chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; dose administered after expiration date. Dose administered today. Bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after expiration date. Dose administered today. Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult 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. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-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 16-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after expiration date. Dose administered today. Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after expiration date. Dose administered today. Bivalent vaccine) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (dose administered after expiration date. Dose administered today. Bivalent vaccine).    It was unknown whether the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. The dosage text of the suspect product was reported as unknown. It was reported that 5 doses administered after expiration date.. There were no reported symptoms at this point. No treatment medication was reported.   This case contains information about patient 2nd out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-729599 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729599:Master case
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Incorrect dose administered, Pain in extremity, Product preparation issue
Clinical narrative: 6/20/2023 Patient was seen yesterday where an order for a COVID Pfizer booster was ordered by provider. Patient was given pfizer bivalent 6m-4yr instead on accident. The entire multidose vial (10 doses) was given without diluent.   Spoke to patient's daughter this morning to make sure patient doesn't have adverse reactions. Patient's daughter stated the only symptom patient reported before bed was a arm soreness, no S/S of infections. But patient is still currently sleeping so patient's daughter will check on patient when she wakes up.   6/21/2023 - patient experienced mild fatigue, otherwise no other symptoms
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Fatigue, Oedema, Pyrexia
Clinical narrative: erythema, edema, fatigue and fever
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered, Pain in extremity, Product preparation issue
Clinical narrative: Patient was seen yesterday where an order for a COVID Pfizer booster was ordered by provider. Patient was given pfizer bivalent 6m-4yr instead on accident. The entire multidose vial (10 doses) was given without diluent.   Patient stated the only symptom patient is experiencing is arm soreness, no S/S of infections
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered, No adverse event, Product preparation issue
Clinical narrative: Patient was seen yesterday where an order for a COVID Pfizer booster was ordered by provider. Patient was given pfizer bivalent 6m-4yr instead on accident. The entire multidose vial (10 doses) was given without diluent.   Patient did not experience any side effects when I called her on 6/20/23 at 10a.m. I called patient again on 6/21/2023 at 11am and patient stated she has been asymptomatic
Age: 70.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Facial paralysis, Hypoaesthesia, Injection site erythema
Clinical narrative: On 6/21 patient reported to pharmacist : Patient said both arms were red around immunization site, which had subsided by this time. Her left side of her face is droopy and her arm is numb.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: swelling and redness on vaccine area
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Hypersensitivity
Clinical narrative: pt received allergic reaction from vaccination, pt mother administered antihistamine, pt recovered.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Insomnia, Pain, Swelling, Vaccination site swelling
Clinical narrative: EXTREME SWELLING ADJACENT TO VACINATION SITE.   APPROXIMATELY  6 INCHES WIDE   AND 1 1/2 INCHES HIGH AT FIRST ,      6 INCHES WIDE AND 3/4 INCH HIGH AT THIS TIME, MEASURED AT PHARMACY.      Phamacist and PA both told me to use motrin as a antiinflamatory , use cold compresses and massage to reducepain , sensitivity and swelling in days after adverse reaction. Then after 3 weeks ,swelling was only reduced by a third and pain and sensitivity was still there and then the pharmacist told me to switch over to warm compresses and massage. At this time the pain has diminished but the sensitivity and swelling is still causing sleeplessness , sensitivity to wearing a jacket and is very unsightly.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 5 doses administered after expiration date. Doses administered today. Bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult 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. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-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 16-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown. Dosage text was reported as unknown. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information of 3rd patient out of 5.   This case was linked to US-MODERNATX, INC.-MOD-2023-729599 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729599:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 5 doses administered after expiration date. Doses administered today. Bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult 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. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-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 16-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown. Dosage text was reported as unknown. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information of 4th patient out of 5.   This case was linked to US-MODERNATX, INC.-MOD-2023-729599 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729599:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 5 doses administered after expiration date. Doses administered today. Bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult 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. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-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 16-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.   It was reported that error had not been discussed with patients.  Treatment information was not provided.  This case contains information about patient 5th out of 5 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-729599 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729599:Master case
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: PATIENT'S HUSBAND CAME IN AND SAID SHE DEVELOPED A RASH A COUPLE OF DAYS AFTER VACCINATION. SHE STILL HAS THE RASH. THEY ALSO HAVE BEEN RENOVATING THEIR HOME DURING THIS TIME FRAME.
