Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Both arms are very very itchy; Arm was sore; Can barely walk sometimes; Tightness in shoulder and neck; Left hip, upper thigh muscle hurting; Left hip, upper thigh muscle hurting; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown) via an unspecified route, administered in Left arm on 01Apr2021 (at an age of 72-year-old during vaccination) as a 2nd dose, single dose for COVID-19 immunization. The patient's medical history included ongoing cholesterol; diagnosed may be five or six years ago and was ongoing High blood pressure; about 10 years, since it was diagnosed, she was no longer on hyperthyroidism which was diagnosed around 38 years ago. She reported that she was on iodine done to her neck, and on different medications such as radiation capsule and she went to hypothyroidism. Hyperthyroidism happened right after her husband's death. Her body went into a shock. At an age of 72 years, the patient had 1st flu shot on her left arm on 03Dec2020 and her body doesn't like invasion. She sick for 10 days, from 03Dec2020 to 12Dec2020 and she had everything which can get from the flu: soreness, fever, muscle aches. The patient's family medical history was not provided. The patient's concomitant medications included atorvastatin 10mg, once daily took from unspecified date for a few years and was ongoing for Blood cholesterol, levothyroxine 88mg once daily  had been taking this medication for about 30 years for thyroid, diltiazem 180 mg once daily had been taking this medication for at least a few years for blood pressure, losartan potassium 50mg once daily had been taking this medication for about one-and-a-half years taken for blood pressure and temazepam 15mg once daily had been taking this medication for about 15 years to help her get to sleep and it was prescribed because of her hormones. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6206, Expiry date: Unknown) via an unspecified route, administered in Left arm on 11Mar2021 (at an age of 72-year-old during vaccination) as a 1st dose, single dose for COVID-19 immunization. The patient experienced tightness in shoulder and neck, left hip, upper thigh muscle hurting and Can barely walk sometimes on an unspecified date in Apr2021, Both arms are very very itchy on 07May2021 and Arm was sore was 01 Apr2021. The patient wrote stuff down daily on both her first and second shot. On 01Apr2021 (second dose of vaccine), the patient experienced her arm was sore. She stated that soreness went away by second day and she recovered completely. The tightness of her shoulder and neck started on the third or fourth day of Apr2021, and it stayed in her neck. The tightness was continuing almost every other day and persisting. It gets very tight, and the only relief was putting heat on it. She stated that she placed heat on the area, and it had been helping a little. Her doctor prescribed muscle relaxants, but they didn't work. She had tried creams that did nothing. The only thing that did anything was the heat and that relaxed it. She provided product specific information for the muscle relaxant and creams. She stated the muscle relaxant was methocarbamol. It was prescribed as 750mg every 12 hours as needed. They are 20 tablets, and she takes them by mouth. The patient stated that she can hold the bottle for a prepaid FedEx mailer if Pfizer requests the medication. She stated the use by date would be 18Mar2022. She purchased the Arnicare cream gel over the counter, she bought a couple of bottles. Only inactive ingredients were mentioned on the bottle. On Apr2021, She had left hip, upper thigh muscle hurting same time as the shoulder muscle pain on the third or fourth day after the vaccine. It was continuing. She stated in fact today, at the top of her thigh, it's giving her problems and she's having a hard time walking. It had lingering and persisting. On 07May2021, her both arms are very, very itchy. she can't see bumps or anything, but they are extremely itchy at times. She then clarified that's wrong when she thinks about it about a week after she got the shot. It was ongoing and persisting. This had been happening for two months and had not gone away. She doesn't know if anyone else has had anything like this or not. She had been experiencing this for the last two months. The reporter stated that, she has tried creams for the itchiness and taken allergy pills and nothing seems to work it was taking its time to work and stated that she hopes her side effects don't last much longer but if her symptoms continued past three months should she call us back for treatment recommendations. On third or fourth day after vaccination she can barely walk sometime, she had trouble walking. It was ongoing and persisting. The patient was neither visited Emergency Room nor physician office for the resulted events. The patient had not undergone any relevant tests. The patient reported that, she received her second Pfizer shot vaccine, was still having side effects, and it's been almost two months later. She doesn't know what she can do to prevent all of this. The patient stated that, she doesn't know if anyone else had anything like this or not. She stated that if no one knows what to give her for her side effects. The patient was advised to refer PI Section Adverse Reactions Adverse Reactions in Clinical Trials Adverse reactions following the Pfizer-BioNTech COVID-19 Vaccine that have been reported in clinical trials She was also informed as we do not provide medical advice for side effects, but she may call us back for any updates in the information regarding how long side effects last. She stated she often thought about the dosage of the vaccine she received as she only weighs 112 pounds, and she received the same dosage as someone who might weigh a lot more. She was informed that the dosage of the vaccine was not based on weight. No information in PI regarding weight of individual having side effects due to the dosage was provided to the patient. The patient stated that she had a new doctor and does not know the email address. The patient would like to know if these side effects have been reported before. The outcome of the events arm was sore was recovered on 02Apr2021 and the outcome of other events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.