chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Mobility decreased
Clinical narrative: Severe weakness. Could barely walk and stand up for an entire day. That night when getting up to use the bathroom, I fell on the floor and could not get up. My husband helped me get back to bed. Next day I was better, but not normal, and had a severely swollen upper lip.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Rash, Swelling, Urticaria
Clinical narrative: patient described her reaction as welts on left are near injection sight, rash, and swelling. patient treated with Benadryl for the itching.
Age: 0.83
Sex: M
Vaccine: FLU4, HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Shot given by mistake, no side effects or harm with giving the vaccine, parents notified and okay with event
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Heart rate increased, Hot flush
Clinical narrative: Approximately 30 minutes after injection, heart rate increased, warm flush was felt in the forehead.  Event lasted about 1 minute
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site discomfort, Injection site pain, Injection site pustule
Clinical narrative: c/o discomfort to site for 3 weeks, tender to touch,  small pustule at site the last few days, she was able to express a tiny amout of pus yesterday but none today.  Area is not red or hard
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Pt came into the pharmacy today, 11/22/19, stating that her arm is still sore and painful from the shingrix shot she got in October 2019. Pt stated that in addition to soreness around the area, she also experiences soreness and pain escalating up to her neck and shoulder as well. Pt indicated that she took naproxen, but with little relief. Pt was instructed by pharmacist to consult with her provider for additional treatment plan.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Feeling hot, Induration, Mass, Mobility decreased
Clinical narrative: Patient reports localized redness, warmth, swelling and a large hard lump. States her arm was so sore she couldn't lift it above her head. Reports it lasted for 3 days.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Skin warm, Swelling
Clinical narrative: Patient reports localized redness, warmth, swelling and a large hard lump. States her arm was so sore she couldn't lift it above her head. Reports it lasted for 3 days.
Age: 0.5
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: Double dose of Hib given, no allergic reactions to it , informed patient mother and father
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Father noticed rash on lower lumbar spine on 11/21 on 11/22 rash has progressed up the spinal column in a line. Father states rash looks like hives and is painful to touch. No other symptoms noted. Child is going to see Primary Care Provider this afternoon for further evaluation.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; the patient was inadvertently administered Gardasil 9, that was improperly stored; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-OCT-2019, the patient was inadvertently vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # S005524 (reported as 5000024) and expiration date 29-SEP-2021 (exact dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. The temperature was 30.07F for 35 minutes. Previous temperature excursion was 77F for 30 minutes. Digital data logger was involved.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; one patient was administered improperly stored Varivax; This spontaneous report was received from an administrator and refers to a 15-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S004091 and expiration date 11-FEB-2019 (exact dose and route of administration were not reported) for prophylaxis. Concomitant therapies included properly stored sterile diluent. No adverse effects were reported. The temperature was from 6°F to 14°F (14F) for 420 hours and from 15°F to 46°F (34F) for 106 hours. Previous temperature excursion was from 6°F to 14°F (14F) for 200 hours and from 15°F to 46°F (34.268) for 18 hours. Digital data logger was involved.; Sender's Comments:  US-009507513-1911USA000877:
Sex: F
Vaccine: VARZOS
Symptoms: Cerebral artery occlusion, Cerebral infarction, Facial paralysis, Hypoaesthesia, Infarction
Clinical narrative: Occlusion of the left P2 segment of the left posterior cerebral artery; Acute left territory infarction; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 12-OCT-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On 12-NOV-2017, reported as one month after receiveing zoster vaccine live (ZOSTAVAX), the patient suffered right sided numbness in her arm, facial droop and paresthesias. The patient was hospitalized and diagnosed with acute left territory infarction and occlusion of the left P2 segment of the left posterior cerebral artery. The patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   Upon internal review, infarction and cerebral artery occlusion were considered medically significant.    Infarction and cerebral artery occlusion were considered to be disabling due to the severe, permanent and incurable injuries.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Occlusion of the left P2 segment of the left posterior cerebral artery; Acute left territory infarction; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 12-OCT-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On 12-NOV-2017, reported as one month after receiveing zoster vaccine live (ZOSTAVAX), the patient suffered right sided numbness in her arm, facial droop and paresthesias. The patient was hospitalized and diagnosed with acute left territory infarction and occlusion of the left P2 segment of the left posterior cerebral artery. The patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   Upon internal review, infarction and cerebral artery occlusion were considered medically significant.    Infarction and cerebral artery occlusion were considered to be disabling due to the severe, permanent and incurable injuries.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was administered an improperly stored dose; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about patient's concurrent condition, medical history, drug allergy/reaction, concomitant medication was not reported. On 20-NOV-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S019581 with expiration date of 25-JUN-2021 (dose, frequency, route and anatomical location were not reported) for prophylaxis (product storage error). No adverse effects were reported. It was reported that the vaccine was exposed to a temperature of minus 0.2 degree celsius for a time frame of 2 hours and 40 minutes. There was previous temperature excursion of 42.5 degree celsius for 2 hours and 40 minutes. Data logger was involved. No product quality complaint (PQC) was associated with this report.
