chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Feeling cold, Headache, Hypersomnia
Clinical narrative: Woke with extreme cold, had to close all windows, add clothing and blankets to go back to sleep. Woke with fever and chills, headache and body ache. Slept all day under blankets. No appetite or thirst. Stayed like this for 24 hours, passed in about 36 hours.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Thirst decreased
Clinical narrative: Woke with extreme cold, had to close all windows, add clothing and blankets to go back to sleep. Woke with fever and chills, headache and body ache. Slept all day under blankets. No appetite or thirst. Stayed like this for 24 hours, passed in about 36 hours.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Pyrexia, Rash
Clinical narrative: Fever on 4/7/19. Rash on 4/9/19 with mild cough
Age: 0.42
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: High fever of 103.8 evening after vaccination. Diagnosed as adverse fever reaction by ER as no signs of other infection were present.
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Herpes zoster, Pruritus, Rash, Rash erythematous, Skin irritation
Clinical narrative: Shortly after being given the first dose of the Shingrix (Herpes Zoster) vaccine I started itching on my legs mostly on the right) and about my belt line on my back. The legs which I could see had small reddish bumps on them. When my arrived back at the house on Sunday (out of town) I ask her to look at my back and she said it had a rash like irritation at that location. After telling her that I had received the Shingles vaccine on Thursday night we both agreed that I should call our doctor and have her look at it. I called on Monday and was issued an appointment on Tuesday. It was confirmed by the doctor that I had shingles on my back but she was not 100% sure what was causing the bumps and itching on my leg. I was given a prescription and it got better  after a couple of weeks.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chills, Headache, Myalgia, Tremor
Clinical narrative: Chills, uncontrolled shaking, muscles aches?back and neck, headache, vomiting? lasted 6 hours. Weakness followed for 10 hours
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: Chills, uncontrolled shaking, muscles aches?back and neck, headache, vomiting? lasted 6 hours. Weakness followed for 10 hours
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Pallor, Presyncope
Clinical narrative: NEAR SYNCOPE. PT BECAME PALE AND STATED HE FELT LIGHTHEADED BUT DID NOT ACTUALLY PASS OUT. WE HAD PATIENT LIE DOWN WITH HIS FEET ELEVATED FOR A BRIEF TIME. AFTER A FEW MINUTES HE SAT BACK UP AND FELT NORMAL AGAIN.
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: administered their second dose of ROTATEQ "14 weeks after the administration of the first dose"; have "a slight fever"; Information has been received from a the patient's father referring to a 5 months years old female patient. The concomitant medication included 3 other unspecified vaccines. The patient was pre-mature birth and birth at 35 weeks. No drug reactions/allergies was reported.  On around 05-DEC-2018, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 1x2ml orally for prevention of rotavirus(frequency, lot # and expiration date were not reported). In March 2019(reported as 14 weeks after the administration of the first dose), the patient were administered second dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 1x2ml orally (frequency, lot # and expiration date were not reported)(Inappropriate schedule of product administration).  On 09-MAR-2019, the patient had a slight fever. The outcome of event was not recovered. The patient didn't received treatment for event. The newborn infant lab works were normal. The patient didn't sought medical attention. The causality assessment was not provided.The reporter consulted his attorney for possible legal action against the pediatrician due to a dose of medication administered outside of the prescribing Information.; Sender's Comments:  US-009507513-1903USA005193:
Age: 0.08
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: administered their second dose of ROTATEQ "14 weeks after the administration of the first dose"; have "a slight fever"; Information has been received from a the patient's father referring to a 5 months years old female patient. The concomitant medication included 3 other unspecified vaccines. The patient was pre-mature birth and birth at 35 weeks. No drug reactions/allergies was reported.  On around 05-DEC-2018, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 1x2ml orally for prevention of rotavirus(frequency, lot # and expiration date were not reported). In March 2019(reported as 14 weeks after the administration of the first dose), the patient were administered second dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 1x2ml orally (frequency, lot # and expiration date were not reported)(Inappropriate schedule of product administration).  On 09-MAR-2019, the patient had a slight fever. The outcome of event was not recovered. The patient didn't received treatment for event. The newborn infant lab works were normal. The patient didn't sought medical attention. The causality assessment was not provided.The reporter consulted his attorney for possible legal action against the pediatrician due to a dose of medication administered outside of the prescribing Information.; Sender's Comments:  US-009507513-1903USA005115:
