Sex: M
Vaccine: RAB, TTOX
Symptoms: Pain in extremity, Palpitations, Peripheral swelling, Product dose omission issue, Rabies
Clinical narrative: The patient did not receive the fifth dose of RabAvert; Bit by a bat on 17-Aug-2022, first RabAvert dose on 19-Aug-2022; Headache; Skin issues: the arm were was given the second vaccination the skin broke out and it moved from the injection site and then moved from the elbow to the wrist like a rash and swelling; Skin issues: the arm were was given the second vaccination the skin broke out and it moved from the injection site and then moved from the elbow to the wrist like a rash and swelling; RabAvert was administered at a dose of 0.1 mL; Was coming down with rabies, still think might have the beginning of rabies or meningitis; Was coming down with rabies, still think might have the beginning of rabies or meningitis; Suspect the second vaccination, personally suspect it was tainted or not effective, might be in a situation not fully protected and vaccinated; Side effects are mainly stiffness in the neck and left shoulder, in the left arm too, started going to lower back, not just stiffness but also pain; Side effects are mainly stiffness in the neck and left shoulder, in the left arm too, started going to lower back, not just stiffness but also pain; Confusion; Muscular skeletal pain in the arms and shoulder; Pain in the arm and the neck and some heart palpitations; Pain in the arm and the neck and some heart palpitations; Pain in the arm and the neck and some heart palpitations; Not confused now just thinking slower; Skin issues: the arm were was given the second vaccination the skin broke out and it moved from the injection site and then moved from the elbow to the wrist like a rash and swelling; The patient's hand got swollen and bicep area; It was red below the injection site and the redness started travelling down the arm, passed the elbow; Around the elbow broke out with skin; It was red below the injection site and the redness started travelling down the arm, passed the elbow; Injection site rash; Frontal lobe discomfort; Body isn't tired, mind goes into state of like druggie, it comes like a brick wall, like I want to lay down and close my eyes, not physically tired, just mentally, attacks of extreme mental tiredness; Body isn't tired, mind goes into state of like druggie, it comes like a brick wall, like I want to lay down and close my eyes, not physically tired, just mentally, attacks of extreme mental tiredness; Eyesight fatigue; The discomfort is now in patient's neck, went up the left shoulder; Very tired like want to go to sleep; Case reference number US-BN-2022-002262 is a spontaneous case report initially received from a consumer (reference numbers: USBAV22-1591) on 01-Sep-2022 and concerns a 71-year-old male patient.  The patient's medical history included rapid heart rate.  The patient's concomitant medication included metoprolol tartrate (as reported, brand name unknown) and tamsulosin (as reported, brand name unknown).  On 17-Aug-2022, the patient was bitten by a bat.  On 19-Aug-2022, two days after the exposure, the patient was vaccinated with the first dose of RabAvert (batch number YRBA821A) administered intramuscularly, at a dose reported as 1.0 mL and as 0.1 mL (explicitly coded as 'vaccine underdose' and 'inappropriate schedule of vaccine administered'), in left deltoid for post-exposure treatment to rabies and with co-suspect immunoglobulin human anti-rabies vaccine (HRIG) (batch number not provided) at a dose of 1.9 mL, in right deltoid and at site, via unknown route of administration for unknown indication.  On 22-Aug-2022, three days after the first RabAvert dose, the patient was vaccinated with the second dose of RabAvert (batch number ARBA731A) administered intramuscularly at a dose reported as 1.0 mL and as 0.1 mL (explicitly coded as 'vaccine underdose'), in right deltoid. As reported, nothing happened after first and second RabAvert dose. On the same date, the patient experienced discomfort that was then in the patient's neck. As reported, it went up the patient's left shoulder. The patient was very tired like the patient wanted to go to sleep but the patient's body was not tired, the patient was not physically tired, just mentally, the patient's mind went into state like druggie (verbatim as reported) and it would come like a brick wall, like the patient wanted to lay down and close his eyes. The patient got attacks of extreme mental tiredness but the patient got nine hours of sleep. The patient developed eyesight fatigue.  *On an unspecified, an unknown amount of time after the first dose of RabAvert, the patient had skin issues in the arm the patient was given the second vaccination, the skin just broke out and it moved from the injection site and the moved from the elbow to the wrist like a rash and swelling.*  On 26-Aug-2022, seven days after the first dose, the patient was vaccinated with the third dose of RabAvert (batch number ARBA731A) administered intramuscularly in the left deltoid at a dose reported as 1.0 mL and as 0.1 mL (explicitly coded as 'vaccine underdose'), and with *booster dose* of co-suspect tetanus vaccine (brand name unknown; *also reported as with the second RabAvert dose (to be clarified)) administered in the right arm *at a dose of 0.5 mL* via unknown route of administration for unknown indication. As reported, after RabAvert vaccination, a nurse checked the patients blood pressure, below the injection site, it inflated once. On the same date, the patient was very tired, like he wanted to go to sleep and developed frontal lobe discomfort and injection site rash.   