chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Ventricular extrasystoles
Clinical narrative: started to experience some mild PVCs (premature ventricular contractions); This case was reported by a consumer via call center representative and described the occurrence of premature ventricular contractions in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included premature ventricular contractions (one and a half years ago the patient had an incident of PVC).   On 12th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a week after receiving Shingrix, the patient experienced premature ventricular contractions. On an unknown date, the outcome of the premature ventricular contractions was unknown.   It was unknown if the reporter considered the premature ventricular contractions to be related to Shingrix.  Additional details were provided as follows: The patient stated that one and a half years before receiving the Shingrix vaccine she had an incident of premature ventricular contractions but her doctor ruled out any abnormalities with her heart. The patient received the dose of the Shingrix vaccine in her left deltoid muscle.  After being injected with the vaccine the patient started to experience some mild PVCs (premature ventricular contractions) but on 17th February 2020 her PVCs were so intense that she had to go to the Emergency room.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Feeling cold, Pyrexia
Clinical narrative: shortness of breath; low grade fever; feeling cold/feeling chilly; This case was reported by a consumer via call center representative and described the occurrence of shortness of breath in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 3HT5J, expiry date 26th January 2022) for prophylaxis.   Concomitant products included Flu unspecified (Flu vaccine).   On 27th October 2019, the patient received Shingrix. On an unknown date, less than 9 months after receiving Shingrix and an unknown time after receiving Flu vaccine, Albuterol and Advair, the patient experienced shortness of breath, low grade fever and feeling cold. The patient was treated with salbutamol sulphate (Albuterol), fluticasone propionate, salmeterol xinafoate (Advair), paracetamol (Tylenol) and ibuprofen (Advil). On 15th December 2019, the outcome of the feeling cold was recovered/resolved. On an unknown date, the outcome of the shortness of breath and low grade fever were recovered/resolved.   It was unknown if the reporter considered the shortness of breath, low grade fever and feeling cold to be related to Shingrix.  Additional case details were reported as follows: The patient received her 1st dose of Shingrix and developed the feeling of a low grade fever, feeling chilly or cold all the time, and shortness of breath. The patient consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Flulaval PFS vaccine that was activated on 14May2020 and not administered; This case was reported by a nurse via call center representative and described the occurrence of product storage error in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   On 14th May 2020, the patient received FluLaval Tetra 2019-2020 season. On 14th May 2020, unknown after receiving FluLaval Tetra 2019-2020 season, the patient experienced product storage error. On an unknown date, the outcome of the product storage error was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The nurse reported that they had a Flulaval PFS vaccine that was activated and not administered, they stored it, which led to product storage error. The nurse did not specify if they are going to administer it or not. The reporter did not consent to follow up.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Influenza like illness, Injection site pain, Pain
Clinical narrative: patient complained of flu-like symptoms including diarrhea, aching head-to-toe, dizzy, light-headed and muscle pain at injection site;  patient self-treated with Tylenol ES, rest, and increased fluid intake; still experiencing these effects at 12:20pm 5/20/2020
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood electrolytes normal, Electrocardiogram normal, Hypotonic-hyporesponsive episode
Clinical narrative: HYPOTONIC HYPORESPONSIVE EPISODE APPROX 5-6 HRS AFTER ED VISIT - NL ECG + LYTES. 0 TX
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Hyperhidrosis, Malaise, Pyrexia
Clinical narrative: & Malaise; Chill; Fever; Sweating
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Decreased appetite, Enteral nutrition, Eosinophilic oesophagitis, Gastrointestinal tube insertion, Gastrooesophageal reflux disease
Clinical narrative: Patient not eating and having trouble staying awake, this happened for several days.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Somnolence
Clinical narrative: Patient not eating and having trouble staying awake, this happened for several days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy  dx'd on 4/9/2020
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: SkinRash, Rash & UrticariaPruritus
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; the patient received an improperly stored dose of PROQUAD; the patient received an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant, referring to a patient of an unknown gender and age.   No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 06-MAY-2020 the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (dose, route of administration, vaccination scheme and  anatomical site of vaccination, were not reported, lot # S013712,  expiration date 01-NOV-2020) as prophylaxis (incorrect product storage).  As concomitant therapy a sterile diluent (MERCK STERILE DILUENT) was used to reconstitute the vaccine. The vaccine was stored at a temperature of -9 degrees Celcius to 8 degrees Celcius (6.9 degrees Celcius) for a timeframe of 1 hour and 34 minutes. There was no previous temperature excursion and the call was made due to a digital data logger. No additional adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: zoster related injuries; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In approximately 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, route, dose, lot number and expiration date unknown) as prescribed and/or administered by a pharmacist at a pharmacy for long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to vaccination), the patient was treated by a health care provider for zoster related injuries. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: miserable and horrible side effects; This case was reported by a consumer via out of hour services and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details was provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected an adult as per the vaccine indication. The patient experienced absolutely miserable and horrible side effects after receiving Shingrix. Further information was not reported.  Follow up information received from the consumer on 3rd January 2020: No new information was received.
