chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, an elderly male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On 01-MAY-2012, at 69 years of age, the patient was administered the ZOSTAVAX vaccine at a physician's office (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from his ZOSTAVAX use: dendritic, varicella zoster. The outcome of the dendritic, varicella zoster is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Upon internal review, dendritic, varicella zoster was determined medically significant.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, an elderly female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2015, at approximately 67 years of age, the patient was administered the ZOSTAVAX vaccine at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, an elderly female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On 21-MAY-2013, at 62 years of age, the patient was administered the ZOSTAVAX vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated at a physician for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. It was reported that on 13-FEB-2018, the patient received improperly stored dose of VARIVAX (lot # N017394, expiration date 07-JUN-2019) subcutaneously (dose and anatomical location were not reported) for prophylaxis. The dose of VARIVAX was exposed to a temperature excursion of 11.9 Fahrenheit (F) during a timeframe of 117 hours, which was detected by a digital data logger. The vaccine was reconstituted with properly stored sterile diluent. There were no previous temperature excursions. No adverse event. This is one of seven reports received from the same reporter. Sender's Comments: US-009507513-1903USA001826; US-009507513-1903USA002595; US-009507513-1903USA002596; US-009507513-1903USA002598; US-009507513-1903USA002599; US-009507513-1903USA002600.
Age: 0.42
Sex: M
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a certified medical assistant and refers to a 5 month old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 10-OCT-2018 the patient was vaccinated with improperly stored doses of ROTATEQ lot # N030150, expiration date: 29-AUG-2019, oral for prophylaxis, (strength, dosage and frequency were not provided) and PEDVAXHIB lot number: N031492 expiration date: 02-MAY-2020, for prophylaxis (strength, route, dose or units were not provided). There was digital data logger involved. No adverse effects were reported. The storage characteristics were the following: Temperature: 0°C to 1°C (0.9°C) for 30 minutes. Previous temperature excursion: 0°C to 1°C (1.4°C) for 7 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA005632: US-009507513-1903USA003267: US-009507513-1903USA003268: Original Case: 1903USA003268.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, drug reactions/allergies, past drugs and concomitant medications were unknown. On 06-MAR-2019 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose and frequency were unknown) (lot # N019837; expiry date: 21-FEB-2019) intramuscular for prophylaxis (expired product administered). No adverse effects (no adverse event) reported. No additional information provided.
Sex: U
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report was received from a consumer via Pfizer refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, units, frequency, lot# and expiration date unknown) and PREVNAR 13 (dose, units, frequency, lot# and expiration date unknown). On an unknown date, the patient still got pneumonia and was hospitalized. Outcome of the event was unknown. The reporter's causality assessment was not provided.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a health professional and refers to a patient of unknown age. On an unknown date, the patient was vaccinated with PROQUAD lot # N022954 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date, the patient experienced expired product administered and no adverse event. The outcome of expired product administered and no adverse event was unknown. The reporter considered expired product administered and no adverse event to be not assessed to PROQUAD.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 8 days after receiving SHINGRIX, the patient experienced muscle pain, fever and red rash. On an unknown date, the outcome of the muscle pain, fever and red rash were unknown. It was unknown if the reporter considered the muscle pain, fever and red rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter asked whether it was possible to develop a fever with muscle aches 8 days after the SHINGRIX injection. The fever was gone after about 24 hours, but no other symptoms accompanied the fever such as cold, cough, or any stomach symptoms. Also, then 2 to 3 days, 10 days after vaccination the fever, the patient developed a red rash. The patient wanted to know whether these symptoms match the possible symptoms of side effects of the SHINGRIX injection.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via other manufacturer and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced pain at the injection site, because of thicker suspension. Event took place after use of vaccine. The reporter did not wish to be contacted for follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Impaired work ability, Influenza like illness, Insomnia
