chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Malaise, Nausea
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of feeling bad in a elderly female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced feeling bad, general body pain, swelling arm and skin warm. On an unknown date, the outcome of the feeling bad, general pain, swelling arm and skin warm were unknown. It was unknown if the reporter considered the feeling bad, general body pain, swelling arm and skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient got the shot on Tuesday and felt bad until Saturday that included general achy blah feeling and swollen and warm arm.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Pain, Peripheral swelling, Skin warm
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of feeling bad in a elderly female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced feeling bad, general body pain, swelling arm and skin warm. On an unknown date, the outcome of the feeling bad, general pain, swelling arm and skin warm were unknown. It was unknown if the reporter considered the feeling bad, general body pain, swelling arm and skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient got the shot on Tuesday and felt bad until Saturday that included general achy blah feeling and swollen and warm arm.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: Developed shingles in Right hairline, forehead and in eye. Had severe headaches, lack of appetite, excessive drowsiness. Shingles developed about 5-6 days following vaccine. Treated with steroid eye drop and course of antivirals.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal discomfort, Eye pain, Eye swelling, Facial pain, Headache
Clinical narrative: Developed shingles in Right hairline, forehead and in eye. Had severe headaches, lack of appetite, excessive drowsiness. Shingles developed about 5-6 days following vaccine. Treated with steroid eye drop and course of antivirals.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Ophthalmic herpes zoster, Rash, Scab
Clinical narrative: Developed shingles in Right hairline, forehead and in eye. Had severe headaches, lack of appetite, excessive drowsiness. Shingles developed about 5-6 days following vaccine. Treated with steroid eye drop and course of antivirals.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Decreased appetite, Headache, Herpes zoster, Ophthalmic herpes zoster, Somnolence
Clinical narrative: Developed shingles in Right hairline, forehead and in eye. Had severe headaches, lack of appetite, excessive drowsiness. Shingles developed about 5-6 days following vaccine. Treated with steroid eye drop and course of antivirals.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Muscle spasms, Pain, Pyrexia
Clinical narrative: Initial unsolicited report received from pharmacist on 01-May-2018. This case involves 18 years old female patient who was vaccinated with 0.5 ml single dose of MENACTRA (batch number: U5917AA, expiry date was not reported) once, intramuscularly in left deltoid on 27 Apr 2018 at pharmacy. The patient's medical history and concomitant medication were not reported. On an unspecified date, same day following the vaccination, patient had begun to experience pain, fever, and muscle spasms. Laboratory investigation was not reported. Patient has taken Ibuprofen over the counter but it did not worked. Patient not recovered from muscle spasms (still experiencing) and outcome of other events was not reported. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling, Joint swelling
Clinical narrative: This spontaneous report was received from a medical assistant, and refers to a 67 year old female patient. There were no concurrent conditions, medical history, allergies and concomitant medications reported. On 11-APR-2018, the patient was vaccinated with PNEUMOVAX 23, lot # N030847, expiration date of 09-JUN-2019, intramuscularly (dose, concentration and anatomical place of vaccination were not provided), for immunization. On the same date, within hours of injection, the patient experienced pain and swelling at injection site. On 14-APR-2018, 3 days after injection, pain and swelling extended to forearm and rash developed. Then, on 25-APR-2018, 2 weeks after injection pain and swelling extended to fingers. Because of the events the patient sought for medical attention, was hospitalized on an unspecified date in 2018, and received ADVIL and ice on swelling as treatment. At the time of reporting, the patient had not recovered from pain in extremity, rash, injection site swelling, injection site pain and peripheral swelling. The reporter did not provide a causality assessment between the events and PNEUMOVAX 23.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: This spontaneous report was received from a medical assistant, and refers to a 67 year old female patient. There were no concurrent conditions, medical history, allergies and concomitant medications reported. On 11-APR-2018, the patient was vaccinated with PNEUMOVAX 23, lot # N030847, expiration date of 09-JUN-2019, intramuscularly (dose, concentration and anatomical place of vaccination were not provided), for immunization. On the same date, within hours of injection, the patient experienced pain and swelling at injection site. On 14-APR-2018, 3 days after injection, pain and swelling extended to forearm and rash developed. Then, on 25-APR-2018, 2 weeks after injection pain and swelling extended to fingers. Because of the events the patient sought for medical attention, was hospitalized on an unspecified date in 2018, and received ADVIL and ice on swelling as treatment. At the time of reporting, the patient had not recovered from pain in extremity, rash, injection site swelling, injection site pain and peripheral swelling. The reporter did not provide a causality assessment between the events and PNEUMOVAX 23.
