chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.17
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: KINRIX given out of recommended age range.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: KINRIX was diluted with 1 vial of sterile diluent 0.5 ml and administered to patient. No actual side effects were noted with this patient. Health Nurse, RN, Clinic VP., pharmacy and immunization coordinators notified. Incident report submitted and nurse retrained regarding incident. Attempting to notify patient's parent regarding incident and re-immunize patient.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Adverse reaction, Erythema, Fluid retention, Peripheral swelling
Clinical narrative: Patient stated his arm was swollen, red and had a fluid accumulation. Patient also was physically active after receiving the vaccine. He was going to be seen by his doctor for a routine checkup, and when his doctor saw it, they stated it was a "weird" reaction and that he should use Tylenol and apply heat. Patient states that after following doctor's instructions it is looking better.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Foreign travel, Lip swelling, Rash pruritic
Clinical narrative: Pt is a 17 year old female, here with mom, who presents with recurrent itchy rash and new onset of lip swelling. Timeline: pt got Chicken pox in January 2018, body cleared rash. July 2nd 2018 - HPV and BEXSERO vaccine - day later got spots, then resolved, they come and go. Rash is very itchy, last night PT's lip got swollen - she was drinking a slushie, then was swollen this morning, mom gave her 10 ml of benadryl this morning around 7 am, feels the swelling got better.No new soaps, lotions, detergents, foods. Did travel, dates:  7/14/18 - 7/28/18, got yellow fever vaccine 7/17/18. BEXSERO vaccine 7/2/18 and 8/6/18, HPV vaccine 7/2/18 and 8/6/18. ASSESSMENT/PLAN: R21 Rash  (primary encounter diagnosis) Plan: REFERRAL TO ALLERGY, INT R22.0 Swelling of upper lip Plan: REFERRAL TO ALLERGY, INT.
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: On the evening of administration, the site was sore as would be expected. Twenty hours post injection, I developed headache, 8/10 pain, with body aches and stiff neck on left side. Left arm swelled and watch at wrist became tight. A raised, painful erythematous swelling 6 inches long in circumference and 3 inches high raised around my upper arm about 2 inches below the injection site. The injection site was not unusually red or raised. The red swollen area is around the circumference of my arm on the lateral aspect, not encircling completely to the inner aspect of my arm.
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pain, Peripheral swelling
Clinical narrative: On the evening of administration, the site was sore as would be expected. Twenty hours post injection, I developed headache, 8/10 pain, with body aches and stiff neck on left side. Left arm swelled and watch at wrist became tight. A raised, painful erythematous swelling 6 inches long in circumference and 3 inches high raised around my upper arm about 2 inches below the injection site. The injection site was not unusually red or raised. The red swollen area is around the circumference of my arm on the lateral aspect, not encircling completely to the inner aspect of my arm.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: PT CALLED PHARMACY ON 8/26 INQUIRING ABOUT UNDERARM SWELLING IN LYMPH NODE AREA OF LEFT ARM. TENDERNESS AND PAIN AT THE SITE. TOLD PT TO CONTACT A PRIMARY CARE DOCTOR TO EXAMINE FOR ADVERSE EFFECT, AND TOLD PT TO SEEK IMMEDIATE ATTENTION IF IT BECOMES MUCH WORSE. PT FOLLOWED UP WITH STUDENT HEALTH CENTER THE NEXT DAY. BY TUESDAY WE CHECKED IN WITH PT AND HE REPORTED THE AREA WAS GETTING BETTER AND SWELLING WAS DECREASING.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Patient had severe rash that was warm to touch on right arm.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 10-AUG-2018, the patient was vaccinated with an improperly stored PROQUAD recombinant human albumin (rHA) (Strength, dose, route and anatomical location were not reported) of lot # N016993 with an expiry date of 29-NOV-2018 for prophylaxis. The concomitant therapy included sterile diluent. The PROQUAD underwent a temperature excursion from - 14 degree Celsius to - 10 degree Celsius for a timeframe of 16 minutes. The previous temperature excursion was from - 14 degree Celsius to - 10 degree Celsius for 14 minutes. Digital data logger was involved. No adverse effects were reported. Product quality complaint was not involved.