chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: The ActHIB (component from a Pentacel) was accidentally mixed with Quadracel (instead of the Pentacel DTaP-IPV component), no AE; Quadracel used as a diluent in 2 months old patient, no AE; Initial information received on 31-Mar-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a two months old male patient who received a 0.5 ml dose of the ACT-HIB component from a PENTACEL was accidentally mixed with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot: C5656AA, expiry date: 13-Aug-2021) instead of the DTaP-IPV component of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (first dose, lot: UJ197AAA, expiry date: 02-Mar-2021) on 26-Mar-2020, via an intramuscular route in the left thigh.   The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error due to wrong solution used in drug reconstitution and inappropriate age at vaccine administration.  It was reported that the Pentacel comes with a diluent. The nurse did not use that diluent. They used the Quadracel, which is the DTaP and polio, but they put it in with the HIB powder. That might happened because they were both blue and they were the same size. They were right down below (in the refrigerator). The ActHIB (component from a Pentacel) was accidentally mixed with Quadracel (instead of the Pentacel DTaP-IPV component). So, the Quadracel DTaP-IPV was put in the ActHIB powder.   At the time of reporting, the patient did not 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 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.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: the liquid part of the Pentacel was given to a child, no AE; Initial information received on 31-Mar-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 4 months old female patient who received a dose of only liquid part from the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL](lot: UJ259AAA, expiry date: 14-May-2021) on an unknown date via an intramuscular route in the left rectus formoris on 30-MAR-202.  The reported lot number for DTaP-IPV component- Liquid vial Lot: UJ331AA, expiry date: 14-May-2021 and  ActHib component lot: UJ182AA, expiry date: 08-Mar-2021.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)) for Immunisation.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of reporting, the patient did not experience 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 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.
Age: 64.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine had expired on 08-Mar-2020 but was administered to a patient; Initial information received on 25-Mar-2020 regarding an unsolicited valid non-serious case from a pharmacist in the.  This case involves a 64 years old female patient who was vaccinated with a expired 0.5 ml dose of vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot: U5882AA, expired on 08-Mar-2020) on 25-Mar-2020, via an intramuscular route in the left arm.   The patient's medical history, past medical treatment, past vaccination and family history were not provided.  It was an actual medication error due to expired vaccine used.  At the time of reporting the patient did not experience 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 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.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Tenivac inadvertently administered, no advesre event; Initial information received on 30-Mar-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves an unknown demographic patient who was vaccinated with an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number U5854AB and expiration date 30-Jun-2020) as prophylactic vaccination on an unknown date via unknown route at an unknown administration site.  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 reported at the time of reporting.  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.
Age: 3.0
Sex: F
Vaccine: UNK
Symptoms: Malaise
Clinical narrative: Kids is sick often never a Diagnosis
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain
Clinical narrative: I was given a flu shot at work by nurse brought in to provide the shot. I am not sure which flu vaccine it was. The next morning, the site where the shot was given was very sore. I was expecting this and didn't think anything about it. This pain lasted for months and it was so bad it kept me up at night. I finally went to the doctor who gave me a steroid shot in the arm that relieved the pain. I am who has had many shots - very big shots - and I never had a problem with them. I always had a problem with the flu shot giving me flu like symptoms but never had pain at the site of the shot before. Psychologically, I never had a problem even as a child with shots because I watched my sister (Type 1 diabetic) have shots every day. The pain was very real and significant. Given that I have very prevalent autoimmune disease in my family and I have POTS which researchers have discovered may be an autoimmune disease, I have read that having a shot could be dangerous. Never being prone to getting the flu, even as a child, I have decided to not get the flu shot until more research is done on why people are reacting badly to it.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: How long can the reaction last; This case was reported by a other health professional via interactive digital media and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter asked how long can the reaction last after vaccination.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient receives an expired dose of ActHib described as the ActHIB portion was still within date but the diluent had expired/No AE; Initial information was received on 31-Mar-2020 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff).  This case involves a 12 months old male patient who on 24-Mar-2020  was vaccinated with 0.5 ml dose of  HIB (PRP/T) VACCINE [ACT-HIB] (lot UI959AA  and expiry date of diluent was 07-MAR-2020  and ActHIB 19-Jun-2020) intramuscular route in the left thigh for prophylactic vaccination but the portion of vaccine was still within date but the diluent had expired (expired product administered).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL VACCINE CONJ) [PCV-HAV] for immunisation.  Reporter stated that the box states the medication was expired not the bottle as the expiration date of bottle was 19-Jun-2020 and box had expired on 07-Mar-2020.  No laboratory data was reported.  It was an actual medication error case due to expired vaccine used.   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 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.
