chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 83-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles.  The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects were reported.; Patient was "administered a dose of Havrix and then inadvertently administered a dose VAQTA too soon.''; This spontaneous report has been received from a nurse referring to a 75 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reaction/allergies were not reported.   On 21-MAY-2019, the patient was vaccinated with a dose of hepatitis a virus vaccine inactivated (HAVRIX) (lot# 299X2, expiration date 24-JAN-2022; dose number and route were unknown). On 08-JUL-2019, the patient was inadvertently vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S001832, expiration date 12-MAY-2020; dose number and route was unknown) for prophylaxis (inappropriate schedule of vaccine administered). No adverse effects were reported. The outcome of the events was unknown. No product quality complaint presented.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac failure
Clinical narrative: heart failure; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 22-MAY-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions by healthcare provider in a clinic. On an unspecified date, the patient experienced hear failure. On an unspecified date, the patient was treated by a physician for hear failure. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of heart failure was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 46 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 76 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 01-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles (herpes zoster). On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingle was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 80 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 24-OCT-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 69 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 36.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 42 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 19-APR-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 63 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 25-SEP-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster and post herpetic neuralgia. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster and post herpetic neuralgia. The outcome of the events herpes zoster and post herpetic neuralgia was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 88 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 25-JUL-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 17-SEP-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingle was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Herpes zoster keratitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 76 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 11-JUL-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced ophthalmic herpes zoster. On an unspecified date, the patient was treated by a healthcare provider for ophthalmic herpes zoster. The outcome of the event ophthalmic herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event ophthalmic herpes zoster was considered to be medically significant.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis, Herpes zoster
Clinical narrative: Bell's palsy disease; Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 07-SEP-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced Bell's palsy disease (facial paralysis) and herpes zoster. On an unspecified date, the patient was treated by a physician assistant for facial paralysis and herpes zoster. The outcome of the events facial paralysis and herpes zoster was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event facial paralysis was considered to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms reported; patient was vaccinated with expired VARIVAX; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On 22-JUL-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # N015477 with an expiration date in 18-MAY-2019), for prophylaxis (strength, dose, route and frequency were not provided). No adverse symptoms reported.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: the patient experienced pain in his arm; subsequently experienced a swollen injection site, from the deltoid past the elbow; subsequently experienced a swollen injection site, from the deltoid past the elbow; This spontaneous report was received from a pharmacy student referring to a 68 year old male patient. The patient's pertinent medical history and concomitant medications were not reported. The patient had not drug reactions/allergies.       On 21-JUL-2019, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) intramuscularly in his upper arm (not specified), lot # R025297 with expiration date 08-JUN-2020, for prophylaxis.     On 22-JUL-2019, the patient experienced swollen injection site (injection site swelling), from the deltoid past the elbow (peripheral swelling). Additionally, the patient experienced pain in his arm (pain in extremity). No laboratory diagnostics tests were performed to the patient. It was unknown if the patient received treatment for the events. At the time of reporting, the outcome of the events was reported as not recovered.      The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Vaccine positive rechallenge