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 4 year old male patient. The patient's concurrent conditions included develop mental delay and his concomitant medications included DTAP-IPV, PREVENAR 13 and Enders-Edmonston (+) Jeryl Lynn (+) (Wistar RA 27/3) M-M-R II. No information was provided regarding the patient's medical history, drug reactions, allergies or concomitant medications. On 31-JAN-2012, the patient was vaccinated in the left thigh with second dose of Oka/Merck VARIVAX subcutaneously, lot Number reported as 1285X, expiration date on 10-SEP-2010 for prophylaxis (strength was not reported). An unspecified system in the office flagged that as the Oka/Merck VARIVAX was already expired when it was administered, but she was not sure if the expiration date was correct. It was also reported an error during preparation and administration of Oka/Merck VARIVAX and it was unknown if drug treatment for the experience was required. There were no adverse symptoms reported.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 15th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st August 2018, 67 days after receiving SHINGRIX, the patient experienced fever, headache and pain. On an unknown date, the outcome of the fever, headache and pain were unknown. It was unknown if the reporter considered the fever, headache and pain to be related to SHINGRIX. Additional details were provided as follows: The reporting physician was the patient. The patient received SHINGRIX on left deltoid. The patient had fever of 102 degree C. This case has been linked with US2018151863, reported by the same reporter.
Age: 49.0
Sex: F
Vaccine: MNQ
Symptoms: Immediate post-injection reaction, Product complaint, Product container issue, Skin laceration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of laceration of finger in a 49-year-old female patient who received MENVEO (batch number M17102, expiry date August 2019), (batch number 175301, expiry date unknown) and (batch number SR967, expiry date unknown) for prophylaxis. This case was associated with a product complaint. On 21st August 2018, the patient received MENVEO. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On 21st August 2018, immediately after receiving MENVEO, the patient experienced laceration of finger. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the laceration of finger and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the laceration of finger to be related to MENVEO. Additional details reported as follows: The age at vaccination was not applicable for this report. The case was reported by the Office Manager. The batch number 175301 corresponds to MenCWY part and SR967 corresponds to Men A part of vaccine. Upon receipt of the box, the reporter could hear something rattling around in the box. When opened, there was broken glass throughout the box. When trying to determine how many vials were affected, the reporter cut her hand. There did not appear to be any damage to the box or the tray. There was no evidence of leakage, everything was dry. None of the vaccines were administered and the entire box was available for return. The entire box would be replaced. The patient had denied permission to contact their physician.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 24th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, 8 hrs after receiving SHINGRIX, the patient experienced headache. On an unknown date, the patient experienced muscle pain. On an unknown date, the outcome of the headache and muscle pain were recovered/resolved. It was unknown if the reporter considered the headache and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported headaches and body ache after both doses. The caller stated that after his first shot of SHINGRIX he experienced a headache about 8 hours after the shot which resolved by the third day.  He also experienced a little bit of muscle ache which lasted no more than 3 days. This case has been linked with US2018GSK157252 , reported by the same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Anger, Hypersensitivity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a adult female 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 allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she had an allergic reaction to SHINGRIX but when tried to gather additional information, the patient hung up the call. The patient was very angry and almost incomprehensible.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unwell in a female 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 unwell. On an unknown date, the outcome of the unwell was unknown. It was unknown if the reporter considered the unwell to be related to SHINGRIX. Additional details were provided as follows: The caller stated that she was the second person to receive the SHINGRIX injection from her local heath department and they asked her to call them back if she experienced any side effects because the first person (female) who got the SHINGRIX shot got ill. No further details were remembered by the patient. This case has been linked with cases US2018GSK153695 and US2018151874, reported by same reporter.