Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Nausea, Non-tobacco user, Pain
Clinical narrative: Hoarseness; Nausea; Loss of appetite; Weakness; Headache; whole body ached; pain in the area the shot was applied; some swelling at the injection site; This is a spontaneous report from a contactable nurse.  A 49-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration in the left arm on 15Dec2020 at 15:30 at 49-years-old at a single dose for COVID-19 immunization. The vaccination facility type was a hospital. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): none. There were no additional vaccines administered on the same date of the Pfizer Suspect. The patient's medical history was reported as none. The patient was not a smoker. Family Medical History Relevant to adverse events: none. Concomitant medications included routine medications. On 15Dec2020, the patient experienced: pain in the area the shot was applied (non-serious). On 16Dec2020, the patient experienced: weakness (non-serious), headache (non-serious), whole body ached (non-serious). On 17Dec2020, the patient experienced: loss of appetite (non-serious). On 18Dec2020, the patient experienced: hoarseness (non-serious), nausea (non-serious). On an unspecified date in Dec2020, the patient experienced: some swelling at the injection site (non-serious). The events did not require a visit to an emergency room or physician office; there was no prior vaccinations (within 4 weeks), there was no adverse events following prior vaccinations.  The clinical course was reported as follows: The patient (nurse) had the vaccine administered on 15Dec2020 at about 15:30; and was told to notify if she had any side effects. On the same day, the patient had a lot of pain in the area the shot was applied. The patient received the shot in the left arm and after that, she was feeling weakness, headache, her whole body ached, she had difficultly speaking, and nausea. The patient was advised to call and report anything she experienced after the vaccine.    The patient first started with strong pain in the area where the vaccine was administered. It was very painful, and she had some swelling at the injection site. Next, she had a headache and loss of appetite. The patient had weakness in her body. On 18Dec2020, the headache started with some nausea. There was a very strong pain in her whole body and hoarseness (like she had no voice). The patient clarified later in the call she had a headache prior to 18Dec2020.   The patient reported that the " pain in the area the shot was applied" was better. The patient reported "it is not too annoying like it was yesterday." The patient took acetaminophen for pain and applied ice packs. The patient reported that the weakness was better on 18Dec2020.  The headache was better because she took medication. The whole-body aches: were about the same, a strong pain in her back, in her arms, everywhere. The hoarseness which was clarified by the patient as what was meant when reporting difficultly speaking: The patient clarified she had no voice. On 18Dec2020, in the morning, she felt a hoarseness. The patient never presented this symptom until 18Dec2020. Loss of appetite: This started on 17Dec2020 and it was about the same since starting since she really had not eaten anything.   Nausea: Started on 18Dec2020 in the morning when she woke; she had not done anything because she had lost her appetite. The patient had only fruit juice. The nausea was about the same since starting. " When asked a seriousness criterion for the events: She would describe it has had a cold."  The patient reported that there was no difficulty breathing and so she felt it was not so urgent that there was a need for her to go to the emergency room. The patient received a call from the place where the vaccine was given; and was told if her symptoms were to get worse, she would have to go to the emergency department.  The patient will get the card after her second dose; The patient was given a piece of paper. There was no expiry date or NDC provided on the paper.  The patient reported that she takes nothing other than routine medications.  The patient had no other vaccines on the day she received the COVID vaccine. The patient reported she had no important medical history and has had no reactions to any other vaccines previously. There was no relevant family medical history.  The patient had been able to manage the symptoms herself at this point and did not require any additional trips to the hospital or doctor's office.  Therapeutic measures were taken as a result of pain in the area the shot was applied, and headache. The clinical outcome of the events: pain in the area the shot was applied, weakness, headache, was recovering. The clinical outcome of the event, whole body ached, loss of appetite, hoarseness, nausea was not recovered. The clinical outcome of the event, some swelling at the injection site, was unknown.