chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an other referring to a 12 month old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 13-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX injection (strength, dose, frequency and route were not reported) (lot # N020013 and expiry date: 17-JUL-2019) for prophylaxis. The administered dose of VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiry date were not reported). The vaccine was stored in between -14 degrees Celsius (C) to -10 C (-14.37 C) for 15 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA008334.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient received dose of improperly stored VARIVAX; This spontaneous report was received from an other referring to a 12 month old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 20-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX injection (strength, dose, frequency and route were not reported) (lot # N020013 and expiry date: 17-JUL-2019) for prophylaxis. The administered dose of VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiry date were not reported). The vaccine was stored in between -14 degrees Celsius (C) to -10 C (-14.37 C) for 15 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA008334.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an other referring to a 12 month old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 09-APR-2018, the patient was vaccinated with improperly stored dose of VARIVAX injection (strength, dose, frequency and route were not reported) (lot # N020013 and expiry date: 17-JUL-2019) for prophylaxis. The administered dose of VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # and expiry date were not reported). The vaccine was stored in between -14 degrees Celsius (C) to -10 C (-14.37 C) for 15 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA008334.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red, slightly swollen, warm area on anterior left thigh measuring 10x11cm. Area was slightly itchy, no systemic symptoms.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Dizziness, Hypertonia, Injection site pain, Pain in extremity
Clinical narrative: Notes: After vaccinations, patient became dizzy and pale. He had some tensing of arms and was directed to lay down. Glucose was 76. He was given a juice box and some water. At 5 minutes, BP was normal. At 15 minutes, BP was also normal and dizziness had resolved. He did complain of intense pain extending from upper arm to hand on right side where he received the HPV.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pallor
Clinical narrative: Notes: After vaccinations, patient became dizzy and pale. He had some tensing of arms and was directed to lay down. Glucose was 76. He was given a juice box and some water. At 5 minutes, BP was normal. At 15 minutes, BP was also normal and dizziness had resolved. He did complain of intense pain extending from upper arm to hand on right side where he received the HPV.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Pain
Clinical narrative: 30-45 minutes after receiving MCV4 vaccine and her TRUMENBA she got the worst headache she has ever had and was nauseous. Treated with ADVIL and rest and was ok throughout the rest of the day, just a little nauseous. Then throughout the night she continued to have a headache, body aches, sweaty and chilled, and started puking. No fever, temp was 98.1F.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Vomiting
Clinical narrative: 30-45 minutes after receiving MCV4 vaccine and her TRUMENBA she got the worst headache she has ever had and was nauseous. Treated with ADVIL and rest and was ok throughout the rest of the day, just a little nauseous. Then throughout the night she continued to have a headache, body aches, sweaty and chilled, and started puking. No fever, temp was 98.1F.
Age: 30.0
Sex: F
Vaccine: TYP
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Mild rash/redness around injection site.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Malaise, Pallor
Clinical narrative: Child was sitting in exam room chair to receive vaccines. Immediately after receiving second injection (ADACEL), child became diaphoretic, pale, and stated he did not feel well. RN escorted him to exam table, where he lay down. EMS was called. At no point did child lose consciousness. At no point did child fall or hit any part of his body on any surface. At no point did the child become short of breath. There was no visible or palpable local reaction at the vaccine site. Child was assessed by EMS, sat up, sipped water, stated he felt better. Child was taken by EMS to local ER for further evaluation, his father accompanied him.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Severe flu like symptoms (myalgias, fever, chills, fatigue) that developed 24 hours after vaccine was received and lasted for 48 hours.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Laboratory test abnormal
Clinical narrative: This spontaneous report as received from a nurse midwife refers to a female patient of unknown age. The patient had no medical history, concurrent conditions and concomitant medications. On an unknown date, more than 10 years ago, the patient was vaccinated with GARDASIL injection for recommended vaccination (dose, lot # and expiration date were not reported). It was reported that the patient completed the "HPV series". On an unknown date, the patient tested positive for cervical low grade squamous intraepithelial lesion (LGSIL). The nurse reported that the patient did not have cancer. The outcome of the event was unknown. The causality assessment was not reported.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain, Computerised tomogram normal, Enteroclysis, Ultrasound scan normal, Weight decreased
