chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAPIPV
Symptoms: Discomfort, Product administered to patient of inappropriate age
Clinical narrative: does not feel comfortable; Initial information regarding this spontaneous and non-serious case from case was received from consumer or non-health care professional via Medical Information (MI) (Reference number: 00822738) and forwarded to the pharmacovigilance department on 21-Oct-2021.  This case involves a 7- months-old patient who experienced did not feel comfortable (discomfort) after receiving DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [Frequency: once, lot number and expiry date not reported, Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test 0.5 mL, Strength: standard except for Fluzone HD standard] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious did not feel comfortable (discomfort) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  It was reported "Practice manager reports that QUADRACEL was administered to a 7-month-old patient; asks if there are any recommendations for this situation. Practice manager states the patient did not feel comfortable completing an AE/safety report at time of call; states the patient clinical and quality service director advised the patient against completing AE/safety report at this time."  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: patient received a potentially partial dose and felt a drop on her skin after the injection/ no AE; Initial information regarding an unsolicited valid non-serious case was received from Nurse via Medical Information  (Reference number- 00822914) and transmitted to Sanofi on 21-Oct-2021 in a specific country.  This case involves a 61-year-old female patient who received a potentially partial 0.5 mL (once) dose of INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [FLUZONE] (lot UJ767AA and expiry date 30-Jun-2022) via intramuscular route in the left arm on 19-Oct-2021 for prophylactic vaccination and felt a drop on her skin after the injection (underdose).  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to vaccine underdose (latency was on same day).  It was reported "Nurse asks when can re-administer after a potential partial dose was administered. The patient said she felt a drop on her arm and felt it was an incomplete dose. The MA administered the dose said it was a tiny drop and it was wiped from the skin."  At the time of report, no adverse event 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 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: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 68 year old male patient received two shots of Fluzone HD in the same day with no reported adverse event; Initial information received on 22-Oct-2021 regarding an unsolicited valid non-serious case from a pharmacist via Medical Information (Reference number- 00824268).  This case involves a 68 year old male patient who received two shots of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] in the same day (extra dose administered).  The patient's medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included Varicella Zoster Vaccine Rge (Cho) (Shingrix) for Immunisation.  On 13-Oct-2021, the patient received a 0.7 ml two doses of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ702AB and expiry date: 30-Jun-2022) (Frequency: once) (Solution for injection in pre-filled syringe) via an intramuscular route in the left arm for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered (latency on same day).  It was reported "Pharmacist reports consumer got two shots of Fluzone HD in the same day. He received one injection at the HCP (health care professional) office and one at pharmacy about a half an hour later. He denied he had gotten the Fluzone HD, however, his HCP office confirmed. She asks for any information regarding. Additional Description of event adverse events: Pharmacist reports consumer was given Fluzone HD at pharmacy and then it was confirmed that he had received it 30 minutes prior at HCP office".   At the time of report 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: 66.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: they accidentally administered FLUZONE QUADRIVALENT instead of FLUZONE HIGH DOSE with no reported adverse event; Initial information received on 22-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional and consumer/ non health care professional via Agency (reference number 00824877).  This case involves a 66-year-old male patient who was by mistakenly given dose of suspect and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (wrong product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 21-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7336LA and expire vaccine: 21-Oct-2022) (Frequency Once) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to wrong vaccine administered (latency: same day).  It was reported "Nurse practitioner asks what the proper next steps would be; asks if the patient should still receive FLUZONE HIGH DOSE in addition to the FLUZONE QUADRIVALENT that was already administered."  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: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Fatigue, Pain
Clinical narrative: TIRED; SHOULDER STILL HURTS; pain; Initial information was received on 22-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via Medical information under reference number -00824880).  This case involves a 66-years old female patient who experienced shoulder still hurts (arthralgia), pain and tired (fatigue), after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2021, the patient received a 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number and expiry date not reported) via intramuscular route in the left deltoid for prophylactic vaccination.  On 23-Sep-2021, the patient developed a non-serious shoulder still hurts (arthralgia), pain on same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  On an unknown date, the patient developed a non-serious tired (fatigue) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  It was reported, "her shoulder still hurts almost a month after the vaccination was given. she taken the ibuprophen her dr's nurs recommended but it continues to hurt. she can sleep because of the pain and its hard for her to get dressed. she also states that she's more tired than before the vaccination. she wants to know what to do and if it will be permanent?"  No additional laboratory data was reported.  The patient was treated with IBUPROFEN (IBUPROFEN) for pain.  At time of reporting, the outcome was not recovered for the events arthralgia and pain.  At time of reporting, outcome of the event fatigue was unknown.  There will be no information available on batch number for this case.
