chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2009, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 10-JUN-2016, the patient was treated by a physician for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional information was received as follows: The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional stated that the patient told him that she had gotten the SHINGRIX vaccine at another pharmacy and had a reaction from shoulder to wrist. No further information was available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On 15th March 2018, the patient received the 1st dose of SHINGRIX. On 22nd June 2018, 99 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 22nd June 2018, the patient went to her doctor and diagnosed with shingles. The patient was currently on acyclovir for shingles. The health care professional was asking when the patient could receive the 2nd dose of SHINGRIX. The health care professional did not have any further details at the time of the call.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Cheilitis, Headache, Immediate post-injection reaction, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 11-year-old female patient who received MENVEO (batch number M16130, expiry date 21st July 2018) for prophylaxis. Previously administered products included INFANRIX with an associated reaction of injection site swelling (for details regarding adverse event, refer case US2018115052). Concomitant products included loratadine and melatonin. On 15th May 2018, the patient received MENVEO. On 15th May 2018, immediately after receiving MENVEO, the patient experienced injection site swelling and injection site itching. In May 2018, the patient experienced headache, rash lips, rash and skin discoloration. The patient was treated with ibuprofen, paracetamol (Tylenol), benadryl (nos) (Benadryl) and famotidine (Pepcid). On an unknown date, the outcome of the injection site swelling, injection site itching, headache, rash lips and rash were recovered/resolved and the outcome of the skin discoloration was unknown. The reporter considered the injection site swelling, injection site itching, headache, rash lips, rash and skin discoloration to be related to MENVEO. Additional information was reported as follows: This case was reported by the mother of the patient. The patient received a dose of MENVEO and immediately experienced swelling in arm at site of injection along with itchiness. Caller stated that the patient was given Benadryl and Pepcid right away due to similar reaction with INFANRIX from 2015. The caller reported that swelling was about 3.5 inches around injection site and that 18 hours later patient experienced spots on face and lips that were purple in color. The caller reported that the patient experienced headache as well that Tylenol and ibuprofen did not resolve. Caller reports that events resolved 2 weeks later. Vaccine administration facility information was not obtained during phone consultation. Reporter called back at 2:01 inquiring if the pictures that were associated with the adverse event reports had been received. The sender informed the reporter that he/she would send a follow up and if more information was required she would be contacted by the safety department.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Rash, Skin discolouration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 11-year-old female patient who received MENVEO (batch number M16130, expiry date 21st July 2018) for prophylaxis. Previously administered products included INFANRIX with an associated reaction of injection site swelling (for details regarding adverse event, refer case US2018115052). Concomitant products included loratadine and melatonin. On 15th May 2018, the patient received MENVEO. On 15th May 2018, immediately after receiving MENVEO, the patient experienced injection site swelling and injection site itching. In May 2018, the patient experienced headache, rash lips, rash and skin discoloration. The patient was treated with ibuprofen, paracetamol (Tylenol), benadryl (nos) (Benadryl) and famotidine (Pepcid). On an unknown date, the outcome of the injection site swelling, injection site itching, headache, rash lips and rash were recovered/resolved and the outcome of the skin discoloration was unknown. The reporter considered the injection site swelling, injection site itching, headache, rash lips, rash and skin discoloration to be related to MENVEO. Additional information was reported as follows: This case was reported by the mother of the patient. The patient received a dose of MENVEO and immediately experienced swelling in arm at site of injection along with itchiness. Caller stated that the patient was given Benadryl and Pepcid right away due to similar reaction with INFANRIX from 2015. The caller reported that swelling was about 3.5 inches around injection site and that 18 hours later patient experienced spots on face and lips that were purple in color. The caller reported that the patient experienced headache as well that Tylenol and ibuprofen did not resolve. Caller reports that events resolved 2 weeks later. Vaccine administration facility information was not obtained during phone consultation. Reporter called back at 2:01 inquiring if the pictures that were associated with the adverse event reports had been received. The sender informed the reporter that he/she would send a follow up and if more information was required she would be contacted by the safety department.
