chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR, UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effect reported; the patient was administered MMRII via the intramuscular route; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies.     On 26-JUL-2019, the patient was administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R028523 and expiration date on 04-OCT-2020, for prophylaxis (dose, dose number and anatomical injection were not reported), via intramuscular route (incorrect route of product administration). Besides, the sterile diluent with lot number R032161 and expiration date 18-JUL-2021 (dose, dose number, anatomical injection site were not reported) was used for reconstitution of the vaccine. No adverse effects reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported; A patient was inadvertently administered a expired dose of VAQTA; This spontaneous report was received from a medical assistant, concerning a18 year old patient. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 25-JUL-2019, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis, lot #R013858 and expiration date 12-JUN-2019 (strength, dose, frequency and route of administration were not reported). No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; patient received one dose of improperly stored MMR II; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported.     On 26-JUL-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) albumin status rHA, one dose, lot # R028526, expiry date 04-OCT-2020 via unspecified route. The vaccine was diluted in sterile diluent. Temperature excursion lasted 30 minutes, reached 47 Fahrenheit degrees and was recorded by digital data logger. No previous temperature excursions have occurred. No adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; The vaccine was inappropriately stored at 25 degrees Fahrenheit for 3 hours and 49 minutes; This spontaneous report was received from a receptionist referring to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant medications were no reported.  On 25-JUL-2019, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (lot# R021370 and expiration date 07-NOV-2020) (dose, frequency and route not reported) for prophylaxis. The vaccine was inappropriately stored at 25 degrees Fahrenheit for 3 hours and 49 minutes (product storage error). It was reported that a digital data logger was involved, but no previous temperature excursion information was provided. No adverse effects were reported.  This is one of two cases received by the same reporter.; Sender's Comments:  US-009507513-1907USA016750: US-009507513-1907USA016750:
Sex: M
Vaccine: PPV
Symptoms: Erythema, Fluid retention, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: L arm swelling and pain; L arm swelling and pain; Fluid retention; Erythema; Warmth to touch; This spontaneous report was received from a primary care provided office, concerning to a 66 year old male patient. The patient's concurrent conditions included benign prostatic hyperplasia (BPH), hyperlipidaemia and gout. The patient's allergies was reported as no known allergies. Information regarding the patient's medical history was no reported.   On 06-MAY-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported).         On 06-JUN-2019, the patient experienced L arm swelling and pain (peripheral swelling and pain in extremity), fluid retention, erythema and warmth to touch (skin warm); the patient visited emergency room on the same date, it was unknown if the patient received treatment for the events.     The outcome of the events was recovered and the causality between pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the events was not reported.   This is one of two reports received from the same reporter; Sender's Comments:  US-009507513-1907USA000663:
Age: 13.0
Sex: M
Vaccine: DTAPIPV, HPV9, MEN
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: The patient experienced redness and warmth at injection site; The patient experienced redness and warmth at injection site; This spontaneous report has been received from a pharmacist via a company representative, concerning a 13 year old male patient.      The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 26-JUL-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, anatomical location lot number and expiration date were not reported) for prophylaxis.  On that same day, he was also vaccinated with other suspect therapies included meningococcal vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular 1-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid(DTAP-IPV) (dose, frequency, anatomical location lot number, indication and expiration date were not reported)  Later on 28-JUL-2019,  the patient experienced "redness and warmth" at injection site (injection site erythema and injection site warmth). Therefore, as treatment , he received ibuprofen and fexofenadine hydrochloride (ALLEGRA). In addition, he did not seek for medical attention. At the reporting time, the outcome for both events was unknown.    The causal relationship between injection site erythema, injection site warmth, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and other suspect therapies included meningococcal vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular 1-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid(DTAP-IPV) was not reported.
