chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Daptacel was administered to a 15 months old girl with no AE; Initial information was received on 11-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient who received a 0.5 mL dose of expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number- C5254AA, Expiration date- 18-SEP-2019) via intramuscular route in the right thigh on 11-Feb-2020 for prophylactic vaccination.  Past vaccination included a dose of PEDIARIX at 2, 4, and 6 months of age.  Medical history, past medical treatment and family history were not provided.  Concomitant medications included HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) for prophylactic vaccination on 11-Feb-2020.  It was a case of actual medication error case due to expired vaccine used.  Nurse reported that an expired dose of Daptacel was administered to a 15 months old girl this morning. She states that she drew vaccine up into a syringe, another nurse administered it. They did not notice the expiration date until after administration.  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 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.
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Two doses of Menactra were given to patient with  asplenia on day one and day three/no AE; Initial information received on 12-Feb-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves Adult patient who received two doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] who has Asplenia on day one and day three/no AE (inappropriate schedule of product administration).  This is a case of actual medication error due to inappropriate schedule of product administration.  Medical history, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site and 1 other dose was administered on unknown dates (third day) for suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  The product was administered to the patient.  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: IPV, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was given a SQ injection of IPol instead of a PPD test/no AE; Initial information received on 12-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 48 years old female patient who was given an injection of IPV (VERO) [IPOL] instead of a TUBERCULIN TEST [TUBERCULIN PPD]/no AE (wrong product administered).  Medical history, past vaccination, family history were not reported.  This was a case of actual medication error due to wrong vaccine administered.  On 12-Feb-2020, the patient was supposed to receive TUBERCULIN PPD (TUBERCULIN TEST) (with an unknown batch number) for Tuberculin test but received a dose of suspect IPV (VERO) lot P1A242M expiry date 26-Apr-2020 via subcutaneous route in forearm..  The patient was delayed for observation for 15 minutes. No adverse reactions were observed.  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.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: she had administered an expired dose of Daptacel to a patient, no AE; Initial information received on 12-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient (age and gender not reported) who was vaccinated with an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] via unknown route in unknown administration site for Prophylactic vaccination [Expired product administered ]. The lot number and expiry date not reported.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was actual medication error due to Expired vaccine used.  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 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.  Information on the batch number was requested.
Age: 12.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok Quadrivalent was administered to a 12 year-old child, No AE; Initial information received on 12-Feb-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 12 years old female patient who was vaccinated with 0.5 ml vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA1957 and expiry date: 30-Jun-2020) via intramuscular route in the right deltoid on 12-Feb-2020 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was actual medication error due to inappropriate age at vaccine administration.  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 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.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: she administered a Daptacel vaccine to a 15 month-old child before realizing that it was expired/ no AE; Initial information received on 11-Feb-2020 regarding an unsolicited valid non-serious case received from a certified nursing assistant (CNA).  This case involves a 15 months old male patient who was administered expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] vaccine (expired product administered).  Medical history, medical treatment, family history were not provided.  The patient had received DTaP vaccine in past.  Concomitant vaccinations included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation.  On 11-Feb-2020, the patient received a 0.5mL dose of (frequency: once) suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5366AA expiry date 07-Feb-2020 via intramuscular route in the left thigh for prophylactic vaccination.  This was a case of actual medication error due to expired product administered.  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.