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 12-year-old male patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On 16-AUG-2017, at the age of 11, the patient was vaccinated with the first dose of GARDASIL 9 injection (dose, route of administration, vaccination site, lot number and expiration date were not reported) for prophylaxis. On the same date, the patient was also vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (formulation, dose, route of administration, lot number and expiration date were not reported) and MENACTRA (formulation, dose, route of administration, lot number and expiration date were not reported). On unspecified dates, the patient experienced abdominal pain and weight loss and was referred to multiple unspecified specialists. It was reported the abdominal pain and weight loss resolved on an unspecified date. On 05-MAR-2018, the patient was vaccinated with the second dose of GARDASIL 9 injection (dose, route of administration, vaccination site, lot number and expiration date were not reported) for prophylaxis. On an unspecified date in 2018, the patient experienced exacerbation of abdominal pain and weight loss. It was stated that the symptoms were more severe on an unspecified date. On an unknown date in 2018, the patient was hospitalized (for five days) and on unspecified dates in 2018, upper gastrointestinal (GI) magnetic resonance enteroclysis (MRE), unspecified ultrasound and computerized tomography (CT) scan were performed, which all resulted negative. The patient was treated with omeprazole, nizatidine and "Contaza". The physician reported the patient might have irritable bowel syndrome. The outcome of the events was reported as resolving. It was stated the patient was gaining weight (further described as the patient was at the 38th percentile and dropped to 8th percentile in weight and he was currently at 11.27 percentile). The physician reported that she was not convinced that the patient's symptoms were vaccine related.
Age: 58.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Chills, Diarrhoea, Headache, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of chills in a 58-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. Co-suspect products included ADACEL (batch number C5467BA, expiry date 20th June 2020) for prophylaxis. Additional patient notes included None. On 28th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) and ADACEL. On 2nd July 2018, 4 days after receiving SHINGRIX, the patient experienced chills, electric shock sensation, injection site pain, injection site erythema, headache and diarrhea. The patient was treated with benadryl (nos) (Benadryl) and paracetamol (Tylenol). On an unknown date, the outcome of the chills, electric shock sensation, injection site pain, injection site erythema, headache and diarrhea were recovered/resolved. The reporter considered the chills, electric shock sensation, injection site pain, injection site erythema, headache and diarrhea to be almost certainly related to SHINGRIX. Additional details were provided as follows: No medical history or allergies were reported. The patient received SHINGRIX and ADACEL in the right deltoid. The patient experienced chills, headache, diarrhea, injection site soreness and redness, and an electric feeling in her left toe and right temple. The reporting medical assistant stated that there was a doctor visit required at the office, and that the patient took Benadryl and Tylenol. The patient's symptoms had since resolved. The reporting medical assistant stated that the physician believed the patient's symptoms were most likely related to SHINGRIX, and that the patient might had been an emotional response to the vaccine in relation to the electric feeling that the patient experienced.
Age: 58.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of chills in a 58-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. Co-suspect products included ADACEL (batch number C5467BA, expiry date 20th June 2020) for prophylaxis. Additional patient notes included None. On 28th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) and ADACEL. On 2nd July 2018, 4 days after receiving SHINGRIX, the patient experienced chills, electric shock sensation, injection site pain, injection site erythema, headache and diarrhea. The patient was treated with benadryl (nos) (Benadryl) and paracetamol (Tylenol). On an unknown date, the outcome of the chills, electric shock sensation, injection site pain, injection site erythema, headache and diarrhea were recovered/resolved. The reporter considered the chills, electric shock sensation, injection site pain, injection site erythema, headache and diarrhea to be almost certainly related to SHINGRIX. Additional details were provided as follows: No medical history or allergies were reported. The patient received SHINGRIX and ADACEL in the right deltoid. The patient experienced chills, headache, diarrhea, injection site soreness and redness, and an electric feeling in her left toe and right temple. The reporting medical assistant stated that there was a doctor visit required at the office, and that the patient took Benadryl and Tylenol. The patient's symptoms had since resolved. The reporting medical assistant stated that the physician believed the patient's symptoms were most likely related to SHINGRIX, and that the patient might had been an emotional response to the vaccine in relation to the electric feeling that the patient experienced.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a adult 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 injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported to agent that the patient experienced pain at the injection site following a dose of SHINGRIX which resolved within 3 to 4 days. The healthcare professional did not provide the agent with any further details.
