chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.67
Sex: U
Vaccine: FLUR4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 8 month old receiving a dose of Flublok vaccine, no adverse event; Initial information received on 19-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional and consumer/non-health care professional via media Information (under reference number 00820516) in a specific country.  This case involves a 8 months old, unknown gender patient who was administered with the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age) .  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (same day latency).  It was reported "Voicemail received on 19Oct2021 at 6:55 PM. More information in the Event Information field. Placed in proxy. Hi my name is <Redacted> I I am calling from <Redacted>. Wondering um what the safety risk are for <Redacted> receiving a dose of Flublok vaccine. If you could call me back, again my number is <Redacted>. Thank You."  At time of reporting, no adverse event was reported and the outcome was unknown for the reported event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, Product preparation error, Product preparation issue
Clinical narrative: administered the DTAP-IPV liquid separately from the HIB component, HIB Component was reconstituted with Merck live virus sterile water, then administered to the patient with no AE; Initial information was received on 20-Oct-2021 regarding an unsolicited valid non-serious case received from pharmacist and physician via the Medical Information  under reference number- 00821046.   This case involves a patient of (unknown demographics) who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] that was reconstituted with dtap-ipv liquid separately from the hib component, hib component was reconstituted with merck live virus sterile water (Product preparation issue).   The patient's medical history, past medical treatment(s), vaccination(s), concomitant therapy(s) and family history were not provided.  Concomitant medications included WATER FOR INJECTION (STERILE WATER).  On 19-Oct-2021, the patient received a 0.5ml {total} dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number UJ425AAA and expiry date 21-May-2022 was reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to wrong solution used in drug reconstitution (latency was on same day).   At the time of report, no adverse event reported.   Outcome of event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Syringe issue, Underdose
Clinical narrative: FLUBLOK leaked out around the hub of the needle where it is attached to the syringe/ no adverse event; FLUBLOK leaked out and patient received incomplete dose/ no adverse event; Initial information received on 20-Oct-2021 regarding an unsolicited valid non-serious case from pharmacist and physician via Regulatory authority (under the reference 00821115).  This case involves a 62 years old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] which leaked out around the hub of the needle where it is attached to the syringe and received incomplete dose (syringe issue, underdose).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 20-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (once, total, lot number: QFAA2110 and expiry date: 01-JUN-2022) via an intramuscular route in the left deltoid for prophylactic vaccination.  This case was a special situation due to (syringe leak, vaccine underdose) (latency: same day).  It was reported "While administering the vaccination, the FLUBLOK leaked out around the hub of the needle where it is attached to the syringe. The Pharmacist is unsure exactly how much of the FLUBLOK was received. The Pharmacist asks if the dose was valid or if she needs to be revaccinated. The needle was a twist on."  At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported event.
