Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hiccups, Insomnia, Lymph node pain, Lymphadenopathy
Clinical narrative: my pupils did not adjust to the bright outside light and everything was bright black and white.; had almost a week of sore shoulder blade; I am sure my anemia might play into this some/hemoglobin drops; My brain fog; I had the hiccups often not prolonged, just 3-5 at a time; The edema in my legs and feet got worse during this time; Digestive issues still crop up; My GFR also dropped from 27 to 18; but stuffy runny nose is very common; I was sneezing, blowing my nose so much; not being able to go back to sleep; A few hours later I sat down and fell asleep/wanted to sleep so badly/rarely has a day that she doesn't fall asleep; what little energy I had was gone by the time I left the gym; I could feel the lymph nodes under each arm and the side of of my breast; I could feel the lymph nodes under each arm and the side of of my breast, some of them were tender; my muscles were sore and weaker; but stuffy runny nose is very common; my muscles were sore and weaker; I had chills; had bouts of diarreah my stomach bothered me; A few hours later I sat down and fell asleep, woke up feeling fatigued and had a headache, was in bed early; lot more energy than she had for years; more prone to feel like crying; woke up feeling fatigued/April 20th, in the afternoon, the fatigue got worse; My walking was more difficult on the way out; I was cold when i got home/turned the heat up to 73 degrees, by the time she was done eating and she got her heating pad and blankets; The initial case was missing the following minimum criteria: Unspecified AE and Unspecified product. Upon receipt of follow-up information on (31May2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 14Apr2021 at 12:00 as dose 2, 0.3 ml single (Lot number: EW0164) at the age of 67 years, in left arm for covid-19 immunisation; epoetin alfa (PROCRIT), first regimen since 02Jul2018 (Batch/Lot number: unknown) at unk (40,000), second regimen since 16Jul2018 (Batch/Lot number: unknown) at unk (40,000), third regimen since 13Aug2018 (Batch/Lot number: unknown) at unk (40,000), fourth regimen since 17Dec2018 (Batch/Lot number: unknown) at unk (40,000), fifth regimen since 14Jan2019 (Batch/Lot number: unknown) at unk (40,000), sixth regimen since 15Apr2019 (Batch/Lot number: unknown) at unk (40,000), seventh regimen since 12Jun2019 (Batch/Lot number: unknown) at unk (40,000), eighth regimen since 02Oct2019 (Batch/Lot number: unknown) at unk (40,000), ninth regimen since 02Dec2019 (Batch/Lot number: unknown) at unk (40,000), tenth regimen since 13Jan2020 (Batch/Lot number: unknown) at unk (40,000), eleventh regimen since 20Jan2020 (Batch/Lot number: unknown) at unk (40,000), twelfth regimen since 03Feb2020 (Batch/Lot number: unknown) at unk (40,000), thirteenth regimen since 22Jun2020 (Batch/Lot number: unknown) at unk (40,000), fourteenth regimen since 02Sep2020 (Batch/Lot number: unknown) at unk (40,000), fifteenth regimen since 11Nov2020 (Batch/Lot number: unknown) at unk (40,000), sixteenth regimen since 23Nov2020 (Batch/Lot number: unknown) at unk (40,000), seventeenth regimen since 05Feb2021 (Batch/Lot number: unknown) at unk (40,000), eighteenth regimen since 15Feb2021 (Batch/Lot number: unknown) at unk (40,000), nineteenth regimen since 28Apr2021 (Batch/Lot number: unknown) at unk (40,000), twentieth regimen since 10May2021 (Batch/Lot number: unknown) at unk (40,000), twenty-first regimen since 09Aug2021 (Batch/Lot number: unknown) at unk (40,000), twenty-second regimen since 23Sep2021 (Batch/Lot number: unknown) at unk (40,000), twenty-third regimen since 18Aug2021 (Batch/Lot number: unknown) at unk (40,000), twenty-fourth regimen since 25Oct2021 (Batch/Lot number: unknown) at unk (40,000), twenty-fifth regimen since 22Nov2021 (Batch/Lot number: unknown) at unk (40,000), twenty-sixth regimen since 10Jan2022 (Batch/Lot number: unknown) at unk (40,000), twenty-seventh regimen since 17Jan2022 (Batch/Lot number: unknown) at unk (40,000), twenty-eighth regimen since 23Feb2022 (Batch/Lot number: unknown) at unk (40,000), twenty-ninth regimen since 23Mar2022 (Batch/Lot number: unknown) at unk (40,000), thirtieth regimen since 30Mar2022 (Batch/Lot number: unknown) at unk (40,000), thirty-first regimen since 20Apr2022 (Batch/Lot number: unknown) at unk (40,000), thirty-second regimen since 16May2022 (Batch/Lot number: unknown) at unk (40,000), thirty-third regimen