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a Medical Assistant, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 02-MAY-2018, the patient received a properly stored but expired dose of M-M-R II, lot # M044020 and expiration date on 01-MAY-2018, for prophylaxis (dose, route of administration and anatomical location were not reported). It was reported that the sterile diluent (MERCK) used to reconstitute the vaccine was properly stored. No adverse effects were reported for the patient.
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 02-MAY-2018, the patient received a properly stored but expired dose of M-M-R II, lot # M044020 and expiration date on 01-MAY-2018, for prophylaxis (dose, route of administration and anatomical location were not reported). It was reported that the sterile diluent (MERCK) used to reconstitute the vaccine was properly stored. No adverse effects were reported for the patient.
Age: 48.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, 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 pain in a 48-year-old male patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). Previously administered products included Influenza vaccine with an associated reaction of erythema (received years before the date of reporting, refer case US2018GSK083792). Concomitant products included ibuprofen, vitamin d and ZYRTEC). In March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema, pain, fever and malaise. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, pain, fever and malaise were recovering/resolving. The reporter considered the injection site pain, injection site swelling, injection site erythema, pain, fever and malaise to be almost certainly related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient experienced injection site reactions consisting of redness, pain, swelling, bumps at site. The patient tried ibuprofen and placed ice on the injection site which did not help. The nurse practitioner came to the pharmacy to inject. This case has been linked with case US2018077569 and US2018GSK084023, reported by same reporter.
Age: 48.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 48-year-old male patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). Previously administered products included Influenza vaccine with an associated reaction of erythema (received years before the date of reporting, refer case US2018GSK083792). Concomitant products included ibuprofen, vitamin d and ZYRTEC). In March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema, pain, fever and malaise. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, pain, fever and malaise were recovering/resolving. The reporter considered the injection site pain, injection site swelling, injection site erythema, pain, fever and malaise to be almost certainly related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient experienced injection site reactions consisting of redness, pain, swelling, bumps at site. The patient tried ibuprofen and placed ice on the injection site which did not help. The nurse practitioner came to the pharmacy to inject. This case has been linked with case US2018077569 and US2018GSK084023, reported by same reporter.
Age: 48.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 48-year-old male patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). Previously administered products included Influenza vaccine with an associated reaction of erythema (received years before the date of reporting, refer case US2018GSK083792). Concomitant products included ibuprofen, vitamin d and ZYRTEC). In March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema, pain, fever and malaise. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, pain, fever and malaise were recovering/resolving. The reporter considered the injection site pain, injection site swelling, injection site erythema, pain, fever and malaise to be almost certainly related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient experienced injection site reactions consisting of redness, pain, swelling, bumps at site. The patient tried ibuprofen and placed ice on the injection site which did not help. The nurse practitioner came to the pharmacy to inject. This case has been linked with case US2018077569 and US2018GSK084023, reported by same reporter.
