chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness below injection site; Warmth below injection site; Swollen area; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number L7SY9, expiry date 4th July 2021) for prophylaxis.   On 29th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 31st July 2019, 2 days after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix in left arm on Monday before reporting date. On Wednesday before reporting date, the patient noticed redness and warmth about 1.5 to 2 inches below the injection site. The reporter saw the area and noted that the area was also swollen. The reporter was unable to obtain additional information.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Immediate post-injection reaction, Presyncope
Clinical narrative: Immediately after injection, patient became lightheaded and experienced vasovagal  episode. Recovered quickly. no sequelae.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Abnormal faeces
Clinical narrative: LITTLE BLACK SPECKS IN STOOLS
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Muscle spasms, Pain of skin
Clinical narrative: Had "flu-like" symptoms with low grade fever, chills, and muscle spasms in her chest area last from 4 p.m. on 7/31/19 until 6 a.m. on 8/1/19.  Stated she "felt like she had a sunburn and that her skin hurt when she had goosebumps with the chills".   Took two tablets of Tylenol PM at bedtime and then again during the night.  Also, left deltoid hurt for several days post vaccination but no swelling or redness.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Had "flu-like" symptoms with low grade fever, chills, and muscle spasms in her chest area last from 4 p.m. on 7/31/19 until 6 a.m. on 8/1/19.  Stated she "felt like she had a sunburn and that her skin hurt when she had goosebumps with the chills".   Took two tablets of Tylenol PM at bedtime and then again during the night.  Also, left deltoid hurt for several days post vaccination but no swelling or redness.
Age: 30.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Malaise, Pain
Clinical narrative: Vaccine given 8/2/19, patient noted reaction the next day.  She has no insurance and no primary care provider so came back to the immunization clinic.  Stated her right arm was very swollen with a large bump near the injection site.  Her arm itched and she felt sick, achy with a slight fever.  On 8/5/19 arm is very red, swollen near the injection site and warm to the touch.  She has small bumps that appear to be hives, the bump is still there, but not as large as two days ago.  Patient reports redness and swelling have gone done with the use  of ice.  Patient also complained of pain with range of motion, but is able to raise arm.
Age: 30.0
Sex: F
Vaccine: MNQ
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Urticaria
Clinical narrative: Vaccine given 8/2/19, patient noted reaction the next day.  She has no insurance and no primary care provider so came back to the immunization clinic.  Stated her right arm was very swollen with a large bump near the injection site.  Her arm itched and she felt sick, achy with a slight fever.  On 8/5/19 arm is very red, swollen near the injection site and warm to the touch.  She has small bumps that appear to be hives, the bump is still there, but not as large as two days ago.  Patient reports redness and swelling have gone done with the use  of ice.  Patient also complained of pain with range of motion, but is able to raise arm.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Decreased appetite, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: First shot was administered at 5pm and woke up in a cold sweat, vomiting, body aches, no appetite and extremely tired for 3 days.  Also had 3 lesions that looked like a bug bite, never blistered and scabbed over within 48 hours.  After 3 days energy level returned and had a sharp headache lasting 2 weeks with prickling sensations off and on in hands for many months.  Nine months later, 2nd shot was administered and had some of the same symptoms lasting 24 hours with no lesions.  Headache lasted 3 days and prickling sensation would come and go for many months to follow.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Scab, Skin lesion, Vomiting
Clinical narrative: First shot was administered at 5pm and woke up in a cold sweat, vomiting, body aches, no appetite and extremely tired for 3 days.  Also had 3 lesions that looked like a bug bite, never blistered and scabbed over within 48 hours.  After 3 days energy level returned and had a sharp headache lasting 2 weeks with prickling sensations off and on in hands for many months.  Nine months later, 2nd shot was administered and had some of the same symptoms lasting 24 hours with no lesions.  Headache lasted 3 days and prickling sensation would come and go for many months to follow.