Age: 0.58
Sex: M
Vaccine: FLUR4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 8 months old patient received FLUBLOCK with no reported adverse event.; Initial information regarding an unsolicited valid non-serious case was received from Other Health Care Professional via a consumer/non-health care professional via regulatory authority (Reference number- 00822512) and transmitted to Sanofi on 21-Oct-2021.  This case involves an 8-month-old male patient who was received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccine.   On 19-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ724AA, expiry: 30-Jun-2022, formulation: pre-filled syringe) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  It was reported "The caller is asking recommendations for a patient given FLUBLOCK at 8 months old?"  No other adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: a family came in together for flu shots, but the children received ADACEL instead with no AE; Initial information was received on 21-Oct-2021 regarding an unsolicited valid non-serious case received via an other health care professional via a physician via phone (under agency Inquiry Number: 00822801).  This case is linked to cluster case US-SA-2021SA353235.  This case involves a 24 months old female patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of INFLUENZA VACCINE with no reported adverse event (wrong product administered).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On 21-Oct-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U7055BA and expiry date: 30-Jun-2023) via unknown route in the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered (Latency: same day).  It was reported "Caller states that a family came in together for flu shots, but the children received ADACEL instead of the flu shot. Caller would like to know if there is any safety issue and how will this affect their dosing schedule."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Medication error, Wrong product administered
Clinical narrative: family came in to receive flu shots but the children received ADACEL instead with no AE; Initial information received on 21-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves a 5-year-old male patient whom it was reported "family came in to receive flu shots [INFLUENZA VACCINE] but the children received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead (wrong product administered)".   The patient medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 21-Oct-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot U7055BA and expiry date: 03-Jun-2023] via an unknown route in the right arm for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered [Latency: on the same day].  At time of reporting, the outcome was unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Only injected the liquid portion of Pentacel/no AE; Initial information received on 21-Oct-2021 regarding an unsolicited valid non-serious case received from a Physician, other health care professional and consumer via Medical Information- 00823022.  This case involves a 4 month-old female patient who was only injected the liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (Product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included PNEUMOCOCCAL VACCINE 13V and HEPATITIS B VACCINE.  On 21-Oct-2021, the patient received 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via intramuscular route in the right thigh for prophylactic vaccination.  Batch number and expiry date of diluent was reported U6945AA and 09-Sep-2021 respectively.  It was reported "Stated that she has a question on the Pentacel. Only injected the liquid portion. Can the HIB component be mixed with saline and injected? HCP reports that today, a 4 month-old girl received only the DTaP-IPV portion of her indicated PENTACEL vaccine".  It was a case of an actual medication error due to inappropriate reconstitution technique (latency was on same day).   At the time of report, no adverse event reported.   Second dose of Act-HIB would be administered as corrective.  Outcome of event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for Pentacel.
Sex: M
Vaccine: FLUX
Symptoms: Borrelia test negative, Chronic inflammatory demyelinating polyradiculoneuropathy, Electrophoresis protein normal, Glycosylated haemoglobin normal, Guillain-Barre syndrome
Clinical narrative: CIDP; Guillain-Barre syndrome/acute inflammatory demyelinating polyneuropathy; This literature case was received on 18-Oct-2021 and concerned an elderly, male patient who was 87-year-old at the time of the reporting.   The patient's concurrent conditions and concomitant medications were not provided.  On an unknown date in 2017, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.   On an unspecified date in 2017, shortly after receiving influenza virus vaccine polyvalent, the patient had symptoms, laboratory, and electrophysiological features of Guillain-Barre syndrome/acute inflammatory demyelinating polyneuropathy (GBS/AIDP). Thyroid function tests, haemoglobin A1c, serum protein electrophoresis, syphilis and lyme titers were unremarkable. The patient had incomplete resolution of symptoms with a course of five plasma exchange treatments.  On an unspecified date in 2017, one month after initial diagnosis and treatment, it was determined that the patient's condition had evolved to chronic inflammatory demyelinating polyneuropathy (CIDP), for which he received ongoing plasmapheresis, on every two weeks basis.  At the time of this literature report, the patient was recovering from the events of GBS/AIDP and CIDP, with symptom improvement but not normalization.  The authors did not provide causality assessment.  Company comment: An elderly patient was vaccinated with influenza virus vaccine polyvalent. On an unspecified date in 2017, shortly after receiving influenza virus vaccine polyvalent, the patient had symptoms, laboratory, and electrophysiological features of Guillain-Barre syndrome/acute inflammatory demyelinating polyneuropathy (GBS/AIDP). One month after initial diagnosis and treatment, it was determined that the patient's condition had evolved to chronic inflammatory demyelinating polyneuropathy (CIDP). Causal role of the suspect vaccine is unassessable, due to unclear temporal relationship. Brighton Collaboration criteria could not be assessed due to insufficient information about diagnostic findings.; Sender's Comments: An elderly patient was vaccinated with influenza virus vaccine polyvalent. On an unspecified date in 2017, shortly after receiving influenza virus vaccine polyvalent, the patient had symptoms, laboratory, and electrophysiological features of Guillain-Barre syndrome/acute inflammatory demyelinating polyneuropathy (GBS/AIDP). One month after initial diagnosis and treatment, it was determined that the patient's condition had evolved to chronic inflammatory demyelinating polyneuropathy (CIDP). Causal role of the suspect vaccine is unassessable, due to unclear temporal relationship. Brighton Collaboration criteria could not be assessed due to insufficient information about diagnostic findings.