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: This case was reported by a other health professional via patient support programs and described the occurrence of fainting in a 12-year-old male patient who received BOOSTRIX (batch number 4P9CL, expiry date unknown) for prophylaxis. Co-suspect products included MENVEO (batch number MI7077, expiry date unknown) for prophylaxis. On 21st August 2018, the patient received the 1st dose of BOOSTRIX and the 1st dose of MENVEO. On 21st August 2018, less than a day after receiving BOOSTRIX and MENVEO, the patient experienced fainting. On 21st August 2018, the outcome of the fainting was recovered/resolved. The reporter considered the fainting to be probably related to BOOSTRIX and MENVEO. Additional details were provided as follows: This case was received from other health professional via the vaccine patient assistant program. The patient fainted for approximately 5 seconds following the administration of BOOSTRIX and MENVEO. The reporter was unsure which vaccine caused the reaction. The reporter advised that oxygen was started as it dropped to 93 and slowly went up. The events did not require surgical medical intervention. The patient was not admitted to the hospital overnight or prolong an existing hospitalization. The health care professional did not consider the event as life threatening event. The health care professional did not consider the events to result in persistent or significant disability or incapacity. The event did not resulted in congenital anomaly or birth defect. This case has been linked with case US2018GSK152213, reported by same reporter.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: This case was reported by a other health professional via patient support programs and described the occurrence of fainting in a 11-year-old male patient who received BOOSTRIX (batch number 9PD92, expiry date unknown) for prophylaxis. Co-suspect products included MENVEO (batch number A17074, expiry date unknown) for prophylaxis. On 20th August 2018, the patient received the 1st dose of BOOSTRIX and the 1st dose of MENVEO. On 20th August 2018, less than a day after receiving BOOSTRIX and MENVEO, the patient experienced fainting. On 20th August 2018, the outcome of the fainting was recovered/resolved. The reporter considered the fainting to be probably related to BOOSTRIX and MENVEO. Additional details were provided as follows:  This case was received from other health professional via the vaccine patient assistant program. The patient fainted for approximately 5- 10 seconds following the administration of BOOSTRIX and MENVEO. The reporter was unsure which vaccine caused the reaction. The events did not require surgical medical intervention. The patient was not admitted to the hospital overnight or prolong an existing hospitalization. The health care professional did not consider the event as life threatening event. The health care professional did not consider the events to result in persistent or significant disability or incapacity. The event did not resulted in congenital anomaly or birth defect. This case has been linked with case US2018GSK152212, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia, Rash, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of rash in a 60-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced rash, fever, pain, neck swelling and myalgia. On an unknown date, the outcome of the rash, fever, pain and neck swelling were recovered/resolved and the outcome of the myalgia was unknown. It was unknown if the reporter considered the rash, fever, pain, neck swelling and myalgia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. But, it could be 59 or 60 years old. The patient complained of rash, fever, pain, swelling of neck and back of ears for 3 days and myalgia. It happened a day after receiving the SHINGRIX. The reporter agreed to contact for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of headache in a 52-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, several days after receiving SHINGRIX, the patient experienced headache, fever, chills and myalgia. On an unknown date, the outcome of the headache, fever, chills and myalgia were recovered/resolved. It was unknown if the reporter considered the headache, fever, chills and myalgia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced headache, fever, chills, myalgia for a couple days after the vaccination and the symptoms resolved within 3 days. The reporter agreed to contact for follow up. This case has been linked with case US2018GSK153154, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 47-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain in arm and general body pain. On an unknown date, the outcome of the pain in arm and general body pain were unknown. It was unknown if the reporter considered the pain in arm and general body pain to be related to SHINGRIX. Additional detail were provided as follows: The age at vaccination was not reported. After receiving a dose of SHINGRIX the patient complained of pain in the arm as well as through out his body. The patient had received his dose of SHINGRIX 1 day before. The reporter agreed to contact for follow up.
