chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient with day 2 post vaccination with moderate/severe localized erythema, swelling, warmth, induration and pain to (R) deltoid. Progressive spread of erythema per marked line in past 24 hrs. Covered for potential cellulitis secondary to recent vaccines.
Age: 1.83
Sex: M
Vaccine: PNC13
Symptoms: Abnormal behaviour, Balance disorder, Gait disturbance, Injection site swelling, Injection site vesicles
Clinical narrative: Rash around mouth, chest and back (3/25/19). Fever in evening and at night that got as high as 102.3 degrees (3/25/19). Swelling and blistering at injection site over 3" in length (3/25/19-current). Mild fever (3/26/19). Instability walking - child would lose balance or crash into objects - abnormal behavior for child (3/25/19-3/26/19).
Age: 1.83
Sex: M
Vaccine: PNC13
Symptoms: Oral mucosal eruption, Pyrexia, Rash
Clinical narrative: Rash around mouth, chest and back (3/25/19). Fever in evening and at night that got as high as 102.3 degrees (3/25/19). Swelling and blistering at injection site over 3" in length (3/25/19-current). Mild fever (3/26/19). Instability walking - child would lose balance or crash into objects - abnormal behavior for child (3/25/19-3/26/19).
Age: 60.0
Sex: F
Vaccine: JEV1, MNQ, PPV, TDAP, VARZOS
Symptoms: Body temperature decreased, Chills, Erythema, Fatigue, Pain in extremity
Clinical narrative: I had horrible symptoms for about 5 days. Unsure which vaccine did it to me. Soreness in both arms, but very severe in Right arm (received a total of 5 vaccines). Unable to lift my arm more than 1 or 2 inches. On day 4, my arm had swelling, significant redness and hot to the touch. The area was about 5 cm x 3 cm. Did not go down with TYLENOL or BENADRYL. Other symptoms were extreme fatigue (slept 15 hours one night) and extreme chills. I went to my doctor about another problem while this was going on and my temperature was only 96.2 degrees.
Age: 60.0
Sex: F
Vaccine: JEV1, MNQ, PPV, TDAP, VARZOS
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: I had horrible symptoms for about 5 days. Unsure which vaccine did it to me. Soreness in both arms, but very severe in Right arm (received a total of 5 vaccines). Unable to lift my arm more than 1 or 2 inches. On day 4, my arm had swelling, significant redness and hot to the touch. The area was about 5 cm x 3 cm. Did not go down with TYLENOL or BENADRYL. Other symptoms were extreme fatigue (slept 15 hours one night) and extreme chills. I went to my doctor about another problem while this was going on and my temperature was only 96.2 degrees.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Gait disturbance, Hypoaesthesia, Myalgia
Clinical narrative: 3/20/19 within first few hours of administration patient experienced numbness and tingling in breast which lasted about 10 seconds. On the following day, 3/21/19, patient experienced fatigue. On 3/22/19, patient had severe muscle and joint pain/soreness and pain in hips which caused trouble walking. This lasted the entire day. On 3/23/19 patient had nausea.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Paraesthesia
Clinical narrative: 3/20/19 within first few hours of administration patient experienced numbness and tingling in breast which lasted about 10 seconds. On the following day, 3/21/19, patient experienced fatigue. On 3/22/19, patient had severe muscle and joint pain/soreness and pain in hips which caused trouble walking. This lasted the entire day. On 3/23/19 patient had nausea.
Age: 1.67
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Abnormal behaviour, Balance disorder, Gait disturbance, Injection site swelling, Pyrexia
Clinical narrative: Rash on chest and lower back (1/28/19). Fever in evening and at night that got as high as 102 degrees (1/28/19). Swelling at injection site (1/28/19). Mild fever (1/29/19). Instability walking - child would lose balance or crash into objects - abnormal behavior for child (1/28/19-1/29/19). Note: Child received PCV13 starting at age 18 months (Dose 1 on 11/16/2018), (Dose 2 on 12/19/2018), (Dose 3 on 1/28/2019) -- another dose was given on (Dose 4) 3/25/2019 with adverse reactions. A separate event was filed on this site prior to this one. Note: Child received DTaP starting at age 15 months (Dose 1 on 8/16/2018), (Dose 2 on 11/20/2018 [PENTACEL]), (Dose 3 on 12/19/2018 [PENTACEL]).
