chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (PRIMARY SERIES COMPLETE), for COVID-19 IMMUNIZATION. The following information was reported: ALOPECIA (non-serious), outcome "not recovered", described as "Hair loss". Additional information: Consumer stated, "I wanted to report a side effect from the Pfizer vaccine (Clarified as Pfizer Covid Vaccine). I experienced hair loss two times with two vaccines and I am wondering if I tried another vaccine, if perhaps I would not experience that." When paraphrased the concern, consumer stated, "I have had it more than that but I know for certain two times it caused hair loss." Consumer stated, "I was not sure how many times it caused hair loss but there were two specific times that I knew that." Lab tests "No." Consumer stated, "One of them was Comirnaty 12 and that was the last one. EL9264." When clarified LOT# EL9264 for Comirnaty 12, consumer stated, "They do not have a LOT# on Comirnaty 12. It just says Comirnaty 12. That LOT# that I gave you was for a different shot." When clarified hair loss due to Covid vaccine/Booster shot/Comirnaty 12, consumer stated, "The booster shot."  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400197825 Same Reporter, Patient, AE/Different Product.;
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: Max/Low Temperature reached: 1.0 C or 34.3 F, for less than an hour with no reported adverse event; menquadfi was administered post excursion with no reported adverse event; Initial information received on 07-Jun-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old female patient (Patient 5) who had administered Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] after it was exposed to max/low temperature reached: 1.0 Celsius or 34.3 Fahrenheit for less than an hour due to human error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) for Prophylactic vaccination.  On 06-Jun-2024, the patient received 1X, total 0.5 ml of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (strength: standard, frequency: once, expiry date: 30-Mar-2026 and lot U7945BB) via intramuscular route in the right arm as immunization and was administered post excursion with no reported adverse event (poor quality product administered) (same day latency).  On an unknown date the max/low temperature reached: 1.0 ccelsus or 34.3 f for less than an hour due to human error with no reported adverse event (product storage error).  Human Error: Yes, the extended stability data does not cover the excursion.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 22.0
Sex: M
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: A patient was given YF-Vax that was reconstituted with sterile water instead of the Sanofi-provided diluent with no reported adverse event; Initial information received on 17-Jun-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 22 years old male patient who was given yellow fever vaccine - [YF-VAX] that was reconstituted with sterile water instead of the sanofi-provided diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP); polio vaccine inact (IPV) and Typhoid Vaccine all for Prophylactic vaccination.  On 05-Jun-2024, the patient received a dose of 0.5 ml of suspect yellow fever vaccine - (Solution for injection) (lot: UK032AB; expiry date: 31-Mar-2025) (strength unknown) that was reconstituted with sterile water instead of the sanofi-provided diluent with no reported adverse event (product preparation error) (latency: same day) via subcutaneous route in the right arm for Prophylactic Vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: dose of PENTACEL may have been administered in which the only the diluent was given, the dose may have not been reconstituted with the HIB component with no reported AE; Initial information received on 17-Jun-2024 regarding an unsolicited valid non-serious case received via pharmacist.  This case involves a 2-month-old female patient to whom dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] may have been administered in which the only the diluent was given, the dose may have not been reconstituted with the hib component with no reported ae (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 15-Jun-2024, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection (strength: unknown) (lot: UJ994AA, expiry date: 14-Mar-2024) via intramuscular route in the left thigh as Immunization and dose of pentacel may have been administered in which the only the diluent was given, the dose may have not been reconstituted with the hib component with no reported ae (product preparation error) (latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of pentacel was inadvertently administered to patient with no reported adverse event; Initial information received on 18-Jun-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 9 months old female patient where expired dose of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] was inadvertently administered to patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar) for Prophylactic vaccination.  On 18-Jun-2024, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Powder and suspension for suspension for injection (Strength = standard) (lot- UJ848AA and expiry date- 16-Apr-2024) via intramuscular route in the right thigh for Immunsation (expired product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: given a shingles vaccine that was accidentally frozen and then thawed prior to being administered; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: given a shingles vaccine that was accidentally frozen and then thawed prior to being administered). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 17-JUN-2024 The patient was given a Shingles vaccine that was accidentally frozen and then thawed prior to being administered, which led to incorrect storage of drug. This was not to report the patient had an adverse event, this was to report that the customer who called to report on this situation wanted safety information on this happening, called GSK directly and did not get information on how freezing the vaccine and then thawing it and then administering the vaccine would impact the patient.
