chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 63 year old female patient. The patient's historical condition and concurrent condition were not reported. Drug reaction-allergies included penicillin and sulfas (unspecified). On 26-JUN-2018, the patient was vaccinated with PNEUMOVAX 23 injection, right arm, lot # R006465 and expiry date 24-OCT-2019 (strength, dose, route and frequency were not reported) for prophylaxis. Concomitant therapies included zoster vaccine (unspecified) (manufacturer unknown). On the same date, the patient experienced pain and swelling with a 2 inches red strip at the injection site after vaccination with PNEUMOVAX 23, therefore she sought medical attention with the pharmacist. The adverse events did not represent a significant disability or incapacity, the patient did not require hospitalization and no treatment was given to her. It was also reported that no laboratory diagnostics-studies were performed. The outcome of vaccination site pain, vaccination site erythema and vaccination site swelling was not recovered. The causality assessment between PNEUMOVAX 23 and the aforementioned events was not reported.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (L) deltoid pain, swelling or erythema. No fever or infection.
Age: 19.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Eye movement disorder, Loss of consciousness, Pallor, Posture abnormal, Unresponsive to stimuli
Clinical narrative: I went into the room where Patient was sitting on the table he was due for BEXSERO, HPV and PPD. While getting the vaccine ready he was talking to me about school. I proceeded to give the BEXSERO and HPV and his left deltoid. Again he was still engaging in conversation about school and what class he had tonight. When I gave the vaccines he still seemed fine and I then proceeded to throw the needles in the Sharps container while he was still sitting on the table and again he still seemed fine. I had him stand  up and sit in the chair that I had pulled closer to the computer desk so I can administer his PPD. I proceeded to give his PPD and right as I was finishing I'd seen that his hand jerked that made me look at him and he was getting pale his eyes rolled back, and his head fell back but I caught his head before it went all the way back, I thing went to call his name multiple times to try to wake him. At this time I try to grab the door to call for help. I called a name because that was the name I could think of first. When she came in so did Dr. I then sent her to get the LPN. Dr. and try get the patient to come back too, he did for a second and then past out again. After a few second he came back too. We got him up and on the table where Dr. asked him questioned to see how responsive he. We gave him water and had him lay down for about ten minutes. The got him sitting in a chair for another ten minutes; Dr. assessing him in the meantime. After about 30 minutes of sitting he was fine and was allowed to leave.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Mobility decreased, Pain in extremity
Clinical narrative: Patient states her arm hurt about 5 days. Also she experienced severe lower back discomfort. She could not straighten up. It began the day after the vaccine was given. She has been using her husbands TENS unit which helped, without it she would probably have gone to the hospital. It is beginning to feel better.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: FEVER, CHILLS, BODY ACHES.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Dizziness, Full blood count normal, Metabolic function test normal
Clinical narrative: ON 3/28/18 PATIENT PRESENTED TO PCP. PATIENT RECEIVED ONE IM INJECTION OF DILUENT IN LEFT DELTOID IN ERROR (PER OFFICE VACCINE WAS NOT RECONSTITUTED AT THIS TIME). ERROR IDENTIFIED IMMEDIATELY, AND PATIENT ADMINISTERED SHINGRIX VACCINE IM IN LEFT DELTOID SHORTLY AFTERWARDS ON 3/28/18 ~ 1650.  ON 3/29/18 ~ 1100, PATIENT ENDORSED FEELING DIZZY, GENERALIZED WEAKNESS, FAINTED, ABNORMAL SKIN FEELING, AND JOINT PAIN. NO OTHER SYMPTOMS ENDORSED. PATIENT PRESENTED TO ED FOR FOLLOW UP.  VS STABLE. PATIENT ADMINISTERED 1L LR BOLUS. CMP/CBC NORMAL. PATIENT DISCHARGED ~1500 IN STABLE CONDITION WITH INSTRUCTIONS TO FOLLOW UP WITH PCP IF SYMPTOMS WORSENED.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Product preparation error, Syncope
Clinical narrative: ON 3/28/18 PATIENT PRESENTED TO PCP. PATIENT RECEIVED ONE IM INJECTION OF DILUENT IN LEFT DELTOID IN ERROR (PER OFFICE VACCINE WAS NOT RECONSTITUTED AT THIS TIME). ERROR IDENTIFIED IMMEDIATELY, AND PATIENT ADMINISTERED SHINGRIX VACCINE IM IN LEFT DELTOID SHORTLY AFTERWARDS ON 3/28/18 ~ 1650.  ON 3/29/18 ~ 1100, PATIENT ENDORSED FEELING DIZZY, GENERALIZED WEAKNESS, FAINTED, ABNORMAL SKIN FEELING, AND JOINT PAIN. NO OTHER SYMPTOMS ENDORSED. PATIENT PRESENTED TO ED FOR FOLLOW UP.  VS STABLE. PATIENT ADMINISTERED 1L LR BOLUS. CMP/CBC NORMAL. PATIENT DISCHARGED ~1500 IN STABLE CONDITION WITH INSTRUCTIONS TO FOLLOW UP WITH PCP IF SYMPTOMS WORSENED.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: Stiff neck with pain moving in all directions, and headache up the back of my head. Started several hours after vaccination and I still have it 8 days later. I NEVER get headaches!!!!!!!!!!!
