Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Limb discomfort, Loss of personal independence in daily activities, Malaise, Nausea
Clinical narrative: not feeling good; did not sleep and at night; chest pain; pain in the back near the kidney area; Dizziness; started having pain; I cannot breathe; can't function like this anymore; Pain, by shoulder a 10; Super tired, extremely tired; Pain in the arm, bad/and also my 'thigh on the right'; Arm, described as numb, heavy/Top of body, felt numb/It was bad in the shoulders; Arm, described as numb, heavy; chest is awful/Chest hurt, pressure; feeling weak; nauseous; not normal in my whole body/ Felt awful/ It feels bad; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, NDC number and Expiry Date of Pfizer Covid 19 vaccine: Not Provided), dose 1 via an unspecified route of administration on 16Feb2021 (Batch/Lot number was Not provided, Reason for no lot number: of Pfizer Covid 19 vaccine: Caller unwilling to complete the report) (at the age of 48-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from, she had Covid from Dec2020 (she had Covid over December, and she confirms that it was before she had the vaccine), pregnant, (She only ever had nausea when she was pregnant, a long time ago), nausea (She only ever had nausea when she was pregnant, a long time ago). The patient's concomitant medications were not reported. The patient experienced feeling weak on 24Mar2021, nauseous on 24Mar2021, not normal in my whole body/ felt awful/ it feels bad on 24Mar2021, not feeling good on an unspecified date, did not sleep and at night on an unspecified date, chest is awful/chest hurt, pressure on 24Mar2021, chest pain on an unspecified date, pain in the back near the kidney area on an unspecified date, arm, described as numb, heavy/top of body, felt numb/it was bad in the shoulders on, arm, described as numb, heavy on 24Mar2021, pain, by shoulder a 10 on an unspecified date, super tired, extremely tired on an unspecified date, pain in the arm, bad/and also my 'thigh on the right' on 24Mar2021, dizziness on an unspecified date, started having pain on an unspecified date, i cannot breathe on an unspecified date, can't function like this anymore on an unspecified date. Suspect Product(s): Pfizer Covid-19 Vaccine; Start Date: 16Feb2021. Caller states that she was transferred from two people before us. Spoke for 35mins and 36mins. She's 48 years old and has been having side effects for a week after her first Pfizer COVID 19 vaccine and she's trying to understand why she's "feeling this stuff". She's been feeling weak, nauseous from 24Mar2021 to 27Mar2021, "not normal in my whole body", not feeling good yesterday, did not sleep and at night and her "chest is awful". She's frustrated that we've been asking her questions and not offering solutions. She has asthma, works with kids and has a daughter. She's wondering why she's feeling these side effects and if she needs to go to the ER or wait till morning. She states that she can't go to the ER as she is alone with her daughter and has no family. Caller gave the case number #. From the crosslinked case: Additional to this she mentions that she had chest pain and pain in the back near the kidney area from 9 days now. She has the second dose scheduled on April 21st and is looking for information about the vaccine such as the formulation to write a letter to the (Place name) government so she is not forced to get the second dose due to the reaction to the first dose. She says that she has a daughter, works with kids and has asthma. Age at time of onset of reaction/event: 48 Year. Height (cm): 165. Felt awful, Arm, described as numb, heavy: Date of start of reaction/event: 24Mar2021. Reaction(s)/Event(s) included as Felt awful, Arm, described as numb, heavy, Pain, by shoulder a 10, Chest hurt, pressure, Super tired, extremely tired, Pain in the arm, bad, Dizziness. Additional Context: Caller calling about the vaccine. Reconfirmed with Caller that it was the Pfizer Covid 19 vaccine. Caller said that when she got the vaccine she got paperwork that said that she may have a couple of reactions or side effects for a couple of days. She states, the first two days she felt awful. Caller states her arm, top of her body was not moving and felt numb. It feels bad. The caller said that she had Covid, but the Covid was not as strong. It was bad in the shoulders. Reclarified, that the caller stated she had Covid over December, and she confirms that it was before she had the vaccine. Reclarified, caller reports pain, by the shoulder, out of 1 to 10, it was a 10. Her question is it has been a week and one day, and yesterday she felt awful, her chest hurt, she was super tired, extremely tired, and she has, a history, of asthma. Caller states, the other one is coming soon, clarified as the second vaccine, what will be her reactions, because this one was bad, with the first vaccine. Weight: reports weight as 160 pounds, maybe. Caller states she does not have a healthcare provided. She reports she doesn't have insurance. Adverse Events: Felt awful: Reclarified, Caller states that for the vaccine, you should rest a little bit, but in this country, that she needs to work, she can't recoup, if she feels bad, she has to keep going. Time: caller states she felt it at night. Caller goes on to report that she felt nausea and she felt bad. She said that the pain in the arm started the next day and it was bad. Caller states the nausea she felt at night, she states around 7. She states she was feeling nausea and started having pain, and she only ever had nausea when she was pregnant, a long time ago. She reports that the pain in her arm was for 2 1/2 days, especially the first day. Today is a week and 2 days, since the vaccine, and she is still tired and it was difficult yesterday. Caller also reported pressure in her chest yesterday night. Ongoing: Caller states she is feeling awful, and one day feeling pain in her arm, and for 2 1/2 days, it was very heavy on her arm and feeling