since 31May2022 (Batch/Lot number: unknown) at unk (40,000), thirty-fourth regimen since 22Jun2022 (Batch/Lot number: unknown) at unk (40,000), thirty-fifth regimen since 16Aug2022 (Batch/Lot number: unknown) at unk (40,000), thirty-sixth regimen since 27Sep2022 (Batch/Lot number: unknown) at unk (40,000), thirty-seventh regimen since 12Oct2022 (Batch/Lot number: unknown) at unk (40,000), thirty-eighth regimen since 25Oct2022 (Batch/Lot number: unknown) at unk (40,000), thirty-ninth regimen since 09Nov2022 (Batch/Lot number: unknown) at unk (40,000), fortieth regimen since 18Nov2022 (Batch/Lot number: unknown) at unk (40,000), forty-first regimen since 16Jan2023 (Batch/Lot number: unknown) at unk (40,000), forty-second regimen since 30Jan2023 (Batch/Lot number: unknown) at unk (40,000), forty-third regimen since 22Feb2023 (Batch/Lot number: unknown) at unk (40,000) and forty-fourth regimen since 17Mar2023 (Batch/Lot number: unknown) at unk (40,000). The patient's relevant medical history included: "tooth extraction" (unspecified if ongoing). Concomitant medication(s) included: LANTUS; LABETALOL; LEVOTHYROXINE; LOSARTAN HCTZ; ASPIRINE; VERAPAMIL; SODIUM BICARBONATE; PROAIR HFA; ALPRAZOLAM; ALCLOMETASONE DIPROPIONATE; HALOBETASOL PROPIONATE; AMOXICILLIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PHOSPHATE;CHROMIC CHLORIDE;COLECALCIFEROL;CUPRIC OXIDE;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE SULFATE;NICKEL;NICOTINAMIDE;PANTOTHENIC ACID;POTASSIUM CHLORIDE;POTA; D3; B-COMPLEX [AMINOBENZOIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]; METFORMIN. Past drug history included: Azithromycin, reaction(s): "weakness", notes: Azithromycin 250 MG dose pack-periods of weakness, and balance loss.; Azithromycin, reaction(s): "balance loss"; Amlodipine besylate, reaction(s): "severe weight gain"; Amlodipine besylate, reaction(s): "very severe edema to the point"; Amlodipine besylate, reaction(s): "depression"; Amlodipine besylate, reaction(s): "skin peeled off my leg and my leg was oozing"; Amlodipine besylate, reaction(s): "triggered Bullous Pemphigoid", notes: Pemphigoid darvacett-felt wide awake; Lodine, reaction(s): "but I would just fall asleep with no warning", notes: not drowsy or tired at all, but would just fall asleep with no warning in the middle of things; Astepro nasal spray, reaction(s): "so tired", notes: one spray in each nostril made me so tired, I could not sit down; Nasacort nasal spray, reaction(s): "triggered my asthma"; Nasacort, reaction(s): "dried me up so much there was no saliva", notes: dried me up so much there was no saliva in my mouth; Allegra, reaction(s): "makes me feel very tired", notes: like I want to curl up and sleep, but I can function; Cellcept for Bullous Pemphigoid, reaction(s): "anemic", notes: I became anemic on it; Lisinopril, reaction(s): "extreme coughing"; Lisinopril, reaction(s): "coughed out clots from tooth extraction & ended up with dry socket"; Wixella inhub, reaction(s): "edema that just kept getting worse"; Wixela inhub, reaction(s): "weight gain"; Wixela inhub, reaction(s): "constantly sick"; Wixela inhub, reaction(s): "muscle pain/Sore stomach muscles"; Wixela inhub, reaction(s): "severs restrictive muscle stiffness"; Wixela inhub, reaction(s): "headaches"; Wixela inhub, reaction(s): "sore throat"; Wixela inhub, reaction(s): "constant indigestion", notes: intestinal indigestion; Wixela inhub, reaction(s): "occasional reflux/gerd"; Wixela inhub, reaction(s): "joint pain"; Wixela inhub, reaction(s): "insomnia"; Azithromycin, reaction(s): "Drug allergy: Azithromycin"; Amlodipine besylate, reaction(s): "Drug allergy: Amlodipine besylate"; Ceclor, reaction(s): "Drug allergy: ceclor"; Darvocett, reaction(s): "Drug allergy"; Lodine, reaction(s): "Drug allergy"; Astepro, reaction(s): "Drug allergy", notes: nasal spray; Nasacon, reaction(s): "Drug allergy", notes: nasal spray; Gluten, reaction(s): "Drug allergy"; Azithromycin, reaction(s): "weakness", notes: Azithromycin 250 MG dose pack-periods of weakness, and balance loss.; Amlodipine besylate, reaction(s): "very sleepy"; Amlodipine besylate, reaction(s): "at the same time and it felt like my body was racing"; Amlodipine besylate, reaction(s): "skin peeled off my leg and my leg was oozing"; Gluten, reaction(s): "Sever stomach pain"; Gluten, reaction(s): "I also could never keep my blood sugar in control"; Wixela inhub, reaction(s): "joint pain"; Wixela inhub, reaction(s): "periods both day and night of being hot"; Iron infusions, start date: 04Jun2018, notes: Iron infusions on 04Jun2018 and 11Jun2018. