chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable.  The physician asked so why do some people get flu symptoms after the second (booster) dose of Shingrix The reporter did not consent to follow up. As no further information was available.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in jaw, Swelling face
Clinical narrative: swelling and pain in right jaw
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blood culture negative, Blood lactic acid normal, Blood sodium decreased, Borrelia test negative
Clinical narrative: 4 hours after receiving Shingrix the patient experienced malaise, myalgias, fever, polyarthralgias, and eventually diarrhea and a rash.  These symptoms persisted for 4-5 days prior to hospital presentation.  The patient's rash was macular and truncal at first and eventually became diffuse and urticarial.  After ruling out bacterial or viral infections the patient was started on a 1 week tapering course of oral prednisone.  The following day after receiving prednisone the rash almost completely resolved.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Clostridium test negative, Complement factor C3, Complement factor C4 decreased, Diarrhoea, Malaise
Clinical narrative: 4 hours after receiving Shingrix the patient experienced malaise, myalgias, fever, polyarthralgias, and eventually diarrhea and a rash.  These symptoms persisted for 4-5 days prior to hospital presentation.  The patient's rash was macular and truncal at first and eventually became diffuse and urticarial.  After ruling out bacterial or viral infections the patient was started on a 1 week tapering course of oral prednisone.  The following day after receiving prednisone the rash almost completely resolved.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Polymerase chain reaction, Pyrexia, Rash, Rash macular
Clinical narrative: 4 hours after receiving Shingrix the patient experienced malaise, myalgias, fever, polyarthralgias, and eventually diarrhea and a rash.  These symptoms persisted for 4-5 days prior to hospital presentation.  The patient's rash was macular and truncal at first and eventually became diffuse and urticarial.  After ruling out bacterial or viral infections the patient was started on a 1 week tapering course of oral prednisone.  The following day after receiving prednisone the rash almost completely resolved.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Respiratory viral panel, Total complement activity decreased, Urticaria, White blood cell count normal
Clinical narrative: 4 hours after receiving Shingrix the patient experienced malaise, myalgias, fever, polyarthralgias, and eventually diarrhea and a rash.  These symptoms persisted for 4-5 days prior to hospital presentation.  The patient's rash was macular and truncal at first and eventually became diffuse and urticarial.  After ruling out bacterial or viral infections the patient was started on a 1 week tapering course of oral prednisone.  The following day after receiving prednisone the rash almost completely resolved.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity, Vaccination site bruising, Vaccination site rash
Clinical narrative: Pt states that her arm hurts a lot. It is bruised, red and bumpy at the site of vaccine.
Age: 86.0
Sex: F
Vaccine: FLUR4
Symptoms: Chest discomfort, Feeling abnormal, Headache, Malaise
Clinical narrative: Vaccine was administered at 10:12am on 3/5/20 with no initial problem.  Patient left vaccination room and went to sit in waiting area to meet her husband.  After ~10 minutes, the patient's husband alerted the pharmacy that the patient wasn't feeling well.  She complained of a tight feeling in her chest, a headache, and overall "funny feeling".  Pharmacist advised calling 911 and patient refused.  Patient was alert and responsive.  Pharmacist advised sitting in the waiting area until she felt better.  After a few more minutes, the patient's husband alerted the pharmacy that the patient needed help.  She was still alert and responsive, but was not feeling better.  Of note, the patient reported not taking her blood pressure medication (lisinopril) that morning.  The pharmacist called 911 and emergency responders arrived within a few minutes.  The patient was checked over by EMS and was determined to not need an ambulance.  She began feeling better and left the store without further incident.
Age: 17.0
Sex: M
Vaccine: HPV9, IPV, TD
Symptoms: Anxiety, Blood pressure increased, Chest pain, Heart rate increased, Moaning
Clinical narrative: I am a nurse at the clinic that provided the vaccination.  The adverse event was reported to me by  school nurse at the patient's high school.  The incident was described to me as follows: Pt reported to school's health room at approximately 0930 on 03/05/2020.  He was described as clutching his chest and very anxious, moaning and writhing in pain.  BP 180/100, P 160 and remained elevated during time in health room.  Pt reported pain as "15" on scale of 0 to 10, and said pain was deep in his chest (denied radiation).  He was not pale or diaphoretic.  Pt was asked if he ingested any drugs and stated he did not understand the question.  He remained alert and oriented.  He was taken by ambulance to Medical Center. Treatment and outcome are not known by this writer. The school nurse looked at the student's history and physical.  There was no reported history of chronic health problems with student or family.
