chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site irritation
Clinical narrative: injection site irritation; Vaccine Administered at Inappropriate Site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site irritation in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site irritation and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site irritation and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site irritation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was captured as adult as per vaccine indication. The pharmacist reported that he accidentally injected a Shingrix vaccine subcutaneously, which led to intramuscular formulation administered by other route.  He also stated that the patient reported injection site irritation. The pharmacist stated he was not at the pharmacy on the day of reporting, and had no other information to provide at time of reporting, including information related to patient or product.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Fever; Chills; Unwell; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 7PS9E, expiry date 10th September 2021) for prophylaxis.   On 11th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2019, less than a week after receiving Shingrix, the patient experienced fever, chills and unwell. On an unknown date, the outcome of the fever, chills and unwell were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills and unwell to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on left arm. The pharmacist on the line reporting she gave Shingrix to a patient who was reporting a bad reaction.  The patient had fever, chills, and was feeling really unwell.    The symptoms started either Tuesday night or early Wednesday.
Sex: M
Vaccine: UNK
Symptoms: Condition aggravated, Dermatitis, Lichen planus, Macule, Papule
Clinical narrative: Further cutaneous dissemination and continued symptoms/Lichen planus aggravated; Multiple well-demarcated hyperpigmented macules; Slightly raised agminated papules; [Coalescing into] linera papules, unilaterally on the left posterior trunk, flank and chest; Dermatitis continued to spread; Brown lesions that started on his chest and spread to his trunk; Pruritic; This is a serious literature case, initially received on 10-Jun-2019, concerning an adult male patient of an unspecified age.    The article describes a rare case of linear lichen planus following intramuscular influenza vaccination, not associated with an injection site reaction.   The patient had received multiple, annual vaccinations for influenza and regular vaccinations for other diseases. It was reported that his vaccinations were up-to-date, including 14 consecutive, annual influenza vaccinations, 11 of which were intramuscular. After the previous vaccination, the patient was given a topical corticosteroid. The patient's current condition included linear lichen planus (LLP).   On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for an annual flu vaccination.    On an unspecified date, at 1-year follow-up, the patient reported the inconsistent and minimal use of the topical corticosteroid and received another annual flu vaccination with further cutaneous dissemination and continued symptoms (macule, papule, skin plaque, dermatitis, skin lesion and pruritus) (coded as lichen planus aggravated).   The outcome of the events was not recovered.  The reporter assessed the causality of the event LLP as related to the suspect vaccine as it was reported that the temporal relationship of the onset of LLP to the influenza vaccination was strongly suggestive that the inactivated influenza vaccine was the antigenic trigger. It was reported that immune-related dermatoses might be under-reported, and a vaccine history should be considered in all patients with a skin condition that is otherwise attributed as idiopathic. The reporter also concluded that the somatic mosaicism could be exhibited by genetically predisposed patients who had experienced a triggering environmental input, such as a vaccine.  This case is linked to 201903718 (same patient).; Reporter's Comments: An adult male patient experienced lichen planus aggravation, unspecified period after annual flu vaccination with INN flu vaccine. Considering the prior history of linear lichen planus post-vaccination with INN flu vaccine, the causal role of suspect vaccine cannot be ruled out despite minimal information regarding onset latency between vaccination to event onset. Hence, company assessed the causality as related.  The company assessed the case as serious (medically significant).
Sex: M
Vaccine: UNK
Symptoms: Pruritus, Skin lesion, Skin plaque
Clinical narrative: Further cutaneous dissemination and continued symptoms/Lichen planus aggravated; Multiple well-demarcated hyperpigmented macules; Slightly raised agminated papules; [Coalescing into] linera papules, unilaterally on the left posterior trunk, flank and chest; Dermatitis continued to spread; Brown lesions that started on his chest and spread to his trunk; Pruritic; This is a serious literature case, initially received on 10-Jun-2019, concerning an adult male patient of an unspecified age.    The article describes a rare case of linear lichen planus following intramuscular influenza vaccination, not associated with an injection site reaction.   The patient had received multiple, annual vaccinations for influenza and regular vaccinations for other diseases. It was reported that his vaccinations were up-to-date, including 14 consecutive, annual influenza vaccinations, 11 of which were intramuscular. After the previous vaccination, the patient was given a topical corticosteroid. The patient's current condition included linear lichen planus (LLP).   On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for an annual flu vaccination.    On an unspecified date, at 1-year follow-up, the patient reported the inconsistent and minimal use of the topical corticosteroid and received another annual flu vaccination with further cutaneous dissemination and continued symptoms (macule, papule, skin plaque, dermatitis, skin lesion and pruritus) (coded as lichen planus aggravated).   The outcome of the events was not recovered.  The reporter assessed the causality of the event LLP as related to the suspect vaccine as it was reported that the temporal relationship of the onset of LLP to the influenza vaccination was strongly suggestive that the inactivated influenza vaccine was the antigenic trigger. It was reported that immune-related dermatoses might be under-reported, and a vaccine history should be considered in all patients with a skin condition that is otherwise attributed as idiopathic. The reporter also concluded that the somatic mosaicism could be exhibited by genetically predisposed patients who had experienced a triggering environmental input, such as a vaccine.  This case is linked to 201903718 (same patient).; Reporter's Comments: An adult male patient experienced lichen planus aggravation, unspecified period after annual flu vaccination with INN flu vaccine. Considering the prior history of linear lichen planus post-vaccination with INN flu vaccine, the causal role of suspect vaccine cannot be ruled out despite minimal information regarding onset latency between vaccination to event onset. Hence, company assessed the causality as related.  The company assessed the case as serious (medically significant).