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: patient with rash on her face and neck which the physician diagnosed as chickenpox; This spontaneous report was received from a physician via a field employee referring to a 9 years old female patient.  Information about concomitant medication and drug reactions/allergies was unknown and the patient did not have any pertinent medical history.  On 28-JUN-2010, the patient was vaccinated with her fist dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose detail, route, lot # and expiration date were not reported) with sterile diluent for prophylaxis (was reported as prevention of varicella). On 08-JUN-2013, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose detail, route, lot # and expiration date were not reported) with sterile diluent for prophylaxis (was reported as prevention of varicella).   From 03-MAR-2019 to 10-MAR-2019, the patient went on a cruise. On 19-MAR-2019, the patient came into the office with a rash on her face and neck, which the physician diagnosed as chickenpox. Information about treatment given for the event, lab diagnostics/ studies performed was unknown. The patient was came to the physician's office for sought medical attention. The outcome of the event was reported as not recovered. The causality assessment between sterile diluent, varicella virus vaccine live (oka/merck) (VARIVAX) and the event was not reported.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects.; a 12 month 13 day old patient was administered an expired dose of MMR II.; Information has been received from a nurse referring to a 12 month 13 day old unknown gender patient. Information about pertinent medical history and drug reactions/allergies was not reported. The concomitant medications included Sterile Diluent.  On 25-MAR-2019, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot #:N009799, therapy type: Albumin status rHA (recombinant Human albumin), Expiration date: 24-MAR-2019, dose, frequency, route were not reported) for prophylaxis(expired product administered). No adverse effects.
Sex: U
Vaccine: PPV
Symptoms: Injection site rash, Rash
Clinical narrative: 3 patients had a really bad rash that went from the injection site to their neck and a couple of the patients had the rash go to their face on an unknown date after being administered the PNEUMOVAX 23; 3 patients had a really bad rash that went from the injection site to their neck and a couple of the patients had the rash go to their face on an unknown date after being administered the PNEUMOVAX 23; 3 patients had a really bad rash that went from the injection site to their neck and a couple of the patients had the rash go to their face on an unknown date after being administered the PNEUMOVAX 23; This spontaneous report was received from a pharmacist concerning to a 3 unspecified patients of unknown age (reported as all over of 65 years old). Information regarding the patients' medical history, concurrent condition and concomitant medications was not reported.   In March 2019 (reporter as the last week to 10 days) the patients were vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23) for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported). The pharmacist reported that the all of doses that were administered were from the same lot number.     On an unknown date, the 3 patients had a really bad rash that went from the injection site to their neck and a couple of the patients had the rash go to their face after being administered the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23) (injection site rash and rash).  The patients called to the pharmacy to sought medical attention.   The outcome of the adverse events was unknown.  The causality between pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23) and the adverse events was not reported.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: the patient was administered a dose of MMR II on 06-MAR-2015 and that titers drawn on an unspecified date read as negative; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 06-MAR-2015, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unspecified date, "titers drawn read as negative" (antibody test negative). Subsequently, on 12-FEB-2019, the patient was administered a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis.     The outcome of antibody test negative, as well as, the causality between the event and therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) were unknown.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: an adult patient was vaccinated with a pediatric dose of RECOMBIVAX; no adverse symptoms reported; This spontaneous report was received from a pharmacy intern and refers to an adult patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On an unknown date, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) for prophylaxis (strength, dose, frequency, route, lot number and expiration date were not provided). No adverse symptoms were reported.
Sex: F
Vaccine: HPV9
Symptoms: Biopsy cervix, Human papilloma virus test positive, Maternal exposure before pregnancy, Papilloma viral infection, Precancerous cells present
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse via a company representative refers to a 33 year old female patient. The patient's medical history, concurrent condition and concomitant medications were unknown. On an unknown date, the patient was vaccinated with GARDASIL 9 (strength, dose, unit, frequency, route of administration, Lot/batch number and expiration date unknown) for prophylaxis. The nurse stated that the patient had completed the GARDASIL 9 series, 15 years ago. On an unknown date, the patient underwent Papanicolaou smear test that showed Human Papilloma Virus (HPV) positive pap and was diagnosed with Human Papilloma Virus (HPV) positive pap that had precancerous cells. The patient was told that she was pregnant. The Last Menstrual Period and Estimated Due Date was not known. The patient was rendered treatment for the events. On an unknown date, the patient underwent cone biopsy and the results were not reported. The pregnancy outcome was pending. The outcome of human papilloma virus test positive, exposure before pregnancy and precancerous cells present were unknown. The reporter 's causality assessment was not provided. The patient sought medical attention.