Age: 5.0
Sex: F
Vaccine: COVID19-2, HEP, VARCEL
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: COVID vaccine was not diluted. Pt received full strength dose of vaccine. pt did not exhibit any s/s. No treatment required.
Age: 11.0
Sex: F
Vaccine: COVID19-2, HPV9, MNQ, TDAP, VARCEL
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Vaccine was not diluted. Full strength dose administered. No treatment or adverse s/s noted.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Patient had swelling, itching and soreness in L arm  after vaccination.  no swelling of throat, fever, vomiting, other rash, diarrhea, shortness of breath.Patient is doing well after a dose of benadryl
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity
Clinical narrative: Patient states she has had arm pain since the event and believes it was injected into vein.  She states she can not lift her arm to even brush her hair and has had intense pain going down her arm and into her armpit since the shot.  She sought medical treatment at an Urgent Care and was given oral steroid dose that did not help.  It is now 3 weeks later and she is exasperated with her continuing pain and inability to move her arm.  I phoned her Dr. and they said they would contact patient to decide how to proceed.  As of tonight 7pm 6/21/23 Dr. has not contacted her.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood albumin decreased, Blood alkaline phosphatase normal, Blood chloride increased, Blood urea increased, Creatinine renal clearance
Clinical narrative: Four hours after injection,  patient developed severe diarrhea (green) which continued for 11 days.  Patient did have an ER trip and two visits to her pcp.  Multiple tests were run including stool samples.   Sed rate was 36, stool samples negative, wbc 10, cr cl 1.44, gfr 48, rdw 17%, co2 19, albumen 1, alkaline phos 105, aft 13, bun 28, chlor 112, lymphcytes 23.8 pt prescribed dicyclomine which inreased bowel transit time.  pt states that she is still dehyrated and very tired, stoll normal at this time.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dehydration, Diarrhoea, Faeces discoloured, Fatigue, Full blood count
Clinical narrative: Four hours after injection,  patient developed severe diarrhea (green) which continued for 11 days.  Patient did have an ER trip and two visits to her pcp.  Multiple tests were run including stool samples.   Sed rate was 36, stool samples negative, wbc 10, cr cl 1.44, gfr 48, rdw 17%, co2 19, albumen 1, alkaline phos 105, aft 13, bun 28, chlor 112, lymphcytes 23.8 pt prescribed dicyclomine which inreased bowel transit time.  pt states that she is still dehyrated and very tired, stoll normal at this time.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Glomerular filtration rate, Laboratory test, Lymphocyte count normal, Red blood cell sedimentation rate increased, Red cell distribution width increased
Clinical narrative: Four hours after injection,  patient developed severe diarrhea (green) which continued for 11 days.  Patient did have an ER trip and two visits to her pcp.  Multiple tests were run including stool samples.   Sed rate was 36, stool samples negative, wbc 10, cr cl 1.44, gfr 48, rdw 17%, co2 19, albumen 1, alkaline phos 105, aft 13, bun 28, chlor 112, lymphcytes 23.8 pt prescribed dicyclomine which inreased bowel transit time.  pt states that she is still dehyrated and very tired, stoll normal at this time.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Stool analysis normal, White blood cell count normal
Clinical narrative: Four hours after injection,  patient developed severe diarrhea (green) which continued for 11 days.  Patient did have an ER trip and two visits to her pcp.  Multiple tests were run including stool samples.   Sed rate was 36, stool samples negative, wbc 10, cr cl 1.44, gfr 48, rdw 17%, co2 19, albumen 1, alkaline phos 105, aft 13, bun 28, chlor 112, lymphcytes 23.8 pt prescribed dicyclomine which inreased bowel transit time.  pt states that she is still dehyrated and very tired, stoll normal at this time.