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Urticaria
Clinical narrative: Baby was seen on 4/12/19 in AM for vaccines. Next day (Saturday) baby developed hives all over No other changes in diet. Next day (Sunday) went to ER -> given Benadryl. On 4/16/19 was seen in our office, still with same hives; was Rx cetirizine. No changes in diet, no inject site.
Age: 31.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Client states she received Varicella vaccine on the right upper back of the arm .  She stated that she went in to take a shower at 9:00pm and noted redness, tenderness, and swelling at the site of injection.  The next morning it was an area of redness about 8 inches in length and about 4 inches wide on the upper back portion of her right arm.  There was also a raised area in the middle (Hive-like) 3 inch by 1 inch area. She states it was tender, red, and swollen.  She did not do any comfort measures for it.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Chills, Headache, Hyperhidrosis
Clinical narrative: pain, weakness, fever, shivering, sweating, headache, nausea, balance issues.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: pain, weakness, fever, shivering, sweating, headache, nausea, balance issues.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Histamine intolerance, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PAIN, SWELLING, REDNESS, AND HEAT AT SITE OF INJECTION (WITHIN HOURS, PERSISTED ~7 DAYS) SYSTEMIC HISTAMINE REACTION WITH INTENSE ITCHING (WITHIN 12 HOURS, LASTED A DAY) LOCALIZED RASHES ON LEG W/ITCHING BUT NO PAIN, SAME SIDE AS INJECTION (WITHIN A DAY, PERSISTED FOR ~7 DAYS BEFORE NEW LESIONS STOPPED SHOWING UP; LESIONS HAVE NOT YET HEALED NINE DAYS POST INJECTION)
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin lesion
Clinical narrative: PAIN, SWELLING, REDNESS, AND HEAT AT SITE OF INJECTION (WITHIN HOURS, PERSISTED ~7 DAYS) SYSTEMIC HISTAMINE REACTION WITH INTENSE ITCHING (WITHIN 12 HOURS, LASTED A DAY) LOCALIZED RASHES ON LEG W/ITCHING BUT NO PAIN, SAME SIDE AS INJECTION (WITHIN A DAY, PERSISTED FOR ~7 DAYS BEFORE NEW LESIONS STOPPED SHOWING UP; LESIONS HAVE NOT YET HEALED NINE DAYS POST INJECTION)
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Shivering, headache, muscle ache, fatigue
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain, Cough, Oropharyngeal pain, Periorbital swelling, Vomiting
Clinical narrative: After vaccines, child returned to office in approx. 2 hours.  She had started to c/o sore throat when they left the building, and by the time they got home (about 5-10 mins), she was developing a cough and swelling under her left eye.  Also c/o some abdominal pain. Also was noted to have some  wheezing that was cleared with Abluterol neb 0.083%.  Was given 10 mg Decadron by injection and 3/4 tsp of Benadryl 25 mg-she immediately vomited. Patient has not returned phone call to foup.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Wheezing
Clinical narrative: After vaccines, child returned to office in approx. 2 hours.  She had started to c/o sore throat when they left the building, and by the time they got home (about 5-10 mins), she was developing a cough and swelling under her left eye.  Also c/o some abdominal pain. Also was noted to have some  wheezing that was cleared with Abluterol neb 0.083%.  Was given 10 mg Decadron by injection and 3/4 tsp of Benadryl 25 mg-she immediately vomited. Patient has not returned phone call to foup.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Fall, Feeling abnormal, Loss of consciousness
Clinical narrative: Patient received Menactra first in R arm without issue. Hep A was given in L arm and patient passed out and fell off of exam table and stated that it "made me feel really weird".  He was checked out by provider after incident.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema
Clinical narrative: Redness 7cm x 6cm, Non tender no Fever, no other body rash.
