Age: 65.0
Sex: F
Vaccine: PNC20, VARZOS, PNC20, VARZOS
Symptoms: Malaise, Nausea, Pain, Pain in extremity, Pollakiuria
Clinical narrative: Arm soreness, had Shingrix in right arm, didn't hurt that much, Leg aches/ Leg hurts vaccine made it worse; Nauseous, curled in a ball, though would begin vomiting; chills; fever; Like she had the flu; Body aches; Leg hurts, vaccine made it worse; Had to urinate more frequently; feeling awful; does not know what is in the vaccine she is allergic to; Just drained and tired; Renal disorder; Really sick/just got to where she can move around again; This case was reported by a consumer via other manufacturer and described the occurrence of malaise in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL 20 VALENT CONJUGATE VACCINE (PREVNAR 20) for prophylaxis.   The patient's past medical history included foot surgery (6 weeks ago), vomiting (had a bladder infection at that time and ended up in the hospital for vomiting and she couldn't stop vomiting), shingles (Had shingles with the 2nd covid vaccine) and bladder infection. Previously administered products included COVID 19 VACCINE MODERNA (received first dose on unknown date), COVID 19 VACCINE MODERNA with an associated reaction of illness (received second dose on unknown date, and was sick), Shingles vaccine (received a dose on unknown date) and IV fluids. Concurrent medical conditions included pain. Additional patient notes included None. Concomitant products included paracetamol (Tylenol), ibuprofen and meloxicam.   On 14th July 2022, the patient received Shingrix and the 1st dose of PREVNAR 20. On 14th July 2022, less than a day after receiving Shingrix, the patient experienced pain in arm, nausea, chills, fever and influenza-like symptoms. In July 2022, the patient experienced malaise, general body pain, condition aggravated, urinary frequency, feels awful, allergic reaction, tiredness and renal disorder. On an unknown date, the outcome of the malaise, influenza-like symptoms, general body pain, condition aggravated, urinary frequency, feels awful, allergic reaction, tiredness and renal disorder were unknown and the outcome of the pain in arm, nausea, chills and fever were recovering/resolving.   It was unknown if the reporter considered the malaise, pain in arm, nausea, chills, fever, influenza-like symptoms, general body pain, condition aggravated, urinary frequency, feels awful, allergic reaction, tiredness and renal disorder to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-JUL-2022 Reporter's Comment:  On 14th July 2022, less than a day after receiving PREVNAR 20, the patient experienced pain in arm, nausea, chills, fever and influenza-like symptoms. In July 2022, less than a week after receiving Shingrix and PREVNAR 20, the patient experienced malaise, general body pain, condition aggravated, urinary frequency, feels awful, allergic reaction, tiredness and renal disorder. It was unknown if the reporter considered the malaise, pain in arm, nausea, chills, fever, influenza-like symptoms, general body pain, condition aggravated, urinary frequency, feels awful, allergic reaction, tiredness and renal disorder to be related to PREVNAR 20. The patient was calling about the Prevnar pneumonia vaccine and she just got really sick and so thought she would let Pfizer know as she couldn't call her doctor whose office is closed; just got to where she could move around again and they gave her the vaccine. The morning of the day before reporting when her appointment was at 08:30am and told her there would be nothing but soreness in the arm and that would be all. She did have the whole arm soreness and it was still sore and it was definitely better but it was for most of the day.  After dinner she started to feel nauseous but it was way after dinner when she was about to go to bed and she had the nausea where she thought she would begin vomiting and then started getting chills but did not take her temperature at that time but had chills and fever and felt like she had the flu.  The reporter didn't move and was curled in a ball and felt like she would vomit and wanted to be really still and it was an awful feeling and she hated that.  The clarified it was the Prevnar 20 vaccine and she was administered on 14th July 2022.  Her whole left leg aches and she has body aches all over and these were better but it was hard to determine some of this as she recently had foot surgery that was before the Prevnar 20 and her left leg hurts but the foot surgery was on her right foot and the vaccine made the pain worse and the pain was already there but this made it a lot worse; her foot surgery was 6 weeks ago. Her daughter was a nurse and was concerned mostly because the caller had to urinate almost every hour or may have been more frequently and was worried she had something that was affecting her kidneys and this was the middle of the night last night on the 14th; the frequent urination was not ongoing not today and was getting better and she would not be calling if not. For the chills, fever and nausea, she feels a lot better and is just drained and tired. She had a shot in each arm and had the Shingrix in the right arm and it didn't hurt that much and she was worried about the Shingrix vaccine and the person administering these to the caller said it would be better if she had them in both arms that the soreness would be better; has no lot, expiry date or NDC for the Shingrix or the manufacturer name. The indication of the Prevnar 20 was that she was age 65 and thought as a 65 year old person now she had to get all this stuff and knew they were trying to take care of her.  History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): This was the 1st time she has had Prevnar. 6. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: Vaccine Name: Shingrix Lot Number / Expiry Date: unknown Route, Anatomical Location: No. of Previous Doses: right arm 7. Adverse Event (AE) Details: just got really sick and so thought she would let Pfizer know as she can't call her doctor whose office is closed; just got to where she can move around again and they gave her the vaccine the day before reporting. Several years ago she had some other shingles vaccine and was told this one regarding Shingrix was better and she needed to have it but she does not remember any details of that prior shingles vaccine including name, lot, expiry date or NDC but she got it when it came out at that time because she did not want shingles. Had shingles with the 2nd covid vaccine but it was never clear if it was because of the vaccine or there was something else as she had a bladder infection at that time and ended up in the hospital for vomiting and she couldn't stop vomiting; states the whole thing was murky regarding the situation of not being clear if the shingles was because of the vaccine. Clarified she was not admitted to the hospital at that time but they gave her IV fluids and some medicine and she went home.  Family Medical History and relevant Tests to adverse event was None. Caller verified she had two doses of the Moderna covid vaccine and it was the 2nd dose she got sick on and does not know the dates, lots, expiry dates or NDC numbers to provide but remember they stuck her in the arm and it was very different because it is a different kind of medical care going through a drive through. States for the reported events for the Prevnar 20 vaccine, she just took some Tylenol she thinks and did not have any problem with taking it and has taken it for a while and also takes Meloxicam every day and if she can't sleep then takes Tylenol because she is not supposed to take more Ibuprofen and the Tylenol has expiry date Nov2023. Takes Meloxicam for arthritis. They told her she was super healthy and did all the tests and her lungs were clear and her blood work was good and she was feeling great and this was before the Prevnar 20 and was for a checkup. Caller asks when saying the question about having any testing, how would you know if you are allergic to something in the vaccine, how would you know that; declined transfer to Pfizer medical information and she will talk to her doctor on Monday and is not able to ta k to him today and she does not always see these questions on these things of how do you know if you are allergic and she is not allergic to eggs and eats eggs and is fine and does not know what is in the vaccine she is allergic to She just took some Tylenol she thought and did not have any problem with taking it and had taken it for a while.