Sex: M
Vaccine: TTOX, VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included TETANUS VACCINE for prophylaxis. On 3rd July 2018, the patient received the 1st dose of SHINGRIX and TETANUS VACCINE. On 3rd July 2018, less than a day after receiving SHINGRIX and TETANUS VACCINE, the patient experienced pruritus. On 4th July 2018, the patient experienced shingles. On an unknown date, the outcome of the shingles and pruritus were recovering/resolving. It was unknown if the reporter considered the shingles and pruritus to be related to SHINGRIX. Additional details were provided as follows:  The age at the vaccination was not reported. The patient was administered SHINGRIX in the left arm and Tetanus vaccine in the right arm. It was suggested that he get the shot for Shingles. After further review of his chart, the pharmacist knew that he was overdue for the tetanus shot, so the patient took both vaccines at the same time.  The patient said it started with the itching and then the breakout from shingles.   The patient stated that the next day after getting the vaccines, that he noticed that he was experiencing signs of shingles. The patient said that there was a straight line on the back of his calves on both legs and left hamstring. The patient has had shingles before so he knew what he was talking about. The line from the shingles was about three inches wide and half inch line.   The lines were very itchy but it was getting better at the time of reporting. The patient did report it to his physician who suggested him to try anti itching lotion to treat the itching until it, shingles cleared up. The symptoms were resolving themselves. The patient said it was more of a nuisance than anything. The patient stated that he would not be getting the second dose of the vaccine.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received a couple of years before the reporting date). On 22nd June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 µg. In June 2018, 1 day after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, influenza-like symptoms, general body pain, pain in arm, fever, tiredness, lethargy, listless, injection site erythema and chills. In June 2018, the outcome of the injection site pain, injection site swelling, influenza-like symptoms, general body pain, pain in arm, fever, tiredness, lethargy, listless, injection site erythema and chills were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, influenza-like symptoms, general body pain, pain in arm, fever, tiredness, lethargy, listless, injection site erythema and chills to be related to SHINGRIX. Additional details were received as follows: By the next day of vaccination, the patient experienced soreness, redness and swelling at the injection site. By 48 hours later flu like symptoms and pain in his arm occurred. The patient also noted that all issues were resolved by 72 hours later. The patient would discuss with his doctor about receiving 2nd dose of SHINGRIX, as he was unsure at the reporting time. The patient had denied permission to contact their physician.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Lethargy, Listless, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received a couple of years before the reporting date). On 22nd June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 µg. In June 2018, 1 day after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, influenza-like symptoms, general body pain, pain in arm, fever, tiredness, lethargy, listless, injection site erythema and chills. In June 2018, the outcome of the injection site pain, injection site swelling, influenza-like symptoms, general body pain, pain in arm, fever, tiredness, lethargy, listless, injection site erythema and chills were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, influenza-like symptoms, general body pain, pain in arm, fever, tiredness, lethargy, listless, injection site erythema and chills to be related to SHINGRIX. Additional details were received as follows: By the next day of vaccination, the patient experienced soreness, redness and swelling at the injection site. By 48 hours later flu like symptoms and pain in his arm occurred. The patient also noted that all issues were resolved by 72 hours later. The patient would discuss with his doctor about receiving 2nd dose of SHINGRIX, as he was unsure at the reporting time. The patient had denied permission to contact their physician.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received a couple of years before the reporting date). On 22nd June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 µg. In June 2018, 1 day after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, influenza-like symptoms, general body pain, pain in arm, fever, tiredness, lethargy, listless, injection site erythema and chills. In June 2018, the outcome of the injection site pain, injection site swelling, influenza-like symptoms, general body pain, pain in arm, fever, tiredness, lethargy, listless, injection site erythema and chills were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, influenza-like symptoms, general body pain, pain in arm, fever, tiredness, lethargy, listless, injection site erythema and chills to be related to SHINGRIX. Additional details were received as follows: By the next day of vaccination, the patient experienced soreness, redness and swelling at the injection site. By 48 hours later flu like symptoms and pain in his arm occurred. The patient also noted that all issues were resolved by 72 hours later. The patient would discuss with his doctor about receiving 2nd dose of SHINGRIX, as he was unsure at the reporting time. The patient had denied permission to contact their physician.