On 27-Aug-2022, eight days after the first RabAvert dose, reported as 24 hours after the third dose, the patient developed redness below the injection site which started travelling down the arm and passed the elbow, hand got swollen and bicep area, and around the elbow broke out with skin (verbatim as reported). As reported, blood pressure measurement after RabAvert administration per patient could have affected it because it stopped blood flow for a short period (verbatim as reported).   On 29-Aug-2022, on Monday afternoon, the patient was seen by the patient's doctor and was started on Benadryl (diphenhydramine) as treatment. As reported, it helped but temporarily and no laboratory tests were performed.  *On an unspecified date, reported as after rabies vaccine, the patient was having headache, confusion, and muscular skeletal pain in the arms and shoulder.*  On 02-Sep-2022, 14 days after the first RabAvert dose, the patient was vaccinated with the fourth dose of RabAvert (batch number YRBA****, as reported), at an unknown dose, in right deltoid via unknown route of administration.   *On an unspecified date, reported as after the fourth RabAvert dose, events 'skin issues: the arm were was given the second vaccination the skin broke out and it moved from the injection site and then moved from the elbow to the wrist like a rash and swelling' were considered as resolved. As also reported, the fourth RabAvert dose attenuated the problem the patient was having with the second dose.*  On 08-Sep-2022, the patient recovered from the events 'erythema' and 'peripheral swelling'. As reported, by 08-Sep-2022 rash was reduced.  As reported, the patient had not received the fifth RabAvert dose and had no plans to administer the fifth RabAvert dose (*explicitly coded as 'incomplete course of vaccination'*). As also reported, doctors declined to do a serum test, *the titer, the blood titer to check the immune response, the patient went to the doctor but they ignored the patient's symptoms, and the hospital would not give the patient the fifth dose*.  On 25-Sep-2022, skin tone was normal and event 'rash' was considered as resolved.  *On an unspecified date, reported as after the fourth RabAvert vaccination, headache and muscular skeletal pain went away and the events were considered as resolved.*  *On an unspecified date, reported as after a few months, confusion disappeared and the event was considered as resolved.*  On 31-Oct-2022, the patient recovered from the events 'somnolence', 'frontal lobe discomfort' and 'fatigue', experienced significant relief and event mental fatigue was considered as resolving as it was reported the patient mostly recovered.   *On an unspecified date, reported as a month prior to stiffness in the neck and left shoulder, the patient experienced stiffness in the left arm as well.*   *On an unspecified date, an unknown amount of time after the first dose of RabAvert, the patient developed side effects which were mainly stiffness in the neck and left shoulder.*  *On an unspecified date, reported as for ten days and after rabies vaccine, for the first time stiffness started going to the patient's lower back which the patient had never experienced previously and the patient experienced pain with the stiffness.* *As reported, the patient exercised everyday except on Sundays.*  *On an unspecified date, the patient was not confused just was thinking slower. As reported, the patient made a mistake as an electrical engineer which cost the patient 1000 dollars in damages.*  *On an unspecified date, the patient said that the patient was coming down with rabies and requested the fifth dose but they would not do it.*  *On an unspecified date, the patient had pain in the arm and the neck and some heart palpitations. The patient was put on a heart monitor for two weeks when the pain started as the patient thought it could be a cardiac issue. As reported, the heart thing was ruled out but the patient still thought the patient might have the beginning of rabies or meningitis.*  *As reported, the patient personally suspected the second vaccination was tainted or not effective and that the patient might be in a situation the patient was not fully protected and vaccinated (explicitly coded as 'drug ineffective').*  *At the time of this follow up report, the outcome of the events 'meningitis', 'rabies', 'injection site redness' (27-Aug-2022), 'stiffness', 'pain', 'the discomfort is now in patient's neck, went up the left shoulder', 'pain in arm', 'pain neck', 'palpitations' was unknown, outcome of the event 'drug ineffective' was reported as unknown, event 'eyesight fatigue' was ongoing, and event 'mental fatigue' was resolving.  As reported, the patient still had symptoms that the patient never had in his life.*  The reporter did not provide seriousness and causality assessment for the events 'frontal lobe discomfort', 'eyesight fatigue', *'drug ineffective', 'meningitis' and 'rabies'* but assessed all other reported events as related to RabAvert vaccination. The reporter assessed the events 'it was red below the injection site and the redness started travelling down the arm, passed the elbow', 'hand got swollen and bicep area', 'around the elbow broke out with skin' as non-serious and did not provide seriousness assessment for all other reported events.  Additional information received on 02-Sep-2022 included local case ID.  Additional information received from consumer (reference number: USBAV22-1591) on 30-Sep-2022 included the fourth dose of RabAvert and additional events and is blended into the case narrative above.