Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Body temperature, Inappropriate schedule of product administration
Clinical narrative: Second Dose: Date 30Apr2021; weakness; difficulty in being upright; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 88-year-old female patient received BNT162b2 (BNT162B2), on 30Apr2021 as dose 2, 0.3 ml single (Batch/Lot number: unknown, Expiration Date: 30Apr2021) at the age of 88 years for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Comments: High Blood Pressure; "Acid Reflux" (unspecified if ongoing), notes: Comments: Acid Reflux; "Neuropathy in the feet" (unspecified if ongoing), notes: Comments: Neuropathy in the feet; "known allergies: mold" (unspecified if ongoing); "Known allergies: ragweed" (unspecified if ongoing); "Known allergies: leaves" (unspecified if ongoing); "Known allergies: grass" (unspecified if ongoing). Concomitant medication(s) included: POTASSIUM. Past drug history included: Demerol, reaction(s): "Allergy". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot EL3248, Expiry Unknown.), administration date: 10Feb2021, when the patient was 88-year-old, for COVID-19 immunization, reaction(s): "weakness", "difficulty in being upright"; BNT162b2 (DOSE 1, SINGLE , Lot EL3248, Expiry Unknown.), administration date: 10Feb2021, when the patient was 88-year-old, for Covid-19 Immunization, reaction(s): "sick". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Second Dose: Date 30Apr2021"; ASTHENIA (non-serious), outcome "unknown", described as "weakness"; BALANCE DISORDER (non-serious), outcome "unknown", described as "difficulty in being upright". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Narrative case summary and further information: Case narrative including clinical course, therapeutic measures, outcome and additional relevant information. Report was not related to a study or program. Other Condition and Investigations: Yes. NDC number of Covid Vaccine: Not provided. Other Products: Yes. Additional Context: Caller states that she is calling about the Second Booster, caller further clarified that it was the Pfizer covid vaccine. She wanted to report how bad the second booster was, if she knew it was going to be that bad then she wouldn't have taken it. She had the first dose and was sick but it was nothing close to this time. She had all the symptoms except a few, but it was very severe, she was running a temperature over a 100 which is high for her, she had nausea, she wasn't even able to get up all night, all she could do was lay there and moan, she felt horrible, she wasn't able to eat for 24 hours or more. Email: Decline. Caller retrieves her covid vaccine card. Caller confirms that all the covid vaccines she got were made by Pfizer. Second Dose: Date 30Apr2021 Lot Unknown, Expiry 30Apr2021. Caller clarified that the Lot number is documented starting with F but then she cant make out letter and numbers because it cuts off. It says she received 0.3mL. First Booster: Date 13Sep2021 Lot FF2588, Expiry 31May2021. There is also some number that states  C00 then maybe a 6 and 19. It states that she received 0.3mL. Second Booster: Date 11Jun2022, Lot FM0173, Expiry Unknown. Caller states that after the first and second dose she had symptoms but she really doesn't recall what they were exactly, she does know that she had weakness and had to lay down because just felt as if she could not get up, however it was not for very long. She does remember she had difficulty in being upright. After the First Booster, she also doesn't remember to well what the symptoms were, but she thinks it was the second day after that she had family over and suddenly she felt like she was going to faint and had to lay down. She couldn't even finish preparing dinner because she couldn't be up. Her family took her blood pressure and it was very high, her family wanted her to to go to the ER but she didn't, then the rest of evening she was not up, as far as symptoms she remembers what she experienced with the second booster in other words the 4th dose. After getting the Second Booster she was down for a whole day, she had dizziness, balance problems. It all started 6-8 hours out. She had a sore throat, then she went to bed and woke up an hour later and she just was so ill. She had a horrible headache, she did have headaches with the other doses but it was not as bad. She had Muscle pain and chills in her whole body. Her temperature was running over 100. She was too ill at night, she was so ill she could not even get up, even after finally when she was able to get up and go to the bathroom she was not able to urinate. She had some redness at the injection site and soreness. She was nauseated and wasn't able to get up, when she finally felt safe to get up at 11AM, she was still not able to eat. Being that she is on medication, she cant take them on an empty stomach, so she forced herself to eat, otherwise she didn't eat all day. HCP: Declined. Outcome: At the moment she still has a bad headache and weakness, but is starting to get her appetite back. With the weakness she is not up and about, but she can be up compared to before, after the horrible night and yesterday afternoon, she wasn't able to be up, and could only be up for 2-3 minutes. Her Headaches are now slightly improved but it is still a problem, her weakness improved, and her appetite has improved. Getting back to her temperature, when she was finally able to get up at 11AM it was 100 degrees Fahrenheit, this temperature was taken yesterday 12Jun2022. All vaccines were administered in the Left Arm. Her Arm was sore for a few days, but this time, maybe it depends on the way the injection is given but its not as bad as the past injection with the soreness. Concomitant Medication: She is on her regular medications, caller declined to provide her medications stating that it would take too long, she is on 8 prescription. She is on medications for High Blood Pressure, Acid Reflux, and she is on Potassium. Medical Conditions: There is nothing she can think of right now, she has Neuropathy for which she takes medication, the Neuropathy is in the feet.  Investigation was Unknown. Allergies: She had no allergic reactions with the vaccines, but she is allergic to certain medications like Demerol and others that she cant think of. She is allergic to mold, ragweed, leaves, and grass, she is on medications for these allergies as well, but they are over the counter products. Caller states that she would like to add that the thing is that this reaction was so bad, that if she has to go through this every future injection then she would rather spend the rest of her life at home, just like how she has through most of this covid time period.  The lot number for [BNT162b2], was not provided and will be requested during follow up. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200838766 similar report from same reporter