chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Impaired work ability, Pain, Pyrexia
Clinical narrative: out of commission; fever; pain; fatigue; headache; This case was reported by a consumer via call center representative and described the occurrence of impaired work ability in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (3 years ago). Previously administered products included Zostavax with an associated reaction of pain (received zostavax on an unknown date experienced pain and redness on site of injection).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced impaired work ability, fever, pain, fatigue and headache. On an unknown date, the outcome of the impaired work ability, fever, pain, fatigue and headache were recovered/resolved.   It was unknown if the reporter considered the impaired work ability, fever, pain, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experinced shingles 3 years ago. The patient first had Zostavax with very minor adverse reaction pain and redness on site of injection. The patient read that Zostavax loses efficacy after a coupe of years so the patient decided to take Shingrix. The first dose of Shingrix put the patient out of commission, fever, pain, fatigue, headaches for 2 days and felt better after 4 days. The patient recommended not to take Shingrix due to its side effects. The patient advised to get Zostavax shot every 2 years and side step these horrible side effect of Shingrix. This case has been linked to the US2019AMR124403, reported for the dose 2 of the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm aches; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (3 years ago). Previously administered products included Zostavax with an associated reaction of pain (received zostavax on an unknown date experienced pain and redness on site of injection) and Shingrix (1st dose refer case US2019AMR122681).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient read that Zostavax loses efficacy after a couple of years so the patient decided to take Shingrix. The 1st dose of Shingrix put the patient out of commission, fever, pain, fatigue, headaches for 2 days and felt better after 4 days. The patient figured that the patient would react less on the 2nd shot since the patient would have some immunity from the first shot. The patient was completely wrong the second shot was worse; to the point it had been 5 days since the shot and the patient was barely getting over the worst and the patients arm still aches. The patient recommended not to take Shingrix due to its side effects. The patient advised to get Zostavax shot every 2 years and side step these horrible side effect of Shingrix.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Local reaction, Pyrexia
Clinical narrative: high fever; severe local reaction; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number XC534, expiry date unknown) for prophylaxis.   On 14th April 2018, the patient received the 1st dose of Shingrix. In April 2018, 2 days after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced fever. In April 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain and fever to be related to Shingrix.  Additional details were provided as follows: The physician reported that a patient experienced a severe local injection site reaction with soreness about two days after receiving her first dose of Shingrix. The soreness lasted about a week. The patient also experienced a high fever for a few days. All of the symptoms had resolved. Since the patient also has not received the second dose yet, this would make the patient late for her second dose. The reporter had consented to follow up. The case has been linked to case US2019107258, reported by same reporter.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Contusion, Cough, Herpes zoster, Injection site pain, Nasal congestion
Clinical narrative: shingles; Body aches; Congestion; Coughing; Stinging during vaccination; Sore arm; Rash on armpit/rash on back/rash on above right breast; Bruise on arm and injection site; cought the cold; throat virus; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included pneumococcal vaccine (Pneumonia Shot) for cough.   On 25th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Pneumonia Shot at an unknown dose and frequency. On an unknown date, 5 days after receiving Shingrix, the patient experienced shingles, general body pain, nasal congestion, cough, injection site stinging, pain in arm, rash, bruise, cold and throat infection. The patient was treated with antivirals nos. On an unknown date, the outcome of the shingles, cold and throat infection were unknown and the outcome of the general body pain, nasal congestion, cough, injection site stinging and pain in arm were recovered/resolved and the outcome of the rash and bruise were not recovered/not resolved.   It was unknown if the reporter considered the shingles, general body pain, nasal congestion, cough, injection site stinging, pain in arm, rash, bruise, cold and throat infection to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and an unknown pneumonia vaccine at the same time. As the Shingrix vaccine was being administered it stung. Her arm had a bruise and became sore for five days. The soreness has resolved but there was still a light bruise at the injection site. Right after receiving the vaccine she experienced body aches and felt like she had a throat virus because she had congestion and coughing. She thought she had caught the cold that her both her husband and son had at the same time. It took five says for these symptoms to resolve. Five days after receiving the Shingrix vaccine she noticed one spot above her right breast. More spots developed and formed a line of this rash to under her right armpit. On her back there are two spots. These spots initially stung but did not at the time of reporting. She went to Urgent Care before the date of reporting and was given an antiviral medication. The nurse said she could, potentially, have shingles.  The reporter consented to follow up. The reporter gave permission for her physician to be contacted: Unable to obtain additional information.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Nasopharyngitis, Pain, Pain in extremity, Pharyngitis, Rash