Sex: M
Vaccine: VARZOS
Symptoms: Diaphragmatic paralysis, Dyspnoea
Clinical narrative: paralyzed diaphragm; labored breathing; This case was reported by a pharmacist via call center representative and described the occurrence of diaphragmatic paralysis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced diaphragmatic paralysis (serious criteria GSK medically significant) and labored breathing. On an unknown date, the outcome of the diaphragmatic paralysis and labored breathing were unknown.   It was unknown if the reporter considered the diaphragmatic paralysis and labored breathing to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that he heard from a patient's wife that the patient has experienced a paralyzed diaphragm and labored breathing ever since receiving Shingrix about a year before the date of reporting. The patient was administered Shingrix at a different facility, so additional information about the patient and vaccine dose was unknown. The patient experienced a paralyzed diaphragm and labored breathing receiving Shingrix. The patient has reportedly received medical attention for the events,but what treatment the patient received was unknown. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Apraxia, Blood lead increased, Decreased eye contact, Regressive behaviour, Speech disorder developmental
Clinical narrative: Stopped talking/making noises, regression in speech and eye contact, and developed Apraxia
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Peripheral swelling
Clinical narrative: Left Shoulder pain, upper arm swelling, and decreased range of motion. October 2018 went to Center and received steroid injection. 6-17-19 Continues to left shoulder pain, left upper arm swelling and decreased range of motion.
Age: 22.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Immediate post-injection reaction, Nausea, Pallor
Clinical narrative: Before giving vaccines patient expressed that she was nervous about having vaccines but has never had any reactions in the past. Answered questions regarding vaccines and VIS was given to patient. Immediately after giving vaccines the patient turned  pale, and patient stated her stomach felt sick.  Laid patient down on the exam table.  Patient rest in exam room for 15 minutes and then she sat up and stayed for another 5 minutes.  No injury to patient. Provider notified and patient rechecked/monitored . Vitals Done . Patient observed and symptoms completely resolved. Able to walk out office on own will. Patient made aware to call if any further concerns. .
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; 1 dose of improperly stored VARIVAX was administered to patient on 29-MAY-2019; This spontaneous report was received from a nurse, and refers to a patient of unknown age and gender.No information was provided regarding the patient's medical history or concurrent conditions.   On 29-MAY-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, subcutaneously for prophylaxis (anatomical location was not provided). Lot number was reported as R029510, expiration date 14-OCT-2020. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT).  On an unspecified date, the administered dose underwent a temperature excursion of 18.3 Fahrenheit degrees for a time frame of 8 hours and 47 minutes. There were no previous temperature excursions reported. No adverse effects were reported.  The excursion was called by the Digital Data Logger.  Lot number R029510 is an invalid lot number for varicella virus vaccine live (oka/merck).
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: Positive Hepatitis B Surface Antigen 1 hour After Injection; Initial Report Received on 13-Jun-2019  A pharmacist reported that patient EH, a 41-year-old male (race not provided) was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and tested positive for hepatitis B surface antigen 1 hour after the injection.   The pharmacist was not aware of the patient's medical history.  Concomitant medications were not provided.    On 16-May-2019, the patient received a dose of HEPLISAV-B from a pre-filled syringe in the right deltoid (Lot # E9G4E, expiration date: 29-Dec-2021, NDC # unknown). The patient also received a hepatitis A vaccine in the left arm on the same date.    The patient tested positive for the hepatitis B surface antigen 1 hour later. The pharmacist stated that it was possible that the patient was hepatitis B positive before getting the injection. No further information was provided.   At the time of the report, the outcome of the event was not reported.  The reporter did not provide a seriousness assessment for the event.   Company comment: The company assessed the event of hepatitis B surface antigen positive as non-serious. The event of hepatitis B surface antigen positive is listed per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of hepatitis B surface antigen positive as non-serious. The event of hepatitis B surface antigen positive is listed per HEPLISAV-B USPI.