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received a dose of TDap, before her dose was due, patient's last dose was in 2016 and she received a  dose on 01-Apr-2020/ No AE; Initial information was received on 02-Apr-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 45 years old female patient who in 2016 received dose one of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number not reported) via unknown route in unknown administration site and on 01-Apr-2020 received dose two of the same vaccine (lot U6512AA and expiry date 31-Oct-2021), via intramuscular route in the left deltoid for prophylactic vaccination (inappropriate schedule of product administration)  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) and INFLUENZA VACCINE (FLU) for immunisation.  It was an actual medication error case due to inappropriate schedule of product administration.   At a time of reporting no adverse event reported.  There will be no information available on the batch number of first dose of the product for this case.  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. 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.
Sex: U
Vaccine: RAB
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: patients received day 0 dose of Imovax Rabies but  did not come back yet for day 3  dose/ No  AE; Initial information was received on 31-Mar-2020 regarding an unsolicited valid non-serious case from a nurse  This case involves family of four patients of unknown demographics who were vaccinated with first dose (Day 0) of RABIES (HDC) VACCINE [IMOVAX RABIES] (lot number and expiry date were not reported) via unknown route in an unknown administration site for post exposure immunisation on but the patients did not come back yet for next (Day 3) dose (incomplete course of vaccination)  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  It was an actual medication error case due to incomplete course of vaccination as the family did not come back yet for next (Day 3) dose.  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 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.  There will be no information available on the batch number for this case.
Age: 63.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Tenivac was administered to a patient, no adverse event; Initial information received on 30-Mar-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 63 years old female patient who vaccinated with an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was received.   On 29-Mar-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot number U5854AA, expiry date:25-Jan-2020) via intramuscular route in the left deltoid as prophylactic vaccination.  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  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.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain
Clinical narrative: Patient states she experienced pain immediately upon vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Heart rate increased, Insomnia, Myalgia
Clinical narrative: rapid heartbeat; high fever; felt horrible; my muscles hurting so bad; couldn't sleep last night due to my muscles hurting so bad / Last night I couldn't sleep because my muscles were hurting really bad /; I am feeling extremely tired; This case was reported by a consumer via interactive digital media and described the occurrence of myalgia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2020, the patient received the 1st dose of Shingrix. On 10th March 2020, less than a day after receiving Shingrix, the patient experienced myalgia, insomnia and fatigue. On an unknown date, the patient experienced heartbeats increased, fever and feels awful. On an unknown date, the outcome of the myalgia, insomnia, fatigue, heartbeats increased, fever and feels awful were unknown.   It was unknown if the reporter considered the myalgia, insomnia, fatigue, heartbeats increased, fever and feels awful 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 patient received dose late on the day, before reporting, and experienced myalgia, insomnia and fatigue. The reporter asked, should get 2nd dose dose of Shingrix, if experienced rapid heartbeat, high fever, and felt horrible after the 1st dose.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: rapid heartbeat; high fever; felt horrible; my muscles hurting so bad; couldn't sleep last night due to my muscles hurting so bad / Last night I couldn't sleep because my muscles were hurting really bad /; I am feeling extremely tired; This case was reported by a consumer via interactive digital media and described the occurrence of myalgia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2020, the patient received the 1st dose of Shingrix. On 10th March 2020, less than a day after receiving Shingrix, the patient experienced myalgia, insomnia and fatigue. On an unknown date, the patient experienced heartbeats increased, fever and feels awful. On an unknown date, the outcome of the myalgia, insomnia, fatigue, heartbeats increased, fever and feels awful were unknown.   It was unknown if the reporter considered the myalgia, insomnia, fatigue, heartbeats increased, fever and feels awful 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 patient received dose late on the day, before reporting, and experienced myalgia, insomnia and fatigue. The reporter asked, should get 2nd dose dose of Shingrix, if experienced rapid heartbeat, high fever, and felt horrible after the 1st dose.