Age: 8.0
Sex: F
Vaccine: DTAP
Symptoms: Cheilitis, Drug administered to patient of inappropriate age, Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 8-year-old female patient who received INFANRIX (batch number AC7AG, expiry date 17th October 2016) for prophylaxis. Concomitant products included loratadine and melatonin. On 14th May 2015, the patient received INFANRIX. On 14th May 2015, unknown after receiving INFANRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, less than a month after receiving INFANRIX, the patient experienced injection site swelling, injection site erythema, injection site streaking, rash lips, tongue pigmentation, rash and skin discoloration. The patient was treated with BENADRYL and PEPCID. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site streaking, rash lips, tongue pigmentation, rash and skin discoloration were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown. The reporter considered the injection site swelling, injection site erythema, injection site streaking, rash lips, tongue pigmentation, rash and skin discoloration to be related to INFANRIX. Additional information was reported as follows: This case was previously reported to the physician. This case was reported by the mother of the patient. The patient received a dose of INFANRIX and experienced swelling, redness at injection site with a white streak through it. Caller reported that the patient also experienced purple spots on face, lips and tongue. Caller reported that she took the patient to emergency room for treatment was not admitted and gave the patient BENADRYL and PEPCID which helped. Caller reported that the events resolved about a month after the dose was administered. The vaccine administration facility information was not obtained during phone consultation. This case is linked with case US2018115051, which was reported for different suspect product.
Age: 8.0
Sex: F
Vaccine: DTAP
Symptoms: Rash, Skin discolouration, Tongue pigmentation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 8-year-old female patient who received INFANRIX (batch number AC7AG, expiry date 17th October 2016) for prophylaxis. Concomitant products included loratadine and melatonin. On 14th May 2015, the patient received INFANRIX. On 14th May 2015, unknown after receiving INFANRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, less than a month after receiving INFANRIX, the patient experienced injection site swelling, injection site erythema, injection site streaking, rash lips, tongue pigmentation, rash and skin discoloration. The patient was treated with BENADRYL and PEPCID. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site streaking, rash lips, tongue pigmentation, rash and skin discoloration were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown. The reporter considered the injection site swelling, injection site erythema, injection site streaking, rash lips, tongue pigmentation, rash and skin discoloration to be related to INFANRIX. Additional information was reported as follows: This case was previously reported to the physician. This case was reported by the mother of the patient. The patient received a dose of INFANRIX and experienced swelling, redness at injection site with a white streak through it. Caller reported that the patient also experienced purple spots on face, lips and tongue. Caller reported that she took the patient to emergency room for treatment was not admitted and gave the patient BENADRYL and PEPCID which helped. Caller reported that the events resolved about a month after the dose was administered. The vaccine administration facility information was not obtained during phone consultation. This case is linked with case US2018115051, which was reported for different suspect product.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of myalgia in a 57-year-old patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020) for prophylaxis. Previously administered products included ZOSTAVAX (received on 5th November 2015).  On 18th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced myalgia and influenza-like symptoms. On an unknown date, the outcome of the myalgia and influenza-like symptoms were unknown. The reporter considered the myalgia and influenza-like symptoms to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported, however, it could be 56 or 57 years. The patient was a hospital employee. The patient experienced the adverse events for 2 days. Concomitant medications, vaccination facility, and other specific details were unknown, as no further information was provided during the call. The reporter gave consent to be contacted for follow up information. This case was one of the 9 cases reported by the same reporter. The reporter stated over the phone that about half of the eight patients had experienced flu-like symptoms, one of which was another doctor who could not go to a work related event the next day because of the symptoms. It was unknown which of the eight patients was the concerned doctor.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of chills in a 72-year-old patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020) for prophylaxis. Previously administered products included ZOSTAVAX (received on 20th October 2009).  On 9th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills and influenza-like symptoms. On an unknown date, the outcome of the chills and influenza-like symptoms were unknown. The reporter considered the chills and influenza-like symptoms to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported, however, it could be 71 or 72 years. The patient was a hospital employee. Concomitant medications, vaccination facility, and other specific details were unknown, as no further information was provided during the call. The reporter gave consent to be contacted for follow up information. This case was one of the 9 cases reported by the same reporter. The reporter stated over the phone that about half of the eight patients had experienced flu-like symptoms, one of which was another doctor who could not go to a work related event the next day because of the symptoms. It was unknown which of the eight patients was the concerned doctor.