 day, 50% improvement on 2nd day, continuing at 10% on 3rd day)
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Nausea, Pain, Paraesthesia
Clinical narrative: Pain, redness, swelling, rash at the injection site lasting 3 days (and continuing) Headache ( for 1 day) Body and muscle aches (severe for 1 day, 50% improvement on 2nd day, gone on 3rd day)  Feeling tired very for 2 days Nauseated and vomiting after meals on 2nd day Pins and needles in feet and hands (severe for 1 day, 50% improvement on 2nd day, continuing at 10% on 3rd day)
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Pain, redness, swelling, rash at the injection site lasting 3 days (and continuing) Headache ( for 1 day) Body and muscle aches (severe for 1 day, 50% improvement on 2nd day, gone on 3rd day)  Feeling tired very for 2 days Nauseated and vomiting after meals on 2nd day Pins and needles in feet and hands (severe for 1 day, 50% improvement on 2nd day, continuing at 10% on 3rd day)
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: muscle and joint pain, nausea and stomach pain, shivering, fatigue, headache
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: muscle and joint pain, nausea and stomach pain, shivering, fatigue, headache
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation
Clinical narrative: fist size local redness and inflammation
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Vaccination site warmth
Clinical narrative: I got the chills and am achy all over. Site of vaccination was warm.
Age: 54.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: New hire employee received 1st varicella vaccine on 6/6/19.  Stated she was fine initially and the day after.  However, two days after receiving the vaccine she stated she noted swelling, induration, warmth, redness, and itching to vaccine site.  Treated with icing.  By the third day after receiving vaccine, symptoms started to subside, noted decreased swelling, warmth and redness.  Denies fever, chills, or night sweats.  Stated she has become increasingly allergic or sensitive to various antigens within the last decade such eating chicken, any medications containing epinephrine, etc.  Plan to re-check immunity titer to varicella one month after vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation
Clinical narrative: fist size redness and inflammation
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Entire R thigh edema: "Received DTAP vaccination in R thigh on 6/7/19 - initally area seemed fine but mom noted increased swelling and slight erythema on 6/8  PT  has not been bothered with symptoms.  No fever.  HE has been acting normally and bearing weight without diffixulty.  No itchiness or pain. " Per Dr.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Asthenia, Headache, Hypotension, Insomnia, Tinnitus
Clinical narrative: headache, ringing in ears, blurred vision, tachycardia, low blood pressure, weak, unable to sleep
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Vision blurred
Clinical narrative: headache, ringing in ears, blurred vision, tachycardia, low blood pressure, weak, unable to sleep
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Back pain, C-reactive protein normal, Chest discomfort, Dysphagia, Dyspnoea
Clinical narrative: Patient seen in Emergency Room on 06/08/2019: Patient is a 11  Y 5  M female who presents with pain and swelling of her right arm and difficulty breathing. She had Tdap and meningitis vaccines yesterday. Mom unsure which vaccine she got in which arm. This morning she had swelling, redness, warmth, and pain in right upper arm where she had an injection. Mom called PCP, Dr., who recommended she be seen in UC. She is complaining of chest tightness. Mom thought the right side of her face looked swollen today. She also complains of the right side of her back hurting. She complained of ST yesterday. Today she will not eat or drink. She say it is difficult to swallow. She is not limping. She has no fever. She has not had rhinorrhea, cough, vomiting diarrhea, or fever in the past week. Up to date on vaccines.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Full blood count normal, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient seen in Emergency Room on 06/08/2019: Patient is a 11  Y 5  M female who presents with pain and swelling of her right arm and difficulty breathing. She had Tdap and meningitis vaccines yesterday. Mom unsure which vaccine she got in which arm. This morning she had swelling, redness, warmth, and pain in right upper arm where she had an injection. Mom called PCP, Dr., who recommended she be seen in UC. She is complaining of chest tightness. Mom thought the right side of her face looked swollen today. She also complains of the right side of her back hurting. She complained of ST yesterday. Today she will not eat or drink. She say it is difficult to swallow. She is not limping. She has no fever. She has not had rhinorrhea, cough, vomiting diarrhea, or fever in the past week. Up to date on vaccines.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Oropharyngeal pain, Pain in extremity, Peripheral swelling, Red blood cell sedimentation rate normal, Swelling face
Clinical narrative: Patient seen in Emergency Room on 06/08/2019: Patient is a 11  Y 5  M female who presents with pain and swelling of her right arm and difficulty breathing. She had Tdap and meningitis vaccines yesterday. Mom unsure which vaccine she got in which arm. This morning she had swelling, redness, warmth, and pain in right upper arm where she had an injection. Mom called PCP, Dr., who recommended she be seen in UC. She is complaining of chest tightness. Mom thought the right side of her face looked swollen today. She also complains of the right side of her back hurting. She complained of ST yesterday. Today she will not eat or drink. She say it is difficult to swallow. She is not limping. She has no fever. She has not had rhinorrhea, cough, vomiting diarrhea, or fever in the past week. Up to date on vaccines.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Urine analysis normal
