chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lymphadenopathy
Clinical narrative: patient is having swelling in his lymph node beneath his armpit.
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: expired vaccine given.   EXP:24JUN23
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Arm was swollen, painful, red, itchy including palms with patient reporting low fevers that lasted up to six days after the vaccination on 6/20/2023. The patient reports that the swelling, redness and pain are resolving as of 6/26/2023.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Wrong product administered
Clinical narrative: Immunization specialist was supposed to administer Quadracel and ProQuad and instead accidentally administered PENTACEL and Quadracel.  Patient may have also been administered wrong route on top of wrong vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Immune system disorder, Liver disorder, Nasopharyngitis, Respiratory disorder
Clinical narrative: Since age 20, I've been healthy.  Had the flu maybe 3 times (the last time 40 years ago), rarely caught a cold.  No health issues, other than blood pressure, controlled by Atenelol.  In April 2021, age 67 and 3/4, I got 2 Pfizer Covid vaccines, and have had constant health issues since:  Nasty colds, intestinal issues, skin problems, breast issues and most recently, liver issues.  These vaccines have clearly ruined my immune system.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: Since age 20, I've been healthy.  Had the flu maybe 3 times (the last time 40 years ago), rarely caught a cold.  No health issues, other than blood pressure, controlled by Atenelol.  In April 2021, age 67 and 3/4, I got 2 Pfizer Covid vaccines, and have had constant health issues since:  Nasty colds, intestinal issues, skin problems, breast issues and most recently, liver issues.  These vaccines have clearly ruined my immune system.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nerve injury, Neuralgia, Rash
Clinical narrative: Severe headache (same day) Friday, June 23, 2023  Rash started on back of neck and right shoulder (same nerve pathway of the severe case of Shingles that I had in April, 2023) Contacted pharmacy where I received the vaccine on Saturday, June 24, 2023. Contacted my PCP Monday, June 26. 2023.  Was seen at Urgent Care.  Prescriptions were refilled for anti-viral medication and for Lyrica (Pregagablin 75 mg) for nerve damage pain.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Atrial flutter
Clinical narrative: Reported Symptoms:  10003658:ATRIAL FIBRILLATION;  10003662:ATRIAL FLUTTER;
Age: 74.0
Sex: U
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis, Laboratory test, Pulmonary thrombosis, Thrombectomy
Clinical narrative: On January 15, 2023 I experienced a EP-DVT had to have emergency surgery to suck Blood clots out of my lungs
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient Received Moderna Bivalent Booster dose given as vaccine #1 in Primary Series Rather than the Bivalent dose designated For Primary Series
Age: 0.8
Sex: M
Vaccine: COVID19-2, HEP
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient Received Moderna Bivalent Booster dose given as vaccine #1 in Primary Series Rather than the Bivalent dose designated For Primary Series
Age: 0.6
Sex: F
Vaccine: COVID19-2, DTAPIPVHIB, PNC13, RV5
Symptoms: Underdose
Clinical narrative: Patient Received Moderna Bivalent Booster dose given as vaccine #1 in Primary Series Rather than the Bivalent dose designated For Primary Series
Age: 0.6
Sex: M
Vaccine: COVID19-2, DTAPIPVHIB, PNC13, RV5
Symptoms: Underdose
Clinical narrative: Patient Received Moderna Bivalent Booster dose given as vaccine #1 in Primary Series Rather than the Bivalent dose designated For Primary Series
Age: 0.8
Sex: M
Vaccine: COVID19-2, HEP
Symptoms: Underdose
Clinical narrative: Patient Received Moderna Bivalent Booster dose given as vaccine #1 in Primary Series Rather than the Bivalent dose designated For Primary Series
Age: 0.7
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient Received Moderna Bivalent Booster dose given as vaccine #1 in Primary Series Rather than the Bivalent dose designated For Primary Series
Age: 0.7
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient Received Moderna Bivalent Booster dose given as vaccine #1 in Primary Series Rather than the Bivalent dose designated For Primary Series
Age: 0.8
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient Received Moderna Bivalent Booster dose given as vaccine #1 in Primary Series Rather than the Bivalent dose designated For Primary Series
Age: 0.7
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient Received Moderna Bivalent Booster dose given as vaccine #1 in Primary Series Rather than the Bivalent dose designated For Primary Series
Age: 0.7
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Underdose
Clinical narrative: Patient Received Moderna Bivalent Booster dose given as vaccine #1 in Primary Series Rather than the Bivalent dose designated For Primary Series
Age: 0.7
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient Received Moderna Bivalent Booster dose given as vaccine #1 in Primary Series Rather than the Bivalent dose designated For Primary Series
Sex: U
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient Received Moderna Bivalent Booster dose given as vaccine #1 in Primary Series Rather than the Bivalent dose designated For Primary Series
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Reported Symptoms:  10037844:RASH; Narrative:  A 76yrs old male was reported with Pfizer Covid - 19 vaccine induced pruritic rash on December 12, 2022 by a PCC attending physician.  It was reported as an observed mild pruritic rash on arm.  Per the attending physician's Assessment /Plan note  The patient had
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Reported Symptoms: 10013963:DYSPNEA: 10043528:THROAT TIGHTNESS;  Narrative:  A 54yo female with PMH of multiple medical problems which included, Bilateral Sensorineural Hearing Loss, Knee Pain, lumbosacral spondylosis, Cervicalgia, Generalized Anxiety Disorder, Asymptomatic diverticulosis, Pain of right shoulder, GERD, Chronic PTSD, Insomnia, and Sleep Apnea.  Pharmacist reported on December 13.