Age: 48.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 48-year-old male patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). Previously administered products included Influenza vaccine with an associated reaction of erythema (received years before the date of reporting, refer case US2018GSK083792). Concomitant products included ibuprofen, vitamin d and ZYRTEC). In March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema, pain, fever and malaise. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, pain, fever and malaise were recovering/resolving. The reporter considered the injection site pain, injection site swelling, injection site erythema, pain, fever and malaise to be almost certainly related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient experienced injection site reactions consisting of redness, pain, swelling, bumps at site. The patient tried ibuprofen and placed ice on the injection site which did not help. The nurse practitioner came to the pharmacy to inject. This case has been linked with case US2018077569 and US2018GSK084023, reported by same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Headache, Hyperhidrosis
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pounding in head in a 62-year-old female patient who received SHINGRIX (batch number P539L, expiry date 29th January 2020). On 1st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, 13 hrs after receiving SHINGRIX, the patient experienced pounding in head, chills, fever, sweating, nausea, vomiting, diarrhea, injection site erythema, injection site swelling, weakness generalized and general body pain. The patient was treated with TYLENOL, BENADRYL and ZOFRAN. On an unknown date, the outcome of the pounding in head, chills, fever, sweating, nausea, vomiting, diarrhea, injection site erythema, injection site swelling, weakness generalized and general body pain were not recovered/not resolved. The reporter considered the pounding in head, chills, fever, sweating, nausea, vomiting, diarrhea, injection site erythema, injection site swelling and weakness generalized to be probably related to SHINGRIX. The reporter considered the general body pain to be possibly related to SHINGRIX. Additional information was received as follows: On 1st May 2018, at 11:00 the patient received SHINGRIX on right deltoid. The other health care professional felt that SHINGRIX possibly caused these reactions because the patient was fine before they received SHINGRIX. The other health care professional spoke with the patient over phone and recommended treatment drugs.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pounding in head in a 62-year-old female patient who received SHINGRIX (batch number P539L, expiry date 29th January 2020). On 1st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, 13 hrs after receiving SHINGRIX, the patient experienced pounding in head, chills, fever, sweating, nausea, vomiting, diarrhea, injection site erythema, injection site swelling, weakness generalized and general body pain. The patient was treated with TYLENOL, BENADRYL and ZOFRAN. On an unknown date, the outcome of the pounding in head, chills, fever, sweating, nausea, vomiting, diarrhea, injection site erythema, injection site swelling, weakness generalized and general body pain were not recovered/not resolved. The reporter considered the pounding in head, chills, fever, sweating, nausea, vomiting, diarrhea, injection site erythema, injection site swelling and weakness generalized to be probably related to SHINGRIX. The reporter considered the general body pain to be possibly related to SHINGRIX. Additional information was received as follows: On 1st May 2018, at 11:00 the patient received SHINGRIX on right deltoid. The other health care professional felt that SHINGRIX possibly caused these reactions because the patient was fine before they received SHINGRIX. The other health care professional spoke with the patient over phone and recommended treatment drugs.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pounding in head in a 62-year-old female patient who received SHINGRIX (batch number P539L, expiry date 29th January 2020). On 1st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, 13 hrs after receiving SHINGRIX, the patient experienced pounding in head, chills, fever, sweating, nausea, vomiting, diarrhea, injection site erythema, injection site swelling, weakness generalized and general body pain. The patient was treated with TYLENOL, BENADRYL and ZOFRAN. On an unknown date, the outcome of the pounding in head, chills, fever, sweating, nausea, vomiting, diarrhea, injection site erythema, injection site swelling, weakness generalized and general body pain were not recovered/not resolved. The reporter considered the pounding in head, chills, fever, sweating, nausea, vomiting, diarrhea, injection site erythema, injection site swelling and weakness generalized to be probably related to SHINGRIX. The reporter considered the general body pain to be possibly related to SHINGRIX. Additional information was received as follows: On 1st May 2018, at 11:00 the patient received SHINGRIX on right deltoid. The other health care professional felt that SHINGRIX possibly caused these reactions because the patient was fine before they received SHINGRIX. The other health care professional spoke with the patient over phone and recommended treatment drugs.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Eyelid oedema
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of eye infection in a 74-year-old female patient who received SHINGRIX. On 28th April 2018, the patient received SHINGRIX. In April 2018, 2 days after receiving SHINGRIX, the patient experienced eye red. On 28th April 2018, the patient experienced eye infection and swelling of eyelid. The patient was treated with antibiotics nos. On an unknown date, the outcome of the eye infection, swelling of eyelid and eye red were unknown. It was unknown if the reporter considered the eye infection, swelling of eyelid and eye red to be related to SHINGRIX. Additional details were provided as follows: The patient experienced eyelid swelling about 3 to 4 hours after the vaccination of SHINGRIX. About 48 hours later, the patient reported redness on the eyelids. On the day of reporting, the patient was seen by the health care professional and the left eye lid was still swollen and red. The patient had reported that the right eyelid also felt swollen and red but at time of office visit on the day of reporting, the health care professional did not notice and the left eye remained the same. The secondary infection of the eye was diagnosed and the patient was placed on unspecified antibiotics. It was not known where the patient was given SHINGRIX (physician office or clinic or pharmacy).