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 elderly 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 recovered/resolved. 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 patient was in his late 60's. The patient experienced very sore arm which was rated as 7 on the scale of 1 to 10, for approximately 3 days. The reporter did not agree for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Impaired work ability, Myalgia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fatigue in a female patient who received SHINGRIX for prophylaxis. 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 fatigue and myalgia. On an unknown date, the outcome of the fatigue and myalgia were unknown. It was unknown if the reporter considered the fatigue and myalgia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had fatigue and myalgia and missed a days work. The reporter agreed for follow up. This case has been linked with case US2018GSK153230, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Dysgeusia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of taste altered in a adult patient who received SHINGRIX for prophylaxis. On 16th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced taste altered. On an unknown date, the outcome of the taste altered was unknown. It was unknown if the reporter considered the taste altered to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st of the two SHINGRIX vaccine. Over the weekend, she called saying that she got altered taste in her mouth. She said it started as a bad taste. The reporter was asking was that a normal side effect.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Hypopnoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 82-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (after receiving 1st dose on 24th April 2018, refer case US2018151874). On 13th August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced fatigue, muscle pain, shortness of breath, headache, influenza-like symptoms, chills, fever, pain, muscle discomfort and shallow breathing. On 20th August 2018, the patient experienced nausea. In August 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the fatigue, muscle pain, shortness of breath and muscle discomfort were not recovered/not resolved and the outcome of the nausea, influenza-like symptoms, chills, fever and pain were recovered/resolved and the outcome of the shallow breathing was unknown. The reporter considered the fatigue, muscle pain, nausea, shortness of breath, headache, influenza-like symptoms, chills, fever, pain, muscle discomfort and shallow breathing to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX shot in left deltoid. The patient experienced extreme fatigue, headache for 3 days, chills, fever, aching, flu-like symptoms. The patient was so tired a day before reporting after running errands that she was "almost nauseous." The patient still felt very tired on the reporting date. The patient stated that if she did much of anything the muscles in her back and shoulder ache. The patient said she was having difficulty taking deep breaths. She said it was uncomfortable to take a deep breath from the diaphragm so she was taking shallow breaths. The patient said that if she took a deep breath she would experience muscular discomfort "like a pleurisy" especially under the left shoulder blade. The patient reported her experience with the second shot to the pharmacy and to the health department but not her primary care physician. The patient had denied permission to contact their physician because she said the physician was unaware of these events.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Musculoskeletal discomfort, Myalgia, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 82-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (after receiving 1st dose on 24th April 2018, refer case US2018151874). On 13th August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced fatigue, muscle pain, shortness of breath, headache, influenza-like symptoms, chills, fever, pain, muscle discomfort and shallow breathing. On 20th August 2018, the patient experienced nausea. In August 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the fatigue, muscle pain, shortness of breath and muscle discomfort were not recovered/not resolved and the outcome of the nausea, influenza-like symptoms, chills, fever and pain were recovered/resolved and the outcome of the shallow breathing was unknown. The reporter considered the fatigue, muscle pain, nausea, shortness of breath, headache, influenza-like symptoms, chills, fever, pain, muscle discomfort and shallow breathing to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX shot in left deltoid. The patient experienced extreme fatigue, headache for 3 days, chills, fever, aching, flu-like symptoms. The patient was so tired a day before reporting after running errands that she was "almost nauseous." The patient still felt very tired on the reporting date. The patient stated that if she did much of anything the muscles in her back and shoulder ache. The patient said she was having difficulty taking deep breaths. She said it was uncomfortable to take a deep breath from the diaphragm so she was taking shallow breaths. The patient said that if she took a deep breath she would experience muscular discomfort "like a pleurisy" especially under the left shoulder blade. The patient reported her experience with the second shot to the pharmacy and to the health department but not her primary care physician. The patient had denied permission to contact their physician because she said the physician was unaware of these events.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 82-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (after receiving 1st dose on 24th April 2018, refer case US2018151874). On 13th August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced fatigue, muscle pain, shortness of breath, headache, influenza-like symptoms, chills, fever, pain, muscle discomfort and shallow breathing. On 20th August 2018, the patient experienced nausea. In August 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the fatigue, muscle pain, shortness of breath and muscle discomfort were not recovered/not resolved and the outcome of the nausea, influenza-like symptoms, chills, fever and pain were recovered/resolved and the outcome of the shallow breathing was unknown. The reporter considered the fatigue, muscle pain, nausea, shortness of breath, headache, influenza-like symptoms, chills, fever, pain, muscle discomfort and shallow breathing to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX shot in left deltoid. The patient experienced extreme fatigue, headache for 3 days, chills, fever, aching, flu-like symptoms. The patient was so tired a day before reporting after running errands that she was "almost nauseous." The patient still felt very tired on the reporting date. The patient stated that if she did much of anything the muscles in her back and shoulder ache. The patient said she was having difficulty taking deep breaths. She said it was uncomfortable to take a deep breath from the diaphragm so she was taking shallow breaths. The patient said that if she took a deep breath she would experience muscular discomfort "like a pleurisy" especially under the left shoulder blade. The patient reported her experience with the second shot to the pharmacy and to the health department but not her primary care physician. The patient had denied permission to contact their physician because she said the physician was unaware of these events.