chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at the injection site, fever of 101, body aches, chills, headache, tiredness.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Pain and swelling at the injection site, fever of 101, body aches, chills, headache, tiredness.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Fungal skin infection, Middle insomnia, Poor quality sleep, Pyrexia, Rash
Clinical narrative: He started not sleeping good and waking up in the middle of the night rubbing his legs together a lot when he was laying down and then the low grade fever started and then there was this really horrible rash that started and had lasted 3 days now also he has started to get a yeast infection on his peepee.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. On 13-JUL-2018, the patient was vaccinated with properly stored but expired PROQUAD (rHA) 1 dosage form (DF) lot # N001490 expiration date 12-JUL-2018  (dose, route of administration and anatomical location were not provided) for prophylaxis. Concomitant therapies included sterile diluent (lot# and expiration date were not reported). No adverse effects were reported.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Chills, Computerised tomogram, Eye haemorrhage, Headache
Clinical narrative: Approx. two hours after getting the vaccine, I started getting chills, a fever, and general body malady. On or about May 30th, I got a headache and my eyes became red. On June 5th the headache had not gone away. On June 15th my left eye suffered a hemorrhage, due to the constant headache I imagine. On the weekend of June 16-17 I spent most of it in the emergency room due to the severe headache, the following weekend the same scenario. I was finally able to see a neurologist on June 21st who sent me to get and MRI immediately. On June 26th I got my MRI test done, and reviewed it with a neurologist on June 27th when I was diagnosed with trigeminal neuralgia.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Nuclear magnetic resonance imaging brain, Ocular hyperaemia, Pyrexia, Scan with contrast
Clinical narrative: Approx. two hours after getting the vaccine, I started getting chills, a fever, and general body malady. On or about May 30th, I got a headache and my eyes became red. On June 5th the headache had not gone away. On June 15th my left eye suffered a hemorrhage, due to the constant headache I imagine. On the weekend of June 16-17 I spent most of it in the emergency room due to the severe headache, the following weekend the same scenario. I was finally able to see a neurologist on June 21st who sent me to get and MRI immediately. On June 26th I got my MRI test done, and reviewed it with a neurologist on June 27th when I was diagnosed with trigeminal neuralgia.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Trigeminal neuralgia
Clinical narrative: Approx. two hours after getting the vaccine, I started getting chills, a fever, and general body malady. On or about May 30th, I got a headache and my eyes became red. On June 5th the headache had not gone away. On June 15th my left eye suffered a hemorrhage, due to the constant headache I imagine. On the weekend of June 16-17 I spent most of it in the emergency room due to the severe headache, the following weekend the same scenario. I was finally able to see a neurologist on June 21st who sent me to get and MRI immediately. On June 26th I got my MRI test done, and reviewed it with a neurologist on June 27th when I was diagnosed with trigeminal neuralgia.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Musculoskeletal disorder
Clinical narrative: Severe spasm in left arm lasted until 4:30 am 7/22/18. Do not have full use of arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: 2 degree temp fever, serious chills/shivering, aching.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Pain in extremity
Clinical narrative: Distal half of index finger became very very sore on the second day after the shot. No outside damage or injure is detected. It appears slightly red around the nail bed.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: BLISTER ON CHEST - POSSIBLE SHINGLES.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt came back 1 week later after receiving vaccination with complaints of redness/swelling/heat/itching/pain  at injection site. She said this occurred about  a day after receiving vaccination. She said reaction is improving and getting better and was coming to the pharmacy for recommendations. She was told to use ice, benadryl, tylenol or ibuprofen to help with symptoms. She was told to contact doctor and let them know and if reaction starts getting worse or doesn't get better (it is improving) to go see doctor and let us know.
