chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Lip blister, Pain, Pyrexia, Rash
Clinical narrative: broke out in a rash on my neck and face; blisters inside my bottom lip; rash on my neck now looks like a burn / same wtih my cheeks; experienced chills; fever; body aches; This case was reported by a consumer and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included drug allergy.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced chills, fever, general body pain, rash, lip blister and red rash. On an unknown date, the outcome of the chills, general body pain and lip blister were recovered/resolved and the outcome of the fever was unknown and the outcome of the rash and red rash were not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, general body pain, rash, lip blister and red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The received Shingrix and experienced chills, fever and body aches. That lasted 24 hours. The patient broke out in a rash on neck and face and blisters inside my bottom lip.  The blisters are gone, however it was day four of dealing with symptoms.  The rash on my neck looks like a burn, and the same with my cheeks.  The patient was allergic to a few medicines and had reactions to some, after stopping taking the medication. The patient cannot think of anything else that had done that would had caused this to happen to my face and neck.
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: broke out in a rash on my neck and face; blisters inside my bottom lip; rash on my neck now looks like a burn / same wtih my cheeks; experienced chills; fever; body aches; This case was reported by a consumer and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included drug allergy.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced chills, fever, general body pain, rash, lip blister and red rash. On an unknown date, the outcome of the chills, general body pain and lip blister were recovered/resolved and the outcome of the fever was unknown and the outcome of the rash and red rash were not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, general body pain, rash, lip blister and red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The received Shingrix and experienced chills, fever and body aches. That lasted 24 hours. The patient broke out in a rash on neck and face and blisters inside my bottom lip.  The blisters are gone, however it was day four of dealing with symptoms.  The rash on my neck looks like a burn, and the same with my cheeks.  The patient was allergic to a few medicines and had reactions to some, after stopping taking the medication. The patient cannot think of anything else that had done that would had caused this to happen to my face and neck.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: arm is sore / cannot lift it without pain; cannot lift it without pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th June 2020, the patient received the 2nd dose of Shingrix. On 8th June 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and arm was sore and cannot lift it without pain.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event, Vaccine positive rechallenge
Clinical narrative: severe side effects; This case was reported by a consumer and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse event (received 1st dose of unknown date, refer case US2020AMR099935).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and experience more severe side effects.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR099935:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: more severe side effects with the second dose of Shigrix compared to the first; This case was reported by a consumer and described the occurrence of adverse event 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 adverse event. On an unknown date, the outcome of the adverse event was recovered/resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and experience more severe side effects. For tolerances of 2nd dose, refer case US2020AMR099926, reported by same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR099926:same reporter
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: Low titer; This case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in a 19-year-old male patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.  Additional details were provided as follows: The reporter reported that a 19 year old patient needed a booster dose of Engerix-B due to a low titer. The reporter could not identify what previous vaccination series for Hepatitis consisted of.  The reporter consented to follow up.  No specific data given when asked by the agent during the call.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Coronavirus infection, Rash papular, Rash pruritic
Clinical narrative: COVID-19; rash/ rash on his back/ felt bumpy like he scraped or fell; not bleed but felt itchy; This case was reported by a consumer via call center representative and described the occurrence of coronavirus infection in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2020, the patient received Shingrix. On 13th March 2020, 70 days after receiving Shingrix, the patient experienced coronavirus infection (serious criteria GSK medically significant). In March 2020, the patient experienced papular rash and itchy rash. On an unknown date, the outcome of the coronavirus infection, papular rash and itchy rash were unknown.   It was unknown if the reporter considered the coronavirus infection, papular rash and itchy rash to be related to Shingrix.  Additional information was provided as follows: On 13th March 2020, the patient contracted COVID-19. Between 2 and 3 months, after receiveng vaccine, the patient developed a rash at the base of his spine that was 1 inch long half inch wide. It did not bleed but felt itchy. Between 3 and 4 months, the patient developed another rash half way up on his back near the spine. It was not itching but felt bumpy like he scraped or fell. Two weeks later, he developed another rash on the backside of his arm near his elbow and wrist. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: negative Hepatitis-B titers; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 22-year-old female patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The age at the vaccination was not reported. The physician assistant reported that the patient had negative Hepatitis-B titers after completing the childhood vaccine series.  They are considering Engerix-B to administer a booster.  The name of the original Hepatitis vaccination not noted. The reporter consented to follow up. The reporter could not read the pediatric note in the chart that gave the Hep-B vaccine name and lot information.