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Fatigue, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: fever of 99.3 degrees Fahrenheit; Bedridden; Headache; Feel tired; injection site became painful/The whole muscle at the injection site ached/painful to touch/ Tenderness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th February 2020 10:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 19th February 2020, immediately after receiving Shingrix , the patient experienced injection site pain. On 19th February 2020 03:00, the patient experienced tiredness. On 19th February 2020 06:00, the patient experienced headache. On 20th February 2020, the patient experienced fever and bedridden. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the tiredness, headache and fever were recovered/resolved and the outcome of the bedridden was unknown.   It was unknown if the reporter considered the injection site pain, tiredness, headache, fever and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 54 years or 55 years. The patient received Shingrix in the left arm. The patient reporter the injection site became painful almost immediately after vaccination.  Around 3:00 pm, 5 hours after receiving the vaccination, she began to feel tired.  At 6:00 pm, 8 hours after vaccination, she developed a headache and took Motrin.  In the morning of 20th February 2020, 1 day after vaccination, the patient noted that she had a fever of 99.3 degrees F and a headache. She again took Motrin. The patient stayed in bed until 5:00 pm because of the symptoms. She had not had the symptoms since but stated she had been continuously taking Motrin so she did not know if that was masking the symptoms. The patient stated that the whole muscle at the injection site ached after vaccination although it was not as painful and only painful to the touchon the day of reporting. The reporter given permission to contact but unable to obtain additional details. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever of 99.3 degrees Fahrenheit; Bedridden; Headache; Feel tired; injection site became painful/The whole muscle at the injection site ached/painful to touch/ Tenderness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th February 2020 10:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 19th February 2020, immediately after receiving Shingrix , the patient experienced injection site pain. On 19th February 2020 03:00, the patient experienced tiredness. On 19th February 2020 06:00, the patient experienced headache. On 20th February 2020, the patient experienced fever and bedridden. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the tiredness, headache and fever were recovered/resolved and the outcome of the bedridden was unknown.   It was unknown if the reporter considered the injection site pain, tiredness, headache, fever and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 54 years or 55 years. The patient received Shingrix in the left arm. The patient reporter the injection site became painful almost immediately after vaccination.  Around 3:00 pm, 5 hours after receiving the vaccination, she began to feel tired.  At 6:00 pm, 8 hours after vaccination, she developed a headache and took Motrin.  In the morning of 20th February 2020, 1 day after vaccination, the patient noted that she had a fever of 99.3 degrees F and a headache. She again took Motrin. The patient stayed in bed until 5:00 pm because of the symptoms. She had not had the symptoms since but stated she had been continuously taking Motrin so she did not know if that was masking the symptoms. The patient stated that the whole muscle at the injection site ached after vaccination although it was not as painful and only painful to the touchon the day of reporting. The reporter given permission to contact but unable to obtain additional details. The reporter consented to follow up.