Sex: U
Vaccine: VARZOS
Symptoms: Blood glucose increased
Clinical narrative: Increase blood sugar; This case was reported by a consumer via call center representative and described the occurrence of blood sugar increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2019, the patient received Shingrix. On 12th November 2019, 1 days after receiving Shingrix, the patient experienced blood sugar increased. On an unknown date, the outcome of the blood sugar increased was unknown.   It was unknown if the reporter considered the blood sugar increased to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication. The patient took the vaccine last night from day of reporting and on day of reporting patient sugar in the morning showed to be 295. Normally the patient morning sugar around 150. The patient enquired whether Shingrix vaccine shot cause to increase blood sugar level. The permission to follow up was denied.      Lab Comments: On an unknown date, the patient did lab test.
Sex: U
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Inflammation, Injection site erythema, Injection site swelling
Clinical narrative: Injection site swelling which inflamed to the size of grapefruit; Redness at the injection site; Inflamed Swelling; This case was reported by a pharmacist via sales rep and described the occurrence of extensive swelling of vaccinated limb in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema and inflammatory swelling. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and inflammatory swelling were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and inflammatory swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient had injection site swelling which inflamed to the size of grapefruit. The reporter agreed to follow-up with GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: mild side effects; This case was reported by a consumer and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had mild side effect symptoms. The reporter asked was it ok for me to be around a six month old baby after my second shingrix shot.
Sex: U
Vaccine: VARZOS
Symptoms: Pneumonitis
Clinical narrative: Inflammatory pulmonary condition; This case was reported by a physician via call center representative and described the occurrence of lung inflammation in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced lung inflammation (serious criteria hospitalization). On an unknown date, the outcome of the lung inflammation was recovered/resolved.   It was unknown if the reporter considered the lung inflammation to be related to Shingrix.  Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient developed an inflammatory pulmonary condition and the patient was necessitating hospitalization. The patient was admitted to the hospital and was discharged with apparent resolution of their condition. This case has been linked with case US2019AMR207416, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pneumonitis
Clinical narrative: Inflammatory pulmonary condition; This case was reported by a physician via call center representative and described the occurrence of lung inflammation in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced lung inflammation (serious criteria hospitalization). On an unknown date, the outcome of the lung inflammation was unknown.   It was unknown if the reporter considered the lung inflammation to be related to Shingrix.  Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient developed an inflammatory pulmonary condition and the patient was necessitating hospitalization. The patient was admitted to the hospital and was discharged with apparent resolution of their condition. This case has been linked with case US2019AMR207405, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash below injection site down to elbows; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 497D9, expiry date 11th September 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient experienced rash below injection site down to her elbows after receiving Shingrix. The reporter consented to follow-up.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Injection site rash, Malaise, Pyrexia, Rash
Clinical narrative: Malaise; Fever; Flat rash at injection site, in Crevices of arms, and near back and buttocks; injection site rash; This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose and Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced malaise, fever, rash and injection site rash. On an unknown date, the outcome of the malaise, fever, rash and injection site rash were unknown.   It was unknown if the reporter considered the malaise, fever, rash and injection site rash to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist called and reported that she had given Shingrix concomitantly with Flu injection,  The patient was reporting malaise, fever, flat rash at injection site, crevices of arms, and near back and buttocks. The reporter did not have lot and expiration date for  Shignrix at time of call. The Vaers Details were updated. The reporter consented to follow-up.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Herpes zoster, Pain, Rash pruritic, Vaccination failure
