chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Incomplete course of vaccination, Influenza like illness, Pain
Clinical narrative: Flu like symptoms; arm pain; achy; vomiting; diarrhea; Fatigue; inappropriate Schedule of Vaccine; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms, pain in arm, pain, vomiting, diarrhea, fatigue and incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms, pain in arm, pain, vomiting, diarrhea, fatigue and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm, pain, vomiting, diarrhea and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The age group of the patient was not reported, but selected as an adult as per vaccine indication. After vaccination with dose of Shingrix, the patient experineced flu like symptoms consisting of fatigue, aching, vomiting, diarrhea and arm pain. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Flu like symptoms; arm pain; achy; vomiting; diarrhea; Fatigue; inappropriate Schedule of Vaccine; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms, pain in arm, pain, vomiting, diarrhea, fatigue and incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms, pain in arm, pain, vomiting, diarrhea, fatigue and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm, pain, vomiting, diarrhea and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The age group of the patient was not reported, but selected as an adult as per vaccine indication. After vaccination with dose of Shingrix, the patient experineced flu like symptoms consisting of fatigue, aching, vomiting, diarrhea and arm pain. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: rash on arms, back and legs/ rash was itchy; rash looks and feels like chickenpox/spots look like pimples; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received the 1st dose of Shingrix. On 7th September 2019, 25 days after receiving Shingrix, the patient experienced itchy rash and varicella-like rash. On an unknown date, the outcome of the itchy rash and varicella-like rash were not recovered/not resolved.   It was unknown if the reporter considered the itchy rash and varicella-like rash to be related to Shingrix.  Additional details were provided as follows: The reporter was patient.  The patient received Shingrix in her left arm.  The patient stated that on Saturday, she developed a rash on her arms, back and legs. The rash was itchy and looked and felt like chickenpox. She also stated that, the spots looked like pimples. The patient consented to follow up and provide details of her physician. The patient did not provide any additional information.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; Rash / rash on face; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On 3rd September 2019, less than 2 months after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had first dose of Shingrix about 7 weeks ago.  Last Tuesday patient thought she had a rash on her face, believed to be from antibacterial cleaner she placed on her face while visiting friend in hospital. The reporter's friend referred the patient to see a physician after having seen the rash.  The patient was seen by dermatologist on day of reporting and diagnosed with Shingles. The patient was prescribed three different medications she stated, but names were not provided. It was reported that emergency room visit was required. The reporter consented to follow up. In the XML document outcome of events was reported as recovering, but in system its mentioned as not recovered, so kept as reported in system.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The report was via chat  The reporter was a family nurse practitioner student. The patient experienced flu like symptoms after receiving Shingrix. The reporter did not have the batch number and expiry date or the exact date of vaccination. The report was via chat and the reporter did not elaborate on what exact flu like symptoms were experienced by the patient.
Sex: F
Vaccine: FLUA3
Symptoms: Throat tightness
Clinical narrative: Not able to sleep; Trouble breathing; Throat closed up; Tired all day; Coughing; Feeling achy; This is a spontaneous case, initially received from other non-health professional via Communications (reference number: SEQ19-02681) on 13-Sep-2019, concerning a 65-year-old, female patient.   The patient's medical history included Augmentin (amoxicillin, clavulanic acid) for unknown indication.   On 12-Sep-2019, the patient was administered Fluad [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose, route of administration, anatomical location, batch number and expiration date: not reported] as protection against seasonal influenza.  On the same day, 12 hours after vaccination, the patient's throat closed up and she had trouble breathing. The patient was not able to sleep, had been tired all day, along with coughing and feeling achy. As reported, the patient had a reaction similar to this after taking Augmentin years ago, but at that time, she also had a rash, which she did not have now.   The patient did not seek medical treatment, but it was unknown if she received any treatment.  At the time of initial reporting, the outcome of the events was not resolved (reported as ongoing).  The reporter assessed the case as serious and did not provide causality assessment.  The reporter did not give consent to be contacted for further information.  Company comment: A 65-year-old, female patient experienced insomnia, dyspnoea, throat tightness, fatigue, cough and pain after vaccination with the suspect product Fluad (TIV). Chronology is plausible. Reportedly, the patient had a reaction similar to this after taking Augmentin years ago. Patient medical history of reported Augmentin reaction with similar events suggest presence of allergic predisposition which was not reported. Presence of adjuvants in vaccine (egg-derivates) may have triggered some sort of allergic reaction in the patient. Medical data of the patient is necessary for the assessment of causality. For now, considering provided information, causality is assessed as related to the product for the events of dyspnoea, throat tightness, fatigue, cough and pain, however not related to insomnia due to physiological inconsistency.; Reporter's Comments: A 65-year-old, female patient experienced insomnia, dyspnoea, throat tightness, fatigue, cough and pain after vaccination with the suspect product Fluad (TIV). Chronology is plausible. Reportedly, the patient had a reaction similar to this after taking Augmentin years ago. Patient medical history of reported Augmentin reaction with similar events suggest presence of allergic predisposition which was not reported. Presence of adjuvants in vaccine (egg-derivates) may have triggered some sort of allergic reaction in the patient. Medical data of the patient is necessary for the assessment of causality. For now, considering provided information, causality is assessed as related to the product for the events of dyspnoea, throat tightness, fatigue, cough and pain, however not related to insomnia due to physiological inconsistency.