Sex: F
Vaccine: RAB
Symptoms: Muscle spasms
Clinical narrative: Muscle spasms in her arms and legs; This case was reported by a consumer via call center representative and described the occurrence of muscle spasm in a female patient who received Rabies NVS (RabAvert) for prophylaxis.   The patient's past medical history included animal bite and tingling (Prior to getting the vaccine, the patient had tingling in her left arm).   On an unknown date, the patient received RabAvert at an unknown dose. On an unknown date, unknown after receiving RabAvert, the patient experienced muscle spasm. On an unknown date, the outcome of the muscle spasm was recovering/resolving.   It was unknown if the reporter considered the muscle spasm to be related to RabAvert.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. It was reported as the patient was given the series of the Rabavert vaccine after exposure to a bat.  Prior to getting the vaccine, the patient had tingling in her left arm.  After receiving the vaccine the patient had muscle spasms in her arms and legs and patient visited the emergency room four times.  The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Swelling
Clinical narrative: Swelling; Redness; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In November 2019, unknown after receiving Shingrix, the patient experienced swelling, erythema and fatigue. On an unknown date, the outcome of the swelling, erythema and fatigue were recovered/resolved.   It was unknown if the reporter considered the swelling, erythema and fatigue to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported. The events occurred 5 months prior to the date of reporting and lasted for 3 days. No further details were provided.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site dryness, Injection site exfoliation
Clinical narrative: has dry flaky skin in the shape of a circle where she got the injection; has dry flaky skin  in the shape of a circle where she got the injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site dryness in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number 2K9T2, expiry date 30th April 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 24th January 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site dryness and injection site exfoliation. On an unknown date, the outcome of the injection site dryness and injection site exfoliation were recovering/resolving.   It was unknown if the reporter considered the injection site dryness and injection site exfoliation to be related to Shingrix.  Additional case details were reported as follows: The reporter stated that the patient had dry flaky skin in the shape of a circle where she got the injection after vaccination. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: ActHIB is given with sterile water/no AE; Initial information received on 02-Apr-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 1 years old male patient who was administered HIB (PRP/T) VACCINE [ACT-HIB] with sterile water (Inappropriate reconstitution technique, PT- Product preparation issue).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 09-Mar-2020, the patient received a fourth 0.5mL dose of suspect HIB (PRP/T) VACCINE lot UJ116AAA expiry date 24-Aug-2020 via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to product preparation error.  At the time of this 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 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.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fall, Fatigue, Gait inability
Clinical narrative: shivering, sweating, fatigue, severe dizziness, collapsed 3 times in 24 hours, hurt  myself when I fell and can't walk now. Called Dr., the nurse I spoke with said the Doctor said she has heard of this and it will go away in 2-3 days... would have been even worse if my husband hadn't been home (he often travels for work).  Can't do anything without him because of the injury.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Syncope
Clinical narrative: shivering, sweating, fatigue, severe dizziness, collapsed 3 times in 24 hours, hurt  myself when I fell and can't walk now. Called Dr., the nurse I spoke with said the Doctor said she has heard of this and it will go away in 2-3 days... would have been even worse if my husband hadn't been home (he often travels for work).  Can't do anything without him because of the injury.
Age: 0.17
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no known ADR to present
Age: 59.0
Sex: M
Vaccine: FLUR4
Symptoms: Imaging procedure, Musculoskeletal pain
Clinical narrative: PT COMPLAINING OF A SORE SHOULDER ON 3/30/2020 AFTER GETTING A FLU SHOT ON 10/26/2020. Telephonic - pain on top of shoulder. No chronic dz reported but on f/u mentioned that he does have HTN.. Another pharmacist(son?) & his PCP said the shot was given too high, but unk. Pt had shoulder surgery 3-5 yrs ago. Intermittent pain, improvement w/ occ ibu & heat. Worsens when raising hand above head or inwardly rotating. Asking for options to help improve. Disc trying ice no more than 20' at a time, regular use of ibu x 7 days for poss inflammation, APAP, and/or slow gentle movement to strengthen & stretch. Emphasized the importance of pain free ROM. He reported that MD took imaging 1 mo ago, nothing seen. Seeing the MD that did the shoulder surgery could help, but with current COVID outbreak, minimizing elective contact w/ other pts & hcp would be rec. Rec taking ibu w/ food/antacids if chooses to take regularly. Disc poss s/e. Follow up with staff on 4/8/2020, he didn't try any of the things we talked about, confirmed that his shoulder hurt after the shot typical of most shots, but then never stopped. He has been doing a lot of remodeling that has also made it sore. Emphasized again the importance of pain free ROM, he will try the heat more often & ibuprofen more regularly w/ food.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Middle insomnia, Pain
Clinical narrative: Patient reports that she had soreness at the site of the Shingrix injection that started 1 day after her injection. She thought the pain would go away but she continues to have it (duration >6 months) in her right arm. The pain wakes her up at night and hurts when lifting her arm in the motion of her putting on her deodorant.