Age: 82.0
Sex: M
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: the medication leaks out and one time the needle just came off, with no AE; nurse went to inject the patient and the vaccine leaked down his arm, with no AE reported; Initial information received on 22-Oct-2021 regarding an unsolicited valid non-serious case from another health professional via Medical Information (Reference number- 00824901).  This case involves a 82-year-old male patient who was vaccinated with suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] experienced needle was loose under the luer lok adaptor and some of the vaccine leaked out (underdose and syringe issue).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 19-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ765AC and expiry date: 30-Jun-2022) (Frequency = once) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to vaccine underdose and syringe issue. (latency on same day).  It was reported "when she attached the needle to the FLUZONE HIGH DOSE QUADRIVALENT vaccine the needle was loose under the luer lok adaptor and no matter how hard she tries to tighten it, it will not tighten and just continues to turn without locking. When a nurse preps the dose and or attempts to inject the dose, the medication leaks out and one time the needle just came off."  At time of reporting, no adverse event was reported.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: the patient received PENTACEL subcutaneously and not intramuscularly at the 4 month visit, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00824918) and transmitted to Sanofi on 22-Oct-2021.   This case involves a four-month-old (unknown gender) patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot and expiry date not reported) via subcutaneous route at an unknown administration site on an unknown date for prophylactic vaccination (incorrect route of product administration).  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to inappropriate route of vaccination (latency was on same day).  It was reported "Caller states they have a new 9-month patient that has already had their routine 2, 4, and 6-month shots. However, the patients mother stated that at the 4-month visit the patient received PENTACEL subcutaneously and not intramuscularly. Patient also received a dose of PENTACEL at their 6-month visit. The new MD would like to know if the patient should be revaccinated for the incorrect administration of PENTACEL?"  At the time of report, no adverse event 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.  There will be no information available on batch number for this case.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Apatient received last year flu vaccine/ no AE; Initial information was received on 22-Oct-2021 regarding an unsolicited valid non-serious case from an Other healthcare professional via Global Media Information (under reference- 00825023) and transmitted to Sanofi on 22-Oct-2021.  This case is linked to case 2021SA356217 and 2021SA356045.  This case involves a five-year-old male patient who received an expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] by mistake with no adverse event (Expired product used).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 22-Oct-2021, the patient received a 0.5 ml (once) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UJ562AA and expiry date 30-Jun-2021] via intramuscular route in the left thigh for prophylactic vaccination.  It was reported "3 patients received last years flu vaccine by mistake and would like to know how to proceed?"  First time product used: Yes. Still using product: No. Was Device Used: Yes.  It was a case of actual medication error due Expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse 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 by the regulatory authority. 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: 7.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: A patient received last years flu vaccine no AE; Initial information regarding an unsolicited valid non-serious case was received from Other Health Care Professional via a consumer/non-health care professional via Global Medical Information (GMI) (Reference number- 00825044) and transmitted to Sanofi on 22-Oct-2021.  This case is linked to cases 2021SA355038 and 2021SA356045 (same reporter).  This case involves a 7 year old male patient who was received last years INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 22-Oct-2021, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ562AA, expiry: 30-Jun-2021) via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported "Caller states that 3 patients received last years flu vaccine by mistake and would like to know how to proceed?"  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 by the regulatory authority. 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: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient received last years flu vaccine no AE; Initial information regarding an unsolicited valid non-serious case was received from Other Health Care Professional via a consumer/non-health care professional via Global Medical Information (GMI) (Reference number- 00825045) and transmitted to Sanofi on 22-Oct-2021.  This case is linked to cases 2021SA355038 and 2021SA356217 (same reporter).  This case involves a11 years old female patient who received last years INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered) by mistake.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was given to the patient.   On 22-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (once, lot UJ562AA, expiry: 30-Jun-2021) via an unknown route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported "Caller states that 3 patients received last years flu vaccine by mistake and would like to know how to proceed?"  At the 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 by the regulatory authority. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Facial pain, Herpes zoster, Post herpetic neuralgia, Pruritus