Sex: U
Vaccine: FLU4
Symptoms: Caesarean section, Cleft palate, Foetal exposure during pregnancy
Clinical narrative: Cleft palate; Foetal exposure during pregnancy; This is a spontaneous case, initially received from other non-health professional via Med Communications (reference number: SEQ18-02462) on 13-Sep-2019, concerning a neonate patient of unspecified sex.  The mother was an adult, female patient, whose medical history and concomitant medications were not reported.   On an unspecified date, the patient's mother was administered Afluria Quadrivalent [influenza vaccine; dose, route of administration, anatomical location, batch number and expiry date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for an unknown indication.  On 09-Jul-2019, the mother delivered neonate through caesarean delivery. The neonate was born with cleft palate. It was also reported that the neonate did not have any other problem, and there were no problems during delivery. No further details regarding neonate were provided.   At the time of initial reporting, the outcome of the event cleft palate was not reported.   This case is linked to 201905290, the corresponding mother case.  Company Comment: Reportedly, the neonate subject of unspecified sex was delivered with cleft palate after foetal exposure during pregnancy with the suspect product Afluria Quadrivalent. Chronology is unclear but plausible. No medical history and concomitant medications were provided. Foetal exposure during pregnancy is assessed as not related. For event cleft palate, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reporter's Comments: Reportedly, the neonate subject of unspecified sex was delivered with cleft palate after foetal exposure during pregnancy with the suspect product Afluria Quadrivalent. Chronology is unclear but plausible. No medical history and concomitant medications were provided. Foetal exposure during pregnancy is assessed as not related. For event cleft palate, causal role of the suspect product cannot be totally excluded and is assessed as related.
Age: 0.17
Sex: M
Vaccine: UNK
Symptoms: Screaming, Tremor
Clinical narrative: Child screamed (high-pitched) for 4 hours and then shook/tremored starting approximately 4 hours after he received a Comvax vaccine. Parents elected to discontinue all vaccines for the child after this event, and he is now a healthy neurotypical 6-year old boy.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Fatigue, Feeling of body temperature change, Headache, Lethargy
Clinical narrative: Six hours after injection headache, muscle aches, nausea and hot and cold feelings developed lasting throughout the night into next day.  Several bouts of diarrhea also . General malaise and lethargy for one full day after shot into second day. Finally third day symptoms subsided except for a tired feeling.  Took Advil several times for headache and muscle aches.....some relief.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Malaise, Myalgia, Nausea
Clinical narrative: Six hours after injection headache, muscle aches, nausea and hot and cold feelings developed lasting throughout the night into next day.  Several bouts of diarrhea also . General malaise and lethargy for one full day after shot into second day. Finally third day symptoms subsided except for a tired feeling.  Took Advil several times for headache and muscle aches.....some relief.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient reported to me today 09/19/2019.  She said at first it was very sore especially when she was lifting her arms where she got the injection.  Today she reported  she the injection site is red, hot, and swollen and planning to see her Doctor tomorrow.  She is also thinks that the pharmacist might have given the shot too high ( she said she is a former nurse and kind knows if it is high or low).