Sex: F
Vaccine: VARZOS
Symptoms: Cognitive disorder, Condition aggravated, Dizziness, Feeling abnormal, Hypersensitivity
Clinical narrative: worsening migraine; mild cognitive impairment; tremors; sustained vertigo; brain fog; tingling in right hand; subjective visual disturbance/ dizzy episodes which had affected eyes; dizzy episodes; This case was reported by a lawyer and described the occurrence of migraine aggravated in a female patient who received Herpes zoster (Shingrix) for prophylaxis.  The follow-up information received via Medical record on 03 April 2020. The patient concurrent medical conditions included migraine. As per the Medical record, on 19 April 2019, the patient had GSK suspect vaccine included immunizations varicella zoster 50 yrs plus (shingrix - shingles) 0.5 ml intramuscular administered per md order. The second dose shingrix appointment scheduled. On 26 April 2019, the patient reported that he  had took a Shingles Vaccine last week, after 5 minutes while sitting in car got an allergic reaction with an episode of Vertigo that lasted 90 seconds. The patient had some dizzy episodes which had affected eyes, tremors and right hand tingling along with vertigo. The patient had Sumatriptan (Imitrex) 50 mg oral tablet take one tablet by mouth at onset of migraine headache. May repeat 1 time after 2 hours if migraine is not relieved. On 16 May 2019, the patient experience more brain fog. On 16 May 2019, the patient had MRI of brain and brain stem wo/w contrast which shows mild cognitive impairment, tremor and migraine. Since the patient had worsening migraines, at times numbness on hands/fingers, feels experiencing more brain fog. On 28 May 2019, the patient hospitalized and diagnosed with mild cognitive impairment, tremor and migraine. On 30 May 2019, the patient had a reaction to Shingrix as well subjective visual disturbance. The patient discharged on same day. On 23 April 2019, the patient had vertigo.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Magnetic resonance imaging brain abnormal, Migraine, Paraesthesia, Scan with contrast abnormal
Clinical narrative: worsening migraine; mild cognitive impairment; tremors; sustained vertigo; brain fog; tingling in right hand; subjective visual disturbance/ dizzy episodes which had affected eyes; dizzy episodes; This case was reported by a lawyer and described the occurrence of migraine aggravated in a female patient who received Herpes zoster (Shingrix) for prophylaxis.  The follow-up information received via Medical record on 03 April 2020. The patient concurrent medical conditions included migraine. As per the Medical record, on 19 April 2019, the patient had GSK suspect vaccine included immunizations varicella zoster 50 yrs plus (shingrix - shingles) 0.5 ml intramuscular administered per md order. The second dose shingrix appointment scheduled. On 26 April 2019, the patient reported that he  had took a Shingles Vaccine last week, after 5 minutes while sitting in car got an allergic reaction with an episode of Vertigo that lasted 90 seconds. The patient had some dizzy episodes which had affected eyes, tremors and right hand tingling along with vertigo. The patient had Sumatriptan (Imitrex) 50 mg oral tablet take one tablet by mouth at onset of migraine headache. May repeat 1 time after 2 hours if migraine is not relieved. On 16 May 2019, the patient experience more brain fog. On 16 May 2019, the patient had MRI of brain and brain stem wo/w contrast which shows mild cognitive impairment, tremor and migraine. Since the patient had worsening migraines, at times numbness on hands/fingers, feels experiencing more brain fog. On 28 May 2019, the patient hospitalized and diagnosed with mild cognitive impairment, tremor and migraine. On 30 May 2019, the patient had a reaction to Shingrix as well subjective visual disturbance. The patient discharged on same day. On 23 April 2019, the patient had vertigo.