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder blade pain in a 77-year-old female patient who received SHINGRIX for prophylaxis.  On 30th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 8th July 2018, 8 days after receiving SHINGRIX, the patient experienced shoulder blade pain. On 9th July 2018, the patient experienced pain in hip and neck pain. In July 2018, the patient experienced muscle soreness. On an unknown date, the outcome of the shoulder blade pain was recovered/resolved and the outcome of the muscle soreness was unchanged and the outcome of the pain in hip and neck pain were unknown. It was unknown if the reporter considered the shoulder blade pain, muscle soreness, pain in hip and neck pain to be related to SHINGRIX. Additional details were updated as follows: The patient received SHINGRIX on the left arm. On day 8, post vaccination, the patient's left shoulder blade was in pain and on day 9 the pain in shoulder blade was better. On day 9, the pain moved to both hips and the neck. Less than a month after vaccination her muscles were in pain and sore. The patient had denied permission to contact their physician. No further details were provided by the patient. All questions were asked.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 9th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site tenderness. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth and injection site tenderness were recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth and injection site tenderness to be related to SHINGRIX. Additional details were received as follows: The pharmacist reported that the patient received a dose of SHINGRIX and experienced injection site reaction which included redness and swelling and hot and tender to the touch. The reporter reported that now at 4 days after, there were still redness and very warm to the touch.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 19th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 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 recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient had some redness at the injection site. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 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 follow: The age at vaccination was not reported. The patient reported that, she took SHINGRIX on a Tuesday and later she experienced the shingles.
Sex: U
Vaccine: MENB
Symptoms: Injection site vesicles
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site blisters in a patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site blisters was unknown. It was unknown if the reporter considered the injection site blisters to be related to BEXSERO. Additional details were provided as follows: The reporting physician had reported this case previously to VAERS. The age at vaccination was not reported. The physician stated that he had the patient, who had blistering at the injection site, after administration of BEXSERO. This case was linked with US2018GSK123548, reported by the same reporter.
Sex: F
Vaccine: HPVX, MENB
Symptoms: Syncope
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fainting in a female patient who received BEXSERO for prophylaxis. Co-suspect products included HPV 16-18 (HPV vaccine) for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose and HPV vaccine at an unknown dose. On an unknown date, unknown after receiving BEXSERO and HPV vaccine, the patient experienced fainting. On an unknown date, the outcome of the fainting was unknown. It was unknown if the reporter considered the fainting to be related to BEXSERO and HPV vaccine. Additional details were provided as follows: The age at vaccination was not reported. The physician did not agree for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of adverse event in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter had several patients who developed side effects from the vaccine. The reporter agreed to be followed up. This is one of the 2 cases, reported by same reporter.
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable consumer, who is also the patient. This male patient of an unspecified age received TRUMENBA via an unspecified route of administration on 11Jul2018 at single dose for immunisation. Relevant medical history and concomitant medications were not reported. The patient reported that he received meningococcal group b rlp2086 1 day prior to this report and experienced joint pain, chills, headache, general body soreness, fatigue and redness at the injection site in Jul2018. The outcome of the events was unknown.