Sex: M
Vaccine: VARZOS
Symptoms: Facial asymmetry, Facial paralysis, Hypoaesthesia, Visual impairment
Clinical narrative: left facial droop with left cheek numbness/Left-sided Bell's palsy (primary; Partial paralysis; left facial droop with left cheek numbness; Forehead sparing; visual disturbance; facial asymmetry; This case was reported by a lawyer and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingrix) for product used for prophylaxis.  The initial information was received on 13 May 2020 via medical records (case is now medically confirmed). As per the pharmacy record, the patient had Shingrix vial kit on 30 April 2018 and 10 August 2018.On 31 August 2018, the patient presents with Left-sided Bell's palsy (primary), complaint of left facial droop with left cheek numbness symptoms were of acute onset, constant, moderate in severity, and without alleviating or exacerbating factors. The patient had partial paralysis ((total or near total paralysis of lower face) and forehead sparing was noted. The patient had  facial asymmetry and visual disturbance.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Pain, Pruritus, Swelling
Clinical narrative: increasing tenderness; redness; swelling; pain; It itched and the induration was about 15-20 mm; It itched and the induration was about 15-20 mm; This is a spontaneous report from a contactable nurse. A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 12May2020 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2020, the patient experienced increasing tenderness, redness, swelling, pain for the first 6 days. It itched and the induration was about 15-20 mm on an unspecified date in May2020. The outcome of events was unknown.   No Follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Tenderness
Clinical narrative: increasing tenderness; redness; swelling; pain; It itched and the induration was about 15-20 mm; It itched and the induration was about 15-20 mm; This is a spontaneous report from a contactable nurse. A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 12May2020 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2020, the patient experienced increasing tenderness, redness, swelling, pain for the first 6 days. It itched and the induration was about 15-20 mm on an unspecified date in May2020. The outcome of events was unknown.   No Follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 0.83
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 10 month old patient received dose of Quadracel vaccine/No AE; Initial information was received on 13-May-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 10-month-old male patient who received dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  On 11-May-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot C5656AA expiry date 13 August 2021] via unknown route at an unknown administration site for prophylactic vaccination.  It was a case of 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 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.  This case is linked to cases 2020SA129677 (Same reporter).
Sex: U
Vaccine: RAB
Symptoms: Product dose omission
Clinical narrative: patient who had first dose 10APR2020, second dose 17APR2020 and the dose due 01MAY2020 was not given, no AE; Initial information received on 14-May-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves patient of unknown demographics who had first dose of RABIES (HDC) VACCINE [IMOVAX RABIES] on 10-Apr-2020, second dose 17-Apr-2020 (lot number and other dosing details for all the regimens were not reported ,via unknown route in unknown administration site as prophylactic vaccination) and the dose due on 01-May-2020 that was not given and hence the dose was missed.   Medical history, medical treatment(s), vaccination(s) and family history were not provided.   This was potential medication error case due to missed dose.  It was not reported whether affected vaccine was administered to any one and experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 49.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired dose of the Tenivac single-dose vial today (15 May 2020), as a booster dose/No adverse event; Initial information received on 15-May-2020 regarding an unsolicited valid non-serious case received an other health professional.  This case involves a 49 years old male patient who was administered an expired dose of vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  Medical history, medical treatment, vaccination and family history were not provided. No concomitant medication was given to the patient.   On 15-May-2020, the patient received a booster dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U5854AB) (Expiry date: 25 January 2020) via unknown route at an unknown administration site for immunization.  It was a case of an 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 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: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Diarrhoea, Headache, Pyrexia
Clinical narrative: headache, cough, fever, diarrhea.  Told her to take Tylenol and anti diarrhea medication and consult doctor if it doesn't resolve.