Clinical narrative: Patient seen in Emergency Room on 06/08/2019: Patient is a 11  Y 5  M female who presents with pain and swelling of her right arm and difficulty breathing. She had Tdap and meningitis vaccines yesterday. Mom unsure which vaccine she got in which arm. This morning she had swelling, redness, warmth, and pain in right upper arm where she had an injection. Mom called PCP, Dr., who recommended she be seen in UC. She is complaining of chest tightness. Mom thought the right side of her face looked swollen today. She also complains of the right side of her back hurting. She complained of ST yesterday. Today she will not eat or drink. She say it is difficult to swallow. She is not limping. She has no fever. She has not had rhinorrhea, cough, vomiting diarrhea, or fever in the past week. Up to date on vaccines.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Eyelid pain, Mobility decreased, Pyrexia
Clinical narrative: 4 days: unable to lift arm, general weakness, chills, fever, painful eyelids
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Erythema, Eyelid pain, Pyrexia
Clinical narrative: 4 days: fever, chills, weakness. Painful eyelids. Red welts/white pustules on back/chest.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pustular, Urticaria
Clinical narrative: 4 days: fever, chills, weakness. Painful eyelids. Red welts/white pustules on back/chest.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy, Eczema, Onychomycosis, Pruritus, Urticaria
Clinical narrative: Intense itching continues with urticarial lesions. Have had Prednisone - oral and Cortisone Creams, 4 Biopsies Ultraviolet lite Treatments for 6 weeks. Have seen 1 Family Practice provider and 5 Dermatologist for this.  11/15/18 Dr., Derm - Prednisone 12/4/18, Dr. - Cortisone Cream 1/27/19 Dr., Urgent Care  Cortisone shot, LAB, Zyrtec. 2/18/19, PA, Dermatology  Betamethasone diprop Cream 3/14/19 Dr., Derm  Prednisone (1) Biopsy - severe spongiotic dermatitis no fungus (2) Toenail clipping - fungus  4/10/19 Dr. - Derm  Prednisone 60 mg decreasing  TCM 1% Cream 2 - Zyrtec + Atarax 2-4 x day UV Lite Treatments  3x wk. 5/23/19 Dr Hydrocortisone Cream 2.5% D/C Lite Treatments D/C Terbinatine for Toenail fungus  Refer 5/30/19 Dr. - Derm Pending  - 2 Biopsies                 LABS - multiple                 Try: Neurontin 300 mg three x day. Still Itching! Note: Dr. - consulted physician - that they have 3 cases of the same S/S I have with Shingrix!
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, Splenectomy
Clinical narrative: Patient received Pneumovax instead of Prevnar; on 09-MAR-2019 the pt received Pneumovax 23/ she had prior Pneumovax 23 4 years prior; splenoctomy; This spontaneous report was received from a health professional also reported as vaccine coordinator and refers to a 31-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 15-APR-2015, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dose, route, site of administration, lot number and expiration date were not reported) for prophylaxis.  On 08-MAR-2019, the patient underwent a splenectomy in a large hospital (no further information provided).  On 09-MAR-2019, the patient was vaccinated with another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dose, route, site of administration, lot number and expiration date were not reported) for prophylaxis when she was supposed to receive pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (dose, route, site of administration, lot number and expiration date were not reported) for prophylaxis.  On an unknown date in May 2019, reported as about 2 months post operation, the patient was supposed to receive second dose of unspecified serogroup B meningococcal vaccine, second dose of unspecified meningococcal ACYW polysaccharide vaccine (dates of first doses were not reported) and another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). However, the healthcare professional decided that the patient would not receive pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) again since she had been already vaccinated on 09-MAR-2019. At the time of reporting, the healthcare professional was wondering if it would be safe for the patient to receive pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) now.   The outcome of the event was unknown. The causality between the event and the suspect therapy was not reported.  Upon internal review, the event of splenectomy has been upgraded to medically significant.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no adverse effects; two patients, received improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age.  Concomitant therapy included sterile diluent lot number S007963 expiration date 02-AUG-2021 (dosage schedule, route, anatomical location, lot number and expiration date were not reported).  The patient's historical condition and drug reactions or allergies were not reported.      On 28-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot number R030800 and expiration date 22-APR-2019, for prophylaxis(dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of the vaccine experienced a temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit. Total frame from 15-MAY-2019 to 31-MAY-2019 (16 days, 384 hours).  No previous temperature excursion. It was not recorded by a data logger.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA000935:
Sex: U
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; On unknown date in 2018, the patient received one dose of PREVNAR 13; This spontaneous report has been received from a pharmacist, concerning a 67 year old patient of unknown gender and ethnicity.  The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported. The patient had no underlying chronic conditions.   On unspecified date in 2012, the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (frequency, anatomical location, lot and expiration date were not reported) for prophylaxis.        Later, on unspecified date in 2018, the patient received one dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (other suspect therapy) (inappropriate schedule of product administration). No adverse effects reported.