Age: 53.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Arthralgia, Neck pain, Pain, Paraesthesia
Clinical narrative: Patient called on the phone stating that after 24 hours of adminstration of shingrix and prevnar 20 vaccine, patient felt tingling sensation  and pain that was radiating from neck to hips and outward on the right side. She spoke with intern and pharmacist and was advised to call her doctor right away or go to urgent care.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: pt came to clinic for immunization with parent. verified pt name, dob, and  allergies with parent. explained to parent what vaccines will be given. parent  verbalized understanding. Vaccines administered.  upon completion of the 3rd and final vaccine [HPV], pt got up and fainted. father  caught the pt. pt responsive, and observed. pt offered water, O2 sat 99%, P 84.  pt refused blood pressure check because of the squeezing pain.   after the incident the father stated that pt has a hx of fainting after vax when  pain is felt. notified father to let healthcare providers know ahead of time to  be aware of possible syncope.  pt returned to normal pallor and left in stable condition walking with father.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Accident, Circumstance or information capable of leading to medication error, Fungal foot infection, Haematoma, Mobility decreased
Clinical narrative: Fungus toe left big after hematoma under nail was cleaned the first podiatrist failed to send lab specimen and second podiatrist submitted 06/27/2022 after 1st podiatrist unable to write accurate record. 1. Podiatrist consulted June 2021.  Sept 13, 2000 accident hematomas under both large toe nail was cleaned the nails not growing correctly changed in nail composition lifted off the skin under toe nails.  NO biopsy on the nails were removed both left & right big toes.  With a prescription written told right & left big toes had developed fungus June 2021 with incorrect medical record no biopsy thus changed doctor June 2022 with biopsy performed 6/27/2022 left big toe fungus prescription of Clotrimazole Topical solution still using June 2021 to June 2, 2023. NOT resolved. Never had any skin foot changes until April 2021 multiple medical problems. Submitted grievance first physician failed to file VAERS or biopsy & wrong diagnosis NEVER BIOPSY that the second performed  ALL records on electronic records wrong. NOT resolved. Large toe nail on right and left have not grown back to normal.  Twice a day require prescription to place on the toe.  With NO ability to bend as damaged nerve.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nail disorder, Nail growth abnormal, Nail matrix biopsy, Nail operation, Nerve injury
Clinical narrative: Fungus toe left big after hematoma under nail was cleaned the first podiatrist failed to send lab specimen and second podiatrist submitted 06/27/2022 after 1st podiatrist unable to write accurate record. 1. Podiatrist consulted June 2021.  Sept 13, 2000 accident hematomas under both large toe nail was cleaned the nails not growing correctly changed in nail composition lifted off the skin under toe nails.  NO biopsy on the nails were removed both left & right big toes.  With a prescription written told right & left big toes had developed fungus June 2021 with incorrect medical record no biopsy thus changed doctor June 2022 with biopsy performed 6/27/2022 left big toe fungus prescription of Clotrimazole Topical solution still using June 2021 to June 2, 2023. NOT resolved. Never had any skin foot changes until April 2021 multiple medical problems. Submitted grievance first physician failed to file VAERS or biopsy & wrong diagnosis NEVER BIOPSY that the second performed  ALL records on electronic records wrong. NOT resolved. Large toe nail on right and left have not grown back to normal.  Twice a day require prescription to place on the toe.  With NO ability to bend as damaged nerve.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Onycholysis, Onychomycosis
Clinical narrative: Fungus toe left big after hematoma under nail was cleaned the first podiatrist failed to send lab specimen and second podiatrist submitted 06/27/2022 after 1st podiatrist unable to write accurate record. 1. Podiatrist consulted June 2021.  Sept 13, 2000 accident hematomas under both large toe nail was cleaned the nails not growing correctly changed in nail composition lifted off the skin under toe nails.  NO biopsy on the nails were removed both left & right big toes.  With a prescription written told right & left big toes had developed fungus June 2021 with incorrect medical record no biopsy thus changed doctor June 2022 with biopsy performed 6/27/2022 left big toe fungus prescription of Clotrimazole Topical solution still using June 2021 to June 2, 2023. NOT resolved. Never had any skin foot changes until April 2021 multiple medical problems. Submitted grievance first physician failed to file VAERS or biopsy & wrong diagnosis NEVER BIOPSY that the second performed  ALL records on electronic records wrong. NOT resolved. Large toe nail on right and left have not grown back to normal.  Twice a day require prescription to place on the toe.  With NO ability to bend as damaged nerve.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site nodule
Clinical narrative: Mom called stating the pt had knots @ the injection sites to both legs but seems to be worse on the L leg. Pt acts like the L leg is uncomfortable @ times, 0 bruising, 0 erythema, 0 drainage, 0 fevers. Also c/o L leg spasming @ times. No other complaints
Age: 0.67
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: No Adverse Effect.
