Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Muscle disorder, Muscle spasms, Musculoskeletal discomfort, Pain
Clinical narrative: his joints and his knee immediately was swollen; got sick; both of his legs have severe cramps and spasms of the muscles; numbing and spasms in his back and numbness in his lower extremities; is sore, achy and his hamstring is so maxed out from being cramped up all the time; until yesterday he was able to walk/ he cannot make it down the stairs without help; feels like a lava lamp where in his knee he feels fluid moving around and it is so painful; numbing and spasms in his back and numbness in his lower extremities; I can't go to work; My hamstring is hyperextended; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 26 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Oct2021 (Lot number: FF2589, Expiration Date: 31Dec2021) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "two herniated discs in his spine" (unspecified if ongoing), notes: Patient history: two herniated discs in his spine; "broken finger" (unspecified if ongoing), notes: As a kid, he had a regular thing of a broken finger; "car accident" (unspecified if ongoing), notes: car accident when he was a kid; "sports related spasms" (unspecified if ongoing), notes: sports related spasms. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, lot No.: FF2589 , expiry date: 31Dec2021, anatomical location: left arm), administration date: 15Sep2021, when the patient was 26 years old, for Covid-19 Immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset Oct2021, outcome "not recovered", described as "both of his legs have severe cramps and spasms of the muscles"; JOINT SWELLING (non-serious) with onset 06Oct2021, outcome "not recovered", described as "his joints and his knee immediately was swollen"; MUSCULOSKELETAL DISCOMFORT (non-serious), HYPOAESTHESIA (non-serious) all with onset 2021, outcome "unknown" and all described as "numbing and spasms in his back and numbness in his lower extremities"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "is sore, achy and his hamstring is so maxed out from being cramped up all the time"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "not recovered", described as "until yesterday he was able to walk/ he cannot make it down the stairs without help"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "feels like a lava lamp where in his knee he feels fluid moving around and it is so painful"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "I can't go to work"; MUSCLE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "My hamstring is hyperextended"; ILLNESS (non-serious) with onset 06Oct2021, outcome "unknown", described as "got sick".  Additional information:   PQC Present: No AE Present: Yes  PQC Details:   Product: COMIRNATY Question: Caller states he is calling about the Pfizer Covid Vaccine and had two of the Pfizer covid vaccines and took the vaccine in Oct2021 and immediately after taking it, they obviously tell you that you get soreness or sick or whatever and that is cool and regular vaccine stuff but he took the vaccine and his joints and his knee immediately was swollen and it has been pretty much like that ever since up until yesterday and he was able to walk and live life and work and literally both of his legs have severe cramps and spasms of the muscles and it is really horrible shit; states up until yesterday he was able to walk and is on his way to the hospital now and is sore, achy and his hamstring is so maxed out from being cramped up all the time and he cannot make it down the stairs without help and is not able to go to work and does not know anything and he was in good health and wanted to know if this is a common symptom or something rare and what to do before pursuing medical or legal assistance. Caller is aware that Pfizer unable to offer treatment recommendations or medical advice and is referred to his doctor. Callback made at 3:45pm 19Jan2022. Caller confirms he received the adult formulation. He states "this is really life changing. I can't go to work. I can't make it down the steps. I have to see an orthopedic doctor. My hamstring is hyperextended. You can see the muscle popping out and its been that way for two weeks. Caller says he has reported this to someone at Pfizer but he isn't sure if it was agent or not. 26 year old male.  Agent- potential duplicate AE with additional information. Response: Spoke from the PI: Table 2: Study 2 - Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose - Participants 16 Through 55 Years of Age - Reactogenicity Subset of the Safety Population. Stated swelling is not reported however joint pain is. Pfizer is unable to make treatment recommendations. Referred caller to HCP.  