Sex: M
Vaccine: FLUX
Symptoms: Plasmapheresis, Thyroid function test normal, Treponema test negative
Clinical narrative: CIDP; Guillain-Barre syndrome/acute inflammatory demyelinating polyneuropathy; This literature case was received on 18-Oct-2021 and concerned an elderly, male patient who was 87-year-old at the time of the reporting.   The patient's concurrent conditions and concomitant medications were not provided.  On an unknown date in 2017, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.   On an unspecified date in 2017, shortly after receiving influenza virus vaccine polyvalent, the patient had symptoms, laboratory, and electrophysiological features of Guillain-Barre syndrome/acute inflammatory demyelinating polyneuropathy (GBS/AIDP). Thyroid function tests, haemoglobin A1c, serum protein electrophoresis, syphilis and lyme titers were unremarkable. The patient had incomplete resolution of symptoms with a course of five plasma exchange treatments.  On an unspecified date in 2017, one month after initial diagnosis and treatment, it was determined that the patient's condition had evolved to chronic inflammatory demyelinating polyneuropathy (CIDP), for which he received ongoing plasmapheresis, on every two weeks basis.  At the time of this literature report, the patient was recovering from the events of GBS/AIDP and CIDP, with symptom improvement but not normalization.  The authors did not provide causality assessment.  Company comment: An elderly patient was vaccinated with influenza virus vaccine polyvalent. On an unspecified date in 2017, shortly after receiving influenza virus vaccine polyvalent, the patient had symptoms, laboratory, and electrophysiological features of Guillain-Barre syndrome/acute inflammatory demyelinating polyneuropathy (GBS/AIDP). One month after initial diagnosis and treatment, it was determined that the patient's condition had evolved to chronic inflammatory demyelinating polyneuropathy (CIDP). Causal role of the suspect vaccine is unassessable, due to unclear temporal relationship. Brighton Collaboration criteria could not be assessed due to insufficient information about diagnostic findings.; Sender's Comments: An elderly patient was vaccinated with influenza virus vaccine polyvalent. On an unspecified date in 2017, shortly after receiving influenza virus vaccine polyvalent, the patient had symptoms, laboratory, and electrophysiological features of Guillain-Barre syndrome/acute inflammatory demyelinating polyneuropathy (GBS/AIDP). One month after initial diagnosis and treatment, it was determined that the patient's condition had evolved to chronic inflammatory demyelinating polyneuropathy (CIDP). Causal role of the suspect vaccine is unassessable, due to unclear temporal relationship. Brighton Collaboration criteria could not be assessed due to insufficient information about diagnostic findings.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: the vaccine is expired at time of vaccination; This spontaneous report was received from a registered nurse, referring to a 9 weeks old female patient.  There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-OCT-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# T040223, expiration date 12-JAN-2021; dose was not reported) orally for prophylaxis (Expired product administered).   This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-2110USA003436:
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Chest discomfort, Fatigue, Musculoskeletal discomfort, Pain
Clinical narrative: internal symptoms on left shoulder blade; internal symptoms left chest area; Burning; aches; tired; itching; This case was reported by a consumer via call center representative and described the occurrence of shoulder discomfort in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (have had Shingles since patient was 16).   In June 2021, the patient received the 1st dose of Shingrix. In October 2021, between 3 and 5 months after receiving Shingrix, the patient experienced shoulder discomfort, chest discomfort, burning sensation, pain, tiredness and pruritus. On an unknown date, the outcome of the shoulder discomfort, chest discomfort, burning sensation, pain, tiredness and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the shoulder discomfort, chest discomfort, burning sensation, pain, tiredness and pruritus to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. At the time of reporting patient was 62 years old. The patient received a dose of Shingrix in first week of June 2021. The patient wished to receive his/her second on Thursday of this week from the reporting day, but he/she noticed for the last week that he/she had the internal symptoms on the left shoulder blade. The patient also experienced symptoms on left chest area, burning, aches, tired, itching but no actual external breakout. The patient was suggested to receive the 2nd dose till the internal symptoms were gone. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: internal symptoms on left shoulder blade; internal symptoms left chest area; Burning; aches; tired; itching; This case was reported by a consumer via call center representative and described the occurrence of shoulder discomfort in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (have had Shingles since patient was 16).   