Age: 17.0
Sex: M
Vaccine: HPV9, IPV, TD
Symptoms: Pain
Clinical narrative: I am a nurse at the clinic that provided the vaccination.  The adverse event was reported to me by  school nurse at the patient's high school.  The incident was described to me as follows: Pt reported to school's health room at approximately 0930 on 03/05/2020.  He was described as clutching his chest and very anxious, moaning and writhing in pain.  BP 180/100, P 160 and remained elevated during time in health room.  Pt reported pain as "15" on scale of 0 to 10, and said pain was deep in his chest (denied radiation).  He was not pale or diaphoretic.  Pt was asked if he ingested any drugs and stated he did not understand the question.  He remained alert and oriented.  He was taken by ambulance to Medical Center. Treatment and outcome are not known by this writer. The school nurse looked at the student's history and physical.  There was no reported history of chronic health problems with student or family.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Client displayed hives near the injection site shortly after injection.  The client was not scratching the area nor did he state that it was itchy, but wanted to see the band-aid.  Mother pulled up his sleeve and noticed the small, red, raised wheals on the right arm, shoulder and axillary area.  I gave him an ice pack and a chewable 12.5 mg Benedryl tablet.  Symptoms did not worsen and the client was breathing regularly and talking well after the 15 minute recommended wait period.  Mother stated that he has never had hives after a vaccine before.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Body temperature increased
Clinical narrative: Between 101.3 and 103.3 degrees Farenheit temperature for 48 hours.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: DIZZINESS, NAUSEA, VOMITING
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptoms reported.; adult patient inadvertently received a pediatric dose of VAQTA; This spontaneous report was received from a medical assistant referring to a adult patient of unknown gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions and allergies were not provided.  On 27-FEB-2020, the patient was inadvertently vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter, once (strength, number of dose administered, vaccination scheme frequency was not reported; lot number S002505 has been verified to be a valid, expiration date reported and validated as 04-APR-2020) as prophylaxis. (incorrect dose administered). No product confusion was reported. No symptoms were reported for the patient.
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Malaise
Clinical narrative: he was sick for approximately 3 days; This spontaneous report was received from a male patient of unknown age referring to himself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown dates, the patient was vaccinated with two doses of zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis. Other suspect therapies included sterile diluent.  On an unknown date after receiving both doses, the patient was sick for approximately 3 days. The outcome of the event was reported as recovering.  The causality assessment between the event and the suspect vaccine was not reported.
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered Infanrix by mistake instead of TDAP. They were supposed to receive Boostrix.; This case was reported by a nurse via sales rep and described the occurrence of adult use of a child product in a adult patient who received DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient received Infanrix at an unknown dose. On an unknown date, unknown after receiving Infanrix, the patient experienced adult use of a child product. On an unknown date, the outcome of the adult use of a child product was unknown.  Additional case details were reported as follows: The age at vaccination was not reported. The patient was administered Infanrix by mistake instead of TDAP, which led to adult use of a child product. The patient was supposed to receive Boostrix. The patient identifiers were not available at the time of reporting. This is 1 of the 9 linked cases reported by the same reporter. The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Physician diagnosed patient with Shingles; Rash; This case was reported by a physician via sales rep and described the occurrence of shingles in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised. Concomitant products included mycophenolic acid (Cellcept).   On 13th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed rash several days later. The patient was diagnosed patient with Shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: I am feeling nauseous; This case was reported by a consumer via call center representative and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose and had no reaction.).   On 20th February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, 2 hrs after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was unknown.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The patient received Shingrix and after two hours felt nauseous. Not sure if just a coincidence.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Bedridden, Fatigue, Headache, Myalgia