Age: 14.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: PATIENT  FAINTED AFTER RECEIVING  VACCINATIONS NOTED ABOVE.  PATIENT TURNED PALE.  ASSISTED TO FLOOR AND ELEVATED HIS LEGS ON A CHAIR.  BLOOD PRESSURE  60/44.  PATIENT'S COLOR RETURNED AFTER ABOUT 40 MINUTES.  LIPS PINK.  SPEAKING COHERENTLY.  ORIENTED. ATE A POPSICLE AND DRANK WATER.  BLOOD PRESSURE 102/58.  HR 70 REGULAR ON DISCHARGE FROM  HEALTH DEPARTMENT. LATER, FAMILY STATED THAT THE PATIENT HAD FAINTED WITH 5 Y/O VACCINES.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling,  erythema, and warmth surrounding the injection sight approximately 2 inches in diameter on patient's left deltoid. Redness warmth and swelling is localized to injection sight. Treatment will include over the counter Zyrtec, over the counter Motrin, and over the counter hydrocortisone cream twice daily. Advised to ice injection sight.  Will follow up 08/09/2019 for evaluation. No signs or symptoms of systemic allergic reaction.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Altered state of consciousness, Dizziness, Loss of consciousness
Clinical narrative: APPROIMATELY 3-5 MINUTES AFTER IM INJECTION OF HPV GARDASIL IN PATIENTS RIGHT ARM, PATIENT STATED THAT SHE FELT LIGHTHEADED. GAVE PATIENT A DRINK OF WATER, PATIENT PASSED OUT TO FLOOR. DOCTOR CAME INTO ASSESS, CLEARED PATIENT TO LEAVE. MOTHER CALLED TO REPORT THAT PATIENT ALMOST PASSED OUT AGAIN AT HOME AND THEN FELL ASLEEP ON COUCH. MD GAVE FOLLOW UP PHONE CALL TO MOTHER AND PATIENT.
Sex: M
Vaccine: HEPAB
Symptoms: Injection site vesicles
Clinical narrative: Blister below the injection site; This case was reported by a other health professional via call center representative and described the occurrence of blister in a male patient who received HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received Twinrix at an unknown dose. On an unknown date, less than a day after receiving Twinrix, the patient experienced blister. On an unknown date, the outcome of the blister was unknown.   It was unknown if the reporter considered the blister to be related to Twinrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the dose of Twinrix in an unknown arm and got a blister on the same arm a few inch below the injection site on the same day.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Feeling abnormal, Influenza
Clinical narrative: Flu; Felt bad/didn't feel good; Chills; This is a spontaneous case, initially received from other non-health professional (consumer) on 28-Nov-2018, concerning a 77-year-old, elderly female patient.  On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for an unknown indication.  On an unspecified date, within 24 hours after vaccination, the patient felt bad (did not feel good) for 1-2 days. In addition, the patient also experienced chills and got flu.  The outcome of the events was recovered within 1 to 2 days.  Follow up received from other non-health professional on 11-Dec-2018: The reporter stated that, she did not remember the name of flu vaccine. The patient experienced the events within 24 hrs after the vaccination and recovered from the events in 1 to 2 days. The as determined causality of the events, narrative and case comment were amended accordingly.; Reporter's Comments: A 77-year-old female patient experienced symptoms of felt bad, chills and reported to have got flu, within 24 hours after receipt of INN flu vaccine. Considering the fact that influenza vaccine needs minimum 2-3 weeks to provide immune protection against influenza infection, vaccination failure and causal role of suspect vaccine for the event flu can be ruled out. Hence, the company assessed the causality of event flu as not related to suspect vaccine. The company assessed the case as serious (medically significant).
