chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Irritability, Rash erythematous, Rash macular, Vomiting
Clinical narrative: a few minutes after the vaccines were administered, patient had blotchy red rash on face, vomited, and remained irritable for about 20 minutes. No urticaria elsewhere. No rash at any injection site. Administered diphenhydramine. 15-20 min later patient asymptomatic, happy, smiling. Called father later that evening, and patient has remained well.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Alopecia, Constipation, Cortisol increased, Gastrointestinal disorder, Hair texture abnormal
Clinical narrative: Immediately, my digestive system ceased to function resulting in severe, chronic constipation.  I stopped having periods for 3 months.  My hair turned to the texture of straw and started falling out in fistfuls.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction
Clinical narrative: Immediately, my digestive system ceased to function resulting in severe, chronic constipation.  I stopped having periods for 3 months.  My hair turned to the texture of straw and started falling out in fistfuls.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Chest pain, Chills
Clinical narrative: For 3 days: Chills, fever (1st 48 hours) Aches & pains head, back, chest, arms, stomach, hips (1st 48 hours) Sore throat  & pain in sinuses, neck, ears, teeth, jaws, (starting second 24 hours for 36 hours) Nausea (1st 24 hours) Pain at injection site (1st 72 hours)
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Headache, Injection site pain, Nausea, Neck pain
Clinical narrative: For 3 days: Chills, fever (1st 48 hours) Aches & pains head, back, chest, arms, stomach, hips (1st 48 hours) Sore throat  & pain in sinuses, neck, ears, teeth, jaws, (starting second 24 hours for 36 hours) Nausea (1st 24 hours) Pain at injection site (1st 72 hours)
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain in extremity, Pain in jaw, Pyrexia, Sinus pain
Clinical narrative: For 3 days: Chills, fever (1st 48 hours) Aches & pains head, back, chest, arms, stomach, hips (1st 48 hours) Sore throat  & pain in sinuses, neck, ears, teeth, jaws, (starting second 24 hours for 36 hours) Nausea (1st 24 hours) Pain at injection site (1st 72 hours)
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Toothache
Clinical narrative: For 3 days: Chills, fever (1st 48 hours) Aches & pains head, back, chest, arms, stomach, hips (1st 48 hours) Sore throat  & pain in sinuses, neck, ears, teeth, jaws, (starting second 24 hours for 36 hours) Nausea (1st 24 hours) Pain at injection site (1st 72 hours)
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site mass, Pain, Pruritus
Clinical narrative: Patient received subq Varivax on Monday 7/13/20, no reaction that day. Patient awoke on Tuesday 7/14/20 with a large lump at the site of injection. Patient reports, itching, redness, and pain. Over Tuesday to Wednesday, the lump became larger- "larger than her fist". Patient denies fever or trouble breathing. She has taken Tylenol for the pain. Patient was counseled to see a physician about reaction.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Rash
Clinical narrative: shingles rash and in her eyes and lips; shingles rash; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 11-JUL-2017, the pt was vaccinated in a pharmacy with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot #, expiration date were unknown) for the prevention of shingles and routine health maintenance. Shortly after receiving zoster vaccine live (ZOSTAVAX) inoculation, pt suffered severe side effects including shingles rash and in her eyes and lips and was diagnosed by physicians with shingles and herpes zoster ophthalmicus. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX); pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries; also suffered serious, progressive, permanent and incurable injuries; as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct result of use of zoster vaccine live (ZOSTAVAX), the pt incurred medical expenses and other economic harm. The outcome of shingles and herpes zoster ophthalmicus was considered as not recovered. The causal relationship between shingles, herpes zoster ophthalmicus and zoster vaccine live (ZOSTAVAX) was considered related. Upon internal review, the events were considered as disabling.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: vomiting; This spontaneous report as received from a physician via a company representative concerning a 2-month-old patient of an unknown gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. In approximately July 2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally, for prophylaxis(concentration, dose, frequency, lot # and expiry date were not reported). In approximately July 2019 (reported as a week after receiving the dose), the patient experienced vomiting. No product quality complaint (PQC) involved. The outcome of vomiting was unknown. The action taken was not applicable. The causality assessment between the vomiting and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event.; administered a dose that had been improperly stored; This spontaneous report was received from a medical assistant and refers to a 9-day-old male patient. There was no information about his concurrent conditions, concomitant therapies or medical history provided. On 10-JUL-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, orally, lot # 1660944, expiration date 16-APR-2021 (strength and dose were not reported) for prophylaxis.  On an unknown date, the dose of the vaccine was exposed to temperature excursion at 0.5 Celsius degree (C) for 1 hour 49 minutes. There was no previous temperature excursion. The call was due to digital data logger. No additional adverse effect was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 13-APR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 26-MAY-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Ear pain, Face injury, Facial paralysis, Head injury, Hypoaesthesia