Age: 0.92
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: patient was administered a dose of improperly stored VARIVAX on 07/09/2019; No adverse effects were reported; 4th dose of VARIVAX; administered a booster dose of VARIVAX (3rd dose); First dose of VARIVAX administered on 14-JUN-2008 and 2nd dose on 30-JUN-2008; Was administered a dose of VARIVAX on 06/14/2008, which was too early to the patient; This spontaneous report was received from a physician referring to a 11 month old patient of an unknown gender. Information regarding the patient's medical history, concurrent conditions and drug reactions/allergies was not reported.  On 14-JUN-2008, the patient was administered, too early, a first dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis.  On 30-JUN-2008, the patient was administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis and there was not enough time between the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) and this dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (captured on #1907USA007163). Additionally, on this same date, the patient also received a second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (discrepant information as it was reported as "counted as the first dose of varicella virus vaccine live (oka/merck) (VARIVAX)").  Then, on 23-JUN-2011, a booster dose (third dose) of varicella virus vaccine live (oka/merck) (VARIVAX) was administered.  On 09-JUL-2019, the patient was vaccinated with a fourth dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot No. R022116 (verified to be a valid lot number), expiration date reported and established as 02-AUG-2020, which was reconstituted with a properly stored sterile diluent.  Varicella virus vaccine live (oka/merck) (VARIVAX) was improperly stored at a temperature, total time in range, between 6°F to 14°F (7.9°F), during a time frame of 15 minutes. No previous temperature excursions neither adverse effects were reported. The call was because of a data logger.; Sender's Comments:  US-009507513-1907USA007163:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; The vaccine was inappropriately stored at 25 degrees Fahrenheit for 3 hours and 49 minutes; This spontaneous report was received from a receptionist referring to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant medications were no reported.  On 26-JUL-2019, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (lot# R021370 and expiration date 07-NOV-2020) (dose, frequency and route not reported) for prophylaxis. The vaccine was inappropriately stored at 25 degrees Fahrenheit for 3 hours and 49 minutes (product storage error). It was reported that a digital data logger was involved, but no previous temperature excursion information was provided. No adverse effects were reported.  This is one of two cases received by the same reporter.; Sender's Comments:  US-009507513-1907USA016666: US-009507513-1907USA016666:
Age: 19.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect; Altered dosing schedule: patient had Gardasil 9 on 8/11/2016, 6/30/2017 and 7/30/2019; This spontaneous report was received from a physician refers to a 19 years old patient (age at second vaccination). The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2016 the patient was vaccinated with first dose, on 30-JUN-2017, patient was vaccinated with second dose and on 30-JUL-2019 patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R003557, expiry date: 20-NOV-2020) 0.5 milliliter (0,2,6) for prophylaxis (inappropriate schedule of product administration) at an altered dosing schedule). No adverse effects reported (no adverse event).  This case is linked to case# 1907USA016663 (same reporter and different patient).; Sender's Comments:  US-009507513-1907USA016663:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported.; patient received improperly stored PROQUAD; This spontaneous report has been received from a nurse referring to a 4-year-old patient of unknown gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. Concomitant therapies included sterile diluent.     On 27-JUN-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S002924, expiration date: 28-JUL-2020, dose, frequency, route were not reported) for prophylaxis (product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with properly stored sterile diluent. No adverse effect was reported. No product quality complaint (PQC) was involved.  The administered doses experienced a temperature excursion at 6 Fahrenheit scale to 14 Fahrenheit scale (10.4 F) for 1 hour and 30 minutes. There was previous temperature excursion, total time in the range 6 Fahrenheit scale to 14 Fahrenheit scale (14 F) for 1 hour 56 minutes and total time in the range 15 Fahrenheit scale to 46 Fahrenheit scale (29 F) for 5 hours. Data logger was involved.  This is one of three linked cases received from the same reporter.; Sender's Comments:  US-009507513-1907USA002200: US-009507513-1907USA002134:
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes virus infection (type was not known located on buttocks). Concomitant products included valaciclovir hydrochloride (Valaciclovir).   On 17th May 2019, the patient received the 1st dose of Shingrix. On 17th May 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 24th May 2019, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported that she experienced pain at the injection site for one week. The reporter consented to follow up. For tolerance to the 2nd dose of Shingrix, refer case US2019132862.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles/symptoms were shingles like; This case was reported by a pharmacist and described the occurrence of shingles in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 377MK, expiry date unknown) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Shingrix. On 6th July 2019, 5 days 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 patient experienced shingles 5 to 6 days after receiving their 1st dose of Shingrix.  It was unknown if symptoms remained, at the time of reporting. The reporter declined to provide initials, and stated that symptoms were shingles-like and that the physician thought the patient developed shingles. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Peripheral swelling