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Vaccination time: 11 AM), administration date: 24Mar2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "Allergy", "arm was just a little sore", "Other than a little fatigue"; Tetanus shot, for immunization, reaction(s): "Localized redness", "swelling"; Flu vaccine (Flu vaccine constantly sick and at the drs and anti biotics all three years I got it), for immunization, reaction(s): "constantly sick"; Tetnus, for immunization, reaction(s): "Allergy"; Flu vaccine, for Immunization, reaction(s): "Allergy"; Wixela inhub, reaction(s): "Allergy". The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "not recovered", described as "A few hours later I sat down and fell asleep, woke up feeling fatigued and had a headache, was in bed early"; FEELING COLD (non-serious) with onset Apr2021, outcome "not recovered", described as "I was cold when i got home/turned the heat up to 73 degrees, by the time she was done eating and she got her heating pad and blankets"; GAIT DISTURBANCE (non-serious) with onset Apr2021, outcome "not recovered", described as "My walking was more difficult on the way out"; ENERGY INCREASED (non-serious) with onset Apr2021, outcome "unknown", described as "lot more energy than she had for years"; CRYING (non-serious) with onset Apr2021, outcome "unknown", described as "more prone to feel like crying"; FATIGUE (non-serious) with onset Apr2021, outcome "not recovered", described as "woke up feeling fatigued/April 20th, in the afternoon, the fatigue got worse"; CHILLS (non-serious) with onset 21Apr2021, outcome "not recovered", described as "I had chills"; DIARRHOEA (non-serious) with onset 21Apr2021, outcome "not recovered", described as "had bouts of diarreah my stomach bothered me"; MUSCULAR WEAKNESS (non-serious) with onset 21Apr2021, outcome "not recovered", MYALGIA (non-serious), outcome "not recovered" and all described as "my muscles were sore and weaker"; VISUAL IMPAIRMENT (non-serious), outcome "not recovered", described as "my pupils did not adjust to the bright outside light and everything was bright black and white."; MUSCULOSKELETAL PAIN (non-serious), outcome "not recovered", described as "had almost a week of sore shoulder blade"; ANAEMIA (non-serious), outcome "not recovered", described as "I am sure my anemia might play into this some/hemoglobin drops"; BRAIN FOG (non-serious), outcome "recovering", described as "My brain fog"; HICCUPS (non-serious), outcome "recovering", described as "I had the hiccups often not prolonged, just 3-5 at a time"; OEDEMA PERIPHERAL (non-serious), outcome "recovering", described as "The edema in my legs and feet got worse during this time"; GASTROINTESTINAL DISORDER (non-serious), outcome "not recovered", described as "Digestive issues still crop up"; GLOMERULAR FILTRATION RATE DECREASED (non-serious), outcome "not recovered", described as "My GFR also dropped from 27 to 18"; RHINORRHOEA (non-serious), NASAL CONGESTION (non-serious), outcome "not recovered" and all described as "but stuffy runny nose is very common"; SNEEZING (non-serious), outcome "not recovered", described as "I was sneezing, blowing my nose so much"; INSOMNIA (non-serious), outcome "recovering", described as "not being able to go back to sleep"; SOMNOLENCE (non-serious), outcome "not recovered", described as "A few hours later I sat down and fell asleep/wanted to sleep so badly/rarely has a day that she doesn't fall asleep"; ASTHENIA (non-serious), outcome "recovering", described as "what little energy I had was gone by the time I left the gym"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "I could feel the lymph nodes under each arm and the side of of my breast"; LYMPH NODE PAIN (non-serious), outcome "not recovered", described as "I could feel the lymph nodes under each arm and the side of of my breast, some of them were tender". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for epoetin alfa was unknown. Therapeutic measures were not taken as a result of gait disturbance, feeling cold, muscular weakness, visual impairment, musculoskeletal pain, anaemia, brain fog, hiccups, oedema peripheral, gastrointestinal disorder, glomerular filtration rate decreased, rhinorrhoea, sneezing, insomnia, somnolence, asthenia, lymphadenopathy, diarrhoea, lymph node pain, myalgia, fatigue, chills, headache, nasal congestion.  