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site warmth, Wrong product administered
Clinical narrative: very tired; painful at site of injection; very red and hot to touch; very red and hot to touch; patient was inadvertently given meningococcal group b rlp2086 instead of PPD intradermally on the left forearm; This is a spontaneous report from a contactable healthcare professional. An 18-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), intradermal on 29May2019 at a single dose for immunization instead of tuberculin PPD intradermally on the left forearm. The patient's medical history and concomitant medications were not reported. On 29May2019, the patient was inadvertently given meningococcal group b rlp2086 instead of PPD intradermally on the left forearm. On 31May2019 (reported as after 48 hours), the patient reported that she was very tired and painful at site of injection. The injection site was 128 mm x 68 mm and very red and hot to touch. The outcome of the events was unknown.  Information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Myalgia
Clinical narrative: muscle pain; This is a spontaneous report based on the information received by Pfizer from Merck Center (Manufacturer Report Number: 01214239). A contactable consumer reported that a patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced muscle pain on an unspecified date with outcome of unknown.    No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Fever a few days after. Rash showing up yesterday and on my torso and face  Progressively itching and has been spreading more
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, HPVX, PPV, RVX
Symptoms: Adenovirus test positive, Arrhythmia, Cardiomyopathy, Cardioversion, Endotracheal intubation
Clinical narrative: On Saturday, by noon, patient had painful gas with grunting and vomited a little bit. By 8pm started with gas pain, grunting, weighing down, then became unresponsive.   Ambulance took patient to ER, given rescue breathing, CPR, and shocks were required.   At hospital patient was intubated, had arrhythmia, respiratory issues. Patient taken to air to Hospital were she is in ECMO now.   Patient is still at the hospital now. They are treating her for myocarditis or cardiomyopathy.  Patient has positive Adoneno virus screen test for some type of infection. Myocarditis is an adverse event to resuscitation.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, HPVX, PPV, RVX
Symptoms: Flatulence, Grunting, Lung assist device therapy, Myocarditis, Respiratory disorder
Clinical narrative: On Saturday, by noon, patient had painful gas with grunting and vomited a little bit. By 8pm started with gas pain, grunting, weighing down, then became unresponsive.   Ambulance took patient to ER, given rescue breathing, CPR, and shocks were required.   At hospital patient was intubated, had arrhythmia, respiratory issues. Patient taken to air to Hospital were she is in ECMO now.   Patient is still at the hospital now. They are treating her for myocarditis or cardiomyopathy.  Patient has positive Adoneno virus screen test for some type of infection. Myocarditis is an adverse event to resuscitation.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, HPVX, PPV, RVX
Symptoms: Resuscitation, Unresponsive to stimuli, Vomiting
Clinical narrative: On Saturday, by noon, patient had painful gas with grunting and vomited a little bit. By 8pm started with gas pain, grunting, weighing down, then became unresponsive.   Ambulance took patient to ER, given rescue breathing, CPR, and shocks were required.   At hospital patient was intubated, had arrhythmia, respiratory issues. Patient taken to air to Hospital were she is in ECMO now.   Patient is still at the hospital now. They are treating her for myocarditis or cardiomyopathy.  Patient has positive Adoneno virus screen test for some type of infection. Myocarditis is an adverse event to resuscitation.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Hyperacusis, Photophobia, Screaming
Clinical narrative: Just a few hours after receiving them, blood curdling non stop screaming lasting longer than 3 hours,  she acted like she was bothered by light movement and sound
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Erythema, Feeling abnormal
Clinical narrative: SHE CALLED AND LET ANOTHER PHARMACIST KNOW THAT SHE HAD 100 DEGREE TEMP AND A PINK GRAPEFRUIT SIZE RED MARK ON HER ARM. SHE ALSO DID NOT FEEL GOOD FOR 2 DAYS.