Clinical narrative: muscle aches; upset stomach; headache; tiredness; in bed all day today; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th February 2020, the patient received the 2nd dose of Shingrix. On 20th February 2020, 1 days after receiving Shingrix, the patient experienced myalgia, upset stomach, headache, tiredness and bedridden. On an unknown date, the outcome of the myalgia, upset stomach, headache, tiredness and bedridden were not recovered/not resolved.   It was unknown if the reporter considered the myalgia, upset stomach, headache, tiredness and bedridden to be related to Shingrix.  Additional details were provided as follows: The pateint had shingles vaccine on the day before reporting and had in bed all day on the day of repoting with muscle aches, upset stomach, headache and tiredness.  The reporter inquired how long did the symptoms usually last.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: redness on arm from shoulder to elbow; This case was reported by a pharmacist via sales rep and described the occurrence of erythema of extremities in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 4M2C7, expiry date 19th December 2021) for prophylaxis.   On 17th November 2019, the patient received Shingrix (intramuscular) .5 ml. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was recovered/resolved.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional details were provided as follows: After the Shingrix shot received on left arm, the patient had redness on arm from shoulder to elbow and went away after 3 weeks. The patient did not hurt or itch just red. The reporter agree to follow up from GSK
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event to be related to Shingles vaccine.  Additional details were reported as follows: The patient's demographics were not reported. The patient received shingles vaccine and experienced side effect and now wanted to know about how long does side effect may last. No other information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Axillary mass, Pain
Clinical narrative: Armpit lump; Burning pain normal; This case was reported by a other health professional via interactive digital media and described the occurrence of axillary lump in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced axillary lump and pain burning. On an unknown date, the outcome of the axillary lump and pain burning were unknown.   It was unknown if the reporter considered the axillary lump and pain burning 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 captured as adult as per the vaccine indication. After receiving Shingrix, the patient experienced armpit lump and burning pain.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Entire arm hurt terribly /Painful; redness and heat at site injection; redness and heat at site injection; This case was reported by a consumer and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   In February 2020, the patient received the 2nd dose of Shingrix. In February 2020, immediately after receiving Shingrix, the patient experienced pain in arm, injection site erythema and injection site warmth. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient stated that, received a dose of Shingrix 48 hours ago from the date of reporting. The patient experienced painful immediately after vaccination. The patient stated that, after vaccination, the entire arm was hurt terribly, and also had injection site redness and heat. The patient reported that the arm  pain was slowly subsiding but the redness and heat at site injection has continued to grow. This case linked with case US2020AMR033849 reported by same reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Entire arm hurt terribly /Painful; redness and heat at site injection; redness and heat at site injection; This case was reported by a consumer and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   In February 2020, the patient received the 2nd dose of Shingrix. In February 2020, immediately after receiving Shingrix, the patient experienced pain in arm, injection site erythema and injection site warmth. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient stated that, received a dose of Shingrix 48 hours ago from the date of reporting. The patient experienced painful immediately after vaccination. The patient stated that, after vaccination, the entire arm was hurt terribly, and also had injection site redness and heat. The patient reported that the arm  pain was slowly subsiding but the redness and heat at site injection has continued to grow. This case linked with case US2020AMR033849 reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Painful; This case was reported by a consumer and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The patient's demographic details were not reported. The age at the vaccination was not reported. The reporter had spoken to one other person who said her 2nd dose was painful. This case linked with case US2020AMR033841, reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Painful; This case was reported by a consumer and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The patient's demographic details were not reported. The age at the vaccination was not reported. The reporter had spoken to one other person who said her 2nd dose was painful. This case linked with case US2020AMR033841, reported by same reporter.
