chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Dizziness, Injection site pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of light headedness in a 65-year-old female patient who received SHINGRIX. Concomitant products included PREVENAR 13. In March 2018, the patient received SHINGRIX (intramuscular). In March 2018, 1 day after receiving SHINGRIX, the patient experienced injection site pain. In March 2018, the patient experienced light headedness and injection site burning. In March 2018, the outcome of the light headedness was recovered/resolved. On an unknown date, the outcome of the injection site burning and injection site pain were unknown. The reporter considered the light headedness to be probably related to SHINGRIX. It was unknown if the reporter considered the injection site burning and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received PREVNAR 13 at the same visit in the other arm. Approximately 8 hours after administration of SHINGRIX, the patient became light headed. At the time of injection it burned at injection site and experienced pain at the injection site the day after administration. The reporter thought the light headedness might be related to SHINGRIX but he was not sure.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site rash in a 59-year-old female patient who received SHINGRIX. On 16th March 2018, the patient received the 1st dose of SHINGRIX. On 23rd March 2018, 7 days after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient experienced rash below the injection site in the morning but by the afternoon on the same day it had substantially decreased. The reporter did not feel like this was an allergic reaction or needed the physician consult. The reporter believed the adverse event had resolved, but was not sure.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: INJECT SITE REACTION WITH REDNESS AND TENDERNESS.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Asthenia, Lethargy, Pyrexia, Rash erythematous, Rash morbilliform
Clinical narrative: Minor fever on Day 5-8 after the vaccine, then generally very lethargic/no energy from Day 8-10. On Day 11-13, noticed red spots popping up, first around his groin area, then most prominent on face where it looks like a minor form of measles.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Anxiety, Fatigue, Insomnia
Clinical narrative: Patient reports hours later he was extremely anxious, wanting to "pull his hair out." He does not have history of anxiety. Later that night and for another 3 days had sever exhaustion during the day time and insomnia at night.
Age: 18.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient filled out consents for vaccines listed above, and marked she was not pregnant, the vaccines were given. She came back about 10 min later asking what would happen if she was pregnant; after speaking with her and questioning her she finally disclosed she was in fact pregnant and was due 9/13/18. Her OB doctor was notified and she was educated on potential risks.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Swelling in the right arm from the shoulder down to the elbow that began the evening after receiving the vaccination. The patient complains of pain in the right arm.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of extensive swelling of vaccinated limb in a female patient who received SHINGRIX. In March 2018, the patient received SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limn and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb was recovering/resolving and the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The patient received SHINGRIX 5 to 6 days ago and experienced some extreme swelling from shoulder to hand, and some excess redness at the injection site. It was reported that 5 to 6 days later, there was still some swelling, but not that much.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003075: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA003062: US-009507513-1804USA003063.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6° Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA003075: US-009507513-1804USA002453.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA002453: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA003075: US-009507513-1804USA003062.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA002453: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA003075: US-009507513-1804USA003062.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA003064: US-009507513-1804USA002453: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA003075: US-009507513-1804USA003062.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA002453: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA003075: US-009507513-1804USA003062.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dermatitis diaper, Fatigue, Gait disturbance, Malaise, Skin ulcer
Clinical narrative: Severe diaper rash-ulcers. Sick, tired, wouldn't walk well for 12 days-no diarrhea. No other viral symptoms.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pain, Pain in jaw
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of jaw pain in a 53-year-old female patient who received BOOSTRIX (batch number TF422, expiry date 15th December 2019). The patient's past medical history included accident (hit top of head with bike rack, prior to vaccination with BOOSTRIX). On 26th March 2018, the patient received BOOSTRIX (intramuscular). On 27th March 2018, 1 days after receiving BOOSTRIX, the patient experienced jaw pain, pain and stiffness. On an unknown date, the outcome of the jaw pain, pain and stiffness were not recovered/not resolved. The reporter considered the jaw pain, pain and stiffness to be possibly related to BOOSTRIX. Additional details were provided as follows: The patient was administered BOOSTRIX in the right arm. The patient experienced stiffness and achiness described as affecting full body that got worse in the morning. The patient had denied permission to contact their physician.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hand swelling in a 56-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). Co-suspect products included Nystatin and Triamcinolone Cream for vaginal infection. Concomitant products included amlodipine, fluconazole and Miconazole. On 28th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and Nystatin and Triamcinolone Cream (vaginal) at an unknown dose and frequency. On 28th March 2018, less than a day after receiving SHINGRIX, the patient experienced hand swelling. Nystatin and Triamcinolone Cream was continued with no change. On an unknown date, the outcome of the hand swelling was not recovered/not resolved. It was unknown if the reporter considered the hand swelling to be related to SHINGRIX. Additional details were reported as follows: At 13:00 hours, the patient received SHINGRIX in unknown deltoid. The pharmacist reported that, the patient might had experienced swelling of her hands for not using the vaginal cream with gloves, but was not sure. The patient went to the emergency room and was discharged home and to follow-up with her physician on an unknown date.