Age: 74.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Oropharyngeal pain, Respiratory symptom, Respiratory tract congestion
Clinical narrative: sore throat; head cold; respiratory symptoms; discomfort/ Within 2.5-3 hours her head became very congested/ 07Oct2023 as she felt very lousy the whole day; her head hurt and she got worse after that; fever; her head hurt and she got worse after that; all her joints became achy and she felt sick; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), NASOPHARYNGITIS (head cold), RESPIRATORY SYMPTOM (respiratory symptoms), DISCOMFORT (discomfort/ Within 2.5-3 hours her head became very congested/ 07Oct2023 as she felt very lousy the whole day) and CONDITION AGGRAVATED (her head hurt and she got worse after that) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. UT8104BA) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose, lot number EL9269) on 31-Jan-2021, PFIZER BIONTECH COVID-19 VACCINE (2nd dose, lot number EN6201) on 21-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (3rd dose, lot number FD8810) on 21-Oct-2021, PFIZER BIONTECH COVID-19 VACCINE (4th dose, lot number FK9896) on 04-Apr-2022, PFIZER BIONTECH COVID-19 VACCINE (5th dose, lot number GH9702) on 23-Sep-2022, Influenza vaccine and Flu. Past adverse reactions to the above products included No adverse event with Flu, Influenza vaccine, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 06-Oct-2023, the patient received dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 06-Oct-2023 at 6:00 PM, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 06-Oct-2023, the patient experienced OROPHARYNGEAL PAIN (sore throat), NASOPHARYNGITIS (head cold), RESPIRATORY SYMPTOM (respiratory symptoms), DISCOMFORT (discomfort/ Within 2.5-3 hours her head became very congested/ 07Oct2023 as she felt very lousy the whole day), CONDITION AGGRAVATED (her head hurt and she got worse after that), PYREXIA (fever), HEADACHE (her head hurt and she got worse after that) and ARTHRALGIA (all her joints became achy and she felt sick). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram. On 08-Oct-2023, CONDITION AGGRAVATED (her head hurt and she got worse after that), PYREXIA (fever) and HEADACHE (her head hurt and she got worse after that) had resolved. At the time of the report, OROPHARYNGEAL PAIN (sore throat) and DISCOMFORT (discomfort/ Within 2.5-3 hours her head became very congested/ 07Oct2023 as she felt very lousy the whole day) was resolving, NASOPHARYNGITIS (head cold) and RESPIRATORY SYMPTOM (respiratory symptoms) had not resolved and ARTHRALGIA (all her joints became achy and she felt sick) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Within three hours of vaccination she came down with sore throat, head cold, respiratory symptoms, Patient uses a CPAP machine. Patient got the Spikevax on 06Oct2023 around 6:00pm together with the flu shot as the vaccine provider said it was okay to take them together. Within 2.5-3 hours her head became very congested, all her joints became achy and she felt sick, She had sore throat, her head hurt and she got worse after that. She said that before she went to bed there was a lot of discomfort and she took Tylenol 500 mg. She lost the whole day of Saturday, 07Oct2023 as she felt very lousy the whole day. Next day, 08Oct2023, when she woke, she felt as if a "cloud has been lifted off". She did not have any temperature all along, no fever. At that time of the call she still did not feel herself but she is functioning.   Most recent FOLLOW-UP information incorporated above includes: On 09-Oct-2023: Live FU with significant information accepted reporter details updated, new event, medical history, historical vaccine, concomitant medication and treatment were added. I- narrative was updated