chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Skin laceration, Syringe issue
Clinical narrative: the syringe broke and cut her; the syringe broke and cut her; This spontaneous report was received from a patient (nurse) via human resource registered nurse (Rn) regarding a 44-year-old female patient. The patient's medical history, concurrent conditions, concomitant medications and drug allergies/reactions were not provided. On 05-SEP-2019, while the patient was receiving vaccination of pneumococcal vaccine, polyvalent (23 valent) (PNEUMOVAX23) a dose (1 dosage form) (lot# R033080, expiry date: 06-JUN-2020) (strength, dose number anatomical location and route of administration were not provided) for prophylaxis, "the syringe broke and cut her (injury, syringe issue)". The syringe broken into two pieces and the location was on finger flange of the syringe. The patient sought medical attention and washed her hand and placed a band-aid. The syringe tip cap was attached properly prior to use and the syringe tray was intact and undamaged on receipt. The cellophane cover of the syringe tray was intact and completely sealed. The syringe carton was not damaged prior to use. The outcome of the events was unknown. The reporter's causality assessment was not reported.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: PREGNANCY; A nurse prospectively reported that a 16-year-old female subject was inadvertently vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) during the first trimester of pregnancy.  On 21 October 2005 the subject received a dose of Boostrix (lot AC52B001AB) during the 1st trimester of pregnancy.  The date of the last menstrual cycle was not reported.  The estimated due date is June 2006. Follow-up will not be available.  Upon internal review done on 13 Sep 2019, the pregnancy outcome was updated to lost to follow-up.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: PREGNANCY; This case was reported by a healthcare professional and described the occurrence of drug exposure during pregnancy in a 18-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis.   On 30 May 2007 at 10:00 the subject received 1st dose of Boostrix at 0.5 ml in the left arm. The subject was 21 weeks pregnant at the time of vaccination.  No adverse events were reported.  At the time of reporting the outcome of the event was was unspecified.  Upon internal review done on 13th September 2019, the pregnancy outcome was updated to lost to follow-up.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: PREGNANCY; This case was reported by a consumer and described the occurrence of pregnancy in a 17-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report.  The subject's medical history, concurrent conditions, and concurrent medications were not provided.  In April 2007 the subject received an unspecified dose of Boostrix (unknown).   On an unspecified date, the subject, who was immunized two months earlier, told the reporter that she was pregnant.   The reporter, who works with providing immunizations to a school district, refused to provide any further details.  Upon internal review done on 13th September 2019, the pregnancy outcome was updated to lost to follow-up.
Sex: F
Vaccine: TDAP
Symptoms: Extensive swelling of vaccinated limb, Injection site swelling
Clinical narrative: Swelling; This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 10-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43E4T, expiry date 1st October 2021) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, less than 6 months after receiving Boostrix, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the outcome of the extensive swelling of vaccinated limb was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb to be related to Boostrix.  Additional information received were as follows: The age at vaccination was not reported. The reported batch number 43E47 was updated to 43E4T as per sales data sheet. The healthcare professional reported that the patient had swelling the size of a goose egg at the site of Injection with Boostrix, which led to extensive swelling of vaccinated limb. The reporter consented to follow up. This case is 1 of the 4 linked cases, reported by the same reporter.
Sex: U
Vaccine: TDAP
Symptoms: Injection site reaction
Clinical narrative: Reactions at the site of Injection; This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43E4T, expiry date 1st September 2021) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, less than 6 months after receiving Boostrix, 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 Boostrix.  Additional details were provided as follows: Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient had reactions at the site of injection with Boostrix. The batch number reported for Boostrix(43E47) did not exist and was updated to 43E4T, as per sales database. The reporter consented to follow up. This was one of the 6 cases, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Burning mouth syndrome
Clinical narrative: Burning Mouth Syndrome; This case was reported by a consumer via call center representative and described the occurrence of burning mouth syndrome in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced burning mouth syndrome. The patient was treated with nortriptyline. On an unknown date, the outcome of the burning mouth syndrome was unknown.   It was unknown if the reporter considered the burning mouth syndrome to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced burning mouth syndrome after receiving Shingrix. The patient went to dentist and primary care doctor and they said that they fell it also could be the vaccination. The patient took Nortiptyline from primary care.