Age: 1.08
Sex: F
Vaccine: MMRV
Symptoms: Blood electrolytes normal, Blood glucose normal, Body temperature increased, Dyskinesia, Fatigue
Clinical narrative: 13 month old with 1st seizure episode. had MMRV vaccine morning of 7/20, father noted in afternoon that while pt was playing, she then started have jerking movement of body, exts lasted ~1min this afternoon. Somewhat tired afterwards. Brought pt to clinic and pt was already back to baseline. No reported fever. At the clinic, axillary temp was 99.2, rectal temp was 99.2. Pt's been doing well since the episode. No reported additional fever. Baseline blood work for lytes/glc were ok. Past medical hx: "small ASD and possible mild pulmonary valve stenosis" from cardio eval previously. otherwise, healthy.
Age: 1.08
Sex: F
Vaccine: MMRV
Symptoms: Seizure
Clinical narrative: 13 month old with 1st seizure episode. had MMRV vaccine morning of 7/20, father noted in afternoon that while pt was playing, she then started have jerking movement of body, exts lasted ~1min this afternoon. Somewhat tired afterwards. Brought pt to clinic and pt was already back to baseline. No reported fever. At the clinic, axillary temp was 99.2, rectal temp was 99.2. Pt's been doing well since the episode. No reported additional fever. Baseline blood work for lytes/glc were ok. Past medical hx: "small ASD and possible mild pulmonary valve stenosis" from cardio eval previously. otherwise, healthy.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Pain
Clinical narrative: Flu like symptoms for approximately 24 hours. My whole ached from head to feet. Miserable!!
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Haemorrhage, Pallor, Scratch
Clinical narrative: Patient was given vaccine and vaccine information statement, walked to clinic area, sat down in waiting area, while nurse put the HPV vaccine in the computer and printed out her record. Patient  fell out of chair in waiting room onto the floor. Patient was pale, stated she was afraid she was going to pass out before vaccine so had a friend ready to drive her but told no one in the clinic.  Assisted her back into the chair, had a small superficial scratch on her right temple, no bleeding and no hematoma. No other injury noted. BP at 1:01 pm was 142/89, pulse 93. States she is terrified of shots and had not eaten. Gave her a pack of snack crackers and some water. She left with her friend after 30 minutes.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Soreness, redness at injection site. Muscle pain, tiredness, headache, shivering, possible fever, and upset stomach.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia
Clinical narrative: Soreness, redness at injection site. Muscle pain, tiredness, headache, shivering, possible fever, and upset stomach.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Syncope, Vomiting
Clinical narrative: Patient fainted within 50 sec. after given the GARDASIL 9 dose. Recovered and fainted a second time followed by vomiting. I requested pt stay seated for 15 minute under supervision of Parent and pharmacist and pt managed to eat a small amount of a candy bar and recover sufficiently to walk to the vehicle waiting for her.
Age: 1.17
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Crying, Cyanosis, Fall, Full blood count normal, Metabolic function test normal
Clinical narrative: Patient had low grade (101 or less) fevers starting about 24 hours after vaccines. Mother gave ibuprofen as needed. On 7/28, patient made a loud crying noise then fell down with all extremities extended. They began to shake and lower face turned blue. Shaking lasted about 1 minutes. Family took to emergency room.
Age: 1.17
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Tremor
Clinical narrative: Patient had low grade (101 or less) fevers starting about 24 hours after vaccines. Mother gave ibuprofen as needed. On 7/28, patient made a loud crying noise then fell down with all extremities extended. They began to shake and lower face turned blue. Shaking lasted about 1 minutes. Family took to emergency room.