Age: 49.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Axillary web syndrome, Induration, Tenderness
Clinical narrative: I felt cording in my armpit. It extends from about halfway down my bicep, across my armpit, and then around into my breast tissue. It's hard and painful when palpating.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site discolouration, Injection site pain, Injection site rash, Rash erythematous
Clinical narrative: Patient received HPV vaccine on 6/13/24, and a pink rash occurred at the injection site 3 days later. On 6/20/24, the rash at the injection site turned purple and is painful. Patient has tried ibuprofen and benadryl to help with reaction, but no improvement. Patient plans to see a provider on 6/26/24 if no improvement.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Cold sweat, Dizziness, Loss of consciousness, Pallor
Clinical narrative: Pt received vaccination, stepped into waiting room 1-2 minutes after receiving vaccine and sat next to FOP. FOP reports while sitting pt passed out for approx. 5 seconds. Pt returned to consciousness still sitting in chair. Pt was looking pale. Pt c/o dizziness, light headed, clammy.  Gave pt, water- 16-32 oz, pop rocks, and chips ahoy cookies. Took patients vital signs, and proceeded to get nurse/doctor.  Vitals signs: 1415 BP 56/29, HR 41, RR 14, Spo2 99% 1421 BP89/56, HR, 57, RR 16, Spo2 96%, 1426 BP 100/68, HR 64, RR 16, Spo2 96%, 1431 BP104/69, HR 50, RR 18, Spo2 98%, Final 1436 BP 105/69, HR 48, RR 18, Spo2 98%. Provider accessed pt and released when feeling better around 1440.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Fall, Immediate post-injection reaction, Nausea, Syncope, Vomiting
Clinical narrative: At 14:41 patient fainted immediately after administration of second vaccine Bexsero. Patient fell and hit head on floor. Patient regained consciousness immediately and was alert and oriented. Patient then experienced nausea and vomiting at 14:45.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Bursitis, C-reactive protein increased
Clinical narrative: Heel bursitis, joint pain, lower leg, weakness, lower back pain, hip pain. high CRP, cardiac lab levels.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: Heel bursitis, joint pain, lower leg, weakness, lower back pain, hip pain. high CRP, cardiac lab levels.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Redness/ swelling
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt started feeling itchy under the skin where the injection site is, visible bump was observed. Pt's right arm is red starting from the location of the injection to her elbow.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Abdominal pain, Conjunctivitis viral, Diarrhoea, Eye discharge, Pyrexia
Clinical narrative: One full week of fever (highest recorded 101.7 F rectal), bilateral viral conjunctivitis with bright green/yellow lacrimal exudate lasting 2 weeks, vomiting, diarrhea (no frank blood in stool) lasting over 1 week, painful abdomen (no palpable hardened region), excessive gas. Symptoms self-resolved.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: One full week of fever (highest recorded 101.7 F rectal), bilateral viral conjunctivitis with bright green/yellow lacrimal exudate lasting 2 weeks, vomiting, diarrhea (no frank blood in stool) lasting over 1 week, painful abdomen (no palpable hardened region), excessive gas. Symptoms self-resolved.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: atrial fibrillation (an erratic heartbeat); This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation (an erratic heartbeat)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation (an erratic heartbeat)) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation (an erratic heartbeat)) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   None of the allergy, concomitant diseases and risk factor were reported. The concomitant medication was not reported by reporter. Patient stated that he never had atrial fibrillation before until he got the shots. The treatment medication was not reported by reporter.  Company Comment: This is a spontaneous case concerning a male patient of unknown age, with no reported medical history, who experienced the serious (due to medically significant ) unexpected, AESI of Atrial fibrillation. The event occurred on an unknown data after the second dose of mRNA-1273 vaccine; the patient had received the first dose on 22-Mar-2021, and the second dose on 19-Apr-2021. Clinical course, supportive diagnostic procedures and treatment were not provided. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report
Age: 81.0
Sex: F
Vaccine: PNC20, PNC20, PNC20
Symptoms: Peripheral swelling
Clinical narrative: couldn't move her fingers up and down; her hand started to swell; have so much problems with my left hand; The initial case was missing the following minimum criteria: [unspecified product]. Upon receipt of follow-up information on [18Jun2024], this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP.  An 81-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 20Feb2024 as dose number unknown, single (Lot number: HL617Z) at the age of 81 years, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MOVEMENT DISORDER (non-serious) with onset 20Feb2024, outcome "recovering", described as "couldn't move her fingers up and down"; MUSCULOSKELETAL DISORDER (non-serious) with onset 20Feb2024, outcome "unknown", described as "have so much problems with my left hand"; PERIPHERAL SWELLING (non-serious) with onset 20Feb2024, outcome "unknown", described as "her hand started to swell". The events "couldn't move her fingers up and down", "her hand started to swell" and "have so much problems with my left hand" required physician office visit. Additional information: Caller went yesterday for a shot for pneumococcal and she went to her doctor and he said that she should get that vaccination. So she got the shot yesterday right away in her left arm and that was fine. But in the evening, afternoon, her hand started to swell and couldn't move her fingers up and down. So today, it is a little better but not 100 percent. She can move most of the things as down but cannot move them up so she was wondering if it is normal. The patient saw doctor on 23Feb2024.
