chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; the patient received one dose  of improperly stored MMR II; This spontaneous report has been received from a registered nurse concerning to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, past drug reactions or allergies and concomitant medications were not reported.  On 15-AUG-2019, the patient received one dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (Albumin status of rHA (recombinant human albumin) (M-M-R II)  (route of administration and anatomical location were not reported) (lot#: R031681, expiration date: 01-NOV-2020) reconstituted with properly stored sterile diluent (lot#: N029636, expiration date: 29-MAR-2020) for prophylaxis. The total temperature was above 47 degrees Fahrenheit (48.1 degrees Fahrenheit) for a total time frame of 7 hours. There were no previous temperature excursions. The call was due to a data logger. No adverse effects reported.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No known adverse effects; a patient received a dose of VAQTA on 13-FEB-2019 and on 05-JUN-2019; This spontaneous report has been received from a pharmacist concerning to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, past drug reactions or allergies and concomitant medications were not reported.  On 13-FEB-2019, the patient received a dose of Hepatitis A Vaccine, Inactivated (VAQTA) (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis and on 05-JUN-2019, the patient received another dose of Hepatitis A Vaccine, Inactivated (VAQTA) (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). There were no known adverse effects.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; received expired dose; This spontaneous report as received from a other health professional refers to a patient of unknown age.    On 21-AUG-2019 the patient was inadvertently vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # N030175 expiry date: 16-JUN-2019) for prophylaxis.       On 21-AUG-2019, 1 day after onset of therapy the patient experienced expired product administered.  On an unknown date the patient experienced no adverse event.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse efffects; patient was administerd with an improperlystored dose of VARIVAX; This spontaneous report as received from a other health professional refers to a patient of unknown age.    On 16-AUG-2019 the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # R018141 and expiry date 25-JUN-2019, 1 dosage form, intramuscular for prophylaxis.    Concomitant therapies included sterile diluent(STERILE DILUENT).   On 16-AUG-2019, 1 day after onset of therapy the patient experienced product storage error.  On an unknown date the patient experienced no adverse event.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; Administered an improperly stored dose of Varivax; This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported.  On 20-AUG-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dosage information, route of administration, anatomical location was unknown) of lot # S006021 and expiration date of 27-FEB-2021 for prophylaxis (Product storage error). The concomitant medication included sterile diluent (lot# R019504 and expiration date 04-NOV-2020) which was reported to be stored properly. No adverse effects were reported. It was reported that the vaccine was exposed to a temperature of -14 degree Celsius (C) to -10 degree Celsius (-10.5 C) for a time frame of 58 minutes. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse symptoms; vaccinated with improperly stored vaccine; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions.      On 21-AUG-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S000133, expiry date:02-JAN-2021 strength, dosage information, route of administration and anatomical locations were unknown) for prophylaxis. No adverse symptoms were reported. It was reported that the vaccine was exposed to a temperature of 15 degree fahrenheit to 46 degree fahrenheit (45.1fahrenheit) for a time frame of 1 hours and 51 minutes. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint was reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; administered an expired dose; This spontaneous report was received from an other health professional (medical assistant) refers to a 41 year old patient.     The patient's medical history, concurrent conditions and concomitant medications were unknown. On 21-AUG-2019, the patient was inadvertently administered an expired dose (expired product administered) of hepatitis a vaccine, inactivated (VAQTA) (lot # R014952 exp.date: 09-AUG-2019) (strength, dose, frequency, anatomical location were unknown) for prophylaxis. No adverse events was reported. No product quality issue was reported. The outcome of expired product administered and no adverse event was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: injection site reaction /huge side efects; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but it could be 61 or 62 years. The patient had huge side effects after vaccine. The patient reported that one in 100K reactions which he guessed was ok but in this case were both at the same time and same place of injection and one day apart. The patient's perception was that the whole lot had something wrong. The reporter just want to report the incident and make sure no one else was hurt. The reporter gave permission to follow up. This case had been linked to the case US2019AMR147386, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: injection site reaction / huge side effects; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but it could be 62 or 63 years. The patient had huge side effects after vaccine. The reporter reported that one in 100K reactions which reporter guessed was ok but in this case were both at the same time and same place of injection and one day apart. The reporter's perception was that the whole lot had something wrong. The reporter just want to report the incident and make sure no one else was hurt. The reporter gave permission to follow up. This case had been linked to the case US2019AMR147376, reported by same reporter.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Pain in extremity, Pyrexia, Weight decreased