Clinical narrative: This case was reported by a consumer via interactive digital media twitter and described the occurrence of influenza like illness in a female patient who received SHINGRIX for prophylaxis. Previously administered products included Flu shot (received on an unknown date without any reaction). On 25th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced influenza like illness and feeling abnormal. On 25th February 2019, the patient experienced insomnia. On an unknown date, the outcome of the influenza like illness, insomnia and feeling abnormal were unknown. It was unknown if the reporter considered the influenza like illness, insomnia and feeling abnormal to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient got the SHINGRIX last night of reporting and thought symptoms were at the extreme. The patient was not breaking out in hives and did not have an allergic reaction to it. It stopped the patient from working on the day of reporting in addition, the patient could not sleep until 4 AM last night. This was not very common and the patient felts like had been hit by a mack truck. The patient had the flu shot before and never had any reaction. The patient felt like had the flu or something worse. The patient asked that, how long was this supposed to last.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Extensive swelling of vaccinated limb, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of extensive swelling of vaccinated limb in a adult patient who received 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 extensive swelling of vaccinated limb, fever, chills, pain in arm, radiating pain and swelling arm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, fever, chills and swelling arm were unknown and the outcome of the pain in arm and radiating pain were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, fever, chills, pain in arm, radiating pain and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The reporter was informed about the Pfizer Medical Information department. The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. The patient received vaccine on unknown arm. The patient experienced terrible reaction after receiving SHINGRIX. The patient experienced fever, chills, arms were swollen twice the normal size, the swelling went down to the elbow. The patient also experienced radiating pain down the arm that lasted for about a week. The nurse administered the vaccine properly. The patient asked if the same reaction would occur after receiving the 2nd dose of SHINGRIX and asked whether to receive the 2nd dose of SHINGRIX or not.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of extensive swelling of vaccinated limb in a adult patient who received 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 extensive swelling of vaccinated limb, fever, chills, pain in arm, radiating pain and swelling arm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, fever, chills and swelling arm were unknown and the outcome of the pain in arm and radiating pain were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, fever, chills, pain in arm, radiating pain and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The reporter was informed about the Pfizer Medical Information department. The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. The patient received vaccine on unknown arm. The patient experienced terrible reaction after receiving SHINGRIX. The patient experienced fever, chills, arms were swollen twice the normal size, the swelling went down to the elbow. The patient also experienced radiating pain down the arm that lasted for about a week. The nurse administered the vaccine properly. The patient asked if the same reaction would occur after receiving the 2nd dose of SHINGRIX and asked whether to receive the 2nd dose of SHINGRIX or not.
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. The patient's past medical history included hiatal hernia and esophageal acid reflux. Concurrent medical conditions included rheumatoid factor positive. On an unknown date, the patient received the 1st dose of SHINGRIX and Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a day after receiving SHINGRIX and Influenza vaccine Quadrivalent unspecified season and less than a day after receiving SHINGRIX and Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site pain and influenza-like symptoms. On an unknown date, the outcome of the injection site pain and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the injection site pain and influenza-like symptoms to be related to SHINGRIX and Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The reporter was a dentist and patient. The reporter stated that she received the 1st dose of SHINGRIX a few months before the date of reporting and received a flu shot (unknown manufacturer) on the same day. The patient stated that she received the flu vaccine in one arm and the SHINGRIX vaccine in the other arm. The patient stated that she experienced pain at both injection sites and could not lay down on either arm. The patient stated that she also experienced flu like symptoms after receiving both vaccines that day. The symptoms resolved in a few days. It was unknown if the reporter considered the injection site pain and influenza-like symptoms to be related to SHINGRIX and Influenza vaccine Quadrivalent unspecified season. For tolerance after 2nd dose refer case US2019036192.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on unknown date see case US2019015732). On 27th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. The patient was treated with Steroid (Not Specified). On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient demographic details were updated. No error made in prescribing, dispensing or prescription. The doctor of medicine could not make a connection between the SHINGRIX shot and the patient's arm pain. The patient was still having pain 8 months later but found out other factors were involved, his doctor of medicine told him he had broken both collarbones at one timing his life has both a torn bicep and triceps. The doctor of medicine said these factors contribute to his arm pain. The arm pain was from elbow to shoulder. The doctor of medicine had given patient 2 steroid shots which has helped him a lot. They were contemplating surgery.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Pain, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 72-year-old female patient who received SHINGRIX (batch number MX2LT, expiry date 19th February 2020) for prophylaxis. On 19th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities, tingling and pain. On an unknown date, the outcome of the erythema of extremities, tingling and pain were not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, tingling and pain to be related to SHINGRIX. Additional details were provided as follows: The Pharmacist reported that a patient received SHINGRIX and around 8:00 pm that evening, she experienced redness around the injection site on her right arm and then it moved to the lower part of her arm three days later. One week later, the redness has traveled to her shoulder blade and the backside of her arm and near her elbow and below the elbow on her right side. The patient was also experiencing tingling and pain. Consent to follow up was provided.