Age: 81.0
Sex: F
Vaccine: PNC20, PNC20, PNC20
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: couldn't move her fingers up and down; her hand started to swell; have so much problems with my left hand; The initial case was missing the following minimum criteria: [unspecified product]. Upon receipt of follow-up information on [18Jun2024], this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP.  An 81-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 20Feb2024 as dose number unknown, single (Lot number: HL617Z) at the age of 81 years, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MOVEMENT DISORDER (non-serious) with onset 20Feb2024, outcome "recovering", described as "couldn't move her fingers up and down"; MUSCULOSKELETAL DISORDER (non-serious) with onset 20Feb2024, outcome "unknown", described as "have so much problems with my left hand"; PERIPHERAL SWELLING (non-serious) with onset 20Feb2024, outcome "unknown", described as "her hand started to swell". The events "couldn't move her fingers up and down", "her hand started to swell" and "have so much problems with my left hand" required physician office visit. Additional information: Caller went yesterday for a shot for pneumococcal and she went to her doctor and he said that she should get that vaccination. So she got the shot yesterday right away in her left arm and that was fine. But in the evening, afternoon, her hand started to swell and couldn't move her fingers up and down. So today, it is a little better but not 100 percent. She can move most of the things as down but cannot move them up so she was wondering if it is normal. The patient saw doctor on 23Feb2024.
Age: 81.0
Sex: F
Vaccine: PNC20, PNC20, PNC20
Symptoms: Mobility decreased, Peripheral swelling
Clinical narrative: couldn't move her fingers up and down; her hand started to swell; have so much problems with my left hand; The initial case was missing the following minimum criteria: [unspecified product]. Upon receipt of follow-up information on [18Jun2024], this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP.  An 81-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 20Feb2024 as dose number unknown, single (Lot number: HL617Z) at the age of 81 years, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MOVEMENT DISORDER (non-serious) with onset 20Feb2024, outcome "recovering", described as "couldn't move her fingers up and down"; MUSCULOSKELETAL DISORDER (non-serious) with onset 20Feb2024, outcome "unknown", described as "have so much problems with my left hand"; PERIPHERAL SWELLING (non-serious) with onset 20Feb2024, outcome "unknown", described as "her hand started to swell". The events "couldn't move her fingers up and down", "her hand started to swell" and "have so much problems with my left hand" required physician office visit. Additional information: Caller went yesterday for a shot for pneumococcal and she went to her doctor and he said that she should get that vaccination. So she got the shot yesterday right away in her left arm and that was fine. But in the evening, afternoon, her hand started to swell and couldn't move her fingers up and down. So today, it is a little better but not 100 percent. She can move most of the things as down but cannot move them up so she was wondering if it is normal. The patient saw doctor on 23Feb2024.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received MMR (Priorix) for prophylaxis.   On 18-JUN-2024, the patient received Priorix. On 18-JUN-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Expired vaccine administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-JUN-2024 RN Supervisor reported that Priorix vaccine was administer to a patient (unknow details) after the expiration date which led to expired vaccine used. No further details were available at the moment of the call.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Cough, Dysphonia, Dyspnoea, Electrocardiogram, Erythema
Clinical narrative: Vaccine given at 12:20 pm. Noted itchiness on shoulders, under ears, and on head around 12:40pm as well as bounding pulse in head. Went back to the pharmacist at 12:45pm who noted extreme redness in the face. Was given 25 mg PO Benadryl. Noted small patch of hives on right shoulder and on stomach at this time. At 12:55pm, pharmacist recommended going to urgent care after redness / itchiness did not seem to resolve. Also noted minor lip swelling and slight hoarse voice at this time. Left the pharmacy at 1:00pm for urgent care. However, during the drive, noted hives were spreading down both arms as well as redness and changed destination to the ER. Also noted increased itchiness going down both legs. Arrived at the ER at 1:15pm. Experienced a near syncopal episode with nausea walking into the ER but was resolved after sitting down. Noted