chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Respiratory tract infection
Clinical narrative: Respiratory infection; Information has been received from a lawyer via a case in litigation (# 1711USA002107) referring to a currently  69 year old female patient. Information about concurrent condition, medical history and concomitant medication was unknown. In 2016 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown, reported as Pneumonia vaccine) (strength, dose, route, lot# and expiration date not reported) for prophylaxis. On an unknown date, the patient experienced adverse reaction of respiratory infection. The outcome of respiratory infection was unknown. The reporter considered respiratory infection to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown, reported as Pneumonia vaccine).      Upon internal review, the event respiratory infection was determined to be medically significant.; Sender's Comments:  US-009507513-1711USA002107:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Joint range of motion decreased, Limb discomfort
Clinical narrative: Felt tired; Arm discomfort; Limited range of motion of arm; This case was reported by a pharmacist via call center representative and described the occurrence of arm discomfort in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number JC55P, expiry date 15th November 2021) for prophylaxis.   On 15th August 2019, the patient received the 2nd dose of Shingrix. On 16th August 2019, 1 days after receiving Shingrix, the patient experienced arm discomfort and joint range of motion decreased. On an unknown date, the patient experienced tiredness. On an unknown date, the outcome of the arm discomfort and joint range of motion decreased were not recovered/not resolved and the outcome of the tiredness was unknown.   It was unknown if the reporter considered the arm discomfort, joint range of motion decreased and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and a day after began experiencing arm discomfort and limited range of motion of her arm. It had slightly improved but had not resolved. She also felt tired but feels tired normally. The reporter consented to follow up. The registered pharmacist agreed to follow up. This case is 2 of the 2 linked cases, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event, Ill-defined disorder
Clinical narrative: Bad Reaction; This case was reported by a consumer via call center representative and described the occurrence of ill-defined disorder in an unspecified number of  adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not applicable. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The reporter stated that, when she was at doctor's office with her husband for his regular follow up visit, the physician mentioned that some patients had a bad reaction to the first dose of Shingrix and they denied to get the second dose of Shingrix. No further details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Felt like had the flu; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years 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 age at vacination was not reported. The patient stated that, after vaccination with dose of Shingrix, felt like had the flu. The patient asked, if it was ok, that her husband wanted to get Shingrix shot at the same time of his flu shot. The patient stated that, her husband received Pneumovax, 2 weeks ago and said to wait 4 weeks to get Shingix shot.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Tiredness; This case was reported by a consumer and described the occurrence of tiredness in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2019, the patient received Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The day before reporting, the patient received dose of Shingrix and experienced tiredness. The patient asked, how long should tiredness side effect last.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle soreness; This case was reported by a consumer and described the occurrence of muscle soreness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2019, the patient received Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced muscle soreness. On an unknown date, the outcome of the muscle soreness was unknown.   It was unknown if the reporter considered the muscle soreness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. In the afternoon on the day of reporting, the patient received dose of Shingrix and experienced muscle soreness. The patient asked, how long did it typically last and when was it ok to exercise.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever; Felt tired; This case was reported by a nurse via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fever and tiredness. On an unknown date, the outcome of the fever and tiredness were unknown.   It was unknown if the reporter considered the fever and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the OBGYN on staff reported a fever of 101.6F and that they felt tired the day after receiving the 2nd dose of Shingrix. The reporter consented to follow up.  The nurse did not have any specific data to report.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a physician via call center representative and described the occurrence of rash in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient developed a rash and had developed more within the last 3 to 4 days from the time of reporting. The reporter stated that the patient did not know the exact date of the vaccination nor the expiration date and lot number.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Dizziness, Heart rate increased, Influenza like illness