Sex: M
Vaccine: MENB
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable consumer, who is also the patient. This male patient of an unspecified age received TRUMENBA via an unspecified route of administration on 11Jul2018 at single dose for immunisation. Relevant medical history and concomitant medications were not reported. The patient reported that he received meningococcal group b rlp2086 1 day prior to this report and experienced joint pain, chills, headache, general body soreness, fatigue and redness at the injection site in Jul2018. The outcome of the events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Asthenia, Pain, Product storage error, Swelling
Clinical narrative: This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received PREVNAR 13; (lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The reporter wanted to know what are the expected side effects of PREVNAR 13 after it was frozen and then stored at a refrigerator. On an unspecified date, the patient experienced local pain, swelling and weakness on an unspecified date. The outcome of the events was unknown. Information regarding lot/batch number has been requested.
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Chills, Fatigue, Headache, Impaired work ability
Clinical narrative: This is a spontaneous report from a non-contactable consumer reported for his/her son. A 22-year-old male patient received the first dose of TRUMENBA at single dose for immunization on 11Jul2018. Relevant medical history and concomitant medications were unknown. On 11Jul2018 the patient experienced chills, fever, joint pain, muscle aches, fatigue and headache and had to leave work as a result of these symptoms. He took Ibuprofen. Fever and chills resolved but some joint pain and headache remained, the outcome of muscle ache was unknown. The patient also reported a rash at the injection site and injection site warmth last night. The outcome of these last two events were unknown. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Injection site rash, Injection site warmth, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable consumer reported for his/her son. A 22-year-old male patient received the first dose of TRUMENBA at single dose for immunization on 11Jul2018. Relevant medical history and concomitant medications were unknown. On 11Jul2018 the patient experienced chills, fever, joint pain, muscle aches, fatigue and headache and had to leave work as a result of these symptoms. He took Ibuprofen. Fever and chills resolved but some joint pain and headache remained, the outcome of muscle ache was unknown. The patient also reported a rash at the injection site and injection site warmth last night. The outcome of these last two events were unknown. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: TD
Symptoms: Wrong drug administered
Clinical narrative: Initial unsolicited report received from a pharmacist on 06-Jul-2018. This case involves a 62-year-old male patient who was vaccinated once with a 0.5 ml dose of TENIVAC (batch number: US856AA, expiry date: 26-Jan-2020) via intramuscular in the left arm instead of TDAP (batch number, expiry date, route and site of administration were unknown) on 06-Jul-2018. The patient's medical history and concomitant medication were not reported. It was a case of actual medication error due to wrong vaccine administered. It was not reported whether the patient experience any adverse events or not. The reporter enquired about administration of TDAP to the patient. 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.
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Initial unsolicited report received from a nurse on 09-Jul-2018. This case involves a 2 months old female patient who experienced who was vaccinated with a 0.5 ml first dose of ACT-HIB (batch number: UI799AAB, expiration date: 08-Jul-2018, dose in series was not reported) via intramuscular route in the left thigh on 09-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included ROTAVIRUS VACCINE and PREVENAR, PARACETAMOL for an unknown indication. It was a case of actual medication error due to expired vaccine used. It was not reported whether the patient had experienced any adverse events or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 10-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves an 18 months old male patient who was vaccinated with an expired dose of ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DAPTACEL for Immunisation; and Hepatitis A vaccine for Immunisation. On 09-Jul-2018, the patient received a 0.5 mL expired dose of suspect HIB (PRP/T) Vaccine lot YU802AA, expiry date: 08-Jul-2018, in left thigh. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: M
Vaccine: IPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial unsolicited report received from a medical representative on 03-Jul-2018. This case involves a male patient (age not reported) who was wrongly vaccinated with a 3.0 ml dose of IPOL (Batch number: M1453, expiration date, dose in series, route and site of administration were not reported) instead of 0.5 ml of on an unknown date. It was a case of actual medication error due to overdose since medical assistant thought that was a single dose vial and drew up the remainder of the vial. At the time of reporting, the patient didn't experience 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. Documents held by sender: none.