Age: 38.0
Sex: F
Vaccine: PPV, PPV, PPV, PPV, PPV, PPV, PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, White blood cell count increased
Clinical narrative: -Patient states that within hours her arm swelled and was painful and couldn't be moved
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Back pain, Dizziness
Clinical narrative: Felt dizzy & back pain 5 months after administration of HPV
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Contusion, Dizziness, Face injury, Fatigue
Clinical narrative: Vaccine was administered at 3:30 pm Friday, 6/12/2020.   I noted extreme fatigue and dizziness on Saturday morning 6/13.  My blood pressure was low for me at 85/70.  By 9 pm on Sat. 6/13, my lips started to swell.  I lips were significantly swollen by Sunday, 6/14, and the low blood pressure persisted.  When I awoke and stood up out of bed on Monday, 6/14, I fainted, hit my face into the window frame/wall.  I bruised my chin and upper lip and have sore upper teeth.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Oral contusion, Syncope, Toothache
Clinical narrative: Vaccine was administered at 3:30 pm Friday, 6/12/2020.   I noted extreme fatigue and dizziness on Saturday morning 6/13.  My blood pressure was low for me at 85/70.  By 9 pm on Sat. 6/13, my lips started to swell.  I lips were significantly swollen by Sunday, 6/14, and the low blood pressure persisted.  When I awoke and stood up out of bed on Monday, 6/14, I fainted, hit my face into the window frame/wall.  I bruised my chin and upper lip and have sore upper teeth.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Patient reported generalized muscle aches and pains lasting  24 hours post-injection.
Age: 0.33
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: parents stated no adverse effect to patient receiving vaccine
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received her first GARDASIL9 on an unspecified date in February 2020/the patient is at the pharrnacy today, 06/10/2020, to receive her second dose of GARDASIL9; This spontaneous report as received from a pharmacist refers to a 22-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in February 2020, the patient was vaccinated with the firs dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 10-JUN-2020, the patient was at a pharmacy to get her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. It was unknown if the patient received her second dose of the vaccine.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse affects reported.; Medical assistant called reporting fuat patient was administered fuere first dose of MMR at 24 monfus on 2/12/2019 and fue second dose was administered on 6/12/2020.; This spontaneous report was received from a physician, referring to a 3 years old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 12-FEB-2019, at the age of 24 months, the patient was vaccinated with the first dose of measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), on 12-JUN-2020 the patient was vaccinated with the second dose of measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, vaccination scheme, anatomical site of vaccination, lot number and expiration date were not reported for any of the vaccines) as prophylaxis (inappropriate schedule of product administration). No additional adverse event were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or additional adverse effects reported; unspecified dose in PROQUAD immunization series were administered after being improperly stored; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 08-JUN-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S022914, expiration date 19-JAN-2021 (exact dose, dose number, dose site and route of administration were not provided) for prophylaxis. Diluent was properly stored.  Administered dose of vaccine was exposed to the temperature excursion of -14.06 degrees Celsius for 10 minutes. There were previous temperature excursions, -14.28 degrees Celsius for 55 minutes, -13.72 degrees Celsius for 55 minutes and -12.92 degrees Celsius for 5 hours on unknown dates. Digital Data Logger was involved. No symptoms or additional adverse effects were reported.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif on two consecutive days (did not skip a day in-between); Spontaneous case was received on 26MAR2020.  A nurse reported that a female consumer who "took Vivotif on two consecutive days (did not skip a day in-between)" (PT: Inappropriate schedule of product administration). She was receiving Vivotif for immunization. The consumer did not take Vivotif doses according to the schedule. She took the two doses of took Vivotif on two consecutive days (did not skip a day in-between). The nurse did not know the exact dates the consumer took the Vivotif. Action taken with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif on two consecutive days (Inappropriate schedule of product administration) instead of taking them on every other day. Considering the nature of the event, the causality of Vivotif of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took Vivotif on two consecutive days (Inappropriate schedule of product administration) instead of taking them on every other day. Considering the nature of the event, the causality of Vivotif of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Age: 54.0
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix had fever and cannot even get out of bed.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Axonal neuropathy, Balance disorder, Dysaesthesia, Essential tremor, Flank pain
