Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Eye pain, Hangover, Headache
Clinical narrative: fever; chills; eye pain; headache; increased pain in joints; she felt like she had a bad hangover; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number US-AMGEN-USASL2021040220). This case was split from master case AER #2021293217 to capture a female patient received second dose of BNT162B2 and experienced fever, chills, eye pain, headache, arthralgia aggravates, hangover effect.  This non-serious solicited report (USASL2021040220) was reported on 12Mar2021 by a consumer from a commercial program (PSP00086) and involves a 52 year old, female patient who felt bad for three days after the vaccine [PT: feeling abnormal] and swollen lymph nodes under her arm [PT: lymphadenopathy] while receiving Enbrel with Single Dose Prefilled Syringe. No historical medical condition was reported. The patient's current medical condition included ankylosing spondylitis. No concomitant medications were provided. The patient's co-suspect medication included COVID-19 Vaccine. The patient began Enbrel with Single Dose Prefilled Syringe on an unknown date. On 06Mar2021, the patient withheld Enbrel and received the COVID-19 vaccine on 07Mar2021. In Mar2021, the patient stated she felt bad for three days after the vaccine and had a swollen lymph nodes under her arm for approximately two days. This has improved and she will resume Enbrel today. No treatment information was received. The outcome of the events feeling abnormal and lymphadenopathy was reported as recovered/resolved. The events feeling abnormal and lymphadenopathy was resolved on an unknown date in Mar2021. The causal relationship between the events feeling abnormal, lymphadenopathy and Enbrel with Single Dose Prefilled Syringe was not provided by the consumer. The reporter did not and would never have access to lot number. Follow up has been requested.  Follow-up (01Apr2021): This is a follow-up spontaneous report from a contactable consumer, based on information received by Pfizer (Manufacturer control number US-AMGEN-USASL2021040220).  ADDITIONAL INFORMATION RECEIVED ON 01Apr2021. In this follow up, the patient really felt bad/described as increased joint pain and exhaustion [PT: arthralgia, PT: fatigue] while receiving Enbrel with Single Dose Prefilled Autoinjector. On an unknown date in Mar2021, the patient switched from Enbrel with Single Dose Prefilled Syringe to Enbrel with Single Dose Prefilled Autoinjector due to an unspecified reason. Since an unknown date in Mar2021 last week and especially worse for the past three days, the patient really felt bad which was described as increased joint pain and exhaustion. On 01Apr2021, day of this report, the patient stated these symptoms were improving. No treatment information was received. The outcome of the events arthralgia and fatigue was reported as recovering/resolving. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events arthralgia and fatigue. The causal relationship between the events arthralgia, fatigue and Enbrel with Single Dose Prefilled Syringe was not provided by the consumer. The causal relationship between the events feeling abnormal, arthralgia, fatigue, lymphadenopathy and Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up is not required.  Follow-up (15Apr2021): This is a follow-up spontaneous report from a contactable consumer, based on information received by Pfizer (Manufacturer control number US-AMGEN-USASL2021040220).  ADDITIONAL INFORMATION RECEIVED ON 15Apr2021: Action taken with Enbrel, Single Dose Prefilled Autoinjector for the previously reported event arthralgia was updated to not applicable. In this follow up, it was reported that the patient had increased pain in joints [PT: arthralgia], fever [PT: pyrexia], eye pain [PT: eye pain], chills [PT: chills], headache and increased pain in joints [PT: headache] while receiving Enbrel, Single Dose Prefilled Autoinjector. On 09Apr2021, the patient held Enbrel for receiving second dose of COVID-19 (corona virus disease-2019). On 10Apr2021, the patient received the second dose of the COVID-19 (corona virus disease-2019) vaccination. After that on an unknown date in Apr2021, over the following three days she experienced fever, chills, eye pain, headache, increased pain in joints. Also she felt like she had a bad hangover. Additionally, the patient stated that these symptoms have currently improved. The patient would restart Enbrel tomorrow of this report. The outcome of the events pyrexia, eye pain, chills, and headache were reported as recovering/resolving. The causal relationship between the events pyrexia, eye pain, chills, headache and Enbrel with Single Dose Prefilled Syringe and Single Dose Prefilled Autoinjector was not provided by the consumer.  No follow-up attempts are possible. No further information is expected