Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, COVID-19, Headache, Musculoskeletal stiffness, Neck mass
Clinical narrative: Really bad stiff neck; lump in the neck/lymph node that is a lump in her neck above the collar bone on left side; body aches/Bones aching kind of like the beginning of COVID; headache; having a fever of 101F; Sick; This is a spontaneous report from a contactable consumer. This female consumer reported for herself that:  Serious: No  Patient characteristics:  Sex: Female  Reaction(s)/Event(s): MedDRA version for reaction/event term LLT: N/A Reaction/event in MedDRA terminology (LLT): Medical Information Potential AE  Drug(s) Information: Characterization of drug role: SUSPECT Proprietary medicinal product name: PFIZER-BIONTECH COVID-19 VACCINE   Active Substance Information Active Drug substance names: PFIZER-BIONTECH COVID-19 VACCINE    Narrative case summary and further information:  Case narrative: Originating AE Request: REQ-# Attachments: 1  Reporter Subtype: Patient  PQC Present: No AE Present: Yes  Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE  Question: Caller said she has been transferred from hospital and has reported the AEs (possible duplicate AE); Caller got the first dose of the Pfizer BioNTech COVID-19 vaccine on 25Jan2021 3:22PM in (State name). The next day (26Jan2021), she ended up having a fever of 101F, stiff neck, headache, lump in the neck, and body aches. Her fever broke the next day (27Jan2021) and the other symptoms slowly went away also that day.  She mentioned that she had COVID-19 in Jul. She got hospitalized because of pneumonia. She got discharged for that then 14 days later she was hospitalized again because of her high grade fever and collapsed left lung. She also mentioned that she has an autoimmune disease "immunoglobulin anemia" and she has infusions once a week with a medication called "Hiventa". She said that she came from a family of doctors and her uncle who is an immunologist recommended her to call Pfizer to see if we do have recommendations about taking the second dose of the Pfizer vaccine considering her conditions.  (This REQ pertains to her AEs after her first dose)  Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE  Question: Caller mentioned that she had COVID-19 in Jul. She got hospitalized because of pneumonia. She got discharged for that then 14 days later she was hospitalized again because of her high grade fever and collapsed left lung. She also mentioned that she has an autoimmune disease "immunoglobulin anemia" and she has infusions once a week with a medication called "Hiventa". She said that she came from a family of doctors and her uncle who is an immunologist recommended her to call Pfizer to see if we do have recommendations about taking the second dose of the Pfizer vaccine considering her conditions.  Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE  Question: Caller said her uncle who is an immunologist recommends her to go the Emergency Room if her fever breaks to 103F or higher because her lung might collapse. She wanted to know if Pfizer has any recommendations on that.  Follow-up (03Feb2021): This is a follow-up spontaneous report from a contactable consumer. This 60-year-old consumer reported for herself that:  Patient characteristics: Age at time of onset of reaction/event: 60 Age at time of onset of reaction/event (Unit): YEAR Weight (kg): 58.97 Height (cm): 164 Sex: Female  Relevant medical history and concurrent conditions: Structured information (Patient episode name): COVID-19 Patient Medical start date: Jul2020 Patient Medical comments: Verbatim: COVID-19    Relevant medical history and concurrent conditions: Patient Medical start date: 2013 Patient Medical continuing: Yes Patient Medical comments: Verbatim: Connective tissue disease    Relevant medical history and concurrent conditions: Structured information (Patient episode name): Gamma globulinemia Patient Medical start date: 2013 Patient Medical continuing: Yes Patient Medical comments: Verbatim: Gamma globulinemia  Relevant medical history and concurrent conditions: Patient Medical start date: 18Nov2020 Patient Medical continuing: No Patient Medical end date: 18Nov2020 Patient Medical comments: Verbatim: Bladder surgery  Relevant medical history and concurrent conditions: Structured information (Patient episode name): Pleurisy Patient Medical start date: 2016 Patient Medical continuing: No Patient Medical end date: 2016 Patient Medical comments: Verbatim: Pleurisy  Relevant medical history and concurrent conditions: Structured information (Patient episode name): Pneumonia Patient Medical comments: Verbatim: Pneumonia  Relevant medical history and concurrent conditions: Patient Medical start date: 2016 Patient Medical continuing: No Patient Medical end date: 2016 Patient Medical comments: Verbatim: West Nile Virus    Relevant medical history and concurrent conditions: Patient Medical start date: 2015 Patient Medical comments: Verbatim: Sick with all kinds of weird viruses    Reaction(s)/Event(s): Reaction/event as reported by primary source: Sick   Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: UNKNOWN  Reaction(s)/Event(s): Reaction/event as reported by primary source: Bones aching kind of like the beginning of COVID   Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED  Reaction(s)/Event(s): Reaction/event as reported by primary source: Really bad headache   Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED  Reaction(s)/Event(s): Reaction/event as reported by primary source: Fever   Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED  Reaction(s)/Event(s): Reaction/event as reported by primary source: Really bad stiff neck   Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED  Reaction(s)/Event(s): Reaction/event as reported by primary source: lymph node that is a lump in her neck above the collar bone on left side   Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: UNKNOWN  Results of tests and procedures for investigation of the patient: Date: Nov2020 Test: Bloodwork Result: Enlarged red blood cells   More information available (Y/N): No  Results of tests and procedures for investigation of the patient: Date: Jan2021 Test: Bloodwork Result: Normal   More information available (Y/N): No  Drug(s) Information: Characterization of drug role: SUSPECT Proprietary medicinal product name: Pfizer COVID-19 vaccine   Batch/lot number: EL9263   Dosage text: Unknown strength/volume/dose injection to left arm 15:22   Pharmaceutical form (Dosage form): Injection   Indication for use in the case: Vaccination Date of start of drug: 25Jan2021 Action(s) taken with drug: UNKNOWN  Drug(s) Information: Characterization of drug role: CONCOMITANT Proprietary medicinal product name: Hizentra   Dosage text: 9 grams subcutaneously once weekly   Indication for use in the case: Gamma globulinemia Date of start of drug: 2014  Narrative case summary and further information:  Case narrative:  Submitted by Call Centre 1 Ref: #; ININ: # Selected Report Type: Initial Patient Ethnicity: (Ethnicity withheld) Is the patient also the reporter? Yes Reporter type: Consumer or other non-health professional Reporter telephone: (Phone withheld)  Primary / Prescribing Healthcare Professional Info HCP name: Dr. (Name) HCP Occupation/Specialty: Primary Care Physician HCP postal address: (Address withheld) HCP telephone: (Phone withheld)  Dates for Sick: (From: Jan2021 To: Unknown) Dates for Bones aching kind of like the beginning of COVID: (From: Jan2021 To: Unknown) Dates for Really bad headache: (From: Jan2021 To: Unknown) Dates for Fever: (From: Jan2021 To: Unknown) Dates for Really bad stiff neck: (From: Jan2021 To: Unknown) Dates for lymph node that is a lump in her neck above the collar bone on left side: (From: Jan2021 To: Ongoing)  Is Pfizer COVID-19 Vaccine a Pfizer product? Yes Pfizer COVID-19 Vaccine manufacturer: Unspecified  Dates for Pfizer COVID-19 Vaccine: (Start: 25Jan2021 Stop: Unspecified)  NDC number of Pfizer COVID-19 Vaccine: Unknown Expiry Date of Pfizer COVID-19 Vaccine: Unknown  Other Products: Yes Dates for Concomitant Products Hizentra: (Start: 2014 Stop: Ongoing)  Patient History: Yes Patient history: COVID-19 (From: Jul2020 To: Unspecified) Additional Information for Other Conditions: Hospitalized in Jul2020 for this with double pneumonia, left lung collapsed. Because had double pneumonia and collapsed lung she has to see a Pulmonologist for another chest X-ray to see the damage that COVID has done. Patient history: Connective tissue disease (From: 2013 To: Ongoing) Patient history: Gamma globulinemia (From: 2013 To: Ongoing) Additional Information for Other Conditions: 2013 all her cells, everything collapsed: B cells, T cells, C cells were all below average; that's when they realized she had autoimmune disorder Gamma globulinemia and connective tissue disease. Patient history: Bladder surgery (From: 18Nov2020 To: 18Nov2020) Patient history: Pleurisy (From: 2016 To: 2016) Additional Information for Other Conditions: Thinks initially had this in 2016.Hospitalization related to this. Patient history: Pneumonia (From: Unspecified To: Unspecified) Additional Information for Other Conditions: Had pneumonia like 7 times so she is susceptible. Because of this history she has gotten the Pneumonia vaccine and Prevnar 13 vaccine. Prevnar 13 when she was too young, in her 50s like 4-5 years ago because had pneumonia so many times. Prevnar 13:Lot/NDC/Expiry: Unknown, does not have product. She thinks there is a Prevnar 23 now she will have to look into. Patient history: West Nile Virus (From: 2016 To: 2016) Additional Information for Other Conditions: Hospitalized for this. Patient history: Sick with all kinds of weird viruses (From: 2015 To: Unspecified) Additional Information for Other Conditions: Started getting sick a lot with all kinds of weird viruses that she was hospitalized for starting when she moved to (State name) around 2015  Investigation Assessment: Yes  Additional Context: This consumer was administered her first dose of Pfizer COVID-19 Vaccine 25Jan2021. She reported before she got Pfizer COVID-19 Vaccine she had history of COVID in Jul2020. After administered Pfizer COVID-19 Vaccine she initially started getting sick unknown date and time, but either around night of 25Jan2021 or 26Jan2021. Sick further described as: started with her bones aching kind of like the beginning of COVID, then really bad headache, then fever. She also had a really bad stiff neck that went away. Fever started at night she thinks 26Jan2021; Temperature reached 101 degrees Fahrenheit; by the next day when she woke up