Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Dizziness, Headache
Clinical narrative: pain in her left big toe, left ankle, left knee, & left hip; a rash on her left leg; Shingles rash started; nerve pain from Shingles; she started to feel a burning skin sensation on the left side of her thigh; Diarrhea; joint pain; heart palpitations; dizzy; Chills; Headache; Muscle pain; Fever; she had a shooting pain in her left leg; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0162), second dose via intramuscular, administered in left arm on 17Apr2021 at 08:45 (at the age of 47-year-old) as dose 2, 0.3 ml single for COVID-19 immunisation; hydroxychloroquine (HYDROXYCHLOROQUINE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) and ongoing, at 200 mg, 2x/day for Sjogren's syndrome. Medical history included Sjogren's syndrome from Sep2020 and ongoing Sjogren's disease took Hydroxychloroquine (or Plaquenil) 200mg, twice a day, palpitations from Dec2020 and ongoing, hypertension from Dec2020 and ongoing, hypersensitivity from an unknown date and unknown if ongoing she took 1 Allegra daily for seasonal allergies for 7 to 8 years. No concomitant medications were not reported. Report is not related to a study or programme. No investigation assessment was reported. Vaccine was not administered at military facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines on same date COVID vaccine was administrated. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8730, Expiration Date: Jul2021), first dose via unspecified route of administration on 27-MAR-2021 (at the age of 47-year-old) as dose 1, single for COVID-19 immunisation and experienced she wasn't feeling well, High blood pressure and Palpitations. It was reported that caller stated she wanted to report side effects for the COVID-19 Vaccine. She said she had an autoimmune disease, and her rheumatologist wanted her to get the COVID-19 Vaccine, as soon as possible. Reported she had her first COVID-19 Vaccine in her left arm on 27Mar2021, providing Pfizer Lot Number: ER8730 and Expiration Date: Jul2021. She said she had her second COVID-19 Vaccine in her left arm on 17Apr2021 at 8:45, providing Pfizer Lot Number: EW0162. She said she did not have expiration date for the second COVID-19 vaccine dose, or the vaccine NDC Number. Reported she saw her rheumatologist this morning, and her rheumatologist traced back her symptoms to the date she received her second COVID-19 Vaccine dose. She said after she received her second COVID-19 Vaccine dose on 17Apr2021, she started to feel severe joint pain on 23Apr2021. She said she thought she had gout and contacted her rheumatologist. She said on 26Apr2021, she started to feel a burning skin sensation on the left side of her thigh. She said she waited a couple days, and on Sunday (02May2021), she woke up with Shingles. She said her doctor told her the Shingles might be related to the COVID-19 Vaccine because after her second COVID-19 Vaccine dose, all of sudden, she was not feeling too well, and her symptoms were bad. She said her doctor prescribed her Shingles medication. Reported Shingles was pretty painful. She said she had severe pain while taking a shower when the water drops hit her skin. She said she experienced that severe pain (clarified as a burning sensation) before she had the Shingles rash. She clarified on 26Apr2021 she had a burning sensation start, and the burning sensation was killing her when she took a shower, and when she was wearing a dress. She said she did not email her doctor until 28Apr2021 that something was not quite right. She said on Sunday (02May2021), the burning sensation improved, and then she saw a rash on her left leg, and the Shingles rash started. She said when she talked with her doctor today (03May2021), her doctor confirmed she had Shingles. She said at first, she thought what she was experiencing was Lupus because of her recent Sjogren's disease diagnosis (in Sep2020). Reported she had been contacting her rheumatologist because she had discomfort and this and that. She said her rheumatologist traced down her symptoms to her second COVID-19 Vaccine dose. She said she had problems with her left side, and her rheumatologist said the second COVID-19 Vaccine dose triggered the problems. Reported after she had her first COVID-19 Vaccine dose, she experienced heart palpitations. She said the COVID-19 Vaccine facility called paramedics or EMTs. She said her blood pressure increased too, but she didn't remember what her blood pressure readings were because she wasn't feeling well. She clarified she had a previous problem with palpitations and high blood pressure before the COVID-19 Vaccine. She said the paramedics or EMTs monitored her for a whole hour, and then released her to the COVID-19 Vaccine facility staff, who monitored her for another 20 minutes. She said the paramedics or EMTs offered to take her to the hospital, but she said she would be OK. She said she took her heart palpitation medicine earlier that day (clarified as Metoprolol 25mg) and didn't take anything to treat the heart palpitations she experienced after her first COVID-19 Vaccine dose. She did not have her Metoprolol 25mg prescription to provide the NDC, Lot, and Expiration Date. Reported after her second COVID-19 Vaccine, she experienced the same issue with heart palpitations. She said the COVID-19 Vaccine facility wanted to call the paramedics or EMTs again, but she told them she didn't want that. She said her husband was with her at the time, so the COVID-19 Vaccine facility made her wait for 45 minutes. She said she was also dizzy and told the COVID-19 