Clinical narrative: aching; tiredness; Threw up; Vaccination failure; shingles; Itchy rash; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (multiple outbreaks of shingles in the past, though this was the first this year).   On 12th June 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, the patient received the 2nd dose of Shingrix. On 8th November 2019, 149 days after receiving Shingrix and less than 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and itchy rash. On an unknown date, the patient experienced pain, tiredness and vomiting. On an unknown date, the outcome of the vaccination failure, shingles and itchy rash were unknown and the outcome of the pain, tiredness and vomiting were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and itchy rash to be related to Shingrix and Shingrix. It was unknown if the reporter considered the pain, tiredness and vomiting to be related to Shingrix.  Additional information was reported as follows: One day after 2nd dose of Shingrix, the patient experienced aching, tiredness and threw up. The patient had broke out in an itchy rash which was identified as shingles.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: aching; tiredness; Threw up; Vaccination failure; shingles; Itchy rash; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (multiple outbreaks of shingles in the past, though this was the first this year).   On 12th June 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, the patient received the 2nd dose of Shingrix. On 8th November 2019, 149 days after receiving Shingrix and less than 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and itchy rash. On an unknown date, the patient experienced pain, tiredness and vomiting. On an unknown date, the outcome of the vaccination failure, shingles and itchy rash were unknown and the outcome of the pain, tiredness and vomiting were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and itchy rash to be related to Shingrix and Shingrix. It was unknown if the reporter considered the pain, tiredness and vomiting to be related to Shingrix.  Additional information was reported as follows: One day after 2nd dose of Shingrix, the patient experienced aching, tiredness and threw up. The patient had broke out in an itchy rash which was identified as shingles.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Headache, Pain, Pyrexia
Clinical narrative: Body aches; Chills; Fever of 102 Fahrenheit; Severe headache; Could not get out of bed for 36 hours, immobilized; This case was reported by a nurse via call center representative and described the occurrence of general body pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2019, the patient received the 1st dose of Shingrix. On 23rd October 2019, less than a day after receiving Shingrix, the patient experienced general body pain, chills, fever, headache and bedridden. On an unknown date, the outcome of the general body pain, chills, fever, headache and bedridden were unknown.   It was unknown if the reporter considered the general body pain, chills, fever, headache and bedridden to be related to Shingrix.  Additional details were provided as follows: The patient experienced body aches, chills, fever of 102 degree F, fatigue, severe headache and could not get out of bed for 36 hours, immobilized. The reporter did not consent to follow-up. This case was linked to case US2019206669 reporter by same reporter for different patient.      Lab Comments: On 23rd October 2019, Lab test performed
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Body aches/Pain; This case was reported by a nurse via call center representative and described the occurrence of general body pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2019, the patient received the 1st dose of Shingrix. On 23rd October 2019, less than a day after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and on the same day  experienced Body aches and pain. The reporter did not consent to follow-up. This case was linked with case US2019206668 same reporter different patient.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: hives around neck; rash around neck; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number HL2CM, expiry date 21st January 2020) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced hives and rash. On an unknown date, the outcome of the hives and rash were recovered/resolved.   It was unknown if the reporter considered the hives and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient reported that 3 days after first dose of Shingrix the patient experience hives and rash around neck and resolved on its own. The Vaers details were updated. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Arrhythmia, Condition aggravated, Malaise
Clinical narrative: arrhythmia; the arrhythmia got worse; feel bad; This case was reported by a pharmacist via call center representative and described the occurrence of arrhythmia in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 592DX, expiry date 6th December 2021) for prophylaxis.   Concurrent medical conditions included arrhythmia.   On an unknown date, the patient received Shingrix. On 13th November 2019, less than a day after receiving Shingrix, the patient experienced arrhythmia (serious criteria GSK medically significant), condition aggravated and feeling unwell. On an unknown date, the outcome of the arrhythmia was not recovered/not resolved and the outcome of the condition aggravated and feeling unwell were unknown.   It was unknown if the reporter considered the arrhythmia, condition aggravated and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient with heart condition, arrhythmia, received a dose of Shingrix and after the administration started to feel bad and the arrhythmia got worse. The reporter did not consent to follow-up.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 6 year-old chile received Pentacel as 5th dose in DTaP series; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 years old patient who received 5th dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and Fluravada.  On 17-Oct-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot #UJ157AAA, exp; 2/3/2021) at a dose of 0.5 ml via intramuscular route in the left vastus lateralis.  It was a case of actual medication error due to inappropriate age at vaccine administration  At the time of reporting, no adverse event was reported.  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 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.