nausea on that same day, at night. Caller said that on another day in the morning she also had nausea. Caller said that she has been feeling dizziness and tired now. Reclarified, on 24Mar2021, the same day at night and the nausea was at 7 and the pain in the arm was from the 24-26Mar2021. Arm, numb, heavy: Time: caller states at night. Ongoing: caller states it has completely resolved, maybe Wednesday, Thursday, Friday, Saturday, maybe Sunday. Reclarified, caller states she went to the doctor to check on something else, and it was completely resolved on Sunday. Reclarified, caller states she needs to be at work, and right now she has to be at work and she is driving. Caller states she doesn't want to be in pain anymore. Caller wants to know if she has to go to the doctor, as she can't function like this anymore. Caller was given the option to continue report or be transferred to. Caller states that she doesn't want to take the other vaccine if it is going to be worse, because the reactions are very scary and she has a daughter. Caller states she is just trying to see what is next, and what are the effects, Pfizer needs. Caller states she does not understand what this report is for, because it says on the paper that if someone has information, to call this number. Caller was given the purpose and what it does, as well as the Medical Information Department. Caller states that she has her question, but is this a survey with questions about her reaction. Caller states that she feels uncomfortable about this survey with questions about her health. Caller states she feels intimidated because she is another race. Caller states she told the lady before this call, and she was given this number and held for 25 minutes. Caller was referred to a healthcare provider as a possible resource for her concern. Caller states that she doesn't have one, and she wants to see if this is normal. Caller states she doesn't feel right, with the survey, this morning before work. Caller repeats that she needs to know something about the reactions to the vaccine. Caller states the paper she got with her vaccine says if she had any reactions to call this number, not be a part of a survey if she had an amazing experience. Caller states this is a health issue and it is taking over her and her job. Caller states she has already been talking for 36 minutes. Caller declined to complete report. Full details not obtained. Caller not answering questions directly. Details are as provided by caller with clarifying attempts. Caller notified that Medical Information and/or Pfizer is unable to provide medical advice but may have resources to help answer some questions. Caller spoke very fast and Call Handler asked for multiple clarifications. Caller declined websites. Caller mentioned that in the morning she was on the phone for 40 minutes and was not given useful information for her and she wasted time. Reaction(s)/Event(s) included Last week it was my arm on both of my arm on the right and today nausea and then it went away but it's tiredness. I cannot breathe. I was not sleeping because of my chest, it's my chest and last week it was my arm and also my 'thigh on the right' and today nausea, I am kind of scared to take the next one. Other Products: Not Provided. Consumer stated, "Well, I don't know if you are (incomplete sentence), I mean I got the vaccine (Unspecified Vaccine) last week, last Wednesday and I am 'feeling' weak and I am feeling awful like super weak with nausea two days in a row. I guess it was at work but before this I can easily work and my problem is right now I cannot breathe at all why, I mean it's in my head or (incomplete sentence) but yesterday I was not sleeping because of my chest, it's my chest and last week it was my arm and also my 'thigh on the right' and today nausea and then it went away but its tiredness. I feel super tired, extremely tired and I am just, I couldn't sleep like I have to work, I have a daughter I need so much that I don't rest (Clarification unknown). It never happened to me at all because I never had a vaccine. Well, when I was growing up I was not a sick person, you know. I mean I am kind of scared to take the next one because if I am going to feel like that, I don't know if it is a reaction, it is more than a 'week'. I mean it says you have tiredness or something you have to call on the phone number. What would you do, I don't know because I don't know if I am going to take the second vaccine. I mean I could have worse reaction." When requested for permission to probe questions for a safety report, consumer stated, "No, it's not a right time. I can't talk." LOT: Consumer stated, "I am driving, I mean I have to reach work." Consumer was unwilling to share further information, hence, product details (Expiration date, NDC#, UPC#) reporter type and other details were unknown. Limited information was available over the call. Dates for Pfizer Covid 19 vaccine: (Start: Unspecified Stop: Unspecified). For events, feeling weak, outcome was recovered on 27Mar2021, nauseous, outcome was recovered on 27Mar2021, not normal in my whole body/ felt awful/ it feels bad, outcome was not recovered, not feeling good, outcome was unknown, did not sleep and at night, outcome was unknown, chest is awful/chest hurt, pressure, outcome was unknown, chest pain, outcome was not recovered, pain in the back near the kidney area, outcome was not recovered, arm, described as numb, heavy/top of body, felt numb/it was bad in the shoulders, outcome was recovered on an unspecified date in 2021, arm, described as numb, heavy, outcome was not recovered, pain, by shoulder a 10, outcome was unknown, super tired, extremely tired, outcome was not recovered, pain in the arm, bad/and also my 'thigh on the right', outcome was recovered on 26Mar2021, dizziness, outcome was unknown, started having pain, outcome was unknown, I cannot breathe. outcome was unknown, can't function like this anymore, outcome was unknown.    No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.