Age: 1.67
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Rash
Clinical narrative: Rash on chest and lower back (1/28/19). Fever in evening and at night that got as high as 102 degrees (1/28/19). Swelling at injection site (1/28/19). Mild fever (1/29/19). Instability walking - child would lose balance or crash into objects - abnormal behavior for child (1/28/19-1/29/19). Note: Child received PCV13 starting at age 18 months (Dose 1 on 11/16/2018), (Dose 2 on 12/19/2018), (Dose 3 on 1/28/2019) -- another dose was given on (Dose 4) 3/25/2019 with adverse reactions. A separate event was filed on this site prior to this one. Note: Child received DTaP starting at age 15 months (Dose 1 on 8/16/2018), (Dose 2 on 11/20/2018 [PENTACEL]), (Dose 3 on 12/19/2018 [PENTACEL]).
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Electromyogram abnormal, Injected limb mobility decreased, Injection site pain, Nerve conduction studies abnormal
Clinical narrative: Developed vague right shoulder pain and subsequent weakness. Seen in clinic approx 11 days later with persistent pain symptoms and developing weakness. Concern for Parsonage Turner syndrome (neuralgic amyotrophy), which was confirmed on 10 Jan 2019 with EMG/nerve conduction studies performed by Neurology clinic. On follow-up in clinic 4 Feb 2019, pain in shoulder was improved, weakness persisted, but pain had shifted to distribution consistent with musculocutaneous nerve. Given continued pain and confirmed diagnosis of neuralgic amyotrophy, decision made to treat with 2 week prednisone course. On follow-up by phone on 26 Mar 2019, pt reported that pain and mobility of her right arm were improving, as well as weakness but some weakness still persisted.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Neuralgia, Neuralgic amyotrophy
Clinical narrative: Developed vague right shoulder pain and subsequent weakness. Seen in clinic approx 11 days later with persistent pain symptoms and developing weakness. Concern for Parsonage Turner syndrome (neuralgic amyotrophy), which was confirmed on 10 Jan 2019 with EMG/nerve conduction studies performed by Neurology clinic. On follow-up in clinic 4 Feb 2019, pain in shoulder was improved, weakness persisted, but pain had shifted to distribution consistent with musculocutaneous nerve. Given continued pain and confirmed diagnosis of neuralgic amyotrophy, decision made to treat with 2 week prednisone course. On follow-up by phone on 26 Mar 2019, pt reported that pain and mobility of her right arm were improving, as well as weakness but some weakness still persisted.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness present at the site of injection.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HEP
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 6-month-old male patient. This patient was very behind on immunizations. No information regarding the patient's drug reactions or allergies and concomitant therapies was provided. Historical vaccine included unspecified hepatitis B vaccine on 08-SEP-2018. On 19-MAR-2019, the patient accidentally received both RECOMBIVAX HB lot # R021370, expiry date: 07-NOV-2020, 0.5 milliliter for prophylaxis (route of administration and injection site were not reported) and PEDIARIX for prophylaxis (dose, frequency, route of administration, injection site, lot # and expiration date were not reported). No adverse event was reported. The outcome of incorrect dose administered and inappropriate schedule of product administration was unknown. Sender's Comments: US-009507513-1903USA010025: US-009507513-1903USA010012.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Product preparation issue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received SHINGRIX (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis. On 19th March 2019, the patient received SHINGRIX. On 19th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX vaccine in the right deltoid. Nurse practitioner reported that the patient received SHINGRIX diluent which was reconstituted with another SHINGRIX diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient presented with soreness at the injection site afterwards.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 16th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th March 2019, 1 days after receiving SHINGRIX, the patient experienced fever, chills, pain, injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the fever, chills, pain, injection site pain and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the fever, chills, pain, injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The day after receiving SHINGRIX the patient experienced low grade fever, aches, chills and left arm soreness. The patient could barely lift his arm because of the soreness. The reporter did not consent to follow-up.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus
Clinical narrative: Mom reports redness initially noted to right arm yesterday. Father drew a circle around area last night; area measured 5x3 cm last night. Denies pain. Reports area is slightly itchy, but mom has not seen child scratching. Afebrile. Denies other sick symptoms. Acting normal per mom. Patient given cephalexin suspension 250 mg/5ml, 6.5 ml, orally, every 12 hours, 10 days, for cellulitis.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt was given DTaP and should have had Tdap - no adverse events, vaccine admin error only.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEP, HEPA, MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient reported to office on 02/19/2019. Patient had only ever received Hep #1 shortly after birth, no other vaccines have ever been administered. QUADRACEL (DTaP-IPV) administered as first dose to unvaccinated patient at this visit. No adverse events reported from parent. Per CDC, it will count in series but DTaP, and IPV should have been administered separately as this was the patient's first dose of DTaP and IPV. Advised to complete VAERS.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Pyrexia
Clinical narrative: Fever, chills, headache, stomach discomfort. Not sure how long it will last.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Pt developed fever of 101 the day after the vaccination. Fever went up to 102 but controlled well with TYLENOL. No other symptoms.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Influenza like illness
Clinical narrative: Aches all over and in joints. Flu like symptoms. Mild Headache. Fever of 100.5 - low level. Lack of energy - tiredness. Took 2 - 4 Ibuprofen every 4 to 6 hours and slept 10 hours. Symptoms peaked at 24 hours and were pretty much clear after 40 hours after injection.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Aches all over and in joints. Flu like symptoms. Mild Headache. Fever of 100.5 - low level. Lack of energy - tiredness. Took 2 - 4 Ibuprofen every 4 to 6 hours and slept 10 hours. Symptoms peaked at 24 hours and were pretty much clear after 40 hours after injection.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema
Clinical narrative: Pt reported developed redness in arm. Went to ER and was given antibiotic to treat cellulitis.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Irritability
Clinical narrative: Redness to left thigh and fussiness hours after vaccine.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Myalgia, Pyrexia
Clinical narrative: On March 26th 2019  patient  cancelled second dose of SHINGRIX, stating he had a bad reaction to the  first one. Reports he had high fever, achy muscles & was unable to sleep for 2days following 2/2019 SHINGRIX administration. There are no previous reports on his medical record regarding reaction to the vaccine and he did not mention any lingering adverse reaction.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: An expired Hep A vaccine was given on 03/26/19 to a patient in our clinic. The vaccine expired 03/25/19.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Blood test, Computerised tomogram, Confusional state, Gait disturbance
Clinical narrative: Severe weakness, trouble walking, confusion, tingling.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Severe weakness, trouble walking, confusion, tingling.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Expired product administered
Clinical narrative: This spontaneous report refers to a 4 month old female patient. The patient's pre-existing physician-diagnosed allergies, birth defects, medical conditions included eczematous rash. Illness at time of vaccination were reported as none. Historical vaccines included ENGERIX-B. Concomitant medications included PEDVAXHIB, PREVNAR, IPOL and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 11-MAR-2019, the patient was vaccinated with an expired second dose of ROTATEQ orally (lot # R000911, expiration date: 28-FEB-2019) for prophylaxis. The reporter stated that she went to the vaccine refrigerator, grabbed all the vaccines that the patient was due and prepared them to be administered. Then she went to the patient (pt) room and administered the ROTATEQ vaccine first and then the other 4 vaccines. She had the patient wait for 5 min to make sure there were no reactions to the vaccines. She left the room, then went back and evaluated the patient's vaccine sites. There were no reactions. Then, she let the patient and her parents leave. Subsequently, she entered the vaccine's information in to the computer and it said the ROTATEQ was expired. The administered dose of the vaccine did not have any temperature excursion prior to the administration. Also, it was reported the patient received an unspecified prescription drug treatment for the experience.