Age: 59.0
Sex: U
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 59 yo patient administer Fluzone High-Dose rather than Quadrivalent, no AE; 59 yo patient administer Fluzone High-Dose rather than Quadrivalent, no AE; 59 yo patient administer Fluzone High-Dose rather than Quadrivalent, no AE; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 59 years old patient who was vaccinated with first dose 0.5 ml INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ288AA via intramuscular route in the left deltoid instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Batch number, expiration date, dose and site of administration was not reported) on 12-Nov-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered, Inappropriate age at vaccine administration and overdose. It was reported that the patient was accidentally administered with Fluzone HD rather than Quadrivalent at a flu clinic.  At the time of reporting, no adverse event was reported.  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 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.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: 9x10 cm of redness and  5x5cm of localized swelling. Instructed mom to  apply cold compresses on site of injection
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Nausea, Pain
Clinical narrative: This was her 2nd dose.  1st  day, she had bad chills and alot of body ache all over.  2nd day N&V and bad HA  and all over body aches.  Was able to eat something the 2nd evening.  She is back to work, but still has a lingering mild HA, foggy head feeling and  occasional chills.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This was her 2nd dose.  1st  day, she had bad chills and alot of body ache all over.  2nd day N&V and bad HA  and all over body aches.  Was able to eat something the 2nd evening.  She is back to work, but still has a lingering mild HA, foggy head feeling and  occasional chills.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Rash vesicular
Clinical narrative: PATIENTS IS A DOCTOR   BILATERAL PROFUSE  RASH (CHICKENPOX LIKE BUT NO BLISTERS OR WEEPING) TO NECK , ARMS, ARMPITS, CHEST - PT STATES THAT HE FEELS THE RASH IS NOW STARTING TO IMPROVE NO NERVE PAIN
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient has swelling in the upper arm that is just below the injection site and goes to just above the elbow. Patient did state that the red area/swelling was higher up on her arm last night. There is a raised area of redness that is fevered and painful to touch. The area does not itch the patient. I have advised the patient to take OTC allergy medication and a OTC anti-inflammatory. I also advised the patient that if there was no improvement or it seemed to be getting worse, to seek care at a walk-in clinic or go to the ER for evaluation.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dyspnoea, Injection site pain, Musculoskeletal pain
Clinical narrative: WITHIN 6 HOURS OF RECEIVING VACCINE, PATIENT EXPERIENCED BILATERAL SHOULDER/ARM PAIN, CHILLS, FEVER > 100F, SHORTNESS OF BREATH, AND WEAKNESS - SYMPTOMS LASTED 8 HOURS THEN RESOLVED
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: WITHIN 6 HOURS OF RECEIVING VACCINE, PATIENT EXPERIENCED BILATERAL SHOULDER/ARM PAIN, CHILLS, FEVER > 100F, SHORTNESS OF BREATH, AND WEAKNESS - SYMPTOMS LASTED 8 HOURS THEN RESOLVED
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient had an extremely sore arm that worsened after a few days and persisted for 8 days.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Hypoaesthesia, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: MRI showed myocitis, has numbness in 3rd, 4th, and 5th fingers on left hand, pain, hot inflammation at the injection site severe pain in elbow, said it was given too high
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Magnetic resonance imaging abnormal, Myositis
Clinical narrative: MRI showed myocitis, has numbness in 3rd, 4th, and 5th fingers on left hand, pain, hot inflammation at the injection site severe pain in elbow, said it was given too high
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting full amount of breast milk eaten and diarrhea several times.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection was given sub-q in lower portion of upper arm instead of IM in deltoid.  Experienced pain, redness, heat and swelling at site for the past 3 days. These symptoms are still ongoing.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash pruritic
Clinical narrative: Patient had 6 circular bumps with clear, small blisters in them on the opposite arm on the inner bicep, the wrist, and back of hand.  The bumps were itchy. The bumps began 24 hours after the immunization.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Rash
Clinical narrative: PATIENT STATES THAT SHE NOTICED A RASH ABOUT THREE DAYS AFTER GETTING HER FLU SHOT  AND SHE HAD A APPOINTMENT WITH HER DERMATOLOGIST IN DRS OFFICE  AND SHE ORIGIANALLY THOUGHT IT MAY BE EXEMA BUT PATIENT RETURNED  TWO WEEKS LATER AND  THE RASH HAD GOTTEN WORSE  AND DOCTOR SAID ITS A RECATION FROM HER FLU SHOT  PATIENT STILL HAS RASH  AS OF 11/22/2019  AND STILL RECIVING TREATMENT .