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Movement disorder, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 59-year-old female patient who received SHINGRIX. On 20th March 2018, the patient received SHINGRIX. In March 2018, less than a month after receiving SHINGRIX, the patient experienced pain, joint range of motion decreased and movement disorder. On an unknown date, the outcome of the pain, joint range of motion decreased and movement disorder were not recovered/not resolved. It was unknown if the reporter considered the pain, joint range of motion decreased and movement disorder to be related to SHINGRIX. Additional details were provided as follows: After receiving the SHINGRIX vaccine, the patient had lots of pain with it. On the 8th day, the patient developed decreased range of motion in her arm. She had difficulty reaching up. The patient already saw her doctor who told her to give it more time. The patient wanted information from GSK as to whether this side effect was seen or not.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Injection site pain, Malaise, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a 69-year-old male patient who received SHINGRIX. In February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site burning, malaise, nausea, vomiting, fever and chills. On an unknown date, the patient experienced sweating. On an unknown date, the outcome of the injection site burning, malaise, nausea, vomiting, fever, chills and sweating were recovered/resolved. The reporter considered the injection site burning, malaise, nausea, vomiting, fever, chills and sweating to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported the following adverse reactions after SHINGRIX that was administered on the left arm approximately 1.5 months before the reporting date. The events occurred that night after the injection, lasted for about 30 to 40 minutes and then stated he could tell it was getting better about an hour later. The patient requested to remain anonymous and was reluctant to answer some questions.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a 69-year-old male patient who received SHINGRIX. In February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site burning, malaise, nausea, vomiting, fever and chills. On an unknown date, the patient experienced sweating. On an unknown date, the outcome of the injection site burning, malaise, nausea, vomiting, fever, chills and sweating were recovered/resolved. The reporter considered the injection site burning, malaise, nausea, vomiting, fever, chills and sweating to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported the following adverse reactions after SHINGRIX that was administered on the left arm approximately 1.5 months before the reporting date. The events occurred that night after the injection, lasted for about 30 to 40 minutes and then stated he could tell it was getting better about an hour later. The patient requested to remain anonymous and was reluctant to answer some questions.
Sex: U
Vaccine: FLU4
Symptoms: Skin reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of localized skin reaction in a patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced localized skin reaction. On an unknown date, the outcome of the localized skin reaction was unknown. It was unknown if the reporter considered the localized skin reaction to be related to Influenza vaccine Quadrivalent unspecified season. Additional information was received were as follows: The age at vaccination was not reported. The physician's office called pharmacist reporting that the patient got a severe localized skin reaction with the flu vaccine. The reporter did not know which flu vaccine was administered to the patient. The reporter did not had any patient information or any other details.
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 15-year-old female patient who received BEXSERO. On an unknown date, the patient received BEXSERO (intramuscular). On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. The reporter considered the injection site pain to be almost certainly related to BEXSERO. Additional details were provided as follows: This case was reported by a certified medical assistant (CMA) who was a medical science liaison with GlaxoSmithKline. The age at vaccination not reported. The reporter heard these events at a dinner meeting last night, no specific dates were known. The patient received the dose of BEXSERO in unknown arm and experienced pain in the arm after receiving BEXSERO. This case was linked with US2018054841, reported by the same reporter.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Rash
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of rash in a 16-year-old male patient who received BEXSERO. Co-suspect products included Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine and Human Papilloma virus 9 valent. In October 2017, the patient received BEXSERO, Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine and Human Papilloma Virus 9 Valent. In October 2017, less than a month after receiving BEXSERO, Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine and Human Papilloma Virus 9 Valent, the patient experienced rash. In October 2017, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to BEXSERO and Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 15 or 16 years old. The healthcare professional reported that the event was regarding BEXSERO in combination with human papillomavirus vaccine (HPV-9) and meningococcal vaccine (MCV-4). The patient experienced a rash on his arm. It was unknown if the reporter considered the rash to be related to HPV 9 vaccine. The healthcare professional did report this to GSK in October 2017 as well.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in an unspecified number of patients who received SHINGRIX. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The healthcare professional (HCP) stated that, some patients experienced mild fever after receiving a dose of SHINGRIX vaccine. This case was one of the 3 cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received SHINGRIX. In March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were not recovered/not resolved. It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to SHINGRIX. Additional were provided as follows: The age at vaccination was not reported. The patient had 1st SHINGRIX shot 7 days ago and her arm was still slightly red and swollen. The reporter wanted to know if there was something that could be done to get the swelling down.
