chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Feeling cold, Pain in extremity, Pyrexia, Vaccine positive rechallenge
Clinical narrative: had to the first dose was a very sore arm; low grade fever; chilly; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on unknown date, refer case US2020AMR078358.).   On 6th May 2020, the patient received the 2nd dose of Shingrix. In May 2020, less than a week after receiving Shingrix, the patient experienced pain in arm, fever and chilliness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the fever and chilliness were unknown.   It was unknown if the reporter considered the pain in arm and chilliness to be related to Shingrix. The reporter considered the fever to be possibly related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received Shingrix and arm hurting pretty significantly chilly and also developed a low grade fever. The reporter asked could fever be a side effect of the 2nd dose of Shingrix. The reporter thinking the fever was associated with the shot but with all the Covid going around at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter reported for her uncle. The age at the vaccination was not reported. The patient received Shingrix and experienced flu like symptoms. The reporter consented to follow up. Limited information was provided by the caller about her patient. This case linked with US2020075688 and US2020075686, reported by same reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Insomnia, Pyrexia
Clinical narrative: fever; Could not sleep that night; Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th May 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 4th May 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms and sleeplessness. On 6th May 2020, the patient experienced fever. On an unknown date, the outcome of the influenza-like symptoms and sleeplessness were recovered/resolved and the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, sleeplessness and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm and later that evening she developed flu like symptoms and could not sleep that night. Flu like symptoms lasted for approximately 24 hours.  The patient stated that at the time of reporting she has a fever. The reporter did not consent to follow up. The patient stated that she did not have an health care professional.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site rash, Rash
Clinical narrative: Rash to ventral thighs where vaccines were administered.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Blood test normal, Laboratory test, Lymphadenopathy, Mass, Seizure
Clinical narrative: A few days after the vaccination, patient started shaking his head involuntarily as if he was shaking water out of his ear. I asked my husband to observe and see if he also noticed this. He did. There was no rhyme or reason as to when it would happen. When my husband also observed this behaviour  I immediately called Dr. patient's  pediatrician. My doctor said that patient was probably having seizures and that we should stop vaccinating for now and maybe permanently. He stated that he believed it was a vaccine reaction. I was a wreck. I felt guilty for injuring my son and didn't sleep for days knowing that these seizures may never go away. I stopped observing the head shaking about three weeks after the initial observation. Eight months after that we noticed a huge lump under his mandible. we were referred to a pediatric head and neck doctor. he had labs done and also measured the lump. the blood work came back normal but he did say the size of this lymph node was not normal and that we would have to keep an eye on it. At that moment in time he ruled out cancer because of his labs.it took almost a year for that lump to go back to a normal size.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Tremor, Vaccination complication
Clinical narrative: A few days after the vaccination, patient started shaking his head involuntarily as if he was shaking water out of his ear. I asked my husband to observe and see if he also noticed this. He did. There was no rhyme or reason as to when it would happen. When my husband also observed this behaviour  I immediately called Dr. patient's  pediatrician. My doctor said that patient was probably having seizures and that we should stop vaccinating for now and maybe permanently. He stated that he believed it was a vaccine reaction. I was a wreck. I felt guilty for injuring my son and didn't sleep for days knowing that these seizures may never go away. I stopped observing the head shaking about three weeks after the initial observation. Eight months after that we noticed a huge lump under his mandible. we were referred to a pediatric head and neck doctor. he had labs done and also measured the lump. the blood work came back normal but he did say the size of this lymph node was not normal and that we would have to keep an eye on it. At that moment in time he ruled out cancer because of his labs.it took almost a year for that lump to go back to a normal size.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Bursitis infective, Imaging procedure, Laboratory test