Age: 1.17
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 month old patient, of unknown gender. Patient's current conditions, medical history, concomitant medications, drugs allergies or reactions were not reported. On 22-MAR-2019, the patient was vaccinated with improperly stored dose of the following vaccine: VARIVAX lot # R018780 and expiration date 01-JUL-202 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis. Non improperly stored sterile diluent used was reported. The vaccines were exposed to a temperature of 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.9 Fahrenheit degrees) for 66 minutes. There was a previous temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.0 Fahrenheit degrees) for 35 minutes. It was reported that digital data logger was involved. No adverse effects were reported. This case is one of six same reporter cases. Sender's Comments: US-009507513-1903USA011480: US-009507513-1903USA011573: US-009507513-1903USA011572: US-009507513-1903USA011571: US-009507513-1903USA011574.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a  12 month old patient, of unknown gender . Patient's current conditions, medical history, concomitant medications, drugs allergies or reactions were not reported. On 20-MAR-2019 , the patient was vaccinated with improperly stored dose of the following vaccine: VARIVAX lot # R018780  and expiration date 01-JUL-2020 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis. Non improperly stored sterile diluent used was reported. The vaccine was exposed to a temperature of 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.9 Fahrenheit degrees) for 66 minutes. There was a previous temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.0 Fahrenheit degrees) for 35 minutes. It was reported that digital data logger was involved. No adverse effects were reported. This case is one of six same reporter cases.; Sender's Comments: US-009507513-1903USA011480: US-009507513-1903USA011572: US-009507513-1903USA011573: US-009507513-1903USA011574: US-009507513-1903USA011570:
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old patient, of unknown gender. Patient's current conditions, medical history, concomitant medications, drugs allergies or reactions were not reported. On 22-MAR-2019, the patient was vaccinated with improperly stored dose of the following vaccine: VARIVAX lot # R018780 and expiration date 01-JUL-2020, (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis. Non improperly stored sterile diluent used was reported. The vaccines was exposed to a temperature of 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.9 Fahrenheit degrees) for 66 minutes. There was a previous temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.0 Fahrenheit degrees) for 35 minutes. It was reported that digital data logger was involved. No adverse effects were reported. This case is one of six same reporter cases. Sender's Comments: US-009507513-1903USA011480: US-009507513-1903USA011573: US-009507513-1903USA011572: US-009507513-1903USA011571: US-009507513-1903USA011570.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: 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, concurrent conditions, concomitant medications or drug reactions/allergies. On 26-MAR-2019, the patient was vaccinated with an expired dose of VAQTA, intramuscular, lot # R010368, expiration date 25-MAR-2019 for prophylaxis (dose was not reported) (expired product administered). The outcome of the event expired product administered was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 25-MAR-2019 the patient was vaccinated with VARIVAX lot # R023501 for prophylaxis.       On 25-MAR-2019, 1 day after onset of therapy the patient experienced product storage error. On an unknown date the patient experienced no adverse event.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional by phone. This case is linked to case 2019SA077259 (same reporter). This case involves a 24 months old female patient who was vaccinated with a 0.5 ml dose of ACT-HIB with diluent (lot number: U6001AA and expiry date: 21-Feb-2019, dose in series and route of administration were not reported) in the right deltoid on 14-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PROQUAD; PREVNAR 13; PEDIARIX and HAVRIX on an unknown date. It was a case of actual medication error due to expired vaccine used as ACTHIB after 2 doses were given on 14-Mar-2019 to 2 related patients with the Diluent exp date of 21 Feb 2019 and the Lyophilized powder exp date of 14 Nov 2019. No side effects reported. 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. Documents held by the sender: none.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional by phone. This case is linked to case 2019SA077240 (same reporter). This case involves a 12 months old male patient who was vaccinated with a 0.5 ml dose of ACT-HIB with diluent (lot number: U6001AA and expiry date: 21-Feb-2019, dose in series and route of administration were not reported) in the right deltoid on 14-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine live PROQUAD; PREVENAR 13; PEDIARIX and HAVRIX on an unknown date. It was a case of actual medication error due to expired vaccine used. No side effects reported. 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. Documents held by the sender: none.
