Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Nausea, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: diarrhea; rash; nausea; the generic name is covid19 vaccine MRNA and it says covid19 tris-tris 5-11y; tiredness; sore arm; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 72-year-old female patient received BNT162b2 omicron (kp.2) (PFIZER-BIONTECH COVID-19 VACCINE (2024-2025 FORMULA)), on 13Sep2024 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "menopause" (unspecified if ongoing); "Blood pressure" (ongoing); "nervous response" (ongoing); "Headaches" (unspecified if ongoing), notes: she takes some OTC medications, Extra Strength Tylenol for headaches or TMJ or whatever as needed; "TMJ" (unspecified if ongoing), notes: she takes some OTC medications, Extra Strength Tylenol for headaches or TMJ or whatever as needed; "Seasonal allergies" (unspecified if ongoing), notes: takes an old antihistamine called chlortrimeton 4mg as needed and 1 tablet every 4 hours as needed; "Allergies" (unspecified if ongoing), notes: Takes Benadryl and Flonase; "To sleep" (unspecified if ongoing), notes: Takes Benadryl at night and takes two of those almost every night; "Constipation" (unspecified if ongoing), notes: takes Miralax as needed; "High cholesterol" (ongoing); "bone health" (unspecified if ongoing); "dry eyes" (unspecified if ongoing); "multiple myeloma" (unspecified if ongoing). Concomitant medication(s) included: CALTRATE 600+D3 taken for osteoporosis, osteopenia, bone disorder (ongoing); CENTRUM SILVER WOMEN 50+ (ongoing); METOPROLOL SUCCINATE EXTENDED RELEASE taken for blood pressure abnormal (ongoing); OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing); VENLAFAXINE taken for nervous system disorder (ongoing); SIMVASTATIN taken for blood cholesterol increased (ongoing); PROLIA taken for plasma cell myeloma, bone disorder (ongoing); RESTASIS taken for dry eye (ongoing); ACYCLOVIR [ACICLOVIR] taken for antiviral treatment, start date: Mar2023 (ongoing); REVLIMID (ongoing); DARATUMUMAB, start date: 2023 (ongoing); XARELTO taken for thrombosis prophylaxis; EXTRA STRENGTH TYLENOL taken for headache, temporomandibular pain and dysfunction syndrome; CHLOR TRIMETON taken for seasonal allergy; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE] taken for multiple allergies, sleep disorder; FLONASE [MOMETASONE FUROATE] taken for multiple allergies; MIRALAX taken for constipation. Vaccination history included: Bnt162b2 (Dose number unknown, single), administration date: 2021, for COVID-19 immunization, reaction(s): "she was tired and had a sore arm", "she was tired and had a sore arm", "Multiple myeloma". The following information was reported: NAUSEA (non-serious) with onset 13Sep2024, outcome "recovered" (16Sep2024); PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 13Sep2024, outcome "unknown", described as "the generic name is covid19 vaccine MRNA and it says covid19 tris-tris 5-11y"; DIARRHOEA (non-serious) with onset 14Sep2024, outcome "recovered" (16Sep2024), described as "diarrhea"; RASH (non-serious) with onset 14Sep2024, outcome "not recovered"; PAIN IN EXTREMITY (non-serious) with onset Sep2024, outcome "recovered" (18Sep2024), described as "sore arm"; FATIGUE (non-serious) with onset Sep2024, outcome "recovered" (16Sep2024), described as "tiredness". The event "rash" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of diarrhoea.  Additional information: Patient stated she had the Pfizer covid vaccine on Friday, 13Sep2024 and had the typical symptoms, tiredness, sore arm, nausea and diarrhea. By Saturday, 14Sep2024 night, she started with a rash on neck, by Sunday, 15Sep2024 it was on abdomen right under breast and by Monday, it progressively got worse as the week has gone on, it's on stomach, spots on legs and down one shoulder. What she trying to say was she have a lot of rash, it doesn't scratch, clarified, it doesn't itch. Pfizer should have a treatment for the rash, since they make the vaccine. She've been on the phone for an hour plus and no one can tell me how to get rid of the rash. Patient taken Pfizer vaccines since 2021 and never had a rash before. She have been getting a big run around, if patients are having reactions, for her to