Clinical narrative: Sore arm; Fever; Chills; Diarrhea; loss weigh; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2019, the patient received the 1st dose of Shingrix. On 5th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, fever, chills and diarrhea. In August 2019, the patient experienced weight loss. On 6th August 2019, the outcome of the pain in arm, fever and chills were recovered/resolved. On an unknown date, the outcome of the diarrhea was not recovered/not resolved and the outcome of the weight loss was unknown.   It was unknown if the reporter considered the pain in arm, fever, chills, diarrhea and weight loss to be related to Shingrix.  Additional case details were reported as follows: In the night of getting Shingrix the patient experienced sore arm, fever, chills and diarrhea.  The patient recovered from everything by next day except the diarrhea which has been persistent. Due to diarrhea patient had lost weight from 110 pounds to 106 pounds. No further details were provided. The reporter gave permission to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: Back Pain; This case was reported by a other health professional via call center representative and described the occurrence of back pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2019, the patient received the 2nd dose of Shingrix. On 13th August 2019, 1 days after receiving Shingrix, the patient experienced back pain. The patient was treated with ambiguous medication nos (Cortisone (Nos)) and prednisone (Prednisone (Oral)). On an unknown date, the outcome of the back pain was unknown.   It was unknown if the reporter considered the back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient. The patient made an appointment with primary care physician after experiencing bad back pain. The patient received cortisone and oral prednisone taper.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number 9JG52, expiry date 27th September 2021) for prophylaxis.   On 12th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm. After vaccination, the patient developed are of redness about 100mm at the injection site, then shortly after that, the patient developed a 2cm area of redness below the injection site area that smaller in size with another area of redness 2cm below that one. The reporter reported that, the areas of redness were aligned down the patient's arm. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Swelling at injection site; Itchy Rash at injection site; Itchy Rash at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included liver transplant (a liver transplant recipient on immune suppression medications.). Concomitant products included cyclosporin (Cyclosporine) and everolimus.   On 13th August 2019, the patient received the 2nd dose of Shingrix. On 15th August 2019, 2 days after receiving Shingrix, the patient experienced injection site swelling, injection site rash and injection site itching. On an unknown date, the outcome of the injection site swelling, injection site rash and injection site itching were unknown.   It was unknown if the reporter considered the injection site swelling, injection site rash and injection site itching to be related to Shingrix.  Additional case details were reported as follows: The patient was a liver transplant recipient on immune suppression medications (cyclosporine and everolimus) received second Shingrix vaccine two days ago from date of reporting and was now experiencing swelling and an itchy rash at the injection site. The reporter gave permission to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Incomplete course of vaccination, Influenza like illness, Injection site pain, Musculoskeletal pain
Clinical narrative: Injection site pain/pain/entire arm and entire body; Tingling; Shoulder pain; pain at injection site/entire arm; Inappropriate schedule of vaccine; Headache; Flu Like Symptoms; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included chicken pox.   In November 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, between 10 and 11 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced general body pain, tingling sensation, headache, influenza-like symptoms, shoulder pain and incomplete course of vaccination. On an unknown date, the outcome of the general body pain, tingling sensation, headache, influenza-like symptoms, shoulder pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the general body pain, tingling sensation, headache, influenza-like symptoms and shoulder pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient states he received the first dose of Shingrix vaccine in early November of 2018.  It had been over 6 months and he has not yet received his second dose of the Shingrix vaccine.  The patient experienced headache and flu like symptoms that lasted for about 3 days.  The patient also experienced pain at injection site, entire arm and entire body.  Now the pain was still present only at the shoulder.  The patient also had soreness present near the upper shoulder, and sometimes he gets a tingling sensation radiating from shoulder down.  