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Confusional state, Dizziness, Fatigue, Headache
Clinical narrative: Chills, nausea, extreme fatigue, confusion, dizziness, headache for past 24 hours.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Chills, nausea, extreme fatigue, confusion, dizziness, headache for past 24 hours.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction, treatment Benadryl.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever 101.1, body ache, lethargy. After tylenol was given at 6:30 a.m., the fever went away, but the body ache and lethargy remained.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal dreams, Decreased appetite, Diarrhoea, Insomnia, Nausea
Clinical narrative: Early 7/2, nausea, loss of appetite. Evening 7/2, vomiting. Night of 7/2, insomnia, vivid dreams. Early 7/3 AM diarrhea, loss of appetite.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Early 7/2, nausea, loss of appetite. Evening 7/2, vomiting. Night of 7/2, insomnia, vivid dreams. Early 7/3 AM diarrhea, loss of appetite.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nodule, Pain in extremity, Skin discolouration, Skin warm
Clinical narrative: PT WOKE ON 7/1, 2ND DAY AFTER SHOT WITH VERY SORE ARM, PALM-SIZED KNOT, HAND PRINT-SIZED REDNESS, WARM TO THE TOUCH. PT PRESENTED TO PHARMACY 7/2 TO SHOW ME THE REACTION. IT WAS ABOUT 1/2 THE SIZE OF WHAT SHE REPORTED IT WAS ON 7/1. SHE SAID IT WAS IMPROVING. PT REPORTS IT IS ONLY SLIGHTLY DISCOLORED AS OF THE MORNING OF 7/3.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Wrong vaccination given. Was to give MMR. No adverse reactions noted at this time.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: At office visit 4/12/18, patient stated that since receiving the influenza vaccine, he has been having left arm pain, numbness, and tingling especially when lifting his arm. Symptoms have not improved since the injection.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: MMRV was given in error. Should have gotten MMR. No adverse reactions noted at this time.
Age: 55.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Headache, Laboratory test normal, Nerve block, Neurological examination normal, Occipital neuralgia
Clinical narrative: Headache, described by patient as worse headache of their life. Patient was referred to the emergency department where they were diagnosed with left-sided occipital nerve pain (possible cluster headache). Physical and neurologic exan normal. Labs within normal limits. Gave patient IV fluids, diphenhydramine 50 mg IV, ketorolac 15 mg IV, and ondansetron 4 mg IV with limited improvement. Gave occipital nerve block using bupivacaine 0.5% 1.5 mL and lidocaine-epinephrine 1% 2.5 mL, which resulted in significant improvement. Prescribed gabapentin 100 mg TID x1 week upon discharge for patient to use if symptoms recurred.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Severe redness over most of arm.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Lethargy, Malaise, Pyrexia
Clinical narrative: Patient states she had 101 degree fever, headache, chills, malaise, lethargy for 48 hours.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient accidentally given only the diluent portion of vaccine and was not given the powdered portion of the vaccine. No adverse reactions occurred.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: The day after receiving her first dose of SHINGRIX, the patient developed a red, spreading rash that was warm to the touch. It continued to spread for 5 days, and was not alleviated by several doses of diphenhydramine. The patient then sought medical treatment with her PCP, who prescribed both Cephalexin in case of cellulitis, and Methylprednisolone in case of allergic reaction to vaccine. One day after starting both medications, rash began resolving.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from the patient's mother reporting on his 13-year-old son. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 22-MAR-2018, the patient received the second dose of GARDASIL for prophylaxis, lot # 0420AE and expiration date 12-JAN-2014 (strength, dose and route of administration were not reported). On 05-APR-2013 (reported as "about 2 to 3 weeks after vaccination"), the patient developed a wart (skin papilloma) on his left elbow. The patient did not receive treatment for the adverse event or sought medical attention. The outcome of the event skin papilloma as well as its causal relationship with GARDASIL was not reported.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Malaise, Pain
Clinical narrative: Got 2nd SHINGRIX injection after waiting 2 months after first and got similar side effects including body aches, headache, malaise. Lot no 32PE4, exp 1/23/2021.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cold sweat, Dizziness, Injection site erythema, Injection site pain