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Blood urine present, Full blood count, Haematuria, Headache, Petechiae
Clinical narrative: Pt. presented to office with scattered petechia on proximal UE, proximal LE, diffusely on anterior and posterior trunk, very few on ankles and dorsal surface feet; peeling of skin on periphery of trunk 2 days after receiving vaccine. Rash was itchy. Pt. also with headache , but resolved by time of visit. Afebrile, no other s/s of illness, is well-appearing. 3 days after vaccine, rash was not progressing, but not resolving. No other new s/s.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Rash pruritic, Skin exfoliation, Streptococcus test negative
Clinical narrative: Pt. presented to office with scattered petechia on proximal UE, proximal LE, diffusely on anterior and posterior trunk, very few on ankles and dorsal surface feet; peeling of skin on periphery of trunk 2 days after receiving vaccine. Rash was itchy. Pt. also with headache , but resolved by time of visit. Afebrile, no other s/s of illness, is well-appearing. 3 days after vaccine, rash was not progressing, but not resolving. No other new s/s.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: scalp began itching and then hives appeared on torso and arms
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Headache, Pain
Clinical narrative: Patient experienced extreme headache, chills, and aches within 30 minutes of receiving vaccine.  Nurse advised her to take pain reliever and rest.  Patient reported feeling improved 20-30 minutes later.  Symptoms did not return as of 2 days later.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Blood test normal, Erythema, Induration, Injection site erythema, Injection site induration
Clinical narrative: Entire left arm became severely swollen, red, hard, warm to touch.  This gradually subsided over the course of the next 5 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Peripheral swelling, Skin warm
Clinical narrative: Entire left arm became severely swollen, red, hard, warm to touch.  This gradually subsided over the course of the next 5 days.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patients arm was severely swollen and red and was hot to touch.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness at the injection site; swelling at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 29th July 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovering/resolving.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional information received were as follows: The patient experienced  injection site erythema and injection site swelling. The redness was 1 to 1.5 inch round.
Sex: M
Vaccine: HPVX, MEN, MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: was supposed to get the 3rd dose of HPV and the MA grabbed the wrong one and gave him by mistake a meningitis vaccine; has gotten Menactra in the past on 2009 and then in June 2013, so it has been at least 6 yrs since his last dose; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 24 years old male patient who received meningitis vaccine instead of HPV VACCINE and reported that patient was supposed to get the 3rd dose of HPV and the MA grabbed the wrong one and gave him by mistake a meningitis vaccine and has gotten MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] in the past on 2009 and then in June 2013, so it has been at least 6 years since his last dose.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  In 2009, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site. In June 2013 he also received a dose of the same vaccine with an unknown batch number via unknown route in unknown administration site.  On an unknown date the patient received a dose of meningitis vaccine produced by unknown manufacturer instead of HPV vaccine (dosing details not reported, lot number not reported) via unknown route and site of administration.  It was a case of actual medication error due to wrong vaccine administered and extra dose administered.  It was unknown if 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.  There will be no information available on the batch number for this case.  List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Dizziness, Headache
Clinical narrative: dizziness; headache; Initial information received on 29-Jul-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11 years old patient (gender not reported) who experienced dizziness and headache, while he/she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6522AB, expiry date, dose, dose in series and site of administration were not reported) via unknown route.  On an unknown date, the patient developed a non-serious dizziness and headache following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  No Lab data was reported.  Final diagnosis was headache and dizziness.   It was not reported if the patient received a corrective treatment.  The outcome of the events were not reported.  Documents held by the sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: The DTap-IPV diluent portion of Pentacel was administered in the left thigh of a patient without being used to reconstitute the HIB portion; Initial information received on 30-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 29-Jul-2019, the patient received a fourth dose 0.5ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ122AAA, expiry date 29-Sep-2020 via intramuscular route in the left thigh.  It was an actual medication error due to inappropriate reconstitution technique.  It was reported that the DTap-IPV diluent portion of Pentacel was administered in the left thigh of a patient without being used to reconstitute the HIB portion.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4 month old patients had received a Quadracel/No adverse effects reported.; Initial information received on 30-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 months old female patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot C54978A, expiry date- 17-Jul-2020 via intramuscular route in the right thigh on 29-Jan-2019.  The patient's past vaccination(s) included DAPTACEL and IPV in NOV-2018. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation on 29-JAN-2019.  It was a case of actual medication error due to inappropriate age at vaccine administration.  No adverse effects reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Full blood count, Headache, Pyrexia, White blood cell count increased
Clinical narrative: a severe Headache with Fever; a severe Headache with Fever; Initial information received on 30-Jul-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2019SA209485.  This case involves an 11 years old male patient who experienced a severe headache with fever, while he received 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.  Concomitant medications included HPV VACCINE (HPV VACCINE); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP).  On 27-Jul-2019, the patient received a dose of suspect 0.5 ml MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6522AB and expiry date: 29-Jan-2021 via unknown route in the left deltoid.  On an unknown date, following the vaccination the patient experienced fever (pyrexia) and headache.  Relevant laboratory test results included: Full blood count - On an unknown date: [increase in WBC]  (Other relevant tests included no lab data.)  Final diagnosis was fever and severe headache.  The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]).  The outcome of the events was reported as unknown at the time of reporting.  List of documents held by sender: none.