Product: COMIRNATY Question: Caller states he is calling about the Pfizer Covid Vaccine and had two of the Pfizer covid vaccines and took the vaccine in Oct2021 and immediately after taking it, they obviously tell you that you get soreness or sick or whatever and that is cool and regular vaccine stuff but he took the vaccine and his joints and his knee immediately was swollen and it has been pretty much like that ever since up until yesterday and he was able to walk and live life and work and literally both of his legs have severe cramps and spasms of the muscles and it is really horrible shit; states up until yesterday he was able to walk and is on his way to the hospital now and is sore, achy and his hamstring is so maxed out from being cramped up all the time and he cannot make it down the stairs without help and is not able to go to work and does not know anything and he was in good health and wanted to know if this is a common symptom or something rare and what to do before pursuing medical or legal assistance. Caller is aware that Pfizer unable to offer treatment recommendations or medical advice and is referred to his doctor. Callback made at 3:45pm 19Jan2022. Caller confirms he received the adult formulation. He states "this is really life changing. I can't go to work. I can't make it down the steps. I have to see an orthopedic doctor. My hamstring is hyperextended.  You can see the muscle popping out and its been that way for two weeks. Response: Spoke from the PI: Table 2: Study 2  Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose - Participants 16 Through 55 Years of Age - Reactogenicity Subset of the Safety Population.  Stated swelling is not reported however joint pain is. Pfizer is unable to make treatment recommendations.  Referred caller to HCP.  Apologized to caller.  Follow up (19Jan2022): This is a spontaneous follow-up report received from the contactable consumer (Patient). This male consumer (Patient) reported for himself that:  Updated Info- patient weight and RMH and vaccination facility address updated, new events  additional info: Is report related to a study or programme? No  Dates for his joints and his knee immediately was swollen: (From: Unspecified To: Unspecified) Reporter seriousness for his joints and his knee immediately was swollen: Unspecified  Dates for both of his legs have severe cramps and spasms of the muscles: (From: Unspecified To: Unspecified) Reporter seriousness for both of his legs have severe cramps and spasms of the muscles: Unspecified  Dates for is sore, achy and his hamstring is so maxed out from being cramped up all the time and he cannot make it down the stairs without help: (From: Unspecified To: Unspecified) Reporter seriousness for is sore, achy and his hamstring is so maxed out from being cramped up all the time and he cannot make it down the stairs without help: Unspecified  Dates for in his knee he feels fluid moving around and it is so painful: (From: Unspecified To: Unspecified) Reporter seriousness for in his knee he feels fluid moving around and it is so painful: Unspecified  Is Pfizer Covid vaccine a Pfizer product? Yes Pfizer Covid vaccine manufacturer: Unspecified Dates for Pfizer Covid vaccine: (Start: 15Sep2021 Stop: Unspecified) NDC number of Pfizer Covid vaccine: Unknown Why was the patient taking Pfizer Covid vaccine (Verbatim): 1st dose  Additional Context:  Caller states he is calling about the Pfizer Covid Vaccine and had two of the Pfizer covid vaccines and took the vaccine in Oct2021 and immediately after taking it, they obviously tell you that you get soreness or sick or whatever and that is cool and regular vaccine stuff but he took the vaccine and his joints and his knee immediately was swollen and it has been pretty much like that ever since up until yesterday and he was able to walk and live life and work and literally both of his legs have severe cramps and spasms of the muscles and it is really horrible stuff; states up until yesterday he was able to walk and is on his way to the hospital now and is sore, achy and his hamstring is so maxed out from being cramped up all the time and he cannot make it down the stairs without help and is not able to go to work and does not know anything and he was in good health and wanted to know if this is a common symptom or something rare and what to do before pursuing medical or legal assistance. Caller is aware that Pfizer unable to offer treatment recommendations or medical advice and is referred to his doctor.   Caller states he was told of the list of symptoms and this was definitely not on the list regarding his reported events and the list for sure was talking about rare heart disease or whatever comes from it like swelling and mucous and nobody said this to him about his reported events; states he literally feels like a lava lamp where in his knee he feels fluid moving around and it is so painful and he sleeps and wakes up to go to work and has done nothing physical and has had no injuries and got the Pfizer Covid vaccine and immediately got sick and swollen and cramps for the past few months.  Patient details: Caller states his height is 5'9'' or 5'10'' and declined to provide his ethnicity.  