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of chills in a 72-year-old patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020) for prophylaxis. Previously administered products included ZOSTAVAX (received on 5th January 2007).  On 20th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills and influenza-like symptoms. On an unknown date, the outcome of the chills and influenza-like symptoms were unknown. The reporter considered the chills and influenza-like symptoms to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported, however, it could be 71 or 72 years. The patient was a hospital employee. Concomitant medications, vaccination facility, and other specific details were unknown, as no further information was provided during the call. The reporter gave consent to be contacted for follow up information. This case was one of the 9 cases reported by the same reporter. Additionally this case was linked with case US2018GSK117734, reported by the same reporter the same patient (for 2nd dose). The reporter stated over the phone that about half of the eight patients had experienced flu-like symptoms, one of which was another doctor who could not go to a work related event the next day because of the symptoms. It was unknown which of the eight patients was the concerned doctor.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of chills in a 72-year-old patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020) for prophylaxis. Previously administered products included ZOSTAVAX (received on 5th January 2007), SHINGRIX with an associated reaction of chills and SHINGRIX with an associated reaction of influenza like illness (refer case US2018115074, for 1st dose). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills and influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills and influenza-like symptoms were unknown. The reporter considered the chills and influenza-like symptoms to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported, however, it could be 71 or 72 years. The patient was a hospital employee. Concomitant medications, vaccination facility, and other specific details were unknown, as no further information was provided during the call. The reporter gave consent to be contacted for follow up information. This case was one of the 9 cases reported by the same reporter. The reporter stated over the phone that about half of the eight patients had experienced flu-like symptoms, one of which was another doctor who could not go to a work related event the next day because of the symptoms. It was unknown which of the eight patients was the concerned doctor.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of general body pain in a 69-year-old patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020) for prophylaxis. Previously administered products included ZOSTAVAX (received on 17th July 2013). On 17th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, itchy upper limbs, rash, erythema of extremities, injection site erythema and injection site swelling. On an unknown date, the outcome of the general body pain, itchy upper limbs, rash, erythema of extremities, injection site erythema and injection site swelling were unknown. The reporter considered the general body pain, itchy upper limbs, rash, erythema of extremities, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported, however, it could be 68 or 69 years. The patient was a hospital employee. The rash was described as being on the whole arm. The red streaks were on the lower part of the upper arm to the elbow. The symptom of itching was of the arm. Concomitant medications, vaccination facility, and other specific details were unknown, as no further information was provided during the call. The reporter gave consent to be contacted for follow up information. This case was one of the 9 cases reported by the same reporter. The reporter stated over the phone that about half of the eight patients had experienced flu-like symptoms, one of which was another doctor who could not go to a work related event the next day because of the symptoms. It was unknown which of the eight patients was the concerned doctor.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of general body pain in a 69-year-old patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020) for prophylaxis. Previously administered products included ZOSTAVAX (received on 17th July 2013). On 17th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, itchy upper limbs, rash, erythema of extremities, injection site erythema and injection site swelling. On an unknown date, the outcome of the general body pain, itchy upper limbs, rash, erythema of extremities, injection site erythema and injection site swelling were unknown. The reporter considered the general body pain, itchy upper limbs, rash, erythema of extremities, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported, however, it could be 68 or 69 years. The patient was a hospital employee. The rash was described as being on the whole arm. The red streaks were on the lower part of the upper arm to the elbow. The symptom of itching was of the arm. Concomitant medications, vaccination facility, and other specific details were unknown, as no further information was provided during the call. The reporter gave consent to be contacted for follow up information. This case was one of the 9 cases reported by the same reporter. The reporter stated over the phone that about half of the eight patients had experienced flu-like symptoms, one of which was another doctor who could not go to a work related event the next day because of the symptoms. It was unknown which of the eight patients was the concerned doctor.