Sex: F
Vaccine: VARZOS
Symptoms: Tremor, Vertigo, Visual impairment
Clinical narrative: worsening migraine; mild cognitive impairment; tremors; sustained vertigo; brain fog; tingling in right hand; subjective visual disturbance/ dizzy episodes which had affected eyes; dizzy episodes; This case was reported by a lawyer and described the occurrence of migraine aggravated in a female patient who received Herpes zoster (Shingrix) for prophylaxis.  The follow-up information received via Medical record on 03 April 2020. The patient concurrent medical conditions included migraine. As per the Medical record, on 19 April 2019, the patient had GSK suspect vaccine included immunizations varicella zoster 50 yrs plus (shingrix - shingles) 0.5 ml intramuscular administered per md order. The second dose shingrix appointment scheduled. On 26 April 2019, the patient reported that he  had took a Shingles Vaccine last week, after 5 minutes while sitting in car got an allergic reaction with an episode of Vertigo that lasted 90 seconds. The patient had some dizzy episodes which had affected eyes, tremors and right hand tingling along with vertigo. The patient had Sumatriptan (Imitrex) 50 mg oral tablet take one tablet by mouth at onset of migraine headache. May repeat 1 time after 2 hours if migraine is not relieved. On 16 May 2019, the patient experience more brain fog. On 16 May 2019, the patient had MRI of brain and brain stem wo/w contrast which shows mild cognitive impairment, tremor and migraine. Since the patient had worsening migraines, at times numbness on hands/fingers, feels experiencing more brain fog. On 28 May 2019, the patient hospitalized and diagnosed with mild cognitive impairment, tremor and migraine. On 30 May 2019, the patient had a reaction to Shingrix as well subjective visual disturbance. The patient discharged on same day. On 23 April 2019, the patient had vertigo.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 55 years old patient received an expired dose of Tenivac vaccine/No AE; Initial information received on 01-Apr-2020 regarding an unsolicited valid non-serious case received from the other health care professional (medical assistant).  This case involves a 55 years old female patient who received an expired 0.5 ml booster dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] lot U5882AA, expiry date: 08-Mar-2020 via intramuscular route in the left deltoid o 01-Apr-2020 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  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 holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Blindness, Deafness, Dyspnoea, Headache
Clinical narrative: Patient stated she experienced headache, hearing/vision loss for short period of time, faint, weakness, shortness of breath - during the day after vaccine
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Syncope
Clinical narrative: Patient stated she experienced headache, hearing/vision loss for short period of time, faint, weakness, shortness of breath - during the day after vaccine
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Computerised tomogram normal, Facial paralysis
Clinical narrative: My son started to have little no movement on the right side of his face. I took him to the ER and he was diagnosed with Bell Palsy.