Clinical narrative: not feelingwell; arm pain; This case was reported by a other health professional via interactive digital media and described the occurrence of feeling unwell in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2019, the patient received Shingrix. On 21st July 2019, less than a day after receiving Shingrix, the patient experienced swelling arm. On 22nd July 2019, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell and swelling arm were unknown.   It was unknown if the reporter considered the feeling unwell and swelling arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient did not feel good in morning of reporting, after his shingles shot day before reporting. The patients arm swollen from shingles shot day before reporting. The patient asked could he apply warm or cold compress.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site macule, Injection site pain, Vaccine positive rechallenge
Clinical narrative: small dot at the injection; tenderness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number H3MJ9, expiry date September 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of extensive swelling of vaccinated limb (1st dose received on 14th March 2019. Please refer the case US2019104323).   On 10th July 2019, the patient received the 2nd dose of Shingrix. On 10th July 2019, less than a day after receiving Shingrix, the patient experienced injection site tenderness. On 11th July 2019, the patient experienced injection site macule. The patient was treated with benadryl (nos) (Benadryl). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site tenderness and injection site macule were unknown.   It was unknown if the reporter considered the injection site tenderness and injection site macule to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix and experienced tenderness at the injection site. The patient reported that she took Benadryl 25 mg thirty minutes before the injection and another 25 mg that night before bedtime. When she woke up the next morning she had no tenderness and only saw a small dot at the injection site. The patient continued taking Benadryl 25 mg twice a day on the next two following days because she wanted to prevent any side effects she had experienced with the first Shingrix injection.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pruritus, Pyrexia
Clinical narrative: Fever; Chills; Shaking; Muscle Pain; Fatigue; Itching on both arms and abdomen; Hives on both arms and abdomen; This case was reported by a consumer via call center representative and described the occurrence of fever in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 53RF3, expiry date 17th October 2021) for prophylaxis.   On 17th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 18th July 2019, 1 days after receiving Shingrix, the patient experienced fever, chills, tremor, muscle pain, fatigue, pruritus and hives. The patient was treated with prednisone. On 19th July 2019, the outcome of the fever, chills, tremor, muscle pain and fatigue were recovered/resolved. On an unknown date, the outcome of the pruritus and hives were recovering/resolving.   It was unknown if the reporter considered the fever, chills, tremor, muscle pain, fatigue, pruritus and hives to be related to Shingrix.  Additional information received were as follows: The patient stated that next day post vaccination she woke up with fever, chills, shaking, muscle pain, and fatigue. The patient also experienced itching and hives on both arms and abdomen. On 19th July 2019, the patient went to urgent care and was prescribed prednisone ointment. The patient consented to follow up. No further details were provided.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor, Urticaria
Clinical narrative: Fever; Chills; Shaking; Muscle Pain; Fatigue; Itching on both arms and abdomen; Hives on both arms and abdomen; This case was reported by a consumer via call center representative and described the occurrence of fever in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 53RF3, expiry date 17th October 2021) for prophylaxis.   On 17th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 18th July 2019, 1 days after receiving Shingrix, the patient experienced fever, chills, tremor, muscle pain, fatigue, pruritus and hives. The patient was treated with prednisone. On 19th July 2019, the outcome of the fever, chills, tremor, muscle pain and fatigue were recovered/resolved. On an unknown date, the outcome of the pruritus and hives were recovering/resolving.   It was unknown if the reporter considered the fever, chills, tremor, muscle pain, fatigue, pruritus and hives to be related to Shingrix.  Additional information received were as follows: The patient stated that next day post vaccination she woke up with fever, chills, shaking, muscle pain, and fatigue. The patient also experienced itching and hives on both arms and abdomen. On 19th July 2019, the patient went to urgent care and was prescribed prednisone ointment. The patient consented to follow up. No further details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Diplopia, Nuclear magnetic resonance imaging normal
Clinical narrative: double vision; This case was reported by a consumer via call center representative and described the occurrence of double vision in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, 3 days after receiving Shingrix, the patient experienced double vision. In July 2019, the outcome of the double vision was recovered/resolved.   It was unknown if the reporter considered the double vision to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that he received the 1st dose of Shingrix approximately 3 to 4 days ago and three days later he experienced double vision. He went to the emergency room and they did an Magnetic resonance imaging and found nothing. The double vision resolved within 24 hours. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema
Clinical narrative: extensive swelling of vaccinated limb; raised red area around injection site; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 5JX9Z, expiry date 5th November 2021) for prophylaxis.   On 21st July 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The pharmacist reported that the patient received Shingrx and experienced raised red area about 4 inches in diameter around the injection site. There is discrepancy between the vaccination date reported in the structured field (22nd July 2019) and the vaccination date reported in the source document (21st July 2019).