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Feeling hot, Hypokinesia, Incomplete course of vaccination, Injection site pain
Clinical narrative: soreness at the injection site.; felt like he had a fever; Could barely move around; . He is now past 6 months and has not gotten the 2nd dose yet; fatigued such that he could barely move around; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 13th August 2019, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fatigue. On an unknown date, the patient experienced injection site pain, feeling hot, movements reduced and incomplete course of vaccination. On an unknown date, the outcome of the fatigue was recovered/resolved and the outcome of the injection site pain, feeling hot, movements reduced and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the fatigue, injection site pain, feeling hot and movements reduced to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and  within 3-4 hours he felt very fatigued such that he could barely move around.  The fatigue lasted about 24 hours before resolving. The patient also felt like he had a fever, but the thermometer did not show a fever. He had some soreness at the injection site.  Till the time of reporting the patient did not received 2nd dose of Shingrix which led to incomplete course of administration. Reporter consented to follow up. This case has been linked with case US2020029075, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site pain, Pyrexia
Clinical narrative: fever; feeling tired; feeling weak; sore at injection site; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th February 2020, the patient received the 2nd dose of Shingrix (intramuscular). In February 2020, less than a week after receiving Shingrix, the patient experienced fever, tiredness, feelings of weakness and injection site pain. On an unknown date, the outcome of the fever, tiredness, feelings of weakness and injection site pain were unknown.   It was unknown if the reporter considered the fever, tiredness, feelings of weakness and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received second dose of Shingrix and  experienced fever, feeling tired, feeling weak and soreness at injection site. The patient did not consent to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: achiness at the injection site; Injection site knot; injection site turned red in a small spot /She developed a knot,; whole muscle from the elbow up  to her shoulder got sore; she got warm, like a fever just at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shoulder replacement. Previously administered products included Shingles vaccine (received shingles vaccine a year ago before reporting date).   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain, injection site lump, injection site warmth, injection site erythema and muscle soreness. On an unknown date, the outcome of the injection site pain, injection site lump, injection site warmth, injection site erythema and muscle soreness were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site lump, injection site warmth, injection site erythema and muscle soreness to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient after vaccination started having achiness at the injection site. The patient developed a knot, as big the palm of her hand, at the injection site.  The patient got warm like a fever just at the injection site. The knot at the injection site turned red in a small spot, next  the whole muscle from the elbow up  to her shoulder got sore. The patient stated that it would not be sore if she is standing up, but when she rolled over or moved it. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: achiness at the injection site; Injection site knot; injection site turned red in a small spot /She developed a knot,; whole muscle from the elbow up  to her shoulder got sore; she got warm, like a fever just at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shoulder replacement. Previously administered products included Shingles vaccine (received shingles vaccine a year ago before reporting date).   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain, injection site lump, injection site warmth, injection site erythema and muscle soreness. On an unknown date, the outcome of the injection site pain, injection site lump, injection site warmth, injection site erythema and muscle soreness were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site lump, injection site warmth, injection site erythema and muscle soreness to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient after vaccination started having achiness at the injection site. The patient developed a knot, as big the palm of her hand, at the injection site.  The patient got warm like a fever just at the injection site. The knot at the injection site turned red in a small spot, next  the whole muscle from the elbow up  to her shoulder got sore. The patient stated that it would not be sore if she is standing up, but when she rolled over or moved it. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: received the first dose of Shingrix via subcutaneous route; Pain in the injection site; Redness  in the injection site; Itching  in the injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number DJ3FL, expiry date 5th March 2022) for prophylaxis.   On 18th February 2020, the patient received the 1st dose of Shingrix (subcutaneous). In February 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site itching. On 18th February 2020, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site itching and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site itching to be related to Shingrix.  Additional case details were reported as follows: The patient received the first dose of Shingrix via subcutaneous route, which led to intramuscular formulation administered by other route. The patient started to experienced pain, redness, itching in the injection site. This was a medication error with harm. As per sales data sheet reported batch number was changed from KH DJ3FL to DJ3FL. This is 1 of the 17 cases, reported by same reporter. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: tired; burned when injected; redness; heat; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 19th February 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and injection site burning. On 21st February 2020, the patient experienced tiredness. On an unknown date, the outcome of the injection site erythema, injection site warmth and tiredness were recovering/resolving and the outcome of the injection site burning was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, tiredness and injection site burning to be related to Shingrix.  Additional details were provided as follows: The pateint received Shingrix and experienced  burned when injected, pain, redness and heat at the injection site. The patient very tired at the time of reporting and did not want to get out of bed. The follow up consent was granted.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness at injection site; raised area at injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th January 2020, the patient received Shingrix. On 10th February 2020, 31 days after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were resolved with sequelae.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided. The patient experienced redness and a raised area at the injection site after the injection. The follow up consent was granted.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Malaise, Middle insomnia
Clinical narrative: Sore arm that increasingly became more painful as the day went on.  During the night, I woke up from the pain in my arm, my head hurt and I was shivering.  Now my arm continues to be extremely painful and  feel a general malaise: achy, headache, weak. I have been taking extra strength acetaminophen since 9:30 pm last night.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore arm that increasingly became more painful as the day went on.  During the night, I woke up from the pain in my arm, my head hurt and I was shivering.  Now my arm continues to be extremely painful and  feel a general malaise: achy, headache, weak. I have been taking extra strength acetaminophen since 9:30 pm last night.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Pt reported that the day after injection he experienced increased fatigue, headache, nausea, and reported that his "arm felt like it was punched." Pt reported 3/6/2020 that he has continued to have headaches and fever with nausea. Pt is taking Tylenol OTC for pain and fever relief.