Vaccine facility she just wanted to go home and lie down. She said after she got home from her second COVID-19 Vaccine, she rested and was fine. Reported later in the day on 17Apr2021, she experienced all the COVID-19 Vaccine side effects listed on Pfizer's website. She clarified she had chills, headache, joint pain, muscle pain, fever, and diarrhea. Chills, Headache, Muscle pain, Fever, Diarrhea. Reported she took Tylenol Arthritis, and nothing for the diarrhea. She said she knew the diarrhea would stop eventually. She said she was at work and did not have the Tylenol Arthritis NDC, Lot, and Expiration Date. Reported she took Hydroxychloroquine (or Plaquenil) 200mg, twice a day, for Sjogren's Disease. She said the Hydroxychloroquine normally helped her joint pain pretty good, but this time, the Hydroxychloroquine didn't work for her joint pain. She said her joints were killing her, and the joint pain got worse, and worse, on her daily (Hydroxychloroquine 200mg) medication. She said the Hydroxychloroquine 200mg did not actually help. Reported she was at work and didn't have her Hydroxychloroquine 200mg prescription bottle to provide the NDC, Lot, and Expiration Date. Reported she first started Hydroxychloroquine 200mg, twice a day in Dec2020. She said she had severe palpitations at that time, so her rheumatologist put the Hydroxychloroquine 200mg on hold, and sent her to a cardiologist. She said she had been seeing the cardiologist since Dec2020. She clarified after the cardiologist did all his exams, he put her on Metoprolol 25mg, twice a day, to lower her heart rate, and blood pressure. She said she had been taking the Metoprolol 25mg since Feb2021, and did not have the NDC, Lot, and Expiration Date. She said she restarted the Hydroxychloroquine 200mg, twice a day, in Mar2021. Reported her doctor told her she prescribed an anti-viral, and she needed to pick-up her prescription from the pharmacy. She said she did not know the name of the anti-viral, and did not have the NDC, Lot, and Expiration Date. She said the doctor told her if her Shingles becomes too painful, she would prescribe something stronger for pain. No further details provided. Reported her doctor told her that part of the pain she had been experiencing since her second COVID-19 Vaccine could be nerve pain from Shingles. She said she had left side pain that had worsened. She said she had pain in her left big toe, left ankle, left knee, and left hip. She said she had a shooting pain in her left leg. Reported she took 1 Allegra daily for seasonal allergies for 7 to 8 years. She said she did not have her Allegra with her to provide the UPC/NDC, Lot, and Expiration Date. Caller asked if anyone else had reported getting Shingles after the second COVID-19 Vaccine. The caller was offered transfer to Pfizer Medical Information and declined. She said her doctor had told her yes, that others had reported getting Shingles after the COVID-19 Vaccine. She said her husband had also sent her an article of a few cases of people with autoimmune diseases that experienced Shingles. 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): COVID-19 Vaccine, Lot Number: ER8730, Expiry Date: Jul2021, Route: Intramuscular, Anatomical Location: Arm, Left, No. of Previous Doses: None, Date: 27Mar2021. Reported after her first COVID-19 Vaccine dose, she experienced heart palpitations. She said her blood pressure increased too, but she did not remember what her blood pressure readings were because she was not feeling well. She said after her second COVID-19 Vaccine, she experienced the same issue with heart palpitations. She said later in the day on 17Apr2021, she experienced all the COVID-19 Vaccine side effects listed on Pfizer's website. She clarified she had chills, headache, joint pain, muscle pain, fever, and diarrhea. She said after she received her second COVID-19 Vaccine dose on 17Apr2021, she started to feel severe joint pain on 23Apr2021. She said she thought she had gout and contacted her rheumatologist. She said on 26Apr2021, she started to feel a burning skin sensation on the left side of her thigh. She said on Sunday (02May2021), the burning sensation improved, and then she saw a rash on her left leg, and the Shingles rash started. She said when she talked with her doctor today (03May2021), her doctor confirmed she had Shingles. Patient reported she had severe joint pain after her second COVID-19 Vaccine. She said she took Hydroxychloroquine 200mg, twice a day, for Sjogren's Disease. She said the Hydroxychloroquine normally helped her joint pain pretty good, but this time, the Hydroxychloroquine did not work for her joint pain. She said her joints were killing her, and the joint pain got worse, and worse, on her daily Hydroxychloroquine 200mg medication. She said the Hydroxychloroquine 200mg did not actually help. Reported she was at work and did not have her Hydroxychloroquine 200mg prescription bottle to provide the NDC, Lot, and Expiration Date. Adverse event did not require a visit to emergency room but visited to physician office. No relevant tests were reported. The outcome of the events rash on her left leg, shingles rash, joint pain, she had a shooting pain in her left leg was not recovered. The outcome of the event she started to feel a burning skin sensation on the left side of her thigh was recovering. The outcome of the events nerve pain from shingles and pain in her left big toe, left ankle, left knee, & left hip was unknown. The outcome of the events heart palpitations, dizzy, chills, headache, muscle pain, fever and diarrhea were recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.