chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Immediate post-injection reaction, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX. On 31st August 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced fever and shivers. On 2nd September 2018, the outcome of the injection site pain was recovered/resolved. In September 2018, the outcome of the fever and shivers were recovered/resolved. It was unknown if the reporter considered the injection site pain, fever and shivers to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had a SHINGRIX vaccination and experienced immediate pain and soreness at the injection site that lasted a couple of days along with fever and shiver symptoms. The patient had his 2nd SHINGRIX vaccination today 16th November 2018 at a pharmacy and experienced no pain or any symptoms. The patient did not feel the medicine enter to his arm which he did the first time. Also there was a loud swishing noise when the pharmacy employee injected him. The patient was asking that did this sound was normal. Was there a blood test which he could get to verify that he received the 2nd SHINGRIX vaccination. Due to the shortage of the SHINGRIX vaccination and unethical people in society. The patient concern was he got a shot of air.
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Movement disorder, Muscle atrophy, Muscular weakness, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 8th November 2018, the patient received the 1st dose of SHINGRIX. On 8th November 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. In November 2018, the patient experienced pain in arm, movement disorder, weakness of arms, muscle atrophy and numbness in fingers. The patient was treated with VALTREX, TORADOL and LYRICA. On an unknown date, the outcome of the pain in arm, movement disorder, muscle atrophy, numbness in fingers and vaccine administered at inappropriate site were unknown and the outcome of the weakness of arms was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, movement disorder, weakness of arms, muscle atrophy and numbness in fingers to be related to SHINGRIX. Additional details were reported as follows: The patient experienced severe arm pain, the patient couldn't lift arm, about 5 days after vaccination. The patient experienced severe arm pain and weakness. The sharp pains was down arm. They started the patient in VALTREX, did a pretnazone shot, a TORADOL shot and at the time of reporting the patient was on LYRICA. The patient on the day of reporting, said about 3 by 4 pain gone, but still had weakness. The patient was still on LYRICA. The physician said there was some muscle atrophy. The patient had numbness in thumb when the sharp upper arm pain strikes. The patient did mention to her that he thought the injection was given lower on his arm, which led to vaccine administered at inappropriate site. The reporter requested to follow up with the office to know that their adverse event was reported and to discuss. The reporter did agree to follow up from GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 8th November 2018, the patient received the 1st dose of SHINGRIX. On 8th November 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. In November 2018, the patient experienced pain in arm, movement disorder, weakness of arms, muscle atrophy and numbness in fingers. The patient was treated with VALTREX, TORADOL and LYRICA. On an unknown date, the outcome of the pain in arm, movement disorder, muscle atrophy, numbness in fingers and vaccine administered at inappropriate site were unknown and the outcome of the weakness of arms was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, movement disorder, weakness of arms, muscle atrophy and numbness in fingers to be related to SHINGRIX. Additional details were reported as follows: The patient experienced severe arm pain, the patient couldn't lift arm, about 5 days after vaccination. The patient experienced severe arm pain and weakness. The sharp pains was down arm. They started the patient in VALTREX, did a pretnazone shot, a TORADOL shot and at the time of reporting the patient was on LYRICA. The patient on the day of reporting, said about 3 by 4 pain gone, but still had weakness. The patient was still on LYRICA. The physician said there was some muscle atrophy. The patient had numbness in thumb when the sharp upper arm pain strikes. The patient did mention to her that he thought the injection was given lower on his arm, which led to vaccine administered at inappropriate site. The reporter requested to follow up with the office to know that their adverse event was reported and to discuss. The reporter did agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a adult patient who received SHINGRIX for prophylaxis. In October 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The nurse reported that, 5 to 6 weeks before the time of reporting the patient received SHINGRIX. At the time of reporting, the patient appeared to had shingles on their abdomen. The reporter wanted to know the information about on outbreaks post vaccination. The reporter was agreed to follow up from GlaxoSmithKline. This case was considered as suspected vaccination failure, as the details regarding vaccination schedule and exact time to onset for the event were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX (batch number MY2B2, expiry date unknown) for prophylaxis. On 8th November 2018, the patient received SHINGRIX (intramuscular). On 8th November 2018, several minutes after receiving SHINGRIX, the patient experienced shingles and rash. The patient was treated with antivirals for systemic use (Antiviral). On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. On the day of reporting, the patient received SHINGRIX on left deltoid. A few minutes after receiving SHINGRIX, the patient experienced a rash on the axilla area on the opposite side where the vaccine was administered. The cause of this rash was unknown, but shingles was being considered as a cause. A reaction to the vaccine and/or a yeast infection were considered as possible causes. The nurse declined to provide patient information. The nurse declined postal follow-up and agreed for phone call follow-up only.