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient was administered with an expired dose of daptacel, no AE; Initial information received on 11-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 months old male patient (also reported as 18 months) who was vaccinated with a 0.5 mL dose of expired Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel], (fourth dose in series, lot C5366AA, expiry date: 07-Feb-2020) via intramuscular route in the thigh on 11-Feb-2020, for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 8.0
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: an eight year old patient received two does of Daptacel vaccine/no AE; Initial information received on 12-Feb-2020 and additional information received on 13-Feb-2020 regarding an unsolicited valid non-serious case received from the nurse.  This case involves an eight year old patient (gender unknown) who received only two doses of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot number and expiry date not reported via unknown route in unknown administration site on an unknown date for prophylactic vaccination [Product administered to patient of inappropriate age]  Medical history, medical treatment, vaccination and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration.  It was reported that 8 year old patient's parents have chosen to do alternative vaccine scheduled. The patient has only received 2 doses of the Daptacel. Parents have chose to do delayed immunization schedule and patient has only received two doses of Daptacel.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Daptacel vaccine that was administered, NO AE; Initial information received on 13-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 18 months old female patient who was vaccinated with expired 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5366BA and expiry date: 07-Feb-2020) via intramuscular route in the left thigh on 12-FEB-2020 for Prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE).  It was actual medication error due to Expired vaccine used.  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 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.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: 4 year old female patient was given a expired dose of Daptacel, no AE; Initial information received on 13-Feb-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 years old female patient who received a 0.5 mL fifth dose expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] Frequency = once for prophylactic vaccination (lot C5367AA  and expiry date: 13-Jan-2020) via intramuscular route in the left deltoid on 13-FEB-2020.  Medical history, medical treatment, vaccination and family history were not provided.   It was a case of 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose was given inadvertently by nurse to patient, no adverse event; Initial information received on 12-Feb-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves an 18 month old patient (gender was not reported) who was vaccinated with a 0.5 ml dose of expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (fourth dose, lot C5366AA  and expiration date 07-Feb-2020) via an unknown route in the left thigh on an unknown date.  Medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  No adverse event was 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: a HCP administered to a patient a pentacel vaccine that  was expired, no adverse event; Initial information received on 12-Feb-2020 regarding an unsolicited valid non-serious case from a non-health care professional.  This case involves a two-month-old patient (gender was not reported) who was vaccinated with a 0.5 ml dose of expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot C5544AA and expiration date 06-Oct-2019) via an intramuscular route in the left vastus lateralis on 08-Oct-2019 for prophylactic vaccination.  Medical history was not reported and concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used.  No adverse event was 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: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying
Clinical narrative: Inconsolable Crying; Initial information received on 13-Feb-2020 regarding an unsolicited valid non-serious case received from  other health professional.  This case is linked to case 2020SA041905 (same reporter).  This case involves a 6 months old male patient who experienced inconsolable crying (crying), while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza Vaccine Inact Split Virion 4v (Fluzone Quadrivalent) for prophylactic vaccination; Pneumococcal Vaccine Conj 13v (Crm197) (Prevnar 13) for prophylactic vaccination; and Rotavirus Vaccine (Rotavirus Vaccine) by mouth for prophylactic vaccination on 12-Feb-2020.  On 12-Feb-2020, the patient received a third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ190AAA and expiration date 22-Feb-2021) via intramuscular route in the left thigh for prophylactic vaccination.  On an unknown date, the patient developed a non-serious inconsolable crying (crying) (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  No laboratory data reported.  Final diagnosis was crying.   It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event crying.