Sex: U
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Fever of 103; This case was reported by a other health professional via other manufacturer and described the occurrence of fever in a adult patient who received Hepatitis B vaccine for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included tofacitinib citrate (Xeljanz).   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, less than 9 months after receiving Hepatitis B vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. In 2019, the patient experienced fever. The patient after receiving the last injection in February 2019 experienced fever of 103. The reporter stated that the patient was missing 2 months due to insurance mishap and another 1 month down the line due to switching pharmacies and noticing that he needed xeljanz again. The patient reported that xeljanz was working very well.      Lab Comments: On an unknown date body temperature was recorded
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site red; Injection site swollen; Injection site painful; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  On 5th September 2019, at 13:37 hrs. the injection site was still red, swollen and painful. The patient enquired should I be concerned. The follow up was not required. The clarification has been requested for the onset date of event.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Large patch of redness on her left arm; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, 1 day after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was recovered/resolved.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient received Shingrix on left arm. The day after vaccination, the patient noticed a large patch of redness on her left arm that went up and down her arm. The red area was approximately 6 inches long. The reporter consented to follow up. The caller did not provide any additional details.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Pain at injection site; Inadvertantly administered into bursae; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number K9M5N, expiry date 7th November 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The pharmacist called to report that the patient inadvertantly received Shingrix into bursae, which led to vaccine administered at inappropriate site. The patient had ongoing pain at injection site. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injeciton site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a 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, less than 2 years after receiving Shingrix, the patient experienced injection site cellulitis. The patient was treated with sulfamethoxazole (Bactrium (Sulfamethoxazole)). On an unknown date, the outcome of the injection site cellulitis was unknown.   It was unknown if the reporter considered the injection site cellulitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient developed cellulitis at injection site after receiving vaccine. The reporter consented to follow up. The reporter did not have lot or expiration date, as the vaccine was given somewhere else. The reporter did not provide vaccination facility information. This case has been linked with case US2019160454, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site urticaria
Clinical narrative: hives on left arm at injection site; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 28th June 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On 5th July 2019, the patient experienced injection site hives. On 30th June 2019, the outcome of the injection site pain was recovered/resolved. On 8th July 2019, the outcome of the injection site hives was recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient after receiving vaccine had immediate injection site pain that lasted for 1 to 2 days. The patient one week after receiving vaccine noticed hives on her left arm at the injection site that lasted for 2 to 3 days. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months 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 provided as follows: The age at vaccination was not reported. The patient had a history of previous episodes of shingles before receiving Shingrix. The patient had multiple episodes of shingles after the first dose of shingles. The patient would like to remain anonymous. The patient did not consent to follow up.
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Nausea, Retching, Vomiting
Clinical narrative: diarrhea; dry heaving; nausea; vomiting; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 30-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   In August 2019, the patient received Flu vaccine. On an unknown date, less than a week after receiving Flu vaccine, the patient experienced diarrhea, dry heaves, nausea and vomiting. On an unknown date, the outcome of the diarrhea, dry heaves, nausea and vomiting were recovering/resolving.   It was unknown if the reporter considered the diarrhea, dry heaves, nausea and vomiting to be related to Flu vaccine.  Additional details were provided as follows: The patient experienced frequent diarrhea, dry heaving, nausea, and vomiting. The patient consented to follow up. Emergency room visit was required. The patient did not provide any additional information. The patient did not have healthcare professional contact information at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Oral herpes
Clinical narrative: cold sore; This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a male patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient developed a cold sore immediately after getting first Shingrix vaccine. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: barely move her arm; generalized arm pain at the injection site; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2019, the patient received Shingrix. On 28th August 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injected limb mobility decreased was unknown.   It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient had generalized arm pain at the injection site starting at the time of vaccination. The patient stated that she can barely move her arm. The patient is also a former practice manager who is acquainted with the field representative. The field representative did not have any additional contact information other than the patient's phone number to follow up with her.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on abdomen and a little onto back; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The caller reported that 3 days after getting Shingrix, she developed a rash on her abdomen and a little onto her back.  The rash was not itchy or raised.  The event resolved in about 2 to 3 days.  The caller would provide only her initials.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 2G2T7, expiry date unknown) for prophylaxis.   On 3rd September 2019, the patient received Shingrix (intramuscular). In September 2019, less than a week 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 information received were as follows: The nurse reported that the patient received Shingrix on left deltoid and experienced shingles. The healthcare professional did not had the expiry date.
