Sex: F
Vaccine: RAB
Symptoms: Feeling abnormal, Incorrect route of product administration, Malaise, Pain in extremity, Viral titre
Clinical narrative: I'll just die, I really don't care anymore, I really don't; I've been sweating and h-huffing; Box that was room temperature; The patient got half a shot and they were supposed to give me two; You see all the white stuff at the bottom; She did it subcutaneous; Had a hole in my head; Have no energy to wash my hair or anything; Not feeling good; Blood pressure this morning was, let's see. It was 169 over 101, pulse 81; The patient was miserable/really scared and just not me; They weren't "venting" it and they weren't mixing it right and so that is why I skipped the 5th dose; They were giving it wrong/ they were foaming it and they were pulling it up with the diluent away from the freeze dried, using the wrong size needle/hald or in the bone; Third shot was spewed and therefore skipped; Deathly sick/ sick; Case reference number US-BN-2021-001604 is a spontaneous case report initially received on 12-Apr-2021 from a consumer via Med Communication (reference number: USBAV21-0155) and concerns a female patient of an unspecified age (over the age of 21).  The patient's medical history and concomitant medication details were not provided.   The patient's historical vaccine included unspecified rabies vaccine (approximately 15 years ago), with no adverse reaction.  On an unspecified date, a dog licked the patient's hand, the patient started to gag and the doctor gave her two shots of an unspecified vaccine, at an unknown dose, route of administration or anatomical location, for an unknown indication.   On an unspecified date in 2005, the patient had a series of unspecified shots, but the third shot was missed, as it was spewed, as reported (explicitly coded as 'Product dose omission issue'). After that, the fourth and fifth shot were done correctly.  On 31-Oct-2005, the patient had a dog bite and developed a big pink softball size circle on her right side of back and her legs were a little bit heavier than usual.  On an unspecified date in Dec-2005, the patient got a bat bite twice on her head and once on her shoe (also reported as in her hand), but the doctor could not see anything. The patient stated that the doctor didn't know that the bat bite could be seen so the patient got half of unspecified vaccine but was supposed to get two, as reported (explicitly coded as 'Incomplete dose administered'). The patient went down to the urgent clinic and received unspecified yellow mixture after which she felt deathly sick, as reported.  On an unspecified date, in February, five months later (as reported) and about a month and a half after bat bite, the patient was vaccinated with three shots (outside Hospital) at an unknown dose, route of administration or anatomical location, for an unknown indication. The box with vaccine was at room temperature (explicitly coded as 'Product storage error'), so the patient didn't know if it would work, and then the patient had two more shots and cleared up.  On 05-Jun-2020, the patient went to get a titer done.  On 22-Jun-2020, 17 days after, the result of titer was 2.74 (units not provided).   On 23-Jun-2020, the patient's letter was dated.  On an unspecified date in 2020, after inoculation, titer was 22, in orange line (as reported).  On an unspecified date in 2020, the patient was miserable after being attacked by raccoon and had to go on Abilify a little bit, because the shots weren't hanging in. The patient thought that she got half of a shot, as reported (explicitly coded as 'Incomplete dose administered') and the titer came back with the result of 13 (units not provided).   On 05-Jun-2020, the patient was vaccinated with the first shot of RabAvert vaccine (Inactivated Rabies Virus Vaccine; batch number: not provided) at an unknown dose, route of administration or anatomical location, for an unknown indication, and the patient stated it was very bad. * The shot looked funny and they did not release the pressure and she saw liquid in the bottom of the vial, as stated.*   *On 08-Jun-2020, the patient received the second dose of RabAvert vaccine (Inactivated Rabies Virus Vaccine; batch number: not provided) at an unknown dose, route of administration or anatomical location, for an unknown indication.*  *On 12-Jun-2020, the patient received the third dose of RabAvert vaccine (Inactivated Rabies Virus Vaccine; batch number: not provided) at an unknown dose, route of administration or anatomical location, for an unknown indication.*  *On 19-Jun-2020, the patient received the fourth dose of RabAvert vaccine (Inactivated Rabies Virus Vaccine; batch number: not provided) at an unknown dose, route of administration or anatomical location, for an unknown indication.*  After receiving four shots of a series, the patient's brother said that they were giving it wrong. They were not "venting" it and they weren't mixing it right and so that was why the patient skipped the fifth dose, as reported (explicitly coded as 'Product preparation error'). The patient's brother also stated that they weren't doing right, that they were foaming it and that they were pulling it up with the diluent away from the freeze dried, using the wrong sized, too long needle, (explicitly coded as 'Product administration error'). As reported, it was possible to see all the white stuff at the bottom (explicitly coded as 'Liquid product physical issue').  