Clinical narrative: Ear pain (Acute Recurrent otitis media); Facial Trauma; Head trauma; Numbness; Segmental and somatic dysfunction of cervical region; Segmental and somatic dysfunction of cervical region; Bell's Palsy; This case was reported by a lawyer and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  The initial information received on 08 July 2020 via medical records (The case is medically confirmed). As per the records he had underwent Throat surgery. As per the pharmacy records the male patient was receiving Shingrix during 27 September 2019 and on 10 January 2020. As per the records, he had ear pain Onset: 2 week(s) Acute recurrent otitis media; duration: 2 Week(s). On 17 February 2020, his discharge Instructions included Bell's Palsy and he had left side drooping, he also had Facial ,Head Trauma and Numbness. As per the assessment dated 26 May 2020, he was present with bells palsy since February 2020. He had segmental and somatic dysfunction of cervical region and segmental and somatic dysfunction of upper extremity.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Otitis media, Otitis media acute, Somatic dysfunction
Clinical narrative: Ear pain (Acute Recurrent otitis media); Facial Trauma; Head trauma; Numbness; Segmental and somatic dysfunction of cervical region; Segmental and somatic dysfunction of cervical region; Bell's Palsy; This case was reported by a lawyer and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  The initial information received on 08 July 2020 via medical records (The case is medically confirmed). As per the records he had underwent Throat surgery. As per the pharmacy records the male patient was receiving Shingrix during 27 September 2019 and on 10 January 2020. As per the records, he had ear pain Onset: 2 week(s) Acute recurrent otitis media; duration: 2 Week(s). On 17 February 2020, his discharge Instructions included Bell's Palsy and he had left side drooping, he also had Facial ,Head Trauma and Numbness. As per the assessment dated 26 May 2020, he was present with bells palsy since February 2020. He had segmental and somatic dysfunction of cervical region and segmental and somatic dysfunction of upper extremity.
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Arthralgia, Depression, Headache, Joint swelling, Pain
Clinical narrative: Swollen joints; Depression; Headache; General body pain; Joint pain; This is a spontaneous report based on the Information received by Pfizer from Pharmacovigilance (MFR. Control No: 20K-163-3461869-00) from a contactable physician.  Spontaneous report from a physician of a 64-year-old female with events of non-serious Swollen joints, Depression, Headache, General body pain and Joint pain with Humira (ADALIMUMAB) via subcutaneous at 40 mg for Rheumatoid arthritis from 06Jul2019. There was no reported medical history. The patient did not receive any concomitant medication. On unknown dates, the patient experienced Swollen joints, Depression, Headache, General body pain and Joint pain. On unknown dates, Swollen joints, Depression, General body pain and Joint pain resolved. The outcome of the event headache was unknown. Prevnar (PNEUMOCOCCAL VACCINE CONJ 7V (CRM197)) and Shingrix (VARICELLA ZOSTER VACCINE RGE (CHO)) were also considered suspect. The patient was treated with Prednisone. Causality for Humira (ADALIMUMAB) The reporter's causality for the event(s) of swollen joints, Depression, Headache, General body pain and Joint pain was not provided. The action taken in response to the events for adalimumab was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Rheumatoid arthritis
Clinical narrative: Swollen joints; Depression; Headache; General body pain; Joint pain; This is a spontaneous report based on the Information received by Pfizer from Pharmacovigilance (MFR. Control No: 20K-163-3461869-00) from a contactable physician.  Spontaneous report from a physician of a 64-year-old female with events of non-serious Swollen joints, Depression, Headache, General body pain and Joint pain with Humira (ADALIMUMAB) via subcutaneous at 40 mg for Rheumatoid arthritis from 06Jul2019. There was no reported medical history. The patient did not receive any concomitant medication. On unknown dates, the patient experienced Swollen joints, Depression, Headache, General body pain and Joint pain. On unknown dates, Swollen joints, Depression, General body pain and Joint pain resolved. The outcome of the event headache was unknown. Prevnar (PNEUMOCOCCAL VACCINE CONJ 7V (CRM197)) and Shingrix (VARICELLA ZOSTER VACCINE RGE (CHO)) were also considered suspect. The patient was treated with Prednisone. Causality for Humira (ADALIMUMAB) The reporter's causality for the event(s) of swollen joints, Depression, Headache, General body pain and Joint pain was not provided. The action taken in response to the events for adalimumab was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in jaw, Trismus