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from consumer on 08-Dec-2022 included patient's date of birth, concomitant medication, batch numbers and anatomical location for administered vaccines, date of administration for fourth dose, information that fifth dose was not administered, onset, cessation dates and outcome for reported events. New events 'asthenopia' and 'head discomfort' were added. New event special situation 'product dose omission issue' was added.   Follow up information received from the consumer (reference number: USBAV23-0441) on 22-Mar-2023: New information included dosage information for tetanus vaccine, additional details, new non-serious AE 'not confused now just thinking slower', 'pain in the arm and the neck and some heart palpitations' and 'skin issues: the arm were was given the second vaccination the skin broke out and it moved from the injection site and then moved from the elbow to the wrist like a rash and swelling' and new SAEs 'was coming down with rabies, still think might have the beginning of rabies or meningitis'. Confirmation that the patient did not receive fifth dose of RabAvert which led to recoding of a non-event was provided.; Reporter's Comments: A 71-year-old male patient was bitten by a bat. Two days later, the patient received the first dose of RabAvert, intramuscular, 0.1 mL, which is considered vaccine underdose and inappropriate schedule of vaccine administered, and 1.9 mL of HRIG as post-exposure prophylaxis. On day 3, the patient received the second dose of RabAvert administered intramuscularly at a dose reported as 1.0 mL and as 0.1 mL, which is considered as vaccine underdose. On the same date, the patient experienced discomfort that was then in the patient's neck. As reported, it went up the patient's left shoulder. The patient was very tired like the patient wanted to go to sleep but the patient's body was not tired, the patient was not physically tired, just mentally, the patient's mind went into state like druggie and it would come like a brick wall, like the patient wanted to lay down and close his eyes. The patient got attacks of extreme mental tiredness, but the patient got nine hours of sleep. The patient developed eyesight fatigue. On an unspecified, an unknown amount of time after the first dose of RabAvert, the patient had skin issues in the arm the patient was given the second vaccination, the skin just broke out and it moved from the injection site and the moved from the elbow to the wrist like a rash and swelling. On day 7, the patient received the third dose of RabAvert, applied in the left arm, administered intramuscularly in the left deltoid at a dose reported as 1.0 mL and as 0.1 mL, which is considered as vaccine underdose as well as co-suspect Tetanus shot in the right arm. On the same date, at unknown amount of time after the vaccination, the patient was still very tired, like he wanted to go to sleep and developed frontal lobe discomfort. The patient also developed injection site rash. Reportedly, 24h after the third dose, the patient developed redness below the injection site which started travelling down the arm and passed the elbow, hand got swollen and bicep area, and around the elbow broke out with skin. The patient started treatment with Benadryl which helped but temporarily. On the day 14 after the first dose, the patient was vaccinated with the fourth dose of RabAvert. Reportedly, the patient did not receive the fifth dose of RabAvert and had no plans to administer it, which is considered as incomplete course of vaccination. On an unspecified date, reported as a month prior to stiffness in the neck and left shoulder, the patient experienced stiffness in the left arm as well. Also, an unknown amount of time after the first dose of RabAvert, the patient developed side effects which were mainly stiffness in the neck and left shoulder. On an unspecified date, reported as for ten days and after rabies vaccine, for the first time stiffness started going to the patient's lower back which the patient had never experienced previously and the patient experienced pain with the stiffness. Also, on an unspecified date, the patient said that the patient was coming down with rabies (medical significance) and requested the fifth dose but they would not do it. On an unspecified date, the patient had pain in the arm and the neck and some heart palpitations. The patient was put on a heart monitor for two weeks when the pain started as the patient thought it could be a cardiac issue. As reported, the heart thing was ruled out, but the patient still thought the patient might have the beginning of rabies or meningitis (medical significance). As reported, the patient personally suspected the second vaccination was tainted or not effective and that the patient might be in a situation the patient was not fully protected and vaccinated, which is considered as drug ineffective (medical significance). Erythema, rabies, meningitis, musculoskeletal stiffness, pain, confusional state, musculoskeletal pain, pain in extremity, neck pain, palpitations, bradyphrenia, swelling, sleepiness, mental fatigue, head discomfort and asthenopia are unlisted, whereas neck discomfort, rash, fatigue, headache, injection site rash and injection site erythema are listed per summary for RabAvert. Peripheral swelling is listed but unlisted per summary. Vaccine underdose, incomplete course of vaccination, drug ineffective and inappropriate schedule of product administration