Clinical narrative: diarhea; Dizzy Spells; flu-like symptoms; increased heart rate, 106 bpm; Feeling weak; increased respiratory rate; injection site pain; injection site firmness; Injection Site Swelling; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included pneumococcal immunization.   On 10th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th September 2019, 12 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, heart rate increased, feelings of weakness, respiratory rate increased, injection site pain, injection site induration and injection site swelling. On 11th September 2019, the patient experienced diarrhea and dizzy spells. The patient was treated with antihistamine (Anti Histamine). On an unknown date, the outcome of the influenza-like symptoms, heart rate increased, respiratory rate increased and diarrhea were resolved with sequelae and the outcome of the feelings of weakness, injection site pain, injection site induration, injection site swelling and dizzy spells were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, heart rate increased, feelings of weakness, respiratory rate increased, injection site pain, injection site induration, injection site swelling, diarrhea and dizzy spells to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient stated that 12 hours later vaccination experienced flu like symptoms, increased heart rate, feeling weak, increased respirator rate, and injection site pain, swelling and firmness. The patient stated that after 24 hours of vaccination experienced diarrhea and dizzy spells. At the time of reporting all events resolved except feeling weak, injection site pain, injection site induration and injection site swelling. The patient stated that he went to healthcare professional regarding the events experienced and was told to take over the counter anti histamines. The healthcare professional told to avoid future pneumonia and all vaccines. The patient consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Respiratory rate increased
Clinical narrative: diarhea; Dizzy Spells; flu-like symptoms; increased heart rate, 106 bpm; Feeling weak; increased respiratory rate; injection site pain; injection site firmness; Injection Site Swelling; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included pneumococcal immunization.   On 10th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th September 2019, 12 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, heart rate increased, feelings of weakness, respiratory rate increased, injection site pain, injection site induration and injection site swelling. On 11th September 2019, the patient experienced diarrhea and dizzy spells. The patient was treated with antihistamine (Anti Histamine). On an unknown date, the outcome of the influenza-like symptoms, heart rate increased, respiratory rate increased and diarrhea were resolved with sequelae and the outcome of the feelings of weakness, injection site pain, injection site induration, injection site swelling and dizzy spells were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, heart rate increased, feelings of weakness, respiratory rate increased, injection site pain, injection site induration, injection site swelling, diarrhea and dizzy spells to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient stated that 12 hours later vaccination experienced flu like symptoms, increased heart rate, feeling weak, increased respirator rate, and injection site pain, swelling and firmness. The patient stated that after 24 hours of vaccination experienced diarrhea and dizzy spells. At the time of reporting all events resolved except feeling weak, injection site pain, injection site induration and injection site swelling. The patient stated that he went to healthcare professional regarding the events experienced and was told to take over the counter anti histamines. The healthcare professional told to avoid future pneumonia and all vaccines. The patient consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: redness at injection site; swelling at injection site / swelling; warm to the touch / warmness at injection site; fever; sore arm / arm soreness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 249DB, expiry date 8th November 2021) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 12th September 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site warmth, fever and pain in arm. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth, fever and pain in arm were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, fever and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm. The reporter reported that one day after receiving dose 1 of Shingrix, the patient experienced redness at injection, warmness at injection site, arm pain, arm soreness, fever, and swelling. The patient went to urgent care and was given unspecified medications. The symptoms were improving. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Bump located a couple inches below the injection site; Warm bump; Red bump; This case was reported by a nurse via sales rep and described the occurrence of injection site swelling 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, 5 days after receiving Shingrix, the patient experienced injection site swelling, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site erythema were unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to Shingrix.  Additional case details were reported as follows: The healthcare professional did not provide patient demographics, lot number, or expiration date of vaccine. The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The patient experienced a bump approximately five days after receiving dose one of Shingrix. The healthcare professional described bump as being located a couple inches below the injection site, 1.5 inches in diameter, warm, and red.  The outcome for bump was unknown.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site reaction, Pain, Skin warm
Clinical narrative: warmth to touch; injection site reaction; knot at injection site; body aches; This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th June 2019, 1 days after receiving Shingrix, the patient experienced injection site reaction, injection site lump and general body pain. On 7th September 2019, the patient experienced skin warm. On an unknown date, the outcome of the injection site reaction, injection site lump, general body pain and skin warm were recovered/resolved.   It was unknown if the reporter considered the injection site reaction, injection site lump, general body pain and skin warm to be related to Shingrix.  Additional case details were provided as follows: The patient received Shingrix in left deltoid. On 27th June 2019 and day after Shingrix, the patient experienced injection site reaction. On 7th September 2019, the patient reported, she felt as she developed a delayed injection site reaction. All the events had resolved. The reporter did not consent to follow-up.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine; shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 20th June 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In July 2019, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were provided as follows: The patient reported for herself. In July 2019, the patient developed shingles after receiving one dose of Shingrix.  The patient forgot to receive the 2nd dose according to the recommended dosing schedule and till the time of reporting she did not receive the 2nd dose, which led to incomplete course of vaccination. The patient did not consent to follow-up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Fatigue, Headache, Myalgia