Clinical narrative: muscle ache; This case was reported by a nurse via call center representative and described the occurrence of muscle pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date(refer case US2019127856)).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the muscle pain was recovered/resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix in an unknown arm. The reporter was the patient who wanted to remain anonymous and refused to answer questions. The patient received dose of Shinrix in the opposite arm and experienced deep muscle ache for 6 weeks before it resolved. Limited data were reported, as the patient did not want a report filed and wanted to get off phone. For the tollerence of 1st dose, refer case US2019127856, reported by same reporter. This case has been linked with master case US2019AMR128562, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: swollen injection site; sore injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The reporter was the patient,wanted to remain anonymous and refused to answer questions. The nurse patient reported that, at the time of reporting to the clinic, they told her that they had other patients, had the same reaction of severely sore and swollen at injection site. This case has been linked with US2019AMR128561 and US2019127856 reported by the same reporter.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at injection site; Redness at injection site; Itching at injection site; Injection site Pain; Injection site Warm to Touch; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received in February 2019, for tolerance refer case US2019AMR128501).   On 11th July 2019, the patient received the 2nd dose of Shingrix. On 11th July 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site itching, injection site pain and injection site warmth. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site itching, injection site pain and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site itching, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient's wife reported the case.  Approximately 2 days following the 2nd dose of Shingrix, the patient experienced swelling, redness, itching, pain, and warm to touch, all at the injection site.  The reporter stated, by the third day, all symptoms were resolved. The reporter provided details of the patient's physician for further follow up.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Swelling at injection site; Redness at injection site; Itching at injection site; Injection site Pain; Injection site Warm to Touch; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received in February 2019, for tolerance refer case US2019AMR128501).   On 11th July 2019, the patient received the 2nd dose of Shingrix. On 11th July 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site itching, injection site pain and injection site warmth. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site itching, injection site pain and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site itching, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient's wife reported the case.  Approximately 2 days following the 2nd dose of Shingrix, the patient experienced swelling, redness, itching, pain, and warm to touch, all at the injection site.  The reporter stated, by the third day, all symptoms were resolved. The reporter provided details of the patient's physician for further follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: muscle ache/ muscles were tender to the touch; swollen arm/swollen at injection site; sore arm/sore at injection site.; This case was reported by a nurse via call center representative and described the occurrence of swelling arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm, pain in arm and muscle pain. On an unknown date, the outcome of the swelling arm, pain in arm and muscle pain were recovered/resolved.   It was unknown if the reporter considered the swelling arm, pain in arm and muscle pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient,wanted to remain anonymous and refused to answer questions. The patient reported that, at the time of reporting to the clinic, they told her that they had other patients,had the same reaction. The patient stated that, she had sever swollen and sore injection site reaction and also had swollen and sore arm for a significant amount of time including the bicep and forearm for almost 2 months. It was a deep muscle ache lasting beyond 4 weeks which the muscles were tender to the touch and achy. Limited data were reported, as the patient did not want a report filed and wanted to get off phone. For tolerance to 2nd dose of Shingrix, refer case US2019AMR128561.  This case was linked with the master case US2019AMR128562, reported by the same reporter.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number BF4J5, expiry date 5th July 2021) for prophylaxis.   On 29th April 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, 49 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 received Shingrix in Left deltoid. The reporter stated that, the patient and his wife received the Shingrix vaccine on 29th April 2019. About 7 weeks after the 1st dose, the patient got the shingles. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Pain, Rash
Clinical narrative: pain; warm; rash; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 9235B, expiry date 29th November 2021) for prophylaxis.   On 12th July 2019, the patient received Shingrix. On 14th July 2019, 2 days after receiving Shingrix, the patient experienced pain, feeling of warmth and rash. On an unknown date, the outcome of the pain, feeling of warmth and rash were not recovered/not resolved.   The reporter considered the pain, feeling of warmth and rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The reporter wanted to  speak to medical information on how to instruct patient to treat these symptoms. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering)
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) (batch number ZP3P9, expiry date 10th September 2021) for prophylaxis.   On 12th April 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient's age at event onset was not reported but it could be 72 years or 73 years. The patient received Shingrix in left deltoid. On an unknown date in July 2019, the patient developed shingles. The reporter consented to follow up and provided contact details. There was a discrepancy in the reported outcome of the event shingles. In database, outcome was mentioned as recovering/resolving and in the database, it was autoloaded as not recovered/not resolved. However outcome of the event is captured as autoloaded in database.
