Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swollen arm/got the vaccine on her left arm and experienced swolleness on that arm; swollen, as well as the hand, not allowing her to put rings on/hands swelled up and are swollen to this day; her daughter experienced a miscarriage 2 days ago; first received the Johnson & Johnson's Janssen COVID-19 Vaccine last year, and received the Pfizer Covid 19 vaccine; first received the Johnson & Johnson's Janssen COVID-19 Vaccine last year, and received the Pfizer Covid 19 vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent (mother).  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Dec2021 (Batch/Lot number: unknown) at the age of 32 years (as reported) as dose 2 (booster), single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 14Dec2021, outcome "unknown" and all described as "first received the Johnson & Johnson's Janssen COVID-19 Vaccine last year, and received the Pfizer Covid 19 vaccine"; ABORTION SPONTANEOUS (medically significant) with onset 22Jan2022, outcome "unknown", described as "her daughter experienced a miscarriage 2 days ago"; VACCINATION SITE SWELLING (medically significant), outcome "not recovered", described as "swollen arm/got the vaccine on her left arm and experienced swolleness on that arm"; PERIPHERAL SWELLING (medically significant), outcome "not recovered", described as "swollen, as well as the hand, not allowing her to put rings on/hands swelled up and are swollen to this day". The patient underwent the following laboratory tests and procedures: blood test: negative, notes: daughter went to her regular doctor and they did Blood work and it was all perfect and said it can't be nothing. Clinical course: The mother states that her daughter got the vaccine on her left arm and experienced swolleness on that arm. The mother stated that her daughter was experiencing the swollen arm for 1 month now and was still experiencing it today. Reporter also stated that they discovered her daughter was pregnant 2 weeks after getting the Pfizer Covid 19 dose. Caller then states that her daughter experienced a miscarriage 2 days ago, which she later specified confirmed as 22Jan2022. Caller was asking if there was data regarding the prolonged swollen arm and on how long does it last. Furthermore, mother stated that since receiving the booster dose, the arm on which she (the daughter) received the vaccine has been swollen, as well as the hand, not allowing her to put rings on. Caller also states that daughter found out she was pregnant after receiving the Pfizer Covid vaccine booster, and since has suffered a miscarriage. Additionally, caller wants to know if the virus was injected into her daughter with the booster dose. It was relayed that the daughter experienced her hands swelled up and are swollen to this day. Mother was referred her to her medical provider. The mother did say she would like to report to the news media or something. Agent clarified that the mother was reporting a swollen arm where the vaccine was placed in her left arm. The mother states the arm that her daughter received the vaccine in, her hand is swelling up for over a month, she can't get rings on and she usually wears a size 5 and she was now wearing a size 6. Stated that the right hand was fine. States her daughter went to her regular doctor and they did blood work and it was all perfect and said it can't be nothing, it could be a reaction to the vaccine and it's been over a month and her hand was still swollen. Caller clarifies her daughter had a miscarriage on Saturday, 22Jan2022. Caller states she was concerned about the swelling, did it cause a blood clot, why was it so swollen. Caller states her daughter got J&J a year ago and that is out of her system by now. Caller relays she did got to her healthcare provider and blood tests were negative and they said the vaccine was the only thing. States the agent had nothing about hand swelling, that he stated it should be for 2 days. Caller states the only other question he (agent) couldn't answer was after the booster do they recommend a couple of weeks to get pregnant or time for not trying to get pregnant. States her daughter has gone to 2 different doctors and one said the vaccine caused the miscarriage and the other one said no it did not cause the miscarriage. States it depends on if they are pro vaccine and you will get 2 different opinions. Caller states she would like to know statistically have there been any complaints or data saying miscarriage after the vaccine. Caller is asking is it a virus going into the body with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.