Clinical narrative: Patient received both vaccinations on 02/01/2020. He presented to the pharmacy today (5/12/2020) and claimed that he was hospitalized for septic bursitis. He claimed that he was on multiple IV antibiotics and treatments to treat the septic bursitis. He couldn't tell me exactly when he was hospitalized and the duration of stay because he stated that he thought he  was hospitalized in January and that he thought that he had received the vaccinations in December. In actuality, patient had received the vaccines on 02/01/2020.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Complex regional pain syndrome, Muscular weakness, Nerve conduction studies, Pain in extremity, Paraesthesia
Clinical narrative: Patient first noted right arm pain on 11/1/19, sudden onset, without previous injury.  She was seen by PCP on 11/4/19. The patient was referred to Rheumatology and is still being seen (as of 5/12/20). She experienced pain, paresthesias and progressive weakness of the right arm. Work up included ultrasound (suspicion of shoulder syndrome although the ultrasound was negative) and nerve conduction study. She is currently on Cymbalta and Lyrica, suspect complex regional pain syndrome due to influenza vaccination.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound scan normal
Clinical narrative: Patient first noted right arm pain on 11/1/19, sudden onset, without previous injury.  She was seen by PCP on 11/4/19. The patient was referred to Rheumatology and is still being seen (as of 5/12/20). She experienced pain, paresthesias and progressive weakness of the right arm. Work up included ultrasound (suspicion of shoulder syndrome although the ultrasound was negative) and nerve conduction study. She is currently on Cymbalta and Lyrica, suspect complex regional pain syndrome due to influenza vaccination.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Headache, Injection site pain, Mobility decreased, Muscular weakness
Clinical narrative: The Prevnar13 vaccine, given 4/20/2020, was very painful and I could not move my arm, then I nearly fainted. It took several minutes to be able to sit up and several more minutes to be able to walk and I could move my arm, but it hurt badly. The muscles were weak, the shoulder was swollen a bit (no bruising). I also had slight nausea for a week, with a little fatigue and a slight headache. It was 2-1/2 weeks before the pain and weakness in my arm was nearly gone. There is still a bit of pain at times. I did report this to my physician.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pain, Presyncope, Swelling
Clinical narrative: The Prevnar13 vaccine, given 4/20/2020, was very painful and I could not move my arm, then I nearly fainted. It took several minutes to be able to sit up and several more minutes to be able to walk and I could move my arm, but it hurt badly. The muscles were weak, the shoulder was swollen a bit (no bruising). I also had slight nausea for a week, with a little fatigue and a slight headache. It was 2-1/2 weeks before the pain and weakness in my arm was nearly gone. There is still a bit of pain at times. I did report this to my physician.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Erythema, Feeling cold, Livedo reticularis, Urticaria
Clinical narrative: a few minutes after receiving the vaccinations, pt developed what mother described as hives on his legs -in popliteal area and on his arms -in the antecubital fossa when i entered the room at 1145 i did not see any hives. lower legs were slightly mottled in appearance -skin was cool to touch and i asked mom to cover child with his blanket. Slight erythema noted on the calf of his right leg. Mother breastfed child and cuddled him -i returned in a few minutes and skin had completely normal appearance.
Age: 70.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood test normal, Electromyogram normal, Fatigue, Gait inability, Muscle disorder