The patient mentioned he has had chicken pox as a young boy. The reporter did not give consent to follow up. No further details were provided.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Injection site pain/pain/entire arm and entire body; Tingling; Shoulder pain; pain at injection site/entire arm; Inappropriate schedule of vaccine; Headache; Flu Like Symptoms; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included chicken pox.   In November 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, between 10 and 11 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced general body pain, tingling sensation, headache, influenza-like symptoms, shoulder pain and incomplete course of vaccination. On an unknown date, the outcome of the general body pain, tingling sensation, headache, influenza-like symptoms, shoulder pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the general body pain, tingling sensation, headache, influenza-like symptoms and shoulder pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient states he received the first dose of Shingrix vaccine in early November of 2018.  It had been over 6 months and he has not yet received his second dose of the Shingrix vaccine.  The patient experienced headache and flu like symptoms that lasted for about 3 days.  The patient also experienced pain at injection site, entire arm and entire body.  Now the pain was still present only at the shoulder.  The patient also had soreness present near the upper shoulder, and sometimes he gets a tingling sensation radiating from shoulder down.  The patient mentioned he has had chicken pox as a young boy. The reporter did not give consent to follow up. No further details were provided.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: 3 year old that was administered Pentacel but was only given the Dtap-IPV portion and not the ActHIB; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years old patient who received only Dtap-IPV portion and not the ActHIB from the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ095AA Dtap IPV Lot UJ108AA, ActHIB: LOT: UJ095AAA (Expiry date 24-Jul-2020) via intramuscular route in the left thigh on 01-Aug-2019.  The patient's past vaccination(s) included Pentacel on 15-JUL-2016, Pentacel on 16-SEP-2016 and Pentacel on 16-NOV-2016.  Concomitant vaccination included Hep A and Prevnar.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to Inappropriate reconstitution technique.  At a time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation issue
Clinical narrative: liquid component of Pentacel was administered to patient without the powdered component/no AE; Initial information received on 15-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse with live follow-up on same date.  This case involves a patient of unknown demography who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that liquid component of Pentacel was administered to patient without the powdered component/no AE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate reconstitution technique.  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 the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: second dose of Daptacel administered after 2 days of first vaccination; small erythematous papules all over her body, but not on the injection it was itching.; small erythematous papules all over her body, but not on the injection which did not itch; Initial information received on 15-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 14 months old patient who experienced small erythematous papules all over her body, but not on the injection which did not itch, small erythematous papules all over her body, but not on the injection it was itching while received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  On 16-Apr-2019, the patient received a first dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5307AA via intramuscular route in unknown administration site and on 18-Apr-2019 also received a second dose of the same vaccine lot C5523AA.  On 16-Apr-2019, the patient developed a non-serious small erythematous papules all over her body, but not on the injection which did not itch (rash erythematous) six hours following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  18-Apr-2019, the patient developed a non-serious small erythematous papules all over her body, it was itching (rash pruritic) two days following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  It was also case of actual medication error due to inappropriate schedule of vaccine administered second dose of Daptacel administered after 2 days of first vaccination.  (Other relevant tests included no lab data.) Final diagnosis was Erythematous rash and Itchy rash.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  The patient outcome is reported as Unknown for erythematous rash and Itchy rash.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: a patient was administered Imovax Rabies vaccine on day 0 on 24-JUL-2019, Day 8 on 01-AUG-2019 and Day 15 on 15-AUG-2019; Initial information received on 15-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 75 years old male patient who was administered RABIES (HDC) VACCINE [IMOVAX RABIES] vaccine on day 0 on 24-Jul-2019, day 8 on 01-Aug-2019 and day 15 on 15-Aug-2019 lot number not reported via unknown route in unknown administration site.  The patient's past medical history included Animal bite on 24-Jul-2019. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate schedule of vaccine administered.  Adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.  List of documents held by sender: none.