Clinical narrative: I had my second shingle shot at Pharmacy on June 25 2018 and the pharmacist applied a band aid first and gave the injection to me with band aid on. That afternoon I was not feeling well and didn't do much because the pain was severe. The soreness which I also had with the first shot on 4/21/2018 so I didn't think much about it. The next day, I felt weak, clammy, and dizzy. I immediately laid down on bed till the dizziness went away. I put ice on the site to help with pain. On the 20th of June, I went to take my bath and had a really red site where I had my shot. I took some pictures if needed and can mail them to you.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Wrong technique in product usage process
Clinical narrative: I had my second shingle shot at Pharmacy on June 25 2018 and the pharmacist applied a band aid first and gave the injection to me with band aid on. That afternoon I was not feeling well and didn't do much because the pain was severe. The soreness which I also had with the first shot on 4/21/2018 so I didn't think much about it. The next day, I felt weak, clammy, and dizzy. I immediately laid down on bed till the dizziness went away. I put ice on the site to help with pain. On the 20th of June, I went to take my bath and had a really red site where I had my shot. I took some pictures if needed and can mail them to you.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Impaired work ability, Influenza
Clinical narrative: Took the new shingles vaccine and have 10 days of severe flu symptoms with inability to work for several days. Began one day after vaccine. My wife took vaccine at same time and had similar protracted flu and bronchitis.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Pain
Clinical narrative: Fatigue, chills, generalized soreness and at site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Paraesthesia, Tremor
Clinical narrative: Tingling in left arm and shaking hand on 4th day. Also slight headache first day. Left arm very sore for several days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site pain, Myalgia, Oral herpes, Restlessness
Clinical narrative: Patient had pain at the time of injection. She stated that she had worked out immediately before coming to the pharmacy and her muscle was tense. Later that night, when she went out to dinner, she started sweating and had muscle aches throughout her body. She felt restless all night and then a cold sore later emerged on her lip. Patient does have history of cold sores.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Hives, redness, itchy, sore. Spread down arm to elbow.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Gait disturbance, Hot flush
Clinical narrative: Extremely tired, body aches, needed help to walk. Chills and hot flashes, headache and stomach pain. It was scary having my legs not work.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal disorder, Pain
Clinical narrative: Extremely tired, body aches, needed help to walk. Chills and hot flashes, headache and stomach pain. It was scary having my legs not work.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report was received from the patient's mother referring to her 18 year old daughter. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On unspecified date in March 2012, the patient was vaccinated with the first dose of GARDASIL (strength, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On unspecified date in August 2012, the patient received the second dose of GARDASIL (strength, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. The reporter stated that the patient never received the third dose of GARDASIL and did not receive any dose of GARDASIL 9. No adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received SHINGRIX 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 swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were unknown. It was unknown if the reporter considered the swelling arm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter said that the patient who was the cousin of his wife experienced severe reaction to the dose of SHINGRIX. The reporter said that he was sitting across the table from the patient and that she said that her arm was all swollen and that it hurt a lot. It was unknown if the reporter granted permission to be contacted, as he declined to answer any form questions, so no further details provided beyond what is already documented above.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 18th June 2018, the patient received the 1st dose of SHINGRIX. On 19th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, pain in arm, chills, fever and swelling arm. On an unknown date, the outcome of the injection site pain, pain in arm, chills, fever and swelling arm were not recovered/not resolved. The reporter considered the injection site pain, pain in arm, chills, fever and swelling arm to be almost certainly related to SHINGRIX. Additional details were provided as follows: The health care professional reported that a patient received the 1st dose of SHINGRIX on 18th June 2018 and experienced pain at the injection site and upper arm, swelling of the arm, fever and chills. The reactions started on 19th June 2018, the patient called the pharmacy and reported the symptoms on 23rd June 2018. The patient had seen the physician on 24th June 2018. The symptoms had not resolved till the date of reporting. No additional information was provided.