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a nine-years-old female patient who was vaccinated with a 0.5 ml dose of DAPTACEL instead of ADACEL lot C5254AA expiry date 18-Sep-2019 via unknown route in the left deltoid, on 01-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included IPOL POLIO VACCINE for Immunisation; and PROQUAD for Immunisation. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was reported that the patient got DAPTACEL DTaP instead of ADACEL Tdap on 01MAR2019. She states that they had checked the State database and the child was flagged for a DTAP because she did not get the full 5 in the series and that it was also their fault because they did not check the age viability before giving the DAPTACEL. Plan is to offer booster Td in 10 years. It was unknown whether patient experienced any adverse reaction. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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 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: 23.0
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Product dose omission
Clinical narrative: Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 23 years old female patient who received her 1ml first dose of IMOVAX RABIES (Batch number, expiration date, dose, route and site of administration was not reported) and a dose of IMOGAM RABIES-HT on 14-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Missed dose of vaccine and extra dose administered of Immunoglobulin. A patient received her first IMOVAX injection and missed her day 3 dose of the IMOVAX. The patient received IMOGRAM on day 0 and also on day 3. It was unknown whether patient experienced any adverse event following vaccination. 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: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 20-Mar-2019 regarding an unsolicited valid non-serious case received from other health care professional (Medical assistant). This case involves a 17 years old female patient who received vaccine MENACTRA. The patients past medical history and family history were not provided. Concomitant medications included BEXSERO on unknown date. On 19-Mar-2019, the patient received a 0.5 ml Booster dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5848AA, expiry date 11-Mar-2019 via unknown route in the right deltoid. It was an actual medication error due to expired vaccine used. It was reported that 17 years old was given Expired MENACTRA (expiry date 11-Mar-2019) vaccination on 19-Mar-2019. The patient did not experience 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.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 20-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (with unknown demographics) who was vaccinated with a dose of ACT-HIB lot UI904AAA (Expiry date 19-SEP-2019 ) via unknown route in unknown administration site, on 18-Mar-2019. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication case error due inappropriate reconstitution technique. It was reported that nursing staff mixed sterile water instead of diluent for ACTHIB vaccine and injected. It was not reported that if any adverse reaction was experienced. 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.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PPV, RVX
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: Initial information received on 20-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse by phone. This case involves a 2 months old female patient who was vaccinated with 0.5 ml dose of PENTACEL (Batch number: reported as for ACTHIB C5594AA and for DTaP-IPV: C5444AA, expiry date: 27-Oct-2019) via intramuscular route in the right thigh on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197); HEPATITIS B VACCINE and ROTAVIRUS VACCINE on an unknown date. It was a case of actual medication error due to inappropriate reconstitution technique. It was unknown if any adverse event occurred or not following the vaccination. 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. Documents held by the sender: none.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 20-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 months old male patient received 0.5 ml fourth dose of QUADRACEL lot C5497AA, expiry date- 17-Jul-2020 via unknown route in the right thigh on 19-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. There were no symptoms. 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. Documents held by the sender: none.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site swelling