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye infection, Eyelid oedema, Ocular hyperaemia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of eye infection in a 74-year-old female patient who received SHINGRIX. On 28th April 2018, the patient received SHINGRIX. In April 2018, 2 days after receiving SHINGRIX, the patient experienced eye red. On 28th April 2018, the patient experienced eye infection and swelling of eyelid. The patient was treated with antibiotics nos. On an unknown date, the outcome of the eye infection, swelling of eyelid and eye red were unknown. It was unknown if the reporter considered the eye infection, swelling of eyelid and eye red to be related to SHINGRIX. Additional details were provided as follows: The patient experienced eyelid swelling about 3 to 4 hours after the vaccination of SHINGRIX. About 48 hours later, the patient reported redness on the eyelids. On the day of reporting, the patient was seen by the health care professional and the left eye lid was still swollen and red. The patient had reported that the right eyelid also felt swollen and red but at time of office visit on the day of reporting, the health care professional did not notice and the left eye remained the same. The secondary infection of the eye was diagnosed and the patient was placed on unspecified antibiotics. It was not known where the patient was given SHINGRIX (physician office or clinic or pharmacy).
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Blood test, Bone pain, Cardiac monitoring
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse event in a adult male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced adverse event (serious criteria hospitalization). 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 the vaccination was not reported. The reporter reported that her husband landed in Intensive Care Unit 24 hours after having the SHINGRIX vial kit vaccine. After reporting the medical complications to the pharmacists, he said her husband was the 2nd person to have an adverse reaction. Apparently this drug had just been released early this year and the public was the guinea pig. The pharmacists said he would not recommend it any further. This case was linked to the case US2018GSK081835, reported by the same reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chest X-ray, Chills, Echocardiogram, Feeling abnormal, Feeling cold
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse event in a adult male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced adverse event (serious criteria hospitalization). 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 the vaccination was not reported. The reporter reported that her husband landed in Intensive Care Unit 24 hours after having the SHINGRIX vial kit vaccine. After reporting the medical complications to the pharmacists, he said her husband was the 2nd person to have an adverse reaction. Apparently this drug had just been released early this year and the public was the guinea pig. The pharmacists said he would not recommend it any further. This case was linked to the case US2018GSK081835, reported by the same reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Heart rate decreased, Hyperhidrosis, Intensive care, Myalgia, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse event in a adult male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced adverse event (serious criteria hospitalization). 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 the vaccination was not reported. The reporter reported that her husband landed in Intensive Care Unit 24 hours after having the SHINGRIX vial kit vaccine. After reporting the medical complications to the pharmacists, he said her husband was the 2nd person to have an adverse reaction. Apparently this drug had just been released early this year and the public was the guinea pig. The pharmacists said he would not recommend it any further. This case was linked to the case US2018GSK081835, reported by the same reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Somnolence
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse event in a adult male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced adverse event (serious criteria hospitalization). 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 the vaccination was not reported. The reporter reported that her husband landed in Intensive Care Unit 24 hours after having the SHINGRIX vial kit vaccine. After reporting the medical complications to the pharmacists, he said her husband was the 2nd person to have an adverse reaction. Apparently this drug had just been released early this year and the public was the guinea pig. The pharmacists said he would not recommend it any further. This case was linked to the case US2018GSK081835, reported by the same reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Adverse event, Intensive care
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse event in a adult male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced adverse event (serious criteria hospitalization). 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 the vaccination was not reported. The reporter reported that her husband landed in Intensive Care Unit 24 hours after having the SHINGRIX vial kit vaccine. After reporting the medical complications to the pharmacists, he said her husband was the 2nd person to have an adverse reaction. Apparently this drug had just been released early this year and the public was the guinea pig. The pharmacists said he would not recommend it any further. This case was linked to the case US2018GSK081835, reported by the same reporter.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Facial pain, Toothache, Trigeminal neuralgia