Age: 94.0
Sex: M
Vaccine: FLUX
Symptoms: Condition aggravated, Guillain-Barre syndrome
Clinical narrative: Reported Symptoms:  10018767:GUILLAIN-BARRE SYNDROME;    Narrative:  Per  December 12. 2022 Nurse Practitioner's documentation  A 94yo male who presented for tele visit to establish care with Geriatrics and with PMH of Cochlear Implant, Alzheimer's Dementia, OA of Knee and Guillain Barre Syndrome (from flu shot)  No other
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Reported Symptoms: 10046735:URTICARIA; Narrative:  A 43yo female patient was reported with a historical ADR of Covid-19 vaccine induced Urticaria by PCC attending physician. His report included "
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Reported Symptoms:  10037844:RASH; 10037844:RASH;    Narrative:  A 69yo female with PMH of DM type II, HTN, MST, Anxiety and Chronic Pain.  On January 5, 2023, RN reported the patient had a historical ADR of Influenza vaccine
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Immunisation reaction
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: A 63yo  female with PMH of Allergic Rhinitis,  Low Back Pain, Hypothyroidism, Hyperlipidemia and HTN.  On February 8, 2023, RN @1303 reported the patient had a historical ADR of Moderna Covid - 19 vaccine induced anaphylaxis.  In the COVID screening note by the nurse,  it was further clarified as
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen & red at injection site
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: site rash, red spot/bumps w/ itch that slowly spread (w/i 24 hours) hive like blisters formed. Took allergy medication w/i 24 hours itching stopped next day Hives disappeared and then 2 days later redness left
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site vesicles
Clinical narrative: site rash, red spot/bumps w/ itch that slowly spread (w/i 24 hours) hive like blisters formed. Took allergy medication w/i 24 hours itching stopped next day Hives disappeared and then 2 days later redness left
Sex: M
Vaccine: DTPPVHBHPB, FLU4, PNC13, DTPPVHBHPB, FLU4, PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given influenza vaccine at his appointment on 1/9/2023 and he is 3 months old and it was not on schedule.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2556772-1. The original narrative from the sender is the following:  Patient was given Influenza vaccine at his appt on 1/9/2023 and he is 3 months old and it was not on schedule. He is not due to receive the vaccine until he is 6 months old.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient was given influenza vaccine at his appointment on 1/9/2023 and he is 3 months old and it was not on schedule.".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, FLU4, HIBV, DTPPVHBHPB, FLU4, HIBV
Symptoms: Medication error
Clinical narrative: Medication error. Combination Vaxelis was administered instead of the ordered DTaP, resulting in extraneous dose of Hep B, out of schedule IPV and duplicate HIB vaccine; Combination Vaxelis was administered instead of the ordered DTaP, duplicate HIB vaccine; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2565932-1. The original narrative from the sender is the following:  Medication error. Combination Vaxelis was administered instead of the ordered DTaP, resulting in extraneous dose of Hep B, out of schedule IPV and duplicate HIB vaccine. No reactions noted at the time of service. No report from parent/guardian of adverse reaction. Parent was notified by provider.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Medication error. Combination Vaxelis was administered instead of the ordered DTaP, resulting in extraneous dose of Hep B, out of schedule IPV and duplicate HIB vaccine and Combination Vaxelis was administered instead of the ordered DTaP, duplicate HIB vaccine".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, FLU4, HIBV, DTPPVHBHPB, FLU4, HIBV
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: Medication error. Combination Vaxelis was administered instead of the ordered DTaP, resulting in extraneous dose of Hep B, out of schedule IPV and duplicate HIB vaccine; Combination Vaxelis was administered instead of the ordered DTaP, duplicate HIB vaccine; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2565932-1. The original narrative from the sender is the following:  Medication error. Combination Vaxelis was administered instead of the ordered DTaP, resulting in extraneous dose of Hep B, out of schedule IPV and duplicate HIB vaccine. No reactions noted at the time of service. No report from parent/guardian of adverse reaction. Parent was notified by provider.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Medication error. Combination Vaxelis was administered instead of the ordered DTaP, resulting in extraneous dose of Hep B, out of schedule IPV and duplicate HIB vaccine and Combination Vaxelis was administered instead of the ordered DTaP, duplicate HIB vaccine".