Age: 44.0
Sex: F
Vaccine: FLU3, HEPAB, TDAP
Symptoms: Back pain, Bone pain
Clinical narrative: This spontaneous case, initially received from other non-health professional (reporting on herself) on 29-Jan-2018, concerning a 44-year-old, adult, female patient. On an unspecified date in 2009, the patient had received influenza vaccine for prophylaxis and developed pain, aches and sniffles after vaccination. The patient had no medical history and the current conditions were unknown. The patient's concomitant medications included vitamin D, vitamin B12, iron and probiotic, known as AMAZING GRASS RAW RESERVE (as reported). On 18-Jan-2018, the patient was administered FLUVIRIN (dose: reporter was not sure if received the full dose of 0.5 ml [as reported], route of administration: intramuscular, anatomical location: right deltoid, batch number: 179802P and expiry date: 31-May-2018). According to recent follow-up from VAERS, the suspect product was reported as INN flu vaccine which was previously coded to FLUVIRIN product with batch number which kept as it was. On the same day, the patient administered non-company suspect product BOOSTRIX (dose: 1 (first dose as reported), anatomical location: left arm, batch number: TF422 [as reported], expiry date: 31-Dec-2019 [Dec-2019 as reported] and route of administration: not reported) and TWINRIX (dose: 1 [first dose as reported], anatomical location: left arm, batch number: Z75Y2 (as reported), expiry date: 31-Mar-2020 [Mar-2020 as reported] and route of administration: not reported). On 22-Jan-2018, 4 days after vaccination, the patient complained of severe lower back pain. The patient also experienced bone pain. On an unspecified date, it was reported that, the patient went to physician and stated that the back pain was not muscular but pain in her bones. On 23-Jan-2018 and 24-Jan-2018, after 5 days of vaccination, the patient's condition was worsened (condition aggravated). The patient was treated with ALEVE and Epsom salt. On 25-Jan-2018 and 26-Jan-2018, the patient was stabilized. On 27-Jan-2018, the patient was a little bit better. On 29-Jan-2018, the patient's condition was again worsened due to low back pain. The patient's treatment measures associated with the event included heating the lower back, soaking with salts, stretching, massage, walking on the treadmill since the reporter felt better with walking and biking but still the patient was experiencing the issues. At the time of this report, the patient had not recovered from the events (severe lower back pain, bone pain and condition aggravated). The reporter considered this case as non-serious. The reporter considered the low back pain and bone pain to be possibly related to BOOSTRIX and TWINRIX. The patient's physician did not believe that the events were related to the vaccines. This case was linked to 201802743 due to same patient. Follow-up received from the reporter on 09-Mar-2018: The reporter confirmed that, the full dose (0.5 ml) was administered to the patient. The outcome of the events (back pain and condition aggravated) was changed from not recovered to recovering. Narrative was amended accordingly. Follow up retrieved from VAERS (VAERS ID: 736546), reported to VAERS by other non-health professional on 29-Jun-2018: The VAERS ID (736546) was added in the additional information. The patient's historical vaccine (influenza vaccine), concomitant medications (vitamin D, vitamin B12 and iron), the verbatim (low back pain) for the event back pain, the new adverse event (bone pain), the treatment drugs (ALEVE and Epsom salt) and treatment measures (stretching and massage) were added. The patient's current conditions were unknown. The brand name (BOOSTRIX and TWINRIX), anatomical location (left arm), batch number and expiry date for the co-suspects were updated. The outcome of the event for back pain and condition aggravated was changed from recovering to not recovered. Added reporter's comment. The narrative was amended accordingly.