Sex: F
Vaccine: FLU4
Symptoms: Injection site hypoaesthesia, Injection site pain
Clinical narrative: Injection site pain; Injection site numbness; Initial information received on 13-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an female patient who experienced injection site pain (vaccination site pain) and injection site numbness (vaccination site hypoaesthesia), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ212AB (Expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On  13-Feb-2020, the patient developed a non-serious injection site pain (vaccination site pain) and injection site numbness (vaccination site hypoaesthesia) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Final diagnosis was Vaccination site hypoesthesia and Vaccination site pain.   It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for Vaccination site hypoesthesia and Vaccination site pain.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Magnetic resonance imaging abnormal, Tendon rupture
Clinical narrative: patient reports pain and difficulty elevating left arm after injection; He went to the walk in clinic and was prescribed a steriod; Later he had an MRI that showed a rupture of the left supraspinaturs tendon of the rotator cuff; He is now doing physical therapy but still has pain in the arm.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: I woke the morning after I got the shot with soreness to touch the area of the injection site, there was about 3-4" diameter red spot around site, it was hot and hard. The 2nd day was the same. The 3rd day the hardness went away, it was a little less red, it was a little less sore to the touch, but it itched unmercifully. Tylenol did not help, ibuprofen did not help, ice did not help,  Young Living Panaway essential oil took the itch away completely. Today is day 4, it is still a still sore to the touch, it is pink not red, the hardness has gone away, it is still itchy, the Panaway essential oil still relieves the itch
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Bursa disorder, Injection site pain, Joint effusion, Magnetic resonance imaging abnormal, Muscle strain
Clinical narrative: Persistent right shoulder pain leading to several visits and prompting US, MRI and ortho referral due to high-grade Articular sided partial-thickness tear at the supraspinatus and infraspinatus junction involving 50% tendon thickness with signal abnormality spanning 2.2 CM in AP dimension, mild long head biceps tenosynovitis, small glenohumeral jont effusion with mild synovitis, mild subacromial/subdeltoid, and moderate subcoracoid bursal distention with a small amount of debris. minimal AC joint degenerative change, mild degenerative change in the superior labrum
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Osteoarthritis, Rotator cuff syndrome, Synovitis, Tenosynovitis, Ultrasound scan abnormal
Clinical narrative: Persistent right shoulder pain leading to several visits and prompting US, MRI and ortho referral due to high-grade Articular sided partial-thickness tear at the supraspinatus and infraspinatus junction involving 50% tendon thickness with signal abnormality spanning 2.2 CM in AP dimension, mild long head biceps tenosynovitis, small glenohumeral jont effusion with mild synovitis, mild subacromial/subdeltoid, and moderate subcoracoid bursal distention with a small amount of debris. minimal AC joint degenerative change, mild degenerative change in the superior labrum
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Gait disturbance, Injection site rash, Rash macular
Clinical narrative: Child started developing a red splotch/rash at night and by morning it was covering his thigh and he was limping.
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain
Clinical narrative: Throat pain; This case was reported by a physician via sales rep and described the occurrence of throat pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced throat pain. On an unknown date, the outcome of the throat pain was unknown.   It was unknown if the reporter considered the throat pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a throat pain after Shingrix dose. The reporter did not agree to follow up from GSK.
Sex: F
Vaccine: MMR
Symptoms: Manufacturing product shipping issue
Clinical narrative: MMR II was shipped without the DILUENT MRK; This spontaneous report was received from a pharmacist referring to a 48 year old female patient. The patient's medical history included unspecified immunisation. Information about patient's concurrent condition, concomitant medication was not reported.  On 07-FEB-2020, the patient was unable to get the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) albumin status: rHA (recombinant Human albumin) (lot #R036582, expiry date:17-DEC-2020) because it was shipped without sterile diluent (product dispensing error). It was reported that the patient was scheduled for the vaccine because she had negative titers and needed to receive the vaccine as she was a medical device salesperson and needed it for her job.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Pruritus, Rash erythematous