Clinical narrative: shingles; Body aches; Congestion; Coughing; Stinging during vaccination; Sore arm; Rash on armpit/rash on back/rash on above right breast; Bruise on arm and injection site; cought the cold; throat virus; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included pneumococcal vaccine (Pneumonia Shot) for cough.   On 25th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Pneumonia Shot at an unknown dose and frequency. On an unknown date, 5 days after receiving Shingrix, the patient experienced shingles, general body pain, nasal congestion, cough, injection site stinging, pain in arm, rash, bruise, cold and throat infection. The patient was treated with antivirals nos. On an unknown date, the outcome of the shingles, cold and throat infection were unknown and the outcome of the general body pain, nasal congestion, cough, injection site stinging and pain in arm were recovered/resolved and the outcome of the rash and bruise were not recovered/not resolved.   It was unknown if the reporter considered the shingles, general body pain, nasal congestion, cough, injection site stinging, pain in arm, rash, bruise, cold and throat infection to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and an unknown pneumonia vaccine at the same time. As the Shingrix vaccine was being administered it stung. Her arm had a bruise and became sore for five days. The soreness has resolved but there was still a light bruise at the injection site. Right after receiving the vaccine she experienced body aches and felt like she had a throat virus because she had congestion and coughing. She thought she had caught the cold that her both her husband and son had at the same time. It took five says for these symptoms to resolve. Five days after receiving the Shingrix vaccine she noticed one spot above her right breast. More spots developed and formed a line of this rash to under her right armpit. On her back there are two spots. These spots initially stung but did not at the time of reporting. She went to Urgent Care before the date of reporting and was given an antiviral medication. The nurse said she could, potentially, have shingles.  The reporter consented to follow up. The reporter gave permission for her physician to be contacted: Unable to obtain additional information.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Multiple sclerosis
Clinical narrative: multiple sclerosis diagnosis; This case was reported by a pharmacist via call center representative and described the occurrence of multiple sclerosis in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd April 2019, the patient received the 1st dose of Shingrix. On an unknown date, 46 days after receiving Shingrix, the patient experienced multiple sclerosis (serious criteria GSK medically significant). On an unknown date, the outcome of the multiple sclerosis was unknown.   It was unknown if the reporter considered the multiple sclerosis to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient received Shingrix and was diagnosed with Multiple Sclerosis a month before the date of reporting. The exact date of multiple sclerosis diagnosis was unknown. The health care professional did not have the lot number and expiry date.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Sore Arm, chills, fever, shivering, joint pain, headache, extreme fatigue. Lasted 24 hours.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Sore Arm, chills, fever, shivering, joint pain, headache, extreme fatigue. Lasted 24 hours.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Rash erythematous
Clinical narrative: red rash and inflammation
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to clinic with possible vaccine reaction to Right thigh. Mom noticed while bathing him 7/9/2019 that his thigh was swollen, red, and warm to the touch. Parent denied fever, pain, itching, facial swelling, wheezing or rash elsewhere. Patient has never had any other adverse reactions to prior immunizations. Patient was prescribed benadryl 1.5 tsp every 6 hours as needed for rash. Encouraged to go to the ER if symptoms worsen. A circle was drawn around the rash with permanent marker for point of reference.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: Fever 101, shaking, Pulse 123, Blood Pressure  151/66, muscle aches Client took a junior advil gone in a.m.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Nausea
Clinical narrative: Pt reported  headache, nausea, joint aches, and fatigue after 2nd dose of Shingrix which she did not experience after the 1st dose. Symptoms lasted approx 24 hours and resolved on their own.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: high fever swelling and redness to all of upper arm
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site
Age: 0.75
Sex: M
Vaccine: DTAP
Symptoms: Acoustic stimulation tests, Speech disorder developmental
Clinical narrative: speech regression by end of September 2016,
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Injection site urticaria, Rash, Rash erythematous, Rash papular, Urticaria
Clinical narrative: Patient's immunizations were given by CMA as prescribed. Within several moments, patient developed an erythematous raised rash on her face and fine erythematous papules on her body. Rash on her face was most consistent with urticaria. Patient also developed a large wheal at the site of Ipol injection. She was given 6.25 mg of Benadryl PO and referred to allergy for evaluation prior to her next set of immunizations.