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling, Vaccination site inflammation
Clinical narrative: redness and swelling around injection site; redness and swelling around injection site; redness and swelling around injection site; Initial information received on 19-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves Infant male patient of unknown age who experienced redness and swelling around injection site, while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, following the vaccination the patient experienced vaccination site inflammation with symptoms (vaccination site erythema and vaccination site swelling).  (Other relevant tests included no lab data.)  Final diagnosis was vaccination site inflammation.  It was not reported if the patient received a corrective treatment.  The outcome of the event was reported as unknown at the time of reporting.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 16.0
Sex: M
Vaccine: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received a dose of Tenivac after it had experience extended transit time on 20 Jul 2019/ No symptoms reported; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff) via phone.  This case is linked to case 2019SA203084 (same reporter).  This case involves a 16 years old male patient who was vaccinated with 0.5 ml dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (Batch number: U6265AA and expiry date: 19-Apr-2021) via intramuscular route in the left arm on 20-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included patient received MCV 4 and Meningococcal B vaccine.   It was a case of actual medication error due to Incorrect product storage.  No symptoms reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by the sender: none.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines that were not on the ice packs melted and the temperature was warm, extended transmit time/ no symptoms reported; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff) by phone.  This case is linked to case 2019SA203083 (same reporter).  This case involves a 4 months old female patient who was vaccinated with a 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] (Batch number: UJ112AAC and expiry date: 21-Jun-2020) via intramuscular route in the left quad on 20-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13); POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) on an unknown date.  It was a case of Incorrect product storage.  No symptoms reported.  Documents held by the sender: none.
Sex: F
Vaccine: TD
Symptoms: Underdose, Wrong technique in product usage process
Clinical narrative: Tenivac was not shaken before administration; that she is concerned she did not get the full dose; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a female patient of unknown age who received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and reported that Tenivac was not shaken before administration and that she is concerned she did not get the full dose.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to wrong technique in product usage process and vaccine underdose.  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.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt has red swelling with heat to left thigh which is being treated with Keflex and Benadryl.  Provider reports cellulitis of left thigh.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Angiogram, Chest X-ray, Computerised tomogram head, Headache, Laboratory test
Clinical narrative: Within 6 hrs of admin- onset of fever and headache.    Both symptoms continued for 18 days.  Resulting in need for hospitalization for Tylenol overdose, sepsis work up.   Resulting DX viral meningitis although not totally confirmed by testing.  Symptoms of headaches and neck pain still continue for 22 days currently.   Fever has stayed resolved state.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lumbar puncture, Meningitis viral, Neck pain, Nuclear magnetic resonance imaging brain, Overdose
Clinical narrative: Within 6 hrs of admin- onset of fever and headache.    Both symptoms continued for 18 days.  Resulting in need for hospitalization for Tylenol overdose, sepsis work up.   Resulting DX viral meningitis although not totally confirmed by testing.  Symptoms of headaches and neck pain still continue for 22 days currently.   Fever has stayed resolved state.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Ultrasound abdomen
Clinical narrative: Within 6 hrs of admin- onset of fever and headache.    Both symptoms continued for 18 days.  Resulting in need for hospitalization for Tylenol overdose, sepsis work up.   Resulting DX viral meningitis although not totally confirmed by testing.  Symptoms of headaches and neck pain still continue for 22 days currently.   Fever has stayed resolved state.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Within 6 hrs of admin- onset of fever and headache.    Both symptoms continued for 18 days.  Resulting in need for hospitalization for Tylenol overdose, sepsis work up.   Resulting DX viral meningitis although not totally confirmed by testing.  Symptoms of headaches and neck pain still continue for 22 days currently.   Fever has stayed resolved state.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: reddness and swelling in arm
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: PATIENT COMPLAINED OF SHOULDER PAIN FOLLOWING VACCINATION. PAIN HAS SUBSIDED AND PT RESUMED HIS DIALY ACTIVITIES NORMALLY, I AM REPORTING THIS INCIDENT JUST IN CASE PAIN RECURS OR COMPLICATIONS FOLLOW LATER
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropod bite, Erythema, Pruritus, Swelling
Clinical narrative: Patient had a bug bite in the middle of the red/swollen area, this bite occurred roughly around the same time as the patient's NP reported it as a "systemic reaction," the patient reported she was scratching it in the middle of the night and a friend recommended she visit the doctor but the patient waited 2 days before seeking any medical attention. She claims the bug bite had nothing to do with the reaction yet the redness was more towards the bug bite than the administration site. She took benedryl and applied some ice, the "internal itch" stopped upon benedryl admin. but the swelling/redness took an extra day to diminish.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Pyrexia, Rash pruritic
Clinical narrative: Patient ran a fever for >2 days, pain swelling and lump at injection site, and broke out in a pustular rash under breasts that were very itchy.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pustular
Clinical narrative: Patient ran a fever for >2 days, pain swelling and lump at injection site, and broke out in a pustular rash under breasts that were very itchy.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site mass, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient ran a fever for >2 days, pain swelling and lump at injection site, and broke out in a pustular rash under breasts that were very itchy.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Patient ran a fever for >2 days, pain swelling and lump at injection site, and broke out in a pustular rash under breasts that were very itchy.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Tendonitis