Clinical narrative: itching on his back, chest,stomach, legs and back of his neck; full blown red spots on his chest; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pruritus (for tolerance of 1st dose refer case US2020023462).   On 26th December 2019, the patient received the 2nd dose of Shingrix. On 27th December 2019, 1 days after receiving Shingrix, the patient experienced pruritus and red rash. The patient was treated with topical steroid nos (Steroid Cream). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pruritus and red rash were unknown.   The reporter considered the pruritus to be related to Shingrix. It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: The patient did not had any allergy history. The day after vaccination the patient had a full blown red spots on his chest and back.  The patient had severe itching on his back, chest,stomach, legs and back of his neck but not his face.    The patient underwent blood work but nothing was found from that.  The patient was prescribed a bandaid fix steroid cream that resolved the issue, but it returned. The patient also saw dermatologist but no resolution. The patient had itching 2 months after the vaccination.      Lab Comments: Laboratory test performed on an unknown date
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Acupuncture, Gait disturbance, Mobility decreased, Muscle spasms, Musculoskeletal pain
Clinical narrative: Pain / body aches/ pain in her legs; Pain in her legs; Pain in her legs was so bad that it caused her to limp; Pinching in her left shoulder; Difficulty lifting both arms; Muscle stiffness; Muscle spasms/ Knots; This case was reported by a consumer via call center representative and described the occurrence of muscle stiffness in a 58-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 30th December 2019, the patient received Boostrix. On 31st December 2019, 1 days after receiving Boostrix, the patient experienced muscle spasm. On an unknown date, the patient experienced muscle stiffness, general body pain, leg pain, limping, shoulder pain and mobility decreased. The patient was treated with non-drug therapy (Acupuncture). On an unknown date, the outcome of the muscle stiffness, muscle spasm, general body pain, leg pain, limping, shoulder pain and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the muscle stiffness, muscle spasm, general body pain, leg pain, limping, shoulder pain and mobility decreased to be related to Boostrix.  Additional details were received as follows: The patient received Boostrix in upper arm. The patient experienced muscle stiffness, muscle spasms and also experienced knots. The patient stated that the knot started in her left buttock, went down her IT band, then behind her left knee and calves. The knots spread to other leg and was in neck. The knot in buttock was the size of an egg and knots in legs were the size of a walnut. The patient stated that the acupuncture helped reduce the knots, but they return with physical activity. The patient stated that the pain started right away after vaccination and her whole body aches and the pain in her legs was so bad that it caused her to limp. The patient also reported pinching in her left shoulder and difficulty lifting both arms. The patient consented to contact healthcare professional.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Nodule, Pain, Pain in extremity
Clinical narrative: Pain / body aches/ pain in her legs; Pain in her legs; Pain in her legs was so bad that it caused her to limp; Pinching in her left shoulder; Difficulty lifting both arms; Muscle stiffness; Muscle spasms/ Knots; This case was reported by a consumer via call center representative and described the occurrence of muscle stiffness in a 58-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 30th December 2019, the patient received Boostrix. On 31st December 2019, 1 days after receiving Boostrix, the patient experienced muscle spasm. On an unknown date, the patient experienced muscle stiffness, general body pain, leg pain, limping, shoulder pain and mobility decreased. The patient was treated with non-drug therapy (Acupuncture). On an unknown date, the outcome of the muscle stiffness, muscle spasm, general body pain, leg pain, limping, shoulder pain and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the muscle stiffness, muscle spasm, general body pain, leg pain, limping, shoulder pain and mobility decreased to be related to Boostrix.  Additional details were received as follows: The patient received Boostrix in upper arm. The patient experienced muscle stiffness, muscle spasms and also experienced knots. The patient stated that the knot started in her left buttock, went down her IT band, then behind her left knee and calves. The knots spread to other leg and was in neck. The knot in buttock was the size of an egg and knots in legs were the size of a walnut. The patient stated that the acupuncture helped reduce the knots, but they return with physical activity. The patient stated that the pain started right away after vaccination and her whole body aches and the pain in her legs was so bad that it caused her to limp. The patient also reported pinching in her left shoulder and difficulty lifting both arms. The patient consented to contact healthcare professional.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Peripheral swelling
Clinical narrative: swelling of right arm; blisters below the injection site; This case was reported by a other health professional via call center representative and described the occurrence of swelling arm in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 44N5L, expiry date unknown) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced swelling arm and blister. On an unknown date, the outcome of the swelling arm and blister were unknown.   It was unknown if the reporter considered the swelling arm and blister to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix and developed swelling of the right arm, a raised area described as a large mosquito bite, and a couple of blisters below the injection site. It was unknown if the event was ongoing.  The patient would like to receive the 2nd dose and it had been more than 6 months since the initial dose. The follow up consent was granted. The reported batch number was updated from 44NSLto 44N5L, as per sales data sheet.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient said she had light colored welts on face.  None noted at time of assessment.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Nausea