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of adult patients 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 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 reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The reporter stated she heard everyone was getting sick from the vaccine. When asked to clarify, stated heard patients reporting flu like symptoms. This case has been linked with US2018GSK152273, reported by same reporter.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (Notes-Headache and muscle ache after receiving 1st dose on 24th May 2018, see case US2018151975). On 20th August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, 4 hrs after receiving SHINGRIX, the patient experienced headache, muscle pain and general body pain. On an unknown date, the outcome of the headache and muscle pain were recovered/resolved and the outcome of the general body pain was unknown. It was unknown if the reporter considered the headache, muscle pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported headaches and body ache after both doses. It showed up within 4 to 5 hours. The patient received his second shot of SHINGRIX on 20th August 2018 and he got a headache about 4 to 5 hours after the shot. The headache had been continued and had not yet resolved. The caller also reported that he was experiencing mild tolerable body or muscle aches that had not resolved till the reporting date. This case has been linked with US2018151975, reported by the same reporter for the same patient.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Headache, Inflammation, Influenza, Mobility decreased
Clinical narrative: This is a spontaneous report from a contactable consumer. A 50-year-old female patient received PREVNAR 13 (lot number and expiration date were not reported), via an unspecified route of administration on 23Aug2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient stated "I had pain in my arms that affected so much that I could not move my arms" on the evening of 23Aug2018. During Friday morning (24Aug2018), the patient stated "I had redness and inflammation in the arms. I have like almost like flu symptoms like headache, and muscle ache, "throat" little stuffy. I still have little bit of rash in my arm not too much but a little of rash. I guess instead of rash leave it as redness." Therapeutic measures were taken as a result of the events of arm pain and included treatment with TYLENOL at 1000 mg tablet orally once a day and ADVIL orally at 2 tablets 200 mg a day. The patient recovered from the events of inflammation in the arms on 26Aug2018 with duration of 2 days. The outcome of the event of "pain in my arms" and redness in the arms was recovering. The outcome of the other events was unknown. The information on the batch number of the vaccine has been requested.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Pain in extremity, Throat irritation
Clinical narrative: This is a spontaneous report from a contactable consumer. A 50-year-old female patient received PREVNAR 13 (lot number and expiration date were not reported), via an unspecified route of administration on 23Aug2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient stated "I had pain in my arms that affected so much that I could not move my arms" on the evening of 23Aug2018. During Friday morning (24Aug2018), the patient stated "I had redness and inflammation in the arms. I have like almost like flu symptoms like headache, and muscle ache, "throat" little stuffy. I still have little bit of rash in my arm not too much but a little of rash. I guess instead of rash leave it as redness." Therapeutic measures were taken as a result of the events of arm pain and included treatment with TYLENOL at 1000 mg tablet orally once a day and ADVIL orally at 2 tablets 200 mg a day. The patient recovered from the events of inflammation in the arms on 26Aug2018 with duration of 2 days. The outcome of the event of "pain in my arms" and redness in the arms was recovering. The outcome of the other events was unknown. The information on the batch number of the vaccine has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Dizziness, Erythema, Hyperhidrosis
Clinical narrative: Patient stated she developed around 8pm that evening she started to sweating, chills, nausea, her arm swelled/redness, and severe vertigo/dizziness and diarrhea for 3 days. She stated on 08-30-18 that her arm was feeling better, less tender and the other symptoms subsided. I contacted Md office and they have been informed as well.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Peripheral swelling, Tenderness, Vertigo
Clinical narrative: Patient stated she developed around 8pm that evening she started to sweating, chills, nausea, her arm swelled/redness, and severe vertigo/dizziness and diarrhea for 3 days. She stated on 08-30-18 that her arm was feeling better, less tender and the other symptoms subsided. I contacted Md office and they have been informed as well.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: 13 x 10 cm area of erythema, swelling from shoulder to elbow.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: Extreme tiredness, some soreness which has abated over time.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Pain, Vomiting
Clinical narrative: Per pt's chart, he had vomited initially after vaccine. Pt's grandfather called on 8-31-18 and stated pt had neck stiffness in rt hand side of neck and it hurt to move his neck in any direction at about 11 AM today. Pt's grandfather gave pt 1-200 mg ADVIL orally at around 1 PM which pt states did not really help, however he states he can move his neck more now. Pt states it hurts to look up now. Writer sent a message to pt's primary, Dr., to address.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Light headedness and soreness at the injection site developed last night. This morning I woke up with muscle pain, headache, and fatigue.