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a 84-year-old patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020) for prophylaxis. On 16th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were unknown. The reporter considered the injection site pain and pain in arm to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported, however, it could be 83 or 84 years. The patient was a hospital employee. The patient did not have any previous vaccination with ZOSTAVAX. The patient experienced pain at the site of injection and arm. Concomitant medications, vaccination facility, and other specific details were unknown, as no further information was provided during the call. The reporter gave consent to be contacted for follow up information. This case was one of the 9 cases reported by the same reporter. The reporter stated over the phone that about half of the eight patients had experienced flu-like symptoms, one of which was another doctor who could not go to a work related event the next day because of the symptoms. It was unknown which of the eight patients was the concerned doctor.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 66-year-old patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020) for prophylaxis. On 21st March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills. On an unknown date, the outcome of the chills was unknown. The reporter considered the chills to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported, however, it could be 65 or 66 years. The patient was a hospital employee. The patient did not have any previous vaccination with ZOSTAVAX. Concomitant medications, vaccination facility, and other specific details were unknown, as no further information was provided during the call. The reporter gave consent to be contacted for follow up information. This case was one of the 9 cases reported by the same reporter. Additionally, this case has been linked with case US2018GSK117828, reported by the same reporter for the same patient (2nd dose). The reporter stated over the phone that about half of the eight patients had experienced flu-like symptoms, one of which was another doctor who could not go to a work related event the next day because of the symptoms. It was unknown which of the eight patients was the concerned doctor.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 78-year-old female patient who received SHINGRIX for prophylaxis. On 27th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. The patient was treated with Antihistamines. In June 2018, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injection site swelling was recovered/resolved. The reporter considered the injection site erythema and injection site swelling to be probably related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on the left arm. The patient experienced the swelling and redness at injection site and it was a size of 2 inch circle. No further information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Fatigue, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, headache, bone pain, tiredness, pain, feeling miserable and influenza-like symptoms. On an unknown date, the outcome of the fever, headache, bone pain, tiredness, pain, feeling miserable and influenza-like symptoms were unknown. It was unknown if the reporter considered the fever, headache, bone pain, tiredness, pain, feeling miserable and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had side effects and questioned that, would she experience them again with the 2nd dose. The patient experienced fever (body temperature: 100 degree F). The patient had achy bones, was tired, sore and felt fly like symptoms. Lab Comments: On an unknown date, the patient's body temperature was found to be 100 degree F.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, headache, bone pain, tiredness, pain, feeling miserable and influenza-like symptoms. On an unknown date, the outcome of the fever, headache, bone pain, tiredness, pain, feeling miserable and influenza-like symptoms were unknown. It was unknown if the reporter considered the fever, headache, bone pain, tiredness, pain, feeling miserable and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had side effects and questioned that, would she experience them again with the 2nd dose. The patient experienced fever (body temperature: 100 degree F). The patient had achy bones, was tired, sore and felt fly like symptoms. Lab Comments: On an unknown date, the patient's body temperature was found to be 100 degree F.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX early in the morning and experienced flu like symptoms until the same time the following morning. It was verified verbally that the vaccine was given intramuscularly.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that one of his patients stated that after receiving SHINGRIX experienced arm hurt more than any other vaccination ever had.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shivering in an unspecified number of adult patients who received SHINGRIX for prophylaxis. 