Sex: F
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: expired dose of Ipol was inadvertently administered; Initial information received on 30-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an 11 years old female patient who inadvertently received an expired dose of vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Immunisation; and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  On 30-Jul-2019, the patient received a single 0.5 ml fourth dose of suspect IPV (VERO) lot N1G411M (expiry date: 28-Jul-2019) via intramuscular route in the right deltoid.  It was a case of actual medication error due to expired vaccine used.  It was not reported if any adverse event was experienced.  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: Product preparation issue
Clinical narrative: patient who received only partial of the Pentacel vaccine, just the Hib portion; 2 month old received vaccine in arm; Initial information received on 30-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old male patient who received first dose of 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ134AA, expiry date- 11-Oct-2020 via intramuscular route in upper lateral limb site on 29-Jul-2019. The patient only received HIB portion of the vaccine.  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) for Immunisation; and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) and  ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was a case of actual medication error due to inappropriate reconstitution technique and Vaccine administered at inappropriate site.  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 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.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: DTAP-IPV was administered to the patient, the powdered ActHIB was never mixed/ No AE; Initial information received on 30-Jul-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 months old male patient who was administered second 0.5 ml dose of DTAP-IPV from DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] the powdered ACT-HIB was never mixed lot UJ084AA via intramuscular route in the left thigh on 30-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVENAR) for Immunisation; ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation; and HIB VACCINE (HIB) for Immunisation.  It was a case of actual medication error due to inappropriate reconstitution technique.  No adverse event 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.
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Pain, Pyrexia
Clinical narrative: body aches; low grade fever; a 12 years old female was administered a dose of Menactra on 05-Jul-2018 and again on yesterday; Initial information received on 31-Jul-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a 12 years old female patient who experienced body aches and low grade fever, while she received 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.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP).  On 05-Jul-2018, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot M17054, expiration date : 31-MAR-2019 and another dose was administered on unknown dates for suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Expiry date and lot number of this dose not reported).  On an unknown date, the patient experienced a non-serious body aches (pain) and low grade fever (pyrexia) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was an actual medication error due to extra dose administered. A 12 years old female patient was administered a dose of Menactra on 05-Jul-2018 and again on yesterday   (Other relevant tests included no lab data.)  Final diagnosis was low grade fever and body aches.   It was not reported if the patient received a corrective treatment.  The patient was not recovered from low grade fever and body aches.  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 batch number of the last dose requested.  List of documents held by sender: none.