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 83-year-old female patient who received SHINGRIX for prophylaxis. On 2nd October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, 1 day after receiving SHINGRIX, the patient experienced pruritus and red blotches. On an unknown date, the outcome of the pruritus was recovering/resolving and the outcome of the red blotches was recovered/resolved. It was unknown if the reporter considered the pruritus and red blotches to be related to SHINGRIX. Additional information was reported as follows: The patient received the vaccine in left arm. The next day following vaccination, the reporter began to experience itching on the upper part of her body for a whole month. After that it subsided a little, but the patient still had it six weeks after the vaccination. The itching started under her breasts and extended up to the sides of her neck. The patient had small red blotches on her upper chest which resolved after a couple of weeks. The itching had reduced in severity but had still not fully resolved at the time reporting. The patient enquired if the reaction experienced by her was normal or not, as it was not listed as one of the side effects. The patient also enquired whether the same thing would happen after vaccination with the second dose also and how long it would take to stop it altogether. The patient was told there are two types of vaccines, one with eggs as an ingredient and one without, where the person who told the patient had requested one without eggs and was given that one. The patient's pharmacist said that he didn't knew anything about this, that there was only one type with eggs. The patient requested to enlighten her on this and would much prefer not having eggs in her system. The reporter provided permission for her physician to be contacted but couldn't provide the name of physician because they had left the practice. Unable to obtain additional information.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Coagulation test normal, Gait disturbance, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of leg pain in a 90-year-old male patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, 14 days after receiving SHINGRIX, the patient experienced leg pain, swelling of legs, walking difficulty and knee pain. The patient was treated with Ice Pack (No Medication). On an unknown date, the outcome of the leg pain and knee pain were unknown and the outcome of the swelling of legs and walking difficulty were recovered/resolved. It was unknown if the reporter considered the leg pain, swelling of legs, walking difficulty and knee pain to be related to SHINGRIX. Additional details were provided as follows: Around 2nd or 3rd October 2018, the patient received 2nd dose of SHINGRIX. About 2 weeks later, the patient developed pain in upper part of his leg and he had difficulty walking. Then the patient developed swelling in his leg and severe pain went down to his foot. The patient saw his physician and they tested for a blood clot which was negative. It was 3 weeks till the time of reporting after the event started and he still had pain in his left foot, left lower leg and left knee if he touched it. It does not usually hurt with regular activity. The swelling went down within about 24 to 36 hours after it peaked, but it did onset gradually. The patient was treated the swelling with ice packs. The reporter did not consent to follow-up.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of leg pain in a 90-year-old male patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, 14 days after receiving SHINGRIX, the patient experienced leg pain, swelling of legs, walking difficulty and knee pain. The patient was treated with Ice Pack (No Medication). On an unknown date, the outcome of the leg pain and knee pain were unknown and the outcome of the swelling of legs and walking difficulty were recovered/resolved. It was unknown if the reporter considered the leg pain, swelling of legs, walking difficulty and knee pain to be related to SHINGRIX. Additional details were provided as follows: Around 2nd or 3rd October 2018, the patient received 2nd dose of SHINGRIX. About 2 weeks later, the patient developed pain in upper part of his leg and he had difficulty walking. Then the patient developed swelling in his leg and severe pain went down to his foot. The patient saw his physician and they tested for a blood clot which was negative. It was 3 weeks till the time of reporting after the event started and he still had pain in his left foot, left lower leg and left knee if he touched it. It does not usually hurt with regular activity. The swelling went down within about 24 to 36 hours after it peaked, but it did onset gradually. The patient was treated the swelling with ice packs. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced localized erythema, skin warm and local swelling. On an unknown date, the outcome of the localized erythema, skin warm and local swelling were unknown. It was unknown if the reporter considered the localized erythema, skin warm and local swelling to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter stated that the patient developed a raised, red area on the left deltoid muscle that was warm to touch after their dose of SHINGRIX. The reporter stated that the area was large and was about the size of a baseball. The reporter consented to follow up. The reporter was also the niece of the patient.
Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site reaction
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site reaction in a 74-year-old patient who received SHINGRIX (batch number GG2GA, expiry date 16th April 2021) for prophylaxis. On 16th November 2018, the patient received SHINGRIX (subcutaneous). On 16th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site reaction and intramuscular formulation administered by other route. The patient was treated with steroid cream. On an unknown date, the outcome of the injection site reaction and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX subcutaneously above the left bicep, which led to intramuscular formulation administered by other route. The patient developed an injection site reaction and was given a steroidal cream.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site pain, Injection site swelling, Rash erythematous, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 72-year-old male patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain, diarrhea, red rash and itchy rash. The patient was treated with Antibiotics (Brand Names Not Known) and topical Steroid Cream. On an unknown date, the outcome of the injection site swelling, injection site pain and diarrhea were unknown and the outcome of the red rash and itchy rash were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site pain, diarrhea, red rash and itchy rash to be related to SHINGRIX. Additional information was reported as follows: The patient's wife reported the case. The patient was vaccinated with the second dose of SHINGRIX, approximately three weeks ago before the date of reporting. The patient experienced injection site swelling and injection site pain and diarrhea. The patient also experienced rash on his back and legs that was red and itchy. The patient was treated by dermatologist with antibiotics and steroid cream but the rash and itchiness had not resolved. The reporter requested to remain anonymous and declined to follow up with the physician. Consent to follow-up was not provided.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of tiredness in a 63-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received on an unknown date). In August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness and muscle pain. On an unknown date, the outcome of the tiredness and muscle pain were recovered/resolved. It was unknown if the reporter considered the tiredness and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's wife and also a registered nurse. The patient received SHINGRIX in the arm and within 24 hours the patient felt very tired and developed severe muscle pain. These symptoms lasted for approximately 6 weeks before going away. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in approximately 5 adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The physician reported that she had seen approximately 5 patients reporting heat and redness at the injection site following the 1st dose of SHINGRIX. The SHINGRIX vaccine had been administered at several local pharmacies. The reporting physician did not keep a log of patient information and had no access to product details. The patients reported symptoms to the doctor over the last few months. It was possible but not verifiable that these patients had previously been reported.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of loose stools in a 67-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included multiple sclerosis and diabetes. In November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, 3 days after receiving SHINGRIX, the patient experienced loose stools and pain in arm. On an unknown date, the outcome of the loose stools and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the loose stools and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the left arm approximately 2 weeks ago from the date of reporting. The patient stated that 3 days after receiving the dose he developed loose watery stools. The patient stated that he tried not eating for a couple of days and also tried a bland diet and nothing seems to be helping with the loose stools. The patient also reported soreness around the injection site on his left arm. The patient did not consent to be followed-up.
Sex: M
Vaccine: FLUX
Symptoms: Torticollis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of torticollis in a adult male patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced torticollis. On an unknown date, the outcome of the torticollis was unknown. It was unknown if the reporter considered the torticollis to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. After receiving unknown Flu vaccine, the patient experienced torticollis. The physician consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. Six months before the date of reporting, the patient received 1st dose of SHINGRIX and experienced pain in arm. For tolerance to the 2nd dose of SHINGRIX refer case US2018216884, reported by the same reporter for the same patient.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Dizziness, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose six months before the date of reporting, refer case US2018216881). In November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms, dizziness and blood pressure decreased. In November 2018, the outcome of the influenza-like symptoms and dizziness were recovered/resolved. On an unknown date, the outcome of the blood pressure decreased was unknown. It was unknown if the reporter considered the influenza-like symptoms, dizziness and blood pressure decreased to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. Two weeks before the date of reporting, the patient received 2nd dose of SHINGRIX and experienced flu-like symptoms which lasted 48 hours, dizziness and blood pressure decreased.