Sex: M
Vaccine: HEP, PPV
Symptoms: Fatigue, Feeling abnormal, Hypersensitivity
Clinical narrative: allergic reaction on my shoulder; feeling terrible; exhaustion; This spontaneous report was received from a male consumer referring to himself. The patient's concurrent condition, pertinent medical history were not reported. The patient was allergic to Horse serum. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, frequency, dose number, lot/batch #, expiration date was not reported) in the left shoulder for prophylaxis. On the same day the patient was injected with other suspect therapy which was, hepatitis b virus vaccine rhbsag (yeast) (1018 iss adj) (HEPLISAV) (dose, strength, frequency, dose number, lot/batch #, expiration date was not reported) on left shoulder.     Subsequently, the patient experienced exhaustion (fatigue), an allergic reaction on shoulder (hypersensitivity) and the patient felt terrible (feeling abnormal). No product quality complaint was involved. The outcome of hypersensitivity, fatigue and feeling abnormal was reported as not recovered/not resolved. The reporter's causality assessment was not reported.
Sex: U
Vaccine: DTAPIPVHIB, MMR, UNK
Symptoms: Drug hypersensitivity, Febrile convulsion
Clinical narrative: promethazin (Allergy); fever seizure; Initial information received on 10-Jun-2019 regarding an unsolicited valid non-serious case received from a Physician.  This case involves a 15 months old patient who experienced promethazin (allergy) and fever seizure, while he/she received vaccines MMR and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and while treated with PROMETHAZINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot "C5544AA" via unknown route in unknown administration site.  On an unknown date, the patient started taking PROMETHAZINE dosage unknown (with an unknown batch number).  On an unknown date, the patient received a dose of suspect MMR not produced by Sanofi Pasteur lot R008031 via unknown route in unknown administration site.  On an unknown date, the patient developed promethazin (Allergy) (drug hypersensitivity) and fever seizure (Febrile convulsion) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, MMR and PROMETHAZINE.  Final diagnosis was fever seizure and promethazin (allergy).  Action taken with promethazin was unknown  It was not reported if the patient received a corrective treatment.  The outcome is reported as Unknown for promethazin (allergy) and patient was Recovering from fever seizure.  Follow-up information was received on 08-Jul-2019 from a Physician.  Age of patient, suspect vaccine, event updated in field and narrative.  Documents held by sender: none.