Sex: F
Vaccine: HPV9
Symptoms: Ovarian cyst
Clinical narrative: This spontaneous report was received from an office manager via a company representative referring to a female adolescent patient of unknown age (between the age of 13 and 14 years old). The patient's medical history, concurrent conditions or concomitant therapies were unknown. In 2018 (also reported as: "about one year ago"), the patient was vaccinated with the first dose of GARDASIL 9 (strength, route, anatomical location, lot number and expiration date were unknown) for prophylaxis. On an unknown date, the patient experienced a "cyst on ovaries" after having GARDASIL 9 administered. The patient completed one injection of a two dose series. Additionally, it was reported that no treatment was given, no laboratories diagnostic or studies were performed. The case did not involve caner or overdose. At the time of the report, the outcome of ovarian cyst was not provided. The reporter did not assess the relatedness between ovarian cyst and GARDASIL 9.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; Was inadvertently administered one expired dose of VAQTA; This spontaneous report was received from a nurse practitioner concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 05-APR-2019, the patient was inadvertently vaccinated with an expire dose of hepatitis a vaccine, inactivated (VAQTA) (dose, frequency, route and anatomical site were unknown) lot # N031940, expiration date 23-NOV-2018, for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine administered to one patient; no adverse effect; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications and concurrent conditions were unknown.  On an unknown date, the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) for prophylaxis, lot # R017799 and expiration date 19-DEC-2019 (strength, frequency, and route of administration were not reported).         The patient experienced no adverse events. It was reported that the temperature excursion was at a temperature of 9.5 F during 11 Hours 59 Minutes; no previous temperature excursions were reported. Digital datta logger was involved.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: chickenpox; This spontaneous report was received from a physician assistant refers to a 4-year-old female patient. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, units, frequency, lot# and expiration date unknown) for prevention of chicken pox. It was unknown who administered the dose to patient. On a later unspecified date, within the last 6 months the patient experienced chicken pox. The patient sought the medical attention. The outcome of chicken pox was reported as recovered, so the physician does not want to send the samples. Causality of the event was not reported. No PQC (product quality complaint) was present.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a consumer concerning her daughter patient of unknown age and race. There was no information about the patient's medical history, drug reactions, allergies, concurrent conditions or concomitant medications to be reported. It was reported that the patient received her first shot of GARDASIL 9 (strength, dose, route, lot number and expiration date not reported) for prophylaxis, sometime "probably on an unspecified date in fall 2017". At the reporting time, the patient had not received the second dose, as she was away in college. The patient did not experience any adverse event. There was no product quality complaint (PQC) reported.
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: This spontaneous report was received from a consumer's grandmother and refers to a 4 year old male patient.The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis(strength, dosage schedule, route, indication, lot number and expiration date were not reported). On an unknown date, after the appointment the doctor's office called to say that the shots may have been mixed up (wrong product administered), and that the 4 year old may have gotten his sister's intended GARDASIL 9 shot (inappropriate age at vaccine administration). The doctor's office was unsure, and will be testing the 11 year old sister for titers of GARDASIL 9 to rule out the possible misuse of the vaccine. The patient seek for medical attention. The outcome of product administered to patient of inappropriate age and wrong product administered was unknown.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported.; expired dose of ROTATEQ which was administered on 4/8/2019; This spontaneous report was received from a physician referring to a patient of unknown age and unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided.   On 08-APR-2019, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (strength, dose and route were not reported; lot # N030366 and expiration date 13-MAR-2019) for prophylaxis (expired product administered). No adverse effects were reported.