Age: 18.0
Sex: M
Vaccine: SMALL
Symptoms: Migraine, Rash erythematous, Rash generalised
Clinical narrative: Small bumps all over his skin; Migraine; Information received from a consumer on 01MAY2019.   A male patient aged 18 years experienced small bumps all over his skin following the administration of ACAM (smallpox (vaccinia) vaccine live).   On 22APR2019, the patient received ACAM dose in the upper left arm (route, lot and dosage unknown).  On 29APR2019, patient revisited the facility that had vaccinated him and the doctor reported that the he was healing. The patient reported that for the last two days (30APR2019), he had developed small red bumps all over his skin and also had migraine for two days. Patient had a concern that he might have accidentally inoculated himself because the vaccination area was covered except for one night when he had left it open to air out.  He also stated that he knows it did not come in contact with anything. Patient has been on internet and doesn't think his bumps look like smallpox. He denied to provide any further information and does not want to go through an adverse event report. Outcome of the event at the time of report was unknown.  Patient's medical history was not reported.  Allergies: not reported  Concomitant medications and Concurrent Medical conditions: not reported  Company Comment: There is not enough information to properly assess this case. The Company considers that the macular rash is not assessable and the diagnosis of autoinoculation cannot be made. The reporter was concerned of possible autoinoculation but he ruled out himself of the possible autoinoculation. it is odd that one day after the doctor's no lesions were noted. Migraine is not a known phenomenon of  ACAM2000.and considered not related.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: one of the nurses gave a patient only the liquid part of Pentacel; Initial information received on 07-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient (age and gender unknown) who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number, expiry date not reported via unknown route in unknown administration site.  It was an actual medication error due to inappropriate reconstitution technique.  It was reported that one of the nurses gave a patient only the liquid part of Pentacel. The reconstitution guide was not provided because the nurse meant to give it this way and it was not done in error on her part  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none. Information on batch number was requested for this case.
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: patient received a double dose of Menactra; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 15 years old male patient who received double 0.5 ml dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6204AA) via intramuscular route in the right deltoid (first dose) and left deltoid (second dose), on 11-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  It was an actual medication error case due to extra dose administered.   It was reported that the caller did not realize a dose of Menactra had been given and gave a second dose.  It was unknown whether the patient had any adverse reactions.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 1.83
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: they gave doses of Acthib and pentacel on the same day/no AE; Based on additional information received on 12-Jun-2019, case becomes valid as patient was identifiable.  Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 22 months old male patient who received vaccines HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL).  The patients past medical history family history were not provided.  No concomitant medication received.   On 10-Jun-2019, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (left thigh, second dose) and DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (right thigh, first dose) lot number not reported via intramuscular route.  It was an actual medication error due to extra dose administered.  It was reported that they gave 2 doses of Acthib and Pentacel on the same day.  It was reported that no adverse reaction was there after the injection.   Information on lot number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.  Follow-up information received on 12-Jun-2019 regarding an unsolicited non-serious case received from a Health Care Professional-Other.  Case becomes valid. Patient age was added. Suspect PENTACEL was added. Dosing details of both suspects added.   Information on lot number was requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Mobility decreased
Clinical narrative: cannot lift arm above head and numbness in fingers and collerbone
Age: 50.0
Sex: U
Vaccine: UNK
Symptoms: Abdominal discomfort, Abdominal pain, Chills, Dyspnoea, Erythema
Clinical narrative: Itchy, red, swollen, trouble breathing and shallowing, pain where shot was given, muscle pain, feeling tired, headache, shivering, upset stomach, vomiting, belly pain, and tingling of the lips.
Age: 50.0
Sex: U
Vaccine: UNK
Symptoms: Fatigue, Headache, Hypopnoea, Injection site pain, Myalgia
Clinical narrative: Itchy, red, swollen, trouble breathing and shallowing, pain where shot was given, muscle pain, feeling tired, headache, shivering, upset stomach, vomiting, belly pain, and tingling of the lips.
Age: 50.0
Sex: U
Vaccine: UNK
Symptoms: Paraesthesia oral, Pruritus, Swelling
Clinical narrative: Itchy, red, swollen, trouble breathing and shallowing, pain where shot was given, muscle pain, feeling tired, headache, shivering, upset stomach, vomiting, belly pain, and tingling of the lips.
Age: 1.75
Sex: M
Vaccine: MMR
Symptoms: Rash morbilliform
Clinical narrative: measles like rash
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: RED, SWOLLEN, AND PAINFUL UPPER RIGHT ARM WHERE THE VACCINE WAS ADMINISTERED, THE SWOLLEN AREA ALSO FELT WARM TO TOUCH.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Diffuse Maculopapular rash starting 6/17/19
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Pyrexia, Rash generalised, Rash papular, Vaccination complication
Clinical narrative: On day 10 following the vaccination, child developed a fever and loss of appetite. His fever went up to 101 and shortly after he started breaking out in red bumps on his face. They increased onto both cheeks, forehead, neck, throat, both arms, torso and on his legs. He was taken to the doctor and it was confirmed that it was a reaction to the vaccination. His rash increased in severity but his fever broke and his appetite returned. The rash is still there as of this report.