Sex: M
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: gave some doses of ActHIB to patients without the dilulent, did not use the supplied 0.4% Sodium Chloride diluent, used sterile diluent instead; Initial information received on 08-Jul-2019 and additional information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA188132 and 2019SA188109 (same reporter).  This case involves a 19 months old male patient who was vaccinated with a 0.5 ml dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot U1919AA and Exp. Date 04-JUN-2019) via intramuscular route in the right thigh (reported as right leg)  on an unknown date of March or April 2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong solution used in drug reconstitution. The girl that had given the shot did not use the supplied 0.4% Sodium Chloride diluent that was in the box. She used sterile diluent instead. The one in the box was supposed to be used.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Muscular weakness
Clinical narrative: weakness in arm for 9 months following injection; Initial information received on 03-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 62 years old male patient who experienced weakness in arm for 9 months following injection, while he received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Type 2 diabetes mellitus in 2008.  Concomitant medications included GLIPIZIDE (GLIPIZIDE) for Type 2 diabetes mellitus since 2009; and METFORMIN (METFORMIN) for Type 2 diabetes mellitus since 2017.  In October 2016, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and Expiry date unknown)via intramuscular route in unknown administration site.  On an unknown date, the patient developed a non-serious weakness in arm for 9 months following injection (muscular weakness) (Unknown latency) following the administration of INFLUENZA VACCINE.  in 2019, the patient received Prevenar 13 and experienced adverse events.  Final diagnosis was weakness in arm for 9 months following injection.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for weakness in arm for 9 months following injection.  Information on the batch number was requested.  Documents held by sender: none
Sex: M
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: ActHIB is mixed with a sterile diluent instead of the supplied 0.4% Sodium Chloride; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA186114 and 2019SA188109 (same reporter).  This case involves a 18 months old male patient who was vaccinated with a 0.5 ml dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot U1919AA and Exp. Date 04-Jun-2019) via intramuscular route in the right thigh (reported as right leg) on an unknown date of March or April 2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong solution used in drug reconstitution. It was reported that, ActHIB is mixed with a sterile diluent instead of the supplied 0.4% Sodium Chloride diluent that was in the box.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: given a 12 year old patient Daptacel instead of Adacel; given a 12 year old patient Daptacel instead of Adacel; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves a 12 years old male patient who was vaccinated with a dose (sixth dose) of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot C5281AA and Exp. Date 05-Oct-2019) via unknown route in unknown administration site on an unknown date.  The patient's medical history not reported and concomitant vaccination included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 4 month old inadvertently given dose of Ipol and Pentacel, patient has already had dose of polio in Pediarex; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old female patient who was administered 0.5 ml dose of IPV (VERO) lot N1G511M in the right thigh, on 09-Jul-2019 and also recieved DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (Pentacel). It was reported patient has already had dose of polio in DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (Pediarix) (also reported as Pediarex)  The patients past medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It was as actual medication error case due extra dose administered.  At the time of reporting, adverse reaction was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a couple of years ago they had a patient having a procedure, and so they delayed the vaccine; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of an unknown demographics who received vaccine of delayed schedule. The vaccine involved was IPV (VERO) [IPOL] (batch number, expiry date, route and site of administration were unknown).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate schedule of vaccine administered.  It was unknown whether the patient had any adverse event.  A patient started their Ipol schedule later than they should have but he is not at work to provide any template information. Also mentions a couple of years ago they had a patient having a procedure, and so they delayed the vaccine.  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.  Documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Product preparation issue
Clinical narrative: only diluent administered  pt to return for complete  immunization.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Large 6x6 cm erythematous Welt: Where + of left thigh @ site of PROQUAD vaccine - warm + swollen to touch - Continued Mon on 4th day after vaccine.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: fever, swelling at site of vaccination
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; A patient was administered a dose of improperly stored ROTATEQ; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient medical history, concurrent conditions and concomitant medications were not reported.  On 09-JUL-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S009940, expiration date 04-OCT-2020, orally, for prophylaxis (strength, dose and frequency were not reported). The temperature of storage and time frame of the excursion were above 47°F (92.3° F) for 3 hours 11 minutes and above 47°F (73°F) for 9 hours. There was a digital data logger involved, but there was no previous temperature excursion.   No adverse effect was reported.; Sender's Comments:  US-009507513-1907USA007439: US-009507513-1907USA007438:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; A patient was administered a dose of improperly stored ROTATEQ; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient medical history, concurrent conditions and concomitant medications were not reported.  On 09-JUL-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #R035673  has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date reported and establish as 19-SEP-2020, orally, for prophylaxis (strength, dose and frequency were not reported). The temperature of storage and time frame of the excursion were above 47°F (92.3° F) for 3 hours 11 minutes and above 47°F (73°F) for 9 hours. There was a digital data logger involved, but there was no previous temperature excursion.   No adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA005362:01266335 US-009507513-1907USA005377:01266338 US-009507513-1907USA005308: US-009507513-1907USA007439:
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Musculoskeletal discomfort, Paralysis
Clinical narrative: Neck pain; couldn't get out of bed; almost paralyzed; This case was reported by a consumer via call center representative and described the occurrence of paralysis in a 64-year-old 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 paralysis (serious criteria GSK medically significant), neck discomfort and bedridden. On an unknown date, the outcome of the paralysis, neck discomfort and bedridden were unknown.   It was unknown if the reporter considered the paralysis, neck discomfort and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient had 1st vaccine and had almost paralyzed for 24 hours. The patient neck was really at worst. The patients pharmacist told that he would report about it and didn't had to take 2nd dose. The patient was afraid to take 2nd dose and could not get out of bed for 2 days.