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaxelis inadvertantly given as 12 month dose; No patient harm or reaction to this vaccine; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2583520-1. The original narrative from the sender is as follows:  Vaxelis inadvertently given as 12 month dose. No patient harm or reaction to this vaccine.  Due to the nature of the event, the causal relationship between Vaxelis and the reported events of "no adverse event and product administered to patient of inappropriate age" is not applicable.  The case is considered "off label use".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: Vaxelis inadvertantly given as 12 month dose; No patient harm or reaction to this vaccine; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2583520-1. The original narrative from the sender is as follows:  Vaxelis inadvertently given as 12 month dose. No patient harm or reaction to this vaccine.  Due to the nature of the event, the causal relationship between Vaxelis and the reported events of "no adverse event and product administered to patient of inappropriate age" is not applicable.  The case is considered "off label use".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HIBV, DTPPVHBHPB, HIBV
Symptoms: Accidental overdose, Wrong product administered
Clinical narrative: Vaxelis and Hiberix were given on the same day; Hiberix was given by mistake instead of PCV vaccine/ The patient was supposed to receive Vaxelis and PCV vaccine but received Hiberix vaccine by mistake.; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2586733-1. The original narrative from the sender is as follows:  Vaxelis and Hiberix given on same day; Hiberix given by mistake instead of PCV vaccine; This case was reported by a physician via call center representative and described the occurrence of accidental overdose in a 2-ear-old male patient who received Hib (Hiberix) (batch number EK5Y2, expiry date 25th May 2023) for prophylaxis. Co-suspect products included VAXELIS for prophylaxis. On 8th February 2023, the patient received Hiberix and VAXELIS> On 8th February 2023, unknown after receiving Hiberix, the patient experienced accidental overdose and wrong vaccine administered. On an unknown date, the outcome of the accidental overdose and wrong vaccine administered were unknown. Additional information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The reporter reported that the patient was almost 3 years old and received Vaxelis and Hiberix vaccine, The reporter stated that the patient was supposed to receive Vaxelis and PCV vaccine but received Hiberix vaccine by mistake. The vaccine administration facility was the same as the primary reporter. The reporter did consent to follow up. Additional supportive information: The reporter reported that that were intending to administered PCV vaccine and inadvertently administered Hiberix instead of PCV vaccine, which led to wrong vaccine administered. The patient received Vaxelis and Hiberix vaccine on same day, which led to accidental overdose.  Due to the nature of the events, the causal relationship between Vaxelis and the events "accidental overdose and wrong product administered is not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Vomiting projectile
Clinical narrative: Patient developed projectile vomiting that would not stop; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2592273-1. The original narrative from the sender is as follows:   Mom called on 03-MAR-2023 to report that patient developed projectile vomiting that would not stop. She was taken to ER and after 3 hours wait and no vomiting, she was taken home with no further evaluation. Mom called to inform us that she did not want patient to receive any further combo vaccines and wanted to give single vaccines once at a time.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Patient developed projectile vomiting that would not stop".   No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Injection site pain, Injection site rash, Injection site reaction, Rash erythematous, Rash papular
Clinical narrative: Red raised rash located around injection site; Red raised rash located around injection site; Red raised rash located around injection site; Injection site reaction; injection site pain; This case was retrieved during the monitoring on 12-APR-2023 with the following Primary ID 2592367-1. The original narrative from the sender is as follows:   Red raised rash located around injection site, Injection site reaction, Injection site pain.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Red raised rash located around injection site", Injection site reaction", "injection site pain.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Injection site pain, Injection site reaction, Rash erythematous, Rash papular