Sex: U
Vaccine: ANTH
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered Anthrax the last week of January that expired December 2018; No adverse reactions; Received a spontaneous report on 05MAR2019.  The patient who traveled overseas, reported that a patient was administered Anthrax the last week of January that expired December 2018. A patient safety report was filled out and the incident was reported to VAERS. Patient displayed no adverse reactions. Policy changes were made to ensure lot numbers and expiration dates are checked prior to administration.  No further information is expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: 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 69-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received when patient was 60 years of age). On 4th December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.  It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient had experienced some pain with 1st dose of injection of SHINGRIX vaccine. The event was resolved.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Injected limb mobility decreased, Injection site erythema, Injection site urticaria, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 25th March 2019, the patient received the 1st dose of SHINGRIX .5 ml. On 25th March 2019, several hours after receiving SHINGRIX, the patient experienced pain in arm, injection site wheal, injection site redness and injected limb mobility decreased. On 26th March 2019, the patient experienced generalized muscle aches. On 27th March 2019, the patient experienced itching eyes and itchy legs. On 26th March 2019, the outcome of the generalized muscle aches was recovered/resolved. On an unknown date, the outcome of the pain in arm, injection site wheal, injection site redness and injected limb mobility decreased were unknown and the outcome of the itching eyes was recovering/resolving and the outcome of the itchy legs was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, injection site wheal, injection site redness, injected limb mobility decreased, generalized muscle aches, itching eyes and itchy legs to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for herself. The patient received the SHINGRIX vaccine into the left arm. A few hours after receiving the vaccine, the patient's arm was very sore and there was a large, red, welt at the injection site. The patient could barely move her arm. The next morning, she had muscle aches all over her body. The aches lasted about 12 hours. It was severe for about 8 hours and then better for the last 4 hours. The morning after that (27th March 2019), the patient developed itching that started in her eyes and traveled to arms and legs. It was less severe but the itching was present at the time of reporting. The reporter provided the consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 25th March 2019, the patient received the 1st dose of SHINGRIX .5 ml. On 25th March 2019, several hours after receiving SHINGRIX, the patient experienced pain in arm, injection site wheal, injection site redness and injected limb mobility decreased. On 26th March 2019, the patient experienced generalized muscle aches. On 27th March 2019, the patient experienced itching eyes and itchy legs. On 26th March 2019, the outcome of the generalized muscle aches was recovered/resolved. On an unknown date, the outcome of the pain in arm, injection site wheal, injection site redness and injected limb mobility decreased were unknown and the outcome of the itching eyes was recovering/resolving and the outcome of the itchy legs was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, injection site wheal, injection site redness, injected limb mobility decreased, generalized muscle aches, itching eyes and itchy legs to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for herself. The patient received the SHINGRIX vaccine into the left arm. A few hours after receiving the vaccine, the patient's arm was very sore and there was a large, red, welt at the injection site. The patient could barely move her arm. The next morning, she had muscle aches all over her body. The aches lasted about 12 hours. It was severe for about 8 hours and then better for the last 4 hours. The morning after that (27th March 2019), the patient developed itching that started in her eyes and traveled to arms and legs. It was less severe but the itching was present at the time of reporting. The reporter provided the consent to follow up.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired Daptacel vaccine/ no side effects; Initial information received on 03-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 22 months old male patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patients past medical history and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) on 03-Apr-2019.  On 03-Apr-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5171AA, expiry date 23-Mar-2019 via unknown route in the left thigh.  It was an actual medication error due to expired vaccine used.  It was reported that patient received expired Daptacel vaccine on 03-Ap-2019 which got expired on 23-Mar-2019.  The patient did not experience 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: F
Vaccine: DTAP, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 7 year old female given Daptacel instead of Tdap on 16MAR2019 outside of recommend age/No AE; 7 year old female given Daptacel instead of Tdap on 16MAR2019 outside of recommend age/No AE; Initial information received on 03-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 7 years old female patient who received vaccines DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5202AA, Expiry date- 16-May-2019 via unknown route in the right thigh on 16-Mar-2019 instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  It was a case of actual medication error due to Inappropriate age at vaccine administration and wrong vaccine administered.  It was reported that 7-year-old female given Daptacel instead of Tdap on 16MAR2019 outside of recommend age.   No side effects reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Dermatitis allergic
Clinical narrative: Allergic rash; Initial information received on 03-Apr-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient of unknown demography who experienced allergic rash, while he/she received vaccine TETANUS TOXOID.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious allergic rash (dermatitis allergic) (Unknown latency) following the administration of TETANUS TOXOID.  (Other relevant tests included No lab data reported.)  Final diagnosis was allergic rash.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for allergic rash.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Decreased appetite, Fatigue, Injection site erythema, Irritability