Sex: F
Vaccine: TD, TDAP
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: inadvertently reeceived Tenivac instead of recommended Adacel vaccination during preganancy; inadvertently reeceived Tenivac instead of recommended Adacel vaccination during preganancy; Initial information received on 08-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist by phone.  This case involves adult female patient of unknown age who was vaccinated with a dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date, while she was pregnant.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient had no previous pregnancies.  It was a case of vaccine exposure during pregnancy.  It was a case of actual medication error due to wrong vaccine administered.  It was unknown if any adverse event occurred or not following the vaccination.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Information on batch number was requested.  Documents held by the sender: none.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: 3 patients received Ipol on 24Jun2019 and 27Jun2019 that expired on 23Jun2019; Initial information received on 08-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer or non-HCP (Office Staff).  This case involves 3 patients who received an expired dose of IPV (VERO) [IPOL] (batch number, route and site of administration was not reported and expired on 23-Jun-2019) on 24-Jun-2019 and 27-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to expired vaccine administered.  It was unknown whether the patients had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: administered the DTaP/IPV vaccine instead of reconstituting with the HIB to make it a Pentacel; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old patient who was vaccinated with administered the DTAP/IPV vaccine instead of reconstituting with the HIB to make it a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (formulation: unknown, the reported lot numbers for DTaP/IPV, Lot: U6469AB, Expiration Date: 11-Oct-2020, HIB, Lot: UJ134AA, Expiration Date: 11-Oct-2020, Box, Lot: UJ134AAA, 11-Oct-2020) via intramuscular route in the left thigh  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) FOR IMMUNISATION.  It was an actual medication error due to inappropriate reconstitution technique  It was unknown whether the patient had 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.  List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Patient was inadvertently administered an expired Menactra vaccine; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 11 years old male patient who received expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U5948AB, expiry date- 03-Jul-2019 via unknown route in unknown administration site on 09-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation.  It was a case of actual medication error due to expired vaccine used.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB, IPV
Symptoms: Extra dose administered
Clinical narrative: 4 month old inadvertently given dose of Ipol and Pentacel; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old female patient who received vaccines IPV (VERO) [IPOL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that experienced 4 month old inadvertently given dose of Ipol and Pentacel.  The patient's past vaccination(s) included PEDIARIX. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 09-Jul-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ102AA and expiry date: 19-Sep-2020 via intramuscular route in the left thigh.  On 09-Jul-2019, the patient received a dose of suspect IPV (VERO) lot UJ102AA and Expiry date: 19-Sep-2020 via intramuscular route in the left thigh.  It was a case of actual medication error due to extra dose administered.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   List of documents held by sender: none.