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: Dysphagia, Dyspnoea, Hypoaesthesia, Injection site pain, Nasal congestion
Clinical narrative: Vaqta was injected into the left arm.  Patient felt "immediate severe" pain with numbness in tingling in left, and then right arm and chest.  She went back to work.  About 1.5 hours after the vaccine was given, she was "white as a sheet" and felt like her "throat was closing."  She described difficulty swallowing and shortness of breath.  She was taken to the ED and treated with epinephrine 0.3mg IM, Benadryl IV, Solumedrol IV, and Pepcid IV.  She was prescribed an epineprhine autoinjector for home use and a Medrol dose pack.  She reports that she had "cold symptoms" with a sore throat, stuff nose, and "neck pain" for about two weeks after the vaccine was given.
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: Nasopharyngitis, Neck pain, Pallor, Throat tightness
Clinical narrative: Vaqta was injected into the left arm.  Patient felt "immediate severe" pain with numbness in tingling in left, and then right arm and chest.  She went back to work.  About 1.5 hours after the vaccine was given, she was "white as a sheet" and felt like her "throat was closing."  She described difficulty swallowing and shortness of breath.  She was taken to the ED and treated with epinephrine 0.3mg IM, Benadryl IV, Solumedrol IV, and Pepcid IV.  She was prescribed an epineprhine autoinjector for home use and a Medrol dose pack.  She reports that she had "cold symptoms" with a sore throat, stuff nose, and "neck pain" for about two weeks after the vaccine was given.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: Flu-like symptoms 6 hours after vaccination: moderate fever (101-102), headache, nausea, dizziness, loss of appetite, joint pain only on side of injection (left knee and hip), fatigue.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Influenza like illness, Nausea, Pyrexia
Clinical narrative: Flu-like symptoms 6 hours after vaccination: moderate fever (101-102), headache, nausea, dizziness, loss of appetite, joint pain only on side of injection (left knee and hip), fatigue.
Age: 53.0
Sex: M
Vaccine: MMR
Symptoms: Chills, Paraesthesia, Piloerection, Sensitive skin
Clinical narrative: Patient presented to PCP office today with c/o skin sensitivity, chills, parathesia to the abdominal area and back area, reporting a "goosebump like sensation" on abdominal wall. Denied this sensation anywhere else.  Reports that he received travel vaccinations on 6/11/19 including MMRII, Typhoid and Yellow Fever.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: left upper arm with erythematous warm, tender lesion at site of varicella vaccine, no drainage. Dr. diagnosed reaction as cellulitis and patient was prescribed AUGMENTIN 875-125 MG TABS
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pronounced swelling, redness, warmth, itching, and pain at and around injection sites within hours following vaccination.  Swelling and redness increased daily to cover the width of the outer arm from the shoulder to close to elbow along with increased itching.  Swelling measured and marked daily.  Made an appointment and seen at pediatrician office the following day (6/14/19).  Directed to give motrin for pain, Zyrtec, and antihistamine topical cream to help with itching.  Prescription provided for Cephalexin if swelling increased through weekend.  Referred to allergist to try to pinpoint what is causing the reaction.  Last set of immunizations was 5/21/2013 and more pronounced reaction occurred at immunization site of left thigh.  Was seen at urgent care and pediatrician office following that event as well.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Headache, fever, body aches, left arm very sore, slight nausea since the first evening Monday.  Today is Wednesday and I am hoping this will all clear up soon.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site warmth, Insomnia, Oedema, Pain in extremity
Clinical narrative: Patient felt her arm getting sore a couple hours after the immunization and had trouble sleeping from the pain. She woke up and felt heat radiating from the site and her arm was swollen. She went to her doctor the day after the immunization (6/19). The doctor escribed Keflex to treat and also told the patient to take oral Benadryl OTC. Apply ice and Tylenol and to notify MD if not better. Keep arm elevated.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Patient felt her arm getting sore a couple hours after the immunization and had trouble sleeping from the pain. She woke up and felt heat radiating from the site and her arm was swollen. She went to her doctor the day after the immunization (6/19). The doctor escribed Keflex to treat and also told the patient to take oral Benadryl OTC. Apply ice and Tylenol and to notify MD if not better. Keep arm elevated.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: pt was receiving 3 vaccines at well child visit. Pt was given 2 doses of MMRV (Proquad) at visit. MA gave Kinrix to Right Thigh IM, followed by Proquad to Right thigh IM accidentally instead of Havrix Hep A, patient then kicked next (3rd) syringe (Havrix) out of MA hand removing the needle and causing a waste of vaccine. MA asked LVN to draw up Proquad  and confirmed the need for Proquad, LVN then drew up and gave injection while MA held patient for injection. after leaving the room MA realized mistake and advised LVN/Clinical Supervisor that patient had been given 2 proquads by accident. mother of child was asked to return to office within 30 minutes of realization. patients provider was notified followed by Clinic manager, She contacted Health department and Merck to report incident, Poison control was contacted. and pt was observed in office by both provider and clinic supervisor. pt not having any adverse reactions at that time. mother was given ER precautions and adverse reactions to watch for. pt will return to office in the morning for follow up. pt will return to office at a later date to receive Havrix Hep A that she did not receive at this visit. Mother voiced understanding to all instructions given.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Extensive swelling and pain noted at the site of injection.