hives were spreading down both legs at 1:20pm at which point the triage nurse brought me back. Noted tachycardia (HR 145); other vitals ok, and systemic red rash / hives. Around 1:30pm, was evaluated and had IV access. Was given 50 mg IV Benadryl, 40 mg IV Pepcid, and 125 mg IV Solu-Medrol. Following Solu-Medrol administration, experienced heat sensation, shortness of breath, and brief coughing spell (resolved after 10-15 seconds). Was given nebulized racemic epinephrine and albuterol. By 1:45pm, noted resolution in tachycardia and swelling in face. Continued to experience mild tightness in throat, redness in the face, and patchy rash on arms and legs over the next 2 hours. By the time of ER discharge at 4:15pm, only experiencing redness on knees and redness in face. Was prescribed a 3-day prednisone taper.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Feeling hot, Headache, Injection site pruritus, Lip swelling, Nausea
Clinical narrative: Vaccine given at 12:20 pm. Noted itchiness on shoulders, under ears, and on head around 12:40pm as well as bounding pulse in head. Went back to the pharmacist at 12:45pm who noted extreme redness in the face. Was given 25 mg PO Benadryl. Noted small patch of hives on right shoulder and on stomach at this time. At 12:55pm, pharmacist recommended going to urgent care after redness / itchiness did not seem to resolve. Also noted minor lip swelling and slight hoarse voice at this time. Left the pharmacy at 1:00pm for urgent care. However, during the drive, noted hives were spreading down both arms as well as redness and changed destination to the ER. Also noted increased itchiness going down both legs. Arrived at the ER at 1:15pm. Experienced a near syncopal episode with nausea walking into the ER but was resolved after sitting down. Noted hives were spreading down both legs at 1:20pm at which point the triage nurse brought me back. Noted tachycardia (HR 145); other vitals ok, and systemic red rash / hives. Around 1:30pm, was evaluated and had IV access. Was given 50 mg IV Benadryl, 40 mg IV Pepcid, and 125 mg IV Solu-Medrol. Following Solu-Medrol administration, experienced heat sensation, shortness of breath, and brief coughing spell (resolved after 10-15 seconds). Was given nebulized racemic epinephrine and albuterol. By 1:45pm, noted resolution in tachycardia and swelling in face. Continued to experience mild tightness in throat, redness in the face, and patchy rash on arms and legs over the next 2 hours. By the time of ER discharge at 4:15pm, only experiencing redness on knees and redness in face. Was prescribed a 3-day prednisone taper.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Presyncope, Pruritus, Rash, Rash erythematous, Swelling face
Clinical narrative: Vaccine given at 12:20 pm. Noted itchiness on shoulders, under ears, and on head around 12:40pm as well as bounding pulse in head. Went back to the pharmacist at 12:45pm who noted extreme redness in the face. Was given 25 mg PO Benadryl. Noted small patch of hives on right shoulder and on stomach at this time. At 12:55pm, pharmacist recommended going to urgent care after redness / itchiness did not seem to resolve. Also noted minor lip swelling and slight hoarse voice at this time. Left the pharmacy at 1:00pm for urgent care. However, during the drive, noted hives were spreading down both arms as well as redness and changed destination to the ER. Also noted increased itchiness going down both legs. Arrived at the ER at 1:15pm. Experienced a near syncopal episode with nausea walking into the ER but was resolved after sitting down. Noted hives were spreading down both legs at 1:20pm at which point the triage nurse brought me back. Noted tachycardia (HR 145); other vitals ok, and systemic red rash / hives. Around 1:30pm, was evaluated and had IV access. Was given 50 mg IV Benadryl, 40 mg IV Pepcid, and 125 mg IV Solu-Medrol. Following Solu-Medrol administration, experienced heat sensation, shortness of breath, and brief coughing spell (resolved after 10-15 seconds). Was given nebulized racemic epinephrine and albuterol. By 1:45pm, noted resolution in tachycardia and swelling in face. Continued to experience mild tightness in throat, redness in the face, and patchy rash on arms and legs over the next 2 hours. By the time of ER discharge at 4:15pm, only experiencing redness on knees and redness in face. Was prescribed a 3-day prednisone taper.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Tachycardia, Throat tightness, Urticaria