Clinical narrative: Herpes Zoster; Post Herpetic Neuralgia; vision problems; Information has been received from a lawyer referring to a female patient of unknown age regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. In or around 23-JUN-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, anatomical location, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered vision problems and subsequent facial pain, burning, and itching and was diagnosed with herpes zoster and post herpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient also had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of vision problems, herpes zoster and post herpetic neuralgia was considered as not recovered and causal relationship was assessed as related.  ALL events of vision problems, herpes zoster and post herpetic neuralgia were considered as disability by the lawyer.
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Herpes Zoster; Post Herpetic Neuralgia; vision problems; Information has been received from a lawyer referring to a female patient of unknown age regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. In or around 23-JUN-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, anatomical location, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered vision problems and subsequent facial pain, burning, and itching and was diagnosed with herpes zoster and post herpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient also had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of vision problems, herpes zoster and post herpetic neuralgia was considered as not recovered and causal relationship was assessed as related.  ALL events of vision problems, herpes zoster and post herpetic neuralgia were considered as disability by the lawyer.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Illness, Incomplete course of vaccination
Clinical narrative: ill for a few months; incomplete course of vaccination; This case was reported by a consumer via interactive digital media and described the occurrence of illness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced illness and incomplete course of vaccination. On an unknown date, the outcome of the illness was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the illness to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient for herself/himself. The age at vaccination was not reported for the 1sr dose and not applicable for the 2nd dose. The patient received a shot of Shingrix and at the 6 month mark when patient was due for 2nd shot was ill for a few months. As of today (on the day of reporting) the patient have not had his/her 2nd shot and asked that he/she need to start all over. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles after being vaccinated./ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported for reporter's husband. The age at vaccination was not reported. The reporter stated the patient got a terrible case of Shingles after been vaccinated with Shingles vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: git the vaccine and after i had the shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles vaccine and after had the shingles. The physician told him/her sometimes he/she could not get sick. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took the vaccine THEN had Shingles/ suspected vaccination failure; light case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingles vaccine and had shingles. The physician assured that it was a light case. The patient was thrilled that he/she did not have heavy case as they were horrible. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Injection site pain
Clinical narrative: sore at the site of injection; AST elevated; ALT elevated; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th October 2021, the patient received the 1st dose of Shingrix (intramuscular). In October 2021, less than a week after receiving Shingrix, the patient experienced injection site pain, aspartate aminotransferase increased and alanine aminotransferase increased. On an unknown date, the outcome of the injection site pain, aspartate aminotransferase increased and alanine aminotransferase increased were unknown.   It was unknown if the reporter considered the injection site pain, aspartate aminotransferase increased and alanine aminotransferase increased to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced her arm was sore at the site of injection. The reporter also reported that her AST (Aspartate aminotransferase) (58 units per liter of serum) and ALT (Alanine aminotransferase) (78 units per liter of serum) lab values were elevated after receiving the first dose of Shingrix. The reporter consented the follow up.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Malaise, Pruritus