Sex: M
Vaccine: MNQ, UNK
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient was administered an extra dose of Menactra instead of the Meningococcal B; Patient was administered an extra dose of Menactra instead of the Meningococcal B; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 18 years old male patient who experienced patient was administered an extra dose of menactra instead of the meningococcal b while he received vaccines MENINGOCOCCAL VACCINE B and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Aug-2019, the patient received a 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6220AA via intramuscular route instead of MENINGOCOCCAL VACCINE B not produced by Sanofi Pasteur.  It was a case of actual medication error due to extra dose administered and wrong vaccine administered.  It was unknown if any adverse event 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.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: gave an expired dose of Menactra/no AE; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an 18 years old male patient who received an expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient received VARICELLA ZOSTER VACCINE (VARICELLA VACCINE as concomitant therapy.   On 26-Aug-2019, the patient received a 0.5 ml single dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5986AA via intramuscular route in the right deltoid.  It was a case of actual medication error due to expired vaccine used.  It was unknown whether adverse event was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: patient was given Menactra today that had an expiration date of 8/14/19/no AE; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown demographics who received an expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  It was unknown whether adverse event was observed or not.  Information on the batch number was requested.  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.
Age: 4.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 4 year old patient was accidentally given the Adacel vaccination instead of Daptacel/no AE; a 4 year old patient was accidentally given the Adacel vaccination instead of Daptacel/no AE; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 4 years old male patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Prefilled Syringe) instead of 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 MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  On 20-Aug-2019, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number U5748AA via intramuscular route in the left thigh.  It was of actual medication error due to Product administered to patient of inappropriate age and wrong product administered..  It was reported that no adverse event was observed.  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.
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: allergies with Tetanus; Initial information received on 05-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves unknown demographic patient who experienced allergies with tetanus, while 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 and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious allergies with tetanus (allergy to vaccine) (Unknown latency) following the administration of TETANUS TOXOID.  (Other relevant tests included no lab data.) Final diagnosis was allergies with tetanus.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for allergies with tetanus.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: accidentally gave Fluzone High Dose to a 19 year old female patient/ no AE; accidentally gave Fluzone High Dose to a 19 year old female patient/ no AE; Initial information received on 05-Sep-2019 regarding an unsolicited valid non-serious case received from Non-HCP (Office Staff).  This case involves a 19 years old female patient who received 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ221AA (Expiry date 01-Apr-2020) via unknown route in the left arm, on 04-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration and overdose.  It was reported that accidentally gave Fluzone High Dose to a 19 year old female patient.  At the time of reporting no adverse reaction 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.