Clinical narrative: STARTING ON 3-7-2020 PT STARTED HAVING HER MUSCLES NOT REACTING TO HER MOVEMENTS. PT WAS TAKING IBUPROFEN TO HELP WITH MUSCLE ISSUES.  ON 3-16-20 PT WENT TO MD AND WAS DIAGNOSED MYOSITIS.  SHE WAS PUT ON 2 WEEKS OF PREDNISONE AND HAD NO RELIEF.  PT HAD A TELEVIST WITH MD ON 3-30-20 AND WAS PUT ON 20MG PREDNISONE FOR 1 WEEK, THEN DECREASED TO 10MG. PT IS CURRENTLY ON 5MG PREDNISONE.  PT WAS FINALLY ABLE TO WALK ABOUT A WEEK AGO.  DURING THE PREVIOUS TIME THE PT COULD NOT WALK WITHOUT BEING ASSISTED BY HER HUSBAND.  PT FELT REALLY SICK AND TIRED DURING THIS PERIOD. SHE IS CURRENTLY  DOING STRETCHES TO BE ABLE TO WALK FAR DISTANCES.  HER LEGS ARE BETTER BUT HER ARMS/SHOULDERS ARE STILL IN PAIN
Age: 70.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Musculoskeletal pain, Myositis, Pain in extremity, Walking aid user
Clinical narrative: STARTING ON 3-7-2020 PT STARTED HAVING HER MUSCLES NOT REACTING TO HER MOVEMENTS. PT WAS TAKING IBUPROFEN TO HELP WITH MUSCLE ISSUES.  ON 3-16-20 PT WENT TO MD AND WAS DIAGNOSED MYOSITIS.  SHE WAS PUT ON 2 WEEKS OF PREDNISONE AND HAD NO RELIEF.  PT HAD A TELEVIST WITH MD ON 3-30-20 AND WAS PUT ON 20MG PREDNISONE FOR 1 WEEK, THEN DECREASED TO 10MG. PT IS CURRENTLY ON 5MG PREDNISONE.  PT WAS FINALLY ABLE TO WALK ABOUT A WEEK AGO.  DURING THE PREVIOUS TIME THE PT COULD NOT WALK WITHOUT BEING ASSISTED BY HER HUSBAND.  PT FELT REALLY SICK AND TIRED DURING THIS PERIOD. SHE IS CURRENTLY  DOING STRETCHES TO BE ABLE TO WALK FAR DISTANCES.  HER LEGS ARE BETTER BUT HER ARMS/SHOULDERS ARE STILL IN PAIN
Age: 70.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Chills, Fatigue, Gait disturbance, Headache
Clinical narrative: STARTING ON 3-7-2020 PT STARTED HAVING HER MUSCLES NOT REACTING TO HER MOVEMENTS. PT WAS TAKING IBUPROFEN TO HELP WITH MUSCLE ISSUES.  ON 3-16-20 PT WENT TO MD AND WAS DIAGNOSED MYOSITIS.  SHE WAS PUT ON 2 WEEKS OF PREDNISONE AND HAD NO RELIEF.  PT HAD A TELEVIST WITH MD ON 3-30-20 AND WAS PUT ON 20MG PREDNISONE FOR 1 WEEK, THEN DECREASED TO 10MG. PT IS CURRENTLY ON 5MG PREDNISONE.  PT WAS FINALLY ABLE TO WALK ABOUT A WEEK AGO.  DURING THE PREVIOUS TIME THE PT COULD NOT WALK WITHOUT BEING ASSISTED BY HER HUSBAND.  PT FELT REALLY SICK AND TIRED DURING THIS PERIOD. SHE IS CURRENTLY  DOING STRETCHES TO BE ABLE TO WALK FAR DISTANCES.  HER LEGS ARE BETTER BUT HER ARMS/SHOULDERS ARE STILL IN PAIN
Age: 70.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Inflammation, Loss of personal independence in daily activities, Mobility decreased, Muscle spasms, Muscle tightness
Clinical narrative: STARTING ON 3-7-2020 PT STARTED HAVING HER MUSCLES NOT REACTING TO HER MOVEMENTS. PT WAS TAKING IBUPROFEN TO HELP WITH MUSCLE ISSUES.  ON 3-16-20 PT WENT TO MD AND WAS DIAGNOSED MYOSITIS.  SHE WAS PUT ON 2 WEEKS OF PREDNISONE AND HAD NO RELIEF.  PT HAD A TELEVIST WITH MD ON 3-30-20 AND WAS PUT ON 20MG PREDNISONE FOR 1 WEEK, THEN DECREASED TO 10MG. PT IS CURRENTLY ON 5MG PREDNISONE.  PT WAS FINALLY ABLE TO WALK ABOUT A WEEK AGO.  DURING THE PREVIOUS TIME THE PT COULD NOT WALK WITHOUT BEING ASSISTED BY HER HUSBAND.  PT FELT REALLY SICK AND TIRED DURING THIS PERIOD. SHE IS CURRENTLY  DOING STRETCHES TO BE ABLE TO WALK FAR DISTANCES.  HER LEGS ARE BETTER BUT HER ARMS/SHOULDERS ARE STILL IN PAIN
Age: 70.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Musculoskeletal pain, Oropharyngeal pain, Pain, Paralysis, Paranasal sinus discomfort
Clinical narrative: STARTING ON 3-7-2020 PT STARTED HAVING HER MUSCLES NOT REACTING TO HER MOVEMENTS. PT WAS TAKING IBUPROFEN TO HELP WITH MUSCLE ISSUES.  ON 3-16-20 PT WENT TO MD AND WAS DIAGNOSED MYOSITIS.  SHE WAS PUT ON 2 WEEKS OF PREDNISONE AND HAD NO RELIEF.  PT HAD A TELEVIST WITH MD ON 3-30-20 AND WAS PUT ON 20MG PREDNISONE FOR 1 WEEK, THEN DECREASED TO 10MG. PT IS CURRENTLY ON 5MG PREDNISONE.  PT WAS FINALLY ABLE TO WALK ABOUT A WEEK AGO.  DURING THE PREVIOUS TIME THE PT COULD NOT WALK WITHOUT BEING ASSISTED BY HER HUSBAND.  PT FELT REALLY SICK AND TIRED DURING THIS PERIOD. SHE IS CURRENTLY  DOING STRETCHES TO BE ABLE TO WALK FAR DISTANCES.  HER LEGS ARE BETTER BUT HER ARMS/SHOULDERS ARE STILL IN PAIN
Age: 70.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Rhinorrhoea, Sinus pain, Somnolence, Swelling, Vaccination complication
Clinical narrative: STARTING ON 3-7-2020 PT STARTED HAVING HER MUSCLES NOT REACTING TO HER MOVEMENTS. PT WAS TAKING IBUPROFEN TO HELP WITH MUSCLE ISSUES.  ON 3-16-20 PT WENT TO MD AND WAS DIAGNOSED MYOSITIS.  SHE WAS PUT ON 2 WEEKS OF PREDNISONE AND HAD NO RELIEF.  PT HAD A TELEVIST WITH MD ON 3-30-20 AND WAS PUT ON 20MG PREDNISONE FOR 1 WEEK, THEN DECREASED TO 10MG. PT IS CURRENTLY ON 5MG PREDNISONE.  PT WAS FINALLY ABLE TO WALK ABOUT A WEEK AGO.  DURING THE PREVIOUS TIME THE PT COULD NOT WALK WITHOUT BEING ASSISTED BY HER HUSBAND.  PT FELT REALLY SICK AND TIRED DURING THIS PERIOD. SHE IS CURRENTLY  DOING STRETCHES TO BE ABLE TO WALK FAR DISTANCES.  HER LEGS ARE BETTER BUT HER ARMS/SHOULDERS ARE STILL IN PAIN