Clinical narrative: Initial information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a physician by phone. This case is linked to cases 2019SA082205, 2019SA082209, 2019SA082210 and 2019SA082211 (same reporter). This case involves a 2 months old female patient who experienced upper leg was very swollen site reaction, while she received vaccines ROTATEQ, PREVENAR 13 and PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. On 15-Mar-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ095AA. On an unknown date, the patient received a 0.5 ml dose of suspect PREVENAR 13 not produced by Sanofi Pasteur lot X49142. On an unknown date, the patient received a 0.5 ml dose of suspect ROTATEQ not produced by Sanofi Pasteur lot R034700. On an unknown date, the patient developed a non-serious upper leg was very swollen site reaction(vaccination site swelling) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, PREVENAR 13 and ROTATEQ. No Lab data was reported. Final diagnosis was upper leg was very swollen site reaction. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for upper leg was very swollen site reaction. Documents held by the sender: none.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary pain, Injection site pain
Clinical narrative: Sore injection site and under arm.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Bed rest, Chills, Decreased appetite, Injection site erythema, Injection site induration
Clinical narrative: The next morning I had fever, chills, aches and no appetite - pain and a hard, red lump in upper left arm which continued for 5-6 days. No treatment - just bedrest . Reported to the pharmacist the following Thursday, March 21.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Pain, Pyrexia
Clinical narrative: The next morning I had fever, chills, aches and no appetite - pain and a hard, red lump in upper left arm which continued for 5-6 days. No treatment - just bedrest . Reported to the pharmacist the following Thursday, March 21.
Age: 13.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Injection site pain, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 13 year old patient was inadvertently given MMRV instead of MMR and Varicella separately. MMRV is indicated for children 1-12 years of age. I spoke with Immunization Registry, and they reported there is no need for further immunization or treatment needed. I also spoke with mom and explained situation to her-mom reports mild erythema in very small area around injection site and some slight tenderness, but no other symptoms.
Age: 15.0
Sex: F
Vaccine: HEP, IPV
Symptoms: Abdominal pain, C-reactive protein, Diarrhoea, Full blood count, Lipase
Clinical narrative: Patient presented to ED at about 1340 with severe abdominal pain and loose stools, mom said she also had fever, no fever while at ED.
Age: 15.0
Sex: F
Vaccine: HEP, IPV
Symptoms: Metabolic function test, Pyrexia, Urine analysis
Clinical narrative: Patient presented to ED at about 1340 with severe abdominal pain and loose stools, mom said she also had fever, no fever while at ED.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Atrial tachycardia, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: Ectopic Atrial Tachycardia.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Oral herpes
Clinical narrative: FIRST SHOT created flu like symptoms but most noted here are the three episodes of cold sores over my lips and nose over the next month. Reason to fill out this VAERS report is to tell you that when I took my second shot (3/8/19), I took my ACYCLOVIR TABS at the same time and only developed flu like symptoms. People with a chronic problem of cold sores would really benefit from antiviral medications when getting the vaccine.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Pain, Pyrexia
Clinical narrative: SHINGRIX, booster shot: high fever, body pains, headaches, dizziness, now over 24 hours.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Injection site pain, Pyrexia
Clinical narrative: Patient c/o fever, pain to the site redness and diarrhea x 2 days.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Chapped lips, Erythema, Lip erythema, Peripheral swelling, Pruritus
Clinical narrative: Red, swelling, itching in left arm for approx. 6 days, low grade fever for approx. 3 days, red rough skin on top lip next morning that lingered for more than 1 month.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Pyrexia
Clinical narrative: Red, swelling, itching in left arm for approx. 6 days, low grade fever for approx. 3 days, red rough skin on top lip next morning that lingered for more than 1 month.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Back pain, Chills, Headache, Pyrexia
Clinical narrative: Fever, chills, upset stomach, headache, back ache - all symptoms resolved within 24 hours.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Patient got redness and swelling that did not go away for a few months.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Nausea
Clinical narrative: Dizziness, lightheadedness, nausea, headaches, & chills.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: The area where the vaccine was administered is swollen, hot and hard to the touch.