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Area of erythema developed to (R) thigh.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Outbreak of hives on legs for a duration of 2-2.5 months. Non perscription topical ointment used.  Experation of vaccine 10/19/21 Dosage: 50 mcg/0.5 ml
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives noted on Rt wrist, on left arm adjacent to vaccine site, left elbow & on arm below vaccine site hives started 1 hour after vaccination
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Decreased appetite, Diarrhoea, Headache
Clinical narrative: I had the first dose on 1-14-2020. Within a half hour I had severe chills, muscle aches, headache, back pain, nausea, then diarrhea. I got extremely hot to touch and spiked a fever to 102. I was unsure it was from the vaccine because their was a virus going around at the time. Then I got the second dose on 4-9-2020 at 8:30 am. By 9:30 am I was having all the above symptoms again. Everything was the same as the first dose only worse this time. Both times it lasted 3 full days. I watched my temperature and took Tylenol to bring it down. I couldn't eat anything for 2 days each time. I was required to have this vaccine prior to transplant. I had the Zostavax years ago with no reaction.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia, Skin warm, Vaccine positive rechallenge
Clinical narrative: I had the first dose on 1-14-2020. Within a half hour I had severe chills, muscle aches, headache, back pain, nausea, then diarrhea. I got extremely hot to touch and spiked a fever to 102. I was unsure it was from the vaccine because their was a virus going around at the time. Then I got the second dose on 4-9-2020 at 8:30 am. By 9:30 am I was having all the above symptoms again. Everything was the same as the first dose only worse this time. Both times it lasted 3 full days. I watched my temperature and took Tylenol to bring it down. I couldn't eat anything for 2 days each time. I was required to have this vaccine prior to transplant. I had the Zostavax years ago with no reaction.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13
Symptoms: Injection site reaction, Local reaction
Clinical narrative: LOCALIZED RXN TO MMR/PREVNAR--- > LEFT THIGH  TYLENOL / WARM COMPRESSES
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Pyrexia, Vomiting
Clinical narrative: FEVER, ERYTHEMA AND PAIN AT SITE OF INJECTION, SEEMS LIKE CELLULITIS AND VOMITING
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Patient received vaccine Wed 4-8-20. She noticed itchiness 4-10-20. The itchiness increased on 4-11-20 & also noticed swelling, rosey red & warm to touch. She called & spoke w/ Dr's office who told her with normal range for now & to take Benadryl & a warm compress. I advised cool compress & to follow up w/MD. Pt reported 6" spreading toward elbow.
Age: 67.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Hypoaesthesia, Injection site mass, Injection site pain, Migraine
Clinical narrative: On 10/13/2018, 24 hours after my Hepatitis A vaccination in my LEFT ARM, the left shoulder muscle pain was extremely tender. No surprise, I thought that was expected. By bedtime a severe headache (HA) began. Initially the HA came on as a wallop of excruciating sudden onset pain on my LEFT-SIDE. Similar to a migraine HA but with no sensitivity to smell, light or sound. It was deep in the skull from crown of my head behind left temple & ear to right above my cervical spine. I had also kinked my neck several times as I turned my head, so I thought it was a cervical pressure issue. The HA was followed by verious nerve pains, causing tingling to numb extremities. The nerve pain did not last, however a slight tingling numbness near the left temple has remained. The next morning a lump on the muscle over my left shoulder blade was found, and for a short time my right shoulder was also cramping. All the above pain reactions occurred at various times over the course of the first 10 days, beginning within 24 hours of the Hep A vaccination shot. Every day since 10/13/2018 at 4pm... the day following my HepA immunization pain began. First in my left shoulder, nearest the injection site. By 2am, a sudden onset severe migraine headache (9) began. Then again (3-9) occurring intermittently.Sudden onset intermittent waves of LEFT side skull pain(2-8) was persistent through the next four days.   10/17 - Day 5  I took 50mg Benadryl to help me get to sleep, but headache pain(8) came back before daylight. On Thursday 10/18 - Day 6  I began taking Tylenol PM, 1000mg Acetaminophen with 50mg Benadryl, at bedtime. Before daylight I was awaken by LEFT side throbbing headache skull & cervical pain(8).  