Age: 1.83
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased, Erythema, Irritability, Oedema, Pain
Clinical narrative: Maximum temperature 103'F relieved by acetaminophen and ibuprofen. Erythema and edema painful to walk, fussy
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Injection site erythema
Clinical narrative: *redness at injection site
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Subsequent to ZOSTAVAX inoculation, pt was treated for shingles; Information has been received from a lawyer and the consumer regarding a case in litigation referring to a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. In 2016, pt was inoculated with zoster vaccine live (ZOSTAVAX) by unknown route, as prescribed and/or administered by a pharmacist at a local pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, on an unknown date, she was treated by a physician for shingles (herpes zoster). As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, she had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medication, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  At reporting time, pt was not recovered from herpes zoster and it was considered to be related to zoster vaccine live (ZOSTAVAX).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Patient reported flu like symptoms the day following vaccination lasting 2 days. Patient self treated with acetaminophen second day following vaccination and experienced relief. Symptoms included headache, aches and pains, fever/chills. These symptoms lasted 2 days as mentioned. Patient also experienced fatigue, which persisted for 3 days following vaccination.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reported flu like symptoms the day following vaccination lasting 2 days. Patient self treated with acetaminophen second day following vaccination and experienced relief. Symptoms included headache, aches and pains, fever/chills. These symptoms lasted 2 days as mentioned. Patient also experienced fatigue, which persisted for 3 days following vaccination.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Baby developed red rash on face  about 5 minutes after receiving vaccines according to guardian. When I examined baby had hives on face and no swelling. Lungs were clear w/o wheezing. Within 5 minutes the rash was starting to fade. Baby was given benadryl 6.25 mg and after 15 minutes rash was completely gone.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Altered state of consciousness, Pallor
Clinical narrative: After receiving immunization approx. 5 min following  patient became pale and felt as though was going to pass out. Juice & soda was given. Ice packs applied to neck & chest area. Patient was observed for approx. 20 min. Vitals taken. Physician was called into room to access pt. Patient was allowed to stand once felt better without any further symptoms.
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Patient said she developed a pimple/ward looking mass on the arm of the injection. she reported to us it occurred about a month after the vaccinations. She said its hurts when she touches it.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Within 12 hours-mild chills and sore arm; within 36 hours- severe nausea and dizziness when I tried to get out of bed, had to crawl to bathroom, chills, very sore arm, redness and swelling at injection site. Had to stay in bed for 2 days. Swelling, redness and arm lasted for several days. Dizziness and nausea has slowly improved but after 4 mos I still have some dizziness when I roll over in bed or get up out of bed. I also have some dizziness when I lay flat on floor to exercise. It last about 5 secs.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Within 12 hours-mild chills and sore arm; within 36 hours- severe nausea and dizziness when I tried to get out of bed, had to crawl to bathroom, chills, very sore arm, redness and swelling at injection site. Had to stay in bed for 2 days. Swelling, redness and arm lasted for several days. Dizziness and nausea has slowly improved but after 4 mos I still have some dizziness when I roll over in bed or get up out of bed. I also have some dizziness when I lay flat on floor to exercise. It last about 5 secs.