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 84-year-old female patient who received SHINGRIX for prophylaxis. On 8th March 2018, the patient received the 1st dose of SHINGRIX. On 21st March 2018, 13 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that the patient reported Shingles outbreak that began within 3 weeks after receiving SHINGRIX. The event resolved with VALTREX. On 28th August 2018, the 2nd dose was given with no reaction. The healthcare professional did not have lot number or expiry date. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. In February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter called for the doctor looking for information on patients who might have developed a rash after getting the SHINGRIX vaccination. The patient was given the 1st dose on Sunday or Monday of the reporting week and within 48 hours developed an acute rash over her torso. No additional details were available.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) and (batch number NR4Z4, expiry date unknown) for prophylaxis. On 8th November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 8th November 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and shoulder pain. On an unknown date, the outcome of the pain in arm and shoulder pain were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and shoulder pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on right deltoid. The pharmacy intern notes the patient reported pain in her arm and shoulder after receiving SHINGRIX series. The pain was described as consistent pain that radiates from injection site to the entire arm, pain continues. The healthcare professional provides lot numbers for both lyophilized powder and diluent. The lot number listed in report was for lyophilized powder. The healthcare professional provides NR424 for diluent but notes the '2' could also be a 'Z', he could not specify which.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. In February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a month after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The patient was 70 to 74 years old. The injection occurred prior to interview in February 2019. Market researcher contracted by GSK reported that during an interview, a patient reported pain and redness at the site where she received the SHINGRIX injection. This lasted for several days, but got less severe with each day.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Hypotension
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of low blood pressure in a 61-year-old female patient who received SHINGRIX (batch number ZT25S, expiry date 6th July 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced low blood pressure. On an unknown date, the outcome of the low blood pressure was unknown. It was unknown if the reporter considered the low blood pressure to be related to SHINGRIX. Additional details were provided as follows: The pharmacy manager called in to report that the patient received SHINGRIX and the health care professional stated that the patient's blood pressure fell severely low. The reporter questioned that should they give the second dose or how to proceed. Lab Comments: Lab test performed on unknown date.
Sex: F
Vaccine: MENB
Symptoms: Presyncope
Clinical narrative: This is a spontaneous report from  a contactable consumer via Pfizer sales representative. A female patient of an unspecified age received TRUMENBA on an unspecified date at single dose for immunisation. Medical history was none. There were no concomitant medications.On an unknown date, after receiving the vaccine, the patient almost fainted. Outcome of the event was unknown. Information on the batch number has been requested.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine contributed to the development of the reported event "almost fainted".
Age: 74.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Chills, Feeling cold, Injection site pain, Injection site swelling, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer. A 74-year-old male patient received PREVNAR 13 (lot number and expiration date were not recovered) via an unspecified route of administration on 19Feb2019 at single dose for immunization and pneumococcal vaccine (PNEUMOCOCCAL POLYSACCHARIDE VACCINE, 23-VALENT), via an unspecified route of administration on 19Feb2019 at single dose for recommended immunization for his age. Medical history included PE (pulmonary embolism), high blood pressure, cholesterol lower and A fib (atrial fibrillation).  Concomitant medication included apixaban (ELIQUIS), diltiazem (CARDIZEM), rosuvastatin calcium (CRESTOR) and metoprolol succinate (TOPROL). The patient experienced a lot of pain and swelling at injection site, felt like he could not get warm, had chills and was shaking, all on on 19Feb2019. The outcome of felt like he could not get warm, had chills and was shaking was recovered on 20Feb2019 and other events recovered on an unspecified date. Information on the batch number has been requested.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Pneumonia, Pulmonary congestion
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A 63-year-old male patient (father) received in Dec2018 a single dose of PREVNAR 13 for immunization. Medical history and concomitant medications were not reported. In the past, in Sep2014, the patient received PNEUMOVAX-23 for immunization. The patient was admitted to hospital recently (unspecified dates) for 5 days with pneumonia and then released. Additionally it was reported that patient had cough and lung congestion. Patient was still taking LEVAQUIN. Final outcome was unknown. Information on the batch number has been requested. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.
