Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product preparation error, Pyrexia
Clinical narrative: Pretty ill for 48 hours; feeling a little faint like she is going to pass out if she stands up too fast/faintness; 102 F temp that wasn't brought down with Tylenol; Arm was insanely sore; lymphodema in armpit; pain in breast tissue; Severe anxiety/faintness and anxiety; Brain fog; Nausea; Loss of appetite; Swollen arm; Severe headache; Body ache; Extreme fatigue; Diarrhea; Slight cough; emotional distress; 8 days late on getting her period; Booster dose; Was mistakenly given 6 doses of the Covid vaccine/it was a full undiluted vial that she received/Advised her it is 0.45 mL undiluted in the vial; it was a full undiluted vial that she received/Advised her it is 0.45 mL undiluted in the vial; Was mistakenly given 6 doses of the Covid vaccine/it was a full undiluted vial that she received/Advised her it is 0.45 mL undiluted in the vial; This is a spontaneous report from a contactable other health care professional from a Pfizer sponsored program.  A 33-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: FF2590), via an unspecified route of administration, administered in Deltoid Left as dose 3 (booster), single on 28Oct2021 (at the age of 33-years-old) for covid-19 immunization. Medical history included high blood pressure. Concomitant medications included influenza vaccine (FLU VACCINE VII) taken for immunisation from 08Oct2021 to 08Oct2021 and Labetalol at 25 mg once daily taken for an unspecified indication from an unspecified start date and ongoing. Historical vaccine included patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on 21Jan2021 as dose 1, single (at the age of 33-years-old) (lot number: EL8982) and dose 2 via an unspecified route of administration on 11Feb2021 as dose 2, single (at the age of 33-years-old) (Lot number: EN6201) both taken for covid-19 immunization. The patient previously experienced known allergies to NSAIDS. On 28Oct2021, the patient was mistakenly given 6 doses of the covid vaccine, which was considered as a booster dose. On an unspecified date the patient experienced the events which was described as pretty ill for 48 hours, 102 f temp that wasn't brought down with tylenol, arm was insanely sore, lymphodema in armpit and pain in breast tissue, severe anxiety, brain fog, nausea, loss of appetite, swollen arm, severe headache, body ache, extreme fatigue, diarrhoea, slight cough and emotional distress. Patient visited emergency room regarding the events. Patient received treatment fever. The treating medication was Tylenol. The patient underwent lab tests and procedures which included body temperature resulted 102 fahrenheit on an unspecified date. Reporter reported the type of medication error as overdose and stage of medication error was at preparation and administration. On 08Nov2021, patient was doing much better physically. No new adverse events have occurred, and she has had a reduction in the previously reported physical symptoms no arm pain, no swollen lymph nodes, diarrhoea, fever, fatigue, or headache were resolved. The only adverse events still lingering were anxiety and reduction in appetite. She also felt a little faint like she was going to pass out if she stood up too fast and she finds fainting felt unusual since it would not be a blood pressure issue. She noticed charted 0.3 mL was administered, but she said recorded it wrong because it was a full undiluted vial that she received, and she asked for confirmation on how much vaccine was in an undiluted vial on unspecified date. Advised her it was 0.45 mL undiluted in the vial. She also mentioned that would be about 180 mcg of the mRNA ingredient and was asking for confirmation. On 15Nov2021, She reported she was doing ok, but still had the same lingering effects as she reported last week of anxiety, low appetite, and felt faint when she stood up. They were no better and no worse and stayed about the same. She also reported that she has been experiencing brain fog since the overdose event, which had also still bothered her. On 22Nov2021, She still had brain fog, and was now 8 days late on getting her period on unspecified date. She took a pregnancy test, and it was negative on unspecified date. She still had low appetite and faintness and anxiety. It was not getting worse, but also not getting better, and staying about at the same level. Therapeutic measures were taken as a result of pyrexia with tylenol. At the time of this report, the outcome of events felt faint, anxiety, brain fog, nausea, loss of appetite were not recovered and illness was recovering; the events pyrexia, pain in extremity, lymphoedema, severe headache, body ache, extreme fatigue, diarrhea were recovered; the outcome of events swollen arm, slight cough were unknown and all other events were not recovered.  No follow-up attempts were needed. No further information was expected.  Follow up (01Nov2021): This is a follow-up spontaneous report from a contactable nurse. This nurse reported in response to HCP telephonic follow-up activity which included that: new events, relevant medical history, concomitant drug, lab data and narrative was updated.  No follow-up attempts were needed. No further information was expected.  Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities. Additional information received on 08Nov2021, 15Nov2021 and 22Nov2021 from contactable nurse and consumer includes: Medical history, new events added, events outcome (not recovered to recovered), and narrative was updated with clinical information.  Follow-up attempts are completed. No further information is expected.