Age: 0.42
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Erythema, Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling
Clinical narrative: swelling to right thigh, knee , lower leg; redness right thigh, knee , lower leg; This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 5-month-old female patient who received Hib (Hiberix) (batch number FG97X, expiry date 17th October 2020) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVNAR) for prophylaxis.   On 11th June 2019, the patient received the 1st dose of Hiberix, Infanrix and PREVNAR. On 11th June 2019, less than an hour after receiving Hiberix and not applicable after receiving Infanrix, the patient experienced extensive swelling of vaccinated limb and redness of legs. On an unknown date, the outcome of the extensive swelling of vaccinated limb and redness of legs were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and redness of legs to be related to Hiberix.  Additional details were provided as follows: The patient had Hiberix vaccine in right thigh. Within five minutes after Hibrix administration, the patient developed redness and swelling to the right thigh, right knee and right lower leg. On the same day, the patient also had Prevnar in right thigh and Infanrix to left thigh. No report of any issue with left thigh or leg. The reporter stated, she was probably going to send patient to allergist but was looking for more information and she was transferred to medical information center for further information. The reporter consented to follow up. It was unknown if the reporter considered the extensive swelling of vaccinated limb and redness of legs to be related to Prevenar.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number XJ57B, expiry date 18th October 2021) for prophylaxis.   On 9th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 12th July 2019, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. On 12th July 2019 at night, the patient went to the pharmacy and reported that she was diagnosed with Shingles. There was a discrepancy in the reported outcome of the event shingles. In database, the outcome was mentioned as recovering/resolving and in the database, it was autoloaded as not recovered/not resolved. However outcome of the event is captured as autoloaded in database.
Sex: F
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Patient received vaccines that were previously exposed to temperatures below 32 degrees F; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA192700, 2019SA193109, 2019SA193112, 2019SA193110, 2019SA193113, 2019SA193107, 2019SA193106, 2019SA193105, 2019SA192698 and 2019SA192699. (Same reporter).  This case involves a 9 months old female patient who received 0.5 mL dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot UI969AAB, expiry date- 04-Apr-2020) via intramuscular route in unknown administration site on 28-Jun-2019, which was previously exposed to temperatures below 32 degrees F.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Genital pain, Pyrexia, Rash, Swelling face
Clinical narrative: Patient developed a rash, low grade fever, pain in private area, and "chipmunk" cheeks
Age: 77.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash pruritic
Clinical narrative: Developed a "migrating" intensily itchy, bumpy rash starting about a week to 10 days following second injection.   The rash began over upper back/shoulder blades and within 2-3 weeks migrated to upper arms and  around chest; within a few more weeks went to abdominal area, then around back to upper buttocks. By end of July the rash is predominantly on thighs with less intense itching on shoulders and chest.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Urticaria
Clinical narrative: Swelling at the injection site, hives around the neck. Patient came in to the doctor's office again for a follow-up appointment on 07/24/2019 and the pt claimed the symptoms still present but are improving.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Axillary pain, Erythema, Fatigue, Insomnia
Clinical narrative: Pain down arm to fingers, shoulder pain, neck pain, underarm pain.  Swollen upper arm. Warm to the touch. Low grade fever, weak and very tired. A few red spots appeared on front of neck that itch. Pain so bad at night, couldn't find a position to sleep without pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Pain down arm to fingers, shoulder pain, neck pain, underarm pain.  Swollen upper arm. Warm to the touch. Low grade fever, weak and very tired. A few red spots appeared on front of neck that itch. Pain so bad at night, couldn't find a position to sleep without pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: Pain down arm to fingers, shoulder pain, neck pain, underarm pain.  Swollen upper arm. Warm to the touch. Low grade fever, weak and very tired. A few red spots appeared on front of neck that itch. Pain so bad at night, couldn't find a position to sleep without pain.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: fever, chills, and shivering lasting for ~ 6 hours
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Cough, Influenza A virus test negative, Influenza B virus test
Clinical narrative: 07/23/19 patine was seen by Dr at his office..  He complained of cough, myalgia, light sensitivity and abdominal pain with fever and chills.  Test for Flu A and B were negative and his urinalysis test was negative.  Levaquin  500mg  daily was ordered .  Dr spoke with patient the next day,   The patient stated he was feeling better and had not taken the antibiotic.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza virus test negative, Myalgia, Photophobia, Pyrexia, Urine analysis normal