Age: 25.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Unknown patient EDC is 6/17/2020
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Pt had an episode of emesis  the evening of the vaccine date and pt had a fever over the weekend after.  Pt also broke out in a rash. Pt seen in clinic by a Healthcare provider
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient has sore arm from the injection and is has been more than 2 months since the vaccine. He claims it only hurts when he lifts it above 45 degrees. He has not tried any physical therapy or attempted
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: PT REQUESTED US TO REPORT: NAUSEA/VOMITING, EXTREME MUSCLE PAIN, RAISED BUMP GREATER THAN 5 CM THAT APPEARED > 72 HRS FROM INJECTION AND INCREASED IN SIZE OVER TIME INSTEAD OF DECREASEING ,  FEVER OF 98 DEGREES
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Depressed level of consciousness, Dizziness, Spinal pain
Clinical narrative: Patient received the vaccine and after 3 to 5 minutes, reported a feeling of dizziness and felt like he was going to pass out. The patient shortly reported sharp spiking, pulsating pain in his spine area and lower back. He rated the pain as 8/10. The pharmacist stayed with the patient and asked question to determine if there are any signs of severe allergic reaction but did not find any. The pharmacist kept talking to the patient for and after a couple of minutes, the patient reported that the feeling of passing out was no longer felt. The pain in the spine and the lower back improved and the patient indicated that he was able to drive home. The patient called back to the pharmacy to tell that he feels fine and he was no longer in pain. The pharmacist followed up with the patient on 05/20/2020 at 7:15pm and the patient indicated that he is fine and is not having any adverse symptoms.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Erythema, Mass
Clinical narrative: *red & has lump (quarter size) otherwise well
Age: 0.58
Sex: F
Vaccine: FLU4
Symptoms: Overdose, Pain, Peripheral swelling, Rash
Clinical narrative: Left leg and foot swollen/ worsened to bilateral leg swollen; Pain; Rash; 7 month old received 0.5ml dose of Afluria Quadrivalent as 2nd dose, rather than 0.25 ml dose; This is a spontaneous case from initially reported by other health professional (nurse) on 08-May-2019, concerning a 07-month-old, infant female patient.  On an unspecified date in past, the patient was administered Flulaval Quadrivalent as a first dose. The patient did not take any concomitant medications during the time of vaccination.  On 23-Apr-2019, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported] as second dose for influenza prophylaxis. It was reported that, the patient received 0.5 ml of the dose instead of 0.25 ml (explicitly coded as overdose).  On 24-Apr-2019, one day after vaccination, the patient developed swelling in her left leg and foot, which worsened to bilateral leg swelling and rash, but these events never became an anaphylactic reaction. On the same day, the patient was taken to emergency room. The nurse was unaware of medications administered when the patient went to the emergency room, but when the patient left, she was prescribed with Tylenol (paracetamol) for the pain.  The outcome of the events was recovering (reported as swelling and rash were less intense and the patient was getting better).  The reporter assessed the case as non-serious.  Non-significant follow up report received by reporter on 19-Jun-2019: Med info number (SEQ19-01552) was updated in the additional information tab. No new information received, so no changes were made in the narrative.; Reporter's Comments: A 07-month-old, female patient experienced peripheral swelling, pain and rash one day after the administration of suspect vaccine Afluria Quadrivalent. It was reported that, the patient received 0.5 ml of the dose instead of 0.25 ml (coded as overdose).  The company assessed the causality of the events peripheral swelling, pain and rash as related to the suspect vaccine due to plausible temporal relationship between the events and suspect vaccine.  The company assessed the causality of the event overdose as not related to the suspect vaccine due to accidental nature of the event.
Sex: M
Vaccine: FLUA3
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered, Product leakage, Syringe issue
Clinical narrative: Some vaccine squirted out onto patient's skin whilst being vaccinated; Some vaccine squirted out onto patient's skin whilst being vaccinated; Some vaccine squirted out onto patient's skin whilst being vaccinated; A leaking syringe; This is a spontaneous case from, reported by a pharmacist to agency (reference ID: SEQ19-03461) and initially received on 30-Sep-2019 and processed together with additional information received on 01-Oct-2019, concerning a 70-year-old, male patient.   The patient had no relevant medical history reported. There were no concomitant medications that interacted with vaccine (as reported).  On 30-Sep-2019, the patient was administered Fluad (TIV) [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, batch number: 262000, expiration date: May-2020, anatomical location and route of administration: not reported] for influenza prophylaxis.  Some vaccine squirted out onto patient's skin whilst being vaccinated due to leaking syringe (explicitly coded as 'Incomplete dose administered' and Accidental exposure to product ).  It was not reported whether the patient experienced any adverse event.  The number assigned to this case is 1048069.  The case was assessed as non-serious. The reporter did not provide causality assessment to Fluad (TIV).  Quality Assurance Investigation for a single syringe unit of Fluad, batch number 262000, noted that leaking at the luer lok was a known issue and user handling was concluded as the root cause, with the use of safety needles as a contributing factor. Therefore, there was no product quality impact, as the units were integral, until they were manipulated by the user.  Follow up received from group on 15-Nov-2019 (reference number: 1048069): number added, complaint closure received. The narrative was amended accordingly.  