On an unspecified date, the patient stated that the last three doses were half or in the bone, she did not use the needles. The patient was supposed to receive five shots, but received only four. The patient read that if she had the five shots within a year, she would only need one booster. The girl came in with brown vials, they were huge and had brown stuff in it. The patient was told to get a titer and she responded that ''whoever she talked to said it takes too long and that she can't wait another three or four weeks, she wanted to have two boosters for the bat because she don't know if it was rabid, and for the raccoon she had one and she don't think that it was very good and she has been sweating and h-huffing''.  On an unspecified date in 2020, the patient thought that the titer after four shots was 16 IU/ml.   On 08-Jul-2020, the patient went to get a titer done.  On 24-Jul-2020, 11 days after, the result was 13.0 IU/ml.  On an unspecified date, reported as on 01-Apr-2021 or 02-Apr-2021, the patient had a problem, realizing that she had a hole in her head.  On an unspecified date in 2021, the patient was outside, and raccoon hit her on her leg and then on Saturday night the patient got nicked on the leg.   On 04-Apr-2021, also reported as on the holiday morning (day zero), the patient was vaccinated with booster dose of RabAvert (Inactivated Rabies Virus Vaccine; batch number: not provided) at an unknown dose, route of administration or anatomical location, for an animal bite. The patient stated that the vaccine looked like water with purple in it. It worked for a while.  On an unspecified date in 2021, the nurse brought in a box that was room temperature (explicitly coded as 'Product storage error'), and also brought in a box that was cold. The patient had one booster shot of RabAvert (Inactivated Rabies Virus Vaccine; batch number: not provided) on a day zero, but stated that 'she was not doing it right on day three, she screwed up' (as reported), so the patient went to the small urgent clinic. When she received the booster, the patient stated ''she did it subcutaneous, it wasn't a Rabavert syringe, it looked pretty watery just a tiny pink on the end'' (explicitly coded as 'Inappropriate route of vaccination'). The patient stated that she ''wasn't very happy with it'' and ''wasn't happy with the first one last year''. The patient stated that, at stage three, the girl was twisting it and not venting it. The patient went downstairs and gave up, felt overwhelmed and miserable. The patient did not know what to do. The patient's blood sugar came down and she gave two blood samples (as reported). The patient thought that it was for her doctor, she put one if for cholesterol, but it was for another doctor on the 21st, as reported. The patient's blood pressure that morning (as reported) was 169 over 101, 81 and then she didn't know if rabies infection had high blood pressure. The patient was tired of doing all the research. The emergency room doctor said that her titer last year was 13 (unites not provided) and that the patient had plenty of immunity and didn't need more than one shot of booster vaccine.   *On an unspecified date, the patient stated that her blood was from 1:30 until 3:00 at room temperature and that she thinks that they did not turned it in because it was supposed to go hospital. The patient said that someone wrote an 'L' and they were not being nice if they gave her a booster on 04-Apr and it was not any good and the patient still do not feel good and they won't give her another because she have had the series within the year. The patient stated that her legs still hurt.*  On an unspecified date in 2021, the patient was sick and was not feeling good, as reported.  On an unspecified date in 2021, today, this afternoon (as reported), it was Wednesday, 166 over 84, pulse 66. The patient had 190 pounds and 5 foot 6 (167.6 cm) so the patient stated that she does need to lose some weight. On holiday, the patient had 199 pounds. Earlier when the patient got home, blood pressure was 122 over 87, pulse 71.  On an unspecified date in 2021, the patient was really scared and just not ''me'', as reported. The patient stated that she would love to have a shot and have more energy. The patient had no energy to wash her hair or do anything. The patient added ''I'll just die, I really don't care anymore, I really don't''.  The event of 'feeling unwell' *was not resolved. * The outcome for all other events was not provided  The reporter assessed the events as non-serious. Causality assessment was not provided.  Additional information received on 12-Apr-2021 from a consumer via Med Communication (reference number: USBAV21-0156) included event details.  Additional information received on 13-Apr-2021 from a consumer via Med Communication (reference number: USBAV21-0157) included details for bat bite, vaccine administered and new reference numbers.  