Age: 26.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Back pain, Crying, Pain, Pain in extremity
Clinical narrative: The first night following the vaccines, I woke up around 1:00AM crying from excruciating pain. I had pain in my lower back radiating down the back of my legs. It was painful to walk, lay down, anything. The pain lasted for about 2 weeks. Did not seek medical attention due to financial reasons.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Due to patient's age she should have been administered a Pediatric dose of Hepatitis A but instead she was administered a Adult dose of Hepatitis A vaccine. Patient did not have any symptoms due to this mix up.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Patient was having joint pain in all joints with mobility difficulty on going, with neck stiffness.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 06-JUL-2018, the patient vas vaccinated with a dose of expired RECOMBIVAX HB thimerosal-free, 5/0.5 mcg/ml, intramuscularly (lot # M010671, expiration date: 02-JUN-2018) for prophylaxis (dose number was not reported). No adverse effects were reported.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 19-JAN-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, in the left deltoid (LD), lot # M031557, expiration date 07-APR-2019 (exact dose was not reported). She failed to receive second dose according to the schedule. On 16-JUL-2018, almost 18 months after the first dose, she was vaccinated with the second dose of GARDASIL 9 intramuscularly, in the right deltoid (RD), lot # N019104, expiration date 02-MAR-2020 (exact dose was not reported). No adverse effects were reported. No prescription drug treatment was required for the experience. The patient did not receive any other vaccinations within 4 weeks prior the reported vaccines.
Age: 0.42
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product use issue
Clinical narrative: This spontaneous report was received from a nurse via the patient's parent, concerning a 5 month old patient of unknown gender. The patient's historical condition, concurrent condition, concomitant therapy, historical drugs or allergies were not reported. On 20-JUL-2018, the patient was inadvertently vaccinated with GARDASIL 9 (strength, dose, route, frequency, lot# and expiration date were not reported)  for prophylaxis, at an unspecified office location. No adverse effects were reported. No product quality complaint was filed.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-JUN-2018, the patient was vaccinated with an improperly stored doses of VARIVAX lot # N029632, expiry date 23-OCT-2019 and lot # N022980, expiry date 23-AUG-2019, subcutaneously for prophylaxis. The doses of vaccine were stored between 15 degrees Fahrenheit (°F) to 46°F (-9 degrees Celsius (°C) to 8°C)) (-7.5°C) for 2 hours 30 minutes. Previous temperature excursions were detected: 15°F to 46°F (-9°C to 8°C) (-5.8°C) for 4 hours 19 minutes. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1808USA000259.
Age: 0.5
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, referring to a 6 month old patient of unknown gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. On 23-JUL-2018, the patient was inadvertently vaccinated with PNEUMOVAX 23 lot number R00646 with expiration date on 24-OCT-2019, for prophylaxis (dose, route of administration, and anatomical site were not reported). The reporter specified that no adverse effects were present.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 5 year old patient of an unspecified gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. The reporter stated that on an unspecified date, the patient was vaccinated with GARDASIL 9 (strength, dosage, frequency, route, lot # and expiration date were not provided), for prophylaxis, instead of PENTACEL. No adverse symptoms were reported.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 13-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-JUN-2018, the patient was vaccinated with an with improperly stored doses of VARIVAX lot # N029632, expiry date 23-OCT-2019 and lot # N022980, expiry date 23-AUG-2019, subcutaneously for prophylaxis. The doses of vaccine were stored between 15 degrees Fahrenheit (°F) to 46°F (-9 degrees Celsius (°C) to 8°C)) (-7.5°C) for 2 hours 30 minutes. Previous temperature excursions were detected: 15°F to 46°F (-9°C to 8°C) (-5.8°C) for 4 hours 19 minutes. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1807USA011374.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site for 3 days after getting the vaccine on an unspecified date. The patient recovered from the even on an unspecified date. Information on batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist.  This report was received Pfizer via a sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced pain at the injection site. The clinical outcome of the pain at the injection site was recovered. The batch/lot numbers for the vaccine, pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), were not provided and will be requested during follow up.