Age: 63.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pentacel administered to a 63 year old stem transplant patient, no AE; Initial information received on 05-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 63 years old male patient received 0.5 ml  first dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ067AAA, Exp. Date 13-Jun-2020) via intramuscular route in the left deltoid on 11-Jul-2019.  The patient's past medical history included Stem cell transplant. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of reporting no adverse reactions 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.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site mass, Injection site nodule, Injection site pain, Injection site reaction
Clinical narrative: Patient scheduled an appointment on 09/12/2019 to report " a knot in his muscle". His mother states it formed shortly after receiving the HPV vaccine the previous month during his annual physical exam. Patient developed a 1.5in x1.5 in mass centrally located in his right deltoid. When pressed it causes him pain.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Headache, Hypophagia, Injection site erythema
Clinical narrative: Injection site swollen, red and itchy; area about 2" diameter; treated with ice packs and dermal antihistamine cream. By 11 PM day of injection, joints in extremities achy. During night, experienced fever, chills, shakes, shivers and aching muscles. Treated with Tylenol. Next day awoke with severe headache and nausea. Didn't eat much due to nausea but did not vomit. Treated headache with Fioricet which I have for PRN use with migraines. It didn't help. Slept during afternoon but not as tired as from first dose of Shingrix. Headache gone after about 36 hours. Site reaction resolved by Thursday, August 8, 2019.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pruritus, Injection site swelling, Myalgia, Nausea, Pyrexia
Clinical narrative: Injection site swollen, red and itchy; area about 2" diameter; treated with ice packs and dermal antihistamine cream. By 11 PM day of injection, joints in extremities achy. During night, experienced fever, chills, shakes, shivers and aching muscles. Treated with Tylenol. Next day awoke with severe headache and nausea. Didn't eat much due to nausea but did not vomit. Treated headache with Fioricet which I have for PRN use with migraines. It didn't help. Slept during afternoon but not as tired as from first dose of Shingrix. Headache gone after about 36 hours. Site reaction resolved by Thursday, August 8, 2019.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Tremor
Clinical narrative: Injection site swollen, red and itchy; area about 2" diameter; treated with ice packs and dermal antihistamine cream. By 11 PM day of injection, joints in extremities achy. During night, experienced fever, chills, shakes, shivers and aching muscles. Treated with Tylenol. Next day awoke with severe headache and nausea. Didn't eat much due to nausea but did not vomit. Treated headache with Fioricet which I have for PRN use with migraines. It didn't help. Slept during afternoon but not as tired as from first dose of Shingrix. Headache gone after about 36 hours. Site reaction resolved by Thursday, August 8, 2019.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Extreme weakness and very tired, pain at injection site.  Felt like I got hit by a truck.  Today is 3rd day after injection and symptoms have lessened, but still sluggish.  Right elbow below injection site warm to touch with slight swelling today.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Sluggishness
Clinical narrative: Extreme weakness and very tired, pain at injection site.  Felt like I got hit by a truck.  Today is 3rd day after injection and symptoms have lessened, but still sluggish.  Right elbow below injection site warm to touch with slight swelling today.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Limb mass, Pain, Skin warm
Clinical narrative: BASEBALL SIZED LUMP ON ARM, VERY WARM TO TOUCH, VERY SORE. OVERALL ACHY FEELING FOR DAYS
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Patient had headache starting the day after the vaccine and it lasted for about 5 days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Body temperature increased, Chest pain, Chills, Headache
Clinical narrative: 1. Very sore arm began about 9pm on day of immunization, radiating to the shoulder, mid-back and sternum. I do not notice any swelling or redness to the site.  2. 3am day after immunization- woke with chills, shakes, body aches, nausea and headache. Temp. was 99.8. I'm taking ibuprofen.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Nausea, Pain, Pain in extremity, Tremor
Clinical narrative: 1. Very sore arm began about 9pm on day of immunization, radiating to the shoulder, mid-back and sternum. I do not notice any swelling or redness to the site.  2. 3am day after immunization- woke with chills, shakes, body aches, nausea and headache. Temp. was 99.8. I'm taking ibuprofen.
Age: 29.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Dizziness, Fatigue, Feeling abnormal, Magnetic resonance imaging abnormal, Malaise
Clinical narrative: Called medical center 9/5/19 to report "since receiving Tdap vaccine  on 4/419 Has not been feeling well" Reports  "Fatigue, Brain Fog, Nausea & dizzyness" Reports under care of private HD who suggested he  "report Tdap possible reaction".
Age: 29.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Nausea, Viral test negative
Clinical narrative: Called medical center 9/5/19 to report "since receiving Tdap vaccine  on 4/419 Has not been feeling well" Reports  "Fatigue, Brain Fog, Nausea & dizzyness" Reports under care of private HD who suggested he  "report Tdap possible reaction".
Age: 29.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Dizziness, Fatigue, Feeling abnormal, Magnetic resonance imaging normal, Malaise
Clinical narrative: Called medical center 9/5/19 to report "since receiving Tdap vaccine  on 4/419 Has not been feeling well" Reports  "Fatigue, Brain Fog, Nausea & dizzyness" Reports under care of private HD who suggested he  "report Tdap possible reaction".