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: temperature excursion of opened IPOL that reached 56.3 degrees F for 1 hour and 30 minute which happened during inventory of products; Initial information received on 31-Jul-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a male patient.  This case involves a temperature excursion of opened IPV (VERO) [IPOL] that reached 56.3 degrees f for 1 hour and 30 minute which happened during inventory of products lot N1G511M and expiry date : 02-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a potential medication error due to incorrect product storage.  It was unknown whether the vaccine was administered or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: client received Tdap and MCV4 vaccines, which he had already received for his age
Age: 59.0
Sex: F
Vaccine: TYP
Symptoms: Blister, Blood culture, Culture, Diarrhoea, Pruritus
Clinical narrative: RASH, BLISTERS ITCHING AND DRAINING. RASH ON TORSO, BILATERAL ARMS AND HANDS, DIARRHEA
Age: 59.0
Sex: F
Vaccine: TYP
Symptoms: Rash, Secretion discharge, Skin culture
Clinical narrative: RASH, BLISTERS ITCHING AND DRAINING. RASH ON TORSO, BILATERAL ARMS AND HANDS, DIARRHEA
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Induration, Pain, Pruritus, Skin warm
Clinical narrative: the patient was well (including the day of the vaccine) until the day of this report / encounter.  parents noted that the left armthat had a red swelling, warmth, and itchiness reported by the patient.  The vaccine associated soreness had faded by this point.no cough, shortness of breath, wheezing, or fever reported .vital signs were within normal limits and the patient had an otherwise nonfocal exam.  The exam itself discloseda11 x 15 cm area of soft tissue induration and "faded" red hue, which was NONtender to touch.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Swelling
Clinical narrative: the patient was well (including the day of the vaccine) until the day of this report / encounter.  parents noted that the left armthat had a red swelling, warmth, and itchiness reported by the patient.  The vaccine associated soreness had faded by this point.no cough, shortness of breath, wheezing, or fever reported .vital signs were within normal limits and the patient had an otherwise nonfocal exam.  The exam itself discloseda11 x 15 cm area of soft tissue induration and "faded" red hue, which was NONtender to touch.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Joint pain, muscle pain, headache, fever and injection site swelling. Five days later, the injection site is red, swollen, itchy, sore and extends down my arm about 7 inches long by about 4 inches wide.  Every joint and muscle in agony for about 36 hrs.  Unable to function for 24 hrs. I have an extremely high pain tolerance and rarely have side effects with medication.  I took lots of ibuprofen for 24 hrs.  My dr. and pharmacist recommended I file this report.  I will not be getting dose 2 of this vaccine.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Loss of personal independence in daily activities, Myalgia, Pyrexia
Clinical narrative: Joint pain, muscle pain, headache, fever and injection site swelling. Five days later, the injection site is red, swollen, itchy, sore and extends down my arm about 7 inches long by about 4 inches wide.  Every joint and muscle in agony for about 36 hrs.  Unable to function for 24 hrs. I have an extremely high pain tolerance and rarely have side effects with medication.  I took lots of ibuprofen for 24 hrs.  My dr. and pharmacist recommended I file this report.  I will not be getting dose 2 of this vaccine.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: development of red, itching, swollen, painful area left posterior upper arm.  pt sought care ED & f/u office visit
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Injection site pain, Injection site reaction, Urticaria
Clinical narrative: Pt complains of flu like symptoms and "feeling awful" for 12 to 36 hours after receiving the shot. Also states she has a sore arm with a "welt" at the site of injection for 4 days after receiving injection.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Decreased eye contact, Hypopnoea, Mental status changes, Pallor, Unresponsive to stimuli