Age: 10.0
Sex: F
Vaccine: MENB
Symptoms: Influenza like illness, Malaise
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a 15-year-old female patient who received BEXSERO. On an unknown date, the patient received BEXSERO (intramuscular). On an unknown date, unknown after receiving BEXSERO, the patient experienced influenza-like symptoms and malaise. On an unknown date, the outcome of the influenza-like symptoms and malaise were unknown. The reporter considered the influenza-like symptoms and malaise to be almost certainly related to BEXSERO. Additional details were provided as follows: This case was reported by a certified medical assistant (CMA) who was a medical science liaison with GlaxoSmithKline. The age at vaccination not reported. The reporter heard these events at a dinner meeting last night, no specific dates were known. The patient received the dose of BEXSERO in unknown arm and experienced flu like symptoms and malaise. This case was linked with US2018054840, reported by same reporter.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old male patient who received SHINGRIX. Concurrent medical conditions included blood cholesterol increased and hyperthyroidism. Concomitant products included Atorvastatin. On 15th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm, injection site inflammation, injection site erythema, injection site pain and injection site warmth. On an unknown date, the outcome of the pain in arm, injection site inflammation, injection site erythema, injection site pain and injection site warmth were recovered/resolved. Reporter considered the pain in arm, injection site inflammation, injection site erythema, injection site pain and injection site warmth to be related to SHINGRIX. Additional information was received as follows: This case was reported by the patient's wife. No diagnosis dates were provided for reported medical history. The reporter did not have lot number or expiration of vaccine. Arm pain described as a painful to sleep on arm and painful in pressure applied to arm. The patient was receiving thyroid medicine for concurrent medical condition hyperthyroidism. The patient was recovered completely after two or three days, exact resolution date was not provided. The reporter denied emergency room or physician visit, or hospitalization to treat reported events. The reporter declined to provide mailing address. No diagnosis dates were provided for reported medical history. The reporter noted that the patient did not need to contact or consult with his healthcare professional for reported events. This case has been linked to the case US2018GK054615, reported by the same reporter.
Age: 61.0
Sex: M
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 61-year-old male patient who received SHINGRIX. Concurrent medical conditions included blood cholesterol increased and hyperthyroidism. Concomitant products included Atorvastatin. On 15th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm, injection site inflammation, injection site erythema, injection site pain and injection site warmth. On an unknown date, the outcome of the pain in arm, injection site inflammation, injection site erythema, injection site pain and injection site warmth were recovered/resolved. Reporter considered the pain in arm, injection site inflammation, injection site erythema, injection site pain and injection site warmth to be related to SHINGRIX. Additional information was received as follows: This case was reported by the patient's wife. No diagnosis dates were provided for reported medical history. The reporter did not have lot number or expiration of vaccine. Arm pain described as a painful to sleep on arm and painful in pressure applied to arm. The patient was receiving thyroid medicine for concurrent medical condition hyperthyroidism. The patient was recovered completely after two or three days, exact resolution date was not provided. The reporter denied emergency room or physician visit, or hospitalization to treat reported events. The reporter declined to provide mailing address. No diagnosis dates were provided for reported medical history. The reporter noted that the patient did not need to contact or consult with his healthcare professional for reported events. This case has been linked to the case US2018GK054615, reported by the same reporter.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 59-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 22nd March 2018, the patient received SHINGRIX .5 ml. On 23rd March 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain. In March 2018, the outcome of the muscle pain was recovered/resolved. The reporter considered the muscle pain to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The registered pharmacist reported that, this patient said he always got muscle aches after a vaccination. The registered pharmacist reported this to VAERS. This case is 1 of 4 cases reported by same reporter.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 55-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 27th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 28th March 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain, general body pain, fever, vomiting, nausea and headache. In March 2018, the outcome of the muscle pain, general body pain, fever, vomiting, nausea and headache were recovered/resolved. The reporter considered the muscle pain, general body pain, fever, vomiting, nausea and headache to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The registered pharmacist reported adverse events to VAERS. This case is 1 of 4 cases reported by same reporter.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 55-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 27th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 28th March 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain, general body pain, fever, vomiting, nausea and headache. In March 2018, the outcome of the muscle pain, general body pain, fever, vomiting, nausea and headache were recovered/resolved. The reporter considered the muscle pain, general body pain, fever, vomiting, nausea and headache to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The registered pharmacist reported adverse events to VAERS. This case is 1 of 4 cases reported by same reporter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 56-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 22nd March 2018, the patient received SHINGRIX .5 ml. On 23rd March 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain. In March 2018, the outcome of the muscle pain was recovered/resolved. The reporter considered the muscle pain to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The registered pharmacist reported that this patient said she always gets muscle aches after a vaccination. The registered pharmacist reported this to VAERS. This case is 1 of 4 cases reported by same reporter.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dysphagia, Throat irritation, Throat tightness
Clinical narrative: Patient describes tightness and itching of throat, and difficulty swallowing.