In June 2021, the patient received the 1st dose of Shingrix. In October 2021, between 3 and 5 months after receiving Shingrix, the patient experienced shoulder discomfort, chest discomfort, burning sensation, pain, tiredness and pruritus. On an unknown date, the outcome of the shoulder discomfort, chest discomfort, burning sensation, pain, tiredness and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the shoulder discomfort, chest discomfort, burning sensation, pain, tiredness and pruritus to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. At the time of reporting patient was 62 years old. The patient received a dose of Shingrix in first week of June 2021. The patient wished to receive his/her second on Thursday of this week from the reporting day, but he/she noticed for the last week that he/she had the internal symptoms on the left shoulder blade. The patient also experienced symptoms on left chest area, burning, aches, tired, itching but no actual external breakout. The patient was suggested to receive the 2nd dose till the internal symptoms were gone. The reporter consented to follow-up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Rash, Skin burning sensation
Clinical narrative: burning sensation, skin on shoulder; circular rash, back of arm; pain, radiated to chest; This case was reported by a physician via sales rep and described the occurrence of burning sensation skin in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th October 2021, the patient received the 1st dose of Shingrix .5 ml. On 18th October 2021, 5 days after receiving Shingrix, the patient experienced burning sensation skin, rash and chest pain. On an unknown date, the outcome of the burning sensation skin, rash and chest pain were unknown.   It was unknown if the reporter considered the burning sensation skin, rash and chest pain to be related to Shingrix.  Additional details were provided as follows: The patient had burning sensation in skin on her shoulder with circular rash in back of the arm not at the injection site 5 days post vaccination and the pain also radiated to the chest area. The reporter stated that, it was very unusual in his opinion and would like a call to provide a more complete information. The reporter consented to follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 49 year old female of unspecified ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: 25-MAY-2021) dose was not reported, 1 total administered on left arm on 09-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 07-OCT-2021, the patient went through an antibody test and result was negative (confirmed immunological vaccine failure). Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211052305-covid-19 vaccine ad26.cov2.s- Confirmed immunological Vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Skin papilloma
Clinical narrative: VACCINE GAVE HIM BOOTY WARTS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine gave him booty warts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine gave him booty warts was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Pain
Clinical narrative: WHOLE BODY SORE; WEAK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced whole body sore, and weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the whole body sore and weak was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: DID NOT REACT GREAT TO THE FIRST SHOT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced did not react great to the first shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of did not react great to the first shot was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bone densitometry, Dizziness, Illness, Pain, Pyrexia
Clinical narrative: Dizziness; sickness; Achiness,pain; fever; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (Dizziness), ILLNESS (sickness), PAIN (Achiness,pain) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DENOSUMAB (PROLIA) injection for Osteoporosis postmenopausal.    The patient's past medical history included Sinus operation (for dilation) on 12-Aug-2020, Stapedectomy (stapes surgery) on 27-Aug-2021 and Arthroscopic surgery (calcified bone removal and an implant was put in and was intubated.). Previously administered products included for Product used for unknown indication: Boniva. Family history included Deafness (Hearing aid user in both ears, no hearing in right ear from 15 years) since an unknown date. Concurrent medical conditions included Hypertension, Blood cholesterol (Blood cholesterol abnormal), Osteoporosis postmenopausal, Carcinoid tumour since 2010 and Hearing aid user (Hearing aid user in both ears). Concomitant products included HYDROCHLOROTHIAZIDE, ZOLPIDEM TARTRATE (AMBIEN), ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]), CALCIUM, MONTELUKAST, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ROSUVASTATIN CALCIUM (CRESTOR), METOPROLOL SUCCINATE (TOPROL) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   In 2008, the patient started DENOSUMAB (PROLIA) (Subcutaneous) 60 milligram every six months. On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced ILLNESS (sickness), PAIN (Achiness,pain) and PYREXIA (fever). In September 2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) and PAIN (Achiness,pain) was resolving, ILLNESS (sickness) had resolved and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Bone densitometry: high (High) seven percent increase in bone.