Age: 2.0
Sex: F
Vaccine: DTAPIPV, HEPA, HIBV, PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine Kinirix was drawn up to give to patient and administered. LHD notified clinic and asked if this was correct and it was. Incident report was complete and LHD is taking care of their part.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Right upper Leg redden and warm to touch. Patient came to walk in clinic on 6-8-19 at 10:39 am and was given Orapred 15mg/ml 5ml to take 45ml with breakfast and lunch for 2 days and then once daily for two days. Patient to return if symptoms worsen. Also to use ice and Benadryl cream to site for swelling.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Oral mucosal eruption, Rash
Clinical narrative: Rash developed on mouth on 6/7/19; Spread to chest, back, and lower legs. Had 12m vaccines on 5/28/2019
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Platelet count decreased, Pyrexia, Thrombocytopenia
Clinical narrative: WAS SEEN AT THE ER ON 5/29 FOR FEVER. VACCINES GIVEN ON 5/28-RESULTING THROMBOCYTOPENIA PLATELETS 63. NO SEQUELAE OR COMPLICATIONG. SELF RESOLVED
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site rash
Clinical narrative: Patient received 2nd dose of Shingrix on 6/3/19. The next day, 6/4/19 patient reported to have a rash at site of injection, shivering for 10 minutes, and chills throughout the day. The next day, 6/5/19 all of the reactions were no longer existent.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Injection site hypoaesthesia
Clinical narrative: patient called the pharmacy several hours after receiving vaccination and complained of numbness in the arm. patient was asked if there was any swelling of lips, tongue, throat, or facial features; which there was not. patient was asked if the numbness was extended to whole arm or just the injection site. patient said near injection site and the surrounding area.  patient had us double check that the correct and in date vaccine was administered, which it was. patient was advised to monitor for any discoloration/darkening of the area surrounding the vaccine, radiating numbness to any other portions of the arm/body or any darkening of the urine along with severe muscle pain or weakness (and also signs of anaphylaxis). if any of these should happen patient was advised to call for emergency services and seek medical care. patient was advised of common side effects from vaccines, which can include transient soreness and discomfort at administration site, and how to seperate them from previously mentioned severe adverse reactions.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Death, Dysarthria, Hallucination, Laboratory test, Muscular weakness
Clinical narrative: Patient's daughter called the clinic to inform the staff that the patient passed away.  She reports that a couple of weeks after getting the vaccine, the patient began experiencing weakness in his knees, slurring of his words and developed hallucinations.  Patient was ultimately admitted to ER and passed away 10 days later.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Culture, Dysphagia, Feeling abnormal, Fungal test, Nausea
Clinical narrative: Patient received vaccine in early afternoon, had nausea and felt funny that night.   Friday morning felt funny then felt fine the rest of the day.   Saturday morning did not feel quite right but then better as the day went on.  Sunday night had sore throat.  Monday, patient had bad sore throat and could not swallow. Patient had to spit every few minutes, there were nodules of white stuff on spit and tongue was white.   On Tuesday went to doctor and given liquid to gargle with Novocain for pain; it was helpful.   Yesterday went to Urgent Care and doctor agreed but they did a culture to see if it was thrush or not; results come back on Monday.   Per reporter, she read that one of the vaccine ingredients from a bark of tree could cause problems with in lining of throat.   Patient went to Reporter spoke to Pharmacy on 6/7 and directed to call VAERS.  Currently, patient feels better when gargles because it helps with pain in throat. Aspirin also helps patient feel better. The symptoms are about the same--not improving.  Patient tested negative for strep and there is no fever.   Per doctor, it is not a bacterial infection--awaiting for results to see if fungal.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Streptococcus test negative, Tongue discolouration
Clinical narrative: Patient received vaccine in early afternoon, had nausea and felt funny that night.   Friday morning felt funny then felt fine the rest of the day.   Saturday morning did not feel quite right but then better as the day went on.  Sunday night had sore throat.  Monday, patient had bad sore throat and could not swallow. Patient had to spit every few minutes, there were nodules of white stuff on spit and tongue was white.   On Tuesday went to doctor and given liquid to gargle with Novocain for pain; it was helpful.   Yesterday went to Urgent Care and doctor agreed but they did a culture to see if it was thrush or not; results come back on Monday.   Per reporter, she read that one of the vaccine ingredients from a bark of tree could cause problems with in lining of throat.   Patient went to Reporter spoke to Pharmacy on 6/7 and directed to call VAERS.  Currently, patient feels better when gargles because it helps with pain in throat. Aspirin also helps patient feel better. The symptoms are about the same--not improving.  Patient tested negative for strep and there is no fever.   Per doctor, it is not a bacterial infection--awaiting for results to see if fungal.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Diarrhoea, Fatigue, Lethargy, Pain