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adult dose of Hep-B (20mcg/1mL) 1mL syringe administered to child.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; Patient received improperly stored dose of VARIVAX; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information regarding his/her pertinent medical history, current conditions and previous drug reactions or allergies were not provided.     On 11-MAR-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (Strength, dose, vaccination scheme and route of administration were not provided; lot number S025609 and expiration date 18-AUG-2021) as prophylaxis. The vaccine was exposed to temperature excursion between 15 degrees Fahrenheit to 46 degrees Fahrenheit (-9 degrees celcius [ºC] to 8ºC) -5.48 ºC, for 7 hours (product storage error).   The vaccine was reconstituted with a sterile diluent (MERCK STERILE DILUENT) and which was stored properly. There was no previous temperature excursion and the call was due to a digital data logger. No additional adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician at a medical office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will 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 will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The event was considered related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first dose of shindrex on September 29, 2019 and forgot about the second dose / received the vaccine May 3; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 29th September 2019).   On 3rd May 2020, the patient received the 2nd dose of Shingrix. On 3rd May 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional information was provided as follows: The age at vaccination was not reported. The patient received 1st dose and forgot about 2nd dose. The physician asked patient to start over after the 1st dose and pharmacist asked not to have both doses. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The patient wated to know who was correct. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature decreased, Cough, Dyspnoea, Heart rate increased, Suspected COVID-19
Clinical narrative: She thinks she already had Covid-19; cough; low temperatures; High heart rate; difficulty breathing; This case was reported by a consumer via call center representative and described the occurrence of suspected covid-19 in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2019, the patient received the 1st dose of Shingrix. On 8th March 2020, 110 days after receiving Shingrix, the patient experienced suspected covid-19, cough, body temperature decreased, heart rate increased and difficulty breathing. On an unknown date, the outcome of the suspected covid-19, cough, body temperature decreased, heart rate increased and difficulty breathing were recovered/resolved.   It was unknown if the reporter considered the suspected covid-19, cough, body temperature decreased, heart rate increased and difficulty breathing to be related to Shingrix.  Additional details were reported as follows: Customer was the patient and emailed on 6th May 2020 the following Shingrix.  The patient received first shot in mid- November 2019, and was due for my 2nd shot when the Covid-19 pandemic hit.  The patient asked my physician to write me a prescription to have my 2nd shot, but he is adamant that I wait until it was safe to do so. He says it was not yet safe (I live in a hot spot area, ). My question for you is this: how long could I really wait to get the 2nd vaccine shot (Shingrix)? was it okay if I wait 7-8 months to get the shot? Called customer on 5/7/2020 and while speaking she mentioned that she thinks she already had Covid-19. She stated that around March 8th or 9th 2020 she experienced cough, low temperatures of about 96 or 97 degrees F, high heart rate (heart rate 123), and difficulty breathing. She was not able to get tested for Covid-19 at that time because she did not qualify for a test (ie: she had not recently traveled). Her coworker tested positive for Covid-19. No indication that her coworker was using any GSK products.  She just told us this to indicate why she feels like she already contracted it]. She recovered after 2 weeks. Consented to follow up.