Clinical narrative: Headache, nausea, joint pain
Age: 32.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient received 3 vaccines.  Patient reports the 36 hours after receiving vaccines, she presented to the ER with complaints of arm pain and swollen.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Balance disorder, Blood glucose increased
Clinical narrative: dizziness, achy, balance issues, double vision, hands hurting (curled), knees and back sore, high blood sugar, very hot then later very cold, later slight ache in center of stomach and nauseous but didn't throw up - for a time felt almost drugged with a terribly dry mouth (like you would when you get a preop shot) and still double vision and poor balance and no appetite (stayed on couch all of one day and part of the next) - took two full days before I felt well
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Diplopia, Dizziness, Dry mouth, Feeling of body temperature change
Clinical narrative: dizziness, achy, balance issues, double vision, hands hurting (curled), knees and back sore, high blood sugar, very hot then later very cold, later slight ache in center of stomach and nauseous but didn't throw up - for a time felt almost drugged with a terribly dry mouth (like you would when you get a preop shot) and still double vision and poor balance and no appetite (stayed on couch all of one day and part of the next) - took two full days before I felt well
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: dizziness, achy, balance issues, double vision, hands hurting (curled), knees and back sore, high blood sugar, very hot then later very cold, later slight ache in center of stomach and nauseous but didn't throw up - for a time felt almost drugged with a terribly dry mouth (like you would when you get a preop shot) and still double vision and poor balance and no appetite (stayed on couch all of one day and part of the next) - took two full days before I felt well
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Nausea, Pain, Pyrexia
Clinical narrative: Fever, body aches, chills, nausea, loss of appetite
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse effects; a dose of expired but properly stored M-M-R II was administered; This spontaneous report as received from a medical assistant refers to a 6 year old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 13-FEB-2020, the patient was vaccinated with an expired dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), albumin status: recombinant Human albumin "rha", lot # R000555, expiration date: 08-JAN-2020 (strength and route of administration were not provided) for prophylaxis. The vaccine was reconstituted in a properly stored sterile diluent. No adverse event reported.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Malaise, Pain
Clinical narrative: have a headache; unwell; achy; I feel tired; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, feeling unwell, pain and tiredness. On an unknown date, the outcome of the headache, feeling unwell, pain and tiredness were unknown.   It was unknown if the reporter considered the headache, feeling unwell, pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received 2nd dose of Shingrix and had tired, achy, unwell and headache. Patient had enquired to take Tylenol as treatment.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Is nausea a common side effect of the second shot; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was unknown.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were received as follows: This case was reported by patient self. The age at vaccination was not reported. The patient experienced nausea after vaccination. The patient asked is nausea a common side effect of the second shot.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: had all the flu like sytems as a reaction; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 10 years before reporting date).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown 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 received as follows: The age at vaccination was not reported. The patient experienced flu like symptoms as a reaction after vaccination. The patient asked whether to proceed with the 2nd shot.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain, Pain in extremity
Clinical narrative: flu-like symptoms; headache; photosensitivity; chills; aches; rash/ spot on her forehead and scalp; neuralgia/ after receiving the Shingrix vaccine the neuralgia has worsened; arm Pain; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 9737P, expiry date 19th March 2022) for prophylaxis.   The patient's past medical history included shingles and post herpetic neuralgia.   On 30th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms, headache, photosensitivity, chills, pain, rash and post herpetic neuralgia. On an unknown date, the outcome of the pain in arm and rash were recovered/resolved and the outcome of the influenza-like symptoms, headache, photosensitivity, chills and pain were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, headache, photosensitivity, chills, pain, rash and post herpetic neuralgia to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix in right deltoid intramuscularly. She had a history of shingles and postherpetic neuralgia, but stated that after receiving the Shingrix vaccine the neuralgia had worsened and not resolved till the time of reporting. She stated that for one day her arm hurt. She had flu like symptoms, headache, photosensitivity, chills, aches. The patient also had a spot on her forehead and scalp, which was resolved. The reporter did not consent to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Photosensitivity reaction, Post herpetic neuralgia, Rash