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 shivering. On an unknown date, the outcome of the shivering was unknown. The reporter considered the shivering to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. During a phone call, the physician told the field representative that the most common side effect from SHINGRIX that some of her patients have had is shivering. This case was one of the 9 cases reported by the same reporter. It was unknown if any of those 8 patients were the patients to which the doctor was referring generally when she said that some of her patients had shivering. Shivering was not specifically provided in the doctor's spreadsheet of symptoms for other 8 patients which was sent to the field representative. Some of the other 8 cases have the symptom of chills, and it was also unknown if the doctor considered the symptom of chills to be shivering or considered shivering to be a separate symptom. So, the patients of the reporter who have had the specific symptom of shivering were currently unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 66-year-old patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (refer case US2018115079, for 1st dose). On 13th June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills was unknown. The reporter considered the chills to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported, however, it could be 65 or 66 years. The patient was a hospital employee. The patient did not have any previous vaccination with ZOSTAVAX. Concomitant medications, vaccination facility, and other specific details were unknown, as no further information was provided during the call. The reporter gave consent to be contacted for follow up information. This case was one of the 9 cases reported by the same reporter. The reporter stated over the phone that about half of the eight patients had experienced flu-like symptoms, one of which was another doctor who could not go to a work related event the next day because of the symptoms. It was unknown which of the eight patients was the concerned doctor.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Platelet count decreased
Clinical narrative: Initial information received on 18-Jun-2018 regarding an unsolicited valid non-serious case received from a Physician. This case involves a four months old female patient who experienced low platelets two weeks after vaccines, while she received vaccine PENTACEL. No medical history was reported. No concomitant therapies were reported. On an unknown date, the patient received a dose of PENTACEL (lot number, expiry date dose details not reported) via unknown route in unknown administration site. On an unspecified date, two weeks after vaccination, the patient had low platelets. No lab data was reported. It was not reported if the patient received a corrective treatment. The patient outcome is not reported for low platelets two weeks after vaccines. List of document held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial unsolicited report valid received from administration on 18 Jun 2018. In this case the patient had received an expired dose of Act-HIB (Batch number, expiration date, dose, route and site of administration was not reported) was administered on an unspecified date. It was an actual medication error due to expired vaccine used. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial unsolicited report received from nurse on 20 Jun 2018. This case was linked to 2018SA168277 (same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a third dose of ADACEL instead of DAPTACEL (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Pyrexia
Clinical narrative: Initial information received on 05-Jun-2018 regarding an unsolicited valid non-serious case received from other health professional (medical assistant). This case involves an 18 years old female patient who experienced fever of 101.2 and headache, while she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Jun-2018, the patient received a single dose of suspect MENACTRA (Lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a non-serious fever of 101.2 (pyrexia), following the administration of MENACTRA. On an unknown date, the patient developed a non-serious headache following the administration of MENACTRA. Final diagnosis was headache and fever of 101.2. The patient was treated with IBUPROFEN. The patient outcome is reported as unknown for fever of 101.2 and as unknown for headache. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Local reaction
Clinical narrative: Initial information received on 20-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves female patient (gender not reported) who experienced extreme local reactions including swelling at injection site, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. On an unknown date, the patient developed a non-serious extreme local reactions including swelling at injection site, following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Relevant tests were not reported. Final diagnosis was extreme local reactions including swelling at injection site. It was not reported if the patient received a corrective treatment. The outcome was reported as Unknown for extreme local reactions including swelling at injection site. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 22-Jun-2018 regarding an unsolicited valid non-serious case received from an office person medical assistant. This case involves a patient (age and gender was not reported), who was vaccinated with an expired dose of ACT-HIB (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to expired vaccine used because the vaccine was expired by one day. it was reported that it was only expired by one day. The patient had not experience any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: HIBV, IPV