Clinical narrative: Red raised rash located around injection site; Red raised rash located around injection site; Red raised rash located around injection site; Injection site reaction; injection site pain; This case was retrieved during the monitoring on 12-APR-2023 with the following Primary ID 2592367-1. The original narrative from the sender is as follows:   Red raised rash located around injection site, Injection site reaction, Injection site pain.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Red raised rash located around injection site", Injection site reaction", "injection site pain.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, FLUN4, PNC13, RV1, DTPPVHBHPB, FLUN4, PNC13, RV1
Symptoms: Circumstance or information capable of leading to medication error, Incorrect product formulation administered
Clinical narrative: Incorrect product formulation administered; Circumstance or information capable of leading to medication error; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2595152-1. The original narrative from the sender is the following:  Also discussed administering her initial Pfizer COVID19 vaccine. Inadvertently ordered a Pfizer 6 month to 4 year bivalent SARS-COV-2 vaccine and this was administered as the first dose in her primary series.  Due to the nature of the events, the causal relationship between Vaxelis and "Circumstance or information capable of leading to medication error and incorrect product formulation administered" was not applicable.  No further information is expected.  Based on the available information, the events were not related to Vaxelis but to another vaccine. Vaxelis should have been considered a concomitant, however the case was retrieved and information was kept as reported in the form.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Injection site nodule
Clinical narrative: Nodule on L thigh; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2597650-1. The original narrative from the sender is as follows:  Nodule on L thigh.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Nodule on L thigh".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Nodule
Clinical narrative: Nodule on L thigh; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2597650-1. The original narrative from the sender is as follows:  Nodule on L thigh.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Nodule on L thigh".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEPA, MMRV, DTPPVHBHPB, HEPA, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh is hot to touch, swollen, very red, painful; Right thigh is hot to touch, swollen, very red, painful; Right thigh is hot to touch, swollen, very red, painful; Right thigh is hot to touch, swollen, very red, painful; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2601986-1. The original narrative from the sender is as follows:  Right thigh is hot to touch, swollen, very red, painful.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Right thigh is hot to touch, swollen, very red, painful".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEPA, MMRV, DTPPVHBHPB, HEPA, MMRV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Right thigh is hot to touch, swollen, very red, painful; Right thigh is hot to touch, swollen, very red, painful; Right thigh is hot to touch, swollen, very red, painful; Right thigh is hot to touch, swollen, very red, painful; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2601986-1. The original narrative from the sender is as follows:  Right thigh is hot to touch, swollen, very red, painful.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Right thigh is hot to touch, swollen, very red, painful".  No further information is expected.
Age: 18.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Chills, Communication disorder, Fatigue, Feeling abnormal, Headache
Clinical narrative: patient states that almost immediately her arm felt tingly, and pain and pain shot through hand into head. started felling fuzzy and couldnt speak well , hands and legs started to shake and went limp and passed out in chair. patient came too and was thirsty, had a headache , loss of color. took a benadryl and lay down for 20 minutes , arm felt "blown up"  like a balloon for a couple of hours. Up until 6/2/23 had felt tired and chills on and off . Patient presented today 6/27/23 stating that lumps have been appearing and disappearing randomly in the areas of lymph nodes since getting the vaccine.
Age: 18.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Hypotonia, Immediate post-injection reaction, Loss of consciousness, Pain, Pain in extremity
Clinical narrative: patient states that almost immediately her arm felt tingly, and pain and pain shot through hand into head. started felling fuzzy and couldnt speak well , hands and legs started to shake and went limp and passed out in chair. patient came too and was thirsty, had a headache , loss of color. took a benadryl and lay down for 20 minutes , arm felt "blown up"  like a balloon for a couple of hours. Up until 6/2/23 had felt tired and chills on and off . Patient presented today 6/27/23 stating that lumps have been appearing and disappearing randomly in the areas of lymph nodes since getting the vaccine.