Age: 54.0
Sex: M
Vaccine: PNC, VARZOS
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a 54-year-old male patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. Concomitant products included PREVNAR. On 18th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 2 days after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant and other: as per reporter), fever (serious criteria other: as per reporter), erythema of extremities, swelling arm and pain in arm. The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the cellulitis and fever were recovered/resolved and the outcome of the erythema of extremities, swelling arm and pain in arm were unknown. It was unknown if the reporter considered the cellulitis, fever, erythema of extremities, swelling arm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: On 18th May 2018, the patient received 1st dose of PREVENAR vaccine on an unknown arm intramuscularly (batch number S43277, expiry date 1st September 2018). The patient received a dose of SHINGRIX vaccine on an unknown arm and 48 hours later receiving dose of SHINGRIX, the patient experienced a fever. The patient also experienced redness, swelling and soreness in the arm in which he received the SHINGRIX vaccine. The patient had to visit the doctor and was diagnosed with cellulitis and received antibiotics for the cellulitis.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of chills in a 76-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 28th February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills, fever and influenza-like symptoms. On an unknown date, the outcome of the chills, fever and influenza-like symptoms were unknown. The reporter considered the chills, fever 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 75 years or 76 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: Chills
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of chills in a 54-year-old patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020) for prophylaxis. On 15th 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 53 or 54 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.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Atrial fibrillation, Heart rate increased, Nausea, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of atrial fibrillation in a 61-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included renal cell cancer. On 25th June 2018, the patient received SHINGRIX. On 28th June 2018, 3 days after receiving SHINGRIX, the patient experienced atrial fibrillation (serious criteria GSK medically significant), pain in arm, pain, heart rate increased, weakness and nausea. On an unknown date, the outcome of the atrial fibrillation, pain in arm, pain, heart rate increased, weakness and nausea were unknown. The reporter considered the atrial fibrillation, pain in arm, pain, heart rate increased, weakness and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a healthcare professional (HCP) for himself. The patient received SHINGRIX in the left deltoid. The patient reported experiencing pain, his arm hurt, felt weak and nausea. The patient reported experiencing atrial fibrillation, clarified as a heart rate of 146. The patient's heart rate was usually 65. The symptoms were not considered life threating or disabling. No emergency room (ER) or doctor visit was required. The caller was unable to clarify if the pain was only in the patient's arm.  Lab Comments: The patient's heart rate was usually 65.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of atrial fibrillation in a 61-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included renal cell cancer. On 25th June 2018, the patient received SHINGRIX. On 28th June 2018, 3 days after receiving SHINGRIX, the patient experienced atrial fibrillation (serious criteria GSK medically significant), pain in arm, pain, heart rate increased, weakness and nausea. On an unknown date, the outcome of the atrial fibrillation, pain in arm, pain, heart rate increased, weakness and nausea were unknown. The reporter considered the atrial fibrillation, pain in arm, pain, heart rate increased, weakness and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a healthcare professional (HCP) for himself. The patient received SHINGRIX in the left deltoid. The patient reported experiencing pain, his arm hurt, felt weak and nausea. The patient reported experiencing atrial fibrillation, clarified as a heart rate of 146. The patient's heart rate was usually 65. The symptoms were not considered life threating or disabling. No emergency room (ER) or doctor visit was required. The caller was unable to clarify if the pain was only in the patient's arm.  Lab Comments: The patient's heart rate was usually 65.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Autoimmune disorder, Blood pressure increased, Constipation, Decreased appetite, Gait disturbance