Clinical narrative: tired; fussy; did not want to eat as much; minor redness at injection site but nothing major; Initial information received on 03-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via other company (Pfizer). This case involves male patient (age unknown) who experienced fussy, tired, did not want to eat as much and minor redness at injection site but nothing major, while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history  and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) on unknown date.  On an unknown date, the patient received injection of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number, expiry date not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious fussy (irritability) with unknown latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. On an unknown date, the patient developed a non-serious tired (fatigue) with unknown latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. On an unknown date, the patient developed a non-serious did not want to eat as much (decreased appetite) with unknown latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. On an unknown date, the patient developed a non-serious minor redness at injection site but nothing major (vaccination site erythema) with unknown latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Lab data was not provided.  Final diagnosis was minor redness at injection site but nothing major, did not want to eat as much, tired and fussy.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for fussy, as Unknown for tired, as Unknown for did not want to eat as much and as Unknown for minor redness at injection site but nothing major.  List of documents held by sender- none.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: administered Pentacel reconstituted with sterile water; Initial information received on 03-Apr-2019 regarding an unsolicited valid non-serious case received from an -other healthcare professional by phone.  This case involves a 4 months old male patient who was vaccinated with 0.5 ml dose of  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Batch number: C5530AA and expiry date: 04-Oct-2019) via intramuscular route in the right thigh on 02-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 13V (CRM197) (Pneumococcal Vaccine Conj 13V (CRM197)) and Rotavirus Vaccine (Rotavirus Vaccine) on an unknown date.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was unknown if any adverse event occurred or not following the 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.   Documents held by the sender: none.
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: received an ActHIB vaccine with an expired diluent; Initial information received on 05-Apr-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2019SA097023 (same reporter).  This case involves female patient of an unknown age (child) who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] with an expired diluent of 18-Feb-2019 lot number not reported via unknown route in unknown administration site.  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 expired vaccine used. The office that received an ActHIB vaccine with an expired diluent of 18Feb2019.  It was unknown if any adverse event was occurred.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: received an ActHIB vaccine with an expired diluent; Initial information received on 05-Apr-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2019SA096852 (same reporter).  This case involves female patient of an unknown age (child) who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] with an expired diluent of 18-Feb-2019 lot number not reported via unknown route in unknown administration site.  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 Expired vaccine used. The office that received an ActHIB vaccine with an expired diluent of 18Feb2019.  It was unknown if any adverse event was occurred.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: a dose of Adacel was administered after the temperature excursion,no adverse event; Initial information received on 04-Apr-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 11 years old male patient who was vaccinated with a 0.5 ml  dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U5980DA and Exp. Date 22-Jun-2020 )via unknown route in the left deltoid on 26-Mar-2019 after temperature excursion.  The patient's medical history not reported and no any concomitant medications received.  It was an actual medication error case due to incorrect product storage.  No any adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: TYP
Symptoms: Dyspepsia
Clinical narrative: experiencing digestive issues; Initial information received on 04-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient (age unknown) who experienced digestive issues, while he/she received vaccine TYPHOID VACCINE ORAL.  The patients past medical history, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect TYPHOID VACCINE produced by unknown manufacturer lot number not reported via oral route.  On an unknown date, the patient developed a non-serious experiencing digestive issues (dyspepsia) with unknown latency following the administration of TYPHOID VACCINE.  Final diagnosis was experiencing digestive issues.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for experiencing digestive issues.  List of documents held by sender- none.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at site of injection; Initial information received on 05-Apr-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves two unknown demographic patients who experienced redness and swelling at site of injection, while they received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number, Exp. Date, dose, route and administration site not reported.  On an unknown date, the patient developed non-serious redness and swelling at site of injection (injection site inflammation) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Details of lab data not reported.  Final diagnosis was redness and swelling at site of injection.   It was not reported if the patient received any corrective treatment.  The event outcome was not reported.  List of documents held by sender: none.
Age: 46.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Musculoskeletal pain, Pain in extremity, Periarthritis, X-ray
Clinical narrative: Received a Flu shot on 10/19/2018. After flu shot was administered, I experienced common arm/shoulder pain, however, the pain never went away; it progressively got worse. The pain got worse as time went on which led to "frozen shoulder".
Age: 46.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Injection site pain
Clinical narrative: Received a Flu shot on 10/19/2018. After flu shot was administered, I experienced common arm/shoulder pain, however, the pain never went away; it progressively got worse. The pain got worse as time went on which led to "frozen shoulder".