Sex: U
Vaccine: PPV
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that a 64-year-old patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) via an unspecified route of administration on an unspecified date at single dose for immunization; and MOTRIN, BACTRIM, CYMBALTA, MACRODANTIN all via unspecified routes of administration on an unspecified date at unknown dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was reported that on unspecified date, the patient experienced allergic to BACTRIM, CYMBALTA, MACRODANTIN, MOTRIN and pneumococcal vaccine. The action taken in response to the event for ibuprofen, sulfamethoxazole, trimethoprim, duloxetine hydrochloride, and nitrofurantoin was unknown. Outcome of the event was unknown. Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 23-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional (medical assistant) and additional information was received on 23-Jul-2018. This case involves a two-months old male patient who was vaccinated with an 0.5 ml first expired dose of PENTACEL (batch number: C5390AA, expiration date: 17-Jul-2018, route and site of administration were not reported) on 20-Jul-2018. The patient's medical history and previous medications were not reported. The patient's concomitant medications included PREVENAR 13; HEPATITIS B VACCINE and ROTAVIRUS VACCINE for Immunisation. It was a case of actual medication error due to expired vaccine used. 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. Documents held by sender: none
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 23-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old male patient who received expired first dose of vaccine DAPTACEL lot B4947AA, expiry date: 31-Mar-2018 (also reported as 05-Mar-2018) via intramuscular route in the left thigh on 23-Jul-2018 due to cut on right ring finger. The patient's past medical history includes cut on right ring finger. It was a case of actual medication error due to expired vaccine used. It was reported that Child was cut with a piece of glass. Parents had chosen to never immunize the child and this was the first vaccination the child has ever received. Patient was suggested to wash with soap and water, keep cut covered and monitor for any signs of infection as corrective treatment. It was unknown if the patient had experienced any adverse event or not, it was reported that there were no signs of infection in the cut. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: Expired product administered
Clinical narrative: Initial information received on 24-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old female patient who received 0.5 ml single dose of vaccine PENTACEL via intramuscular route in left thigh on 23-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE; PREVNAR 13; and ROTAVIRUS VACCINE. It was a case of actual medication error due to expired vaccine used. It was reported that patient was brought in for her PENTACEL vaccine and after injection it was noticed that the diluent was expired (expiry date: 01Jun2018). It was unknown if patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: None.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Rash
Clinical narrative: Initial information received on 25-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult patient who experienced rash, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route. The patient developed a non-serious rash following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. (Other relevant tests included No lab data.) Final diagnosis was rash. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for rash.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial unsolicited report received from office staff on 25-Jul-2018. This case was linked to 2018SA206650 and 2018SA206651 (same reporter). This case involves a four-month old patient (gender not reported) who was vaccinated with 0.5 ml expired second dose of PENTACEL (Batch number: C5402AA, expiration date: 24 Jun 2018, was not reported) via intramuscular route in left leg on 25 Jul 2018. The patients medical history was not reported. Concomitant medications included PREVNAR 13 and ROTATEQ for Immunisation. It was an actual medication error due to expired vaccine used. It was reported that, the patient did not have any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial unsolicited report received from consumer (office staff) on 25-Jul-2018. This case was linked to 2018SA206644 and 2018SA206651 (same reporter). This case involves a four month old patient (gender not reported) who was vaccinated with 0.5 ml second dose of PENTACEL (Batch number: C5402AA, expiration date: 24 Jun 2018, was not reported) via intramuscular route in left leg on 25 Jul 2018. The patients medical history was not reported. Concomitant medications included PREVNAR 13 for Immunisation and ROTATEQ for Immunisation. It was an actual medication error due to expired vaccine used. It was reported that, the patient did not had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 25-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old female patient who was vaccinated with an 0.5 ml expired vial of ACT-HIB (Batch number: UI803AA (Vial), expiration date: 21-Sep-2018 (vial) and (Batch number: U5859AB (diluent) and UI8038AA (box), route and site of administration were not reported). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR 13 and PEDIARIX for Immunisation. It was a case of actual medication error due to expired product administered. It is not reported if the patient 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. Documents held by sender: none.
Age: 10.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial information received on 26-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 10 years old patient who was vaccinated with a dose of DAPTACEL (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: None.