Clinical narrative: neuropathy/idiopathic neuropathy; polyneuropathy, unspecified; chronic right flank pain; post herpetic neuralgia; left hand tremor; essential tremor; burning pain; dysesthesias on the right flank in a T6 distribution; numbness in the feet; post-herpetlc neuritis; poor balance; parenthesis in both feet and legs; sensorimotor peripheral neuropathy in lower extremities; This case was reported by a lawyer and described the occurrence of peripheral sensorimotor neuropathy in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 12 June 2020 via medical records (case now medically confirmed). As per pharmacy record, on 08 July 2018, the patient received suspect included Shingrix vial kit. As per record, on dated 06 November 2019 the patient who presents for evaluation of chronic right flank pain and neuropathy. For her right flank pain agree with post herpetic neuralgia. Her left hand tremor likely benign essential tremor . The patient states she developed burning pain and dysesthesias on the right flank in a T6 distribution and was diagnosis with shingles. This problems started over 20 years ago. The patient had flares where the pain would be intense for several months then die down. The patient complaint numbness in the feet but no pain in the feet. The patient had diagnosis of idiopathic neuropathy, patient complaint of left hand tremor when using the hand. The patient had paresthesia in both feet and legs. The patient assessment included polyneuropathy, unspecified, post-herpetlc neuritis, poor balance and essential tremor.On 06 February 2020, the patient had EMC (electromagnetic compatibility) examination showed abnormal study, there was electro diagnostic evidence of length dependent, axonal, sensorimotor peripheral neuropathy in lower extremities.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Laboratory test abnormal, Neuritis, Neuropathy peripheral
Clinical narrative: neuropathy/idiopathic neuropathy; polyneuropathy, unspecified; chronic right flank pain; post herpetic neuralgia; left hand tremor; essential tremor; burning pain; dysesthesias on the right flank in a T6 distribution; numbness in the feet; post-herpetlc neuritis; poor balance; parenthesis in both feet and legs; sensorimotor peripheral neuropathy in lower extremities; This case was reported by a lawyer and described the occurrence of peripheral sensorimotor neuropathy in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 12 June 2020 via medical records (case now medically confirmed). As per pharmacy record, on 08 July 2018, the patient received suspect included Shingrix vial kit. As per record, on dated 06 November 2019 the patient who presents for evaluation of chronic right flank pain and neuropathy. For her right flank pain agree with post herpetic neuralgia. Her left hand tremor likely benign essential tremor . The patient states she developed burning pain and dysesthesias on the right flank in a T6 distribution and was diagnosis with shingles. This problems started over 20 years ago. The patient had flares where the pain would be intense for several months then die down. The patient complaint numbness in the feet but no pain in the feet. The patient had diagnosis of idiopathic neuropathy, patient complaint of left hand tremor when using the hand. The patient had paresthesia in both feet and legs. The patient assessment included polyneuropathy, unspecified, post-herpetlc neuritis, poor balance and essential tremor.On 06 February 2020, the patient had EMC (electromagnetic compatibility) examination showed abnormal study, there was electro diagnostic evidence of length dependent, axonal, sensorimotor peripheral neuropathy in lower extremities.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Peripheral sensorimotor neuropathy, Polyneuropathy, Post herpetic neuralgia
Clinical narrative: neuropathy/idiopathic neuropathy; polyneuropathy, unspecified; chronic right flank pain; post herpetic neuralgia; left hand tremor; essential tremor; burning pain; dysesthesias on the right flank in a T6 distribution; numbness in the feet; post-herpetlc neuritis; poor balance; parenthesis in both feet and legs; sensorimotor peripheral neuropathy in lower extremities; This case was reported by a lawyer and described the occurrence of peripheral sensorimotor neuropathy in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 12 June 2020 via medical records (case now medically confirmed). As per pharmacy record, on 08 July 2018, the patient received suspect included Shingrix vial kit. As per record, on dated 06 November 2019 the patient who presents for evaluation of chronic right flank pain and neuropathy. For her right flank pain agree with post herpetic neuralgia. Her left hand tremor likely benign essential tremor . The patient states she developed burning pain and dysesthesias on the right flank in a T6 distribution and was diagnosis with shingles. This problems started over 20 years ago. The patient had flares where the pain would be intense for several months then die down. The patient complaint numbness in the feet but no pain in the feet. The patient had diagnosis of idiopathic neuropathy, patient complaint of left hand tremor when using the hand. The patient had paresthesia in both feet and legs. The patient assessment included polyneuropathy, unspecified, post-herpetlc neuritis, poor balance and essential tremor.On 06 February 2020, the patient had EMC (electromagnetic compatibility) examination showed abnormal study, there was electro diagnostic evidence of length dependent, axonal, sensorimotor peripheral neuropathy in lower extremities.