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported. Patient had underwent urine analysis and laboratory test and results were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Adverse event nos; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse event nos) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event nos). At the time of the report, ADVERSE EVENT (Adverse event nos) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided.   This case was linked to MOD-2021-302036 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: big red and hot welt at the injection site; big red and hot welt at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (big red and hot welt at the injection site) and VACCINATION SITE ERYTHEMA (big red and hot welt at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Overweight.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (big red and hot welt at the injection site) and VACCINATION SITE ERYTHEMA (big red and hot welt at the injection site). At the time of the report, VACCINATION SITE WARMTH (big red and hot welt at the injection site) and VACCINATION SITE ERYTHEMA (big red and hot welt at the injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not provided by the reporter. Patient state that they have lupus but didn't mention which type of Lupus as current condition. Patient 1 is schedule to get a Moderna booster today and wonders if it authorized yet and whether it would be a full dose or half a dose   This case was linked to MOD-2021-358543 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest discomfort, Computerised tomogram, Cough, Fatigue
Clinical narrative: Fatigue and tired; Tingling sensation; Tightness in the chest; Wheezing with slight cough; Wheezing with slight cough,did not have a persistent cough and the cough did intensify; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation), CHEST DISCOMFORT (Tightness in the chest), WHEEZING (Wheezing with slight cough), COUGH (Wheezing with slight cough,did not have a persistent cough and the cough did intensify) and FATIGUE (Fatigue and tired) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 003C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PARAESTHESIA (Tingling sensation). In April 2021, the patient experienced CHEST DISCOMFORT (Tightness in the chest), WHEEZING (Wheezing with slight cough) and COUGH (Wheezing with slight cough,did not have a persistent cough and the cough did intensify). On an unknown date, the patient experienced FATIGUE (Fatigue and tired). On 13-Apr-2021, PARAESTHESIA (Tingling sensation) had resolved. At the time of the report, CHEST DISCOMFORT (Tightness in the chest), WHEEZING (Wheezing with slight cough), COUGH (Wheezing with slight cough,did not have a persistent cough and the cough did intensify) and FATIGUE (Fatigue and tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal.         Patient is taking medications for the side effects.   This case was linked to MOD-2021-359055, MOD-2021-358982, MOD-2021-358738 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Wheezing
Clinical narrative: Fatigue and tired; Tingling sensation; Tightness in the chest; Wheezing with slight cough; Wheezing with slight cough,did not have a persistent cough and the cough did intensify; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation), CHEST DISCOMFORT (Tightness in the chest), WHEEZING (Wheezing with slight cough), COUGH (Wheezing with slight cough,did not have a persistent cough and the cough did intensify) and FATIGUE (Fatigue and tired) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 003C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PARAESTHESIA (Tingling sensation). In April 2021, the patient experienced CHEST DISCOMFORT (Tightness in the chest), WHEEZING (Wheezing with slight cough) and COUGH (Wheezing with slight cough,did not have a persistent cough and the cough did intensify). On an unknown date, the patient experienced FATIGUE (Fatigue and tired). On 13-Apr-2021, PARAESTHESIA (Tingling sensation) had resolved. At the time of the report, CHEST DISCOMFORT (Tightness in the chest), WHEEZING (Wheezing with slight cough), COUGH (Wheezing with slight cough,did not have a persistent cough and the cough did intensify) and FATIGUE (Fatigue and tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal.         Patient is taking medications for the side effects.   This case was linked to MOD-2021-359055, MOD-2021-358982, MOD-2021-358738 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Dose 2 :Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Dose 2 :Flu like symptoms) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Family history included Heart failure (NOS) (Patient husband has a heart failure condition, and she works in a construction company and is at high risk).   