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling abnormal, Feeling hot, Flushing, Headache, Musculoskeletal stiffness
Clinical narrative: within two hours flushed, sneezing, very hot, fever, headache, and felt "off". plus stiff and very sore right arm. had to take benadryl to stop reaction.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Pyrexia, Sneezing
Clinical narrative: within two hours flushed, sneezing, very hot, fever, headache, and felt "off". plus stiff and very sore right arm. had to take benadryl to stop reaction.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chills, Dizziness, Nausea
Clinical narrative: chills, dizzy, nauseous, funny filling in chest feeling
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Ear discomfort, Pruritus, Swelling of eyelid, Throat irritation, Urticaria
Clinical narrative: Ears burning, chest and neck got itchy, diffuse hives, wheezing, swelling around the eyes, itchy throat.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: Ears burning, chest and neck got itchy, diffuse hives, wheezing, swelling around the eyes, itchy throat.
Age: 40.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Vaccination site induration, Vaccination site warmth
Clinical narrative: Patient called my work cell to report that she thought she was having a bad reaction to the vaccine she received in her left arm yesterday.   She feels like there is a "rock" under her skin where the vaccine was given and it is slightly warm to the touch. No redness. Localized swelling reported over injection area. Sore at injection site. Used marker to draw circle around swollen area so she could monitor. Not noticing progression since this morning.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased
Clinical narrative: can't move her arm, seen by urgent care,
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth
Clinical narrative: Injection site reaction - warm to touch - went to doctor and prescribed doxycycline hyclate 100mg twice daily for 7 days as prevention
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on arm below injection site
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth
Clinical narrative: Injection site reaction warm to touch- pt did see doctor which stated to just monitor and to get 2nd dose and the reaction should decrease within 5 days - pt is monitoring reaction
Age: 22.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Middle insomnia, Pain, Pain in extremity, Rash erythematous
Clinical narrative: Patient presented to the pharmacy 9/19/19 with a sore left arm. She said it hurt to move it and that the pain woke her up in the middle of the night. The injection sites appeared normal, but there were two small red bumps on the inside of the patients arm that appeared to be a rash. Patient was told to try ice, benadryl, and alternate ibuprofen and tylenol. Patient presented back to the pharmacy 9/19/19, she said the arm was still very sore and the rash had enlarged and spread. She was instructed to follow up with her doctor at this point.
Age: 1.33
Sex: M
Vaccine: DTAP, FLU4, MMR, VARCEL
Symptoms: Rash, Rash papular, Urticaria
Clinical narrative: Diffuse body rash that appeared to be papular vs small discrete hives.  Total body surface.  Rash started at Non the day following vaccines (9/18/19), persisted through the night and resolved by evaluation at 10 AM on 9/19/19.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: UPON ADMINISTRATION THE CONTENTS OF THE SYRINGE ALMOST COMPLETELY SPILLED OUT THE SIDE OF SYRINGE AND DRIPPED DOWN HER ARM.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Middle ear effusion, Nystagmus, Vertigo
Clinical narrative: Vertigo starting at ~7 hours after the vaccine, continuing > 24 hours.
Age: 74.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Asthenia, Cough, Gastrooesophageal reflux disease, Headache, Insomnia
Clinical narrative: Cough, Headache, Sore Throat, Weak, Unable to sleep, and Acid reflux starting around 2 am the morning after vaccines were given
Age: 74.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Oropharyngeal pain
Clinical narrative: Cough, Headache, Sore Throat, Weak, Unable to sleep, and Acid reflux starting around 2 am the morning after vaccines were given
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Blood test, Crying, Irritability, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Extremes irritability, began crying uncontrollably the morning of June 6th and that lasted for weeks. Sometimes crying 15 hrs long during the day. He was then  later diagnosed with Transverse Myelitis on August 14, 2017
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Myelitis transverse, X-ray
Clinical narrative: Extremes irritability, began crying uncontrollably the morning of June 6th and that lasted for weeks. Sometimes crying 15 hrs long during the day. He was then  later diagnosed with Transverse Myelitis on August 14, 2017
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Angioedema, Urticaria
Clinical narrative: PT HAD HIVES AND ANGIOEDEMA. DID NOT STATE TREATMENT. PT IS CURRENTLY HEALTHY
Age: 15.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Anxiety, Eye movement disorder, Lethargy, Loss of consciousness, Nausea