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of atrial fibrillation in a 61-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included renal cell cancer. On 25th June 2018, the patient received SHINGRIX. On 28th June 2018, 3 days after receiving SHINGRIX, the patient experienced atrial fibrillation (serious criteria GSK medically significant), pain in arm, pain, heart rate increased, weakness and nausea. On an unknown date, the outcome of the atrial fibrillation, pain in arm, pain, heart rate increased, weakness and nausea were unknown. The reporter considered the atrial fibrillation, pain in arm, pain, heart rate increased, weakness and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a healthcare professional (HCP) for himself. The patient received SHINGRIX in the left deltoid. The patient reported experiencing pain, his arm hurt, felt weak and nausea. The patient reported experiencing atrial fibrillation, clarified as a heart rate of 146. The patient's heart rate was usually 65. The symptoms were not considered life threating or disabling. No emergency room (ER) or doctor visit was required. The caller was unable to clarify if the pain was only in the patient's arm.  Lab Comments: The patient's heart rate was usually 65.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hyperhidrosis, Kidney enlargement, Nausea, Pain in extremity, Renal pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of atrial fibrillation in a 61-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included renal cell cancer. On 25th June 2018, the patient received SHINGRIX. On 28th June 2018, 3 days after receiving SHINGRIX, the patient experienced atrial fibrillation (serious criteria GSK medically significant), pain in arm, pain, heart rate increased, weakness and nausea. On an unknown date, the outcome of the atrial fibrillation, pain in arm, pain, heart rate increased, weakness and nausea were unknown. The reporter considered the atrial fibrillation, pain in arm, pain, heart rate increased, weakness and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a healthcare professional (HCP) for himself. The patient received SHINGRIX in the left deltoid. The patient reported experiencing pain, his arm hurt, felt weak and nausea. The patient reported experiencing atrial fibrillation, clarified as a heart rate of 146. The patient's heart rate was usually 65. The symptoms were not considered life threating or disabling. No emergency room (ER) or doctor visit was required. The caller was unable to clarify if the pain was only in the patient's arm.  Lab Comments: The patient's heart rate was usually 65.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Retching
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of atrial fibrillation in a 61-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included renal cell cancer. On 25th June 2018, the patient received SHINGRIX. On 28th June 2018, 3 days after receiving SHINGRIX, the patient experienced atrial fibrillation (serious criteria GSK medically significant), pain in arm, pain, heart rate increased, weakness and nausea. On an unknown date, the outcome of the atrial fibrillation, pain in arm, pain, heart rate increased, weakness and nausea were unknown. The reporter considered the atrial fibrillation, pain in arm, pain, heart rate increased, weakness and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a healthcare professional (HCP) for himself. The patient received SHINGRIX in the left deltoid. The patient reported experiencing pain, his arm hurt, felt weak and nausea. The patient reported experiencing atrial fibrillation, clarified as a heart rate of 146. The patient's heart rate was usually 65. The symptoms were not considered life threating or disabling. No emergency room (ER) or doctor visit was required. The caller was unable to clarify if the pain was only in the patient's arm.  Lab Comments: The patient's heart rate was usually 65.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 64-year-old male patient who received SHINGRIX (batch number 539A2, expiry date unknown) for prophylaxis. On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th June 2018, 27 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with antivirals for systemic use (Antiviral). On 22nd June 2018, the outcome of the shingles was recovered/resolved. The reporter considered the shingles to be probably related to SHINGRIX. Additional details were received as follows: This case was reported by a pharmacy technician. The patient received a dose of SHINGRIX in left arm. On 22nd June 2018, the patient was prescribed an antiviral medication. There was no seriousness criteria reported for the patient (hospital overnight or prolong an existing hospitalization, life threatening, persistent or significant disability/incapacity, death, require surgical or medical intervention and congenital anomaly).