Age: 19.0
Sex: M
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 26-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 19 years old male patient who was given an expired second primary dose, 1ml on day seven of IMOVAX RABIES lot M1391, expiry date 24 Jul 2018 via intramuscular route in the left deltoid on 25-Jul-2018 for pre-exposure prophylaxis. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to expired vaccine used. It was reported that patient was vaccinated with expired IMOVAX vaccine on 25-Jul-2018 which expired on 24 Jul 2018. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
Sex: M
Vaccine: HIBV, MENB, MNQ, PPV
Symptoms: Drug administered to patient of inappropriate age, Expired product administered
Clinical narrative: Initial information received on 26-Jul-2018 regarding an unsolicited valid non-serious case received from Nurse. This case involves a 63 years old male patient who was vaccinated with an expired dose of ACT-HIB. The patients past medical history included Asplenia. Concomitant medications included MENACTRA; PNEUMOVAX 23; and BEXSERO. On 26-Jul-2018, the patient received a 0.5 ml single dose of suspect HIB (PRP/T) VACCINE (lot number: Diluent Lot: U5859AB, vaccine lot: UI803AA) Expiry date: 01-July-2018 via intramuscular route in the left deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration and Expired vaccine used. On 26 Jul 2018, patient visited physician. It was unknown whether adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: Initial information received on 26-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an Adult patient (age and gender not reported) who received a dose of vaccine QUADRACEL lot number not reported via unknown route instead of ADACEL lot number not reported. The patient's past medical history included Wound. It was a case of actual medication error due to wrong vaccine administered. It was unknown if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Presyncope
Clinical narrative: Almost syncope, laid pt. back on bed and put her feet up, Dr. came and check vitals of pt. after about 15 min pt. was doing better, all vitals were good, pt. left to go home. Dad said pt. also had same symptoms after first dose.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Neck pain, Pain
Clinical narrative: Horrible pain and a numb arm about 4 hrs after shot. could not lift arm without screaming for 4 days. It is now 12 days later and still have pain, not as bad, and 60-65% mobility in left arm. The shot was administered close to shoulder and I think I hit a nerve. Bad neck pain also.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neck pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Horrible pain and a numb arm about 4 hrs after shot. could not lift arm without screaming for 4 days. It is now 12 days later and still have pain, not as bad, and 60-65% mobility in left arm. The shot was administered close to shoulder and I think I hit a nerve. Bad neck pain also.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Acoustic stimulation tests, Chills, Headache, Pain, Tinnitus
Clinical narrative: I got the soreness shivering and headaches but that went away then I got ringing of ears both it went away after 2 weeks then in June I got the second dose ringing came back and it comes and goes but I went to Dr about it and he sent me to ENT. I question Dr on 4/16/18 if I really need it because I had the original on 2011 I thought that was kind of odd why I needed this. It new on and it a lot better. Okay I believe my Dr. so had it done which I feel if you had the original one it should be just as effective as this new one. When I went to see Dr before I got the vaccine he gave me a PNEUMOVAX vaccine. He did not tell me not to get shingles shot or wait. So that same day I got the shingles vaccine not by Dr because don't keep it in his office gave me a prescription to pharmacy clinic to get the vaccine. So I did. I got all the symptoms and ringing so went to Dr he said he couldn't do nothing for me, he sent me to ENT Dr. So I did. Seen him July 9 2018 took a hearing test he said I have mild tinnitus-and need hearing aids I said no way I need a second opinion for simple reason never had hearing problems no ringing in the ear ever when I was a kid no earaches at all now just out of the clear blue I get ringing I told him when I first got it. He also said we can do a few things before hearing aids your talking around $2,000.00 I said no way let's try other options. He gave me 6 day pack of methylprednisolone 4mg it help it faded. Then came back, so ask him if there was anything else I should do he said watch the caffeine, sodium, saturated fats I told him I do that now I exercise 3 days a week walk every day. I see Dr Oct. 22 2018 also I'm taking flavonoid for ringing for 2 months and it is helping a lot. On the paper they give you that tells you about the vaccine it says other things like dizziness or ringing of the ears the original one I got when I was 60 never affected me like this one.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Cold sweat, Dizziness, Hyperhidrosis, Injected limb mobility decreased