Non-significant follow-up reported by other non-health professional from agency [reference number: SEQ19-04920] on 26-Nov-2019: Additional reference number added. No changes in narrative.  Company comment: Exposure via skin contact, incorrect dose administered, accidental exposure to product and product leakage were associated with the suspect product Fluad (TIV). Chronology is plausible. It was not reported whether the patient experienced any adverse event. Causal role of the suspect product is assessed as not related.; Sender's Comments: Exposure via skin contact, incorrect dose administered, accidental exposure to product and product leakage were associated with the suspect product Fluad (TIV). Chronology is plausible. It was not reported whether the patient experienced any adverse event. Causal role of the suspect product is assessed as not related.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: Facial and head numbness; Stiff neck; Horrible headaches; This is a spontaneous case, reported by other non health professional (consumer) via agency (regulatory reference number: SEQ19-06673) on 15-Nov-2019, concerning a 59-year-old, female patient.  The patient's medical history was not provided. The patient's concomitant medications were not provided.  On 11-Nov-2019 at approximately 5:40 pm, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular (IM), anatomical location: left arm, batch number and expiry date: not reported] for influenza prophylaxis.  On the same day, within one hour and half after vaccination, the patient had a horrible reaction to your Flu Vaccine. The patient developed facial and head numbness along with horrible headaches that continued for more than 48 hours. The headache along with stiff neck continued 72 plus hours later.  On 13-Nov-2019, approximately 47 hours after vaccination, the patient went to emergency room (ER). The doctor did not know what was wrong and thought that the patient had not had a stroke.  On 15-Nov-2019, the outcome of facial and head numbness was resolved.  On 16-Nov-2019, the outcome of headache was resolved.  At the time of this report, the outcome of stiff neck was not reported.  The reporter assessed this case as related to Flucelvax Quadrivalent.  Follow up received from other non health professional (consumer) via agency (reference number: SEQ19-06886) on 10-Dec-2019: Vaccine indication, route of administration and anatomical location updated. It was confirmed that onset date for headache and neck stiffness was 11-Nov-2019. The stop dates for headache and facial and head numbness updated. The outcome of headache and stiff neck updated. Narrative amended accordingly.  The reporter assessed the events as related to Flucelvax Quadrivalent vaccine.  Company Comment: The patient experienced hypoaesthesia, musculoskeletal stiffness and headache after vaccination with the Flucelvax Quadrivalent. Chronology is possible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Reporter's Comments: I had a horrible reaction to your Flu Vaccine.; Sender's Comments: The patient experienced hypoaesthesia, musculoskeletal stiffness and headache after vaccination with the Flucelvax Quadrivalent. Chronology is possible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pain in the area where the injection was administered; This is a spontaneous case, reported by pharmacist to Company [reference number: SEQ19-07615] and initially received on 26-Dec-2019, concerning a 59-year-old, female patient.  The patient had no medical history. The patient did not take any concomitant medications.  On 01-Dec-2019, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: P100142912 and expiration date: not reported] for protection against seasonal influenza.  On the same day, after vaccination, the patient experienced pain in the area where the injection was administered. No corrective treatment was given for the event.  At the time of initial reporting, the patient had not recovered from the event.  The case was assessed as non-serious.  The reporter did not provide causality assessment.  The reporter did not give consent for further follow-up.   Company Comment: The event of 'vaccination site pain' is considered as related to Afluria Quadrivalent.; Sender's Comments: The event of 'vaccination site pain' is considered as related to Afluria Quadrivalent.
Age: 46.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Injection site pain, Muscle spasms, Musculoskeletal pain, Paraesthesia
Clinical narrative: Left upper back pain; Occasional bilateral leg tingling; This is a spontaneous case, initially received from other health professional via Company (reference number: SEQ19-07553) on 20-Dec-2019, concerning a 46-year-old, female patient.   The patient had no relevant medical history and no concomitant medications.   On 09-Dec-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 261222 and expiration date: 30-Jun-2020] for an influenza prophylaxis.   On 11-Dec-2019, two days after vaccination, the patient experienced left upper back pain and occasional bilateral leg tingling.   On 14-Dec-2019, the patient visited emergency room due to events. She was given unspecified muscle relaxer and ibuprofen and referred to a neurologist.   On 19-Dec-2019, the patient visited the neurologist who felt it might be related to Flucelvax Quadrivalent injection.   At the time of this report, the patient was not recovered from the events.  The reporter assessed the case as non-serious.  Company comment: The patient developed back pain and paraesthesia two days after Flucelvax (QIV) was administered. Chronology is plausible. More information regarding medical history and concomitant medications is needed. Based on provided information, causal role of the suspect product is assessed as related for both events.; Reporter's Comments: The neurologist stated that events might be related to Flucelvax Quadrivalent.; Sender's Comments: The patient developed back pain and paraesthesia two days after Flucelvax (QIV) was administered. Chronology is plausible. More information regarding medical history and concomitant medications is needed. Based on provided information, causal role of the suspect product is assessed as related for both events.