Sex: U
Vaccine: RAB
Symptoms: Product dose omission
Clinical narrative: Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves an unknown age patient who past the day seven dose and now he is at two weeks, while he/she supposed to received vaccine IMOVAX RABIES on an unknown date via unknown route in unknown site of administration. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to missed dose. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow up 28-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. No additional information received. List of documents held by sender: none.
Age: 1.67
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a three and half years old female patient who received the first dose vaccine PENTACEL (Batch number, expiry date and dose not reported) when she was 20 months old on an unknown date via unknown route in unknown site of administration. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. It was a case of actual medication error due to Inappropriate schedule of vaccine administered. It was not reported if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV4, MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional via phone. This case involves a 16-years old female patient who received an 0.5ml dose of expired vaccine MENACTRA on 20-Nov-2018 (lot number: U5752AA, expiry date: 16-Nov-2018) via unknown route in the deltoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLULAVAL and Gardasil for Immunisation on 20-Nov-2018. It was a case of actual medication error due to expired vaccine used because the patient had advertently administered an expired MENACTRA (single dose vial). The MENACTRA expired on 16-Nov-2018 and it was administered on 20-Nov-2018. It was not reported if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 48.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Incorrect route of product administration, Injection site vesicles, Wrong product administered
Clinical narrative: Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a other health care professional (Medical Assistant). This case involves a 48 years old female patient who experienced blister developed on her left forearm at the site, while she received vaccine ADACEL instead of TUBERSOL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Sep-2018, the patient received concomitant vaccination with 0.5 ml dose of FLUZONE QUADRIVALENT via intramuscular route. On 10-Sep-2018, the patient received a 0.1 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot CI546CA, expiry date: 21-Nov-2020 via intradermal route in the left forearm. On an unknown date, the patient experienced a non-serious blister developed on her left forearm at the site (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was an actual medication error due to wrong vaccine administered. It was reported that ADACEL was inadvertently administered intradermally to a patient. Patient was supposed to receive TUBERSOL. Other relevant tests included no lab data. Final diagnosis was blister developed on her left forearm at the site. The patient was treated with PREDNISONE for Product used for unknown indication. On an unknown date, the patient was recovering/resolving for blister developed on her left forearm at the site. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Rhinorrhoea
Clinical narrative: Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional (patient himself) via Acroda Affiliate Biogen (RCT-11092018-235603). This case involves a 62 years old male patient who experienced runny nose, sniffling symptoms, while he received vaccine INFLUENZA VACCINE and while treated with AMPYRA and TECFIDERA. The patient's past medical history included Gait disturbance. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included BACLOFEN for Product used for unknown indication. On an unknown date, the patient started taking AMPYRA dosage unknown route unknown (with an unknown batch number) for Gait disturbance and TECFIDERA 240 mg BID oral (with an unknown batch number) for Multiple sclerosis. On 08-Nov-2018, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, dose, dose in series were not reported) via unknown route in unknown administration site. The patient developed a non-serious runny nose, sniffling symptoms following the first dose intake and following the last dose intake of FAMPRIDINE and following the first dose intake and following the last dose intake of DIMETHYL FUMARATE. The patient developed a non-serious runny nose, sniffling symptoms following the administration of INFLUENZA VACCINE. It was also reported as the patient had a flu shot yesterday (from date of initial report) and that is why the patient had the symptoms. No additional information was provided. Other relevant tests included no lab test was reported. Final diagnosis was runny nose, sniffling symptoms. AMPYRA and TECFIDERA actions taken were unknown. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for runny nose, sniffling symptoms. The reporter (patient) did not assess the causal relationship between AMPYRA and runny nose; sniffling symptoms. Documents held by the sender: none.
Age: 24.0
Sex: M
Vaccine: HEPA, HEPA, HEPA
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Pt received Hepatitis A injection at work place clinic on 10/3/2018, started having swelling, redness and a knot  at the injection site shortly after the injection. Area seemed to worsen over the next 2-3 weeks. He says he was treated with steriods and bactrim but no improvement. He has been seen by Dr.
