Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Pain
Clinical narrative: she felt like she was dying; Hurting and aching all over the head and I am chilling; feeling bad; She had been in bed ever since (5:00PM on 20Jun2021); At about 9:00PM, on 20Jun2021, she got diarrhea and was up multiple times throughout the night; Hurting and aching all over the head and I am chilling; she had back issues; I get sick all night; Hurting and aching all over the head and I am chilling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021747928 (Pfizer).  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Jun2021 11:00 (Lot number: EW0172) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy multiple" (ongoing), notes: Verbatim: Allergy multiple; "Sinus infection", start date: 15Jun2021, stop date: 15Jun2021, notes: Verbatim: Sinus infection. Concomitant medication(s) included: AZITHROMYCIN taken for sinusitis, start date: 15Jun2021 (ongoing); TYLENOL taken for sinusitis, start date: 15Jun2021 (ongoing). The following information was reported: ILLNESS (non-serious) with onset 19Jun2021, outcome "unknown", described as "I get sick all night"; CHILLS (non-serious) with onset 20Jun2021 17:00, outcome "recovering", PAIN (non-serious) with onset 20Jun2021, outcome "recovering" and all described as "Hurting and aching all over the head and I am chilling"; HEADACHE (non-serious) with onset 19Jun2021, outcome "unknown", described as "Hurting and aching all over the head and I am chilling"; FEELING ABNORMAL (non-serious) with onset 20Jun2021 17:00, outcome "recovering", described as "feeling bad"; BEDRIDDEN (non-serious) with onset 20Jun2021 17:00, outcome "recovering", described as "She had been in bed ever since (5:00PM on 20Jun2021)"; DIARRHOEA (non-serious) with onset 20Jun2021 09:00, outcome "recovering", described as "At about 9:00PM, on 20Jun2021, she got diarrhea and was up multiple times throughout the night"; FEELING ABNORMAL (non-serious) with onset 21Jun2021 02:00, outcome "unknown", described as "she felt like she was dying"; BACK PAIN (non-serious) with onset 20Jun2021, outcome "unknown", described as "she had back issues". Therapeutic measures were taken as a result of pain, headache, back pain.  Additional information: Additional Context: Concern: Consumer stated, I got the shot Saturday and I get sick all night last night. Just hurting and aching all over the head and I am chilling, so I don't know. I still need the shot and how long does the side effects last? When probed for permission to probe, Consumer stated, I don't know if that kill me though. I want to know how long this is going to last. I was sick all night. Stated she will finish her Z-Pak tomorrow, 22Jun2021. Additional Information for Concomitant Products Tylenol: Stated her doctor gave her the prescription last Tuesday for a sinus infection along with the Z-Pak. She said the Tylenol 500mg was dispensed in a pharmacy bottle with no NDC, Lot & Expiry Date. Additional Information for Other Conditions: Reported she has had allergies for about 40 years, and has been getting allergy shots once a week, for about 10 years. No further details provided. Additional Context: Warm transfer from ## at Pfizer Medical Information, with a consumer who was reporting side effects from the Pfizer BioNTech COVID-19 Vaccine. stated the caller said she had her first Pfizer BioNTech COVID-19 Vaccine on Saturday, 19Jun2021. stated the caller said yesterday (20Jun2021) at 5:00PM, she started feeling bad, and getting chills, and had been in bed ever since. ### stated the caller said at 02:00AM, last night (21Jun2021), she felt like going to the Emergency Room because she felt like she was dying. stated the caller said she was aching allover her body and legs. stated the caller said she had diarrhea (which started at about 21:00, 20Jun2021), and was up multiple times throughout the night for the diarrhea. stated the caller said she had back issues and had taken her back pain medicine for her body aches, and her pain medicine did nothing to help her body aches. stated she did not ask the caller what specific pain medications she took, but she believed the caller stated she used Tylenol or Ibuprofen but was unsure if the caller used a prescription pain medication. Reviewed and clarified the transferring agents report details with the caller. Reported she was the only one (she knows) who got sick from the COVID-19 Vaccine. She stated she called Pfizer Medical Information to ask how long her side effects would last. Reported her right