Clinical narrative: Vaccine given at 12:20 pm. Noted itchiness on shoulders, under ears, and on head around 12:40pm as well as bounding pulse in head. Went back to the pharmacist at 12:45pm who noted extreme redness in the face. Was given 25 mg PO Benadryl. Noted small patch of hives on right shoulder and on stomach at this time. At 12:55pm, pharmacist recommended going to urgent care after redness / itchiness did not seem to resolve. Also noted minor lip swelling and slight hoarse voice at this time. Left the pharmacy at 1:00pm for urgent care. However, during the drive, noted hives were spreading down both arms as well as redness and changed destination to the ER. Also noted increased itchiness going down both legs. Arrived at the ER at 1:15pm. Experienced a near syncopal episode with nausea walking into the ER but was resolved after sitting down. Noted hives were spreading down both legs at 1:20pm at which point the triage nurse brought me back. Noted tachycardia (HR 145); other vitals ok, and systemic red rash / hives. Around 1:30pm, was evaluated and had IV access. Was given 50 mg IV Benadryl, 40 mg IV Pepcid, and 125 mg IV Solu-Medrol. Following Solu-Medrol administration, experienced heat sensation, shortness of breath, and brief coughing spell (resolved after 10-15 seconds). Was given nebulized racemic epinephrine and albuterol. By 1:45pm, noted resolution in tachycardia and swelling in face. Continued to experience mild tightness in throat, redness in the face, and patchy rash on arms and legs over the next 2 hours. By the time of ER discharge at 4:15pm, only experiencing redness on knees and redness in face. Was prescribed a 3-day prednisone taper.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: PROQUAD was administered to a patient on an unspecified date during a temperature excursion; No additional AE; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection 1 dose (lot # x011981, has been verified to be a valid lot number, expiration date and upon internal validation both established as 19-JUL-2024), administered for prophylaxis (strength, exact dose, route of administration and anatomical location were not provided); sterile diluent solution for injection/infusion (reported as injection) 1 dose was also administered as medication dilution (considered as concomitant drug) by health professional.   It was reported that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) underwent a temperature excursion with Temperature 12 Fahrenheit (F) and Time frame 1 hour 0 minutes 0 seconds (product storage error). No previous temperature excursion was reported. There was no additional adverse event (no adverse event).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: development of bilateral PE in 77 y/o male patient after receiving updated dose of Covid-19 vaccine (XBB.1.5)/shortness of breath and presented to the hospital; This spontaneous case was reported by a pharmacist and describes the occurrence of PULMONARY EMBOLISM (development of bilateral PE in 77 y/o male patient after receiving updated dose of Covid-19 vaccine (XBB.1.5)/shortness of breath and presented to the hospital) in a 77-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (development of bilateral PE in 77 y/o male patient after receiving updated dose of Covid-19 vaccine (XBB.1.5)/shortness of breath and presented to the hospital) (seriousness criteria hospitalization and medically significant). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (development of bilateral PE in 77 y/o male patient after receiving updated dose of Covid-19 vaccine (XBB.1.5)/shortness of breath and presented to the hospital) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   COMPANY COMMENT: This is an spontaneous case concerning a 77-year-old male patient with no medical history reported who experienced the serious (due to medically significant and hospitalization) unexpected AESI of pulmonary embolism unknown days after a dose of SPIKEVAX 2023-2024 vaccine. The patient was treated with APIXABAN at an unspecified dose and frequency. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Rash, Rash papular, Skin lesion
Clinical narrative: Patient developed rash on 6-14-24. Erythematous papular rash to face and few scattered lesions over torso and extremities. Patient was seen for rash on 6-24-24. Per Dr., does not appear to look like chicken pox. Suggested use of antihistamine, hydrocortisone, or calamine lotion. Rash did not appear itchy. If rash did not improve in 7-10 days, instructed to come back into office.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Injection site pain, Product administered at inappropriate site, Wrong technique in product usage process
Clinical narrative: The pt showed up at the drive thru complaining of pain and redness at the injection site.  The injection was given on the left back of the arm.  The pt said that the pharmacist put the needle in and pulled it out before putting it in again.  She said that Tylenol was not helping with the pain.  I spoke with GSK and if the vaccine was given the CDC recommends that it does not have to be given again.  Also, the pt got the second dose in 48 days from the first dose.  The CDC also recommends that the patient does not have to be revaccinated with a valid dose after the second dose.  The pt will be contacted to follow up with her physician if pain still  persists.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC20, VARCEL