Age: 1.25
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Ear discomfort, Muscle twitching
Clinical narrative: pt gets twitching with Hib vaccine every time  pt was seen on 5/29 had Hib vaccine, pt went to grand mother's house , immediately after falling sleep , he starts twiching ,grand mother will hold him for 15 minutes, it lasts for 15 minutes, it is persistent, but slowly going away,   pmh similar episodes with prior Hib vaccine as per grandmother. it lasted for couple of weeks, no other problems,   mother reports her previous Pediatrician did one shot at a time, at that time it also happened with Hib, not with Dtap ( he was fine with it)  reviewed video, small twiches on his hand and distal leg, every few seconds , no other problem,  no problems while he is awake,   he has been having "ear tugging"  pmh hx of tongue and lip tie done last week  family denies seizure disorder  Plan  discussed in detail with mohter and grandmother  watched video of twiching,  reassure since patient is not getting any more Hib , and it is getting better, with hx of improving over time, wll not further investigate  hold off on vaccines until 18 months,to observe affter twiching is resolved
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Fatigue, Gait disturbance, Pain in extremity
Clinical narrative: 6/17/19-difficulty walking due to pain in feet, ankles and knees, pain in hands.  Fatigue 6/18/19- Tiredness 6/19/19-Dizziness
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Thinking abnormal
Clinical narrative: 6/17/19-difficulty walking due to pain in feet, ankles and knees, pain in hands.  Fatigue 6/18/19- Tiredness 6/19/19-Dizziness
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient received vaccine on 6/18/19 and presented to pharmacy on 6/19/19 with injection site soreness, redness which had begun to radiate, localized itching, and reports of headache previous night after vaccine administration.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Patient seemed nervous about obtaining a vaccine. After administration, patient stated that he has fainted during vaccination before. Roughly 1-2 minutes after receiving vaccine, patient fainted. He regained consciousness after another minute or two, and asked for some water, which was provided by his father. After another minute or so, the patient stated he felt better, stood on his own and walked unassisted. The entire incident lasted 5 minutes.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Erythema, Peripheral swelling
Clinical narrative: Patient's daughter presented to the pharmacy on 6/19/2019 to pick up an antibiotic for the patient. After talking to the daughter, she said that her mother was dealing with side effects of getting the Prevnar vaccine on 6/13/2019. The daughter explained that her mother was having soreness, redness, fever,  and had a swollen upper arm. The daughter explained that she had taken her mother to see her doctor this morning (6/19/2019) and he prescribed an antibiotic. The daughter also noted that her mother has had a left side mastectomy and had been given the vaccine on her left arm.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Diarrhoea, Genital rash, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: 8 days after vaccine she developed a rash in her vaginal area that improved with nystatin. She woke up on 6/17/19 with what looks like 3 bites on her right thigh and also a rash on her torso. Afebrile. Returned to office for a worsening immunization reaction in the right thigh on 6/18/19. Patient received MMR  in right thigh 6/7/19.  Seen yesterday for rash and red bump on thigh-dx with vaccine reaction. -today with worsening redness on R upper-lateral aspect of thigh-started on Sunday. Seems painful and warm. -Generalized rash since yesterday.  -Last tylenol x 3.5 hours ago. For discomfort -no fever -looser stool x 1 yesterday. None today.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site rash, Injection site warmth, Rash, Rash generalised
Clinical narrative: 8 days after vaccine she developed a rash in her vaginal area that improved with nystatin. She woke up on 6/17/19 with what looks like 3 bites on her right thigh and also a rash on her torso. Afebrile. Returned to office for a worsening immunization reaction in the right thigh on 6/18/19. Patient received MMR  in right thigh 6/7/19.  Seen yesterday for rash and red bump on thigh-dx with vaccine reaction. -today with worsening redness on R upper-lateral aspect of thigh-started on Sunday. Seems painful and warm. -Generalized rash since yesterday.  -Last tylenol x 3.5 hours ago. For discomfort -no fever -looser stool x 1 yesterday. None today.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Small red area, slight hard bump.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Productive cough, Rash, Respiratory tract congestion