Clinical narrative: This case was reported by a consumer via call center presentative and described the occurrence of jaw pain in a 70-year-old male patient who received SHINGRIX. Concomitant products included ibuprofen and SYNTHROID. On 25th April 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th April 2018, 1 days after receiving SHINGRIX, the patient experienced jaw pain. On an unknown date, the patient experienced tooth inflammation. The patient was treated with VICODIN and antibiotics NOS. On an unknown date, the outcome of the jaw pain and tooth inflammation were recovering/resolving. The reporter considered the jaw pain and tooth inflammation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. At the evening of 26th April 2018, the patient experienced pain in lower left part of his jaw. The pain continued to increase over the next several days, and was intolerable. The patient followed up with his dentist on 1st May 2018. Less than a week after receiving SHINGRIX, the patient experienced inflamed nerves. The dentist took x-ray of his mouth and he suggested to do a root canal since the nerves were inflamed. The reporter gave permission to contact their health care provider. The patient reported that root canal was expensive and he would not had to get a root canal done if he had not got the vaccination. The patient would do follow up with his health care provider.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Endodontic procedure, Eye swelling, Orthosis user, Pain in jaw
Clinical narrative: This case was reported by a consumer via call center presentative and described the occurrence of jaw pain in a 70-year-old male patient who received SHINGRIX. Concomitant products included ibuprofen and SYNTHROID. On 25th April 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th April 2018, 1 days after receiving SHINGRIX, the patient experienced jaw pain. On an unknown date, the patient experienced tooth inflammation. The patient was treated with VICODIN and antibiotics NOS. On an unknown date, the outcome of the jaw pain and tooth inflammation were recovering/resolving. The reporter considered the jaw pain and tooth inflammation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. At the evening of 26th April 2018, the patient experienced pain in lower left part of his jaw. The pain continued to increase over the next several days, and was intolerable. The patient followed up with his dentist on 1st May 2018. Less than a week after receiving SHINGRIX, the patient experienced inflamed nerves. The dentist took x-ray of his mouth and he suggested to do a root canal since the nerves were inflamed. The reporter gave permission to contact their health care provider. The patient reported that root canal was expensive and he would not had to get a root canal done if he had not got the vaccination. The patient would do follow up with his health care provider.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Toothache, X-ray dental abnormal
Clinical narrative: This case was reported by a consumer via call center presentative and described the occurrence of jaw pain in a 70-year-old male patient who received SHINGRIX. Concomitant products included ibuprofen and SYNTHROID. On 25th April 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th April 2018, 1 days after receiving SHINGRIX, the patient experienced jaw pain. On an unknown date, the patient experienced tooth inflammation. The patient was treated with VICODIN and antibiotics NOS. On an unknown date, the outcome of the jaw pain and tooth inflammation were recovering/resolving. The reporter considered the jaw pain and tooth inflammation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. At the evening of 26th April 2018, the patient experienced pain in lower left part of his jaw. The pain continued to increase over the next several days, and was intolerable. The patient followed up with his dentist on 1st May 2018. Less than a week after receiving SHINGRIX, the patient experienced inflamed nerves. The dentist took x-ray of his mouth and he suggested to do a root canal since the nerves were inflamed. The reporter gave permission to contact their health care provider. The patient reported that root canal was expensive and he would not had to get a root canal done if he had not got the vaccination. The patient would do follow up with his health care provider.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Endodontic procedure, Pain in jaw, Pulpitis dental
Clinical narrative: This case was reported by a consumer via call center presentative and described the occurrence of jaw pain in a 70-year-old male patient who received SHINGRIX. Concomitant products included ibuprofen and SYNTHROID. On 25th April 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th April 2018, 1 days after receiving SHINGRIX, the patient experienced jaw pain. On an unknown date, the patient experienced tooth inflammation. The patient was treated with VICODIN and antibiotics NOS. On an unknown date, the outcome of the jaw pain and tooth inflammation were recovering/resolving. The reporter considered the jaw pain and tooth inflammation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. At the evening of 26th April 2018, the patient experienced pain in lower left part of his jaw. The pain continued to increase over the next several days, and was intolerable. The patient followed up with his dentist on 1st May 2018. Less than a week after receiving SHINGRIX, the patient experienced inflamed nerves. The dentist took x-ray of his mouth and he suggested to do a root canal since the nerves were inflamed. The reporter gave permission to contact their health care provider. The patient reported that root canal was expensive and he would not had to get a root canal done if he had not got the vaccination. The patient would do follow up with his health care provider.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site vesicles, Injection site warmth