Clinical narrative: jaw pain, the jaw getting sore, mainly felt on the right side of the jaw, having pain when even closing the jaw; the jaw being hard to open, having pain when even closing the jaw, and having jaw to pop with movement; Initial information received on 09-Jul-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 40 year old female patient who experienced jaw pain, the jaw was getting sore, mainly felt on the right side of the jaw, the jaw being hard to open, having pain even when closing the jaw and having jaw to pop with movement (pain in jaw and trismus), while she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Patient had no other vaccine as concomitant medication.  On 30-Jun-2020, the patient received a 0.5 mL booster dose once of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and Expiry date not reported) via an intramuscular route in the left arm for prophylactic vaccination.  On 01-Jul-2020, the patient had jaw pain, the jaw was getting sore, mainly felt on the right side of the jaw, the jaw being hard to open, having pain even when closing the jaw and having jaw to pop with movement (pain in jaw and trismus) one day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported that there had been no change in the jaw pain since it started, that the jaw pain was worse in the morning, that the level of pain with the jaw had stayed consistent, that the more she used the jaw the better she was able to work the jaw and the pain was not as bad.  Other Relevant laboratory test results not provided.  Final diagnosis were pain in jaw and trismus.  The patient was treated with IBUPROFEN for jaw pain and placed heat on that area.  The patient had not recovered from pain in jaw and trismus.  There will be no information available on the batch number for this case.
Age: 0.08
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Ipol vaccine was given to a patient/no AE; Initial information was received on 10-Jul-2020 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves 1 month old male patient who was vaccinated with IPV (VERO) [IPOL] on 07-Jul-2020 which was already expired on 02-MAY-2020 (batch number P1A25, dosing details, route not reported) at left thigh for prophylactic vaccination(Expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Jul-2020, patient received concomitant medications DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); HEPATITIS B VACCINE (HEPATITIS B VACCINE); HIB VACCINE (HIB); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Injection site swelling
Clinical narrative: redness down her arm; reaction of swelling at injection site; Menactra was administered to a patient via subcutaneous route rather than intramuscular; Initial information received on 10-Jul-2020 regarding an unsolicited valid non-serious case from a physician assistant.  This case involves a 22 years old female patient who developed redness down her arm (erythema) and reaction of swelling at injection site (vaccination site swelling), while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment, vaccination and family history were not provided. No concomitant received by the patient.   On 07-Jul-2020, the patient received a dose 0.5 mL of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: LU6365AA and expiration date: 24-Sep-2020) via subcutaneous route in the left arm as prophylactic vaccination. It was reported that the patient had booster then received this dose.  On an unknown date, the patient developed a non-serious redness down her arm (erythema) and  reaction of swelling at injection site (vaccination site swelling), couple of days later following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was also a case of medication error due to inappropriate route of vaccination as the vaccine menactra was administered to a patient subcutaneously rather than intramuscular ( PT: incorrect route of product administration) on 07-Jul-2020.  No laboratory data reported.  Final diagnosis was erythema and vaccination site swelling.  The patient was treated with hydrocortisone cream and benadryl on an unknown date.  The outcome was of events was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.83
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 22 month old patient was injected with Quadracel in error, no AE; Initial information was received on 10-Jul-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (office staff).  This case is linked to case 2020SA182014 (same reporter)  This case involves a 22 month old female patient who was injected in error with 0.5 ml first dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5688AA, expiry 26-Nov-2021) via intramuscular route in unknown administration site for prophylactic vaccination on 06-Jul-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE  for prophylactic vaccination.  It was a case of an actual medication error due to product administered to patient of inappropriate age.  No adverse events were reported  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.25
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 3 month old patient was injected with Quadracel in error,No AE; Initial information was received on 10-Jul-2020 regarding an unsolicited valid non-serious case from a consumer (office staff).  This case is linked to case 2020SA182003 (same reporter)  This case involves a three month old female patient who was injected with 0.5 mL first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL], vial once (lot number: C5688AA, expiry date: 26-Nov-2021) via intramuscular route in the left thigh for prophylactic vaccination on 08-Jul-2020 in error.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to inappropriate age at vaccine administration.