Age: 62.0
Sex: F
Vaccine: MMR
Symptoms: Joint swelling, Lymphadenopathy, Musculoskeletal discomfort, Ocular hyperaemia, Pyrexia
Clinical narrative: Swollen neck lymph nodes, face and neck swelling, bloodshot eyes, low grade fever, joint swelling, throat closing mostly recovered from the most severe symptoms, but still some discomfort in neck. At date of reporting March 22 most symptoms were resolved.
Age: 62.0
Sex: F
Vaccine: MMR
Symptoms: Swelling, Swelling face, Throat tightness
Clinical narrative: Swollen neck lymph nodes, face and neck swelling, bloodshot eyes, low grade fever, joint swelling, throat closing mostly recovered from the most severe symptoms, but still some discomfort in neck. At date of reporting March 22 most symptoms were resolved.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Injection site warmth, Loss of consciousness
Clinical narrative: Dizziness that progressed to a syncopal event; unsure of length of time unconscious; also has heat with swelling at injection site with a 4 inch long red area moving toward elbow.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Dizziness that progressed to a syncopal event; unsure of length of time unconscious; also has heat with swelling at injection site with a 4 inch long red area moving toward elbow.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Dizziness, Migraine, Pain
Clinical narrative: Stomach cramps started early morning March 23. By day break, had sharp pains from head to toe. Also, chills, dizzy, light headed and migraine. All symptoms were gone by Wednesday, March 27.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Insomnia, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: Patient had sore/painful arm immediately after injection, pain became worse and was radiating down arm. Pain persists to this day (3/27/19) and has only mildly subsided. Patient reports he cannot sleep on side of injection and pain limits his activity (putting away groceries after shopping) - so I will indicate there is currently some disability.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash generalised, Roseola
Clinical narrative: Severe rash covering the entire body and fever lasting approximately 72 hours.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Middle insomnia, Myalgia
Clinical narrative: Approximately 10 hours after receiving dose, woke up in middle of sleep with shivering and muscle aches. Did not yet have a fever. By 10 am on 26th started getting a fever and muscle aches got worse. Temp was 101.1. Few hours later temp was 102.5 and by 9 pm that evening, temp hit 103.2 F. Ibuprofen had been take in the am and throughout the day but temp gradually increased.  Severe headache and muscle aches continued as well. On Wednesday (27th) felt better by noon - where headache not as severe and temperature was less than 100 F and muscle aches gradually subsided except for the injection site as that was and still is sore. I had these reactions with the first dose but not nearly as severe as they were with this second dose. With the first dose in September had the shivering and muscle aches with low grade temp but never more than 100 F.  With the 2nd dose these symptoms were extreme compared to the first dose but the recommendation was that one should still get the 2nd dose if you had any of the named reactions listed above.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Approximately 10 hours after receiving dose, woke up in middle of sleep with shivering and muscle aches. Did not yet have a fever. By 10 am on 26th started getting a fever and muscle aches got worse. Temp was 101.1. Few hours later temp was 102.5 and by 9 pm that evening, temp hit 103.2 F. Ibuprofen had been take in the am and throughout the day but temp gradually increased.  Severe headache and muscle aches continued as well. On Wednesday (27th) felt better by noon - where headache not as severe and temperature was less than 100 F and muscle aches gradually subsided except for the injection site as that was and still is sore. I had these reactions with the first dose but not nearly as severe as they were with this second dose. With the first dose in September had the shivering and muscle aches with low grade temp but never more than 100 F.  With the 2nd dose these symptoms were extreme compared to the first dose but the recommendation was that one should still get the 2nd dose if you had any of the named reactions listed above.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Local reaction
Clinical narrative: Patient had small local reaction. Develop shingles right back 5 days after vaccine.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: The patient's arm swelled up a few hours later. It wasn't discolored, but she stated it was painful. She took some acetaminophen and diphenhydramine and it had improved when we spoke this morning (3/27/2019).