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm, Tenderness
Clinical narrative: This spontaneous report was received from a 59-year-old female consumer regarding herself. The patient's current conditions included asthma and hyperparathyroidism. The patient is allergic to citrates. The patient used to donate platelets. The patient's medical history included hives. The patient was first vaccinated with PREVENAR 13 on 24-MAY-2012. On 06-JUN-2018, the patient was vaccinated with PNEUMOVAX 23 in the left arm (dosing details were not reported) instead of PREVENAR 13 for prophylaxis. On 07-JUN-2018, the patient experienced redness and pain that extended to whole upper arm and to the biceps. It was warm and super tender. The patient reported it was not really swollen. The outcome of the events was reported as recovered/resolved on 11-JUN-2018 (also reported as lasted for about 4 days'). Causality assessment was not reported.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: The patient stated that about 1 week after the administration of the second dose, she developed a red, itchy rash around her neck and two spots on her face. The rash lasted about 2 weeks. She also complains of her hair falling out which started about 2-3 weeks after the administration and continues now. She specifically stated that nothing else had changed recently in her meds recently.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Feeling cold, Headache, Hypersomnia
Clinical narrative: Beginning about 24-30 hr after injection. Headache, extreme fatigue, loss of appetite, feeling cold, mild generalized muscle aches. No fever. Severe symptoms lasted about 1 1/2 days. Only treatment was self administered Celebrex, tylenol and rest. Slept 20 hr or so the first day. Headache persisted about 3 days. Fatigue persisted about a week - although much improved after 2 days.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Beginning about 24-30 hr after injection. Headache, extreme fatigue, loss of appetite, feeling cold, mild generalized muscle aches. No fever. Severe symptoms lasted about 1 1/2 days. Only treatment was self administered Celebrex, tylenol and rest. Slept 20 hr or so the first day. Headache persisted about 3 days. Fatigue persisted about a week - although much improved after 2 days.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: On 6/25/18, 4 yo ordered was for vaccinations at his well child visit. CMA pulled the VARIVAX vaccine from the freezer from a box of VARIVAX vials, whose box indicated were not expired. CMA prepared and administered varicella vaccine (VARIVAX) without double checking the expiration date on the vial itself. The VARIVAX vaccine had expired 6/7/18. Investigated the remaining VARIVAX vaccines, and all the remaining vials' expiration dates matched that of the expiration date noted on the box that housed the VARIVAX vaccines - and all of which were not expired. Patient did not have any side effects noted at the time.
Age: 66.0
Sex: F
Vaccine: VARZOS, PPV
Symptoms: Decreased appetite, Headache, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Starting @ 4 hours after vaccination, began experiencing general malaise, very sore arm at injection site, headache, general muscle aches. Over next 3 days, fever of 100.3 (O), continued general "flu-like" symptoms, headache, loss of appetite, very sore arm, redness not only at injection  site but around upper arm. Took ibuprophen with good results until it wore off then symptoms returned.
Age: 66.0
Sex: F
Vaccine: VARZOS, PPV
Symptoms: Malaise, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Starting @ 4 hours after vaccination, began experiencing general malaise, very sore arm at injection site, headache, general muscle aches. Over next 3 days, fever of 100.3 (O), continued general "flu-like" symptoms, headache, loss of appetite, very sore arm, redness not only at injection  site but around upper arm. Took ibuprophen with good results until it wore off then symptoms returned.
Age: 66.0
Sex: F
Vaccine: VARZOS, PPV
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Feeling abnormal
Clinical narrative: Starting @ 4 hours after vaccination, began experiencing general malaise, very sore arm at injection site, headache, general muscle aches. Over next 3 days, fever of 100.3 (O), continued general "flu-like" symptoms, headache, loss of appetite, very sore arm, redness not only at injection  site but around upper arm. Took ibuprophen with good results until it wore off then symptoms returned.
Age: 66.0
Sex: F
Vaccine: VARZOS, PPV
Symptoms: Headache, Loss of personal independence in daily activities, Pain in extremity, Poor quality sleep, Pyrexia
Clinical narrative: Starting @ 4 hours after vaccination, began experiencing general malaise, very sore arm at injection site, headache, general muscle aches. Over next 3 days, fever of 100.3 (O), continued general "flu-like" symptoms, headache, loss of appetite, very sore arm, redness not only at injection  site but around upper arm. Took ibuprophen with good results until it wore off then symptoms returned.
Age: 66.0
Sex: F
Vaccine: VARZOS, PPV
Symptoms: Rash, Rash erythematous
Clinical narrative: Starting @ 4 hours after vaccination, began experiencing general malaise, very sore arm at injection site, headache, general muscle aches. Over next 3 days, fever of 100.3 (O), continued general "flu-like" symptoms, headache, loss of appetite, very sore arm, redness not only at injection  site but around upper arm. Took ibuprophen with good results until it wore off then symptoms returned.