Clinical narrative: Mother reported that patient went to sit down in a chair in the waiting room.  Mother became concerned with patient was not responding to her voice and asked for assistance.  This RN noted that pt had a change in mental status and pale coloring.  Pt had her eyes open, but answering questions or making eye contact with this RN.  Pt was breathing shallow.  EMS notified.  Pt laid on the floor and airway protected with head tilt chin lift.  Pt remained breathing on her own.  Pt spontaneously made eye contact and began talking.  Pt brought to a sitting position, then to a standing position with assistance, and walked with assistance to the ambulance.  Report given to EMS responders.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure immeasurable, Electrocardiogram, Hypotension, Incoherent, Loss of consciousness
Clinical narrative: Visited adult foster care home to give immunization. Administered around 8 AM and had him sitting for 5 mins. After no reported issues he moved to living room and was standing with another resident. Around 8:40 AM the other resident reported that the patient was "passed out." Immediately 2 caregivers and myself checked on the patient. He was barely coherent, swallow breaths, and laying to his left. We used a blood pressure monitor to try to get his blood pressure and called 911. We couldn't get blood pressure so we moved him off the bench onto the floor. I took his blood pressure at 8:41 AM using a wrist monitor and it was 95/53 with 67 pulse. He vomited on himself and was incoherent at this point. He turned pale and was started to talk. 911 arrived and gave him IV fluids and checked his blood pressure and EKG. Still hypotensive they took him to the hospital.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pallor, Vomiting
Clinical narrative: Visited adult foster care home to give immunization. Administered around 8 AM and had him sitting for 5 mins. After no reported issues he moved to living room and was standing with another resident. Around 8:40 AM the other resident reported that the patient was "passed out." Immediately 2 caregivers and myself checked on the patient. He was barely coherent, swallow breaths, and laying to his left. We used a blood pressure monitor to try to get his blood pressure and called 911. We couldn't get blood pressure so we moved him off the bench onto the floor. I took his blood pressure at 8:41 AM using a wrist monitor and it was 95/53 with 67 pulse. He vomited on himself and was incoherent at this point. He turned pale and was started to talk. 911 arrived and gave him IV fluids and checked his blood pressure and EKG. Still hypotensive they took him to the hospital.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Injection site reaction, Pain in extremity
Clinical narrative: Day 1: sore arm; tired Day 2: lightheaded (nearly fainted)-next morning; fever, shivering; large itchy rash in injection site; tired Day 3: tired; large itchy rash Day 4: tired; large itchy rash
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: Day 1: sore arm; tired Day 2: lightheaded (nearly fainted)-next morning; fever, shivering; large itchy rash in injection site; tired Day 3: tired; large itchy rash Day 4: tired; large itchy rash
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Pain, Urinary retention
Clinical narrative: Patient says that he felt cold, shivering, whole body ached and could not urinate.  This started the evening after his vaccination and finally fell asleep about 1 am and slept till 10 am the next morning and felt somewhat better.  He is able to urinate as of 8/7/19 and he is going to follow up with his primary doctor.
Age: 56.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Gait inability, Mobility decreased, Nodule, Pain
Clinical narrative: pain, big knot on bicep, fever, redness, states could not get out of bed/walk the day after
Age: 56.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: pain, big knot on bicep, fever, redness, states could not get out of bed/walk the day after
Age: 1.0
Sex: F
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Client was given a dose of IPV when it was not indicated for client's age.  Client was up to date on IPV.   Client did not have a reaction to the vaccine.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Altered state of consciousness, Cold sweat, Hyperhidrosis
Clinical narrative: Leaving the exam room and entering the lobby patient stated he felt like he was going to pass out. He began to sweat and become clammy. MA's got ice packs to put on patients neck and gave him water to drink. Pt asked for wet paper towels to wipe his face off.  A Nurse Stat was called and they came and evaluated pt and checked his vitals before he was able to leave.