Age: 18.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Pallor, Paraesthesia, Speech disorder, Swelling, Thirst
Clinical narrative: patient states that almost immediately her arm felt tingly, and pain and pain shot through hand into head. started felling fuzzy and couldnt speak well , hands and legs started to shake and went limp and passed out in chair. patient came too and was thirsty, had a headache , loss of color. took a benadryl and lay down for 20 minutes , arm felt "blown up"  like a balloon for a couple of hours. Up until 6/2/23 had felt tired and chills on and off . Patient presented today 6/27/23 stating that lumps have been appearing and disappearing randomly in the areas of lymph nodes since getting the vaccine.
Age: 18.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Tremor
Clinical narrative: patient states that almost immediately her arm felt tingly, and pain and pain shot through hand into head. started felling fuzzy and couldnt speak well , hands and legs started to shake and went limp and passed out in chair. patient came too and was thirsty, had a headache , loss of color. took a benadryl and lay down for 20 minutes , arm felt "blown up"  like a balloon for a couple of hours. Up until 6/2/23 had felt tired and chills on and off . Patient presented today 6/27/23 stating that lumps have been appearing and disappearing randomly in the areas of lymph nodes since getting the vaccine.
Age: 18.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Aphasia, Chills, Feeling abnormal, Headache, Loss of consciousness
Clinical narrative: patient states that almost immediately her arm felt tingly, and pain and pain shot through hand into head. started felling fuzzy and couldnt speak well , hands and legs started to shake and went limp and passed out in chair. patient came too and was thirsty, had a headache , loss of color. took a benadryl and lay down for 20 minutes , arm felt "blown up"  like a balloon for a couple of hours. Up until 6/2/23 had felt tired and chills on and off . Patient presented today 6/27/23 stating that lumps have been appearing and disappearing randomly in the areas of lymph nodes since getting the vaccine.
Age: 18.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Lymphadenopathy, Pain in extremity, Pallor, Paraesthesia, Thirst
Clinical narrative: patient states that almost immediately her arm felt tingly, and pain and pain shot through hand into head. started felling fuzzy and couldnt speak well , hands and legs started to shake and went limp and passed out in chair. patient came too and was thirsty, had a headache , loss of color. took a benadryl and lay down for 20 minutes , arm felt "blown up"  like a balloon for a couple of hours. Up until 6/2/23 had felt tired and chills on and off . Patient presented today 6/27/23 stating that lumps have been appearing and disappearing randomly in the areas of lymph nodes since getting the vaccine.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed that no symptomatic adverse events were reported; Inbound call from medical assistant calling to report temperature excursion for GARDASIL-9.  Caller states that product was administered to patient following the temperature excursion.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 02-MAR-2023, the patient was vaccinated with an improperly storage human papillomavirus (HPV) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #W004648, expiration date: 06-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided). Temperature excursion occurred at 34.4 Fahrenheit (F) for 15 hours. No previous temperature excursion was reported. No additional adverse events were reported. ; Sender's Comments:  US-009507513-2306USA010783:
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Received A Dose of Heplisav-B, and a Dose of Engerix B; Initial Report Received on 20-Mar-2023  This spontaneous report was received from a pharmacist regarding a 48-year-old female patient who received Heplisav-B for the first dose and Engerix-B for the second dose.   Medical history was reported as unknown.   Concomitant medications were not specified.    On 11-Aug-2022, dose 1 of HEPLISAV-B (Lot # unknown, expiration date unknown, and NDC were 43528-002-01), was administered.  On 20-Sep-2022, the second dose of a hepatitis B vaccine administered, which was Engerix-B.    The reporter stated that there was very little information regarding the patient as they had received the 2 prior doses "at a different place".  The reporter had no further information regarding the prescriber or the Heplisav-B dose in question.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Lymphadenopathy, Malaise, Swelling
Clinical narrative: More Swelling than Usual; Swollen Lymph Nodes; COVID Like Symptoms; Initial Report Received on 23-Mar-2023  This spontaneous report was received from a nurse regarding a 32-year-old female patient who received HEPLISAV-B for hepatitis B immunization.   Medical history included lupus.  The patient had no known drug allergies.   Concomitant medications were not specified.    On 28-Feb-2023, a dose of HEPLISAV-B (Lot # 947582, expiration date 24-Jan-2025, NDC 43528-003-05), was administered in the left deltoid.  On 28-Feb-2023, the patient received a dose of HEPLISAV-B for employment.  The patient was described to have more swelling than usually reported.  The patient had swollen lymph nodes and her symptoms were described like she had COVID.    The reporter noted that no other information is available.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatic enzyme increased, Metabolic function test abnormal