Clinical narrative: flu-like symptoms; headache; photosensitivity; chills; aches; rash/ spot on her forehead and scalp; neuralgia/ after receiving the Shingrix vaccine the neuralgia has worsened; arm Pain; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 9737P, expiry date 19th March 2022) for prophylaxis.   The patient's past medical history included shingles and post herpetic neuralgia.   On 30th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms, headache, photosensitivity, chills, pain, rash and post herpetic neuralgia. On an unknown date, the outcome of the pain in arm and rash were recovered/resolved and the outcome of the influenza-like symptoms, headache, photosensitivity, chills and pain were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, headache, photosensitivity, chills, pain, rash and post herpetic neuralgia to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix in right deltoid intramuscularly. She had a history of shingles and postherpetic neuralgia, but stated that after receiving the Shingrix vaccine the neuralgia had worsened and not resolved till the time of reporting. She stated that for one day her arm hurt. She had flu like symptoms, headache, photosensitivity, chills, aches. The patient also had a spot on her forehead and scalp, which was resolved. The reporter did not consent to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Diarrhoea, Feeling abnormal, Injection site erythema, Loss of personal independence in daily activities
Clinical narrative: Injection site redness; Bedridden; Fever; Myalgia; Diarrhea; Nausea; Feeling miserable; Unable to work. In bed all day; This case was reported by a physician via call center representative and described the occurrence of fever in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of erythema (1st dose received and experienced local redness and swelling, refer case US2020AMR024726).   On 9th February 2020, the patient received the 2nd dose of Shingrix. On 9th February 2020, couple of hours after receiving Shingrix, the patient experienced fever, myalgia, diarrhea, nausea, feeling miserable, activities of daily living impaired and bedridden. On an unknown date, the patient experienced injection site erythema. On an unknown date, the outcome of the fever, myalgia, diarrhea, nausea, feeling miserable and activities of daily living impaired were recovering/resolving and the outcome of the injection site erythema was recovered/resolved and the outcome of the bedridden was unknown.   It was unknown if the reporter considered the fever, myalgia, diarrhea, nausea, feeling miserable, activities of daily living impaired, injection site erythema and bedridden to be related to Shingrix.  Additional information was provided as follows: The physician was also the reporter. The patient experienced fever, myalgia, diarrhea, nausea, feeling miserable, could not work and was in bed all day few hours later receiving vaccine. Less than a week after receiving vaccine, the patient experienced injection site redness. On 11th February 2020, the patient felt a little better. The reporter consented to follow up. The physician wanted to be contacted by safety to discuss further. The outcome of the events were reported in source document as fatal, however it was reported as recovering and resolving in database. The outcome of the event  injection site redness was reported in source document as recovered and resolved with sequel, however it was reported as recovered and resolved in database.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Injection site redness; Bedridden; Fever; Myalgia; Diarrhea; Nausea; Feeling miserable; Unable to work. In bed all day; This case was reported by a physician via call center representative and described the occurrence of fever in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of erythema (1st dose received and experienced local redness and swelling, refer case US2020AMR024726).   On 9th February 2020, the patient received the 2nd dose of Shingrix. On 9th February 2020, couple of hours after receiving Shingrix, the patient experienced fever, myalgia, diarrhea, nausea, feeling miserable, activities of daily living impaired and bedridden. On an unknown date, the patient experienced injection site erythema. On an unknown date, the outcome of the fever, myalgia, diarrhea, nausea, feeling miserable and activities of daily living impaired were recovering/resolving and the outcome of the injection site erythema was recovered/resolved and the outcome of the bedridden was unknown.   It was unknown if the reporter considered the fever, myalgia, diarrhea, nausea, feeling miserable, activities of daily living impaired, injection site erythema and bedridden to be related to Shingrix.  Additional information was provided as follows: The physician was also the reporter. The patient experienced fever, myalgia, diarrhea, nausea, feeling miserable, could not work and was in bed all day few hours later receiving vaccine. Less than a week after receiving vaccine, the patient experienced injection site redness. On 11th February 2020, the patient felt a little better. The reporter consented to follow up. The physician wanted to be contacted by safety to discuss further. The outcome of the events were reported in source document as fatal, however it was reported as recovering and resolving in database. The outcome of the event  injection site redness was reported in source document as recovered and resolved with sequel, however it was reported as recovered and resolved in database.