Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pruritus, Rash, Rash erythematous, Rash pruritic
Clinical narrative: The third vaccine was 18Aug2021; The third vaccine was 18Aug2021; miserable and her sugars were high and she couldn't control them; itchy itchy rash; rash redder than ever; got dizzy; vision got blurry; headache that turned to a migraine; chest felt heavy and hard/chest hurt; Rash; itchy and she felt bumps on the back; This is a spontaneous report from a contactable consumer. A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: FD8448), dose 3 via an unspecified route of administration, administered in left arm (at the top of left upper arm) on 18Aug2021 at 08:15 (at the age of 51-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization; bupropion hydrochloride (Bupropion SR 150mg tablet) (ZYBAN), route of administration, start and stop date, batch/lot number and dose were not reported for smoking cessation therapy It was reported as use before: 17Aug2022 states that it was given 17Aug2021. Medication was in prescription bottle and ibuprofen (MOTRIN [IBUPROFEN]), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 800 mg for migraine and arthritis. Medical history included neoplasm malignant (cancer 3 times) from an unknown date and unknown if ongoing. Drug hypersensitivity (found that out like 40 years ago, allergic to all steroids) from an unknown date and unknown if ongoing. Diabetes mellitus (Diabetes), blood pressure abnormal (Blood pressure), blood triglycerides abnormal (Triglycerides), blood cholesterol abnormal (Cholesterol), bipolar disorder (bipolar), weight control and mood disorder (Additional Information for Concomitant Products Trazodone: takes to sleep and it is also a mood stabilizer), arthritis and migraine all from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (MOTRIN [IBUPROFEN]) taken for migraine and arthritis, start and stop date were not reported; atorvastatin calcium (LIPITOR) (Atorvastatin 80mg at night) taken it for 30 years for blood cholesterol abnormal, start and stop date were not reported; glimepiride (AMARYL) (Glimepiride 4mg) taking for 30 years for diabetes mellitus from an unspecified start date and ongoing; eicosapentaenoic acid ethyl ester (VASCEPA) (Icosapent ethyl; 1g capsule; 2 capsules in morning, 2 capsules at night) for almost 2 years taken for blood triglycerides abnormal from an unspecified start date and ongoing; levothyroxine sodium (SYNTHROID) (Levothyroxine 0.175mcg) Takes around 12 or 1 in the morning, when wakes up to swallow it. patient can not eat 2 hours before or after eats taken for an unspecified indication from an unspecified start date and ongoing; lurasidone hydrochloride (LATUDA) (Lurasidone 20mg) taking for 10 years taken for an unspecified indication from an unspecified start date and ongoing; metoprolol succinate (TOPROL XL) (Metoprolol XL 50mg once a day) taken for blood pressure abnormal, start and stop date were not reported; nifedipine (PROCARDIA [NIFEDIPINE]) (Nifedipine 30mg) taken for blood pressure abnormal, start and stop date were not reported; quinapril hydrochloride (ACCUPRIL) (Quinapril 40mg) taken for blood pressure abnormal from an unspecified start date and ongoing; topiramate (TOPAMAX) (Topiramate 200mg at night every day) taken for weight control and bipolar disorder from an unspecified start date and ongoing; linagliptin (TRADJENTA) (Tradjenta 5mg) taken for diabetes mellitus from an unspecified start date and ongoing; trazodone (TRAZODONE) (Trazodone 150mg at night) taken for sleep disorder and affective disorder from an unspecified start date and ongoing; dapagliflozin propanediol monohydrate, metformin hydrochloride (XIGDUO XR) (Xiguduo XR 5-500mg, takes 2 at night) taken for diabetes mellitus, start and stop date were not re-ported. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EN6205; Expiry date: 30Jun2021 and NDC: Unknown) as dose 1, single administered in left arm (Anatomical Location: top, left upper arm) on 28Feb2021 (at the age of 51-years-old) for COVID-19 immunization. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EP7534; Expiry date: 31Jul2021 and NDC: Unknown) as dose 2, single administered in left arm (Anatomical Location: top, left upper arm) on 22Mar2021 for COVID-19 immunization. No prior Vaccinations (within 4 weeks). Patient never had adverse events following prior vaccinations. Family medical history relevant to adverse events reported as no, patient mother and dad were vaccinated and they did not have any of this. Patient had a reaction to it and was calling because patient did not know what to do. The rash won't go away and it itches. Patient can not take nothing. Patient has been to 10 different doctors and has been to a dermatologist, a family doctor and a walk in center and, nobody knows what to do to help her. Patient went to following the vaccine, that was given Wednesday at 8:15 in the morning. Then, patient noticed the rash Thursday morning at noon. It got itchy and felt bumps on back at first. While driving in the car, patient did not know what it was. When patient got home, and looked in the mirror and seen it right down the center of spine. Patient called immediately, to