Age: 66.0
Sex: F
Vaccine: VARZOS, PPV
Symptoms: Decreased appetite, Headache, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Chills, low grade fever 100.4 (O), loss of appetite, headache, light-headedness, weakness, loss of appetite, very sore left arm, red raised rash around upper left arm, poor sleep. Symptoms lasted 5 days. Took ibuprofen & acetaminophen, ibuprofen more effective. Felt terrible for 3 days, last 2 slightly less. Unable to do normal activities for first 3 days.
Age: 66.0
Sex: F
Vaccine: VARZOS, PPV
Symptoms: Malaise, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Chills, low grade fever 100.4 (O), loss of appetite, headache, light-headedness, weakness, loss of appetite, very sore left arm, red raised rash around upper left arm, poor sleep. Symptoms lasted 5 days. Took ibuprofen & acetaminophen, ibuprofen more effective. Felt terrible for 3 days, last 2 slightly less. Unable to do normal activities for first 3 days.
Age: 66.0
Sex: F
Vaccine: VARZOS, PPV
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Feeling abnormal
Clinical narrative: Chills, low grade fever 100.4 (O), loss of appetite, headache, light-headedness, weakness, loss of appetite, very sore left arm, red raised rash around upper left arm, poor sleep. Symptoms lasted 5 days. Took ibuprofen & acetaminophen, ibuprofen more effective. Felt terrible for 3 days, last 2 slightly less. Unable to do normal activities for first 3 days.
Age: 66.0
Sex: F
Vaccine: VARZOS, PPV
Symptoms: Headache, Loss of personal independence in daily activities, Pain in extremity, Poor quality sleep, Pyrexia
Clinical narrative: Chills, low grade fever 100.4 (O), loss of appetite, headache, light-headedness, weakness, loss of appetite, very sore left arm, red raised rash around upper left arm, poor sleep. Symptoms lasted 5 days. Took ibuprofen & acetaminophen, ibuprofen more effective. Felt terrible for 3 days, last 2 slightly less. Unable to do normal activities for first 3 days.
Age: 66.0
Sex: F
Vaccine: VARZOS, PPV
Symptoms: Rash, Rash erythematous
Clinical narrative: Chills, low grade fever 100.4 (O), loss of appetite, headache, light-headedness, weakness, loss of appetite, very sore left arm, red raised rash around upper left arm, poor sleep. Symptoms lasted 5 days. Took ibuprofen & acetaminophen, ibuprofen more effective. Felt terrible for 3 days, last 2 slightly less. Unable to do normal activities for first 3 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Back pain, Chills, Headache, Pain
Clinical narrative: High fever 102.8, severe chills with rigors and ice cold extremities (hands and feet), body ache with pain in back and upper spine area, very bad headache, abdominal pain. Most severe symptoms lasted 48 hours, headache lasted 4 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral coldness, Pyrexia, Spinal pain
Clinical narrative: High fever 102.8, severe chills with rigors and ice cold extremities (hands and feet), body ache with pain in back and upper spine area, very bad headache, abdominal pain. Most severe symptoms lasted 48 hours, headache lasted 4 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: My shot was in the morning, early evening the injection side started to itch, it was very warm. The aching from the site spread down my arm and worked around to my underarm. Today it's still very warm. The dark pink color around the site is now about 4"x5". The aching has gone down underneath my armpit. My range of motion with that arm is limited. I can't raise it above my head.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: My shot was in the morning, early evening the injection side started to itch, it was very warm. The aching from the site spread down my arm and worked around to my underarm. Today it's still very warm. The dark pink color around the site is now about 4"x5". The aching has gone down underneath my armpit. My range of motion with that arm is limited. I can't raise it above my head.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Chills, Cough, Decreased appetite, Fatigue, Nasal congestion
Clinical narrative: A spontaneous report has been received from pharmacist via regulatory authority. The report concerns a male patient of Unknown ethnic origin (age 3 years, height 100 cm, weight 17 kg). No medical history was reported. No concomitant products were reported. The patient received FluMist Quadrivalent (intranasal) 0.2 ml once/single administration, via nasal route, for influenza immunisation on an unknown date. On an unknown date, the patient experienced chills. On an unknown date, the patient experienced cough. On an unknown date, the patient experienced decreased appetite. On an unknown date, the patient experienced pyrexia. On an unknown date, the patient experienced viral infection. On an unknown date, the patient experienced vomiting. On an unknown date, the patient experienced fatigue. On an unknown date, the patient experienced nasal congestion. The patient recovered from the event(s) of chills, cough, decreased