Clinical narrative: 07/23/19 patine was seen by Dr at his office..  He complained of cough, myalgia, light sensitivity and abdominal pain with fever and chills.  Test for Flu A and B were negative and his urinalysis test was negative.  Levaquin  500mg  daily was ordered .  Dr spoke with patient the next day,   The patient stated he was feeling better and had not taken the antibiotic.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 73-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 28-OCT-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles.  The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at injection site; Redness at injection site; Itching at injection site; Injection site Hot to Touch; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In February 2019, less than an hour after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site itching, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site itching, injection site warmth and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site itching, injection site warmth and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient receiving first dose Shingrix in late February 2019. Following vaccination, the patient experienced swelling, redness, itching, pain and hot to touch at the injection site.  It was reported that after the first dose symptoms lasted a day or so.  The reporter had consented to follow up. The case has been linked with the case US2019AMR128477, reported by same reporter for same patient.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak; This case was reported by a consumer and described the occurrence of shingles in a 50-year-old 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, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had 1st dose of Shingrix and it was time for 2nd dose. The patient experienced a mild shingles outbreak. The patient asked, could he go ahead with the 2nd shot
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Cough, Headache, Influenza like illness, Nasal congestion, Pyrexia
Clinical narrative: Fever; Flu-like symptoms; Headache; cough and nasal congestion; cough and nasal congestion; This case was reported by a nurse via call center representative and described the occurrence of fever in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABX769AA, expiry date 31st July 2020) for prophylaxis.   On 12th June 2019, the patient received the 1st dose of Bexsero (intramuscular). On 12th June 2019, less than a day after receiving Bexsero, the patient experienced fever, influenza-like symptoms, headache, cough and nasal congestion. On an unknown date, the outcome of the fever, influenza-like symptoms, headache, cough and nasal congestion were recovered/resolved.   It was unknown if the reporter considered the fever, influenza-like symptoms, headache, cough and nasal congestion to be related to Bexsero.  Additional details were provided as follows: The patient experienced flu-like symptoms which were described as cough and nasal congestion.
Age: 87.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 87-year-old patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date 18th May 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On 15th July 2019, less than a year after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced a red area 5 inches long and 3 inches wide at the Shingrix injection site following Shingrix administration.  The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: chicken pox like rash upper back and torso; itchy rash; This case was reported by a pharmacist via call center representative and described the occurrence of varicella-like rash in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 21st September 2021) for prophylaxis.   On 17th June 2019, the patient received the 1st dose of Shingrix. In June 2019, 2 days after receiving Shingrix, the patient experienced varicella-like rash and itchy rash. In June 2019, the outcome of the varicella-like rash and itchy rash were recovered/resolved.   It was unknown if the reporter considered the varicella-like rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced a chicken pox like rash on upper back and torso that started two days after the Shingrix vaccination, and resolved approximately 5 days later.  The rash was slightly itchy during that time.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number P2275, expiry date 25th September 2021) for prophylaxis.   On 3rd July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 5th July 2019, 2 days after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 83 or 84 years. The pharmacist stated that the patient received Shingrix and developed a rash at the injection site, about 2 inches in diameter. There was no itching, it was not hot to touch, it was just a rash. The rash has resolved, but the date of resolution was unknown to the pharmacist. The reporter did not consent to follow up. The pharmacist stated that the VAERS report was already completed.  No further details were provided, and specialist neglected to clarify whether safety has permission to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Blood glucose increased, Condition aggravated, Type 1 diabetes mellitus
Clinical narrative: sugar blood increased; condition aggravated; This case was reported by a nurse via call center representative and described the occurrence of blood sugar increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus.   On 15th July 2019, the patient received the 1st dose of Shingrix. On 15th July 2019, unknown after receiving Shingrix, the patient experienced blood sugar increased and condition aggravated. On an unknown date, the outcome of the blood sugar increased and condition aggravated were unknown.   It was unknown if the reporter considered the blood sugar increased and condition aggravated to be related to Shingrix.  Additional detauils were provided as follows: The age group was not reported, but selected as an adult as per vaccine indication. The reporter reported that, after receiving dose of Shingrix, the patient had  large increase in there blood sugars.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: pain left arm; Pain in shoulder; pain when moving arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th April 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, shoulder pain and pain upon movement. On an unknown date, the outcome of the pain in arm, shoulder pain and pain upon movement were recovering/resolving.   The reporter considered the pain in arm, shoulder pain and pain upon movement to be related to Shingrix.  Additional information received were as follows: The caller was a patient. The patient received 1st dose of Shingrix on left deltoid. The caller stated that within 24 hours after receiving Shingrix, he experienced pain in the left arm that ascended into his left shoulder.  The patient stated that when he moved the left arm, it was painful.  The patient believed that the pain was related to the vaccine.  The patient stated that it was starting to improve some, but not completely resolved.  The patient was not planning to get the 2nd dose of Shingrix. The reporter consented to follow up. The caller did not provide any additional information.