Age: 24.0
Sex: M
Vaccine: HEPA, HEPA, HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Pt received Hepatitis A injection at work place clinic on 10/3/2018, started having swelling, redness and a knot  at the injection site shortly after the injection. Area seemed to worsen over the next 2-3 weeks. He says he was treated with steriods and bactrim but no improvement. He has been seen by Dr.
Age: 24.0
Sex: M
Vaccine: HEPA, HEPA, HEPA
Symptoms: Arthralgia, Corynebacterium test positive, Injection site swelling, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt received Hepatitis A injection at work place clinic on 10/3/2018, started having swelling, redness and a knot  at the injection site shortly after the injection. Area seemed to worsen over the next 2-3 weeks. He says he was treated with steriods and bactrim but no improvement. He has been seen by Dr.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: ON 12/5/2018 PATIENT CAME TO THE PHARMACY SHARING WITH ME THAT ON OR AROUND 11/30/2018 HE NOTICED HIS ARM WOULD HURT AS HE RAISED IT UP. HE DID MENTION THAT A WEEK OR SO AFTER IMMUNIZATION HE HAD CUT DOWN A TREE. LOOKED AT PATIENT'S ARM SAW NO REDNESS OR SWELLING. PATIENT HAS NOT TAKEN ANY OVER THE COUNTER PAIN RELIEF TO HELP OR APPLIED ANY FORM OF THERAPY TO THE ARM. HE HAS NO FEVER. PATIENT HAS HAD INFLUENZA SHOTS IN THE PAST WITH NO ISSUES.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Pt received vaccine on 12/3/18 at 1:30pm. Itchiness and swelling developed on left arm and hand on 12/4/18 at 6 pm. Pt went to ER doctor on 12/5/18 in the afternoon and doctor suggested antihistamine (allegra) for patient. Pt is doing well today (12/6/18) and swelling has gone down just a little and itchiness as well.
Age: 45.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory nodule that is sore and red.
Age: 45.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Abscess, Culture, Debridement, Fungal test, Gram stain negative
Clinical narrative: Inflammatory nodule that is sore and red.
Age: 45.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Injection site pain, Mycobacterium test negative, Ultrasound scan, Wound treatment
Clinical narrative: Inflammatory nodule that is sore and red.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Gait inability, Injection site pain, Injection site swelling
Clinical narrative: Leg pain and extreme leg swelling, lasted 12 hours, unable to walk on it.
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to touch.
Age: 37.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pharyngeal oedema
Clinical narrative: Upper right arm swelling, redness, severe pain and itch. 2 nights post vaccination, throat swelling relieved by Benadryl. Tylenol not helping with pain at all.
Age: 28.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Hep a #2 was given 6 weeks after the first dose, not at the recommended interval as an error no adverse reactions were reported by the patient or noted on follow up exam 6 months later.
Age: 31.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PATIENT RECEIVED MULTIPLE PNEUMONAX SHOTS STARTING 2012, 2ND, 3RD AND 4TH IN 2016
Age: 31.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: PATIENT RECEIVED MULTIPLE PNEUMONAX SHOTS STARTING 2012, 2ND, 3RD AND 4TH IN 2016
Age: 40.0
Sex: M
Vaccine: FLU3, HEPA, PPV, UNK
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 40.0
Sex: M
Vaccine: FLU3, HEPA, PPV, UNK
Symptoms: Erythema, Pain in extremity
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 53.0
Sex: F
Vaccine: HEPA, PPV, TDAP
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 55.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Pain
Clinical narrative: Headache, body ache, chills, fatigue,upset stomach.