Symptoms: Extra dose administered
Clinical narrative: The MMR, Varicella, and Hepatitis A vaccine were administered to the child on 4/18/24. The MMR, Varicella, and Hepatitis A were inadvertently administered again on 4/25/24.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Ataxia, Autonomic nervous system imbalance, Blood test, Coordination abnormal, Diplopia
Clinical narrative: Shooting pain down spine, veritgo, ataxia, double vision, nystagmus, difficulty with walking and coordination, autonomic issues. Diagnosed as GBS, then acute onset transverse myelitis (relasping).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Guillain-Barre syndrome, Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging neck
Clinical narrative: Shooting pain down spine, veritgo, ataxia, double vision, nystagmus, difficulty with walking and coordination, autonomic issues. Diagnosed as GBS, then acute onset transverse myelitis (relasping).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging thoracic, Myelitis transverse, Nystagmus, Pain, Spinal pain
Clinical narrative: Shooting pain down spine, veritgo, ataxia, double vision, nystagmus, difficulty with walking and coordination, autonomic issues. Diagnosed as GBS, then acute onset transverse myelitis (relasping).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Shooting pain down spine, veritgo, ataxia, double vision, nystagmus, difficulty with walking and coordination, autonomic issues. Diagnosed as GBS, then acute onset transverse myelitis (relasping).
Age: 0.17
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: On the evening of 6/3/24 I received a phone call from the Medical Assistant who administered the vaccines to the patient, stating she discovered the hepatitis B vaccine she administered to the patient was expired by 12 days. The Medical Assistant notified the Practice Manager, after notifying me. Per the CDC guidelines, administering an expired vaccine does not pose significant health risks and is not considered to be as potent as a non-expired vaccine, thus it must be administered again. I discussed these guidelines with the Practice Manager. The following business day, the Practice Manager reached out to the patient's mother to inform her of the incident and explain the plan of care for vaccination in regards to the hepatis B vaccine series, the patient was reported to be doing well by the mother. Mother verbalized understanding and all her questions were answered by the Practice Manager. The Practice Manager and I are actively working on modifying the clinic's current inventory system with the Medical Assistants responsible for performing the clinic inventory to prevent such incidents from ever happening again in the future.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Eye swelling, Pruritus, Rash, Swelling
Clinical narrative: DONOR CALLED CENTER STATING HE WOKE UP WITH A RASH ALL OVER BODY, EYE/ NOSE SWELLING, AND ITCHING TO BODY. DENIED SWELLING, WARMTH, REDNESS TO IMMUNIZATION SITE. DENIED ANY OUT OF ROUTINE ACTIVITIES/FOODS. STATED TOOK TRAZADONE AT BEDTIME LAST NIGHT. THIS WAS APPROX 23 HRS POST IMMUNIZATION.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site on right deltoid red, warm to the touch, and itchy. Parents applied ice pack to area and Ibuprofen. Parent took patient to urgent care to be evaluated. Given crushed Zyrtec with cherry syrup but patient spit out medication due to "didn't like the taste". Parent purchased Claritin and administered medication.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Additional Details: pt stated never really has chest pain however she was experiencing this today shot was given yesterday pt self medicated with naproxen. I contacted MD for patient and RN was calling patient and evaluation would occur over the phone to patient. called pt 6-17-24 4:16pm
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dermatitis allergic, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: for the first 2 days pt had felt tired and had chills, these symptoms disappated and pt is only expierncing, warmth to the site and slight swelling.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Rash
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: for the first 2 days pt had felt tired and had chills, these symptoms disappated and pt is only expierncing, warmth to the site and slight swelling.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bacterial infection, Haematological infection, Hypotension, Injection site bruising, Injection site erythema