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: hives; This case was reported by a nurse via call center representative and described the occurrence of hives in a child female patient who received DTPa (Infanrix) (batch number HY2G7, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, unknown after receiving Infanrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Infanrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse stated that patient developed hives after receiving 3 immunizations in one day, one of which was Infanrix. The reporter had not expiration date. It was unknown if the reporter considered the hives to be related to other 2 vaccines (unspecified). The reporter had consented to follow up.
Age: 19.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: @11:55am, patient received MGC/HPV VACCINE per PCC order. Right after patient received both vaccines, patient stated she's light headed then  went unconscious . Code Blue was paged overhead. Patient is sitting  in chair , placed patient on a lying position on her back with both  legs elevated. Multiple staff members came to help and responded quick. 911 was called.  Vital Signs 146/76,  pulse 76, 02 sat 67 % at 3L /min.   At 12:05 pm, transport arrived. Patient is alert , verbally responsive , stating " i still feel a little light headed". VS 124/80, pulse 77, 02 sat 99%  at 3l/min.   @12:18pm, transport left the building without the patient. Per patient, she feels better , just slight light headedness and per patient, she will stay here in the clinic .  Advised patient to stay in the clinic to be monitored until she feels better.   At 12:22 pm, patient is alert and verbally responsive. Denies pain, no SOB,  no light headedness. Per patient , she feels better. . VS 117/77, pulse 69, o2 sat 99%. Patient left the immunization clinic with her mother. Advised patient to report to his provider regarding the incident that happened today.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: LOCALIZED REDDNESS, SWELLING AND PAIN
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Back pain, Headache, Injection site erythema, Injection site pain
Clinical narrative: Injection site pain, swelling, redness. Headache. Fever. Lower back pain. Extremely tender and painful left armpit
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia, Tenderness
Clinical narrative: Injection site pain, swelling, redness. Headache. Fever. Lower back pain. Extremely tender and painful left armpit
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 17 year old in clinic with limited vaccine history.  Relocated from another country.  Received Tdap in February 2019.  Given Tdap instead of TD for vaccine.  No adverse complications noted.  Pt observed 20 minutes following immunization.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 15 year old in clinic with limited vaccine history.  Relocated from another country.  Received Tdap in February 2019.  Given Tdap instead of TD for vaccine.  No adverse complications noted.  Pt observed 20 minutes following immunization.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Dysstasia, Headache, Heart rate increased
Clinical narrative: Yesterday I took part 1 of 2 of the Shingles Vaccine and got a reaction that was only relieved by taking some Benadryl. Shortly after receiving the shot at the Drug Store I got dizzy, then shaky, my heart rate increased and my vision got funny. After that I became nauseous, got a headache and I found it difficult to stand and breath.  Yes, my arm is sore where injected, but I expected that.  I reported what happened to the pharmacist and she wondered if my doctor would want me to avoid the second shot due in two months.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Tremor, Visual impairment
Clinical narrative: Yesterday I took part 1 of 2 of the Shingles Vaccine and got a reaction that was only relieved by taking some Benadryl. Shortly after receiving the shot at the Drug Store I got dizzy, then shaky, my heart rate increased and my vision got funny. After that I became nauseous, got a headache and I found it difficult to stand and breath.  Yes, my arm is sore where injected, but I expected that.  I reported what happened to the pharmacist and she wondered if my doctor would want me to avoid the second shot due in two months.