Clinical narrative: Cx came into pharmacy approx. 2pm with a complaint about pain in her arm and redness for the past few days after getting a SHINGRIX shot on Tues 5/8/18 at noon.... pt complains pain at injections site and redness. She states it started evening of shot and has persisted (2 days - today is 5/10/18).  She states so painful when she rolls over at night onto that arm the pain wakes her.... pt showed me the site and the redness was about the height of her hand and about as wide.... she also stated it was warm to the touch but not hard... (NOTE: pt did have a single bubble looking bump at the edge of the redness toward the back of the arm which she doesn't know if it was there before the shot). I suggested pt to see her Dr. and have her evaluate the area an bump... pt says she'll try to see Dr. in am before she goes away.  Also, pt did state she has never had a reaction from a shot before and I is leary and doesn't want to get the 2nd dose.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Pain in extremity
Clinical narrative: Cx came into pharmacy approx. 2pm with a complaint about pain in her arm and redness for the past few days after getting a SHINGRIX shot on Tues 5/8/18 at noon.... pt complains pain at injections site and redness. She states it started evening of shot and has persisted (2 days - today is 5/10/18).  She states so painful when she rolls over at night onto that arm the pain wakes her.... pt showed me the site and the redness was about the height of her hand and about as wide.... she also stated it was warm to the touch but not hard... (NOTE: pt did have a single bubble looking bump at the edge of the redness toward the back of the arm which she doesn't know if it was there before the shot). I suggested pt to see her Dr. and have her evaluate the area an bump... pt says she'll try to see Dr. in am before she goes away.  Also, pt did state she has never had a reaction from a shot before and I is leary and doesn't want to get the 2nd dose.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Complex febrile seizure occurring 8 days after administration, fevers to 102.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Peripheral swelling
Clinical narrative: Swelling of arm from elbow to shoulder, temperature of 100.3.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Pt called stating blisters on left thigh. He did not come in for exam.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Rash erythematous, Rheumatoid arthritis
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 69-year old female patient. Information regarding the patient's medical history and concurrent conditions was not provided. The patient had drug allergy to sulfamethoxazole (+) trimethoprim (BACTRIM), meperidine hydrochloride (DEMEROL), cephalexin (KEFLEX) and tramadol hydrochloride (ULTRAM). On 27-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N020502, 08-FEB-2019, as a routine vaccination (dose and route of administration were not provided). On an unknown date (reported as: "after PNEUMOVAX 23"), the patient experienced a red, rash over wrist, that physician diagnosed as rheumatoid arthritis. The patient came to a physician's office and received an unspecified treatment. Subsequently (also reported as "on 11-OCT-2017"), the patient was vaccinated with PREVNAR 13 lot# S35324 (expiration date, dose and route of administration were not provided). The outcome of the event and causality assessment were not provided. Upon internal review, the event of rhematoid arthritis was considered to be medically significant.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to two unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. Since 24-APR-2018, the patients had been administered improperly stored doses of VARIVAX lot # N022980, expiration date on 23-AUG-2019, lot #N027001, expiration date on 28-SEP-2019, for prophylaxis (strength, dose and route of administration were not reported). An sterile diluent (MERCK) was used to reconstitute vaccines. Vaccines were improperly stored at a temperature between 6°F to 14°F (8.5°F) for 38 minutes. No previous temperature excursions neither adverse effects were reported. The call was because of a data logger. The outcome was supported. Follow-up information received from medical assistant on 08-MAY-2018. The patient was identified to be a 4-year-old male patient. On 24-APR-2018, the patient was vaccinated with improperly stored dose of VARIVAX from lot N027001. This is one of the two reports linked via same reporter link. Sender's Comments: US-009507513-805USA004343.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 02-MAY-2018, the patient was inadvertently vaccinated with the third dose of PROQUAD recombinant Human albumin (rHA) lot # N029156 with expiration date 16-APR-2019, intramuscularly, for prophylaxis. No adverse effect was reported. It was stated that the patient received previous doses in 2006 and in 2009.