Clinical narrative: fever; rigors; myalgia; fatigue; huddled down in bed; headaches; shaking; This case was reported by a physician via call center representative and described the occurrence of fever in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received vaccine on an unknown date).   On 4th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th September 2019, 21 hrs after receiving Shingrix, the patient experienced fever, rigors, myalgia, fatigue, bedridden, headache and tremor. On an unknown date, the outcome of the fever and rigors were unknown and the outcome of the myalgia, fatigue, bedridden, headache and tremor were recovered/resolved.   It was unknown if the reporter considered the fever, rigors, myalgia, fatigue, bedridden, headache and tremor to be related to Shingrix.  Additional details were provided as follows: The patient stated that after receiving vaccine experienced fever that felt like rigors and a lot of myalgia that was preceded by fatigue. The patient was huddled down in bed. The patient lost the whole next day because of the myalgia and fatigue. By that afternoon he went home and crawled into bed and  significant shaking and fever started. The patient also experienced headache and was gone by the next morning. The patient slept 17 hours in total. The shaking lasted about a good 3 hours. The patient consented to follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: fever; rigors; myalgia; fatigue; huddled down in bed; headaches; shaking; This case was reported by a physician via call center representative and described the occurrence of fever in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received vaccine on an unknown date).   On 4th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th September 2019, 21 hrs after receiving Shingrix, the patient experienced fever, rigors, myalgia, fatigue, bedridden, headache and tremor. On an unknown date, the outcome of the fever and rigors were unknown and the outcome of the myalgia, fatigue, bedridden, headache and tremor were recovered/resolved.   It was unknown if the reporter considered the fever, rigors, myalgia, fatigue, bedridden, headache and tremor to be related to Shingrix.  Additional details were provided as follows: The patient stated that after receiving vaccine experienced fever that felt like rigors and a lot of myalgia that was preceded by fatigue. The patient was huddled down in bed. The patient lost the whole next day because of the myalgia and fatigue. By that afternoon he went home and crawled into bed and  significant shaking and fever started. The patient also experienced headache and was gone by the next morning. The patient slept 17 hours in total. The shaking lasted about a good 3 hours. The patient consented to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Bacterial infection, Cellulitis, Hypersensitivity, Peripheral swelling, Urticaria
Clinical narrative: Cellulitis; Welts/ welts on their arm; Swelling/ arm swelled up pretty big; allergic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a patient who received HAV (Havrix) for prophylaxis.   Concomitant products included PNEUMOCOCCAL VACCINE (PNEUMOVAX-23).   On 17th September 2019, the patient received Havrix. On an unknown date, less than a week after receiving Havrix, the patient experienced cellulitis (serious criteria GSK medically significant), welts, swelling arm and allergic reaction. On an unknown date, the outcome of the cellulitis, welts, swelling arm and allergic reaction were unknown.   It was unknown if the reporter considered the cellulitis, welts, swelling arm and allergic reaction to be related to Havrix.  Additional details were provided as follows: The age at vaccination not reported at time of report. The pharmacist gave a patient Pneumovax-23 and Havrix in the same arm, then the patient developed what sounds like an allergic reaction.  They had welts on their arm, cellulitis, and the arm swelled up pretty big. The patient's physician told them the reaction was due to bacteria build up because the vaccines were given in the same arm. The reporter stated that vaccines given in their own syringes in separate sites, but in the same arm.  The reporter gave the vaccines at a clinic she ran at the location indicated under vaccine facility details; however, she works out of the address for the contact profile. The reporter does not have any further information, she does not even know who the patient was at this time. Same information as passed along to her. The reporter was consented to follow up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: seizure; This case was reported by a consumer via call center representative and described the occurrence of seizure in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix (intramuscular). In September 2019, less than a week after receiving Shingrix, the patient experienced seizure (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the seizure was recovered/resolved.   It was unknown if the reporter considered the seizure to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient experienced a seizure for which he was hospitalized. On 20th September 2019, the patient was discharged from the hospital. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles after 1st dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of shingles 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, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The pharmacist reported that, the patient experienced Shingles after vaccination with dose of Shingrix. The reporter did not have patient information and expiry date of Shingrix at the time of call. The reporter consent to follow up.