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: a quarter-sized reddened area at the injection site; patient received Menactra subcutaneously rather than intramuscular route; Initial information was received on 10-Jul-2020 regarding an unsolicited valid non-serious case from an other health professional  This case involves a 19 year old female patient who had a quarter-sized reddened area at the injection site (vaccination site erythema), while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] subcutaneously rather than intramuscularly (Incorrect route of product administration).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. No other vaccines were given.   On 09-Jul-2020, the patient received a 0.5 ml once dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6522AA, Expiry date 29-Jan-2021) once via subcutaneous route in the left upper arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious quarter-sized reddened area at the injection site (vaccination site erythema) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was a case of an actual medication error due to Inappropriate route of vaccination as the vaccine was administered into the subcutaneous tissue of the left upper arm rather than deltoid muscle (intramuscularly).  No laboratory data was provided  Final diagnosis was vaccination site erythema.  It was not reported if the patient received a corrective treatment.  At the time of report, outcome of clinical event was unknown.  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: 3.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Pentacel was given to patient / no AE; Initial information received on 10-Jul-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years 1 months old male patient who was vaccinated with an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ100AB) (Expiry date 13-Jun-2020) via unknown route in unknown administration site on 09-Jul-2020 for Prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 16 year-old female received a third Menactra vaccine today, no AE; Initial information received on 10-Jul-2020 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 16 year old female patient who received the third dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] 0.5 mL (lot U6565AB, Expiry date 28-Mar-2021) via intramuscular route in the right deltoid on 10-Jul-2020 for prophylactic vaccination (extra dose administered). The patient received her first Menactra in 2015. She received second one in Dec-2019.   The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. She never had the vaccine prior to 2015.  Patient did not receive any other vaccine as concomitant medication.  It was an actual medication error case due to extra dose administered.  It was reported that patient had immunization records from two different doctors and they did not match. Therefore, there was confusion and that 16 year-old female received a third Menactra vaccine today. The patient received her first Menactra in 2015. She received another in Dec-2019.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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 available on the batch number for first and second dose in this case.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Fever (100) - Took Motrin Nausea - Went away after a few hours Sweats - Went away after a few hours
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes virus infection, Neuralgia, Rash
Clinical narrative: Extream flare-up of existing herpes condition.  Prior to this event, herpes was under control and presented only once or twice a year as mild and very localized rash on left buttox, about the size of a quarter.  One day fter injection, the flare-up was very large on left buttox, with nerve pain extending down leg to foot, as well as in to genital area.  This has persisted for three days after the injection, but deminishing in severvity after the second day.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Malaise, Pyrexia
Clinical narrative: Right leg is swollen and hot. Patient has a rash around injection site. She was slightly feverish and was not feeling well.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Angioedema, Body tinea, Lip swelling, Liver function test normal, Rash
Clinical narrative: 6/6/19 Patient went to an urgent care with a rash on most of his body.  Diagnosed with Tinea Coporis.  6/10/19 Went to Dermatologist. Initial rash spread all over body. Diagnosed with Urticaria Acute Mulitiforme.  6/20/19 Dermatolgist follow up, urticaria improved.  7/3/10 seen at Urgent  Care with swollen face and hives. Diagnosed with hives.  8/7/19 Follow up with Dermatologist, reporting s/s of entire head swelling and lips swelling.  Diagnosed with Chronic Urticaria, Angioedema. Referred to allergist.  9/4/19 Seen by allergist and diagnosed with Chronic Hives and Chronic Urticaria.  Father, wants a VAERS report made.  He fees that symptoms were due to the HPV vaccine.  He feels that patient's autoimmune response warrants further investigation and reporting into the safety and efficacy of the HPV vaccine.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Swelling, Swelling face, Urticaria, Urticaria chronic
Clinical narrative: 6/6/19 Patient went to an urgent care with a rash on most of his body.  Diagnosed with Tinea Coporis.  6/10/19 Went to Dermatologist. Initial rash spread all over body. Diagnosed with Urticaria Acute Mulitiforme.  6/20/19 Dermatolgist follow up, urticaria improved.  7/3/10 seen at Urgent  Care with swollen face and hives. Diagnosed with hives.  8/7/19 Follow up with Dermatologist, reporting s/s of entire head swelling and lips swelling.  Diagnosed with Chronic Urticaria, Angioedema. Referred to allergist.  9/4/19 Seen by allergist and diagnosed with Chronic Hives and Chronic Urticaria.  Father, wants a VAERS report made.  He fees that symptoms were due to the HPV vaccine.  He feels that patient's autoimmune response warrants further investigation and reporting into the safety and efficacy of the HPV vaccine.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Musculoskeletal stiffness, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Pt reported, 2 weeks later, that, one day after receiving the injection, his R hand & all his fingers in the R hand got swollen, red & stiff, couldn't open or close his hand which would lead to pain if he tried.  Right arm was spared.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Hyperhidrosis, Loss of consciousness, Vomiting