Sex: F
Vaccine: HEP, MMR, MNQ
Symptoms: Fatigue, Paraesthesia, Pyrexia, Rash
Clinical narrative: extremely fatigued; experience nerve sensations that felt like electrical shocks all over her body, in her abdomen, calves, thighs, toes, back, hands, everywhere; fever 102 degrees F; slight rash on the arm that vaccine was given; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 14 years old female patient who experienced extremely fatigued, nerve sensations that felt like electrical shocks all over her body, in her abdomen, calves, thighs, toes, back, hands, everywhere, fever 102 degrees f and slight rash on the arm that vaccine was given, while she received vaccines MMR, HEPATITIS B VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past vaccination(s) included MMR. The patient's past medical history, medical treatment(s) and family history were not provided.   On 07-Aug-2019, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site.  On 07-Aug-2019, the patient received a dose of suspect HEPATITIS B VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  On 07-Aug-2019, the patient received a dose of suspect MMR not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  On 13-Aug-2019 around 6 pm or 7 pm, the patient developed a non-serious extremely fatigued (fatigue) 6 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, HEPATITIS B VACCINE and MMR.  On 13-Aug-2019 about 10 pm, 11 pm, or midnight, the patient developed a non-serious experience nerve sensations that felt like electrical shocks all over her body, in her abdomen, calves, thighs, toes, back, hands, everywhere (paraesthesia) and fever 102 degrees f (pyrexia) 6 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, HEPATITIS B VACCINE and MMR.  On 13-Aug-2019, the patient developed a non-serious slight rash on the arm that vaccine was given (vaccination site rash) 6 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, HEPATITIS B VACCINE and MMR.  (Other relevant tests included no lab data.)  Final diagnosis was slight rash on the arm that vaccine was given, fever 102 degrees f, experience nerve sensations that felt like electrical shocks all over her body, in her abdomen, calves, thighs, toes, back, hands, everywhere and extremely fatigued.   The patient was treated with two PARACETAMOL (TYLENOL [PARACETAMOL]).  The patient was Recovering from fever and fatigue and outcome of the other event was unknown.  Information on the batch number was requested.  Documents held by sender: none.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: the ActHIB portion mixed with normal saline of the Pentacel; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1 months and 27 days old male patient who was given ACT-HIB portion mixed with normal saline of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 16-Aug-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE via intramuscular route in the left thigh.  The reported batch numbers were for diluent lot: U6216AB expiration date: 10-Oct-2020, box lot: UJ014AAA expiration date: 10-Oct-2020 and powder lot: UJ014AA expiration date: 10-Oct-2020.  It was an actual medication error inappropriate reconstitution technique.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation issue
Clinical narrative: administered only the liquid portion of Pentacel to a patient and not the reconstitution portion, Symptoms: None reported; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a four months old female patient who received a second 0.5ml dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot C5426AA and Exp. Date 04-Oct-2019 via intramuscular route in the right thigh, on 09-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error case due to inappropriate reconstitution technique.  It was reported that one of her other medical assistants administered only the liquid portion of Pentacel to a patient and not the reconstitution portion.  None symptoms were 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: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: they gave the DTAP-IPV component to a child but forgot the ActHIB part; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 8 months old female patient who received only DTap/IPV part of the Pentacel DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE Pentacel- lot UJ015AAA, Dtap IPV Lot U6218AA, ActHIB- Lot UJ015AA (Expiry date 26-Oct-2020) on 15-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13).  It was a case of actual medication error due to inappropriate reconstitution technique. (It was reported that DTAP-IPV component to a child but forgot the ActHIB part). When she was asked to clarify for the ActHIB NDC number, she mentioned that there were two stickers on the vial with different NDC numbers.  It was unknown whether any adverse events occured.  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: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: patient was given the hib portion with saline and it was given solely as a hib vaccine, without the DTaP-IPV component,Hib component was mixed with a sterile diluent from Merck while administrating Pentacel/No AE; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a 15 months old male patient who was given the Hib portion with saline and it was given solely as a hib vaccine, without the dtap-ipv component, hib component was mixed with a sterile diluent from merck while administrating fourth dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot number not reported via intramuscular route in the left thigh dose four on 16-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  It was an actual medication error due to inappropriate reconstitution technique.  Symptoms: None 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.  List of documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Patient stated that she was "light headed" while she was seated for a few minutes after the immunization. I gave her some water to see if will help while remaining seated. At least 5 minutes has passed but the patient was not feeling any better. Patient also mention that she has not eaten anything yet for the day. A few minutes later she felt nauseated and asked for a garbage can to vomit, which she did. The pharmacy tech had called 911 and the ambulance came about 20 minutes to get her.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Insomnia, Mood altered, Pyrexia
Clinical narrative: Arrived home at 5pm and felt sluggish and wife commented that I didn't seem to be in a good mood. About 9:00 pm I got chilled and went to bed at 9:30, the chilling and headache continued and I got up about 3:00 am. I took 1000 mg of acetaminophen. I took my temp and it was 101 degrees. My chilling and fever gradually subsided until around 730 am. Not much sleep last night!