Age: 73.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 73 year old female consumer referring to herself. The patient medical history included gall bladder surgery. The patient's drug reactions/allergies included morphine and CECLOR. The patient's concomitant medications were reported as none. In 2015, the patient was vaccinated with ZOSTAVAX injection, subcutaneously, vaccine dose to prevent shingles (anatomical location, lot # and expiration date were not provided). Additionally, on 15-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 injection for prophylaxis (dose, frequency, route, lot # and expiration date were not provided). On 16-JAN-2018, the patient was diagnosed with shingles. The patient sought medical attention and was treated with an unknown number of unspecified medications. At the reporting time, the outcome of herpes zoster was reported as not resolved as the patient was still not 100 per cent recovered. None laboratory studies were performed. The reporter did not assess the relatedness between ZOSTAVAX or PNEUMOVAX 23 and the herpes zoster.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 19 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unspecified date, the patient was inadvertently vaccinated with a pediatric dose of VAQTA 25/0.5 injection, intramuscularly lot # N019924 with expiration date 02-SEP-2018 for prophylaxis (accidental underdose). No adverse effect reported.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency, expiry date and route of administration were not reported) (lot # M042599) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency, expiry date and route of administration were not reported) (lot # N000508) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency and route of administration were not reported) (lot # M037669, expiry date: 09-MAY-2018) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 09-MAY-2018, the patient was vaccinated with an expired dose of VAQTA (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 09-MAY-2018 the patient was vaccinated with M-M-R II, intramuscular for prophylaxis. On 09-MAY-2018, 1 day after onset of therapy the patient experienced incorrect route of drug administration. On an unknown date the patient experienced no adverse event. The outcome of incorrect route of drug administration and no adverse event is unknown. The reporter considered incorrect route of drug administration and no adverse event to be not assessed to M-M-R II.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 2 year old female patient. The patients' pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On 24-APR-2018, the patient was vaccinated with improperly stored dose of VARIVAX lot # N022980, expiration date on 23-AUG-2019 for prophylaxis (strength, dose and route of administration were not reported). A sterile diluent (MERCK) was used to reconstitute vaccines. Vaccines were improperly stored at a temperature between 6°F to 14°F (8.5°F) for 38 minutes. No previous temperature excursions neither adverse effects were reported. The call was because of a data logger. The outcome was supported. Sender's Comments: US-009507513-1805USA000900.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse via company representative, refers to a female patient, a nurse of unknown age. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On unspecified dates (reported as "in the past several months"), the patient was vaccinated with PNEUMOVAX 23 dose reported as "one adult dose", route of administration reported as "to her knowledge according to the prescribing information", for pneumonia prevention (strength, frequency, lot# and expiration date were not reported). On unspecified dates, the patient sought medical attention at the physician's office for swelling in her arm at the injection site. It was unknown if the patient received any treatment or if diagnostic laboratories were performed. At the time of reporting, the outcome of injection site swelling was unknown. Additionally, the causality assessment between injection site swelling and PNEUMOVAX 23 was not provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA004261.