Age: 29.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Nausea, Vestibular disorder, Viral test negative
Clinical narrative: Called medical center 9/5/19 to report "since receiving Tdap vaccine  on 4/419 Has not been feeling well" Reports  "Fatigue, Brain Fog, Nausea & dizzyness" Reports under care of private HD who suggested he  "report Tdap possible reaction".
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Gastrointestinal disorder, Injection site erythema, Injection site pain, Nausea, Vomiting
Clinical narrative: Nausea within two hours of injection, Soreness  at injection site within two hours, Enlarged redness around injection site within 24 hrs.- 48 hrs, Vomiting within 48 hrs and continued gastro intestinal  disturbance at 72 hrs.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site vesicles
Clinical narrative: Pt has redness, swelling, and several pimple size fluid blisters on the left deltoid.  The skin is tight along the entire left upper arm.  The redness and swelling when measured is 16cm x 14cm.  Mom states the child complained about it hurting.  Child has no fever.   Cold compresses have been applied for 20 minutes at a time as tolerated.  Tylenol and Motrin have been alternated for pain.  Child is moving arm around with no issues and does not display pain at the time of observation.   Area was marked and instructed mom to watch area and to let us know if the redness extends beyond the markings.  Instructed to continue the compresses.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Skin tightness
Clinical narrative: Pt has redness, swelling, and several pimple size fluid blisters on the left deltoid.  The skin is tight along the entire left upper arm.  The redness and swelling when measured is 16cm x 14cm.  Mom states the child complained about it hurting.  Child has no fever.   Cold compresses have been applied for 20 minutes at a time as tolerated.  Tylenol and Motrin have been alternated for pain.  Child is moving arm around with no issues and does not display pain at the time of observation.   Area was marked and instructed mom to watch area and to let us know if the redness extends beyond the markings.  Instructed to continue the compresses.
Age: 23.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Abdominal pain upper, Flatulence, Influenza like illness, Nausea
Clinical narrative: Took vaccine 6:30am; around 11:00 am: Flu-like/fever symptoms, abdominal pain that came and went in waves, nausea. Over the counter medications (tums and pepto bismol) did nothing for the side effects. Received ondansetron from doctors office after same symptoms occurred on dose #2 and premedicated with that and ibuprofen for dose #3 which lessened all side effects to be manageable with mild stomach ache and gassiness. The 4th capsule/dose had a broken capsule that was leaking powder out of the capsule in the packaging.
Age: 23.0
Sex: F
Vaccine: TYP
Symptoms: Pyrexia
Clinical narrative: Took vaccine 6:30am; around 11:00 am: Flu-like/fever symptoms, abdominal pain that came and went in waves, nausea. Over the counter medications (tums and pepto bismol) did nothing for the side effects. Received ondansetron from doctors office after same symptoms occurred on dose #2 and premedicated with that and ibuprofen for dose #3 which lessened all side effects to be manageable with mild stomach ache and gassiness. The 4th capsule/dose had a broken capsule that was leaking powder out of the capsule in the packaging.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Headache, Heart rate increased, Pain
Clinical narrative: Chills ,,,,, Aches and pain ?. Headache     Rapid Heart Beat Dizziness'
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Diarrhoea, Pain in jaw
Clinical narrative: On 9/11/2019 patient reported to mother that since the day after vaccination she has had mild diarrhea and jaw pain.