Clinical narrative: Administered MCV4 and Hep A vaccine in client's Rt arm IM.  Client conversing with me and her mother throughout but showing some anxiety.  Lt arm vaccines given after were HPV and Tdap.  Shortly after completed with Lt arm, client's eyes rolled back and she appeared to be having a mild seizure. She laid back on table.  Around 15 secs passed and she sat up with help but was very lethargic. Said she was nauseated.  Client's mother went to waiting room to get family member while I stayed with client.  On return we discussed her going to her Dr or the ER.   Client family member attempted to carry her out and she passed out again in hallway.  Held and eased down to floor by family.  No harm to client during transfer.  I called 911 to have client evaluated  for safety purposes. No allergic reaction evident/ no redness, hives or breathing issues, just what appeared as a mild initial seizure and fainting episodes.  Client evaluated by EMS. Blood sugar and vitals within normal limits. Mother verbalized no known previous reactions to any vaccines.  Client transported to local ER for evaluation.  My vaccination info provided to client's mother and my contact information given.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Seizure
Clinical narrative: Administered MCV4 and Hep A vaccine in client's Rt arm IM.  Client conversing with me and her mother throughout but showing some anxiety.  Lt arm vaccines given after were HPV and Tdap.  Shortly after completed with Lt arm, client's eyes rolled back and she appeared to be having a mild seizure. She laid back on table.  Around 15 secs passed and she sat up with help but was very lethargic. Said she was nauseated.  Client's mother went to waiting room to get family member while I stayed with client.  On return we discussed her going to her Dr or the ER.   Client family member attempted to carry her out and she passed out again in hallway.  Held and eased down to floor by family.  No harm to client during transfer.  I called 911 to have client evaluated  for safety purposes. No allergic reaction evident/ no redness, hives or breathing issues, just what appeared as a mild initial seizure and fainting episodes.  Client evaluated by EMS. Blood sugar and vitals within normal limits. Mother verbalized no known previous reactions to any vaccines.  Client transported to local ER for evaluation.  My vaccination info provided to client's mother and my contact information given.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Improperly stored dose; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy details were not reported.     On 12-SEP-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S005874 expiry date 31-OCT-2020 (strength, route of administration were not reported) for prophylaxis (Product storage error). No adverse event was reported. The vaccines was exposed to a lowest temperature of below2 degree Celsius (1.2 Celsius) for a time frame of 24 hours and 36 minutes. No previous temperature excursion was reported. The call was due to digital data logger. No product quality complaint (PQC) was associated with this report.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Muscular weakness
Clinical narrative: Pain during injection / Injection site pain; Weakness in arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number BY2Y4, expiry date 13th November 2021) for prophylaxis.   On 11th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 11th September 2019, immediately after receiving Shingrix, the patient experienced injection site pain and weakness of arms. On an unknown date, the outcome of the injection site pain and weakness of arms were unknown.   It was unknown if the reporter considered the injection site pain and weakness of arms to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that, the patient experienced injection site pain and weakness in arm, during the injection.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pain in extremity
Clinical narrative: Arm pain; arm pain as intermittent only when the arm was moved in an upward motion; Redness; This case was reported by a physician via call center representative and described the occurrence of erythema in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced erythema, pain in arm and pain upon movement. On an unknown date, the outcome of the erythema was recovered/resolved and the outcome of the pain in arm was not recovered/not resolved and the outcome of the pain upon movement was unknown.   It was unknown if the reporter considered the erythema, pain in arm and pain upon movement to be related to Shingrix.  Additional details were reported as follows: The physician reported the patient had experienced redness and arm pain with abduction. HCP describes arm pain as intermittent only when the arm was moved in an upward motion. HCP describes redness as erythema lasting only four or five days after receipt of dose one of Shingrix.  HCP could not provide lot number or expiration date for the dose administered.  No additional details provided. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: shingles; Inappropriate schedule of vaccine; This case was reported by a physician via call center representative and described the occurrence of shingles in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The reported that the patient received the 1st dose of Shingrix on an unknown date last year. About 6 to 8 weeks ago, the patient developed shingles. The patient would like to get the 2nd dose, which led to incomplete course of vaccination. The healthcare professional (HCP) was the patient's son. The reporter did not had the exact date of vaccination or lot/exp.
