Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Off label use, Pain in extremity, Product use issue
Clinical narrative: Patient is breast feeding a 9-month old male baby.On the day following the vaccine (today), the baby refused to take any daytime naps, ate more than usual, and vomited.; Patient is breast feeding a 9-month old male baby.On the day following the vaccine (today), the baby refused to take any daytime naps, ate more than usual, and vomited.  None of these are typical beh; Arm soreness; Fatigue; Mild itching in arm; Headache; This is a spontaneous report from a contactable consumer (patient) reported for herself. This consumer reported information for both mother and baby. This case is the mother report. A 37-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL0104, Expiration date: unknown) intramuscular, administered in arm left on 30Dec2020 at 19:30 pm (age at vaccination was 37 years) as dose 1, single for COVID-19 immunization. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246, Expiration date: unknown) intramuscular, administered in left arm on 20Jan2021 at 15:00 pm (age at vaccination was 37 years) as dose 2, single for COVID-19 immunization. The patient's medical history included Graves disease from an unspecified date in 1994 to an unspecified date in 2002, thyroidectomy from an unspecified date in 2002, ongoing hypocalcemia from an unspecified date in Feb2002, parathyroid damage (Graves disease resulting in thyroidectomy, hypocalcemia due to parathyroid damage) and ongoing hypothyroidism from an unspecified date in Feb2002. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism, 150ug once daily from Feb2002 and ongoing, calcitriol (CALCITRIOL) taken for hypocalcaemia from Feb2002 and ongoing 0.25ug twice daily, fish oil (FISH OIL) taken for pregnancy from Jul2019 and ongoing 1200mg twice daily, calcium (CALCIUM) taken for hypocalcaemia from Feb2002 and ongoing twice daily and folic acid (FOLATE) 1mg, once daily taken for pregnancy from Jul2019 to Aug2020. The facility where the most recent COVID-19 vaccine was administered was Hospital. The vaccine was not administered at Military facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Received vaccine as recommended by pediatrician. No immunizations provided within 2 weeks of mother getting Pfizer vaccine. Mother did not smoke, alcohol, not use illicit drugs during this pregnancy, she had uncomplicated pregnancy during unknown date in Sep2019-Apr2020, she had one previous pregnancy she had no other children and she had miscarriage at 6 weeks. She does not had problems before delivery, she had no problems during pregnancy, her mode of delivery was vaginal birth with epidural and vacuum assist her date of outcome of pregnancy was 05Apr2020, baby father took 1 or 2 drinks during the 9 Months. The patient was breast feeding a 9-month-old male baby. The patient was postpartum, not pregnant. Mother had typical expected reaction to vaccine, reported to Pfizer due to noticing a change in breastfeeding infants habits after the vaccine was given to the mother. The change in child's habits lasted about 48 hours with both doses and then the child would return to normal habits. On the day of vaccination 30Dec2020, the baby refused to take any daytime naps, ate more than usual, and vomited. None of these were typical behavior for the baby on 31Dec2020 at 10:00 am. Baby had 3 breast feeding sessions after patient received vaccine, and then was eating frozen reserves. Since the vaccination, the patient has not been tested for COVID-19. She had arm soreness, fatigue, mild itching in arm and headache. The patient underwent lab tests which included Diasorin SARS-Cov-2Ab: positive (son brought home cold from day-care that whole family caught) on 28Nov2020. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.  Amendment: This follow up report is being submitted to amend previously reported information: Updated the reporter, relevant medical history, concomitant drug onset time and narrative.  Follow-Up (02Jul2021): Follow-up attempts are completed. No further information is expected.  Follow-up (13Jul2021): New information received from a contactable consumer (patient) reported in response to Non-HCP letter sent to consumer via follow-up letter activity which included: Updated the details of 1st and 2nd dose of vaccine and response of the query.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021001188 same vaccine, different patient and AE.