her fever broke. She still had a little bit of a headache. As the day went on all the sick symptoms went away. She still has a lymph node that is a lump in her neck above the collar bone on left side-that is the only thing still ongoing with unknown outcome. The bones aching kind of like the beginning of COVID felt like she did in the beginning when she had COVID in Jul2020. She recovered completely from all the other events on unknown dates. She is not sure if she should call her surgeon about the lymph node that is a lump in her neck. She thought it was kind of unusual to have that kind of a reaction to the first dose of Pfizer COVID-19 Vaccine; she called to ask if these events are normal with the first dose of the Pfizer COVID-19 Vaccine; and if there are recommendations regarding getting the second dose relative to these events.    Reporter: Email: Unknown. Primary: Email: Unknown. Pfizer COVID-19 Vaccine: NDC/Expiry: Unknown, this is not on the CDC vaccine record card she was given. Second dose is scheduled 15Feb2021 Unknown if dose will continue unchanged at this point Primary/Prescriber: Email: Unknown.  VACCINE SUPPLEMENTAL FORM: Patient Details: Patient Last Name: (Name) Patient First Name: (Name)  Address: (withheld) City: (withheld) State: (withheld) Zip Code: (withheld) Phone: (withheld) Patient Age at Time of Vaccination in Years: 60 Pfizer Suspect Vaccine and Vaccination Details: Vaccine Lot Number: EL9263 Vaccine Lot Expire Date: Unknown, not on CDC vaccine record card Time the Vaccination Was Given (24 hour clock): 15:22 Anatomical Location of Administration of Pfizer vaccine considered as suspect: Arm Left For US Only: Vaccination Facility Type: They turned a sports stadium parking lot into a vaccination center For US Only: Vaccine Administered at Military Facility?: No For US Only: Vaccination Facility Address: Facility Name: (withheld) Address: (withheld) City: (withheld) Zip Code: Unknown  State: (withheld) Phone: Unknown 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): None. Additional Vaccines Administered on Same Date of the Pfizer Suspect: Vaccines If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: None. Adverse Event (AE) Details: Provide the time of onset of AE(s): Adverse Event: Sick  Time of Onset (24-hour clock): Unknown Adverse Event: Bones aching kind of like the beginning of COVID Time of Onset (24-hour clock): Unknown Adverse Event: Really bad headache Time of Onset (24-hour clock): Unknown Adverse Event: Fever  Time of Onset (24-hour clock): Unknown Adverse Event: Really bad stiff neck Time of Onset (24-hour clock): Unknown Adverse Event: lymph node that is a lump in her neck above the collar bone on left side Time of Onset (24-hour clock): Unknown Did any AE(s) require a visit to: Emergency Room?: No  Physician Office?: No If the patient was hospitalized, how many days was the hospital stay?: Not applicable, not hospitalized. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. AE(s) following prior vaccinations: None. Patient's Medical History (including any illness at time of vaccination) Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: All relevant information documented in formal fields of other conditions. Family Medical History Relevant to AE(s): Father has heart disease; has a defibrillator; pacemaker and celiac disease. Cancer runs in her family. All of her sisters have had breast cancer, all of her cousins have had breast cancer, all 3 of her aunts died of breast cancer; and another aunt died of leukemia myeloma acute.  Relevant Tests: She takes care of herself and has mammograms. She had some bloodwork done in Nov2020 before bladder surgery, and that bloodwork showed enlarged red blood cells. They did follow up bloodwork in Jan2021 and everything came back normal with that bloodwork. Because cancer runs in her family so strongly she is under the care of a hematologist and cancer specialist. She has bloodwork done every 3 months because when providers looked at her history and hospital history her bloodwork is all over the place, up and down historically.  Is there a Product Complaint: Yes  Description of Product Complaint: This consumer was administered her first dose of Pfizer COVID-19 Vaccine 25Jan2021. She reported before she got Pfizer COVID-19 Vaccine she had history of COVID in Jul2020. After administered Pfizer COVID-19 Vaccine she initially started getting sick unknown date and time, but either around night of 25Jan2021 or 26Jan2021. Sick further described as: started with her bones aching kind of like the beginning of COVID, then really bad headache, then fever. She also had a really bad stiff neck that went away. Fever started at night she thinks 26Jan2021; Temperature reached 101 degrees Fahrenheit; by the next day when she woke up her fever broke. She still had a little bit of a headache. As the day went on all the sick symptoms went away. She still has a lymph node that is a lump in her neck above the collar bone on left side-that is the only thing still ongoing with unknown outcome. The bones aching kind of like the beginning of COVID felt like she did in the beginning when she had COVID in Jul2020.  Pfizer COVID-19 Vaccine: NDC/Expiry: Unknown, this is not on the CDC vaccine record card she was given.  Follow-up (13May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.