Age: 58.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Axillary pain, Erythema, Injection site pain, Injection site reaction, Injection site streaking
Clinical narrative: Patient described having pain in addition to the injection site. The pain radiated to her armpit. She also had pain and stiffness with her right shoulder. She said had extreme pain in trying to raise her arm above her shoulder. There was also 2 red streaks that started about 3 inches from the injection site, (towards to and going into the armpit). The streaks started a couple of inches down and towards the abdomen from the injection site. The pain started that evening. Two days later she came to the pharmacy to show me the reaction. She stated the redness has gone down but is still present. The lesions are still red and raised.
Age: 58.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Musculoskeletal stiffness, Pain, Skin lesion
Clinical narrative: Patient described having pain in addition to the injection site. The pain radiated to her armpit. She also had pain and stiffness with her right shoulder. She said had extreme pain in trying to raise her arm above her shoulder. There was also 2 red streaks that started about 3 inches from the injection site, (towards to and going into the armpit). The streaks started a couple of inches down and towards the abdomen from the injection site. The pain started that evening. Two days later she came to the pharmacy to show me the reaction. She stated the redness has gone down but is still present. The lesions are still red and raised.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Patient had a 3.5 to 4 inch red area surrounding the vaccination site and a sore arm. He denies any fever, chills, sweating, rash or any other symptoms.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms, low grade fever, chills, achey tired feeling.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 11 year old male patient. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 06-AUG-2018, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details unknown, lot# N022583, expiry date: 20-JUN-2020) in the right arm for prophylaxis in a public health clinic/hospital using public funds (Incorrect product storage). Other suspect therapies administered on the same day included MENACTRA (lot # U5948AB) and ADACEL (lot #U5770AA). No other doses of the vaccines were administered previously. No prescription drug treatment was required for the experience. The patient did not receive any reverse reactions to the vaccine. The vaccine was stored at a temperature of 0 Celsius (C) degree to 1 C degree for 41 hours, below 0 C degree (-0.01) for 27 hours and between 9 C degree to 25 C degree (16.4 C) for 12 hours 30 minutes. Previous temperature excursion were 0 C degree to 1 C degree for 27 hours. Data logger was involved. No adverse effect reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1808USA003706:
Age: 0.92
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an 11 month old male patient. Concurrent conditions, medical history, historical or concomitant drugs were not reported. The registered nurse informed that on an unknown date, one day before the the patient's first birthday, he was vaccinated with a dose of VARIVAX, subcutaneously for prophylaxis (strength, dose number, dose, lot # and expiration date were not reported). No adverse effects were reported in the patient.