the primary care physician and went to see Friday at 11:20. Patient had decided to quit smoking a week prior and patient had prescribed her Zyban and patient was on it for a week. Her doctor swore patient was having a reaction to Zyban, that it was not the Pfizer vaccine because patient had 2 doses previously. Patient did not have a reaction to the first 2 doses of the vaccine and argued with patient, that it was not the Zyban because patient was on Zyban for a week and had no side effects, none. Patient had a severe allergic reaction. Doctor told to stop the Zyban and patient did immediately and even contacted pharmacist. When patient asked them how long until it was out of system, they said 3 days. Today, 10Sep2021, patient still has this rash. It went to an itchy, itchy rash. It is annoying and nothing works. Doctor put patient on steroids and the caller states researched everything that the CDC said if get a rash from the vaccine, to only use Tylenol and antihistamine. Patient can not ever take antihistamines, they had an adverse effect and patient can not take them. Patient was allergic to steroids but (name), doctor, said patient was having an allergic reaction to the Zyban. Knowing patient was highly allergic, patient said she could go into anaphylactic shock. Caller knows all about anaphylactic shock and to prevent herself from going into it, patient was miserable for 5 days and took the steroid, that did not do anything for the rash. On the fifth day, the following Tuesday, patient saw doctor again. Patient said, please do not ever prescribe steroids again. Patient was miserable and sugars were high and patient could not control them. Patient had a pounding headache and the Tylenol was not helping. Patient was told did not have to finish the steroids. Then patient went to a dermatologist who said no way it was Zyban. He stated that if it was Zyban, it would have happened within minutes after taking the first pill. He prescribed a steroid ointment to put on the rash 3 times a day. That was on Thursday, and put it on 3 times that Thursday. The following Friday, it felt like someone was pouring hot lava all over her body and it burned and itched. Patient called the dermatologist back to ask what to do. He said to wash it off and stop using it. Nothing worked. Patient thinks it was the Zyban because the dermatologist said it was ok to take the Zyban and it was not the Zyban, but, when patient tried resuming the Zyban, the rash got worse. It was the Zyban acting with the vaccine and making the rash worse. Yesterday, patient had a migraine and also had arthritis. Patient was prescribed 800mg Motrin. The CDC said when patient did her research, to only take Tylenol and antihistamines. Patient could only take Tylenol. Yesterday with the migraine, patient took one 800 mg Motrin and thought, going to have to go to the ER, patient was so sick. Patient swears, the Motrin reacted with the vaccine. Everything she takes reacts with the vaccine. Patient has been to 10 different doctors and nobody knows what to do. Patient had no choice but to contact Pfizer. On 18Aug2021, patient had the vaccine. On 19Aug2021, at noon, patient got the rash. It started on back, then on stomach, breasts and down the soft part of arms. That was when patient used the steroid cream and it went down to the abdomen, butt and upper thighs. Patient has been off of it. Patient only took 4 pills and then got the vaccine and stopped it. Patient had been off it for weeks until patient took Bupropion SR again Wednesday 08Sep2021 and 09Sep2021 and now today, the rash was worse again. Patient did not know what to do. Patient can not take it, patient will not make this rash worse. The Motrin 800mg tablets, patient had been taking that for years. Patient had been prescribed that for years for migraines and arthritis. Patient had been on that and not one time did have a reaction be-fore. Patient got dizzy and vision got blurry and chest hurt after taking Motrin. Patient thought was going to end up in the ER. That was yesterday, Thursday, 9Sep2021, patient had a migraine but the Motrin stopped that for probably about 6 or 7 hours. The Motrin was 800mg. It was during that day that patient woke up with the headache that turned into a migraine. The Motrin took the migraine away but then experienced the dizziness, blurry vision and chest hurt. Patient was not having any trouble breathing but chest felt so heavy and weird. It was mentioned Here's the thing, 3 days ago it was turning skin to like leather, like scaly, like flaking off now and thought it was going away so, called family doctor and asked if could start Zyban again. Yesterday, Thursday, patient had taken 1 Zyban each day, Wednesday and Thursday and today. It was itchier than ever and even redder than ever again because the Zyban was reacting with the vaccine. Patient cannot take anything with this vaccine, not even Motrin. Adverse events require a visit to Physician Office not to emergency Room. Patient had a pounding headache and the Tylenol was not helping. The outcome of the event rash and pruritus were not recovered while other events were unknown.  Follow-up attempts are completed. No further information is expected.