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Erythema, Pruritus
Clinical narrative: Patient reported nurse that he was feeling itchy  after receiving vaccines.  RN noted redness on face and arms patient did not recall if arms were like that before. Patient sent to medical assessment where he also started coughing. Patient given benadryl 50mg  IM, epipen 0.3mg IM. Then transferred to ER via EMS for further treatment.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal swelling
Clinical narrative: patient reported to the pharmacist that she felt she had a lump in her throat the evening of vaccination, she then proceeded to obtain care at the local urgent care as she felt her throat was swelling. Urgent care told her to call the pharmacy to report the event
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt developed an acute shingles outbreak less than 12 hours after recieving the Shingrix immunization
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Swelling, Tenderness
Clinical narrative: Redness, swelling and tenderness.   Redness just below vaccine site, moving inward toward inner arm, approximately 1.5 inches in width.  Warmth is present on affected area.
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Electrocardiogram normal, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Malaise
Clinical narrative: IMMEDIATELY AFTER VACCINATION, PATIENT BECAME PALE AND BEGAN SWEATING. HE COMPLAINED THAT HE DIDN'T FEEL WELL. WE USED AN AMMONIA INHALANT AND IS SEEMED TO HELP AT FIRST BUT THEN HE COMPLAINED OF FEELING WORSE. WE HAD HIM PUT HIS HEAD DOWN AND HE DIDN'T SEEM TO BE DOING BETTER. WE TRIED TO SHIFT HIS WEIGHT IN THE CHAIR WHILE WE WAITED FOR THE AMBULANCE TO ARRIVE AND HE IMMEDIATELY PASSED OUT. USED A SECOND AMMONIA INHALANT ON HIM AND IT STILL TOOK A MOMENT FOR HIM TO REGAIN CONSCIOUSNESS. THE AMBULANCE CREW TOOK HIS BLOOD PRESSURE AND EKG AND SEEMED FINE. HE REFUSED TRANSPORT TO HOSPITAL OR TO HAVE HIS BLOOD SUGAR TAKEN.
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Pallor
Clinical narrative: IMMEDIATELY AFTER VACCINATION, PATIENT BECAME PALE AND BEGAN SWEATING. HE COMPLAINED THAT HE DIDN'T FEEL WELL. WE USED AN AMMONIA INHALANT AND IS SEEMED TO HELP AT FIRST BUT THEN HE COMPLAINED OF FEELING WORSE. WE HAD HIM PUT HIS HEAD DOWN AND HE DIDN'T SEEM TO BE DOING BETTER. WE TRIED TO SHIFT HIS WEIGHT IN THE CHAIR WHILE WE WAITED FOR THE AMBULANCE TO ARRIVE AND HE IMMEDIATELY PASSED OUT. USED A SECOND AMMONIA INHALANT ON HIM AND IT STILL TOOK A MOMENT FOR HIM TO REGAIN CONSCIOUSNESS. THE AMBULANCE CREW TOOK HIS BLOOD PRESSURE AND EKG AND SEEMED FINE. HE REFUSED TRANSPORT TO HOSPITAL OR TO HAVE HIS BLOOD SUGAR TAKEN.