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 4 month old was given ActHIB and Pentacel on same day; Initial information received on 05-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old female patient who received 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ033AA, expiry date 07-Oct-2020) via intramuscular route in thigh and 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]  (lot number and Expiry date unknown) via intramuscular route in thigh.   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 extra dose administered.   It was reported that that 4 month old was given ActHIB and Pentacel on same day.  At the time of vaccination no adverse events were 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.  Information on the batch number of Pentacel was requested.  List of documents held by sender: none.
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product dose omission
Clinical narrative: but missed her second dose (day 7) that was scheduled for yesterday,; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 43 years old female patient who was vaccinated with a first 1 mL dose of vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] lot P1E521M, expiry date: 30-Oct-2020 via unknown route in unknown administration site on 04-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant vaccination was given to the patient.  It is an actual medication error case due to missed dose as the patient missed her second dose (day 7) that was scheduled for 11 Sep 2019.  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 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.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: red, swollen right deltoid; red, swollen right deltoid; red, swollen right deltoid; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 years old patient who experienced red, swollen right deltoid, while he/she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W (MENINGOCOCCAL VACCINE A/C/Y/W); HEPATITIS A VACCINE (HEPATITIS A); and HPV VACCINE (HPV VACCINE) for Immunisation.  On 10-Sep-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot: U6321AA, expiry date: 07-Jun-2021) via intramuscular route in the right deltoid.  On 12-Sep-2019, the patient had red, swollen right deltoid (vaccination site inflammation, vaccination site swelling and vaccination site erythema) two days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Lab data was not reported.  Final diagnosis was red, swollen right deltoid.   The patient was treated with and Tylenol (acetaminophen).  The patient outcome was not reported (unknown).  List of document held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered Quadracel that expired 08/21/2019 to a patient, no AE; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 years old female patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot: C5248AA expiry date: 21-Aug-2019) via intramuscular route in the arm NOS on 12-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was an actual medication error due to expired vaccine used.  At the time of reporting the 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.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: a patient received the DTaP-IPV diluent separately and did not receive Hib/ no AE; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA261800 and 2019SA261801.   This case involves a 12 months old female patient who received DTaP-IPV diluent separately and did not receive Hib (inappropriate reconstitution technique) of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [Pentacel] Lot  UJ060AAA, ActHIB- Lot  UJ060AA (Expiry date 04-Oct-2020) on 28-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It was a case of actual medication error due to inappropriate reconstitution technique.  At a time of reporting no adverse event 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.  Documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: Pain
Clinical narrative: Stinging when entering the arm; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from a non-hcp (office staff).  This case involves Adult female patient who experienced stinging when entering the arm, while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history included Pain with Stinging when entering the arm more than in previous years. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1915 via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious stinging when entering the arm (pain) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was stinging when entering the arm.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for stinging when entering the arm.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity, Injection site swelling
Clinical narrative: deemed to have an allergic reaction; localized swelling of the injection site; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to cases 2019SA257583 and 2019SA257582 (same reporter).  This case involves patient (with unknown demographics) who was deemed to have an allergic reaction (hypersensitivity) and localized swelling of the injection site (vaccination site swelling), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via intramuscular route in unknown administration site.  On an unknown date, the patient had deemed to have an allergic reaction (hypersensitivity) and localized swelling of the injection site (vaccination site swelling) (unknown latency) following the administration of INFLUENZA VACCINE. The swelling was larger compared to any other reactions the staff member has had in the previous years.  Other relevant tests not reported.   Final diagnosis was hypersensitivity.  Ice pack was applied as corrective treatment.  The patient recovered from the events.  Information on the batch number was requested.  Documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity, Injection site swelling
Clinical narrative: deemed to have an allergic reaction; localized swelling of the injection site, The swelling was larger; localized swelling of the injection site, The swelling was larger; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to case 2019SA257467 and 2019SA257582  (same reporter).  This case involves patient (with unknown demographics) who was deemed to have an allergic reaction (hypersensitivity) and localized swelling of the injection site (localized oedema), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via intramuscular route in unknown administration site.  On an unknown date, the patient had localized swelling of the injection site. The swelling was larger compared to any other reactions the staff member has had in the previous years (localized oedema). Upon evaluation by hospital staff physician, the employee was deemed to have an allergic reaction (hypersensitivity). Ice pack was applied (unknown latency) following the administration of INFLUENZA VACCINE.  Other relevant tests not reported.   Final diagnosis was hypersensitivity.  Ice pack was applied as corrective treatment.  The patient recovered from the events.  Information on the batch number was requested.  Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: injection site was extremely itchy; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional (medical assistant).  This case involves an elderly female patient (age not reported) who experienced injection site was extremely itchy (vaccination site pruritus), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious injection site was extremely itchy (vaccination site pruritus), unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that this happened during the 2018-19 season and unclear during which month.  Other relevant tests were not reported.  Final diagnosis was injection site was extremely itchy.  It was not reported if the patient received a corrective treatment.  The outcome of the event was not reported.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: After getting a Pneumovax 0.5 ML shot from Pharmacy I noticed swelling, redness, itching and muscle pain in the area of the injection. No other symptoms have been observed.