Age: 1.58
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 28-Feb-2019 regarding an unsolicited valid non-serious case received from an other health professional. This case is linked to case 2019SA062350 (for 8 year old child). This case involves a 19 month old patient who received first dose of vaccine QUADRACEL (lot C5500CA and Exp. Date 16-Aug-2020) via unknown route in the left thigh (left vastus lateralis). The patient's medical history not reported and no any concomitant medications received at the time of vaccination. It was an actual medication error case due to inappropriate age at vaccine administration. It was unknown whether 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 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: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Incorrect route of product administration
Clinical narrative: Initial information received on 05-Mar-2019 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a six months old female who received a 0.5 ml dose of suspect ACT-HIB (lot UI987AAA and Exp. Date 01-Apr-2020) via subcutaneous route in the left thigh on 04-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due to inappropriate route of vaccination. It was unknown whether the patient 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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 05-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four months old male patient who received a second 0.5 ml dose of the vaccine PENTACEL (lot C5515AA, M035268 and Exp. Date- 15-Sep-2019) via unknown route in the left thigh, on 12-Feb-2019. And was given only the HIB part of the vaccine and the DTAP- IPV part was not administered. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus Vaccine and PREVENAR 13 for Immunisation. It was an actual medication error case due to inappropriate reconstitution technique. It was reported that a four month old child came for his 2nd dose in the series of PENTACEL. This child was given only the HIB part. The HIB vial was diluted with sterile water and given and the DTap- IPV part was not given. It was unknown whether the patient 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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: DTAP, IPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 05-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 18 months old male patient who received a 0.5ml fourth dose of vaccine IPOL batch number and expiration date not reported via unknown route in thigh on 04-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was DAPTACEL in thigh from a multi dose vial. It was an actual medication error due to inappropriate schedule of vaccine administered. A 18 months old patient was administered a fourth dose of IPOL vaccine. It was unknown whether patient experienced any adverse event following vaccination. 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: HEPA, MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: Initial information received on 05-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 27-years-old male patient who was vaccinated with 0.5 ml first dose of MENACTRA, lot U6179AA (Expiry date 29-Mar-2020 ) via subcutaneous route in the left arm on 05-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis A Vaccine intramuscularly in right arm. It was an actual medication error due to inappropriate route of vaccination (MENACTRA was given subcutaneously). It was unknown whether patient experienced any adverse event following vaccination. 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: MNQ
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 05-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a 9 months old female patient who was vaccinated with a 0.5 mL dose of MENACTRA (lot number, expiry date and site of administration were not reported) via intramuscular route instead of PNEUMOCOCCAL VACCINE on 5-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was unknown whether patient experienced any adverse reaction. 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 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: HPVX, MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 05-Mar-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Medical Assistant). This case involves a 11 years old male patient who received vaccine MENACTRA. The patients past medical history and family history were not provided. Concomitant medications included on 04-Mar-2019-ADACEL and HPV Vaccine. On 04-Mar-2019, the patient received a 0.5ml first dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine, lot U5833AA, expiry date 25-Feb-2019 via intramuscular route in the left deltoid. It was a case of actual medication error due to expired vaccine used. It was reported that 11 years child was given an expired MENACTRA (expiry date 25-Feb-2019) on 04-Mar-2019. 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: U
Vaccine: VARZOS
Symptoms: C-reactive protein normal, Red blood cell sedimentation rate normal, Tenosynovitis
Clinical narrative: Reactive tenosynovitis 2 wks after SHINGRIX.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature, Cough, Electrocardiogram, Headache, Nasal congestion
Clinical narrative: Client came to Health Department on 01-18-19 with complaint of severe body aches that started on the second day after receiving an influenza vaccine. Client received an influenza vaccine on 01-15-18. Client also reports headache and temperature that started on 01-16-19. Client did not take temperature with a thermometer. Client denied having nasal congestion or a cough. Client was referred to PCP. Client return to Health Department on 01-28-19. Client was seen by PCP on 01-19-19. Client had had an EKG done. An appointment was scheduled for client to return to HD but client has not returned calls.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Client came to Health Department on 01-18-19 with complaint of severe body aches that started on the second day after receiving an influenza vaccine. Client received an influenza vaccine on 01-15-18. Client also reports headache and temperature that started on 01-16-19. Client did not take temperature with a thermometer. Client denied having nasal congestion or a cough. Client was referred to PCP. Client return to Health Department on 01-28-19. Client was seen by PCP on 01-19-19. Client had had an EKG done. An appointment was scheduled for client to return to HD but client has not returned calls.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given vaccines 13 days too early. Pt should not have received them until 3/13.