Age: 16.0
Sex: F
Vaccine: HPVX, MENB, MNQ
Symptoms: Syncope
Clinical narrative: patient fainted in the room; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A 16-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, Lot# AN2721 and Exp. 20Apr2021, 1st dose), hpv vaccine and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA); all via unspecified routes of administration on 16Sep2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. Three minutes after being vaccinated on 16Sep2019, the patient fainted in the room. After a few minutes of resting in the room she was allowed to walk out with parent and fainted again at checkout. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Muscle spasms, Syncope, Tremor
Clinical narrative: Fainted; Shake hands; Spasm; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A 17-year-old male patient received meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date unknown), via an unspecified route of administration in late Aug2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient fainted within seconds of being given only meningococcal group b rlp2086 in late Aug2019, after a min or so patient woke and started to spasm and shake hands violently. He was restrained and within 30 seconds or so the patient settled down and after a few minutes of being stable was allowed to leave. The events recovered on an unspecified date.  No follow-up attempts are possible, information on the lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: U
Vaccine: DTAP, DTAPIPVHIB, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: exposed to 1.8 C for 1 hour 54 minutes and 1.9 C; Based on additional information received on 27-AUG-2019, case was upgraded to Valid from Non-Valid because patient was involved.  Initial information received on 06-Aug-2019 regarding an unsolicited non-valid non-serious case received from a nurse.  It was reported that vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and HIB (PRP/T) VACCINE [ACT-HIB] exposed to 1.8 c for 1 hour 54 minutes and 1.9 c. It was reported that a patient received Act-Hib but did not produce any adverse event.  Patient's  medical history and concomitant therapies were not reported.  It was of actual medication error due to incorrect product storage..  It was reported that no adverse event was noticed post vaccination with Act-Hib.  Information on the batch number was requested  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.  Follow-up information received on 27-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  Case was upgraded to valid. Significant information in Case was updated.  Information on the batch number was requested
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administered an Expired Menactra to a patient. Expired December 2018/ No AE; Based on information received on 18-SEP-2019, the report previously considered as non-valid became valid: patient identifier reported.  Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a non-health care professional (office staff).  This case involves 18 years old male patient (195 cm and 112.925 kg) who was vaccinated with 0.5 mL dose of expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U5766AE, expiry date- 02-Dec 2018 via intramuscular route in the right arm on 07-AUG-2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  No adverse event occurred post vaccination.  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.  Follow-up information was received on 18-SEP-2019 from Consumer/Non-HCP (practice manager).  Case validity, patient details, lot number, expiry date, dose, route and site of administration updated in field and narrative.  List of documents held by sender: none.
Sex: M
Vaccine: HEP, MNQ
Symptoms: Erythema, Inflammation, Peripheral swelling, Swelling
Clinical narrative: erythema, redness and swelling that went from the upper arm into the axillary area; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 years old male patient who experienced erythema, redness and swelling that went from the upper arm into the axillary area (Inflammation), while he received vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and HEPATITIS B VACCINE .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Sep-2019, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6179AA via intramuscular route in the left deltoid and a dose of suspect HEPATITIS B VACCINE (HEPATITIS B VACCINE) lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious erythema, redness and swelling that went from the upper arm into the axillary area (inflammation) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and HEPATITIS B VACCINE.  Other relevant tests were not reported.  Final diagnosis was erythema, redness and swelling that went from the upper arm into the axillary area.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for erythema, redness and swelling that went from the upper arm into the axillary area.  List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 52 year old male had a Fluzone HD, no side effects; 52 year old male had a Fluzone HD, no side effects; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 52 years old male patient who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (dosage form: prefilled syringe) lot UJ241AB expiry date: 18-Apr-2020 via unknown route in the left deltoid on 18-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given.  It is an actual medication error case due to inappropriate age of vaccine administration and overdose.   It was reported that the patient did not had any side effects.  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: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 49 year old patient was inadvertently given the Fluzone High Dose vaccine; A 49 year old patient was inadvertently given the Fluzone High Dose vaccine; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 49 years old female patient received 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ253AB via unknown route in unknown administration site on 17-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines received.   It was a case of actual medication error due to Inappropriate age at vaccine administration and overdose.  At the time of report, 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.  Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine given outside of indication/no AE; Vaccine given outside of indication/no AE; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves female patient of an unknown age who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ253AB via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Inappropriate age at vaccine administration and overdose.  At the time of report 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.  Documents held by sender: none.