Clinical narrative: injection painful, with both pushes of they syringe.  Unlike any injection I've experienced.  Painful injection , but pain began about 6pm.  Continued painful and restricted mobility of arm. (Had to use left arm to lift or move right arm., hand, no strength in hand?   Pain so intense at 5am left for ER 9-10.  Treated as post immunization reaction.  Given strong ibuprofen.  Went to Primary Dr. 7/30 -- non stop pain, at a  6-7, increased motion of arm.  Primary treated as tendonitis, scripts for diclofenac gel, gabapentin. Instructed to complete Vaers form and advise pharmacy
Sex: F
Vaccine: HPV9
Symptoms: Death
Clinical narrative: unspecified amount of patients died after GARDASIL 9 treatments; This spontaneous report was received from a consumer, who read on internet on a website regarding to unspecified number of female patients of unknown age. The patients' medical history, history of drug reactions/ allergies, concurrent conditions and concomitant medications were unknown to the reporter. On an unknown date, the unspecified number of patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route, lot# and expiry date were not reported) for prophylaxis. On an unknown date, after an unspecified amount of doses the patients died (death) for an unspecified reason. It was unknown if an autopsy was performed. It was unknown to reporter whether the patients received any treatment, also unknown if they sought medical attention and there was any hospitalization or prolonged hospitalization. No product quality compliant (PQC) was reported. The causality assessment was not provided by the reporter.   Upon internal review, the event death was determined to be medically significant.; Reported Cause(s) of Death: died after GARDASIL 9 treatments for an unspecified reason
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: chills; This case was reported by a physician via sales rep and described the occurrence of chills in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was unknown.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional details were provided as follows: The physician shared that some of his patients experienced chills with the 1st dose of Shingrix which had resulted in them refusing the 2nd dose.  The physician did not agree to be followed up.
Sex: M
Vaccine: MEN
Symptoms: Rash
Clinical narrative: Chronic rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a male patient who received Men B NVS (Meningococcal B vaccine) for an unknown indication.   On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, less than a year after receiving Meningococcal B vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. It was reported that the patient had a chronic rash after getting this vaccine 1 year ago.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th July 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovering/resolving.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional case details were reported as follows: The patient had her first Shingrix vaccine on Wednesday earlier to the date of reporting in the left upper arm. On Thursday earlier to the date of reporting, the patient noticed redness of about 10 inches in size but to the side of the injection site.  The patient noted the redness was decreasing but wanted to know if this was a common side effect. The reporter did not gave permission to follow up.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: White blood cell count increased
Clinical narrative: Elevated white blood cells; This case was reported by a pharmacist via call center representative and described the occurrence of white blood cell increased in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number 53RF3, expiry date 17th October 2021) for prophylaxis.   Concurrent medical conditions included cancer and pneumonia.   On 15th July 2019, the patient received the 2nd dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced white blood cell increased. On an unknown date, the outcome of the white blood cell increased was unknown.   It was unknown if the reporter considered the white blood cell increased to be related to Shingrix.  Additional details were received as follows: The patient is an oncology patient and also had a history of pneumonia within the past 6 months The reporter stated that, the patient had the 2nd dose and had elevated white blood cells. To the knowledge of the reporter the patient had no occurrences after the first dose. The reporter consented to follow up.      Lab Comments: In July 2019 blood test was done
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: patient complained of pain with the 1st injection of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacy student reported that a male patient complained of pain with the 1st injection of Shingrix. The reporter consented to follow up. The pharmacy student stated that she did not have any information related to the adverse event (AE) at the time of the call. For tolerance to 2nd dose, refer case US2019AMR133564.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: red, hot injection site; red, hot injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2019, the patient received the 1st dose of Shingrix. On 18th April 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced a red, hot, silver dollar sized injection site reaction. The reporter stated that it lasted for 2 to 3 weeks. The reporter did not consent to follow-up. The consumer declined to provide any further details for this adverse event, did not consent to healthcare professional follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: felt sick; This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell 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, unknown after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The pharmacist reported that the patient felt sick, and did not specify or elaborate, after receiving 1st dose of Shingrix. The pharmacist did not wish to be contacted or provide any details.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Patient has had extreme fatigue going on 7 days. Unable to leave the house.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: MMR shot was intended for subcutaneous injection but I injected it into the deltoid muscle. No adverse events otherwise reported at this time.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Body temperature increased, Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Pt started kindergarten in September, received tdap vaccine on Friday 7/26/19, from PCP office (location and name was not provided). Subsequently started to have expanding redness. Had a temp of 101.3 yesterday. No fever today, arm looks worse, + hot and swollen to touch. + mild itchiness. Cold compress 10 min and 10 min three time/day claritin daily.Demarcate the area. Monitor over the next 5 hrs, If no improvement with above then will start cephalexin due to the extent of erythema cephalexin 250/5 ml , 5 ml po three times/day. ER warning discussed, then to report to urgent care center for in-person eval right away.Advised to contact the doctor and inform of the incident.  F/U with PCP.