Sex: U
Vaccine: HPV9
Symptoms: Dysphagia, Throat irritation, Throat tightness, Urticaria
Clinical narrative: Patient reports tightness and itching in throat, difficulty swallowing, and hives.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Fluctuance, Limb mass, Pain in extremity
Clinical narrative: Arm swelling and pain, including redness and fluctuance of the lower bicep region without firmness or warmth on day of visit. Patient reported firm lump in lower bicep on 04/05/18, fever and fatigue.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Arm swelling and pain, including redness and fluctuance of the lower bicep region without firmness or warmth on day of visit. Patient reported firm lump in lower bicep on 04/05/18, fever and fatigue.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth, Skin tightness
Clinical narrative: Mother reports she noticed child's left arm is red, hot to touch, tight and hard. Red area about the size of her fist. Mother reports that child is not showing signs of discomfort and does not have a fever. Nurse recommended cool compress and ibuprofen. Also recommended that mother mark the area to see if it gets bigger and seek medical attention if it gets bigger or she has any concerns.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Dyspnoea, Paraesthesia oral, Pyrexia, Urticaria, Wheezing
Clinical narrative: Hives, wheezing, difficulty breathing, lip tingling, fever.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: Headache, shivering.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt states that her arm is still sore 7 days later with impaired movement......very concerned about getting the subsequent shot! Was told by immunizer to ice at the beginning. I advised at this point to use heat pad and bring to the attention of her PCP.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Diarrhoea, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Little fever, redness, tenderness at the site, diarrhea the next day, some cough since. Patient had first PREVNAR 13 on 02/24/2017, should have received PPSV23.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in both upper extremities, injection side and other arm.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report was received from a non-healthcare professional via Pfizer refers to a 17 years old female patient. Patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dosing information was not provided) for prophylaxis. On an unknown date, the patient died. It was unknown if the autopsy was performed. The cause of death was unknown. Reporter considered the event to be related to GARDASIL. Upon internal review, death was determined to be medically significant. This is one of the two reports received from the same reporter.; Reported Cause(s) of Death: unknown cause of death.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA002453: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA003075: US-009507513-1804USA003062.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA002453: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA003075: US-009507513-1804USA003062.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA002453: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA003075: US-009507513-1804USA003062.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA002453: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA003075: US-009507513-1804USA003062.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA002453: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA003075: US-009507513-1804USA003062.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: 1 cm redness for 2 days with mild warmth for 1 day.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: Pt was given 2nd Shingrix vaccine on 3/19/2018. On 4/2/2018 he presented to my office with x1 day history of painful itchy rash on left forearm, this was consistent with herpes zoster.
Age: 59.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Arthritis, Blood test, C-reactive protein abnormal, Diarrhoea, Disability
Clinical narrative: On the first day after the flu shot I experienced flu symptoms. Body ache, fatigue, diarrhea which escalated in 2 weeks to inflammation on both arms and legs. I could not reach with my arms and turn a key in my car to start or any movement to use my wrist. I had difficulty walking due to swelling of joints and muscles. I made a non-emergency appointment and blood and urine test were done. A physician called me and said I had a UTI and ask if I had loose bowel movement and I replied, "Yes". I was referred to the Rheumatologist and had additional test run and was prescribed Prednisone 20mg for 1 week then down to 10mg. My Condition continued and doctor's couldn't verify my condition happened due to flu shot. Before the flu shot, I pointed out to my PCP that before the vaccine I was healthy: lower blood pressure, low cholesterol, low glucose. I cut milk and gluten which canceled any asthma symptoms that I had not used an inhaler for asthma since October 2013 and did not see a doctor much. Soon after the vaccine I needed to see a orthopedic physician due to continuing swelling of my right arm showed a bicep tear. My inflammation rate fluctuated with medication and as doctor tried to taper me from steroids the other medication seem to increase the pain. I currently on my 3rd medication with the steroids to control my ESR & C-Reactive Protein levels. At one point place on 5 months disability by physician. On 3/28/2018 I talked to my Primary Care Physician to talk about the prolong inflammation and my response to some of the medications. If I should continue trying other medication and because of inflammation my joints have serious affects. Walking is difficult and was advised by one of the orthopedic doctor that I was seeing that I need a hip replacement. We talked about the flu vaccine or UTI being the possible cause and has placed that in my medical records. She also is placing me on disability a month at a time to see if any new medication will help. Again I have never seen so many different physician as I have had to with this reaction after the vaccine in 9/27/2016.  I haven't been able to work or look conscientiously for work and was let go from my job in April 2017.