Sex: U
Vaccine: PNC13, UNK, UNK, UNK, UNK, UNK, UNK, UNK
Symptoms: Injection site erythema
Clinical narrative: Localized redness at the injection site; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on unspecified date at a single dose for vaccination; anthrax vaccine, smallpox vaccine (four times), yellow fever vaccine, cholera vaccine, plague vaccine, hepatitis a vaccine;hepatitis b vaccine and influenza vaccine, all via an unspecified routes of administration on unspecified dates at unknown doses for vaccination. The patient's medical history and concomitant medications were not reported. The patient had been vaccinated for about everything including anthrax, smallpox (four times), yellow fever, cholera, plague, pneumonia, hep A and B, and annual flu. The patient had never had any significant reaction other than localized redness at the injection site. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch cannot be obtained. No further information is expected.
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Ipol was inadvertently administered to a 2 year old/no ae; Initial information was received on 05-May-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a two-year-old male patient who was inadvertently administered IPV (VERO) [IPOL].  Medical history, medical treatment, vaccination and family history were not provided.  On unknown date, the patient received concomitant medications PREVNAR 13.  On 05-May-2020, the patient received a second 0.5 ml dose of suspect IPV (VERO) [lot P1A251M, expiry date: 02-May-202] via an intramuscular route at the left deltoid.  It was a case of 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: 72.0
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received 2 doses of ActHIB vaccine on different days, no AE; Initial information was received on 06-May-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 72-year-old female patient who received two doses of HIB (PRP/T) VACCINE [ACT-HIB] vaccine on different days (extra dose administered).  AT the time of event, Patient had ongoing a cancer (Neoplasm malignant) and she thinks had a splenectomy.  Medical treatment, vaccination and family history were not provided.  On 14-Feb-2020, the patient received MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) as concomitant medication.  On 14-Feb-2020 and 05-May-2020, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE [lot UJ180AAA, expiry date: 03-Jul-2021] via an intramuscular route at the left arm for prophylactic vaccination.  On 05-May-2020, patient received another dose of MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO).  It was a case of actual medication due extra dose administered. The patient who received two doses of HIB (PRP/T) VACCINE [ACT-HIB] vaccine on different days (extra dose administered).  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: 4.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Overdose
Clinical narrative: the patient reeived 1 ml dose of IPOL instead 0.5 ml, no AE; Initial information received on 07-May-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a four years old female patient who received 1 ml fourth dose of IPV (VERO) [IPOL] instead 0.5 ml (lot: P1F491M, expiry date: 30-Jun-2020) via an intramuscular route in the right vastus lateralis on 07-May-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) on 07-May-2020 for prophylactic vaccination.  It was a case of overdose.  At the time of reporting, adverse event 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: ActHIB was administered but with expired diluent/no AE; Initial information received on 07-May-2020 regarding an unsolicited valid non-serious case from a other health professional (medical assistant).  This case involves a 18 months old male patient who received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (Box: LOT: UI974AAB, expiry date: 01-Apr-2020, Act-HIB: LOT: UI974AA, expiry date: 27-Jul-2020 and Diluent: LOT: U6193AA, expiry date: 01-Apr-2020) via an intramuscular route in the right thigh) for prophylactic vaccination on 22-Apr-2020. The patient ACT-HIB and only diluent portion was expired.   The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation all on 22-Apr-2020.  It was an actual medication error due to Expired medical agent used (Expired product administered).  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: 47.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Ipol was given to a male, no adverse event; Initial information was received on 08-May-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 47 year old male patient who was given an expired IPV (VERO) [IPOL] (Expired product administered).  Medical history, medical treatments, vaccination and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB); HEPATITIS B VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 07-May-2020, the patient received a 0.5 ml dose of suspect IPV (VERO) lot P1A371M, expiry date 27-Apr-2020 via intramuscular route in the left deltoid for prophylactic vaccination  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: 12.