Additional information: In the past, the patient had received Astepro nasal spray, made the patient so tired that she was watching kids that day and had trouble staying awake standing up. Nasacort nasal spray-triggered her asthma and dried her up so much there was no saliva in her mouth, she had to take a sip of water with each bite she took in order to eat. The Tetanus shot Localized redness and swelling bad enough that the Dr looked at it and told me if she got it again to make sure patient only got 1/2 a dose at a time and space it 1-2 weeks apart. On Gluten-Severe stomach pain. Patient also could never keep her blood sugar in control, within 24 hours of stopping all gluten felt like a new person, in a weeks' time patient was able to cut the amount of insulin she was using in half, and except for the time she was on steroids for 9 weeks her A1C has been under 7. Cellcept, patient was on it for treatment for Bullous Pemphigoid. She became anemic on it and when they got aggressive to stop the blistering by doubling the dosage and putting her on steroids her hemoglobin dropped to 8.4. The patient had sun sickness and had some hair loss. The patient was taking a number of prescription medications on a regular basis, including supplements, 1/2 cbdgummy sometimes and probiotic 2 daily, Eye lea injections every 5 weeks. Regarding covid-19 vaccine, the patient ended up making the wrong decision and got the vaccine. The patient suffered 3 months of continuing side effects and even now 2 years later she was not back to where she was before the vaccine. The reported issue occurred after use of a Pfizer product and within an hour. No admission to hospital, no emergency room & physician office due to the event. The patient received dose 2 on 14Apr2021 & she again waited 30 minutes to leave. Her walking was more difficult on the way out (she uses a cane for distance walking). She yawned all the way home. She was cold when she got home and put a sweater on to eat lunch; part way through she turned the heat up to 73 degrees, by the time she was done eating and she got her heating pad and blankets and curled up on the couch and slept about 45 minutes. She woke up feeling great, with a lot more energy than she had for years. She did work around the house, did a lot of upper body/arm exercises, though she only used a 3pound weight, she just wanted to move the arm not overdo it. A few hours later she sat down and fell asleep, woke up feeling fatigued and had a headache, and was in bed early. She woke up at 6 AM exhausted, but wasn't able to go back to sleep, her husband who got his shots the same time was up at & the same way, and he works afternoons. They both took about a 3hour morning nap, he went to work, she did a lot of resting. While the fatigue lessened some, it did not go away nor did the headache. The pattern of either waking up an hour or more early exhausted and not being able to go back to sleep or waking up at 3 o4 in the morning and not being able to go back to sleep for an hour or more lasted almost 2 months. The following Tuesday 20Apr2021, in the afternoon, the fatigue got worse. On 21Apr2021 Wednesday, the fatigue was even worse, her muscles were sore and weaker, she had bouts of diarrhea my stomach bothered her, and she had chills. Her husband had most of those issues but not as severe. This was still happening, but with less severity as far as the digestive issues go. She thought perhaps some of the fatigue and muscle soreness and weakness might have to do with her blood levels dropping, but it was much more of an up and down thing than when her hemoglobin drops. She had her blood work done that following weekend and, in the month, she got the vaccines, her hemoglobin had dropped from 11.8 to 10.2, which is a very big drop in that amount of time for her. She got her Procrit shot 28Apr2021 the following Wednesday. The side effects from the Procrit shot were at least 10 times worse than usual, or the Procrit shot really ramped up the side effects from the vaccine. Some of the side effects are similar, fatigue, headache sore and weak muscles. It was horrible. The Friday after her Procrit shot, she was so tired and wanted to sleep so badly that it was all she could do to not break down in tears. As soon as the kids left, she was on the couch and slept for 2 hours, she took another nap later and was still in bed before 11. She woke up Saturday exhausted and her body felt disjointed. She had a session scheduled with her trainer that morning and went to the