Age: 38.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 1 week after receiving the first dose of Shingrix (given concurrently with first Humira dose) she developed sacral shingles around the anus.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Received Shingrix injection. Had previous shingles vaccine 10 years ago.9 days developed shingles and had to seek medical help. Presently taking Acyclovir 800 mg 4xdaily to try to prevent continued nerve problems.
Sex: U
Vaccine: VARZOS
Symptoms: Product container issue
Clinical narrative: When medical assistant was removing sticker from shingrix vial, it was discovered the vial was broken. PCP and onsite LVN were notified immediately when incident occurred.
Age: 26.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Dizziness, Headache, Hypoaesthesia, Migraine
Clinical narrative: I took the Gardasil 9 vaccine september 3rd, and 6 days later i started suffering headaches and dizziness also on the night of september 11th i suffered from muscle tightness and numbness at the same time plus weakness i ended up at the emergency room it is now the night of september 16 and the headache is still going on its been a week now of headaches and im really worried now and some answers if this is normal or will it go away. I also want to add i had never suffered any migraine problem for a complete week till now wich is why I'm really worried. Thanks
Age: 26.0
Sex: M
Vaccine: HPV9
Symptoms: Muscle tightness
Clinical narrative: I took the Gardasil 9 vaccine september 3rd, and 6 days later i started suffering headaches and dizziness also on the night of september 11th i suffered from muscle tightness and numbness at the same time plus weakness i ended up at the emergency room it is now the night of september 16 and the headache is still going on its been a week now of headaches and im really worried now and some answers if this is normal or will it go away. I also want to add i had never suffered any migraine problem for a complete week till now wich is why I'm really worried. Thanks
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Pyrexia
Clinical narrative: ACHE FULL BODY BODY HAD BURNING FEELING  FEAVER.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: Product preparation issue
Clinical narrative: 08/09/2019 2:30pm presented for 4 month immunizations. I gave patient rotatec, Pneumonccal and Pentacel. When I came back to triage room I saw I did not mix the Hib powder with the Dtap and IPV liquid. I saw the powder in the vial as I was dropping the vials into the sharps container. I took the sharps container and showed it to lpn and lpn the vial Hib in the sharps container. lpn called Sanofi and lpn told me Sanofi said to give Hib vaccine. I gave patient Hib 0.5ml in the right thigh. APRN notified when this occurred.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Hypoaesthesia oral, Oral mucosal eruption, Rash
Clinical narrative: Bumps roof of mouth numbness right side lips rash right arm 15 min. after injection went to ER still on Benedral 9/13/19
Age: 70.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Axillary mass, Gait disturbance, Influenza, Joint stiffness
Clinical narrative: RECEIVED THE MUMPS/MEASLES & RUBELLA VACCINE ON 08/27/2019.  AN ADVERSE REACTION OCCURED 09/08/2019 - FLU SYMPTOMS. ON 09/09/2019 - RASH & NECK LUMPS DEVELOPED.  09/10/2019 - RED BUMPS, WRIST, NECK AND KNEE STIFFNESS, DIAGNOSED WITH MACULOPAPULAR RASH. 09/11/2019 - ITCHING, MINOR WRIST PAIN, 2 FINGERS ON THE RIGHT HAND SWOLLEN, STIFF JOINTS AND NICK, MORE BUMPS ON THE CHEST & BACK, LUMPS UNDER THE EAR ARE TENDER, AND LUMP UNDER THE LEFT ARM PIT IS ALSO TENDER.  THE RIGHT BIG TOE JOINT STARING TO HURT, LIMITS ABILITY TO WALK CORRECTLY.