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired IPOL was administered to patient, no AE; Initial information received on 08-May-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 12 years old male patient who received a 0.5 ml single dose of expired IPV (VERO) [IPOL] (lot: P1A242M, expiry date: 26-Apr-2020) via an intramuscular route in the left deltoid 05-May-2020 for prophylactic vaccination.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  At the time of reporting, the patient did not experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Leg pain started in the afternoon 5/8/202. By evening he had swelling from his (L) hip to (L) knee. Rash started at injection site and spread up to left hip + down to L knee. Mother says Saturday 5/9/20 was the worst day. She called PA on call and was told to give Benadryl + use ice packs to area. By 5-11-2020, swelling + redness was minimal + he was walking normally.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No adverse effects reported.; patient was administered a dose of improperly stored MMR II, ROTATEQ or PEDVAX HIB; This spontaneous report was received from a medical assistant referred to multiple unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  On multiple unspecified dates, the patients were administered a dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot number R030808, expiration date 24-OCT-2020; dose number, anatomical location and route of administration were unknown) for prophylaxis, Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot number R033252, expiration date 29-JUN-2020; dose number, anatomical location and route of administration were unknown) for prophylaxis or Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PEDVAX HIB) (lot number R000877, expiration date 24-SEP-2020; dose number, anatomical location and route of administration were unknown) for prophylaxis (product storage error). No lot information was provided for properly stored sterile diluent used to reconstitute improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).  The time frame: above 47 Fahrenheit scale (52F) for 1 hour 15 minutes. There was previous temperature excursion. Data logger was involved.  This report was considered as non-valid due to lack of patient identifiers.  Follow up information has been received from a medical assistant referred to 12-month-old male patient on 11-MAY-2020. On 25-JAN-2019, the patient was administered a dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA003150: US-009507513-2005USA003275: US-009507513-2005USA003277: US-009507513-2005USA003276:
Age: 16.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient was administered a dose of improperly stored MMR II, ROTATEQ or PEDVAX HIB; This spontaneous report was received from a medical assistant refers to female patient of 16-years-old. The patient's pertinent medical history and drug reactions/allergies were not provided. Concomitant medication included sterile diluent.  On 14-JAN-2020, the patient was administered with a dose (1 dosage form) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot number R030808, expiration date 24-OCT-2020; dose number, anatomical location and route of administration were unknown) for prophylaxis (product storage error). No lot information was provided for properly stored sterile diluent used to reconstitute improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). The vaccine was exposed to above 47 Fahrenheit scale (52F) for the time frame of 1 hour 15 minutes. There was previous temperature excursion. Data logger was involved. No adverse effects were reported. No product quality complaint was filed.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA003851: US-009507513-2005USA003277: US-009507513-2005USA003276: US-009507513-2005USA003275:
Age: 1.0
Sex: M
Vaccine: HIBV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient was administered a dose of improperly stored MMR II, ROTATEQ or PEDVAX HIB; This spontaneous report was received from a medical assistant refers to 12 month old male patient. The patient's pertinent medical history and drug reactions/allergies were not provided. Concomitant medication included sterile diluent.  On 15-NOV-2019, the patient was administered with a dose (1 dosage form) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot number R030808, expiration date 24-OCT-2020, anatomical location and route of administration were unknown) for prophylaxis. Other suspect therapies included haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot# R000877 expiration date: 24-SEP-2020, dose number, anatomical location and route of administration were unknown) for prophylaxis (product storage error). No lot information was provided for properly stored sterile diluent used to reconstitute improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The vaccine was exposed to above 47 Fahrenheit scale (52F) for the time frame of 1 hour 15 minutes. There was previous temperature excursion. Data logger was involved. No adverse effects were reported. No product quality complaint was filed.