Sex: F
Vaccine: TYP
Symptoms: Accidental exposure to product, Exposure via skin contact, Syringe issue
Clinical narrative: Initial information received on 09-Jul-2018 regarding an unsolicited valid non-serious case received from a pharmacist (patient herself). This case involves female patient (age not reported) who got exposed to vaccine, while she received vaccine TYPHIM VI. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient got exposed to a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (injection suspension) lot N1K801M, expiry date: 15-Oct-2019. It was a case of actual medication error due to occupational exposure to product and exposure via skin contact. During injection, the vaccine exploded and went all over the pharmacist who was injecting. It was reported that the piece of the syringe where the needle attaches got separated, fell apart. The syringe was defective because she had given plenty of vaccines. The tip of the syringe separated, fell apart as she was giving the vaccine causing the vaccine to get mostly on her. It was also a case of syringe issue. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Injection site erythema, Pain, Pain in extremity
Clinical narrative: Worsening redness/swelling for 48 hours post injection; pain radiating from arm down to hip.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Worsening redness/swelling for 48 hours post injection; pain radiating from arm down to hip.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Dyspnoea, Gait disturbance, Oxygen saturation decreased, Pyrexia
Clinical narrative: Per Nurse documentation in pt chart on 6/10/15: Wife said husband has had a fever that evening and the next morning after receiving a vaccine. Wife said PRC told her the vaccine was PCV13. Wife said he had had a fever all week, could hardly walk, he was struggling to breathe. She said she did not take him to the ER. Wife said today he is resting, is a tad bit better. She said his breathing is a little bit better today. Wife spoke to daughter in the background and she said breathing is about the same. She said she knows to call 911 if needed. Advised wife that husband to be evaluated in ER now. Daughter got on phone she said dad has COPD. Daughter said SATs down to 90 percent on room air yesterday, and SATs better today. She said they will bring him in to ER.
Age: 90.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling, Malaise, Pruritus, Urticaria
Clinical narrative: UrticariaPruritus and injection site reaction (itching/swelling), general malaise.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis contact, Dermatologic examination abnormal, Dizziness, Pyrexia, Rash
Clinical narrative: Dizziness and fever.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: This is a 65 year-old male who presents with a history of reaction at site of SHINGRIX injection that he got on Tuesday. Reports the first day his arm just felt sore like when you get a tetanus shot. Last night his wife noticed he had red/warm area around injection site left upper arm and had f/c. He felt better on waking, but as the day has gone on his arm has become more painful and he felt warm again. Was advised by telehealth nurse to have evaluated in ED tonight.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Fatigue, Headache, Insomnia, Myalgia
Clinical narrative: At midnight patient reports aching, sore muscles, and blood pressure spikes. Patient felt like coming down with a virus and did not have fever. Patient couldn't go back to sleep and stayed on recliner all night. Symptoms started easing up about 12 hours later. Patient had a headache and took TYLENOL. Patient did not call the doctor. Patient was too tired the rest of the day to be active. Patient still has soreness on arm both sides. Patient mentioned that she had shingles in her right eye on 2012 and took ZOSTAVAX.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Viral infection
Clinical narrative: At midnight patient reports aching, sore muscles, and blood pressure spikes. Patient felt like coming down with a virus and did not have fever. Patient couldn't go back to sleep and stayed on recliner all night. Symptoms started easing up about 12 hours later. Patient had a headache and took TYLENOL. Patient did not call the doctor. Patient was too tired the rest of the day to be active. Patient still has soreness on arm both sides. Patient mentioned that she had shingles in her right eye on 2012 and took ZOSTAVAX.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Injection site discolouration, Injection site induration, Injection site swelling
Clinical narrative: From patient "my arm began to swell around the injection site in a large circle that felt hard. It also had fever and has turned several colors over the past 6 days. On Saturday, I was ill with fever and several blisters and fatigue. So bad I had to go back to bed in the afternoon. The problems have improved over the past 2 days or so, but the site is still swollen somewhat and is discolored."