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: neuropathy/idiopathic neuropathy; polyneuropathy, unspecified; chronic right flank pain; post herpetic neuralgia; left hand tremor; essential tremor; burning pain; dysesthesias on the right flank in a T6 distribution; numbness in the feet; post-herpetlc neuritis; poor balance; parenthesis in both feet and legs; sensorimotor peripheral neuropathy in lower extremities; This case was reported by a lawyer and described the occurrence of peripheral sensorimotor neuropathy in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 12 June 2020 via medical records (case now medically confirmed). As per pharmacy record, on 08 July 2018, the patient received suspect included Shingrix vial kit. As per record, on dated 06 November 2019 the patient who presents for evaluation of chronic right flank pain and neuropathy. For her right flank pain agree with post herpetic neuralgia. Her left hand tremor likely benign essential tremor . The patient states she developed burning pain and dysesthesias on the right flank in a T6 distribution and was diagnosis with shingles. This problems started over 20 years ago. The patient had flares where the pain would be intense for several months then die down. The patient complaint numbness in the feet but no pain in the feet. The patient had diagnosis of idiopathic neuropathy, patient complaint of left hand tremor when using the hand. The patient had paresthesia in both feet and legs. The patient assessment included polyneuropathy, unspecified, post-herpetlc neuritis, poor balance and essential tremor.On 06 February 2020, the patient had EMC (electromagnetic compatibility) examination showed abnormal study, there was electro diagnostic evidence of length dependent, axonal, sensorimotor peripheral neuropathy in lower extremities.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Musculoskeletal discomfort
Clinical narrative: arm problems; Incomplete course of vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of musculoskeletal discomfort in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced musculoskeletal discomfort and incomplete course of vaccination. On an unknown date, the outcome of the musculoskeletal discomfort and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the musculoskeletal discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had musculoskeletal discomfort. The pharmacist denied any additional information about the patient. The reporter did not consent to follow up. The reporter was transferred to medical information for additional assistance regarding the Shingrix vaccine and additional data GSK might had. The patient and has not received a second dose yet, which led to incomplete course of vaccination. This case US2020096487 is a duplicate of US2020096485. All future correspondence will be submitted to US2020096485.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Influenza like illness, Injection site erythema, Injection site pain, Limb discomfort
Clinical narrative: feels like his arm is heavy; injection site soreness; injection site soreness and redness; flu like symptoms; numbness in his entire left arm; tingling on the finger tips / tingling in the finger; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number L7SY9, expiry date 4th July 2021) for prophylaxis.   On 22nd May 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In May 2020, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms. On 22nd May 2020, the patient experienced injection site pain and injection site erythema. On 24th May 2020, the patient experienced numbness of upper extremities and tingling of extremity. On an unknown date, the patient experienced heaviness in arm. On an unknown date, the outcome of the injection site pain, injection site erythema, influenza-like symptoms, numbness of upper extremities, tingling of extremity and heaviness in arm were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, influenza-like symptoms, numbness of upper extremities, tingling of extremity and heaviness in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced intensive injection site soreness and redness as soon as he got home after getting the vaccination. This lasted for a full week. The patient experienced flu like symptoms that lasted for a day.  About 2 days after the vaccination he experienced numbness in his entire left arm and tingling on the fingertips of the left arm.  This was episodic, it comes and goes daily and if he sits relaxed watching tv he feels like his arm was heavy and tingling in the finger comes back. No other details were provided.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: feels like his arm is heavy; injection site soreness; injection site soreness and redness; flu like symptoms; numbness in his entire left arm; tingling on the finger tips / tingling in the finger; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number L7SY9, expiry date 4th July 2021) for prophylaxis.   On 22nd May 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In May 2020, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms. On 22nd May 2020, the patient experienced injection site pain and injection site erythema. On 24th May 2020, the patient experienced numbness of upper extremities and tingling of extremity. On an unknown date, the patient experienced heaviness in arm. On an unknown date, the outcome of the injection site pain, injection site erythema, influenza-like symptoms, numbness of upper extremities, tingling of extremity and heaviness in arm were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, influenza-like symptoms, numbness of upper extremities, tingling of extremity and heaviness in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced intensive injection site soreness and redness as soon as he got home after getting the vaccination. This lasted for a full week. The patient experienced flu like symptoms that lasted for a day.  About 2 days after the vaccination he experienced numbness in his entire left arm and tingling on the fingertips of the left arm.  This was episodic, it comes and goes daily and if he sits relaxed watching tv he feels like his arm was heavy and tingling in the finger comes back. No other details were provided.