Sex: U
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Inappropriate diluent/non-approved diluent to reconstitute the powder; Inappropriate diluent/non-approved diluent to reconstitute the powder; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA910A, expiry date 20-MAR-2024) for prophylaxis.   On 15-JUN-2023, the patient received Menveo. On 15-JUN-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Inappropriate diluent/non-approved diluent to reconstitute the powder) and inappropriate dose of vaccine administered (Verbatim: Inappropriate diluent/non-approved diluent to reconstitute the powder). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 15-JUN-2023 The reporter informed that earlier that day there was a vial of the liquid component of Menveo left without the powder component.  According to the healthcare professional that indicated that the product had probably been administered using a non-approved diluent to reconstitute the powder. The vaccine administration facility was the same as primary reporter. The reporter did not have details on the patients as it was unknown who it was. However, healthcare professional stated that only two doses had been administered that day, so it could be one or the other. The reporter consented to follow up. The patient had probably been administered with Menveo using a non-approved diluent to reconstitute the powder, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023084511:Same reporter
Age: 67.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Angina pectoris
Clinical narrative: ANGINA, UNSPECIFIED
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE. Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE. Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE. Manufacturer: Unknown), for COVID-19 Immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE. Lot: GH9694), for COVID-19 Immunization, reaction(s): "Fever".  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received COVID-19 vaccines and boosters when available (24 hour fever after each).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Investigation, Oxygen saturation, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE. Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE. Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE. Manufacturer: Unknown), for COVID-19 Immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE. Lot: GH9694), for COVID-19 Immunization, reaction(s): "Fever".  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received COVID-19 vaccines and boosters when available (24 hour fever after each).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram oesophagus abnormal, Dehydration, Endoscopy abnormal, Laparoscopic surgery, Oesophageal achalasia
Clinical narrative: ACHALASIA; This spontaneous report received from a patient concerned a 6 decade old of unspecified sex. The patient's height, and weight were not reported. The patient was in perfect health for 50 years. Patient had no any other vaccines in over 30 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, couple months after getting the vaccine, the patient experienced achalasia (which is caused by an auto-immune disorder). Patient had a disastrous, life-threatening six-month nightmare with achalasia. It was reported that surgery was completed for achalasia.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of achalasia was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230636371 and 20230636293.; Sender's Comments: V0: 20230636250-Achalasia . The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Oesophageal manometry, Oesophagocardiomyotomy, Oesophagogastric fundoplasty, Oesophagram, Regurgitation
Clinical narrative: ACHALASIA; This spontaneous report received from a patient concerned a 6 decade old of unspecified sex. The patient's height, and weight were not reported. The patient was in perfect health for 50 years. Patient had no any other vaccines in over 30 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, couple months after getting the vaccine, the patient experienced achalasia (which is caused by an auto-immune disorder). Patient had a disastrous, life-threatening six-month nightmare with achalasia. It was reported that surgery was completed for achalasia.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of achalasia was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230636371 and 20230636293.; Sender's Comments: V0: 20230636250-Achalasia . The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast abnormal, Weight decreased
Clinical narrative: ACHALASIA; This spontaneous report received from a patient concerned a 6 decade old of unspecified sex. The patient's height, and weight were not reported. The patient was in perfect health for 50 years. Patient had no any other vaccines in over 30 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, couple months after getting the vaccine, the patient experienced achalasia (which is caused by an auto-immune disorder). Patient had a disastrous, life-threatening six-month nightmare with achalasia. It was reported that surgery was completed for achalasia.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of achalasia was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230636371 and 20230636293.; Sender's Comments: V0: 20230636250-Achalasia . The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Oesophageal achalasia