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Dose 2 :Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Dose 2 :Flu like symptoms) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-358827 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 35 days since got the first dose and still does not have the second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days since got the first dose and still does not have the second) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Schizoaffective disorder.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days since got the first dose and still does not have the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days since got the first dose and still does not have the second) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had schizoaffective disorder, he had the first dose of the Moderna COVID-19 vaccine in May and did not get the second one in time because he had an episode. The primary doctor said that the should restart the vaccination series. But when he went to get the first dose again they mentioned that he did not need a second dose. No concomitant medications reported. No treatment information was provided.  This case concerns Product dose omission in a 30 year-old male patient with history of schizoaffective disorder.  The patient did not receive the second dose due to the underlying schizoaffective disorder at the time that the second dose was scheduled.  There is no indication that the schizoaffective disorder is worse or different since receiving the first dose of vaccine.; Sender's Comments: This case concerns Product dose omission in a 30 year-old male patient with history of schizoaffective disorder.  The patient did not receive the second dose due to the underlying schizoaffective disorder at the time that the second dose was scheduled.  There is no indication that the schizoaffective disorder is worse or different since receiving the first dose of vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patients got their vaccines from vials that went through a temperature excursion,covid-19 vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Patients got their vaccines from vials that went through a temperature excursion,covid-19 vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patients got their vaccines from vials that went through a temperature excursion,covid-19 vaccination). At the time of the report, PRODUCT STORAGE ERROR (Patients got their vaccines from vials that went through a temperature excursion,covid-19 vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that temperature excursion occurred on 12-OCT-2021 and the vial got warmest of -9.2 C.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Paraesthesia, Tremor
Clinical narrative: burning sensation over part of chest/ ribs were burning/ left leg was burning; Left arm started to tingle/tingling in  lower leg/foot/felt pins and needles; Left hand was shaking; Shooting pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of BURNING SENSATION (burning sensation over part of chest/ ribs were burning/ left leg was burning), PARAESTHESIA (Left arm started to tingle/tingling in  lower leg/foot/felt pins and needles), TREMOR (Left hand was shaking) and PAIN (Shooting pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (burning sensation over part of chest/ ribs were burning/ left leg was burning), PARAESTHESIA (Left arm started to tingle/tingling in  lower leg/foot/felt pins and needles), TREMOR (Left hand was shaking) and PAIN (Shooting pain). At the time of the report, BURNING SENSATION (burning sensation over part of chest/ ribs were burning/ left leg was burning), PARAESTHESIA (Left arm started to tingle/tingling in  lower leg/foot/felt pins and needles), TREMOR (Left hand was shaking) and PAIN (Shooting pain) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  Three of patients friends had the exact same symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow-up received contains no new information.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to patient/Expired dose administered; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient/Expired dose administered) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient/Expired dose administered). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient/Expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.  Lot expired on 14 Oct 2021. Injection was given on 20 Oct 2021. It was reported that on 20-Oct-2021, the vial was initially stored in the refrigerator, and the vial did not went under any temperature excursions. It was reported that the vial did not have any expiration date labelled on it, they checked it using the tool. It was reported that Injection was given within 6 hours window from  puncture.   Most recent FOLLOW-UP information incorporated above includes: On 23-Oct-2021: Follow up information received on 23-OCT-2021 Includes non significant information added.