gym thinking maybe exercise would help her body feel better. She could barely do anything, and what little energy she had was gone by the time she left the gym. She had to stop and rest several times on her way out to the car, her pupils did not adjust to the bright outside light and everything was bright black and white. She thought she was going to have to call EMS when she got to the car, but once she was out of the direct sunlight, her eyesight was fine. She did have to sit a minute before she could get her feet in the car and sit another minute before she had the energy to get going. It was the same way trying to get into the house, she got home around 11:30 and slept until 3:30 had a snack and slept another 3 hours. When she got her blood work redone on 08May2021, the hemoglobin had dropped to 10 instead of starting to go back up. Her days vary greatly, the levels of fatigue and muscle weakness and soreness vary greatly. She had been checking her lymph nodes for about a week after the second shot and they seemed fine. But on 12May2021, she leaned on the arm of the couch and noticed a tender spot under her arm. She could feel the lymph nodes under each arm and the side of her breast, some of them were tender. She had a second Procrit shot on 10May2021. While the side effects were still worse than normal, they weren't as bad as they were with the first Procrit shot. The hemoglobin went up to 11.4 after the second shot. She also had almost a week of sore shoulder blade, she couldn't figure out what had caused it since she has not had enough energy and strength to add exercise back into her daily routine. Then she remembered talking to several people that had side effect as well after the 2nd vaccine, it just showed up sooner. On 05Jun2021 while her muscles are still weak, her energy was improving as is her stamina. But it is not consistent, she will do better one day and be worse the next. Fatigue was still hanging in. She rarely has a day that she doesn't fall asleep at some point for a least a little while. Today she woke up tired, went back to bed after being up about 2 1/2 hours and slept from 11 almost straight through until 3, had an apple and peanut butter and slept off and on until almost 6. She is sure her anemia might play into this some, but when her hemoglobin drops it was a slow decline in energy and strength, and it is steady, not an up and down thing. On 13Jun2021, this past week is the first week that she did not have to take a nap or fall asleep during the day. Her energy is picking up. Her brain fog, which she didn't realize she had until now, is clearing. She still gets cold sometimes, but not as often. And her headaches were rare instead of constant. On 20Jun2021 this week she was back to napping or falling asleep once a day. Some things that seem to be related to the vaccine along with the above. She was more prone to feel like crying, she had the hiccups often not prolonged, just 3-5 at a time, but a few times a day. As she started to feel better, they stopped. Digestive issues still crop up though they have lessened. The edema in my legs and feet got worse during this time, she thought it was because she wasn't able to exercise, but once she started to feel better, even though she was not exercising appreciably more, the edema went back down. As an example of the change in muscle strength- before the vaccine she was using 15-20 pounds weights for chest presses and overhead lifts for 4 sets of 10-12 reps. Leg presses she was doing 150 to 180 pounds. After the vaccines she had trouble doing 5 chest presses with a 3 pounds weight and she couldn't make the leg press machine move at all. Her GFR also dropped from 27 to 18. As of 04Sep2021, her reaction to the last Procrit shot, while still worse, was closer to normal, the further away from the vaccine she gets the closer to normal her reactions to the Procrit seem to get. Her arm strength was almost back to normal, though she is not back to the 20 pounds weights yet. her legs are not near where they were before the vaccine but are improving. The hiccups are mostly gone except when she gets Procrit. While she was not sure if this is just a bad allergy year or another lingering side effect from the vaccine, but stuffy runny nose is very common, and several times she had to switch her training session to virtual, because she was sneezing, blowing her nose so much she wouldn't be able to keep her mask on in the gym. The patient was still experiencing events.