Sex: M
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: did not use the supplied 0.4% Sodium Chloride diluent that was in the box; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA186114 and 2019SA188132 (same reporter).  This case involves a 19 months old male patient who was vaccinated with a 0.5 ml dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot U1919AA and Exp. Date 04-Jun-2019) via intramuscular route in the right thigh (reported as right leg) on an unknown date of March or April 2019.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was an actual medication error case due to wrong solution used in drug reconstitution. It was reported that, Act-HIB is mixed with a sterile diluent instead of the supplied 0.4% Sodium Chloride diluent that was in the box.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PATIENT CALLED STATING SHE HAD REDNESS, SWELLING, AND PAIN AT INJECTION SITE.  SHE STATED IT WAS SWOLLEN, BUT NOT FLUID OR PUS COMING FROM SITE.  SHE STATED SHE WAS GOING TO TAKE SOME IBUPROFEN AND WOULD CALL BACK IF IT GOT WORSE.
Age: 57.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Arthralgia, Bone pain, Fatigue, Immediate post-injection reaction, Joint stiffness
Clinical narrative: Chronic ache in muscles and bones on the left side of the body- especially the left ankle.  The pain is chronic and constant.  Cold aggravates it.  Some intermittent achy-ness in the right ankle.  Body wide joint stiffness and intermittent joint pain-especially in the hips.  Fatigue and tiredness during the day.  These issues began directly after having the vaccines.  No prior history of these problems.
Age: 57.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Myalgia, Pain, Temperature intolerance
Clinical narrative: Chronic ache in muscles and bones on the left side of the body- especially the left ankle.  The pain is chronic and constant.  Cold aggravates it.  Some intermittent achy-ness in the right ankle.  Body wide joint stiffness and intermittent joint pain-especially in the hips.  Fatigue and tiredness during the day.  These issues began directly after having the vaccines.  No prior history of these problems.
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Insomnia, Nausea, Vomiting
Clinical narrative: ONE OF OUR PLASMA DONORS DONATED PLASMA ON 04/15/2019 AND RECEIVED HER VACCINE AFTER DONATING. SHE WAITED FOR 15 MIN AFTER RECEIVING THE VACCINE AND STATED SHE FELT FINE. SHE NEVER RETURNED FOR HER 2ND AND 3RD VACCINE. SHE RETURNED ON 07/15/2019 AND STATED THAT ON THE NIGHT OF 04/15/2019 SHE WAS VOMITING REPEATEDLY AND WAS HAVING TROUBLE SLEEPING BECAUSE OF NAUSEA. SHE ALSO REPORTED SOME HEADACHES. DONOR DENIED EXPERIENCING ANY OTHER SYMPTOMS. SHE FELT BETTER THE NEXT MORNING.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Vomiting
Clinical narrative: Received vaccination in the afternoon.  By 11pm patient had chills, vomiting, and felt very weak.  Chills and vomiting had ceased by the next morning but she continued to feel weak the next day.  Patient states she feels better today (2 days after vaccination).
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 07/11/2019 SUBJECTIVE:  Pt is a 5 y/o female here with mom. Here with complains of redness and welling of leg where she got vaccines yesterday. Had Hep B and varicella vaccine on 7/10/19, is now red, warm; area of redness is ~10 cm in diameter. Denies pain/puritis at this time. On delayed vaccine schedule. Otherwise healthy child. Has had a similar reaction like this before during her last Dtap. No difficulty breathing, lip/tongue/facial swelling o vomiting. Mom reports she thinks pt may have scratched the area after vaccines and is unsure if this has contributed to the reaction.  07/12/2019 Per phone conversation, swelling had spread beyond the line drawn around by approx 1" per mom. Mom was reluctant to start ABX since child had just been on them for cellulitis. 07/15/2019- A call has been palced to parent, unable to provide update at this time.