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Sluggishness
Clinical narrative: Arrived home at 5pm and felt sluggish and wife commented that I didn't seem to be in a good mood. About 9:00 pm I got chilled and went to bed at 9:30, the chilling and headache continued and I got up about 3:00 am. I took 1000 mg of acetaminophen. I took my temp and it was 101 degrees. My chilling and fever gradually subsided until around 730 am. Not much sleep last night!
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Impaired work ability, Influenza like illness, Insomnia, Myalgia
Clinical narrative: In the evening patient could not sleep and had terrible night sweats, shivering, muscle aches and felt like had fever; it  lasted the entire evening. Next day felt like had terrible flu-bug, felt incapacitated and could not go to work.   Vaccine site looked fine and did not see any redness. Symptoms improved by 8/14 but still did not feel good.  On evening of 8/15, red rash appeared at vaccination site, it was hot and painful to touch and as wide, as a hand.   Patient contacted doctor on 8/15 but went in to another facility on 8/16.  Doctor (Dr. at the Urgency Room) thought it looked like cellullitis and prescribed antibiotic, Keflex.  Patient still does not feel well probably at 75% recovery. Arm rash has improved with the antibiotic, he can still see red spot with heat/warm, extreme redness in area has improved; 70-75% recovered.   Patient has not received any other steroid shot since vaccine administered; shot administered at Pain Clinic.  After first vaccine dose, only experienced mild symptoms that were not significant; resolved within 2-3 days and did not require doctor visit.  Patient received the first dose on 5/15 at the same facility
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Night sweats, Pyrexia, Rash erythematous, Vaccination site cellulitis, Vaccination site pain
Clinical narrative: In the evening patient could not sleep and had terrible night sweats, shivering, muscle aches and felt like had fever; it  lasted the entire evening. Next day felt like had terrible flu-bug, felt incapacitated and could not go to work.   Vaccine site looked fine and did not see any redness. Symptoms improved by 8/14 but still did not feel good.  On evening of 8/15, red rash appeared at vaccination site, it was hot and painful to touch and as wide, as a hand.   Patient contacted doctor on 8/15 but went in to another facility on 8/16.  Doctor (Dr. at the Urgency Room) thought it looked like cellullitis and prescribed antibiotic, Keflex.  Patient still does not feel well probably at 75% recovery. Arm rash has improved with the antibiotic, he can still see red spot with heat/warm, extreme redness in area has improved; 70-75% recovered.   Patient has not received any other steroid shot since vaccine administered; shot administered at Pain Clinic.  After first vaccine dose, only experienced mild symptoms that were not significant; resolved within 2-3 days and did not require doctor visit.  Patient received the first dose on 5/15 at the same facility
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site reaction, Vaccination site warmth
Clinical narrative: In the evening patient could not sleep and had terrible night sweats, shivering, muscle aches and felt like had fever; it  lasted the entire evening. Next day felt like had terrible flu-bug, felt incapacitated and could not go to work.   Vaccine site looked fine and did not see any redness. Symptoms improved by 8/14 but still did not feel good.  On evening of 8/15, red rash appeared at vaccination site, it was hot and painful to touch and as wide, as a hand.   Patient contacted doctor on 8/15 but went in to another facility on 8/16.  Doctor (Dr. at the Urgency Room) thought it looked like cellullitis and prescribed antibiotic, Keflex.  Patient still does not feel well probably at 75% recovery. Arm rash has improved with the antibiotic, he can still see red spot with heat/warm, extreme redness in area has improved; 70-75% recovered.   Patient has not received any other steroid shot since vaccine administered; shot administered at Pain Clinic.  After first vaccine dose, only experienced mild symptoms that were not significant; resolved within 2-3 days and did not require doctor visit.  Patient received the first dose on 5/15 at the same facility
Age: 75.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Asthenia, Palpitations
Clinical narrative: racing heart, weakness
Age: 75.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Guillain-Barre syndrome
Clinical narrative: racing heart, weakness
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Peripheral swelling, Swelling face
Clinical narrative: Swelling in arm for day but then came the swelling on the left side of her face that diminished over 2 days but made her very uncomfortable due to her cheek being enlargened as well as the area around her temples of the opposite side of her injection arm. She wasn't necessarily complaining but wanted to make us aware, as well as the manufacturer