Clinical narrative: intermittent itching; Malaise; Chills; Headache; redness developed immediately/red patch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness developed immediately/red patch), PRURITUS (intermittent itching), MALAISE (Malaise), CHILLS (Chills) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 1994, Blood pressure high since 1994, High cholesterol since 1994 and Glaucoma since 2004. Concomitant products included VITAMIN D NOS, BIFIDOBACTERIUM LACTIS, LACTOBACILLUS ACIDOPHILUS (ULTRAFLORA BALANCE), LEVOTHYROXINE from 1994 to an unknown date, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) from 1994 to an unknown date, ROSUVASTATIN from 2016 to an unknown date, TIMOLOL MALEATE from 2004 to an unknown date, IBUPROFEN (ADVIL [IBUPROFEN]), CYANOCOBALAMIN (SUBLINGUAL B12), CALCIUM CARBONATE (CITRICAL [CALCIUM CARBONATE]), ASCORBIC ACID (VITAMIN C ACID), FLAXSEED, CENTRUM SILVER +50, UBIDECARENONE (COQ10 [UBIDECARENONE]) and FISH OIL (OMEGA 3 FISH OIL [FISH OIL]) for an unknown indication.   On 10-Feb-2021 at 5:25 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021 at 1:07 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ERYTHEMA (redness developed immediately/red patch), MALAISE (Malaise), CHILLS (Chills) and HEADACHE (Headache). On 10-Mar-2021 at 1:17 AM, the patient experienced PRURITUS (intermittent itching). On 11-Mar-2021, ERYTHEMA (redness developed immediately/red patch) had resolved. On 24-Mar-2021, PRURITUS (intermittent itching), MALAISE (Malaise), CHILLS (Chills) and HEADACHE (Headache) had resolved.            No Treatments were reported.   This case was linked to MOD-2021-020649 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow-up received on 23-OCT-2021 Updated Patients demographic, Initials, Date of birth, and Event stop details.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: EXTREME HAIRLOSS! It?s been almost two months and I?ve lost about half of my hair.
Age: 78.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Malaise
Clinical narrative: Developed severe COVID-19 like symptoms. Going to the emergency room now.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a male patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.            No concomitant medication was mentioned. No treatment medication was mentioned.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ear; 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 TINNITUS (Ringing in the ear) 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 TINNITUS (Ringing in the ear). At the time of the report, TINNITUS (Ringing in the ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided. The reporter stated that her ENT doctor said she had a handful of patients that have reported the same symptoms as her ringing in the ear after receiving the vaccine. No further information provided. Vaccine manufacturer was unknown.   This case was linked to MOD-2021-359898 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Surgery
Clinical narrative: patient had surgery after the first and second doses of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (patient had surgery after the first and second doses of the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-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 SURGERY (patient had surgery after the first and second doses of the vaccine) (seriousness criterion medically significant). At the time of the report, SURGERY (patient had surgery after the first and second doses of the vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.  This case concerns a patient of an unknown age and gender with a history of Cancer, who experienced the unexpected serious event of Surgery. The event occurred at an unknown time after the second dose of Spikevax. The medical history of Cancer remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender with a history of Cancer, who experienced the unexpected serious event of Surgery. The event occurred at an unknown time after the second dose of Spikevax. The medical history of Cancer remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine was used for doses after expired date/ 1 week after expired date; 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 EXPIRED PRODUCT ADMINISTERED (vaccine was used for doses after expired date/ 1 week after expired date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was used for doses after expired date/ 1 week after expired date). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (vaccine was used for doses after expired date/ 1 week after expired date) 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.  It was reported that there were no side effects has been experienced by patient, the vial did not undergo any temperature excursions. Number of doses/vials: 13 doses total from 3 vials The vial was initially stored in the refrigerator on 10-Sep-2021,  Dates of administration of vaccine: 3 different dates that is on 12Oct2021, 16Oct2021 and 19Oct2021.  7 doses were administered on 19-Oct-2021   This case was linked to MOD-2021-359475 (Patient Link).