Clinical narrative: After 1-2 minutes after vaccines, and while putting on his shoes, pt complained of not being able to move his left arm at all, then said he felt sick. He had sudden onset of wet clammy hot skin all over his body, he said he felt dizzy or light headed, nausea and weakness. We went to find nurse for help, nurses came in, and had pt lay down and put wet napkins on his legs and head and arms. Pt tried to sit up but felt nauseas so he laid back down again for few more minutes when he said he felt weak and sleepy. In all the event was about 20 minutes. He was given some juice to sip. Then he felt better and was able to walk. Nurse walked him to our car and we left. He was fine the rest of the day and evening and has no other symptoms since then.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Malaise, Nausea, Skin warm, Somnolence
Clinical narrative: After 1-2 minutes after vaccines, and while putting on his shoes, pt complained of not being able to move his left arm at all, then said he felt sick. He had sudden onset of wet clammy hot skin all over his body, he said he felt dizzy or light headed, nausea and weakness. We went to find nurse for help, nurses came in, and had pt lay down and put wet napkins on his legs and head and arms. Pt tried to sit up but felt nauseas so he laid back down again for few more minutes when he said he felt weak and sleepy. In all the event was about 20 minutes. He was given some juice to sip. Then he felt better and was able to walk. Nurse walked him to our car and we left. He was fine the rest of the day and evening and has no other symptoms since then.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Chills, Night sweats, Pain
Clinical narrative: Aches, low energy, chills, night sweats.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Bradycardia, Pallor, Syncope
Clinical narrative: Within minutes of vaccination, after walking about of exam room, patient had a syncopal event in the hallway, caught by father. Immediately awakened, pale, mild bradycardia. Recovered promptly. Patient had not eaten anything for greater than 12 hours prior to episode.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Injection site pain, Local reaction, Skin discolouration
Clinical narrative: Large local reaction within 24 hours - redness, inflammation, measuring 10 x 6.5 cm; seen by CRNP 48 hours later, recommended BENADRYL and to return if worsened; reaction subsided but two weeks later, the 10 x 6.5 patch remains discolored with some residual, minimal soreness at site.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Swelling of arm.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood glucose normal, Electrocardiogram normal, Neurological examination normal, Seizure, Syncope
Clinical narrative: Pt was given vaccines today and discharged home. Mother reports Pt had seizure on way home and was instructed to go to this facilities ER was seen in ER on 7/30/18 and Dx with vasovagal syncope, syncope, was convulsive.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness at site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Pain
Clinical narrative: Received SHINGRIX on 7/24/18 at local pharmacy. Noted local pain at injection site briefly. Next morning 7/15/18 redness and tenderness of upper arm and developed whole body soreness. Following day 7/26/18 awakened with face swelling 'like a chipmunk and continued soreness of the left upper arm, but body pain much better. Symptom of facial swelling resolved within 2 hours after OTC ALLEGRA. On 7/27/2018 patient presented to office to report the event, and feels well. The left upper arm has redness, warmth, mild induration in patch 15 x 8 cm, and tenderness only at the injection site. Decision was made to report to VAERS.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Received SHINGRIX on 7/24/18 at local pharmacy. Noted local pain at injection site briefly. Next morning 7/15/18 redness and tenderness of upper arm and developed whole body soreness. Following day 7/26/18 awakened with face swelling 'like a chipmunk and continued soreness of the left upper arm, but body pain much better. Symptom of facial swelling resolved within 2 hours after OTC ALLEGRA. On 7/27/2018 patient presented to office to report the event, and feels well. The left upper arm has redness, warmth, mild induration in patch 15 x 8 cm, and tenderness only at the injection site. Decision was made to report to VAERS.