Age: 74.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: STABBING PAIN SO BAD PATIENT COULD NOT STAND THE PAIN-LITTLE SWOLLEN AREA WENT TO WALKIN CLINIC AND THEY DID NOT KNOW WHAT TO DO SO SENT HIM TO ER AND THEY DID NOT KNOW WHAT TO DO EITHER. HOT PACKS WERE BETTER THAN COLD PACKS, GAVE HIM 3 MOTRIN AND 2 TYLENOL AND SENT HIM HOME IN ASCURSIATING PAIN  AND TOLD HIM TO REPEAT EVERY 6 HOURS-PAIN SUBSIDED ABOUT 2 AM BUT IS EXTREMELY SORE AND HURTS  STILL AND CANNOT MOVE THE ARM UP OR OUT.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Lethargy
Clinical narrative: was very lethargic for about a year; This spontaneous report as received from a receptionist at a provider's office via a company representative refers to an adolescent female patient of unknown age (reported as 13 or 14-year-old). No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, lot # and expiration date were not reported) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis (the company representative was unable to determine which one it was).    On an unknown date, the patient was very lethargic for about a year.  The outcome of the event was unknown.  The relatedness between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Back pain, Headache, Myalgia, Pyrexia
Clinical narrative: Muscle pain in back; Muscle pain in neck / arms; Dull headache; Intestinal upset; Low grade fever; This case was reported by a consumer and described the occurrence of muscular back pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2019 16:00, the patient received the 1st dose of Shingrix. In September 2019, less than a day after receiving Shingrix, the patient experienced muscular back pain, muscle pain, headache dull, gastrointestinal upset and low grade fever. On an unknown date, the outcome of the muscular back pain, muscle pain, headache dull, gastrointestinal upset and low grade fever were not recovered/not resolved.   It was unknown if the reporter considered the muscular back pain, muscle pain, headache dull, gastrointestinal upset and low grade fever to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix and experienced muscle pain in back, neck, arms, dull headache and some intestinal upset. The patient had a low grade fever.  The patient asked if she could take Tylenol or something else to relieve the symptoms.
Sex: F
Vaccine: MENB
Symptoms: Chest pain, Chills, Dyspnoea, Pain, Pyrexia
Clinical narrative: Chills; Soreness; Chest Pain; Difficulty breathing; Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced fever, chills, pain, chest pain and difficulty breathing. On an unknown date, the outcome of the fever, chills, pain, chest pain and difficulty breathing were recovered/resolved.   It was unknown if the reporter considered the fever, chills, pain, chest pain and difficulty breathing to be related to Bexsero.  Additional details were provided as follows: This case was reported by patient's mother. The age at vaccination was not provided. The reporter stated that, after vaccination, the patient experienced fever of 103.4 degree C, which lasted for 5 days. The patient's physician recommended for emergency room visit. No further details were provided. The reporter did not want to provide any demographic or address information. For tolerance to the 2nd dose, refer case US2019AMR161774      Lab Comments: On an unknown date, lab test performed.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Extensive swelling of vaccinated limb, Injection site swelling, Peripheral swelling
Clinical narrative: arm swelling down the arm almost reaching the tip of the finger / arm swelling spread across arm /injection site swelling; bruised arm; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 64-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 7AR35, expiry date 30th June 2020) for prophylaxis.   On 29th August 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). On 31st August 2019, 2 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced extensive swelling of vaccinated limb and bruising of arm. On an unknown date, the outcome of the extensive swelling of vaccinated limb and bruising of arm were recovering/resolving.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and bruising of arm to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. Approximately two days later, the patient experienced extensive swelling of vaccinated limb, injection site swelling, swelling arm and bruising of arm. The reporter reported that, the swelling spread across the arm horizontally, then proceeded downward on the arm, almost reaching the tip of the finger. The swelling did also appear bruised. At the time of reporting, the symptom's were improving. The reporter consented to follow up.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Muscle spasms
Clinical narrative: Sporadic Muscle Spasms; This case was reported by a nurse via call center representative and described the occurrence of muscle spasm in a 24-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number MF9EA, expiry date 1st June 2021) for prophylaxis.   Concurrent medical conditions included muscular dystrophy.   On 14th August 2019, the patient received Boostrix. On an unknown date, less than a month after receiving Boostrix, the patient experienced muscle spasm. On an unknown date, the outcome of the muscle spasm was unknown.   It was unknown if the reporter considered the muscle spasm to be related to Boostrix.  Additional details were provided as follows: The patient received dose of Boostrix in the right deltoid. The healthe care professional stated that, the patient had muscular dystrophy, then received boostrix vaccine and experinced muscle spasms. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Breast cancer female
Clinical narrative: breast cancer; This case was reported by a pharmacist via call center representative and described the occurrence of breast cancer in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th June 2019, the patient received the 1st dose of Shingrix. In September 2019, less than 3 months after receiving Shingrix, the patient experienced breast cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the breast cancer was unknown.   It was unknown if the reporter considered the breast cancer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In the week of date of reporting, the patient was diagnosed with breast cancer. The reporter consented to follow up.