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypersensitivity, Rash, Rash papular, Rash pruritic
Clinical narrative: PATIENT STATES THAT SHE NOTICED A RASH ABOUT THREE DAYS AFTER GETTING HER FLU SHOT  AND SHE HAD A APPOINTMENT WITH HER DERMATOLOGIST IN DRS OFFICE  AND SHE ORIGIANALLY THOUGHT IT MAY BE EXEMA BUT PATIENT RETURNED  TWO WEEKS LATER AND  THE RASH HAD GOTTEN WORSE  AND DOCTOR SAID ITS A RECATION FROM HER FLU SHOT  PATIENT STILL HAS RASH  AS OF 11/22/2019  AND STILL RECIVING TREATMENT .
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling
Clinical narrative: Patients arm immediately swelled up like a bump/bubble at the injection site along with a decent amount of bleeding. A possible vein was hit?
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain
Clinical narrative: Persistent right shoulder pain (site of injection) associated with pain on extension and abduction present for the last two weeks and starting two days after influenza vaccine. No erythema, warmth, or edema.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site rash, Nausea, Pain in extremity
Clinical narrative: Rash on arm of injection, runs from injection site to the elbow. Fever (102F), chills, headache, pain on affected arm and nausea.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Rash on arm of injection, runs from injection site to the elbow. Fever (102F), chills, headache, pain on affected arm and nausea.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Hypersensitivity, Lip swelling, Urticaria
Clinical narrative: pt. reports that at 9:00pm started to experience SOB, lip swelling,  as well as hives. went to ED. diagnosed as an allergic reaction. assessment: Hives/Rash chest, Left arm No indication for epinephrine Intervention: IV fluids for hydration, Solumedrol, Benadryl, Pepcid
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: Pt reported headache and sever chills starting the night after receiving the shot. Chills were bad enough that he was not able to get out of bed. Chills subsided in the morning. Headache persisted until afternoon.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Pt states arm started tingling the day after. She has been having increased tingling in numbness in arm since then. Pt plans to contact PCP.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: PATIENT HAD AN AVERSION TO INJECTIONS AND PASSED OUT UPON INJECTION. PATIENT RECEIVED INJECTION FOR INFLUENZA, HOWEVER PASSED OUT APPROXIMATELY HALFWAY THROUGH ADMINISTRATION OF INJECTION. IMMUNIZATION WAS COMPLETED AS PATIENT BEGAN TO SLUMP OVER AND PASS OUT. PARAMEDICS WERE CALLED AND ADMINISTERED TREATMENT.  ADVERSE REACTION WAS NOT DUE TO INJECTION, BUT TO AVERSION TO NEEDLES/INJECTIONS.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Skin warm, Urticaria
Clinical narrative: Pt mother stated Pt left arm is  warm and swollen and she got hives.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Fatigue, Feeling cold, Hot flush
Clinical narrative: Patient experienced expected side effects, but robust, including sore arm and fatigue.  On administration, patient had almost immediate discomfort in deltoid area.    Additionally, she had waves of nausea and an episode of diarrhea.  She also experienced hot flashes and cold spells.  On Tuesday, the day after the vaccine, she experienced a cold sore on the exterior of her mouth in addition to a sore inside the mouth.   Patient had had immunizations in that same arm  within the last 4 weeks.  3 small red raised areas appeared in this are.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Nausea, Oral herpes, Pain in extremity, Swelling
Clinical narrative: Patient experienced expected side effects, but robust, including sore arm and fatigue.  On administration, patient had almost immediate discomfort in deltoid area.    Additionally, she had waves of nausea and an episode of diarrhea.  She also experienced hot flashes and cold spells.  On Tuesday, the day after the vaccine, she experienced a cold sore on the exterior of her mouth in addition to a sore inside the mouth.   Patient had had immunizations in that same arm  within the last 4 weeks.  3 small red raised areas appeared in this are.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Patient presented to Pharmacy with a mild red rash and pain in area of injection on right arm .... Rash approximately 3 inches diameter