Age: 12.0
Sex: M
Vaccine: HEPA, IPV, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Dizziness, light-headedness
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site rash
Clinical narrative: I had the vaccine around 4:30pm on 7/30/2019. At 12:30am on 7/31/19 I noticed that I was having a terrible headache. The next morning I was feeling flu like symptoms and I couldn't get out of bed except to have a bit of soup. The next morning (Aug. 1, 2019) I noticed a rash near the site of the injection. I called the pharmacy and got these lot numbers: H5495 10/01/21 Shingrex 2MP9L 11/29/21 Diluent
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Bedridden, Erythema, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Itching, redness, and soreness around injection site on 07/26/19 the day after administered at our office. The patient was advised to apply an Ice Pack and Cortisone Cream. She then contacted our office on 08/01/19 to notify us that her arm had became swollen and red all the way down to her wrist with extreme pain to the point where she could not move the arm. She then started with nausea and vomiting and stated that from 07/25/19 to 07/30/19 she was bedridden. She started feeling better on 07/31/19 but has not came into the office for a visit.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Nausea, Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: Itching, redness, and soreness around injection site on 07/26/19 the day after administered at our office. The patient was advised to apply an Ice Pack and Cortisone Cream. She then contacted our office on 08/01/19 to notify us that her arm had became swollen and red all the way down to her wrist with extreme pain to the point where she could not move the arm. She then started with nausea and vomiting and stated that from 07/25/19 to 07/30/19 she was bedridden. She started feeling better on 07/31/19 but has not came into the office for a visit.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site reaction, Musculoskeletal pain, Pain in extremity, Rash erythematous
Clinical narrative: On 7/2019 woke with a red itchy rash on the left arm (where the vaccine was given.  Pain started in shoulder and went into the palm of the hand and the left thumb was numb.  Nurse practioner gave me a steroid shot and a muscle relaxer. I have been using cortisone cream,  but the symptoms are still there. Cannot see my dermatologist until the end of August
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: On 7/2019 woke with a red itchy rash on the left arm (where the vaccine was given.  Pain started in shoulder and went into the palm of the hand and the left thumb was numb.  Nurse practioner gave me a steroid shot and a muscle relaxer. I have been using cortisone cream,  but the symptoms are still there. Cannot see my dermatologist until the end of August
Age: 13.0
Sex: F
Vaccine: HEP, HPV9, IPV, TD
Symptoms: Fall, Head injury, Syncope
Clinical narrative: After receiving injections patient was sitting in chair while I was completing immunization paper work. Looked over and patient was slumping down and fell out of chair, fainted and hit head on floor. Patient was assisted up, ice pack was applied to head, no open wounds no lumps noted.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Induration
Clinical narrative: Left arm with erythematous indurated area
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: started with achiness but during the night fever went above 102 degress with intense shivering and extreme body and head aches.
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: The titres showed sufficient antibodies to only 12 of the 23 serotypes contained in the vaccine; This spontaneous report as received from a nurse practitioner refers to a currently 63-year-old female patient. The patient did not have any known drug reactions or allergies. No information regarding the patient's pertinent medical history and concomitant therapies was provided.  On an unknown date in May 2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly (dose, lot # and expiration date were not reported) for prophylaxis.  On an unknown date in 2019, the patient had a pneumococcal antibody titres performed and it showed sufficient antibodies to only 12 of the 23 serotypes contained in the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). No other adverse effects were reported in the patient. No treatment was given for the event. The patient did not seek medical attention.  The outcome of the event was reported as not recovered/not resolved.  The relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.