arm was not even sore (after getting her first Pfizer BioNTech COVID-19 Vaccine). Reported she had a bad back that she took pain medications for (clarified as Norco 5mg/325mg and Hysingla ER 60mg). She said her symptoms (all over body and leg aches) had improved a little, because she just took a little more medicine about an hour ago (clarified as Hysingla ER 60mg). Treatment: Reported yesterday (20Jun2021) at 6:00PM she took 1 Norco 5mg/325mg (Hydrocodone 5mg/Acetaminophen 325mg) tablet, and then another 1 Norco 5mg/325mg (Hydrocodone 5mg/Acetaminophen 325mg) tablet at 23:00 (on 20Jun2021). She said the Norco 5mg/325mg (Hydrocodone 5mg/Acetaminophen 325mg) tablets were dispensed in a pharmacy bottle with no NDC, Lot, and Expiry Date listed, and were prescribed every 6-8 hours, as needed, for her back pain. Reported she also took Tylenol 500mg tablets that were prescribed by her doctor on Tuesday (15Jun2021) for a sinus infection. She said the Tylenol 500mg tablet prescription was 1-2 tablets, as needed, every 6 hours, and was dispensed in a pharmacy bottle with no NDC, Lot & Expiry Date. Reported she took her regular, daily medicine, Hysingla ER 60mg once a day, which was a time-released, narcotic pain medication for her back pain. She said the Hysingla ER 60mg was dispensed in a pharmacy bottle, and did not have a NDC, Lot, and Expiry Date. She clarified she took her Hysingla ER 60mg about an hour ago, and felt the Hysingla ER 60mg was helping her body aches because she felt an improvement since taking the Hysingla ER 60mg, Reported she was hoping that her symptoms (since getting her first Pfizer BioNTech COVID-19 Vaccine) would only last for 12-24 hours. No further details provided. History of all previous immunization with the Pfizer vaccine considered as suspect: None Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Adverse Event (AE) Details: Provide the time of onset of AE(s): Adverse Event: Stated she started feeling bad, and getting chills, and had been in bed ever since. She said she was aching allover her body and legs. Time of Onset: (24-hour clock): 17:00, 20Jun2021. Adverse Event: She had diarrhea and was up multiple times throughout the night for the diarrhea. Time of Onset: (24-hour clock): 21:00, 20Jun2021. Adverse Event: She said at 2:00AM, last night (21Jun2021), she felt like going to the Emergency Room because she felt like she was dying. Time of Onset: (24-hour clock): 02:00, 21Jun2021. Did any AE(s) require a visit to: Emergency Room: No. Physician Office: No. Prior Vaccinations (within 4 weeks): None. Patients Medical History (including any illness at time of vaccination): Allergies (approximately 40 years), sinus infection (Onset Date: 15Jun2021). Relevant Tests: None. Reported she had taken her back pain medicine, Norco 5mg/325mg (Hydrocodone 5mg/Acetaminophen 325mg) tablet at 6:00PM and 11:00PM on 20Jun2021, as well as Tylenol 500mg (prescribed for a sinus infection) to treat her allover body and leg aches, and the Norco 5mg/325mg and Tylenol 500mg did nothing to help her body aches. Reported the Norco 5mg/325mg (Hydrocodone 5mg/Acetaminophen 325mg) tablets were dispensed in a pharmacy bottle with no NDC, Lot, and Expiry Date listed, and were prescribed every 6-8 hours, as needed, for her back pain. She said the Tylenol 500mg tablets were prescribed by her doctor on Tuesday (15Jun2021) for a sinus infection. She said the Tylenol 500mg tablet prescription was 1-2 tablets, as needed, every 6 hours. She said 20 Tylenol 500mg tablets were dispensed in a pharmacy bottle with no NDC, Lot & Expiry Date. Product strength and count size dispensed: Norco: 5mg/325mg, Tylenol: 500mg, 20 tablets/bottle. Is a sample of the product available to be returned, if requested (Y/N): Not provided Packaging sealed and intact? Dispensed in pharmacy bottles. Question: Caller is a 58-year-old female who received the first dose of the Pfizer Covid 19 vaccine on Saturday. Yesterday evening around 17:00 she began feeling bad and chilling. She has been in bed ever since. She is aching all over and having diarrhea. She has gotten up several times during the night because of the diarrhea. At 2am she felt like going to the the emergency room because she "felt like I was dying". How long will side effects last? "I hurt so bad my whole body and legs" She has back issues and has pain pills but nothing is easing it. Has Tylenol and Ibuprofen. "I can't take the pain. I'm Aching so bad. I don't know what to do."   Follow-up attempts are completed. No further information is expected.