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Feeling hot, Flushing, Hyperhidrosis, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chest burning in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 2 days 11 hrs after receiving SHINGRIX, the patient experienced chest burning, facial flushing and tingling skin. On 15th August 2018, the patient experienced pain in arm. On 16th August 2018, the patient experienced insomnia and sweating. On 17th August 2018, the patient experienced feeling of warmth facial. The patient was treated with ADVIL. On an unknown date, the outcome of the chest burning was recovering/resolving and the outcome of the facial flushing, tingling skin, feeling of warmth facial, pain in arm, insomnia and sweating were unknown. It was unknown if the reporter considered the chest burning, facial flushing, tingling skin, feeling of warmth facial, pain in arm, insomnia and sweating to be related to SHINGRIX. Additional details were provided as follows: The patient wanted to remain anonymous. At 11:00, the patient received SHINGRIX in left arm. The patient did not experience any events the day she received the vaccine. The next day she had an achy arm. Last night (16th August 2018) at approximately 10:00 pm, she felt a burning sensation in her chest and her face was flushed and tingling. She drank cold water and it resolved in 10 to 15 minutes. She woke up at 2:30 am in the morning of reporting date with the same burning event and she was also sweating all over (latency 2 days). She took ADVIL and drank cold water and it resolved within 10 to 15 minutes. Two days after vaccination, she experienced insomnia because the events interrupted her normal sleep pattern. In the morning of reporting date, three days after receiving SHINGRIX, she felt fine except for her face felt a little warm. In August 2018, achy arm was resolved. This case has been linked with US2018149807, reported by same reporter for patient's husband.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chest burning in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 2 days 11 hrs after receiving SHINGRIX, the patient experienced chest burning, facial flushing and tingling skin. On 15th August 2018, the patient experienced pain in arm. On 16th August 2018, the patient experienced insomnia and sweating. On 17th August 2018, the patient experienced feeling of warmth facial. The patient was treated with ADVIL. On an unknown date, the outcome of the chest burning was recovering/resolving and the outcome of the facial flushing, tingling skin, feeling of warmth facial, pain in arm, insomnia and sweating were unknown. It was unknown if the reporter considered the chest burning, facial flushing, tingling skin, feeling of warmth facial, pain in arm, insomnia and sweating to be related to SHINGRIX. Additional details were provided as follows: The patient wanted to remain anonymous. At 11:00, the patient received SHINGRIX in left arm. The patient did not experience any events the day she received the vaccine. The next day she had an achy arm. Last night (16th August 2018) at approximately 10:00 pm, she felt a burning sensation in her chest and her face was flushed and tingling. She drank cold water and it resolved in 10 to 15 minutes. She woke up at 2:30 am in the morning of reporting date with the same burning event and she was also sweating all over (latency 2 days). She took ADVIL and drank cold water and it resolved within 10 to 15 minutes. Two days after vaccination, she experienced insomnia because the events interrupted her normal sleep pattern. In the morning of reporting date, three days after receiving SHINGRIX, she felt fine except for her face felt a little warm. In August 2018, achy arm was resolved. This case has been linked with US2018149807, reported by same reporter for patient's husband.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 15th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st August 2018, 67 days after receiving SHINGRIX, the patient experienced fever, headache and pain. On an unknown date, the outcome of the fever, headache and pain were unknown. It was unknown if the reporter considered the fever, headache and pain to be related to SHINGRIX. Additional details were provided as follows: The reporting physician was the patient. The patient received SHINGRIX on left deltoid. The patient had fever of 102 degree C. This case has been linked with US2018151864, reported by the same reporter.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 73-year-old male patient who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. On 19th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 3rd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm, circumstance or information capable of leading to medication error and extra dose administered. On an unknown date, the outcome of the pain in arm, circumstance or information capable of leading to medication error and extra dose administered were unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that the patient believed that they received the first dose of SHINGRIX but there was no documented that the patient was given the vaccine. The facility was unsure if the patient actually received the first dose of SHINGRIX, but the patient reported that he experienced sore arm after potentially receiving the vaccine. The healthcare professional also reported that the patient had blood drawn on the same date. The healthcare professional reported that the patient may receive 3 doses of SHINGRIX if the dose was previously administered, which led to circumstance or information capable of leading to medication error for extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a adult female patient who received SHINGRIX for prophylaxis. On 16th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced diarrhea, chills and influenza-like symptoms. On an unknown date, the outcome of the diarrhea, chills and influenza-like symptoms were unknown. It was unknown if the reporter considered the diarrhea, chills and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced severe shivers. The reporter would not provide any additional information but stated that her husband experienced the same side effects. This case has been linked with US2018151936, reported by same reporter.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 76-year-old male 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 month after receiving SHINGRIX, the patient experienced fever, influenza-like symptoms and nausea. On an unknown date, the outcome of the fever, influenza-like symptoms and nausea were recovered/resolved. It was unknown if the reporter considered the fever, influenza-like symptoms and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. In 2018, two or three weeks ago from the reporting date, the patient received the SHINGRIX vaccination and experienced fever, nausea, and flu-like symptoms. The symptoms resolved within about two days.