Clinical narrative: PER PATIENT SHE DEVELOPED A RASH ON FACE AND NECK THE EVENING THAT SHE RECEIVED SHINGRIX VACCINE.  PATIENT ALSO STATED THAT SHE DEVELOPED FLUID THAT SHE COUGH UP AND CONGESTION WHICH TURNED INTO BRONCHITIS.  VACCINE ADMINISTERED 3/5/19  BUT ADVERSE REACTION REPORTED 6/19/19.   HER PROVIDER DR ADVISED PATIENT NOT TO GET SECOND SHOT IN THE SERIES.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Confusional state, Crying, Pain, Parainfluenzae virus infection, Resuscitation
Clinical narrative: Patient received the MMR(V) Vaccine at her 12-month checkup. 3 days after, she was crying and screaming and seemed to be in pain. She was inconsolable. The following morning, patient woke up and was acting sluggish and confused. Around 1:30 p.m. patient went into a seizure and her eyes were staring off. Upon arriving at in the Emergency Room, she was rushed back and Respiratory was rushed in. She was put on Oxygen for about 30 minutes before she opened her eyes. We were transported to another Hospital for an overnight observation.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Screaming, Seizure, Sluggishness, Staring
Clinical narrative: Patient received the MMR(V) Vaccine at her 12-month checkup. 3 days after, she was crying and screaming and seemed to be in pain. She was inconsolable. The following morning, patient woke up and was acting sluggish and confused. Around 1:30 p.m. patient went into a seizure and her eyes were staring off. Upon arriving at in the Emergency Room, she was rushed back and Respiratory was rushed in. She was put on Oxygen for about 30 minutes before she opened her eyes. We were transported to another Hospital for an overnight observation.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site erythema
Clinical narrative: Extreme dizziness started 24 to 36 hours after shot, especially when getting up from laying down.  Has improved at this point.  Also fatigued, shivering, headache.  Redness and soreness at sight.  All symptoms have resolved except less dizziness
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Extreme dizziness started 24 to 36 hours after shot, especially when getting up from laying down.  Has improved at this point.  Also fatigued, shivering, headache.  Redness and soreness at sight.  All symptoms have resolved except less dizziness
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: Patient reports pain, swelling that started a couple of days after the vaccination and has persisted until today 6/19/19 when he reported I to me.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site joint pain, Injection site pain, Musculoskeletal discomfort
Clinical narrative: shortly after given injection(doesn't know if it was immediately after or weeks after) pt expereinced soreness to the deltoid muslce and shoulder/joint. those symptoms have been occuring since inject up until early June 2019. In early June 2019, pt started to experience neck soreness for the last 3 weeks.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: first nausea started at work. At home chills started and had fever of 99.7
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac function test normal, Chest discomfort, Dyspnoea, Echocardiogram normal, Headache
Clinical narrative: PT REPORTS FLU-LIKE SYMPTOMS FOLLOWING THE VACCINE AND IN THE EVENING, STATES HE DEVELOPED A SEVERE HEADACHE. HIS ARM WHERE HE RECEIVED THE VACCINE HURT CONSIDERABLY, BUT HE ALSO DEVELOPED CHEST TIGHTNESS AND MUSCLE TIGHTNESS AROUND HIS NECK THAT HE SAYS MADE IT DIFFICULT TO BREATHE. BY THE MORNING SYMPTOMS HAD NOT IMPROVED SO HE WENT TO THE EMERGENCY ROOM WHERE HE WAS ADMITTED. PER PATIENT, CARDIAC TESTS INCLUDING AN ECHO WERE "FINE" AND THE PAIN RESOLVED AFTER SEVERAL DOSES OF TORADOL AND ANOTHER PAIN MEDICATION.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Muscle tightness, Pain, Vaccination site pain
Clinical narrative: PT REPORTS FLU-LIKE SYMPTOMS FOLLOWING THE VACCINE AND IN THE EVENING, STATES HE DEVELOPED A SEVERE HEADACHE. HIS ARM WHERE HE RECEIVED THE VACCINE HURT CONSIDERABLY, BUT HE ALSO DEVELOPED CHEST TIGHTNESS AND MUSCLE TIGHTNESS AROUND HIS NECK THAT HE SAYS MADE IT DIFFICULT TO BREATHE. BY THE MORNING SYMPTOMS HAD NOT IMPROVED SO HE WENT TO THE EMERGENCY ROOM WHERE HE WAS ADMITTED. PER PATIENT, CARDIAC TESTS INCLUDING AN ECHO WERE "FINE" AND THE PAIN RESOLVED AFTER SEVERAL DOSES OF TORADOL AND ANOTHER PAIN MEDICATION.