Clinical narrative: Body pain. 101/103 temp for 3 days; consistent diarrhea for 17 days; lethargy, mental and physical fatigue for 21 days.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Nausea, Pain, Pain in extremity
Clinical narrative: on Saturday afternoon patient began feeling like had the flu.  Patient had body aches, sore arm and nausea.  Sun day patient had sore arm and still felt tired.  Monday arm ached. Patient said never ran a fever.  Patient reports that her arm was never red and never swollen.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: left upper arm redness, swelling and induration, 13 x 11 cm
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash macular, Skin warm, Tenderness
Clinical narrative: Patient arm has red blotch that is spreading, warm to touch, tender at touch, no major pain, no itching
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Pruritus generalised
Clinical narrative: Patient called office and complained of small itchy blisters all over body starting yesterday 6/9/19.  Patient said that he felt otherwise fine, just the itchiness of the bumps.  No complaints of fatigue, fever, or malaise.  Dr. advised patient to take Benadryl tonight to see if any improvement, to call office in the morning if not any better or doing worse.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Pain, Skin warm, Tenderness
Clinical narrative: Adverse event: Pain, Inflammation, redness, warm to touch, tender Treatment: Course of antibiotics Outcomes: patient is doing much better
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Patient said he has swelling lymph node, advise patient to contact his doctor for treatment.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Axillary pain, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: HPV vaccine #2 was given upper R deltoid 4 days ago. Arm was hurting that evening, seemed to be hurting more than usual with a vaccine. Developed swelling and pain in right armpit next day. Day before yesterday mom looked at it and it looked terrible, swollen and red all in her armpit. Family was away for a soccer tournament, decided to wait. Has gotten a little better, still a little swollen, still hurting.  Otherwise feeling fine. Normal energy, normal appetite. Played soccer this weekend. No fever. No vomiting or diarrhea. Sleeping fine at night.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Injection site bruising, Injection site discolouration, Injection site erythema
Clinical narrative: Patient noted bruising at injection site the following morning. Patient felt sore at injection site that evening. Patient also noted area from injection site to half way down left arm to be blackened. Patient stated that blackened coloring changed to red colored 3-4 days after injection. Patient states she felt chills x 6 days. Patient denied fever. Patient stated that both cheeks became reddened. Patient states that she has a history of having reddened cheeks as part of an allergic reaction to allergens.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Patient noted bruising at injection site the following morning. Patient felt sore at injection site that evening. Patient also noted area from injection site to half way down left arm to be blackened. Patient stated that blackened coloring changed to red colored 3-4 days after injection. Patient states she felt chills x 6 days. Patient denied fever. Patient stated that both cheeks became reddened. Patient states that she has a history of having reddened cheeks as part of an allergic reaction to allergens.
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination site cellulitis, Vaccination site vesicles
Clinical narrative: Patient developed satellite vesicles and cellulitis at and around the site of the vaccine.  Approx. 8 additional vesicles.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Rash
Clinical narrative: Patient stated her arm was very red after she received her Shingrix vaccine on 6/6/19. She then noticed a painless rash on her arm on 6/9/19 in the evening. She has had shingles several times in the past and noted this case was mild compared to the others. She was seen by a healthcare provider on 6/10/19 and they diagnosed her with shingles and prescribed an anti-viral for her. She reports not having any shingles symptoms before she received her vaccine.
Age: 52.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Asthenia, Dizziness, Electrocardiogram, Heart rate decreased, Hypotension
Clinical narrative: LOC that occurred a couple minutes after injections. Pt came back, was speaking, then had LOC again along with Urinary incontinence, severe vomiting, low blood pressure, low heart rate. Doctor called to room.  Gave Epi, started IV fluids, called 911. pt was feeling better but still lightheaded and weak. Went to the ER by ambulance.