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Injection site urticaria, Pain in extremity, Wheezing
Clinical narrative: Wheezing, shortness of breath. Hives at and around injection site. Extreme soreness in arm.
Age: 18.0
Sex: F
Vaccine: TYP
Symptoms: Loss of consciousness, Malaise, Seizure
Clinical narrative: PATIENT LEFT PHARMACY AND WAS FEELING FINE AT ABOUT 3:50 PM. AT ABOUT 4:45 PM HER MOTHER CALLED AND SAID PATIENT REPORTED "NOT FEELING WELL", BUT DID NOT ELABORATE AND BEFORE I COULD QUESTION ABOUT SYMPTOM, MOTHER HUNG UP. OVER NEXT COUPLE OF HOURS I RECEIVED SEVERAL MORE CALLS FROM PATIENT'S MOTHER AND FATHER, STATING THAT SHE PASSED OUT AND HAD SEIZURES, AND DID NOT REGAIN CONSCIOUSNESS. THE EMT'S HAD BEEN CALLED AND HAD ARRIVED AND WERE TREATING HER. THEN SHE HAD BEEN TAKEN TO HOSPITAL WHERE SHE REMAINED UNCONSCIOUS. THAT IS THE LAST I HAVE HEARD TO THIS POINT.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Rash macular, Swollen tongue
Clinical narrative: Rash, macular, over trunk and upper and lower extremities. Tongue slightly swollen. Taking BENADRYL. Tongue improved after taking BENADRYL.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise
Clinical narrative: General c/o just not feeling well x 4-5 months since received flu shot in October. Pt called the on call doctor 3/26/19 to make the report. Not that we have seen pt 2x since shot without any c/o.
Sex: M
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: PPV
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a 67 years old patient of unknown gender. The patient's concomitant medications and drug allergies were not reported. The patient concurrent conditions included arthritis. On 12-JUL-2018, the patient was vaccinated with PNEUMOVAX 23 injection for prevention pneumonia (strength, dose, route, anatomical side of administration, lot # and expiry date were not reported). On unknown date following the administration of PNEUMOVAX 23, the patient developed severe Guillain-Barre syndrome. As a result, the patient needed to go to rehabilitation for physical therapy multiple times. It was uncertain if the rehabilitation involved admission to an inpatient facility. It was reported that due to the severity of the patient's reaction this was considered a significant disability. At the time of this report the patient was 90 percent recovered from the adverse event. The causality assessment between PNEUMOVAX 23 and Guillain-Barre syndrome was not reported. Upon internal review, the event Guillain-Barre syndrome was considered to be medically significant.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Borrelia test, Headache, Injection site reaction, Injection site warmth, Lymphadenopathy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received SHINGRIX (batch number X5XY4, expiry date 2nd July 2021) for prophylaxis. On 11th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, fever, chills, tremor, swollen glands and headache. On 12th March 2019, the patient experienced red rash, painful rash, raised rash and heat rash. On an unknown date, the outcome of the injection site pain, fever, chills, tremor, swollen glands and headache were recovered/resolved and the outcome of the red rash, painful rash, raised rash and heat rash were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, fever, chills, tremor, swollen glands, headache, red rash, painful rash, raised rash and heat rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. Post vaccination that evening she experienced soreness at injection site, high fever, chills, uncontrollable shaking, left side headache, and her left side body glands were swollen from waist up. The next day after vaccination she broke out in a circular rash 3 inches across the injection site on the left arm accompanied with red, pain, hot, and raised area. The rash had lessened but it was still present. The soreness at injection site, high fever, chills, uncontrollable shaking, left side headache, and her left side body glands were swollen from waist up was lasted for about 2 days. On 13th March 2019, the patient visited her physician, but she had to see the physician assistant since her physician was not there. The patient was tested for Lyme disease and Rocky Mountain spotted fever. The results came back on the date of reporting and she was negative for the Lyme disease and Rocky Mountain spotted fever. The reporter consented to follow up. No further details were provided.