Additional information received on 16-Apr-2021 from a consumer via Med Communication (reference number: USBAV21-0164) included vaccine error details and new reference.  Additional information received on 16-Apr-2021 from a consumer via Med Communication (reference number: USBAV21-0165) included updated laboratory data, event details and new reference number.  Additional information received on 20-Apr-2021 from a consumer via Med Communication (reference number: USBAV21-0167) included additional event, updated laboratory data and new reference number.  All follow up information are blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information received from the consumer on 03-May-2021:  A year when third shot was missed, dog bite and bat bite added. Titer results updated and added. New laboratory results and events added.  Additional information received on 03-May-2021 from a consumer via Med Communication (reference number: USBAV21-0190) included additional event details and new reference.  Additional information received on 12-May-2021 from a consumer via Med Communication (reference number: USBAV21-0212) included additional event details and new reference.  Additional information received on 14-May-2021 from a consumer via Med Communication (reference number: USBAV21-0219) included additional event details, date of vaccination and new reference.  Additional information received on 18-May-2021 from a consumer via Med Communication (reference number: USBAV21-0223) included route of administration and new reference.  Additional information received on 19-May-2021 from a consumer via Med Communication (reference number: USBAV21-0227) included date of vaccination and new reference.  Follow up information received from the consumer via Med Communication (reference number: USBAV21-0226) on 19-May-2021:  All dates of vaccination in 2020 were provided and outcome for the event 'feeling unwell' was changed from 'Unknown' to 'Not recovered'.  Additional information received on 26-May-2021 from a consumer via Med Communication (reference number: USBAV21-0240) included new reference.; Reporter's Comments: Sickness, hypertension, negative thoughts and head injury are unlisted while malaise, feeling abnormal, asthenia, hyperhidrosis are listed for Rabipur according to the Datasheet v6. Product preparation error, product storage error, product administration error, product dose omission issue, incorrect dose administered, liquid product physical issue and incorrect route of product administration are listed by convention. Reportedly, the patient was bitten by various animals and received all three doses of RabAvert vaccine (2nd dose 3 days after the 1st dose and the 3rd dose 4 days after the 2nd). Eight days after the 3rd dose, the patient received the 4th dose of RabAvert. Patient also reported product preparation error, product storage error, product administration error, product dose omission issue, incorrect dose administered,  liquid product physical issue and incorrect route of product administration. Reportedly, after raccoon bite, patient was vaccinated with RabAvert vaccine and on an unspecified date developed sickness, hypertension, asthenia, negative thoughts, head injury, sweating, malaise and feeling abnormal. Limited information reported on exact start date of all events, medical history, concomitant medications, concurrent vaccinations, treatment given for the events and any further laboratory tests results. Due to lack of information, the causality is assessed as not related for all reported events. Case is non serious.; Sender's Comments: Sickness, hypertension, negative thoughts and head injury are unlisted while malaise, feeling abnormal, asthenia, hyperhidrosis are listed for Rabipur according to the Global Datasheet v6. Product preparation error, product storage error, product administration error, product dose omission issue, incorrect dose administered, liquid product physical issue and incorrect route of product administration are listed by convention. Reportedly, the patient was bitten by various animals and received all three doses of RabAvert vaccine (2nd dose 3 days after the 1st dose and the 3rd dose 4 days after the 2nd). Eight days after the 3rd dose, the patient received the 4th dose of RabAvert. Patient also reported product preparation error, product storage error, product administration error, product dose omission issue, incorrect dose administered,  liquid product physical issue and incorrect route of product administration. Reportedly, after raccoon bite, patient was vaccinated with RabAvert vaccine and on an unspecified date developed sickness, hypertension, asthenia, negative thoughts, head injury, sweating, malaise and feeling abnormal. Limited information reported on exact start date of all events, medical history, concomitant medications, concurrent vaccinations, treatment given for the events and any further laboratory tests results. Due to lack of information, the causality is assessed as not related for all reported events. Case is non serious.