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site nodule, Injection site warmth
Clinical narrative: PT DESCRIBES INFLAMED INJECTION SITE; RED, WARM TO THE TOUCH, "KNOT"; CONTINUING TO MONITOR SYMPTOMS FOR IMPROVEMENT/WORSENING
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 7x7.5 cm erythematous, hot, tender to palpation raised region surrounding site of injection.  Tenderness and tightness right lateral shoulder, right lateral neck and up into the jaw.  No swelling of lips, tongue, no swelling of face, no SOA.  She has prominent local reaction with radiating pain into the lateral right elbow and into the shoulder.  Shoulder ROM is mildly reduced secondary to guarding pain but no obvious joint involvement o f shoulder elbow or cervical spine.  Pain locally, fatigue, malaise.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Joint stiffness, Malaise, Pain
Clinical narrative: 7x7.5 cm erythematous, hot, tender to palpation raised region surrounding site of injection.  Tenderness and tightness right lateral shoulder, right lateral neck and up into the jaw.  No swelling of lips, tongue, no swelling of face, no SOA.  She has prominent local reaction with radiating pain into the lateral right elbow and into the shoulder.  Shoulder ROM is mildly reduced secondary to guarding pain but no obvious joint involvement o f shoulder elbow or cervical spine.  Pain locally, fatigue, malaise.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Grip strength decreased, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient received his flu shot on 10/30/19 and his arm has been hurting since. Patient says the pain radiates down to his forearm but is not sharp or tingly. He also feels like he loses control with tight grips or heavy weights. Patient saw his PCP and the PCP said the shot was given too high. Patient will follow up again in about a week or so for further evaluation. He said there has been slight improvements from the past few nights. He has been taking Tylenol but was advised to try an NSAID to help with the pain.
Age: 15.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: opened vial for ipol is to be stored at 2 Celsius to 8 Celsius.  Temperature excursion for this opened vial at 46.9 F converted to Celsius is 8.28 Celsius for 30 minutes while door was opened to store vaccines in fridge unit.  After the temperature excursion the ipol was administered to the patient.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, TDAP
Symptoms: Chills, Headache, Influenza A virus test negative, Influenza B virus test, Injection site erythema
Clinical narrative: Patient had fever of 102, 4cm erythema at injection site on right arm, nausea, chills, myalgia and headache. Treatment plan for patient included supportive care to get through the next couple of days. Recommended doses of Tylenol and Motrin and staying hydrated.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, TDAP
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Patient had fever of 102, 4cm erythema at injection site on right arm, nausea, chills, myalgia and headache. Treatment plan for patient included supportive care to get through the next couple of days. Recommended doses of Tylenol and Motrin and staying hydrated.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: INJECTION SITE SWELLING, REDNESS, SORENESS FOR A FEW DAYS
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Head discomfort, Paraesthesia, Pharyngeal swelling, Swollen tongue
Clinical narrative: 4:15 pm - throat started feeling swollen, light headed, tingly throughout body. By 5:00 pm throat was closing, base of tongue felt swollen, lightheaded, head pressure. Tingly appendages.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Throat tightness
Clinical narrative: 4:15 pm - throat started feeling swollen, light headed, tingly throughout body. By 5:00 pm throat was closing, base of tongue felt swollen, lightheaded, head pressure. Tingly appendages.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: patient was hit hard by another person at the sight which made the arm numb down to his left wrist. patient did experience at injection site pain, redness, swollen and fever. no gi issues. which had subsided by the day he reported this event (11/22/19).