Age: 40.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Decreased appetite
Clinical narrative: Abdominal pain.  Across my entire abdomen.   I took each pill later in the day.  The next morning I woke up in pain that lasted all day.  It felt like my internal organs were being slowly enzymatically digested.  There was also a little cramping. The pain would oscillate in terms of severity every few hours. It would finally subside right before it was time for me to take the next pill.  I completely lost my appetite for that week, but forced myself to eat semi-regular meals.  It affected my work; students kept asking if I was OK.    In terms of taking the vaccine as directed, the timing was appropriate, including taking on an empty stomach.  But I did not drink as much water as directed when taking each pill.  I would say I drank just half a cup of water with each pill.  Lastly, a week later I went back to the travel clinic for a different vaccine, and informed the doctor of the side effects.  She assured me this is not uncommon, and nothing to be concerned about since the symptoms have subsided.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Deafness, Feeling hot, Nausea, Thirst
Clinical narrative: STATES SHE FELT HOT AND THIRSTY STATES LOST HER HEARING FELT NAUSEATED
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Patient experienced a fainting spell the next day after receiving vaccination
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: patient reports rash on arm at injection site
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Severe shivering for about an hour. House temperature was 74 degrees.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Rash erythematous, Skin warm, Swelling
Clinical narrative: patient experienced a severe rash starting day after getting vaccine. It continued to spread and get worse in the days following, spreading all the way down into her under arm and elbow. The Rash was painful, swollen, red, and warm to the touch. It last for 8 days after her shot. patient also complained of experiences body aches during the same time
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blister, Fatigue, Rash
Clinical narrative: Pain in joints (dispersed throughout body), blister, rash, fatigue, pain so intense he could not leave bed for 1 day
Age: 61.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pain in extremity
Clinical narrative: PATIENT REPORTED THAT SHE IS STILL HAVING OCCASIONAL SORE ARM. IT GOES ON AND OFF. SHE WAS EXERCISING THE OTHER DAY AND IT WAS SORE. PATIENT ORIGINALLY WENT TO THE DOCTOR TO REPORT THE SYMPTOMS AND DOCTOR TOLD HER TO ICE IT FOR 2 WEEKS. TOLD PATIENT TO FOLLOW UP WITH HER DOCTOR
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, fever, severe headache
Age: 28.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Musculoskeletal disorder, Nodule, Pain, Swelling
Clinical narrative: Patient reported  golf ball sized area on arm with redness and swelling and pain so severe she could barely use her arm. The pain and redness took 3 weeks to go away.  6/19/19 She is better now but there is a knot still there in her arm.
Age: 8.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Seizure
Clinical narrative: Child had one witnessed seizure today 6/19/19, possibly 2 unwitnessed seizure. MMR was given 13 days ago.
Age: 8.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Loss of consciousness, Pain, Postictal state, Seizure
Clinical narrative: Child had one witnessed seizure today 6/19/19, possibly 2 unwitnessed seizure. MMR was given 13 days ago.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: fever, muscle pain, fatigue, headache, shivering, nausea
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever, muscle pain, fatigue, headache, shivering, nausea
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Patient states that day after vaccine he experienced dizziness, nausea, and headache lasting several days. Patient called pharmacy on day 6 post-vaccine and said dizzines has not yet subsided but other symptoms have.
Age: 51.0
Sex: F
Vaccine: TYP, VARZOS
Symptoms: Fatigue, Lethargy, Pain, Pain in extremity
Clinical narrative: I began to feel tired, body aches, moderate  to severe pain in arm and very lethargic about two hours after receiving the vaccines.  Based on the information sheet from the CDC, I am confident this is probably from the Shingrix, vaccine rather than the Typhoid vaccine. Since I had them both at the same time in the same arm, it is hard to absolutely confirm which vaccine caused these symptoms.