Clinical narrative: ACHALASIA; This spontaneous report received from a patient concerned a 6 decade old of unspecified sex. The patient's height, and weight were not reported. The patient was in perfect health for 50 years. Patient had no any other vaccines in over 30 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, couple months after getting the vaccine, the patient experienced achalasia (which is caused by an auto-immune disorder). Patient had a disastrous, life-threatening six-month nightmare with achalasia. It was reported that surgery was completed for achalasia.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of achalasia was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230636371 and 20230636293.; Sender's Comments: V0: 20230636250-Achalasia . The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Neuropathy peripheral, Rheumatoid arthritis
Clinical narrative: Patient received 6 dose of COVID-19 Pfizer (3 dose of bivalent); Patient received 6 dose of COVID-19 Pfizer (3 dose of bivalent); Having a lot of pain in his right hip, in right calf and right ankle; Having a lot of pain in his right hip, in right calf and right ankle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 3), for COVID-19 immunization; Bnt162b2, bnt162b2 omi ba.4-5 (Dose 4), for COVID-19 immunization; Bnt162b2, bnt162b2 omi ba.4-5 (Dose 5), for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious), OFF LABEL USE (non-serious), outcome "unknown" and all described as "Patient received 6 dose of COVID-19 Pfizer (3 dose of bivalent)"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "Having a lot of pain in his right hip, in right calf and right ankle". The events "having a lot of pain in his right hip, in right calf and right ankle" required physician office visit. Therapeutic measures were taken as a result of pain in extremity, arthralgia.  Additional information: The patient received the bivalent adult formulation of the Pfizer BioNTech Covid 19 vaccine 7 weeks ago. This has been his 6th dose of the Pfizer Covid vaccines. He was having a lot of pain in his right hip, in right calf and right ankle that has not gone away. He has gone to his primary care physician, he's gone to his rheumatologist, he's gone to the chief medical officer for (Withheld). They're all at a loss at how to help him and he is still having this pain. His rheumatologist has thrown the kitchen sink at him and 7 weeks later he still has all this pain. The pain started two days after receiving the most recent vaccine. He is hoping we can help him. He took the Pfizer booster, and now he has a severe side effect.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Immunisation, Off label use, Pain in extremity
Clinical narrative: Patient received 6 dose of COVID-19 Pfizer (3 dose of bivalent); Patient received 6 dose of COVID-19 Pfizer (3 dose of bivalent); Having a lot of pain in his right hip, in right calf and right ankle; Having a lot of pain in his right hip, in right calf and right ankle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 3), for COVID-19 immunization; Bnt162b2, bnt162b2 omi ba.4-5 (Dose 4), for COVID-19 immunization; Bnt162b2, bnt162b2 omi ba.4-5 (Dose 5), for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious), OFF LABEL USE (non-serious), outcome "unknown" and all described as "Patient received 6 dose of COVID-19 Pfizer (3 dose of bivalent)"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "Having a lot of pain in his right hip, in right calf and right ankle". The events "having a lot of pain in his right hip, in right calf and right ankle" required physician office visit. Therapeutic measures were taken as a result of pain in extremity, arthralgia.  Additional information: The patient received the bivalent adult formulation of the Pfizer BioNTech Covid 19 vaccine 7 weeks ago. This has been his 6th dose of the Pfizer Covid vaccines. He was having a lot of pain in his right hip, in right calf and right ankle that has not gone away. He has gone to his primary care physician, he's gone to his rheumatologist, he's gone to the chief medical officer for (Withheld). They're all at a loss at how to help him and he is still having this pain. His rheumatologist has thrown the kitchen sink at him and 7 weeks later he still has all this pain. The pain started two days after receiving the most recent vaccine. He is hoping we can help him. He took the Pfizer booster, and now he has a severe side effect.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 16.0
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, Product storage error
Clinical narrative: No symptoms reported. No further AE details; Date of excursion: 3/2/2023; This spontaneous report has been received from a pharmacist, regarding a 16-years-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 02-MAR-2023, doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number: W0252273, which was then changed by the validation lot team for the valid lot number: W025273, with an expiration date on 10-AUG-2024) underwent a temperature excursion of 70 degrees Fahrenheit (F), for 9 minutes. No previous temperature excursions were reported.   On 12-JUN-2023, the patient was vaccinated with the improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, at a dose of 0.5 milliliters (ml) once as prophylaxis (lot number: W0252273) (strength, route and anatomical location of administration were not reported) (Product storage error). No symptoms or further adverse events were reported.   This case is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2306USA007844:
Age: 16.0
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported. No further AE details; Date of excursion: 3/2/2023; This spontaneous report has been received from a pharmacist, regarding a 16-years-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 02-MAR-2023, doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number: W0252273, which was then changed by the validation lot team for the valid lot number: W025273, with an expiration date on 10-AUG-2024) underwent a temperature excursion of 70 degrees Fahrenheit (F), for 9 minutes. No previous temperature excursions were reported.   On 12-JUN-2023, the patient was vaccinated with the improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, at a dose of 0.5 milliliters (ml) once as prophylaxis (lot number: W0252273) (strength, route and anatomical location of administration were not reported) (Product storage error). No symptoms or further adverse events were reported.   This case is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2306USA007844:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose was placed into the refrigerator initially on 4-MAY-202 and was administered between 6-JUN-2023 to 9-JUN-2023.; No adverse event; Patient received vaccine after the 30 day BUD between 6-JUN-2023 to 9-JUN-2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 day BUD between 6-JUN-2023 to 9-JUN-2023.), PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-202 and was administered between 6-JUN-2023 to 9-JUN-2023.) and NO ADVERSE EVENT (No adverse event) in an adult 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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 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. In June 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 day BUD between 6-JUN-2023 to 9-JUN-2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-202 and was administered between 6-JUN-2023 to 9-JUN-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 day BUD between 6-JUN-2023 to 9-JUN-2023.), PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-202 and was administered between 6-JUN-2023 to 9-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 (Patient received vaccine after the 30 day BUD between 6-JUN-2023 to 9-JUN-2023.) and PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-202 and was administered between 6-JUN-2023 to 9-JUN-2023.).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that patient did not report other symptoms and no additional doses medications or treatments administered in response. This case is reported for patient 2 out of 9 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-729624 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729624:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: patient received vaccine after the 30 day BUD between 6JUN2023 to 9JUN2023.; The dose was placed into the refrigerator initially on 4-MAY-2023 and administered between  6-JUN-2023 to 9-JUN-2023.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received vaccine after the 30 day BUD between 6JUN2023 to 9JUN2023.), PRODUCT STORAGE ERROR (The dose was placed into the refrigerator initially on 4-MAY-2023 and administered between  6-JUN-2023 to 9-JUN-2023.) and NO ADVERSE EVENT (No adverse event) in an adult 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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    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 EXPIRED PRODUCT ADMINISTERED (patient received vaccine after the 30 day BUD between 6JUN2023 to 9JUN2023.), PRODUCT STORAGE ERROR (The dose was placed into the refrigerator initially on 4-MAY-2023 and administered between  6-JUN-2023 to 9-JUN-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received vaccine after the 30 day BUD between 6JUN2023 to 9JUN2023.), PRODUCT STORAGE ERROR (The dose was placed into the refrigerator initially on 4-MAY-2023 and administered between  6-JUN-2023 to 9-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 (patient received vaccine after the 30 day BUD between 6JUN2023 to 9JUN2023.) and PRODUCT STORAGE ERROR (The dose was placed into the refrigerator initially on 4-MAY-2023 and administered between  6-JUN-2023 to 9-JUN-2023.).    No concomitant medication was reported. The dosage text of the suspect product was reported as unknown. It was reported that 9 adult patients were received vaccine after the 30 day BUD between 6-JUN-2023 to 9-JUN-2023. The dose was placed into the refrigerator initially on 4-MAY-2023. There were no reported symptoms and no additional doses medications or treatments administered in response.    This case contains information about patient 7th out of 9 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-729624 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729624:Master case US-MODERNATX, INC.-MOD-2023-729624:Patient 7