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Hypotension-Severe, Additional Details: She said she passed out. She went to hospital and was diagnosed with a bacterial infection in blood stream., Other Vaccines:  VaccineTypeBrand: Pneumovax 23; Manufacturer: msd; LotNumber: x023559; Route: IM; BodySite: right arm; Dose: 01; VaxDate: 05/23/2024
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Injection site swelling, Loss of consciousness
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Hypotension-Severe, Additional Details: She said she passed out. She went to hospital and was diagnosed with a bacterial infection in blood stream., Other Vaccines:  VaccineTypeBrand: Pneumovax 23; Manufacturer: msd; LotNumber: x023559; Route: IM; BodySite: right arm; Dose: 01; VaxDate: 05/23/2024
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Other Vaccines:  VaccineTypeBrand: boostrix; Manufacturer: glaxoSmithkline biologicals; LotNumber: zf9t5; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site bruising, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Other Vaccines:  VaccineTypeBrand: boostrix; Manufacturer: glaxoSmithkline biologicals; LotNumber: zf9t5; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Other Vaccines:  VaccineTypeBrand: boostrix; Manufacturer: glaxoSmithkline biologicals; LotNumber: zf9t5; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Rph followed-up with the pt and recommended to visit Urgent Clinic. Documentation of the vaccine was provided to the pt. Rph quarantined the lot number b4942; exp 04/06/2026; ndc: 58160-0823-11
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Dizziness, Flushing, Heart rate decreased, Hyperhidrosis
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Blood pressure upon examination by EMT's was very low with low heart rate-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Additional Details: Patient initially said he was feeling a little nauseated and asked for water so we gave him a room temperature bottle of water. This was maybe 1-2 minutes after vaccine was administered. Within a minute or 2 of drinking a sip or 2 of water, patient slumped over against the vaccination screen. He never lost conciousness fully, but was not responsive verbally. This was when I called 911. His BP and HR was low, so they advised him to go via ambulance to the ER for further evaluation., Other Vaccines:  VaccineTypeBrand: Boostrix TDap Vaccine; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: 06/17/2024
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotension, Nausea, Unresponsive to stimuli
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Blood pressure upon examination by EMT's was very low with low heart rate-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Additional Details: Patient initially said he was feeling a little nauseated and asked for water so we gave him a room temperature bottle of water. This was maybe 1-2 minutes after vaccine was administered. Within a minute or 2 of drinking a sip or 2 of water, patient slumped over against the vaccination screen. He never lost conciousness fully, but was not responsive verbally. This was when I called 911. His BP and HR was low, so they advised him to go via ambulance to the ER for further evaluation., Other Vaccines:  VaccineTypeBrand: Boostrix TDap Vaccine; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: 06/17/2024
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild
Age: 88.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Headache, Injection site pain, Nausea, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Mild, Other Vaccines:  VaccineTypeBrand: Arexvy; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 88.0
Sex: F
Vaccine: RSV
Symptoms: Paraesthesia, Tinnitus, Tremor
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Mild, Other Vaccines:  VaccineTypeBrand: Arexvy; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: redness, swelling, soreness at site of injection, pt says no pain, no other body symptoms, Other Vaccines:  VaccineTypeBrand: m-m-r II; Manufacturer: Merck; LotNumber: ; Route: im; BodySite: left arm; Dose: ; VaxDate: 05/28/2024, VaccineTypeBrand: boostrix; Manufacturer: GSK; LotNumber: ; Route: im; BodySite: ; Dose: ; VaxDate: 05/24/2024, VaccineTypeBrand: heplisav; Manufacturer: Dynavax; LotNumber: ; Route: im; BodySite: ; Dose: ; VaxDate: 05/24/2024
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis allergic
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium
Age: 77.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Mild
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium
Age: 81.0
Sex: F
Vaccine: TDAP
Symptoms: Headache
Clinical narrative: Systemic: Headache-Severe