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA003851: US-009507513-2005USA003277: US-009507513-2005USA003150: US-009507513-2005USA003276:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; administered an improperly stored dose of VARIVAX; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications.  On 18-MAR-2020, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck) (VARIVAX) lot number R013564 with expiration date on 13-MAY-2020 (strength , dose, route of administration and anatomical location were not reported) for prophylaxis. It was stated that the sterile diluent  (lot number and expiration date not reported) used for reconstitution was properly stored.  The administered dose of the vaccine experienced a temperature excursion in the range between 15°F to 46°F (15.1°F) for 3 hours 6 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Agitation, Asthenia, Brain natriuretic peptide increased, C-reactive protein increased, Computerised tomogram abdomen normal
Clinical narrative: Patient received first Shingrix vaccine on 4/29/2020.  She awoke the next morning with cold sores -that were recurrent and worse than she is ever had.  Patient presented to clinic on 5/7/2020 as a cold sores were not getting any better with usual treatment of Abreva over-the-counter.  She had also presented with a under the right breast yeast infection during that same clinic visit.  Recently before this visit back at the end of April the patient had increased her Lexapro and we had added a low-dose 100 mg of Wellbutrin nightly -patient reports at the most recent visit that she was doing quite well on both his medication with no concern.  For the cold sore we had decided to go with a valacyclovir 2 g twice a day for 1 day.  For the yeast infection we agreed on ketoconazole.  Patient then called in on 5/8/2020 with concerns of fever, headache, nausea and overall feeling very rundown.  As her PCP I called her to find out in more detail her symptoms and sent her for COVID testing along with influenza and RSV testing.  When she went to go get evaluated at our COVID tent/trailer she was found to be hallucinating and disoriented.  She was then admitted to Hospital for further evaluation.  He became quite agitated and irritable along with paranoid.  Lumbar puncture was unsuccessful but she was admitted for possible management of herpes encephalitis and to exclude COVID-19.  Patient was given haloperidol, lorazepam, acyclovir, tracks own and vancomycin.  She was COVID negative along with influenza and RSV negative.  She had a CT scan of her head and abdomen.  Both showed no concerns for a potential infection as her WBC was 22.4 with a neutrophil percentage of 91.7 and absolute neutrophil count of 20.6.  She also had an elevated d-dimer of 582, elevated PT of 14.6, INR of 1.3, CRP of 118 and a pro BNP f 211.  She was admitted for overnight monitoring, IV fluids and IV acyclovir, vancomycin and ceftriaxone.  Patient left AMA the next morning.  I called the patient today, 5/12/2020, to see how she was doing.  Patient reports that she is otherwise feeling better and is not having any more concerning symptoms at this time.  She agreed to repeat labs today to check the above findings.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head normal, Condition aggravated, Disorientation, Fibrin D dimer increased, Fungal infection
Clinical narrative: Patient received first Shingrix vaccine on 4/29/2020.  She awoke the next morning with cold sores -that were recurrent and worse than she is ever had.  Patient presented to clinic on 5/7/2020 as a cold sores were not getting any better with usual treatment of Abreva over-the-counter.  She had also presented with a under the right breast yeast infection during that same clinic visit.  Recently before this visit back at the end of April the patient had increased her Lexapro and we had added a low-dose 100 mg of Wellbutrin nightly -patient reports at the most recent visit that she was doing quite well on both his medication with no concern.  For the cold sore we had decided to go with a valacyclovir 2 g twice a day for 1 day.  For the yeast infection we agreed on ketoconazole.  Patient then called in on 5/8/2020 with concerns of fever, headache, nausea and overall feeling very rundown.  As her PCP I called her to find out in more detail her symptoms and sent her for COVID testing along with influenza and RSV testing.  When she went to go get evaluated at our COVID tent/trailer she was found to be hallucinating and disoriented.  She was then admitted to Hospital for further evaluation.  He became quite agitated and irritable along with paranoid.  Lumbar puncture was unsuccessful but she was admitted for possible management of herpes encephalitis and to exclude COVID-19.  Patient was given haloperidol, lorazepam, acyclovir, tracks own and vancomycin.  She was COVID negative along with influenza and RSV negative.  She had a CT scan of her head and abdomen.  Both showed no concerns for a potential infection as her WBC was 22.4 with a neutrophil percentage of 91.7 and absolute neutrophil count of 20.6.  She also had an elevated d-dimer of 582, elevated PT of 14.6, INR of 1.3, CRP of 118 and a pro BNP f 211.  She was admitted for overnight monitoring, IV fluids and IV acyclovir, vancomycin and ceftriaxone.  Patient left AMA the next morning.  I called the patient today, 5/12/2020, to see how she was doing.  Patient reports that she is otherwise feeling better and is not having any more concerning symptoms at this time.  She agreed to repeat labs today to check the above findings.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Hallucination, Headache, Influenza virus test negative, International normalised ratio increased, Irritability