appetite, pyrexia, viral infection, vomiting, fatigue and nasal congestion on an unspecified date. The events were considered serious (important medical event). Sender's Comments: Chills, Cough, Decreased appetite, Pyrexia, Viral infection and Vomiting are not listed events in the company core data sheet for Flumist Quadrivalent. Young age could be risk factor for viral infection which could contribute to pyrexia, cough, decreased appetite, chills and vomiting. Due to missing information on exact site of infection, onset date of all events, administration dates of suspect vaccine, risk factors for viral infection present (such as premature birth, contact with an infected person), underlying comorbidities, relevant history, concomitant medications, diagnostic and etiologic workup it is not possible to make a conclusive assessment of the causal relationship of events and Flumist Quadrivalent.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Pyrexia, Viral infection, Vomiting
Clinical narrative: A spontaneous report has been received from pharmacist via regulatory authority. The report concerns a male patient of Unknown ethnic origin (age 3 years, height 100 cm, weight 17 kg). No medical history was reported. No concomitant products were reported. The patient received FluMist Quadrivalent (intranasal) 0.2 ml once/single administration, via nasal route, for influenza immunisation on an unknown date. On an unknown date, the patient experienced chills. On an unknown date, the patient experienced cough. On an unknown date, the patient experienced decreased appetite. On an unknown date, the patient experienced pyrexia. On an unknown date, the patient experienced viral infection. On an unknown date, the patient experienced vomiting. On an unknown date, the patient experienced fatigue. On an unknown date, the patient experienced nasal congestion. The patient recovered from the event(s) of chills, cough, decreased appetite, pyrexia, viral infection, vomiting, fatigue and nasal congestion on an unspecified date. The events were considered serious (important medical event). Sender's Comments: Chills, Cough, Decreased appetite, Pyrexia, Viral infection and Vomiting are not listed events in the company core data sheet for Flumist Quadrivalent. Young age could be risk factor for viral infection which could contribute to pyrexia, cough, decreased appetite, chills and vomiting. Due to missing information on exact site of infection, onset date of all events, administration dates of suspect vaccine, risk factors for viral infection present (such as premature birth, contact with an infected person), underlying comorbidities, relevant history, concomitant medications, diagnostic and etiologic workup it is not possible to make a conclusive assessment of the causal relationship of events and Flumist Quadrivalent.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vision blurred
Clinical narrative: This spontaneous report was received from a pharmacist via company representative, concerning a 64 year old female patient. The patient's medical history and concurrent conditions were not reported. In approximately 2014 (reported as "either 2014 or 2015"), the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU for prophylaxis (dose number, route, lot # and expiration date were unknown). Concomitant medications were not reported. On an unknown date, the patient experienced shingles. Then, on an unspecified date after that, the patient developed vision blurred. The patient saw an unspecified ophthalmologist and the ophthalmologist stated that "the blurred vision was most likely caused from receiving ZOSTAVAX and not from the shingles" because the ophthalmologist had a separate patient that developed blurred vision after receiving ZOSTAVAX, and the separate unspecified patient did not have shingles (captured in MARRS # 1807USA000847). At the time of reporting, the outcome of herpes zoster and vision blurred was unknown. The reporting pharmacist did not provided the causality assessment between the adverse events and ZOSTAVAX. Sender's Comments: US-009507513-1807USA000847.
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 7 month old male patient (also reported as "14 month"). There were no concurrent conditions and illnesses at the time of vaccination. Concomitant therapies included FLUZONE, PENTACEL and PREVNAR 13. The reported stated that on 11-DEC-2017, the patient was vaccinated with the third dose of, ROTATEQ liquid, orally, lot # M025568, expiration date 07-NOV-2017, for prophylaxis. This was an already expired dose.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 13-JUN-2016, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster. The patient has been prescribed calamine (+) camphor (+) diphenhydramine hydrochloride (CALADRYL) lotion topical, acyclovir, gabapentin and tramadol for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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. Additional information has been requested.