Reporter details: Caller states he is a pheresis technician and technically a phlebotomist and not a HCP and declined to provide his mailing address.  HCP information: Caller declined to provide HCP information and states he is headed to the hospital today.  Caller states he tried to ride it out but once he couldn't walk he wanted to report it and states he is trying his best to live his life and the only thing he put in his body was the Pfizer Covid vaccine.  Caller states he had the 1st dose of the Pfizer Covid vaccine on states the 2nd dose was administered on with the same lot and same expiry date and states his patient card has no NDC numbers written on it.  States the reported events were not until the 2-3 week gap between the 1st dose and the 2nd dose of the vaccine and that is when it hit him and he thought it was winter soreness where you get cold and it is common that you feel arthritis things but this is not like anything he has experienced and it is affecting a lot in his life to the point of numbing and spasms in his back and numbness in his lower extremities.  States the 1st dose of the Pfizer Covid vaccine was administered to his left arm in his non-dominant side and thinks his 2nd vaccine dose was administered to his right arm.  VACCINE SUPPLEMENTAL FORM  Time the Vaccination Was Given: 11:00am to 12:00pm  5. 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): Caller states he had the 1st dose of the Pfizer Covid vaccine on states the 2nd dose was administered on and states his patient card has no NDC numbers written on it.  6. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None  7. Adverse Event (AE) Details: Provide the time of onset of AE(s): Caller states he is calling about the Pfizer Covid Vaccine and had two of the Pfizer covid vaccines and took the vaccine in Oct2021 and immediately after taking it, they obviously tell you that you get soreness or sick or whatever and that is cool and regular vaccine stuff but he took the vaccine and his joints and his knee immediately was swollen and it has been pretty much like that ever since up until yesterday and he was able to walk and live life and work and literally both of his legs have severe cramps and spasms of the muscles and it is really horrible shit; states up until yesterday he was able to walk and is on his way to the hospital now and is sore, achy and his hamstring is so maxed out from being cramped up all the time and he cannot make it down the stairs without help and is not able to go to work and does not know anything and he was in good health and wanted to know if this is a common symptom or something rare and what to do before pursuing medical or legal assistance. Caller states he was told of the list of symptoms and this was definitely not on the list regarding his reported events and the list for sure was talking about rare heart disease or whatever comes from it like swelling and mucous and nobody said this to him about his reported events; states he literally feels like a lava lamp where in his knee he feels fluid moving around and it is so painful and he sleeps and wakes up to go to work and has done nothing physical and has had no injuries and got the Pfizer Covid vaccine and immediately got sick and swollen and cramps for the past few months.  8. Additional Information  Did any AE(s) require a visit to: Emergency Room? No; Physician Office? No; If Yes, which AE(s)? If the patient was hospitalized, how many days was the hospital stay?: n/a Hospital Name: n/a City, State:n/a  9. Prior Vaccinations (within 4 weeks): None 10. AE(s) following prior vaccinations: n/a 11. Patient's Medical History (including any illness at time of vaccination)? As a kid, he had a regular thing of a broken finger and had a car accident when he was a kid and has two herniated discs in his spine and was medically cleared for years for that and the only thing he has from that is discomfort slightly and he needs spinal adjustments and stretching and he is good; states he has sports related spasms and never had prolonged or elongated spasms for such an obscene amount of time and if he did not have to live to be a father he would have called a lot sooner but waited to the detriment of his life and thinks something is going on.  12. Family Medical History Relevant to AE(s): None 13. Relevant Tests: None   Caller states he has only had these two vaccines of the Pfizer Covid vaccine and the only other thing was that he got a tattoo and with that is a risk of infection and he got the tattoo and those are the only two types of needles that entered his body and he actually got the tattoo before he got the Pfizer Covid vaccine and the tattoo was in early Sep2021.   States up until now he is a typical rid out out type of person but it has been a few months now and knows it is not something he is healing from any day now and it is hurting up his life.  Follow-up attempts are completed. No further information is expected.   No follow-up attempts are possible. No further information is expected.