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 22-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old patient who experienced 4th dose of this was given in error 1.5 months from the last dose, while he/she received vaccines ACT-HIB and IPOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect IPV (VERO) lot number not reported via unknown route in unknown administration site. The patient developed a non-serious 4th dose of this was given in error 1.5 months from the last dose <<Unknown latency>> following the administration of IPV (VERO) and <<Unknown latency>> following the administration of HIB (PRP/T) VACCINE. Final diagnosis was 4th dose of this was given in error 1.5 months from the last dose. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for 4th dose of this was given in error 1.5 months from the last dose.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial information received on 22-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a seven month age patient (gender unknown) who experienced inadvertently gave 2 doses, one week apart to 7 mos old, no adverse event, while he/she received vaccine [PENTACEL]. The patient's past medical history, medical treatment, vaccination and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to extra dose administered. Patient received two doses of vaccine inadvertently one week apart. Final diagnosis was inadvertently gave 2 doses, one week apart to 7 mos old, no adverse event. The patient outcome is reported as Not Applicable for inadvertently gave 2 doses, one week apart to 7 mos old, no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive  and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Initial information received on 15-Jun-2018 regarding an unsolicited valid non-serious case received from a Physician. This case involves three patients (age and gender not reported) who experienced a large reddened area at the injection site which is hot to touch, after receiving DAPTACEL. No medical history or concomitant therapies were reported. On an unknown date one patient received first dose of DAPTACEL (lot C5180BA, expiry date not reported) via intramuscular route in unknown administration site. On an unknown date other two patients received fifth dose of the DAPTACEL (lot C5180BA, expiry date not reported) via intramuscular route in unknown administration site. On an unknown date (latency not reported) following vaccinations all three patients developed a large reddened area at the injection site which is hot to touch. The area is about the size of a baseball. No further information was provided. No lab data was reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for all three patients. List of document held by sender: none.
Age: 29.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site reaction, Tenderness
Clinical narrative: Initial information received on 20-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional (Nurse). This case involves a 31 years old male patient who experienced tender to touch, site reaction of redness of the site, pea size knot under injection site and had a site reaction, while he received vaccines PNEUMO 23 and ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 18-Jun-2018, the patient received 0.5 ml single dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5875AA (Expiry date: 14-FEB-2020) via intramuscular route in the left deltoid. On 18-Jun-2018, the patient received a dose of suspect PNEUMO 23 not produced by Sanofi Pasteur lot number not reported in unknown administration site. On 20-Jun-2018, The patient developed a non-serious tender to touch 2 days following the administration of ADACEL. On 20-Jun-2018, The patient developed a non-serious site reaction of redness of the site 2 days following the administration of ADACEL. On 20-Jun-2018, The patient developed a non-serious pea size knot under injection site 2 days following the administration of ADACEL. On an unknown date, the patient developed a non-serious had a site reaction <<Unknown latency>> following the administration of PNEUMO 23. Final diagnosis was pea size knot under injection site, site reaction of redness of the site, tender to touch and had a site reaction. Lab tests was not reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for site reaction of redness of the site, as Unknown for tender to touch, as Unknown for pea size knot under injection site and as Unknown for had a site reaction.
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of drug administration
Clinical narrative: Initial information received on 20-Jun-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a 40 years old (reported as in 40s) female patient who was administered ADACEL intravenously. This is the case of actual medication error due to inappropriate route of vaccination. Medical history: It was reported that male trauma patient in 40s. On 20-Jun-2018, the patient received a dose of suspect ADACEL (lot U6092BA, expiry date not reported) via intravascular route in unknown administration site. It was not clear if the patient experienced any adverse event. Lab data and corrective treatment: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Dyspnoea, Hypertension, Panic disorder, Swelling face, Tachycardia
Clinical narrative: Initial information received on 18-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA164901, 2018SA175593 and 2018SA175612. This case involves Adult female patient who experienced hives, hypertensive, Tachy, panicy, short of breath and swollen face, while she received vaccine INFLUENZA VACCINE (reported as flu vaccine). The patient's past medical history included Rubber sensitivity. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported in unknown administration site. The patient developed a non-serious hives (urticaria), hypertensive (hypertension), tachy (tachycardia), panicy (pain), short of breath (dyspnoea) and swollen face (swelling face) following the administration of INFLUENZA VACCINE. (Other relevant tests included No lab data.). Final diagnosis was swollen face, short of breath, panicy, tachy, hypertensive and hives. The patient was treated with SOLUMEDROL. The patient outcome is reported as Unknown for hives, hypertensive, tachy, panicy, short of breath and swollen face. List of documents held by sender: none.