Clinical narrative: Patient received first Shingrix vaccine on 4/29/2020.  She awoke the next morning with cold sores -that were recurrent and worse than she is ever had.  Patient presented to clinic on 5/7/2020 as a cold sores were not getting any better with usual treatment of Abreva over-the-counter.  She had also presented with a under the right breast yeast infection during that same clinic visit.  Recently before this visit back at the end of April the patient had increased her Lexapro and we had added a low-dose 100 mg of Wellbutrin nightly -patient reports at the most recent visit that she was doing quite well on both his medication with no concern.  For the cold sore we had decided to go with a valacyclovir 2 g twice a day for 1 day.  For the yeast infection we agreed on ketoconazole.  Patient then called in on 5/8/2020 with concerns of fever, headache, nausea and overall feeling very rundown.  As her PCP I called her to find out in more detail her symptoms and sent her for COVID testing along with influenza and RSV testing.  When she went to go get evaluated at our COVID tent/trailer she was found to be hallucinating and disoriented.  She was then admitted to Hospital for further evaluation.  He became quite agitated and irritable along with paranoid.  Lumbar puncture was unsuccessful but she was admitted for possible management of herpes encephalitis and to exclude COVID-19.  Patient was given haloperidol, lorazepam, acyclovir, tracks own and vancomycin.  She was COVID negative along with influenza and RSV negative.  She had a CT scan of her head and abdomen.  Both showed no concerns for a potential infection as her WBC was 22.4 with a neutrophil percentage of 91.7 and absolute neutrophil count of 20.6.  She also had an elevated d-dimer of 582, elevated PT of 14.6, INR of 1.3, CRP of 118 and a pro BNP f 211.  She was admitted for overnight monitoring, IV fluids and IV acyclovir, vancomycin and ceftriaxone.  Patient left AMA the next morning.  I called the patient today, 5/12/2020, to see how she was doing.  Patient reports that she is otherwise feeling better and is not having any more concerning symptoms at this time.  She agreed to repeat labs today to check the above findings.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neutrophil count increased, Neutrophil percentage increased, Oral herpes, Paranoia
Clinical narrative: Patient received first Shingrix vaccine on 4/29/2020.  She awoke the next morning with cold sores -that were recurrent and worse than she is ever had.  Patient presented to clinic on 5/7/2020 as a cold sores were not getting any better with usual treatment of Abreva over-the-counter.  She had also presented with a under the right breast yeast infection during that same clinic visit.  Recently before this visit back at the end of April the patient had increased her Lexapro and we had added a low-dose 100 mg of Wellbutrin nightly -patient reports at the most recent visit that she was doing quite well on both his medication with no concern.  For the cold sore we had decided to go with a valacyclovir 2 g twice a day for 1 day.  For the yeast infection we agreed on ketoconazole.  Patient then called in on 5/8/2020 with concerns of fever, headache, nausea and overall feeling very rundown.  As her PCP I called her to find out in more detail her symptoms and sent her for COVID testing along with influenza and RSV testing.  When she went to go get evaluated at our COVID tent/trailer she was found to be hallucinating and disoriented.  She was then admitted to Hospital for further evaluation.  He became quite agitated and irritable along with paranoid.  Lumbar puncture was unsuccessful but she was admitted for possible management of herpes encephalitis and to exclude COVID-19.  Patient was given haloperidol, lorazepam, acyclovir, tracks own and vancomycin.  She was COVID negative along with influenza and RSV negative.  She had a CT scan of her head and abdomen.  Both showed no concerns for a potential infection as her WBC was 22.4 with a neutrophil percentage of 91.7 and absolute neutrophil count of 20.6.  She also had an elevated d-dimer of 582, elevated PT of 14.6, INR of 1.3, CRP of 118 and a pro BNP f 211.  She was admitted for overnight monitoring, IV fluids and IV acyclovir, vancomycin and ceftriaxone.  Patient left AMA the next morning.  I called the patient today, 5/12/2020, to see how she was doing.  Patient reports that she is otherwise feeling better and is not having any more concerning symptoms at this time.  She agreed to repeat labs today to check the above findings.