Clinical narrative: approx. 10 minutes after getting menactra the patient loss consciousness, diapharetic and  vomited.  this patient had not eaten anything all day.  this lasted approx. 10 minutes VS stable and patient was then able to walk out with mother.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Developed redness, swelling & fever up to 101 within  24 hours of vaccination. Treated with oral tylenol, Benadryl  25mg po Qx2 and ice application with improvement  of erythema & resolution of fever
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Lacrimation increased, Myalgia, Pain
Clinical narrative: Right side body aches for 1 month Left side body aches for 1 month All muscle aches different parts of body Each day watery eyes Each muscle I move a day ache the Next day and Burning legs
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Pain in extremity, Thirst
Clinical narrative: Lightheaded and very thirsty even though I had drunk several glasses of water lasted over 24 hours Pain in arm but went away after about 4 hours
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Feeling cold, Hyperhidrosis, Nausea, Pain in extremity, Pyrexia
Clinical narrative: EMPLOYEE REPORTED  AT 7:OOPM  ON 7/12/2020 SHE STRARTED SWEATING, CHILLS, FEVER, SORENESS IN RIGHT ARM   SYMPTOMS LASTED UNTIL 1:00AM THIS MORNING. EMPLOYEE CONTINUES TO FEEL NAUSEA
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm is swollen and red.  Looks like cellulitis but pt is going to go to ER to confirm.  Pt took benadryl but did not work.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Neck pain, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient has pain and swelling on the left arm that radiates to the back and upper neck area.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Patient has pain and swelling on the left arm that radiates to the back and upper neck area.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Moderate pain, redness and swelling of left tricep area, unable to touch.  Fever of 100 degrees, headache, nausea, fatigue, All have occurred since midnight.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Moderate pain, redness and swelling of left tricep area, unable to touch.  Fever of 100 degrees, headache, nausea, fatigue, All have occurred since midnight.
Age: 40.0
Sex: F
Vaccine: DT, TYP, UNK, YF
Symptoms: Amnesia, Neoplasm malignant
Clinical narrative: I wish to report symptoms I had following vaccines I received in 2012, here in my native country, which I now suspect were side effects of the vaccines themselves. On January 31, 2012, I received the vaccines for yellow fever and dT (double bacteria: diphtheria and tetanus). On March 14, 2012 I received vaccines and polio and typhoid fever. These were prescribed to me by a doctor specialized in tropical diseases, to whom I was referred by my employer's doctor, because my job was sending me abroad, where I stayed for 3 weeks. I had previously received the double bacteria and yellow fever vaccines back in 2001, without event. This time, however (in 2012) I passed through a harsh experience.  In 2012, I got married on March 31st, and was already divorced in December, around Christmas time. Throughout the entire year of 2012 I was extremely stressed, as never before in my life. I had seen difficult times before, but they had not impacted my behavior. 2012 was different. Suddenly my memory just disappeared. I couldn?t remember what I had done just a few minutes before. As a teacher, I found that my students were always scared because they had to tell me what I had asked them to do. Note that my memory was really good when I was younger, and this sudden lack of memory came as a surprise to me. In spite of this weirdness, I never thought to go to a doctor, because I attributed it to the high amount of stress I was experiencing at that particular moment in my life.  After my divorce, I went into depression and took the antidepressant Lexapro for about 10 months. At that time, my memory was virtually nonexistent. I asked the psychiatrist and she said that this medicine had this as a side effect, and that my memory would return when I stopped taking the medicine. I always thought the lack of memory was due to the traumatic experience with my ex-husband, until I learned about vaccines' side effects on the neurological system, and remembered that I had received those vaccines in 2012.  Also, in 2017 I was diagnosed with a rare cancer. This was really shocking because I have a vast history of sports activities for more than 20 years, and healthy food intake for my entire life. Again, I related that (the cancer) to the bad experience I had in my marriage.  I?ll probably never have the answers. I just don?t know if there are tests that would establish any relationship between the diseases and the vaccines. I?ll search for it, ask my doctors, and see if there is something we may do to reverse this scenario. In any case, that?s the most reasonable explanation I have as to what has been happening to my body during the last few years.