Age: 46.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Back pain, Paraesthesia
Clinical narrative: Left upper back pain; Occasional bilateral leg tingling; This is a spontaneous case, initially received from other health professional via Company (reference number: SEQ19-07553) on 20-Dec-2019, concerning a 46-year-old, female patient.   The patient had no relevant medical history and no concomitant medications.   On 09-Dec-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 261222 and expiration date: 30-Jun-2020] for an influenza prophylaxis.   On 11-Dec-2019, two days after vaccination, the patient experienced left upper back pain and occasional bilateral leg tingling.   On 14-Dec-2019, the patient visited emergency room due to events. She was given unspecified muscle relaxer and ibuprofen and referred to a neurologist.   On 19-Dec-2019, the patient visited the neurologist who felt it might be related to Flucelvax Quadrivalent injection.   At the time of this report, the patient was not recovered from the events.  The reporter assessed the case as non-serious.  Company comment: The patient developed back pain and paraesthesia two days after Flucelvax (QIV) was administered. Chronology is plausible. More information regarding medical history and concomitant medications is needed. Based on provided information, causal role of the suspect product is assessed as related for both events.; Reporter's Comments: The neurologist stated that events might be related to Flucelvax Quadrivalent.; Sender's Comments: The patient developed back pain and paraesthesia two days after Flucelvax (QIV) was administered. Chronology is plausible. More information regarding medical history and concomitant medications is needed. Based on provided information, causal role of the suspect product is assessed as related for both events.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was provided regarding medical history, concurrent condition, or concomitant medication. In 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose number and route was not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date (reported as "subsequent to zoster vaccine live (ZOSTAVAX) inoculation"), the patient was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Post herpetic neuralgia; shingles; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided.  On or about 05-JUN-2012, pt was inoculated with zoster vaccine live (ZOSTAVAX) by unknown route, as prescribed and/or administered by a pharmacist at a local pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, on an unknown date, she was treated by a physician for shingles (herpes zoster) and post herpetic neuralgia. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, she had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medication, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  At reporting time, pt was not recovered from herpes zoster and post herpetic neuralgia and it was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; Medical Assistant reports on 5/5/2020 an improperly stored VARIVAX was administered to a patient.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 05-MAY-2020, the patient was administered an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S025913, expiration date 20-AUG-2021, strength, dose and route were unknown) for prophylaxis. The Merck sterile diluent that was used to reconstitute the vaccine was properly stored.  Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) was stored at -14 degree Celsius to -10 degree Celsius (-11.2 degree Celsius) for 9 hours and 58 minutes; -9 degree Celsius to 8 degree Celsius (3 degree Celsius) for 13 hours and 35 minutes. There was no previous temperature excursion reported. No additional adverse events.
Sex: U
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: an unspecified patient was administered the third dose of ROTATEQ at age 8 and a half months old on an unspecified date.; This spontaneous report was received from a physician referring to an 8 and a half month years old patient of unknown gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.   On an unknown date, the patient was administered the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, route, batch/lot# and expiration date were not reported) for prophylaxis (inappropriate age at vaccine administration). The physician was in another country . The physician was warm conferenced to Merck.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 4-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004991: US-009507513-2005USA004972: US-009507513-2005USA004992: US-009507513-2005USA004993:
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms or effects reported; patient inadvertently received first dose in VARIVAX immunization series that was reconstituted inadvertently with expired DILUENT; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drug, concurrent conditions, concomitant medication, and previous drug reactions or allergies were not reported.     On 23-MAR-2020, the patient received the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot number R023504 with an expiration date on 16-AUG-2020 (vaccination scheme, route of administration, and anatomical site of injection were not reported), which was reconstituted inadvertently with an expired sterile diluent (MERCK STERILE DILUENT), lot number N028746 with an expiration date on 17-MAR-2020 (strength, dose, frequency, route of administration were not reported), both as prophylaxis (expired product administered). No adverse symptoms or effects were reported nor product quality complain involved.