Age: 9.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 9 year old female patient was inadvertently administered with Flublok vaccine, no AE; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked with case 2019SA262697 (same reporter)  This case involves a 9 years old female patient who was inadvertently received a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1913, expiry date: 29-Jun-2020) via intramuscular route in the deltoid NOS on 16-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9) on 16-Sep-2019, for Immunisation.  It was an actual medication error due to inappropriate age at vaccine administration.  Flublok is not FDA-approved for use in pediatric patients. Nurse stated that neither patient has experienced any adverse event.  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.
Age: 11.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 11 year old patient inadvertently administered the Flublok vaccine, no AE; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked with case 2019SA262695 (same reporter)  This case involves a 11 years old female patient who was inadvertently received a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1913, expiry date: 29-Jun-2020) via intramuscular route in the deltoid NOS on 16-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9); MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) on 16-Sep-2019 for Immunisation.  It was an actual medication error due to inappropriate age at vaccine administration.  The patient had no adverse event at the time of this report.  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.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 70 year old was given Adacel vaccination, no AE; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 70 years old female patient who received 0.5 ml dose vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number not reported via unknown route in unknown administration site on 17-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  It was an actual medication error case due to inappropriate age at vaccine administration.  It was reported that a 70 year old was given Adacel vaccination because her daughter is expecting, and it was recommended that as a grandmother she receive Tdap.  At the time of reporting, no adverse reactions were 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.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: a six month old male patient received only the Pentacel liquid Dtap IPVcomponent without mixing the powder HIB/No AE; Initial information and additional information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old male patient who only the pentacel liquid dtap ipv component without mixing the powder hib while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot U6397AA, expiry date: 29-Sep-2020, dose: 0.5 ml via intramuscular route in the left thigh on 18-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVENAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was an actual medication error due to inappropriate reconstitution technique.  Symptoms: None 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.  List of documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Injury
Clinical narrative: gave a tetanus shot (which did hurt); Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 72 years old female patient who gave a tetanus shot (which did hurt) (injury), while she received vaccine TETANUS TOXOID.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date following the vaccination the patient experienced injury (injury).  It was reported that physician put her on antibiotics in the emergency room.  (Other relevant tests included no lab data.) Final diagnosis was injury.   It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown at the time of reporting.  List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: unable to administer full 0.5 mL to patient. Tried miltiple syringes, needles, etc. Having no trouble administering other vaccines/ No AE; unable to administer full 0.5 mL to patient. Tried multiple syringes, needles, etc. Having no trouble administering other vaccines/ No AE; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves patient who unable to administer full 0.5 ml vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot number not reported via unknown route in unknown administration site on an unknown date, tried multiple syringes, needles.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of vaccine underdose and Liquid product flow abnormal. Staff unable to administer full 0.5 mL to patient. Tried multiple syringes, needles, etc. Having no trouble administering other vaccines.  At the time of report no adverse event was reported.  Information on the batch number was requested.  Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia
Clinical narrative: high fever; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old patient who experienced high fever (pyrexia), while received vaccine 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.  On an unknown date, the patient received a first  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious high fever (pyrexia) (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was high fever.  It was not reported if the patient received a corrective treatment.  On an unknown date, the event outcome is reported as Recovered for high fever.  Information on the batch number was requested.  Documents held by sender: none.