Clinical narrative: Slightly Elevated Liver Enzymes Before Vaccine, More Elevated after Heplisav-B; Initial Report Received on 28-APR-2023  A physician reported that a patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient developed more elevated liver enzymes after vaccine.  Medical history was reported as unknown.    No relevant concomitant medications at the time of vaccination were reported.  In JAN-2023, the patient had a comprehensive metabolic panel (CMP) and the results were "slightly elevated."    On 19-APR-2023, the patient received a dose of HEPLISAV-B (Lot # and expiration date not reported and NDC # 43528-002-01) from a physician.   On 20-APR-2023, 1 day after having been vaccinated with HEPLISAV-B, the patient had a CMP test, and the results were "more elevated."  The physician reported that "Patient had slightly elevated liver enzymes before vaccine, were more elevated after Heplisav-B".  No side effects were reported.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Pregnancy; Earlier dose on 18Nov2019, second dose on 28Apr2023; Initial Report Received on 02-May-2023  A pharmacist reported that a 43-year-old pregnant female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   Medical history, allergies, and concomitant medications at the time of vaccination were unknown.  On 18-Nov-2019, the patient received the first dose of HEPLISAV-B vaccine (Lot #, expiration date, NDC#, route of administration, and site of injection not reported).  On an unknown date, the patient became pregnant.   On 28-Apr-2023, the pregnant patient received the second dose of HEPLISAV-B vaccine (Lot # 941583, expiration date 28-Jan-2025, and NDC # 43528-003-05) intramuscularly in the left arm. The number of weeks gestation and the patient's last menstrual period were unknown. The patient did not report any additional side effects.   No additional information was provided.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure via skin contact, Needle issue, No adverse event
Clinical narrative: Patient did not receive the full dose; Leaked on Patient's Arm; Initial Report Received on 02-May-2023  A non-significant follow-up report received on 05-Jun-2023 that included the QA investigation results of the mixed product quality complaint: the investigation did not identify a potential lot-related issue, there was no trend.  No potential impact to the lot was identified.    the mixed product quality complaint: the investigation did not identify a potential lot-related issue,   there was no trend, this was the first AE associated with HEPLISAV-B lot 941588, no potential impact to   the lot was identified, no CAPA was recommended, and the case was closed on 30-Mar-2023.     A registered nurse reported that a 26-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization, which had a faulty needle connection and some of the HEPLISAV-B leaked on the patient's skin. The patient did not receive the full dose of HEPLISAV-B.  Medical history and concomitant medications at the time of vaccination were not reported. The patient had no allergies or previous reactions to other vaccines.  On 01-May-2023, the patient received the first dose of HEPLISAV-B vaccine (Lot # 941588; expiration date 31-Aug-2025, NDC # 43528-003-05; route of administration not reported) in the left deltoid by the reporting nurse. During the administration,  the needle connection was faulty, and some medication leaked on the patient's arm. The patient did not receive the full dose of HEPLISAV-B vaccine. This was the first dose of the two-dose series. No adverse reactions were reported by the patient.  No additional information was provided.  Company Comment:  The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Received First Dose Heplisav-B, Received Second Dose Engerix; Initial Report Received on 03-May-2023.  A pharmacist reported that a 31 year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for first dose of hepatitis B immunization and then received Engerix-B as the second dose.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 30-Mar-2023, the patient received the first dose of HEPLISAV-B (Lot # 941584, expiration date 31-Jan-2025 and NDC # 43528-003-05) in the left arm (route not reported) from a pharmacist.    On 30-Mar-2023, the patient was vaccinated with HEPLISAV-B as the first dose of hepatitis B immunization. On 01-May-2023 the patient came back to a different store location and received Engerix-B as a second dose, as this is the only brand they had at the location No adverse reactions was reported.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received a 1st dose of the primary series (monovalent) on 18-Apr-2023; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a 1st dose of the primary series (monovalent) on 18-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 19-year-old female patient who received mRNA-1273 (Spikevax) (batch no. FP7136) for COVID-19 prophylaxis.     It was reported that patient had no known conditions and received no other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 18-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .3 milliliter. On 18-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a 1st dose of the primary series (monovalent) on 18-Apr-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a 1st dose of the primary series (monovalent) on 18-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received a 1st dose of the primary series (monovalent) on 18-Apr-2023).    No concomitant medications were reported.  