Age: 72.0
Sex: U
Vaccine: PPV
Symptoms: Chest pain, Erythema, Pain in extremity
Clinical narrative: Redness, soreness-front, back of arm and down chest.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to 4 year old male patient. The patient previously received one dose of measles virus vaccine live (Enders-Edmonston) mumps virus vaccine live (Jeryl Lynn) rubella virus vaccine live (Wistar RA 27/3) (M-M-R), one dose of varicella virus vaccine live (unspecified), 4 doses of diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid and 3 doses of poliovirus vaccine inactivated (unspecified). On 12-JUL-2018 the patient was vaccinated with improperly stored PROQUAD from lot R003292 dose 1, subcutaneous in the left arm for prophylaxis (Product storage error). On the same day, the patient was also vaccinated with KINRIX from lot 53NB2 dose 1, intramuscular in the right arm for prophylaxis. The sterile diluent (manufacturer unknown) (lot# M012716 with expiration date 20-AUG-2018, lot # N030577 with expiration date 19-APR-2019, lot# N027783 with expiration date 17-NOV-2019,lot# M013220 with expiration date 24-SEP-2018, lot# M035268 with expiration date 19-APR-2019; lot # N006322 with expiration date 11-JUL-2019, lot # M012718 with expiration date 10-NOV-2018, lot # N004190 with expiration date 04-JUL-2019, lot # N022038 with expiration date 27-NOV-2019, lot# N030574 with expiration date 05-JUN-2020, lot# N030178 with expiration date 15-JUL-2020) used to reconstitute the vaccines was properly stored. The reporter was not sure which sterile diluent (manufacturer unknown) lot numbers were used.  The vaccines were exposed to temperature excursion of -14 degree Celsius up to -10 degree Celsius for 5 hours total (including the previous exposure to temperature excursion). Data logger was involved. No product quality complaint (PQC) was involved in this case. No symptoms were reported. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1807USA007589.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Malaise
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of upset stomach in a 67-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included herpes zoster (or shingles especially when immunocompromised). In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, immediately after receiving SHINGRIX, the patient experienced upset stomach, malaise and fatigability generalized. On an unknown date, the outcome of the upset stomach, malaise and fatigability generalized were recovered/resolved. It was unknown if the reporter considered the upset stomach, malaise and fatigability generalized to be related to SHINGRIX. Additional information was received as follows: The reporter was the Director of Medical Affairs at GlaxoSmithKline. The age at vaccination was not reported. GlaxoSmithKline employee reported that the patient received the SHINGRIX on an unknown arm. The patient experienced significant stomach upset and gastrointestinal upset with general fatigue which was described as very tired and malaise for four days, immediately following the SHINGRIX vaccine. The patient indicated that she reported her experience to the pharmacist at the pharmacy, where she was vaccinated. The reporter was concerned that the product was defective.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Disturbance in attention, Fatigue, Injection site erythema, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 54-year-old female patient who received SHINGRIX (batch number L9CS4, expiry date 20th April 2021) for prophylaxis. On 21st July 2018 13:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st July 2018, several hours after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On 21st July 2018 21:00, the patient experienced fatigue, attention concentration difficulty and activities of daily living impaired. On an unknown date, the outcome of the fatigue, injection site erythema, injection site swelling and attention concentration difficulty were not recovered/not resolved and the outcome of the activities of daily living impaired was unknown. The reporter considered the fatigue, injection site erythema, injection site swelling, attention concentration difficulty and activities of daily living impaired to be probably related to SHINGRIX. Additional details were provided as follows: The patient was small and petite in her body type. On 21st July 2018 (Saturday), the patient received SHINGRIX on left deltoid. In evening at 21:00 pm, 8 hours after receiving SHINGRIX, the patient started feeling fatigue and lack of focus and went to bed and slept until 23rd July 2018 (Monday). The patient also had redness and swelling at the injection site. At the time of this report, the patient was fatigued; she could not able to focus. The patient was sent home from work on the reporting date. The patient did not receive any treatment for these adverse events and she had rested at home only.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 17th July 2018, the patient received the 1st dose of SHINGRIX. On 17th July 2018, less than a day after receiving SHINGRIX, the patient experienced rash and pruritus. On an unknown date, the outcome of the rash and pruritus were not recovered/not resolved. It was unknown if the reporter considered the rash and pruritus to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the medical assistant. The patient was administered SHINGRIX in the left arm. The patient experienced a rash on her left deltoid area which was 19 cm in length and 8 cm in width, associated with itching. It had gotten worse since the day of getting the vaccine. No further details were provided.