Sex: F
Vaccine: MMR
Symptoms: Blood test normal, Inappropriate schedule of product administration, Measles antibody negative, Mumps antibody test negative, Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccination; inappropriate schedule of vaccine adminstration; Unspecified blood test which came back negative for measles, mumps or rubella immunity; This spontaneous report was received from a nurse refers to a 48-year-old female patient. The patient's pertinent medical history, concurrent conditions, allergies/drug reactions and concomitant medications were unknown. On an unknown date (reported as: when the patient was child), the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (product administered to patient of inappropriate age) (strength, dose, route, anatomical location, lot# and expiration date were not reported) for negative titers. On 14-JAN-2020, the patient underwent unspecified blood test which came back negative for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live immunity (antibody test negative). On 15-JAN-2020, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) (route, dose, anatomical location were not reported) lot # R030806 and expiration date 24-OCT-2020 for negative titers. On 03-MAR-2020, the patient was vaccinated with second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) (inappropriate schedule of vaccine administration). The outcome of the event antibody test negative was unknown. The causality assessment between the event antibody test negative and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) was not reported.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: Inappropriate age at vaccination; inappropriate schedule of vaccine adminstration; Unspecified blood test which came back negative for measles, mumps or rubella immunity; This spontaneous report was received from a nurse refers to a 48-year-old female patient. The patient's pertinent medical history, concurrent conditions, allergies/drug reactions and concomitant medications were unknown. On an unknown date (reported as: when the patient was child), the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (product administered to patient of inappropriate age) (strength, dose, route, anatomical location, lot# and expiration date were not reported) for negative titers. On 14-JAN-2020, the patient underwent unspecified blood test which came back negative for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live immunity (antibody test negative). On 15-JAN-2020, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) (route, dose, anatomical location were not reported) lot # R030806 and expiration date 24-OCT-2020 for negative titers. On 03-MAR-2020, the patient was vaccinated with second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) (inappropriate schedule of vaccine administration). The outcome of the event antibody test negative was unknown. The causality assessment between the event antibody test negative and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) was not reported.
Sex: F
Vaccine: PPV
Symptoms: Asthma
Clinical narrative: it can not be ruled out if that unspecified patient received potential dose of PNEUMOVAX23 prior to being asthmatic/a unspecified 14 year old who has asthma may have received a dose of PNEUMOVAX23 in the past; This spontaneous report has been received from a pharmacist referring to a 14 years old female patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On an unknown date, the patient might had been vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, expiration date, frequency, route and dose details were unknown) for prophylaxis.       On an unknown date, the patient experienced asthma. It could not be ruled out if that the patient received potential dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prior to being asthmatic.      The outcome of asthma was unknown. The causality between the asthma and the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: Patient states he has experienced pain in that arm radiating down the arm and weakness in that arm
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Musculoskeletal pain, Pain in extremity, Sleep disorder
Clinical narrative: her arm remain sore still after the 2nd injection of Shingrix; her shoulder remain sore still after the 2nd injection of Shingrix; sleep disturbance; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm, shoulder pain and sleep disturbance. On an unknown date, the outcome of the pain in arm, shoulder pain and sleep disturbance were recovering/resolving.   It was unknown if the reporter considered the pain in arm, shoulder pain and sleep disturbance to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced arm and shoulder pain after 2nd injection of Shingrix. The patient stated that the pain in her shoulder wakes her up at night. The patient did not consent to follow up.
Age: 1.83
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Dapacel vaccine was administered to the patient, No AE; Initial information was received on 02-Mar-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2020SA058732 and 2020SA058733.  This case involves a 22 months old male patient who was vaccinated with 0.5 ml fourth dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5611BA and expiry date: 07-Feb-2020) via intramuscular route in the left arm on 17-Feb-2020 for prophylactic vaccination (PT Expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT).  It was actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Age: 1.58
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired Dapacel vaccine, No AE; Initial information was received on 02-Mar-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to 2020SA058732 and 2020SA057112 (same reporter)  This case involves a 19 months old male patient who was vaccinated with a third dose of 0.5 ml of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5367AA and expiry date: 30-Jan-2020) via intramuscular route in the left arm on 31-Jan-2020 for prophylactic vaccination (Expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) for Immunisation.  It was actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: he was given an expired Fluzone HD, no AE; Initial information was received on 03-Mar-2020 regarding an unsolicited valid non-serious case from a consumer.  This case involves Adult male patient who experienced he was administered an expired  INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number not reported) (expiry date-Jun-2019) via an unknown route at an unknown administration site for prophylactic vaccination in Dec-2019.  Medical history, past medical treatment, vaccination and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on batch number was requested.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patients age range of 59 to 62 received Fluzone High-Dose, no AE; patients age range of 59 to 62 received Fluzone High-Dose, no AE; Initial information was received on 03-Mar-2020 regarding an unsolicited valid non-serious case from a consumer.  This case is linked to cases 2020SA059552 and 2020SA059571 (same reporter).   This case involves a patient (age range of 59 to 62) who received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination in the last October to November.  Medical history, medical treatment, vaccination and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.  Information on the batch number was requested.