On Friday 10/19 - Day 7 I began taking 1000mg of Acetaminophen every 8 hours with waves of relief lasting only about 2-4 hours (1-8).  On Monday 10/22 - Day 10 I got an appointment at HEALTH ADULT CARE to see my Physician's Assistant.  Due to my past history of Lyme Disease and several previous migraines treated by Imitrex, plus our recent move; my PA concluded that this headache may be caused by muscle spasms rather than the recent Hep A vaccination. I was instructed to stop using heat and only use ice - no heat. PA prescribed:  1) Methylprednisolone (steroid)  2) Cyclobenzaprine (muscle relaxer)
Age: 67.0
Sex: F
Vaccine: HEPA
Symptoms: Muscle spasms, Neck pain, Neuralgia, Pain, Paraesthesia
Clinical narrative: On 10/13/2018, 24 hours after my Hepatitis A vaccination in my LEFT ARM, the left shoulder muscle pain was extremely tender. No surprise, I thought that was expected. By bedtime a severe headache (HA) began. Initially the HA came on as a wallop of excruciating sudden onset pain on my LEFT-SIDE. Similar to a migraine HA but with no sensitivity to smell, light or sound. It was deep in the skull from crown of my head behind left temple & ear to right above my cervical spine. I had also kinked my neck several times as I turned my head, so I thought it was a cervical pressure issue. The HA was followed by verious nerve pains, causing tingling to numb extremities. The nerve pain did not last, however a slight tingling numbness near the left temple has remained. The next morning a lump on the muscle over my left shoulder blade was found, and for a short time my right shoulder was also cramping. All the above pain reactions occurred at various times over the course of the first 10 days, beginning within 24 hours of the Hep A vaccination shot. Every day since 10/13/2018 at 4pm... the day following my HepA immunization pain began. First in my left shoulder, nearest the injection site. By 2am, a sudden onset severe migraine headache (9) began. Then again (3-9) occurring intermittently.Sudden onset intermittent waves of LEFT side skull pain(2-8) was persistent through the next four days.   10/17 - Day 5  I took 50mg Benadryl to help me get to sleep, but headache pain(8) came back before daylight. On Thursday 10/18 - Day 6  I began taking Tylenol PM, 1000mg Acetaminophen with 50mg Benadryl, at bedtime. Before daylight I was awaken by LEFT side throbbing headache skull & cervical pain(8).  On Friday 10/19 - Day 7 I began taking 1000mg of Acetaminophen every 8 hours with waves of relief lasting only about 2-4 hours (1-8).  On Monday 10/22 - Day 10 I got an appointment at HEALTH ADULT CARE to see my Physician's Assistant.  Due to my past history of Lyme Disease and several previous migraines treated by Imitrex, plus our recent move; my PA concluded that this headache may be caused by muscle spasms rather than the recent Hep A vaccination. I was instructed to stop using heat and only use ice - no heat. PA prescribed:  1) Methylprednisolone (steroid)  2) Cyclobenzaprine (muscle relaxer)
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 103 with Tylenol x 3 days
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Pruritus, Skin disorder, Viral infection
Clinical narrative: WITH FIRST DOSE, PATIENT REPORTED BREAKING OUT ON HER SCALP FOLLOWING SECOND DOSE OF JANUARY 2020, PATIENT REPORTED THE BREAK OUTS STARTED ITCHING AND SPREADING TO OTHER BODY PARTS. DOCTOR RULED IT AS ALLERGIC DERMATITIS WHICH PATIENT REPORTS THAT THE ONLY THING CHANGED WAS THE ADMINISTRATION OF THE VACCINE. PATIENT HAS TRIED STEROID SHOTS BY THE DOCTOR WHICH HELPED FOR 4 DAYS. PREDNISONE WAS PRECRIBED FOR OTHER VIRUS INFECTION AND HELPED CALM DOWN SYMPTOMS. DOCTOR THEN PRESCRIBED TRIAMCINALONE AND CLOBETASOL CREAM IN FEBRUARY WHICH HELPED. PATIENT HAS BEEN ON AND OFF CREAM EVERY 2 WEEKS.