Age: 58.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Inflammation, Needle issue, Nodule, Skin reaction, Syringe issue
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 58.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Tenderness
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 44.0
Sex: M
Vaccine: FLU4, HEPA, PPV, UNK
Symptoms: Erythema, Inflammation, Needle issue, Nodule, Syringe issue
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 44.0
Sex: M
Vaccine: FLU4, HEPA, PPV, UNK
Symptoms: Tenderness
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 44.0
Sex: M
Vaccine: FLU4, HEPA, PPV, UNK
Symptoms: Erythema, Inflammation, Nodule
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory Nodule that is red and tender to touch. Resolved after 7 days no treatment.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Axillary pain, Musculoskeletal chest pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: Employee says she started feeling pain on right side muscle area under armpit down to rib cage. The began as stiffness then it felt very sore.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Axillary pain, Musculoskeletal chest pain, Musculoskeletal stiffness
Clinical narrative: Employee says she started feeling pain on right side muscle area under armpit down to rib cage. The began as stiffness then it felt very sore.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Axillary pain, Musculoskeletal chest pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: On October 30, 2018 at approximately 2:07pm got the Flu Vaccine Shot and within an hour began experiencing pain on my right side muscle under my right arm down my rib cage. The pain began as a stiffness and felt very sore. Each day the pain got worse, when I walk it was very sharp and paralyzing. The pain became more intense and I spoke with an ER Nurse at clinic and she advised to take MOTRIN. On November 2, 2018 a approximately 2:00pm, I went back to see the Occupational Nurse and I was advised to continue taking the MOTRIN. The pain got worse and I had a doctor's visit with Dr. on November 15, 2018 at 10:30pm. Dr. prescribed Diclofenac Sodium Gel and to apply to affected area twice a day. The pain has decreased and I'm feeling better, but still a little sore.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Axillary pain, Musculoskeletal chest pain, Musculoskeletal stiffness
Clinical narrative: On October 30, 2018 at approximately 2:07pm got the Flu Vaccine Shot and within an hour began experiencing pain on my right side muscle under my right arm down my rib cage. The pain began as a stiffness and felt very sore. Each day the pain got worse, when I walk it was very sharp and paralyzing. The pain became more intense and I spoke with an ER Nurse at clinic and she advised to take MOTRIN. On November 2, 2018 a approximately 2:00pm, I went back to see the Occupational Nurse and I was advised to continue taking the MOTRIN. The pain got worse and I had a doctor's visit with Dr. on November 15, 2018 at 10:30pm. Dr. prescribed Diclofenac Sodium Gel and to apply to affected area twice a day. The pain has decreased and I'm feeling better, but still a little sore.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Headache, Influenza like illness, Injection site erythema
Clinical narrative: Injection site : redness, swelling, warm to the touch. Flu-like symptoms, muscle aches, nausea, vomiting, headache, dizziness, itching, weakness. Contacted pharmacy when symptoms continued for 2 1/2 days,  they recommended plenty of fluids, Tylenol, rest. If symptoms did not improve return or go to ER to be hydrated. On 4th day symptoms began to subside and some improvement occurred. Took until day 6 to feel somewhat normal. Visited nurse at clinic and was advised to file report.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Nausea, Pruritus
Clinical narrative: Injection site : redness, swelling, warm to the touch. Flu-like symptoms, muscle aches, nausea, vomiting, headache, dizziness, itching, weakness. Contacted pharmacy when symptoms continued for 2 1/2 days,  they recommended plenty of fluids, Tylenol, rest. If symptoms did not improve return or go to ER to be hydrated. On 4th day symptoms began to subside and some improvement occurred. Took until day 6 to feel somewhat normal. Visited nurse at clinic and was advised to file report.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Injection site : redness, swelling, warm to the touch. Flu-like symptoms, muscle aches, nausea, vomiting, headache, dizziness, itching, weakness. Contacted pharmacy when symptoms continued for 2 1/2 days,  they recommended plenty of fluids, Tylenol, rest. If symptoms did not improve return or go to ER to be hydrated. On 4th day symptoms began to subside and some improvement occurred. Took until day 6 to feel somewhat normal. Visited nurse at clinic and was advised to file report.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 20-APR-2007, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 03-MAR-2014, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding patient's concomitant medications, concurrent conditions or medical history. On or about 22-FEB-2008, the patient was vaccinated with ZOSTAVAX (strength, dose, route, anatomical location, lot number and expiration date were not reported), to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On an unknown date in 2008, the patient experienced shingles (Herpes zoster) and on or about 12-APR-2008, was treated by a healthcare provider at an internal medicine. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (Vaccination failure) and suffered serious physical, emotional, and economic damages (Emotional distress), as a result of patient's injuries on unknown dates. The patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering (Emotional distress) (Pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (Condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The relatedness between ZOSTAVAX and the aforementioned events was assessed as related by the reporter. The reporter determined all the events to be serious due to disability, life-threatening and medically significant.