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received menactra injection at age11 and12 years, no AE; Initial information received on 08-Jun-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional.  This case involves a child patient (unknown gender) who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] at age of 11 and12 year (lot number, expiry date, route and site of administration were not reported) for prophylactic vaccination on an unknown date.  Medical history, concomitant therapy, medical treatment, vaccination and family history were not provided.  It was a case of actual medication error due to extra dose administered. A patient received Menactra injection at age 11 and12 years.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: The Menactra vaccine expired on 25may2020, was given to a patient of 15 years old on 08Jun2020, no AE; Initial information received on 15-Jun-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 15 years old male patient who was vaccinated with an expired 0.5ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6207AA, expiry date: 25-May-2020) via intramuscular route in the right deltoid on 08-Jun-2020 for prophylactic vaccination.  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 prophylactic vaccination and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for prophylactic vaccination 08-Jun-2020.  It was an actual medication error case due to expired vaccine used.  Nurse reported that the child came in for a sports physical and received expired Menactra as well as Adacel and Hepatitis A on the same day. States the Hepatitis A was also expired and she was calling Merck.  No adverse event reported at the time of reporting.  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: RAB
Symptoms: Blister, Hepatic enzyme increased, Hypoacusis, Lymphocyte count decreased, Pruritus
Clinical narrative: had trouble hearing the previous consultant and the hold music; rheumatoid nodules; Extremely itchy/ itching; she started having blisters,rash/rash like blisters; rash started on her head when she was working outside and progressed to the tops of her arms, back, hands and surgical sites; Initial information received on 11-Jun-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 59 years old female patient who developed blisters, rash/rash like blisters (rash vesicular) ,rash started on her head when she was working outside and progressed to the tops of her arms, back, hands and surgical sites (rash) and extremely itchy/ itching (pruritus), trouble hearing the previous consultant and the hold music (hypoacusis) and rheumatoid nodules (rheumatoid nodule), while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history included Biopsy.  On an unknown date somewhere in July, the patient received a dose of suspect RABIES (HDC) VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date in Oct-2019, the patient developed a non-serious blisters, rash/rash like blisters (rash vesicular) ,rash started on her head when she was working outside and progressed to the tops of her arms, back, hands and surgical sites (rash) and extremely itchy/ itching (pruritus) (Unknown latency) following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious had trouble hearing the previous consultant and the hold music (hypoacusis) and rheumatoid nodules (rheumatoid nodule) (Unknown latency) following the administration of RABIES (HDC) VACCINE.  Patient also stated that she has been on steroids for blisters and that really helps but it all comes back when she goes off the steroids. States the rash, blisters and itching have been a little better over time but she hesitates to do the acceleration treatment. Mentions she took a couple of doses in March but stopped in February 2020, her liver enzymes were climbing higher and higher and came down when she stopped taking the medication.  Relevant laboratory test results included: On an unknown date: Hepatic enzyme increased:  climbing higher and higher On an unknown date: Lymphocyte count - fairly low  Final diagnosis was rash vesicular, rash, pruritus, hypoacusis and rheumatoid nodule.    An corrective treatment  of steroids was received.  At the time of reporting, the patient was recovering from pruritus, rash and rash vesicular, while the outcome was unknown for  the other two events.  There will be no information on the batch number for this case.