Age: 16.0
Sex: U
Vaccine: MNQ
Symptoms: Blindness, Visual impairment
Clinical narrative: patient reports when she woke on 6/5/20, she "could not see" and "had black in front of my eyes and white spots" No LOC, patient laid down and felt better
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Amylase increased, Computerised tomogram abdomen abnormal, Computerised tomogram pelvis abnormal, Lipase increased, Pancreatitis acute
Clinical narrative: Pancreatitis within 24 hours of injection
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Muscular weakness, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: Arm/shoulder pain, radiating down arm and numbness, tingling and weakness in left arm
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient had a syncopal episode after receiving HPV9 vaccine
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Malaise, Myalgia, Nausea
Clinical narrative: Painful, red injection site. Malaise, fever, body/muscle ache, mild nausea.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Painful, red injection site. Malaise, fever, body/muscle ache, mild nausea.
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: fever, local subq redness and swelling
Age: 1.67
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was due for Dtap and IPV and was given kinrix. Patient had no adverse reactions or symptoms, patient tolerated injection fine. CMA has made incident report with clinic and explained exactly what had happened and has followed guidelines for reporting to alertiis.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: pain to left arm, fever of 101 24 hours after injection, mild chills and body aches.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Headache, Pain
Clinical narrative: A temperature of 100.8 (mine usually is 97.9) Body aches Headache
Age: 1.75
Sex: F
Vaccine: HIBV
Symptoms: Aphasia, Decreased eye contact, Developmental delay, Developmental regression, Fine motor skill dysfunction
Clinical narrative: Directly after this vaccine the child lost all speech, was ahead of her peers verbally and her speech regression was severe and significant. We also noticed no eye contact, loss of fine motor skills/playing, hand flapping, toe walking spinning. stimming, trouble sleeping. She now gets Speech therapy, occupational therapy, and ABA therapies to help with these symptoms and developmental regressions/delays. Her first assessment after the vaccine showed she was on about a 10 month old developmental level which prior to vaccine she had no developmental issues and had hit all milestones on time or ahead of the normal.
Age: 1.75
Sex: F
Vaccine: HIBV
Symptoms: Insomnia, Laboratory test abnormal, Mitochondrial cytopathy, Stereotypy, Toe walking
Clinical narrative: Directly after this vaccine the child lost all speech, was ahead of her peers verbally and her speech regression was severe and significant. We also noticed no eye contact, loss of fine motor skills/playing, hand flapping, toe walking spinning. stimming, trouble sleeping. She now gets Speech therapy, occupational therapy, and ABA therapies to help with these symptoms and developmental regressions/delays. Her first assessment after the vaccine showed she was on about a 10 month old developmental level which prior to vaccine she had no developmental issues and had hit all milestones on time or ahead of the normal.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Lymphadenitis, Pain
Clinical narrative: She developed a headache, chills, body aches. She states that all she has done today is sleep. She feels similar to if she had the flu. She has now developed an axillary lymphadenitis.