are listed per company convention. The patient's medical history included rapid heart rate, and concomitant medication included metoprolol tartrate and tamsulosin. Considering the nature of the events and since the vaccine is inactivated, the events of rabies and meningitis have been considered as not related to the suspect vaccine. Based on the plausible temporal relationship, a causal relationship cannot be ruled out, hence the rest of the events are conservatively assessed as related to RabAvert. Underdose, incomplete course of vaccination and inappropriate schedule of product administration are assessed not related to RabAvert, but to human factor.; Sender's Comments: A 71-year-old male patient was bitten by a bat. Two days later, the patient received the first dose of RabAvert, intramuscular, 0.1 mL, which is considered vaccine underdose and inappropriate schedule of vaccine administered, and 1.9 mL of HRIG as post-exposure prophylaxis. On day 3, the patient received the second dose of RabAvert administered intramuscularly at a dose reported as 1.0 mL and as 0.1 mL, which is considered as vaccine underdose. On the same date, the patient experienced discomfort that was then in the patient's neck. As reported, it went up the patient's left shoulder. The patient was very tired like the patient wanted to go to sleep but the patient's body was not tired, the patient was not physically tired, just mentally, the patient's mind went into state like druggie and it would come like a brick wall, like the patient wanted to lay down and close his eyes. The patient got attacks of extreme mental tiredness, but the patient got nine hours of sleep. The patient developed eyesight fatigue. On an unspecified, an unknown amount of time after the first dose of RabAvert, the patient had skin issues in the arm the patient was given the second vaccination, the skin just broke out and it moved from the injection site and the moved from the elbow to the wrist like a rash and swelling. On day 7, the patient received the third dose of RabAvert, applied in the left arm, administered intramuscularly in the left deltoid at a dose reported as 1.0 mL and as 0.1 mL, which is considered as vaccine underdose as well as co-suspect Tetanus shot in the right arm. On the same date, at unknown amount of time after the vaccination, the patient was still very tired, like he wanted to go to sleep and developed frontal lobe discomfort. The patient also developed injection site rash. Reportedly, 24h after the third dose, the patient developed redness below the injection site which started travelling down the arm and passed the elbow, hand got swollen and bicep area, and around the elbow broke out with skin. The patient started treatment with Benadryl which helped but temporarily. On the day 14 after the first dose, the patient was vaccinated with the fourth dose of RabAvert. Reportedly, the patient did not receive the fifth dose of RabAvert and had no plans to administer it, which is considered as incomplete course of vaccination. On an unspecified date, reported as a month prior to stiffness in the neck and left shoulder, the patient experienced stiffness in the left arm as well. Also, an unknown amount of time after the first dose of RabAvert, the patient developed side effects which were mainly stiffness in the neck and left shoulder. On an unspecified date, reported as for ten days and after rabies vaccine, for the first time stiffness started going to the patient's lower back which the patient had never experienced previously and the patient experienced pain with the stiffness. Also, on an unspecified date, the patient said that the patient was coming down with rabies (medical significance) and requested the fifth dose but they would not do it. On an unspecified date, the patient had pain in the arm and the neck and some heart palpitations. The patient was put on a heart monitor for two weeks when the pain started as the patient thought it could be a cardiac issue. As reported, the heart thing was ruled out, but the patient still thought the patient might have the beginning of rabies or meningitis (medical significance). As reported, the patient personally suspected the second vaccination was tainted or not effective and that the patient might be in a situation the patient was not fully protected and vaccinated, which is considered as drug ineffective (medical significance). Erythema, rabies, meningitis, musculoskeletal stiffness, pain, confusional state, musculoskeletal pain, pain in extremity, neck pain, palpitations, bradyphrenia, swelling, sleepiness, mental fatigue, head discomfort and asthenopia are unlisted, whereas neck discomfort, rash, fatigue, headache, injection site rash and injection site erythema are listed for RabAvert. Peripheral swelling is listed. Vaccine underdose, incomplete course of vaccination, drug ineffective and inappropriate schedule of product administration are listed per company convention. The patient's medical history included rapid heart rate, and concomitant medication included metoprolol tartrate and tamsulosin. Considering the nature of the events and since the vaccine is inactivated, the events of rabies and meningitis have been considered as not related to the suspect vaccine. Based on the plausible temporal relationship, a causal relationship cannot be ruled out, hence the rest of the events are conservatively assessed as related to RabAvert. Underdose, incomplete course of vaccination and inappropriate schedule of product administration are assessed not related to RabAvert, but to human factor.