Age: 61.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Chest X-ray, Dyspnoea, Pruritus generalised, Urticaria
Clinical narrative: Started with hives, general itching, shortness of breath less than 24 hours after administration of vaccine.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Crying, Regressive behaviour, Screaming
Clinical narrative: He cried screamed a lot. He stopped rolling over, sitting alone, and starting to crawl. He stopped it all. Had a in home therapist come once a week to train him into doing all again. He had a second reaction also to MMR at age 1 1/2.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Within a few hours of receiving injection, pt developed redness, swelling and pain in the same arm but not at vaccination site. Redness/swelling in bend of arm and upper arm on the inside but not at where injection was administered.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal distension, Asthenia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient called Friday morning stating that left arm is sore from injection body is weak and has fever. He states a little bit swollen and it hurts. Symptoms started last night.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: Myalgia and Arthralgia
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema multiforme, Pyrexia
Clinical narrative: Arthralgia, fever and erythema multiform.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Arthralgia
Clinical narrative: Arthralgia.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Patient came up to pharmacy and complained about rash on all over her arm and chin. She also stated that she got fever one day after the injection. She doesn't feel itchy by rash. She asked for any OTC medication would help the condition better. I recommended BENADRYL 50mg and Hydrocortisone 1% cream. If she doesn't get better within 2 days, contact her PCP right away.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Shoulder and arm pain, unable to move arm on night of 3/7/19, but getting better this morning (3/8/19).
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Headache and nausea, vomiting. Treatment: acetaminophen 325 mg once, diphenhydramine 50 mg once.
Age: 15.0
Sex: M
Vaccine: MMR
Symptoms: Back pain, Cytomegalovirus test negative, Epstein-Barr virus test negative, Full blood count normal, HIV test negative
Clinical narrative: 2/11-CERVICAL AND AXILLARY LYMPHADENOPATHY, LEFT TESTICULAR PAIN AND SWELLING, SCROTAL ULTRASOUND NEGATIVE;  2/13 BILATERAL TESTICULAR PAIN;  2/19 DIFFUSE, ITCHY MORBILLIFORM RASH; LABS NEGATIVE INCLUDING EBV, CMV, HIV, LFT, CBC;  2/25 HEADACHE, BACK PAIN. NO FEVER.
Age: 15.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Liver function test normal, Lymphadenopathy, Rash morbilliform, Testicular pain
Clinical narrative: 2/11-CERVICAL AND AXILLARY LYMPHADENOPATHY, LEFT TESTICULAR PAIN AND SWELLING, SCROTAL ULTRASOUND NEGATIVE;  2/13 BILATERAL TESTICULAR PAIN;  2/19 DIFFUSE, ITCHY MORBILLIFORM RASH; LABS NEGATIVE INCLUDING EBV, CMV, HIV, LFT, CBC;  2/25 HEADACHE, BACK PAIN. NO FEVER.
Age: 15.0
Sex: M
Vaccine: MMR
Symptoms: Testicular swelling, Ultrasound testes normal
Clinical narrative: 2/11-CERVICAL AND AXILLARY LYMPHADENOPATHY, LEFT TESTICULAR PAIN AND SWELLING, SCROTAL ULTRASOUND NEGATIVE;  2/13 BILATERAL TESTICULAR PAIN;  2/19 DIFFUSE, ITCHY MORBILLIFORM RASH; LABS NEGATIVE INCLUDING EBV, CMV, HIV, LFT, CBC;  2/25 HEADACHE, BACK PAIN. NO FEVER.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Shoulder and arm pain, unable to move arm last night (3/7/19), but improving a little this morning (3/8/19).