Age: 70.0
Sex: M
Vaccine: MMR
Symptoms: Musculoskeletal stiffness, Neck mass, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: RECEIVED THE MUMPS/MEASLES & RUBELLA VACCINE ON 08/27/2019.  AN ADVERSE REACTION OCCURED 09/08/2019 - FLU SYMPTOMS. ON 09/09/2019 - RASH & NECK LUMPS DEVELOPED.  09/10/2019 - RED BUMPS, WRIST, NECK AND KNEE STIFFNESS, DIAGNOSED WITH MACULOPAPULAR RASH. 09/11/2019 - ITCHING, MINOR WRIST PAIN, 2 FINGERS ON THE RIGHT HAND SWOLLEN, STIFF JOINTS AND NICK, MORE BUMPS ON THE CHEST & BACK, LUMPS UNDER THE EAR ARE TENDER, AND LUMP UNDER THE LEFT ARM PIT IS ALSO TENDER.  THE RIGHT BIG TOE JOINT STARING TO HURT, LIMITS ABILITY TO WALK CORRECTLY.
Age: 70.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash erythematous, Rash maculo-papular, Tenderness
Clinical narrative: RECEIVED THE MUMPS/MEASLES & RUBELLA VACCINE ON 08/27/2019.  AN ADVERSE REACTION OCCURED 09/08/2019 - FLU SYMPTOMS. ON 09/09/2019 - RASH & NECK LUMPS DEVELOPED.  09/10/2019 - RED BUMPS, WRIST, NECK AND KNEE STIFFNESS, DIAGNOSED WITH MACULOPAPULAR RASH. 09/11/2019 - ITCHING, MINOR WRIST PAIN, 2 FINGERS ON THE RIGHT HAND SWOLLEN, STIFF JOINTS AND NICK, MORE BUMPS ON THE CHEST & BACK, LUMPS UNDER THE EAR ARE TENDER, AND LUMP UNDER THE LEFT ARM PIT IS ALSO TENDER.  THE RIGHT BIG TOE JOINT STARING TO HURT, LIMITS ABILITY TO WALK CORRECTLY.
Age: 66.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache. I took ibuprofen for the past 20 hours but headache and sore arms did not go away completely. Now I have just taken excedrin.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pt's arm was swollen and painful.
Sex: F
Vaccine: HEP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Infant received Tdap immediately after birth due to medication error.  No adverse effects noted in the first 24 hours.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No adverse events noted.  Patient should have received DTaP at age 4. Tdap was given in error
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: PER PATIENT, SHE AWOKE THE NEXT MORNING WITH RED BUMPS FROM HER LEFT HAND UP HER LEFT ARM THAT LASTED FOR 2 DAYS.  DID NOT GO TO ER/UC, DID NOT REPORT TO CLINIC.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Fever, chills x 1 day (so far)
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary mass, Axillary pain, Lymph node pain
Clinical narrative: within 3-4 hours i felt a  huge soreness under my left armpit and yesterday  a lump formed i think its my lymph node. is a side affect of the flu shot your lymph nodes get inflamed. it hurts if i press on it or press my arm against my side. i have been using heating pad at home and motrin but im concerned.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: NP had ordered and was administering the HPV9 and Flu vaccine to the child.  The sibling was also with the parent and the parent decided she wanted the flu vaccine for the other child also. The flu vaccines were in different compartments but when NP started administering the vaccines she inadvertantly administerd the other flu vaccine to the same patient.  The first flu vaccine was given in the left arm and the other in the right arm.  The parent was told and educated on what had happened.  She was told to contact our office if any adverse effects were noted.  She was watched for 15 minutes in our office without any adverse effects as of yet.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain in extremity, Tenderness
Clinical narrative: Patient states onset of severe pain and tenderness from Left shoulder blade to Left wrist on Wednesday 09/18/2019. Unrelieved by extra strength Tylenol or lidocaine patch. States unable to raise Left arm above ear level.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Dry skin, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Rash is located on the legs and is described as red, flat, nondraining.  Treatments tried at home are Benadryl- 17.5 hours ago Antihistamine cream- 17.5 hours ago  HPI - Additional information: Felt well until 1 night ago. Sx began with red, swollen, nontender, non itchy area on right  lateral thigh that was hot to touch and rough on palpation.