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose received on 2February2021, second dose 1April2021.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 2February2021, second dose 1April2021.) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 2February2021, second dose 1April2021.). On 01-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 2February2021, second dose 1April2021.) had resolved.            No concomitant medication information were provided. No treatment information were provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Insomnia, Malaise, Muscle spasms
Clinical narrative: Charlie horse; It's almost like when you get stung and have an allergic reaction; didn't sleep the whole night; red splotchy; headache; temperature of 101; not feeling good; neck ache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling good), NECK PAIN (neck ache), MUSCLE SPASMS (Charlie horse), VACCINATION COMPLICATION (It's almost like when you get stung and have an allergic reaction) and INSOMNIA (didn't sleep the whole night) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 031A21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was provided by the reporter.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, the patient experienced MALAISE (not feeling good), NECK PAIN (neck ache), VACCINATION COMPLICATION (It's almost like when you get stung and have an allergic reaction), INSOMNIA (didn't sleep the whole night), RASH MACULAR (red splotchy), HEADACHE (headache) and PYREXIA (temperature of 101). On an unknown date, the patient experienced MUSCLE SPASMS (Charlie horse). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of before and after receiving that dose and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (not feeling good), NECK PAIN (neck ache), MUSCLE SPASMS (Charlie horse), VACCINATION COMPLICATION (It's almost like when you get stung and have an allergic reaction), INSOMNIA (didn't sleep the whole night), RASH MACULAR (red splotchy), HEADACHE (headache) and PYREXIA (temperature of 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No history of organ transplant or immunocompromised condition was reported. She was on blood thinners.   This case was linked to MOD-2021-359999, MOD-2021-359904 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up received on 22-0ct-21 contain No new information since reporter was not able to open Follow up letter paper clip.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia, Rash macular, Vaccination complication
Clinical narrative: Charlie horse; It's almost like when you get stung and have an allergic reaction; didn't sleep the whole night; red splotchy; headache; temperature of 101; not feeling good; neck ache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling good), NECK PAIN (neck ache), MUSCLE SPASMS (Charlie horse), VACCINATION COMPLICATION (It's almost like when you get stung and have an allergic reaction) and INSOMNIA (didn't sleep the whole night) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 031A21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was provided by the reporter.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, the patient experienced MALAISE (not feeling good), NECK PAIN (neck ache), VACCINATION COMPLICATION (It's almost like when you get stung and have an allergic reaction), INSOMNIA (didn't sleep the whole night), RASH MACULAR (red splotchy), HEADACHE (headache) and PYREXIA (temperature of 101). On an unknown date, the patient experienced MUSCLE SPASMS (Charlie horse). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of before and after receiving that dose and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (not feeling good), NECK PAIN (neck ache), MUSCLE SPASMS (Charlie horse), VACCINATION COMPLICATION (It's almost like when you get stung and have an allergic reaction), INSOMNIA (didn't sleep the whole night), RASH MACULAR (red splotchy), HEADACHE (headache) and PYREXIA (temperature of 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No history of organ transplant or immunocompromised condition was reported. She was on blood thinners.   This case was linked to MOD-2021-359999, MOD-2021-359904 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up received on 22-0ct-21 contain No new information since reporter was not able to open Follow up letter paper clip.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: After the second dose, she had a sore arm; After the second dose, little swollen; Low grade fever "you know like 100 for one night"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (After the second dose, she had a sore arm), VACCINATION SITE SWELLING (After the second dose, little swollen) and PYREXIA (Low grade fever "you know like 100 for one night") in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 002A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (After the second dose, she had a sore arm), VACCINATION SITE SWELLING (After the second dose, little swollen) and PYREXIA (Low grade fever "you know like 100 for one night"). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (After the second dose, she had a sore arm), VACCINATION SITE SWELLING (After the second dose, little swollen) and PYREXIA (Low grade fever "you know like 100 for one night") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100.   Patient is on Blood thinners.   This case was linked to MOD-2021-359904, MOD-2021-359939.   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up contains No new information