Sex: U
Vaccine: RAB
Symptoms: Headache, Insomnia, Nausea, Vomiting
Clinical narrative: ONE OF OUR PLASMA DONORS DONATED PLASMA ON 04/15/2019 AND RECEIVED HER VACCINE AFTER DONATING. SHE WAITED FOR 15 MIN AFTER RECEIVING THE VACCINE AND STATED SHE FELT FINE. SHE NEVER RETURNED FOR HER 2ND AND 3RD VACCINE. SHE RETURNED ON 07/15/2019 AND STATED THAT ON THE NIGHT OF 04/15/2019 SHE WAS VOMITING REPEATEDLY AND WAS HAVING TROUBLE SLEEPING BECAUSE OF NAUSEA. SHE ALSO REPORTED SOME HEADACHES. DONOR DENIED EXPERIENCING ANY OTHER SYMPTOMS. SHE FELT BETTER THE NEXT MORNING.
Age: 1.75
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Injection site swelling, Vomiting
Clinical narrative: Swelling in leg and vomiting x 3 days
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Diarrhoea, Fatigue
Clinical narrative: Over the course of 7/12/19 and 7/13/19, I experienced the following: Strong muscle aches all over body Stiffness in joints and muscles All over tiredness and weakness Chills Fever Headaches Upset stomach Mild diarrhea  Pain, redness and swelling at injection site  These symptoms began to decline on 7/14/19.  As of 7/15/19, the only symptom remaining is redness, swelling and soreness at injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Joint stiffness
Clinical narrative: Over the course of 7/12/19 and 7/13/19, I experienced the following: Strong muscle aches all over body Stiffness in joints and muscles All over tiredness and weakness Chills Fever Headaches Upset stomach Mild diarrhea  Pain, redness and swelling at injection site  These symptoms began to decline on 7/14/19.  As of 7/15/19, the only symptom remaining is redness, swelling and soreness at injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: Over the course of 7/12/19 and 7/13/19, I experienced the following: Strong muscle aches all over body Stiffness in joints and muscles All over tiredness and weakness Chills Fever Headaches Upset stomach Mild diarrhea  Pain, redness and swelling at injection site  These symptoms began to decline on 7/14/19.  As of 7/15/19, the only symptom remaining is redness, swelling and soreness at injection site.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Rash all over the body, fever.  Amoxicillin and hydroxyzine was called in.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Pt explained that she woke up this morning to leg pain and cramping. She has done nothing different in her daily routine to cause the pain. She had noticed the pain is better when moving and is worse when she sits.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Swelling
Clinical narrative: Swelling of arm and neck.  She returned to the pharmacy and stated that she is ok now.
Age: 21.0
Sex: M
Vaccine: YF
Symptoms: Anaphylactic reaction, Chest discomfort, Erythema, Lacrimation increased, Urticaria
Clinical narrative: Within 10min after vaccination, developed chest tightness, wheezing, eye watering, redness/hives all over. EMS was called.  He received 2 epinephrine shots and antihistamines.  He was taken to ER where he was treated with more meds (type?), and monitored for about 4 hours before being released, feeling completely recovered.  Presumed anaphylactic reaction was followed-up in Allergy Clinic on 11 July 2019.  Because patient had no prior episodes, and regularly ate eggs and gelatin (YF-Vax excipients) with no problems, Allergist opted against extensive testing.  Because YF-Vax not indicated for repeat dosing, patient was allowed to return to work without limitations.
Age: 21.0
Sex: M
Vaccine: YF
Symptoms: Wheezing
Clinical narrative: Within 10min after vaccination, developed chest tightness, wheezing, eye watering, redness/hives all over. EMS was called.  He received 2 epinephrine shots and antihistamines.  He was taken to ER where he was treated with more meds (type?), and monitored for about 4 hours before being released, feeling completely recovered.  Presumed anaphylactic reaction was followed-up in Allergy Clinic on 11 July 2019.  Because patient had no prior episodes, and regularly ate eggs and gelatin (YF-Vax excipients) with no problems, Allergist opted against extensive testing.  Because YF-Vax not indicated for repeat dosing, patient was allowed to return to work without limitations.