Sex: F
Vaccine: RAB
Symptoms: Rash vesicular, Rheumatoid nodule
Clinical narrative: had trouble hearing the previous consultant and the hold music; rheumatoid nodules; Extremely itchy/ itching; she started having blisters,rash/rash like blisters; rash started on her head when she was working outside and progressed to the tops of her arms, back, hands and surgical sites; Initial information received on 11-Jun-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 59 years old female patient who developed blisters, rash/rash like blisters (rash vesicular) ,rash started on her head when she was working outside and progressed to the tops of her arms, back, hands and surgical sites (rash) and extremely itchy/ itching (pruritus), trouble hearing the previous consultant and the hold music (hypoacusis) and rheumatoid nodules (rheumatoid nodule), while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history included Biopsy.  On an unknown date somewhere in July, the patient received a dose of suspect RABIES (HDC) VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date in Oct-2019, the patient developed a non-serious blisters, rash/rash like blisters (rash vesicular) ,rash started on her head when she was working outside and progressed to the tops of her arms, back, hands and surgical sites (rash) and extremely itchy/ itching (pruritus) (Unknown latency) following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious had trouble hearing the previous consultant and the hold music (hypoacusis) and rheumatoid nodules (rheumatoid nodule) (Unknown latency) following the administration of RABIES (HDC) VACCINE.  Patient also stated that she has been on steroids for blisters and that really helps but it all comes back when she goes off the steroids. States the rash, blisters and itching have been a little better over time but she hesitates to do the acceleration treatment. Mentions she took a couple of doses in March but stopped in February 2020, her liver enzymes were climbing higher and higher and came down when she stopped taking the medication.  Relevant laboratory test results included: On an unknown date: Hepatic enzyme increased:  climbing higher and higher On an unknown date: Lymphocyte count - fairly low  Final diagnosis was rash vesicular, rash, pruritus, hypoacusis and rheumatoid nodule.    An corrective treatment  of steroids was received.  At the time of reporting, the patient was recovering from pruritus, rash and rash vesicular, while the outcome was unknown for  the other two events.  There will be no information on the batch number for this case.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MENB, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Menactra was ordered and to be given, patient given Trumenba in error.  No reaction noted.
Sex: U
Vaccine: VARCEL
Symptoms: Abdominal pain, Anaphylactic reaction, Dizziness, Flushing, Tryptase
Clinical narrative: anaphylaxis; This literature marketed report has been received from the authors of a published literature article and refers to a 5 year old patient with maculopapular cutaneous mastocytosis.  On an unknown date, the patient was vaccinated with a second dose of varicella virus vaccine live (oka/merck) (manufacturer unknown) (lot #, strength, dose, route and site of administration were not reported) for prophylaxis.  On an unknown date, the patient experienced flushing, abdominal pain, vomiting, wheezing, dizziness and had an anaphylactic episode two hours after receiving the second dose of varicella virus vaccine live (oka/merck) (manufacturer unknown). Tryptase level was 5.1 ng/mL. The patient was treated with epinephrine.  The outcome of anaphylactic reaction was unknown. The authors considered anaphylactic reaction to be related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown).     Upon internal review, the event of anaphylactic reaction was considered to be medically significant.  This is one of 2 reports derived from the same literature article (cross referenced with MARRS# 2006USA006736).; Sender's Comments:  US-009507513-2006USA004886:
Sex: U
Vaccine: VARCEL
Symptoms: Vomiting, Wheezing
Clinical narrative: anaphylaxis; This literature marketed report has been received from the authors of a published literature article and refers to a 5 year old patient with maculopapular cutaneous mastocytosis.  On an unknown date, the patient was vaccinated with a second dose of varicella virus vaccine live (oka/merck) (manufacturer unknown) (lot #, strength, dose, route and site of administration were not reported) for prophylaxis.  On an unknown date, the patient experienced flushing, abdominal pain, vomiting, wheezing, dizziness and had an anaphylactic episode two hours after receiving the second dose of varicella virus vaccine live (oka/merck) (manufacturer unknown). Tryptase level was 5.1 ng/mL. The patient was treated with epinephrine.  The outcome of anaphylactic reaction was unknown. The authors considered anaphylactic reaction to be related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown).     Upon internal review, the event of anaphylactic reaction was considered to be medically significant.  This is one of 2 reports derived from the same literature article (cross referenced with MARRS# 2006USA006736).; Sender's Comments:  US-009507513-2006USA004886:
Sex: U
Vaccine: HPV4, HPV9, MMR