Age: 52.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Loss of consciousness, Urinary incontinence, Vomiting
Clinical narrative: LOC that occurred a couple minutes after injections. Pt came back, was speaking, then had LOC again along with Urinary incontinence, severe vomiting, low blood pressure, low heart rate. Doctor called to room.  Gave Epi, started IV fluids, called 911. pt was feeling better but still lightheaded and weak. Went to the ER by ambulance.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Acne, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: redness, swelling and pain at injection site and formation of "white head" over injection site lasting 1 week.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient called 6/10/19 (about a week after shot) to ask about warmth and slight redness at injection site. Patient was not in pain or concerned with any other reactions.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Cold sweat, Dizziness, Feeling hot, Flushing, Nausea
Clinical narrative: 10MIN AFTER INJECTION DONOR BECAME HOT, NAUSEOUS, DIZZY,LIGHTHEADED, FLUSHED CLAMMY, EYES BLURRY. TAKEN TO OFFICE. PLACED ON TABLE. EXTREMITIES  ELEVATED, FANNED. NO BREATHING DIFFICULTY, NO RASH. NAUSEA RESOLVED. TOLERATED 12OZ POWERADE. IN OFFICE  EPISODE LASTED 40MIN.  DR NOTIFIED OF EVENT.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Vision blurred
Clinical narrative: 10MIN AFTER INJECTION DONOR BECAME HOT, NAUSEOUS, DIZZY,LIGHTHEADED, FLUSHED CLAMMY, EYES BLURRY. TAKEN TO OFFICE. PLACED ON TABLE. EXTREMITIES  ELEVATED, FANNED. NO BREATHING DIFFICULTY, NO RASH. NAUSEA RESOLVED. TOLERATED 12OZ POWERADE. IN OFFICE  EPISODE LASTED 40MIN.  DR NOTIFIED OF EVENT.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient's upper arm was swollen and red, swollen area was about the size of a softball.  Symptoms set in two days after immunization and patient presented to pharmacy 5 days after immunization.  Advised her to ice the area, take some benadryl at bedtime, and to continue her meloxicam she takes regularly.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site rash, Injection site swelling, Nasopharyngitis, Pyrexia, Upper respiratory tract infection
Clinical narrative: Started right after the MMRV w/ cold sx and fever. Sx of URI started to resolve a few days later then the shot site swelled up and a diffuse rash started. LG fever on and off, spiking. Completely resolved within 2 weeks.
Age: 1.08
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Febrile convulsion, Vomiting
Clinical narrative: vomiting, febrile seizure , acetaminophen & ibuprofen
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Rash
Clinical narrative: RASH ON ARM, PAIN ACROSS SHOULDERS, COULD NOT LIFT RIGHT ARM ABOVE SHOULDER
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Patient reported redness and swelling at the injection site, hives,itching all over chest, arm and face.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Pruritus, Swelling
Clinical narrative: Patient had redness and swelling and was told by the Nurse Prac that her body reacted to the site and led to cellulitis, Had extensive redness and swelling that itched. Benadryl  gave no relief, pt already had appt for more immunizations on 6.10.19 and sought prescriber guidance.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Dyspnoea, Loss of consciousness
Clinical narrative: After few minutes of getting vaccines, pt had difficulty  breathing, lost  consciousness.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Amenorrhoea, Autoimmune disorder, Dizziness, Full blood count, Gastric disorder
Clinical narrative: Initially I became very light headed. By the time I was home I had a fever, could barely move and my entire body was in excruciating pain.  Within a couple weeks I completely stopped menstruating, my thyroid shut down, and eventually my stomach stopped working leading to emergency surgery. I developed an unspecified autoimmune disease with extreme inflammation in the body.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Hormone level abnormal, Inflammation, Inflammatory marker test, Mobility decreased, Pain
Clinical narrative: Initially I became very light headed. By the time I was home I had a fever, could barely move and my entire body was in excruciating pain.  Within a couple weeks I completely stopped menstruating, my thyroid shut down, and eventually my stomach stopped working leading to emergency surgery. I developed an unspecified autoimmune disease with extreme inflammation in the body.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Premature menopause, Pyrexia, Red blood cell sedimentation rate abnormal, Surgery, Thyroid disorder
Clinical narrative: Initially I became very light headed. By the time I was home I had a fever, could barely move and my entire body was in excruciating pain.  Within a couple weeks I completely stopped menstruating, my thyroid shut down, and eventually my stomach stopped working leading to emergency surgery. I developed an unspecified autoimmune disease with extreme inflammation in the body.