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Alanine aminotransferase increased, Anion gap normal, Aspartate aminotransferase increased, Bilirubin conjugated increased, Blood albumin decreased
Clinical narrative: 30 minutes after the vaccine patient developed body aches and chills. He had his blood drawn at that time as part of a routine office visit which showed at elevation in his white blood cells (see below). His condition continued to worsen (feeling more ill) at home and he was sent back to Urgent Care for a recheck. At this point his kidney and liver function tests had deteriorated (see below) and his leukocytosis had increased to 41.27 (see below). Hematology was consulted by Dr. the Urgent Care physician for Clinic and they advised him this was most likely an adverse reaction to the vaccine. Currently patient is having a new symptom of rectal bleeding and we cannot reach him by phone to check on his status. We may send police to his home if no answer to our emails and calls by closing today. If condition worsens he may be directed to the Emergency Department.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Blood alkaline phosphatase normal, Blood bilirubin increased, Blood calcium normal, Blood chloride normal, Blood creatinine increased
Clinical narrative: 30 minutes after the vaccine patient developed body aches and chills. He had his blood drawn at that time as part of a routine office visit which showed at elevation in his white blood cells (see below). His condition continued to worsen (feeling more ill) at home and he was sent back to Urgent Care for a recheck. At this point his kidney and liver function tests had deteriorated (see below) and his leukocytosis had increased to 41.27 (see below). Hematology was consulted by Dr. the Urgent Care physician for Clinic and they advised him this was most likely an adverse reaction to the vaccine. Currently patient is having a new symptom of rectal bleeding and we cannot reach him by phone to check on his status. We may send police to his home if no answer to our emails and calls by closing today. If condition worsens he may be directed to the Emergency Department.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Blood glucose normal, Blood potassium normal, Blood smear test, Blood sodium normal, Blood urea increased
Clinical narrative: 30 minutes after the vaccine patient developed body aches and chills. He had his blood drawn at that time as part of a routine office visit which showed at elevation in his white blood cells (see below). His condition continued to worsen (feeling more ill) at home and he was sent back to Urgent Care for a recheck. At this point his kidney and liver function tests had deteriorated (see below) and his leukocytosis had increased to 41.27 (see below). Hematology was consulted by Dr. the Urgent Care physician for Clinic and they advised him this was most likely an adverse reaction to the vaccine. Currently patient is having a new symptom of rectal bleeding and we cannot reach him by phone to check on his status. We may send police to his home if no answer to our emails and calls by closing today. If condition worsens he may be directed to the Emergency Department.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Carbon dioxide normal, Chills, Differential white blood cell count, Flank pain, Full blood count
Clinical narrative: 30 minutes after the vaccine patient developed body aches and chills. He had his blood drawn at that time as part of a routine office visit which showed at elevation in his white blood cells (see below). His condition continued to worsen (feeling more ill) at home and he was sent back to Urgent Care for a recheck. At this point his kidney and liver function tests had deteriorated (see below) and his leukocytosis had increased to 41.27 (see below). Hematology was consulted by Dr. the Urgent Care physician for Clinic and they advised him this was most likely an adverse reaction to the vaccine. Currently patient is having a new symptom of rectal bleeding and we cannot reach him by phone to check on his status. We may send police to his home if no answer to our emails and calls by closing today. If condition worsens he may be directed to the Emergency Department.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Glomerular filtration rate decreased, Haematocrit increased, Haemoglobin increased, Hepatic function abnormal, Leukocytosis
Clinical narrative: 30 minutes after the vaccine patient developed body aches and chills. He had his blood drawn at that time as part of a routine office visit which showed at elevation in his white blood cells (see below). His condition continued to worsen (feeling more ill) at home and he was sent back to Urgent Care for a recheck. At this point his kidney and liver function tests had deteriorated (see below) and his leukocytosis had increased to 41.27 (see below). Hematology was consulted by Dr. the Urgent Care physician for Clinic and they advised him this was most likely an adverse reaction to the vaccine. Currently patient is having a new symptom of rectal bleeding and we cannot reach him by phone to check on his status. We may send police to his home if no answer to our emails and calls by closing today. If condition worsens he may be directed to the Emergency Department.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Mean cell haemoglobin concentration decreased, Mean cell haemoglobin decreased, Mean cell volume decreased, Mean platelet volume
Clinical narrative: 30 minutes after the vaccine patient developed body aches and chills. He had his blood drawn at that time as part of a routine office visit which showed at elevation in his white blood cells (see below). His condition continued to worsen (feeling more ill) at home and he was sent back to Urgent Care for a recheck. At this point his kidney and liver function tests had deteriorated (see below) and his leukocytosis had increased to 41.27 (see below). Hematology was consulted by Dr. the Urgent Care physician for Clinic and they advised him this was most likely an adverse reaction to the vaccine. Currently patient is having a new symptom of rectal bleeding and we cannot reach him by phone to check on his status. We may send police to his home if no answer to our emails and calls by closing today. If condition worsens he may be directed to the Emergency Department.