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Body temperature increased, Encephalitis, Injection site swelling, Screaming, Vomiting
Clinical narrative: High pitched scream for 5 days straight, 105.6 temperature, encephalitis, vomiting, swollen at injection site.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Blood glucose increased, Chills, Injected limb mobility decreased, Injection site pain, Myalgia
Clinical narrative: Started with myalgias the evening (Tuesday) after vaccine. There was more pain than what I expected at the injection site. The following day (Wednesday) myalgias worsened, fever began reaching 101.9, chills and sensitive skin. The following day (Thursday) the fever peaked at 103.9 upon awakening,  falling to 102.1 that evening. Systemic symptoms (generalized myalgia) were slightly worse. Injection site pain was worse to the point it is difficult to raise my arm up to the side. Tenderness is present to the back of my shoulder and 6 inches from the injection site in the mid deltoid down my upper lateral and posterior upper arm. This AM (Friday) AM temp was 101.1 and is now down to 99.7. Myalgias have pretty much resolved. Extreme glycemic excursion occurred resulting in use of 50% more insulin to result in rather poorly controlled blood sugar for the event.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Pyrexia, Sensitive skin
Clinical narrative: Started with myalgias the evening (Tuesday) after vaccine. There was more pain than what I expected at the injection site. The following day (Wednesday) myalgias worsened, fever began reaching 101.9, chills and sensitive skin. The following day (Thursday) the fever peaked at 103.9 upon awakening,  falling to 102.1 that evening. Systemic symptoms (generalized myalgia) were slightly worse. Injection site pain was worse to the point it is difficult to raise my arm up to the side. Tenderness is present to the back of my shoulder and 6 inches from the injection site in the mid deltoid down my upper lateral and posterior upper arm. This AM (Friday) AM temp was 101.1 and is now down to 99.7. Myalgias have pretty much resolved. Extreme glycemic excursion occurred resulting in use of 50% more insulin to result in rather poorly controlled blood sugar for the event.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Back pain, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Started with myalgias the evening (Tuesday) after vaccine. There was more pain than what I expected at the injection site. The following day (Wednesday) myalgias worsened, fever began reaching 101.9, chills and sensitive skin. The following day (Thursday) the fever peaked at 103.9 upon awakening,  falling to 102.1 that evening. Systemic symptoms (generalized myalgia) were slightly worse. Injection site pain was worse to the point it is difficult to raise my arm up to the side. Tenderness is present to the back of my shoulder and 6 inches from the injection site in the mid deltoid down my upper lateral and posterior upper arm. This AM (Friday) AM temp was 101.1 and is now down to 99.7. Myalgias have pretty much resolved. Extreme glycemic excursion occurred resulting in use of 50% more insulin to result in rather poorly controlled blood sugar for the event.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Started with myalgias the evening (Tuesday) after vaccine. There was more pain than what I expected at the injection site. The following day (Wednesday) myalgias worsened, fever began reaching 101.9, chills and sensitive skin. The following day (Thursday) the fever peaked at 103.9 upon awakening,  falling to 102.1 that evening. Systemic symptoms (generalized myalgia) were slightly worse. Injection site pain was worse to the point it is difficult to raise my arm up to the side. Tenderness is present to the back of my shoulder and 6 inches from the injection site in the mid deltoid down my upper lateral and posterior upper arm. This AM (Friday) AM temp was 101.1 and is now down to 99.7. Myalgias have pretty much resolved. Extreme glycemic excursion occurred resulting in use of 50% more insulin to result in rather poorly controlled blood sugar for the event.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema multiforme, Myalgia, Sedation
Clinical narrative: Sedation, myalgia and erythema multiform.
Age: 48.0
Sex: U
Vaccine: TDAP
Symptoms: Arthralgia, Discomfort, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Patient states she felt discomfort from time of vaccination. Reports deep pain in muscle and joint of right arm. Patient has self-treated with NSAID, VOLTAREN gel and Lidocaine ointment which does help but pain has persisted and limits her activity. Injection site is without signs of infection or muscle, wasting per Dr. Patient to continue supportive measures and will refer to ortho if persists.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid swollen, hot to the touch. Redness covers upper (L) arm, starting just above the acromion process to just above the elbow (6.5 inches), continues around the entire arm. The reaction is confined to the upper (L) arm. This reaction noted on 3-6-19.