It was unknown whether the patient ever been diagnosed with/ tested positive for COVID-19. It was unknown whether patient had Chronic or long-standing health conditions and Acute illnesses at the time of vaccination and up to one month before. Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and or at the time of adverse vent were not reported.  The patient received first dose of the primary series (monovalent) on 18-Apr-2023. Patient was instructed to come back in four weeks foe the second dose of monovalent to complete the series. The patient came as instructed however the monovalent was no longer authorized to use and was given bivalent dose to complete the immunization.   Reporter later realized that the bivalent dose was given too soon.  Patient was instructed to come back in 2 month to receive another bivalent dose for validation.  No adverse events were reported.  No treatment medications were reported.   This case was linked to MOD-2023-726266 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2023: Significant follow-up received include reporter details, patient details (Race and ethnicity), Suspect product dose details and Narrative was updated.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial expired on 19MAY2023 and located in the freezer, thawed and injected on 31MAY2023; No adverse event; Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial expired on 19MAY2023 and located in the freezer, thawed and injected on 31MAY2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 19MAY2023 and located in the freezer, thawed and injected on 31MAY2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial expired on 19MAY2023 and located in the freezer, thawed and injected on 31MAY2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 19MAY2023 and located in the freezer, thawed and injected on 31MAY2023).    Concomitant medication was not reported.  It was reported that, all patients qualified d/+ age greater than 65 or immunocompromised.  Patient received Moderna vaccine as a booster.  Date the vial was initially stored in the refrigerator was 31-May-2023. Vial did not under gone temperature excursion. Moderna vaccines was still effective. There have been no adverse reaction for patient.  Treatment medication was not reported.  This case is for 7th patient out of 20 patients described by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727268.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727268:master case
Sex: F
Vaccine: COVID19-2
Symptoms: Immunisation reaction, Nasopharyngitis
Clinical narrative: cold; reaction to Covid shots; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold) and IMMUNISATION REACTION (reaction to Covid shots) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Pneumonia (Double pneumonia), Cervical cancer, Loss of memory, Pain in spine, Thrombus and Hysterectomy. Concurrent medical conditions included Relapsing-remitting multiple sclerosis, Osteoporosis, Bursitis, Migraine and Atrial fibrillation. Concomitant products included OCRELIZUMAB (OCREVUS), IMMUNOGLOBULIN HUMAN NORMAL (HIZENTRA), APIXABAN (ELIQUIS), ONDANSETRON (ZOFRAN [ONDANSETRON]), BUTORPHANOL TARTRATE, DIAZEPAM, MIRTAZAPINE, TIZANIDINE, METOPROLOL, POTASSIUM, VITAMIN C [ASCORBIC ACID], CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM & VITAMIN D3), OXYCODONE and METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold) and IMMUNISATION REACTION (reaction to Covid shots). At the time of the report, NASOPHARYNGITIS (cold) and IMMUNISATION REACTION (reaction to Covid shots) outcome was unknown.            It was reported that the patient had a "reaction to Covid shots". The patient further clarified that after she received the Moderna Covid vaccine she was always cold, even if it was 90 degrees outside, she has a sweatshirt on. The patient reported that she was not permitted by her doctor to receive the Covid booster because of the reaction.  Treatment information was not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 16-MAY-2023 and was administered on 11-JUN-2023; No adverse event; pediatric patient (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-JUN-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric patient (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-JUN-2023), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 16-MAY-2023 and was administered on 11-JUN-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric patient (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-JUN-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 16-MAY-2023 and was administered on 11-JUN-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric patient (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-JUN-2023), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 16-MAY-2023 and was administered on 11-JUN-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric patient (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-JUN-2023) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 16-MAY-2023 and was administered on 11-JUN-2023).    No concomitant medication was reported. It was reported that 5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-JUN-2023. No PQC was reported. The expiry date was reported as 09-Jun-2023. Vial size was reported as unknown. Vial did not undergo any temperature excursions. Treatment information was not provided.  This case contains information about patient 2nd out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730079 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730079:Master case patient no. 01