Age: 46.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Musculoskeletal pain, Pain in extremity, Periarthritis, X-ray
Clinical narrative: Left shoulder pain
Age: 46.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Injection site pain
Clinical narrative: Left shoulder pain
Age: 30.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Patient was unaware of the pregnancy.  She went for yearly gynecology appointment on 4/9/19 and found out that she was pregnant after having a urine test.  Expected due date is 12/12/19.
Age: 30.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Exposure during pregnancy, Urine analysis
Clinical narrative: Patient was unaware of the pregnancy.  She went for yearly gynecology appointment on 4/9/19 and found out that she was pregnant after having a urine test.  Expected due date is 12/12/19.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Red knot the size of a golf ball, underneath the skin at the injection site that was also hot to the touch and when the knot was pressed the knot could be moved underneath the skin; Red knot the size of a golf ball, underneath the skin at the injection site that was also hot to the touch and when the knot was pressed the knot could be moved underneath the skin; Red knot the size of a golf ball, underneath the skin at the injection site that was also hot to the touch and when the knot was pressed the knot could be moved underneath the skin; This spontaneous report was received from a nurse via company representative referred to 2 female patients who were 3-year-old. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) via subcutaneous route as routine vaccination (dose, lot #, expiry date were not reported). On an unknown date, after being administered with varicella virus vaccine live (oka/merck) (VARIVAX), the patients developed a red knot, the size of a golf ball, underneath the skin at the injection site that was also hot to the touch and when the knot was pressed, the knot could be moved underneath the skin (vaccination site erythema, vaccination site warmth and vaccination site nodule). The patients sought medical attention (unknown if the parents of patients just called the office or if the patients came back into the doctor's office). Reporter did not know if the patients received any treatment for the adverse events. On an unknown date, the patients recovered from the events. Reporter causality was not provided. No Product quality complaint (PQC) was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash, Rash vesicular
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of injection site rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site rash and vesicular rash. On an unknown date, the outcome of the injection site rash and vesicular rash were not reported. It was unknown if the reporter considered the injection site rash and vesicular rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient has been captured as adult as per schedule of SHINGRIX. After receiving the SHINGRIX dose, the patient experienced asymptomatic vesicular rash at the area of injection. The reporter did not wish to be contacted for follow up.
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 female 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 shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a case of Shingles after receiving SHINGRIX. The pharmacist stated he was off work the day of reporting and was unable to provide further details regarding the event. He provided the pharmacy mailing address as noted in mailing address details.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in an elderly male patient who received SHINGRIX for prophylaxis. On 28th March 2019, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site redness, injection site pain and injection site rash. On an unknown date, the outcome of the injection site swelling, injection site redness and injection site pain were recovered/resolved and the outcome of the injection site rash was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site redness, injection site pain and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed redness, swelling and soreness around the injection site but those effects had all resolved. The patient had a rash that developed in the same area, but it had spread down his bicep at the time of reporting. The patient terminated the call to see medical attention.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: pt had swelling in right thigh, redness, warmth
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Moderate pain in arm on April 9 from 5:00 AM to 9:00 PM. Mild pain still there today (4/10). Severe headache, fever 100.3, chills and nausea - April 9 5:00 AM - 6:00 PM - felt much better on April 10.
Age: 37.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Noted baseball sized area of redness that began on Saturday 4/6/19 (day after receipt of vaccine)  that continued to expand in size throughout Tuesday, 4/9/19 and reported area was now size of softball.  No drainage, warmth or tenderness noted.  Denied fever and reported ROM WNL.  As of Wednesday, 4/10/19 reported that area of redness  subsiding and "becoming lighter and difficult to see".
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Local reaction, Vaccination site swelling
Clinical narrative: Pt showed signs of a localized reaction. Red, raised area where vaccine was given.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus
Clinical narrative: Redness, irritation 12cm below injection site, non-circumferential itching.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Moderate to severe muscle aches all over body.   Pain and swelling at sight of injection. Needed ibuprofen to sleep due to body aches. Pain persisted 24 hours before dulling to mild aches.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Ophthalmological examination abnormal
Clinical narrative: First dose, given 12/13/18, Lot #K22Y4, same route and location, also caused shingles but in right eye. We thought it was pink eye. When second shot in series caused same reaction in left, I was referred to eye specialist, noted on this form. He confirmed shingles, prescribed Valacyclovir. Stated primary care doctors should be warned against giving vaccine to patients with prior shingles in eye, which I suffered in December of 2014, some years after having ZOSTAVAX vaccine.