go to other doctors, they say it's a rash and to take Benadryl, why would she take Benadryl, it's not itching. She stated, It said on the internet, pictures on google search all kinds of pictures with this rash, it's not shingles, She had that evaluated, She don't know what it is. Patient was in cancer treatment and takes Revlimid once a day and an injection of Daratumumab that is a chemotherapy. She had the same reaction as last year with the typical sore arm and was tired and had nausea and diarrhea and by Sunday night she had a rash on the neck. Her cancer treatment began since she started having the Pfizer vaccines and began cancer treatment in Mar2023 for multiple myeloma. Patient has more rash on her whole abdomen that was covered on the stomach and last year clarified with the prior Pfizer covid vaccines, clarified she was tired and had a sore arm but other than that she had no nausea, diarrhea or rash with those and she was wondering if there was something that was put into this vaccine this year that she is allergic to. The nausea probably started Friday and diarrhea started on Saturday and Sunday and the rash started Saturday night and worsened Sunday and is progressively worsened; there is just bumps almost looks like shingles but she has been to the doctor and has no pain and it is just a rash. The tiredness, nausea, and diarrhea have stopped and resolved she would say on Monday when she was feeling better and stuck around the house on Tuesday but on Monday 16Sep2024 the tiredness, nausea and diarrhea resolved completely. For the sore arm, it is not ongoing and thinks it has gone away and it resolved completely probably Tuesday or Wednesday and she will say it resolved completely on Wednesday 18Sep2024. Concomitant medications: She takes a lot of medicines; takes Metoprolol Succinate ER 50mg for blood pressure and it is one tablet daily and began the dose of 50mg a year ago in Aug2023 and states she had started taking Metoprolol 25mg 16 years ago. She takes Venlafaxine 37.5mg one tablet in the evening and began that dose of 37.5mg last August and changed the blood pressure medication and states she started taking Venlafaxine 25mg 16 years ago and started that with menopause for a nervous response and they increased it last time when she was deep into cancer treatment. She has some over the counter medications she takes and takes Extra Strength Tylenol for headaches or TMJ or whatever as needed. She takes an old antihistamine called chlortrimeton 4mg as needed for seasonal allergies and takes one table every four hours as needed. Takes Benadryl at night and takes two of those almost every night for allergies as well as to sleep. Takes Flonase as needed for allergies and does two sprays per day per nostril; takes Miralax as needed for constipation and states all these medications cause all kinds of issues. She takes Imodium and did take that as her cancer medications cause diarrhea sometimes so she took the Imodium when she started having the diarrhea after the vaccine and takes one tablet of the Imodium each time after each bout but does not do a full dose of the Imodium as that makes her very constipated. She was under treatment for the blood pressure and for the cancer and those are the two major issues as right now and just being old. She saw her doctor on Monday at urgent care as she couldn't get into her family doctor who looked and said yes it was a rash but the HCP was not familiar with the new covid vaccine and had and not seen anyone with the rash; She is just stumped with this and showed her pharmacist and she was surprised and said it was a good thing she was calling Pfizer. For this current vaccine she received, she stopped at the pharmacy this morning (19Sep2024) and pharmacist gave her information and was concerned and going to call Pfizer as well and this vaccine was Comirnaty 30mcg/0.3mL given in the left arm and she has no lot, expiry date or NDC on the printed information from the pharmacy and the generic name is covid19 vaccine MRNA and it says covid19 tris-tris 5-11y but she does not know what that means. For her previous Pfizer covid vaccines, she has no lots, expiry dates or NDC numbers to provide as her patient card is not with her at this time.