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise, Pyrexia
Clinical narrative: From patient "my arm began to swell around the injection site in a large circle that felt hard. It also had fever and has turned several colors over the past 6 days. On Saturday, I was ill with fever and several blisters and fatigue. So bad I had to go back to bed in the afternoon. The problems have improved over the past 2 days or so, but the site is still swollen somewhat and is discolored."
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site pain, Lethargy, Myalgia
Clinical narrative: Pain at injection site, general muscle aches throughout torso (flu-like), headache, lethargy.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised, Rash generalised, Urticaria
Clinical narrative: Itching all over body starting shortly after injection and continuing to the next day. Rash/hives over body starting shortly after injection and continuing to next day. Advised patient to take BENADRYL and Antiseptic lotions.
Age: 5.0
Sex: M
Vaccine: HEP, MMRV
Symptoms: Rash macular, Rash pruritic
Clinical narrative: Itchy, blotchy rash 24 hours after shots, not accompanied by fever.
Age: 26.0
Sex: U
Vaccine: TDAP
Symptoms: Headache, Nausea, Night sweats, Pain in extremity
Clinical narrative: 1 day after Tdap - Headache, nausea, leg/thigh pain, night sweats.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Pyrexia
Clinical narrative: Dizziness, fever, chills night of vaccine on 6/30/18. Received shot at 1230pm 6/30/18.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Confusional state, Disorientation, Dizziness, Feeling hot, Vomiting
Clinical narrative: Onset of dizziness (6/25). Severe dizziness with vomiting 7/2, 10 days post vaccination. Intermittent dizziness continuing without vomiting. Slight confusion and disorientation. Warmness in the face but no fever. BP and O2 normal.
Age: 50.0
Sex: F
Vaccine: TYP
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria starting approximately 42-44 hours after injection continuing through the time of this report. She denies any rash, just intense itching.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Hyperhidrosis, Oropharyngeal pain, Pain, Pharyngitis
Clinical narrative: Approximately 1 hour after receiving vaccine, pt states he felt chills/body sweats/all over body ache/sore throat. Pt states he saw white patches on the back left side of throat.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Streptococcus test negative
Clinical narrative: Approximately 1 hour after receiving vaccine, pt states he felt chills/body sweats/all over body ache/sore throat. Pt states he saw white patches on the back left side of throat.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chills, Hyperhidrosis, Nausea
Clinical narrative: Patient reports that about an hour after receiving vaccine she had severe left arm pain. This was later followed by chills, nausea, sweating. 24 hours after receiving vaccine, she reports left sided neck pain, left sided back and hip pain, still with nausea. Patient also reports that her hands are very cold and still has sweating.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity, Peripheral coldness
Clinical narrative: Patient reports that about an hour after receiving vaccine she had severe left arm pain. This was later followed by chills, nausea, sweating. 24 hours after receiving vaccine, she reports left sided neck pain, left sided back and hip pain, still with nausea. Patient also reports that her hands are very cold and still has sweating.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a physician via company representative referring to a 20 month old female. No pertinent medical history, drugs reactions/allergies nor concomitant medications were reported. On an unknown date (reported as at "13 months old"), the patient was vaccinated with VARIVAX, subcutaneous (Lot number, expiration date, anatomical location and dosage were not provided) for immunisation. On an unspecified date (reported as "within the last couple of weeks"), the patient was exposed to an unspecified cousin with chickenpox and the patient developed chickenpox on an unspecified amount of time after exposure to her cousin. Physician reported that on an unspecified date, patient's parents contacted physician's office to inform that patient had developed chickenpox. An unknown treatment was given for the adverse event. At the time of reporting, the outcome of varicella was reported as recovering/resolving. The reporting physician did not assess the causal relationship between the adverse event and the vaccination with VARIVAX.