Symptoms: Condition aggravated, Diffuse cutaneous mastocytosis, Flushing, Rash maculo-papular, Swelling
Clinical narrative: accentuation (swelling) of lesions of MPCM; facial swelling; flushing; This literature marketed report has been received from the authors of a published literature article and refers to an adolescent patient with indolent systemic mastocytosis.  On an unknown date, the patient was vaccinated with human papillomavirus vaccine (manufacturer unknown) (lot #, strength, dose, route and site of administration were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot #, strength, dose, route and site of administration were not reported) for prophylaxis.  On an unknown date, the patient experienced facial swelling, flushing and accentuation (swelling) of lesions of maculopapular cutaneous mastocytosis (considered to be progression of indolent systemic mastocytosis). Tryptase level was 62.9 ng/mL.  The outcome of events was unknown. The authors considered facial swelling, flushing and accentuation (swelling) of lesions of maculopapular cutaneous mastocytosis to be related to human papillomavirus vaccine (manufacturer unknown), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown).  The event of indolent systemic mastocytosis progression was considered to be medically significant.  This is one of 2 reports derived from the same literature article (cross referenced with # 2006USA004886).; Sender's Comments:  US-009507513-2006USA004886:
Sex: U
Vaccine: HPV4, HPV9, MMR
Symptoms: Swelling face, Systemic mastocytosis, Tryptase increased
Clinical narrative: accentuation (swelling) of lesions of MPCM; facial swelling; flushing; This literature marketed report has been received from the authors of a published literature article and refers to an adolescent patient with indolent systemic mastocytosis.  On an unknown date, the patient was vaccinated with human papillomavirus vaccine (manufacturer unknown) (lot #, strength, dose, route and site of administration were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot #, strength, dose, route and site of administration were not reported) for prophylaxis.  On an unknown date, the patient experienced facial swelling, flushing and accentuation (swelling) of lesions of maculopapular cutaneous mastocytosis (considered to be progression of indolent systemic mastocytosis). Tryptase level was 62.9 ng/mL.  The outcome of events was unknown. The authors considered facial swelling, flushing and accentuation (swelling) of lesions of maculopapular cutaneous mastocytosis to be related to human papillomavirus vaccine (manufacturer unknown), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown).  The event of indolent systemic mastocytosis progression was considered to be medically significant.  This is one of 2 reports derived from the same literature article (cross referenced with # 2006USA004886).; Sender's Comments:  US-009507513-2006USA004886:
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Presyncope, Skin warm, Vision blurred
Clinical narrative: The patient was seen for a clinic visit with the provider. She experienced the following symptoms within 1 minute post administration of vaccinations (Tdap, MCV4 and HPV): blurry vision, light-headedness, near-syncope and diaphoresis. She was sitting at the time symptoms developed. Blood pressure = 60/30 mmHg, pulse = 61 bpm. Provider notified and returned to the room to examine patient. The patient stated that she had not consumed breakfast this morning, nor had drank a lot of fluids prior to coming to the appointment.  Patient consumed approximately 8 ounces of apple juice and laid down with her lower extremities elevated; applied ice pack to forehead/lower back/neck. BP = 83/54, pulse = 84 bpm. The patient consumed water and graham crackers while sitting back up. Vision back to normal and feeling less faint. Warm to touch, but no more diaphoresis. BP = 95/61, pulse = 73 bpm & 94/63, pulse = 71 bpm. The patient stated she felt better and stood up with father and nurse at her sides. She stated she felt no abnormal symptoms and therefore walked around the room noting she continued to feel well. The provider stated the patient may leave as long as her blood pressure was back to normal, her abnormal symptoms were no longer and she felt well. She recommended that the patient consumed adequate amounts of fluid and eat sometime of substance. The patient and her father expressed understanding. The patient left the clinic by foot after meeting all provider requirements (BP, symptoms, feeling well). She was given more apple juice and graham crackers to take with her. The patient's father will continue to monitor the patient and will drive her home.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Cervical vertebral fracture, Computerised tomogram head, Computerised tomogram neck, Dizziness, Fall
Clinical narrative: Vasovagal Syncope (Fainting) - Felt hot and sweaty, then lightheaded 5-10 minutes after vaccine administration.   C5 fracture secondary to fall from the syncopal episode.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Feeling hot, Hyperhidrosis, Magnetic resonance imaging, Spinal X-ray, Syncope
Clinical narrative: Vasovagal Syncope (Fainting) - Felt hot and sweaty, then lightheaded 5-10 minutes after vaccine administration.   C5 fracture secondary to fall from the syncopal episode.