Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site warmth, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: had the worst pain and it was all over her body; has had random pains in her calves and in her arms and fingers; her hands and abdomen and her head hurt; her hands and abdomen and her head hurt; she is getting the pain with random leg cramps and feet cramps and charley horses.; shakes; she was cold inside; having like lower back pains with this; has sciatica; her balance is off; never had a temperature with this and never ran a temperature with these side effects; This is a spontaneous report from a contactable Nurse. A contactable Nurse reported different events for 2 patients. This is 1 of 3 reports. A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200), dose 1 via an unspecified route of administration, administered in Arm Left on 19Feb2021 18:00 (at the age of 70-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history included stenosis, patient stated she had the carotid artery taken care of about two years ago and her neurologist knew in the hospital and she had been complaining about bending her neck and her neck was stiff and they did a CT scan at that time and found out she has severe stenosis and it just about killed her and she has stenosis in her lower back, passed out (two years ago she was at her daughter's house and passed out on the floor), blocked carotid artery (she had 85 percent blocked carotid artery that was maybe three years ago). There were no concomitant medications and no other products. The patient had first shot of the Pfizer COVID vaccine on 19Feb2021 and went home and that day and felt just fine and by the next morning on 20Feb2021, when she woke up she had the worst pain that you would not believe and it was all over her body and her hands and abdomen and her head hurt; states she clenched her hands so hard that it hurt her little finger and that did not make this too good and it went on for weeks. States since then she has had random pains in her calves and in her arms and fingers and has been tested for arthritis and did not have that. States she has been in pretty good health and has never had a reaction to the flu shot or anything and was still miserable and her balance was off and never had a temperature with this and never ran a temperature with these side effects and the symptoms were still with her and she went to her family doctor and was trying to switch doctors because the doctor was no help to her or her husband. States she went to the health care professional (HCP) and they said to take a Tylenol before the next dose of the Pfizer COVID Vaccine, and she has four kids and was an OBGYN labor nurse and would rather go through labor than have this kind of pain; states her question was what does she do and how can she possibly have the 2nd dose of the Pfizer COVID vaccine if the first time she had this so bad and after the 2nd dose people can have it. States she went to the hospital outpatient clinic; states somebody called her yesterday or the day before and went through a report, but it was from Innovation and the guy was very vague. Caller states she went to see her HCP after the vaccine and the HCP said this was no big deal and it upset her. States her pain began the very next morning and she had the Pfizer Covid vaccine at 6:00 pm and woke up the next morning 12 hours later at 6:00 am and had unbelievable pain and thought she can't believe she was having this; states the pain was ongoing and she was going to say maybe a little better and has it barely at times and not always and gets random pains then it goes all over her body and was strange; states she has shooting pain down her finger maybe a minute and then it would stop and she would maybe have shooting pain in her forearm and that will go on for a minute and then feels like stabbing and hurts so bad; states it just does all over and gets in her legs and now she was getting the pain with random leg cramps and feet cramps and charley horses. States she feels this was very serious of a problem and was asked seriousness criteria and states it was very serious; this report filed as medically significant. States she should have gone to the hospital and it went on an on for weeks and was unbearable and did stay home and the whole thing really got her, and she had no temperature and also had not like chills but shakes and like she was cold inside. States she called a covid hotline and reported this. States she has not started any new medications at the time of the reported event or within two weeks prior and was hardly sleeping at night and having like lower back pains with this and gets thigh pains and has sciatica; states also two years ago she was at her daughter's house and passed out on the floor and was pretty active and found out at that time that she had 85 percent blocked carotid artery and that was maybe three years ago. States her grandson had long QT syndrome and the day he was born his heart tissue was dying and he was age 17 and they thought he had the flu and took him to the HCP and gave him Theraflu and got him home and in bed and he was so sick and took a bath and made him soup and his mom heard him yelling from the bedroom and when they got there he was gone, and she was in the emergency room looking down at him. She stated her weight because of Covid. She told the nurse she spoke to before about her experience and gave her information and she said she would be transferring her over. Caller says that she had an adverse reaction to the Pfizer shot, clarified to Pfizer COVID-19 vaccine, and she had her first shot only. She says she never had a reaction to a shot before, and she was a nurse before she retired so the agent was gauging how she felt seriousness was since she was still having reaction. She says her question was what to do since she had not her second shot and her family doctor and other doctors and the health department didn't answer this question and she was still having same problems. She says nobody in withheld could tell her what she should do for the reaction or for her second dose. She had her first shot done 19Feb2021 and she was supposed to go back 13Mar2021, but she didn't go back. She says that she has a handwritten vaccine card, which doesn't provide the NDC/EXP for the dose she got. The events required visit to physician office. Seriousness criteria-Other medically important condition. The outcome of the events she is getting the pain with random leg cramps and feet cramps and charley horses, her balance is off, never had a temperature with this and never ran a temperature with these side effects was not recovered. The outcome of the events shakes, she was cold inside, having like lower back pains with this, has sciatica was unknown and the outcome of other events was recovering. Reaction assessed: had the worst pain and it was all over her body and her hands and abdomen and her head hurt. Drug result: Related. Reaction assessed: has had random pains in her calves and in her arms and fingers, Source of assessment: Primary Reporter,  Drug result: Related.   Conclusion from product quality complaints group of previously completed investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6200 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6200, fill lot EN5332, and the formulated drug product lot EN5321. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There was no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.