Age: 11.0
Sex: U
Vaccine: HPV4, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Got what looks like hives on legs after 11yr shot. Not itchy. Got 25 mg Benadryl & rash on legs went away. Was on both legs, both thighs and knee. No where else. Started to fade after Benadryl. No SOB or swelling
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Feeling abnormal, Hypopnoea, Muscle rigidity, Nausea
Clinical narrative: A few minutes after the vaccine the patient was feeling weak and her legs "felt funny". Then all her muscles locked up and her head was cocked to the side, eyes were closed, and breathing was shallow. I administered an EpiPen 0.3mg in her thigh while the technician called 911. She was instantly responsive, breathing was normal, and muscles were no longer rigid. She felt weak and nauseous. The EMTs arrived and checked her vitals and for signs of allergic reaction. They saw no rash, swelling, or hives, so they think it was a vagal response. They took her to the hospital for a further check. The father was here and followed her to the hospital. The mother works at the primary care doctor's office and was meeting them
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Posture abnormal
Clinical narrative: A few minutes after the vaccine the patient was feeling weak and her legs "felt funny". Then all her muscles locked up and her head was cocked to the side, eyes were closed, and breathing was shallow. I administered an EpiPen 0.3mg in her thigh while the technician called 911. She was instantly responsive, breathing was normal, and muscles were no longer rigid. She felt weak and nauseous. The EMTs arrived and checked her vitals and for signs of allergic reaction. They saw no rash, swelling, or hives, so they think it was a vagal response. They took her to the hospital for a further check. The father was here and followed her to the hospital. The mother works at the primary care doctor's office and was meeting them
Age: 86.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Chest X-ray, Injection site pain, Intensive care, Magnetic resonance imaging, Mechanical ventilation
Clinical narrative: She had a 75 o/o tear in rotor cuff very painful back to the dr almost every other day she passed July 6 2020 of respiratory and multi focal pneumonia. She was independent before vaccine but was in extreme pain 1 hour later
Age: 86.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Pneumonia, Product administered at inappropriate site, Rotator cuff syndrome, X-ray limb
Clinical narrative: She had a 75 o/o tear in rotor cuff very painful back to the dr almost every other day she passed July 6 2020 of respiratory and multi focal pneumonia. She was independent before vaccine but was in extreme pain 1 hour later
Age: 86.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Arthralgia, Death, Magnetic resonance imaging, Pneumonia, Respiratory disorder
Clinical narrative: She had a 75 o/o tear in rotor cuff very painful back to the dr almost every other day she passed July 6 2020 of respiratory and multi focal pneumonia. She was independent before vaccine but was in extreme pain 1 hour later
Age: 86.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Rotator cuff syndrome
Clinical narrative: She had a 75 o/o tear in rotor cuff very painful back to the dr almost every other day she passed July 6 2020 of respiratory and multi focal pneumonia. She was independent before vaccine but was in extreme pain 1 hour later
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Rash vesicular
Clinical narrative: Rash behind left ear, up into scalp, down neck, across chest, up side of face,  numbness in upper left gum area, Headache.eft side of head
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Hypoaesthesia oral, Rash
Clinical narrative: Rash behind left ear, up into scalp, down neck, across chest, up side of face,  numbness in upper left gum area, Headache.eft side of head
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, and pain at the injection site. Warm to the touch. By early evening of day 1, there was a noticeable, circular swelling with defined raised edges like a welt, the size of a quarter. On day 2, , the swelling measured 2  3/4  inches at 7 p.m.  On day 3,  the swelling was 3 inches in diameter.  Now, in the evening of day 3, the swelling is more diffuse, an oval 3 1/2 inches high by 2 1/2 inches wide, with muscle pain lessened.  Application of ice pack hasn't seemed to make a difference.
Age: 34.0
Sex: F
Vaccine: FLUR4
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin decreased, Metrorrhagia, Pregnancy test positive
Clinical narrative: I received the flu shot on 10/2/2018. I was trying to conceive at the time. I received a positive pregnancy test on 10/21/18, and on 10/28/18, I began to have spotting. Dr?s appt and bloodwork on 10/29/18 showed low levels of HCG, and by 10/31/18, HCG had dropped even lower. I had never had a miscarriage before.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects; Expired vaccine used; This spontaneous report was received from a registered nurse and refers to a 5 year old patient of unknown gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 09-JUL-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis, lot# R018777 and expiration date 01-JUL-2020 (dose, strength, frequency, and route of administration were not reported). The vaccine was reconstituted with sterile diluent(MERCK STERILE DILUENT) invalid lot# reported as 000494.  The patient experienced no adverse events.