Age: 34.0
Sex: M
Vaccine: YF
Symptoms: Rash
Clinical narrative: circular skin rash to right tricep
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about on 23-OCT-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.    On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.    The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).    Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Drug eruption, Rash
Clinical narrative: rash/Drug Eruption; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, drug reaction, allergies or concomitant medications. On or around 25-MAR-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location not provided) for routine health maintenance and for prevention o shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX) the patient suffered rash/drug eruption which lasted several months following vaccination. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX), the patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of Zoster Vaccine Live (ZOSTAVAX). At the reporting time, the patient had not recovered from the event of rash/drug eruption. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   The reporter considered rash/drug eruption as a disabling event.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Anaphylactic shock, Lip swelling, Rash generalised, Swelling face, Urticaria
Clinical narrative: Anaphylactic shock; Hives; Rashes; Face and lip swollen; Face and lip swollen; This is a spontaneous report from contactable nurse via a Pfizer Sales Representative.  A 16-year-old female patient received the first dose of meningococcal group b rlp2086 (TRUMENBA) via an unspecified route of administration on 27Dec2018 at single dose for immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced anaphylactic shock, hives and rashes all over the body, face and lip swollen. Lip covered bottom half of mouth. The patient went to ER (hospitalization was also considered as seriousness criteria). The patient recovered from the events on an unspecified date. It took about a month for full recovery.  The information on the batch number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Loss of consciousness, Malaise
Clinical narrative: passed out; doesn't feel well; This is a spontaneous report from a contactable nurse via a Company representative.  A female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA) intramuscular on 26Jul2019 at single dose for meningitis b routine vaccination. Relevant medical history and concomitant medications were not reported. On 26Jul2019, the patient was asked to wait after she was administered meningococcal group b rlp2086, and the patient passed out while waiting and did not feel well. The outcome of the events was unknown.  The information on the batch number has been requested.; Sender's Comments: As syncope following the vaccination with TRUMENBA is the known adverse event profile of the suspected vaccine, the event passed out is considered related to TRUMENBA in light of the close time association.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Head injury, Myoclonus, Syncope
Clinical narrative: Syncope. Fell to ground and hit head. Had 2-3 myoclonic jerks. Awoke immediately thereafter and was alert and oriented.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Tenderness
Clinical narrative: Patient presented  8/3 in the afternoon with a complaint of soreness/tenderness near the injection site and redness several inches below the injection site.  Patient self treated soreness with OTC pain relievers. 8/4 patient state tenderness and redness improved and mostly resolved. Fully resolved by 8/6 per patient report.
Age: 56.0
Sex: M
Vaccine: HEP, VARZOS
Symptoms: Arthralgia, Fatigue, Musculoskeletal pain, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Note: I also had a Hepatitis B vaccine on the same day.   My shoulder and back felt stiff.   I also felt tired once or twice a day for about 2 weeks.  My right shoulder and shoulder blade still feels achey.  My bones in my fingers feel arthritic, and sometimes the bones in my toes.  I have not had arthritis before, so my adjective may not be accurate.   My finger bones feel fragile, and I need to clench my fists slowly because the metacarpus bones and proximal phalanges  feel swollen at the knuckles.  Not really a feeling of pain in my hands.  Skin around armpits and shoulder blades feel tight.
Age: 56.0
Sex: M
Vaccine: HEP, VARZOS
Symptoms: Skin tightness
Clinical narrative: Note: I also had a Hepatitis B vaccine on the same day.   My shoulder and back felt stiff.   I also felt tired once or twice a day for about 2 weeks.  My right shoulder and shoulder blade still feels achey.  My bones in my fingers feel arthritic, and sometimes the bones in my toes.  I have not had arthritis before, so my adjective may not be accurate.   My finger bones feel fragile, and I need to clench my fists slowly because the metacarpus bones and proximal phalanges  feel swollen at the knuckles.  Not really a feeling of pain in my hands.  Skin around armpits and shoulder blades feel tight.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt received the flu vaccine the day prior to reporting to the ER.  Pt's caregiver c/o redness, swelling and pain to LUE at the site of injection
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: localized erythema at injection site, without pain, pruritus, desquamation, or any signs of infection
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: With fever and chills for 2 days as well as fatigue for several days after. Pt specifically requests we report this reaction.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: no pain upon injection.  next day no symptoms. 2nd day swelling of upper left arm. 3rd day area red, wam and swollen.  size 8 inches high and 4 inches wide with medial and posterior progression from injection site.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: On July 30, 2019, patient was seen at Pediatrics for the first dose of three HPV.  On July 31, 2019, we noticed a raised, red, slightly itchy rash (hives)  in patient's armpits and around his neck.  We took photographs.  The next morning August 1,  the rash had spread to his front and side torso, and on both of his legs.  We quickly scheduled a same-day appointment with Dr. for the late afternoon.  By the time of the appointment with Dr., however, the rash had almost completely disappeared.  My husband, who brought patient to the appointment, showed our photographs to Dr., who advised that patient not continue with the HPV vaccine series.  Patient stated that he was not in any distress during the course of the rash, only slight itching.  After August 1, the rash did not recur.