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Cold sweat, Dizziness, Feeling hot, Hyperhidrosis, Loss of consciousness
Clinical narrative: As soon as the needle was inserted into patient Left arm she "passed out" she has s/s of vasovagal response. She was unresponsive for about 20 seconds once conscious again she was hot, clammy, sweating, nauseous, and dizzy. Vitals taken low BP noted patient was given water at her request and a cool towel applied to the back of her neck.  Vitals taken at 5 minutes after episode BP noted to be WNL. Patient then reported that she had "passed out" before during vaccination.  after sitting and recovering for 20 minutes the patient left our facility in the care of a family member.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Presyncope, Unresponsive to stimuli
Clinical narrative: As soon as the needle was inserted into patient Left arm she "passed out" she has s/s of vasovagal response. She was unresponsive for about 20 seconds once conscious again she was hot, clammy, sweating, nauseous, and dizzy. Vitals taken low BP noted patient was given water at her request and a cool towel applied to the back of her neck.  Vitals taken at 5 minutes after episode BP noted to be WNL. Patient then reported that she had "passed out" before during vaccination.  after sitting and recovering for 20 minutes the patient left our facility in the care of a family member.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Rash
Clinical narrative: Painful shoulder felt like severe bruising.  ROM limited Rash on abdomen- occurring approximately 48 hours after vaccine.  Not sure if related.  Responded to topical Benadryl cream
Age: 17.0
Sex: F
Vaccine: IPV, TD
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, pain
Age: 0.25
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Parents reported fever x 24 hours
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Muscle contractions involuntary, Musculoskeletal stiffness, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: After administration of the vaccine, the patient had seizure like activity, arms clenched, body stiffened and unresponsive for several seconds.  After the incident the patient reported that this type of reaction had happened before in the past.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: low measles titer; This spontaneous report was received from a office manager regarding to a 20 year old female patient. The patient's medical history and concurrent condition were not reported. Concomitant medications included, during the time of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 3rd dose the patient was on birth control therapy (brand and manufacturer unknown) reported. On 06-FEB-1996, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) via subcutaneous, lot # 1181B has verified to be invalid and expiry date September 1997 (strength and dose were not reported) for prophylaxis and on 02-MAR-2000, the patient vaccinated 2nd dose (strength, dose, route, lot # and expiry date were not reported). The reporter stated that on 22-AUG-2015, the patient was performed a titer test that showed a low measles titer (viral titer decreased). Then the patient was vaccinated with third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # L007577 and expiry date 05-MAR-2017, (strength, dose, route were not reported) for prophylaxis. The outcome of viral titer decreased was unknown.
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abortion spontaneous, Human papilloma virus test positive, Maternal exposure before pregnancy, Papilloma viral infection
Clinical narrative: four miscarriage; acute HPV positive; "she can not have any children"; This spontaneous retrospective pregnancy report was received from a patient's mother and a 22-year-old female patient, referring herself. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. The patient's mother medical history included Human papilloma virus (HPV) and cervical cancer.  On an unknown dates (reported as around age 11 or 12 years or older when she first received the vaccine), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) 3 doses (lot#, expiration date, dose, frequency and route of administration not specified) for prophylaxis.  On an unknown date, the patient became pregnant. The Last Menstrual Period (LMP), due date and Estimated date of delivery (EDD) were not provided. The patient reported that she experienced four miscarriages on an unknown date and was acute HPV positive. The pregnancy outcome was spontaneous abortion. The patient was told by an unspecified individual that "she can not have any children". The outcome of the events was not provided. The reporter considered the events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). Legal issue was involved.  Upon internal review, the event miscarriages was determined to be medically significant.  This is one of four reports concerning the same patient (linked reports #: 1908USA008892, 1908USA008893, 1908USA008894).; Sender's Comments:  US-009507513-1908USA008893: US-009507513-1908USA008894: US-009507513-1908USA008892: