chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Headache, Muscle tightness, Tendon disorder
Clinical narrative: affected all my muscles and they're still tight; affected all my tendons; headaches; Initial information received on 16-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a patient (unknown demographics) who had affected all muscles and they were still tight (muscle tightness), affected all tendons (tendon disorder) and headaches (headache) after receiving INFLUENZA VACCINE and COVID-19 VACCINE.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site and a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient affected all muscles and they were still tight (muscle tightness), affected all tendons (tendon disorder) and headaches (headache) (non-serious, unknown latency) following the administration of vaccines.  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was reported "I got the senior flu shot in Sept. Since I always get one I did not expect the reaction I got. I am auto-immune for the coronavirus disease (COVID) vaccines The flu shot affected all my muscles and tendons, and they were still tight today. I still get headaches too. No more vaccines for me."  It was not reported if the patient received a corrective treatment.  The patient did not recovered for the reported events.  There would be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Nasopharyngitis
Clinical narrative: made me sick; have a cold from time to time; Initial information received on 16-Nov-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (unknown demographics) whom made sick (illness) and cold from time to time (nasopharyngitis) after receiving INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s), Concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient fell sick (illness, non-serious) and cold from time to time (nasopharyngitis, non-serious) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was reported "Some people would drink manure tea if told, have not had a flu shot in over fifty years, the one I had made me sick and other who got it were sick too, I may have a cold from time to time but not the flu, must not really work cause they keep pushing one every year."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported events.  There would be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; Initial information was received on 16-Nov-2021 regarding an unsolicited valid serious case received from a- Social Media via a consumer/non-health care professional.  This case involves a patient (unknown demographics) who had anaphylactic reaction after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious anaphylactic reaction (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  Information on batch number was requested for this case.; Sender's Comments: This case concerns a patient (unknown demographics) who had anaphylactic reaction after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination and laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 15-Nov-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves a patient (unknown demographics) who had flu (influenza) after receiving INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was reported "Thanks, but I'll pass. Stopped getting the flu shot 18 years ago, and stopped getting the flu. And the one time I has it before that, a quick round of Tamiflu took care of it with no side effects."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There would be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: worst flu; Initial information was received on 16-Nov-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional via Medical information (under reference number - US-SA-SAC20211123000304)  This case involves a patient of (unknown demographics) who experienced worst flu (influenza), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious worst flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  No additional laboratory data was 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 event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: Shipment of FLUBLOK that took too long in route to the facility so it was found not suitable, They state this FLUBLOK was then administered to two patients by mistake, with no reported AE; Initial information received on 02-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via Media Information (under the reference 00839503).  This case involves two patients (unknown demographics) whom INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] was administered by mistake and also involves temperature excursion due to shipment of flublok that took too long in route to the facility so it was found not suitable (product storage error).  The patients medical history, medical treatment(s), vaccination(s), Concomitant medication(s) and family history were not provided.  On an unknown date, the patients received a dose of suspect FLUBLOK QIV (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual case of incorrect product storage (unknown latency).  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 would be no information on the batch number for this case.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: Physician states that a nurse administered both PENTACEL and ACTHIB to a 2-month old patient/no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician and consumer/non-health care professional via Medical Information (MI) (Reference number- 00854395) and transmitted to Sanofi on 11-Nov-2021.  This case involves a 2-month-old patient nurse administered both DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and HIB (PRP/T) VACCINE [ACT-HIB] (extra dose administered).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect HIB (PRP/T) VACCINE (solution, dosage text 1x) and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [frequency: once, Dose:  0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin TB skin test, strength: standard except for Fluzone HD, lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  It was an actual medication error case due to extra dose administered  (latency: same day)  it was reported "Physician states that a nurse administered both PENTACEL and ACTHIB to a 2-month old patient. Physicians asks if there is information regarding the toxicity of this. Physician states she does not have time to complete an AE report at time of call because she needs to call the patient's mother."  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 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 the batch number for this case.
Age: 1.25
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 15 months old patient received a dose of FLUBLOK vaccine by accident/ No AE; Initial information received on 12-Nov-2021 regarding an unsolicited valid non-serious case from a physician via consumer via Global Medical Information (GMI) number: 00856152.  This case involves a 15 months old male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] by accident (product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for prophylactic vaccination.  On 11-Nov-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Injection, time interval unit: total, frequency: once, strength: standard lot number: UJ725AA, expiry date: 30-JUN-2022 via intramuscular route in the right thigh 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 "Physician is calling to advise that a 15 months old child received FLUBLOK by accident. Doctor is wanting to know what they should do. Doctor is also asking if it would increase patients Hydronephrosis."  Product used, First time product used : Yes and Still using product : No.  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 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: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: FLUZONE HIGH-DOSE QUADRIVALENT at a high of 49.6F for 5 hours and 10 minutes with no reported adverse event; Initial information regarding this valid unsolicited non-serious case via Medical Information (Reference number- 00858018) was received from other health care professional and transmitted to Sanofi on 15-Nov-2021.  This case involved an unknown age and unknown gender patient who experienced fluzone high-dose quadrivalent at a high of 49.6f for 5 hours and 10 minutes with no reported adverse event (Product storage error) when received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ716AC and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (unknown latency) the patient experienced and reported non-serious fluzone high-dose quadrivalent at a high of 49.6f for 5 hours and 10 minutes with no reported adverse event (product storage error) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "HCP reporting a temperature excursion due to a delay in transport between facilities."  No laboratory data was reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the event outcome reported as 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: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Nurse reporting an expired dose of MENACTRA was inadvertently administeredwith no reported adverse event; Initial information received on 15-Nov-2021 regarding an unsolicited valid non-serious case from a Other Health Care Professional via Non-Healthcare Professional via physician via Medical Information (Reference number- 00858521).  This case involves a 13-year-old female patient who was inadvertently vaccinated with the expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Expired product administered).  The patient past medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and COVID-19 VACCINE (COVID-19 VACCINE) for prophylactic vaccination.  On 15-Nov-2021, the patient received a 0.5 ml first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6785AA and expiry date: 31-Oct-2021, Suspension for injection) (Frequency once) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error case due to Expired product administered (latency on same day).  It was reported "Call received from Nurse reporting an expired dose of MENACTRA was inadvertently administered. Caller with question on whether dose needs repeating?".  At 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: 32.0
Sex: M
Vaccine: TD, TDAP
Symptoms: Medication error, Product label confusion, Wrong product administered
Clinical narrative: Stated that she gave a patient the Tenivac and should have been Adacel with no reported adverse event; staff member getting confused on the labeling between the two vaccines with no reported adverse event; Initial information received on 16-Nov-2021 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 32-year-old male patient who stated that she gave a patient the DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and should have been DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered) and staff member getting confused on the labeling between the two vaccines (product label confusion).  The patient medical history, medical treatment(s), vaccination(s), and family history were not provided.  No other concomitant vaccines reported.    On 15-Nov-2021, the patient received a 0.50 mL dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [lot U6603AA, expiry date: 05-Mar-2022] via an intramuscular route in the left deltoid for prophylactic vaccination. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered and product label confusion [Latency: on the same day].  At time of reporting, the outcome was unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Administered an expired Pentacel to a patient with no reported adverse event; Initial information received on 17-Nov-2021 regarding an unsolicited valid non-serious case from other healthcare professional and a consumer/non-healthcare professional via Medical Information (under reference number 00862209).  This case involves a patient (unknown age and gender) who was administered an expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) 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 expired vaccine used (same day latency).  It was reported "Caller stated she called yesterday because they administered an expired Pentacel to a patient and would like more information. Caller provided a case number that did not populate: 00862739. Perhaps the correct inquiry number is 00861739. The caller states that she doesn't have time to provide additional Adverse event (AE) information but she accepts a call back or paperwork from regulatory authority. This is all the information she provided at the time of her call."  At 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.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient received an expired dose of FLUZONE HIGH-DOSE QUADRIVALENT vaccine/ No AE; Initial information received on 18-Nov-2021 regarding an unsolicited valid non-serious case received from a pharmacist via consumer.  This case involves an unknown age and gender patient who received an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "Patient received expired Fluzone High Dose, when can patient be re-vaccinated with current seasons vaccine. Any timing/ spacing considerations."  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.  There will be no information on the batch number for this case.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the shot and shingles twice/Suspected vaccination failure; shingles, feeling of hot electric wires wrapped around waist; pain; 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain 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 had the Shingle shot and shingles twice and described it as a feeling of hot electric wires wrapped around waist. The patient reported it was like anything else the shot helps but once get it, the pain could last almost a year with flare ups. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Stem cell transplant
Clinical narrative: Stem Cell Transplant; This case was reported by a pharmacist via call center representative and described the occurrence of stem cell transplant in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced stem cell transplant. On an unknown date, the outcome of the stem cell transplant was unknown.   It was unknown if the reporter considered the stem cell transplant to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The pharmacist reported that a patient had a stem transplant after receiving the first dose of Shingrix.  The patient did not know what the indication for the stem cell transplant was or if the disease started before or after Shingrix. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: DEATHLY ILL; This spontaneous report received from a consumer via a company representative concerned multiple patients of unknown race and ethnicity. The patients height and weight were not reported. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry : Unknown) dose, frequency 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, family members and friends had died from the virus, they had became deathly ill within days and months after the vaccine. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event deathly ill was fatal. This report was serious (Death).; Sender's Comments: V0: 20211143279-COVID-19 VACCINE AD26.COV2.S-Deathly ill. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: DEATHLY ILL
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced COVID-19 (covid). At the time of the report, COVID-19 (covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant drugs were not reported. Treatment medication includes monoclonal antibodies This spontaneous case concerns a 66-year-old female patient with no details on relevant medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 5 months after the second dose of mRNA- 1273 vaccine. Very limited information regarding clinical course was provided. Unspecified treatment with monoclonal antibodies was given. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Drug ineffective was not captured since information regarding the appropriateness of the schedule of vaccination is not available at this moment.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Follow-up received on 18-NOV-2021, contains no new information; Sender's Comments: This spontaneous case concerns a 66-year-old female patient with no details on relevant medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 5 months after the second dose of mRNA- 1273 vaccine. Very limited information regarding clinical course was provided. Unspecified treatment with monoclonal antibodies was given. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Drug ineffective was not captured since information regarding the appropriateness of the schedule of vaccination is not available at this moment.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter realized one patient had not received a Moderna vaccine.  So, the total number reported was 47 . Concomitant drugs were not reported. Treatment details were not given.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Vomiting
Clinical narrative: he has not stopped vomiting since 1-2 hours after receiving the vaccine; Patient got expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of VOMITING (he has not stopped vomiting since 1-2 hours after receiving the vaccine) and EXPIRED PRODUCT ADMINISTERED (Patient got expired vaccine) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Bee sting hypersensitivity, Drug allergy (Hydralazine), Drug allergy (METOCLOPERAMIDE), Drug allergy (NORVASC), Drug allergy (LASIX), Coronary artery disease and Congestive heart failure.    On 28-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced VOMITING (he has not stopped vomiting since 1-2 hours after receiving the vaccine) and EXPIRED PRODUCT ADMINISTERED (Patient got expired vaccine). The patient was treated with ONDANSETRON HYDROCHLORIDE (ZOFRAN [ONDANSETRON HYDROCHLORIDE]) (intramuscular) ongoing since an unknown date for Vomiting, at a dose of UNK (Zofran shot). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient got expired vaccine) had resolved. At the time of the report, VOMITING (he has not stopped vomiting since 1-2 hours after receiving the vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Follow-up includes: Patient Demographics, Medical history and Suspect information were updated
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Transfusion
Clinical narrative: a transfusion of blood 3 months ago in the hospital; This spontaneous case was reported by a pharmacist and describes the occurrence of TRANSFUSION (a transfusion of blood 3 months ago in the hospital) in a 90-year-old female patient 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 first 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 TRANSFUSION (a transfusion of blood 3 months ago in the hospital) (seriousness criterion hospitalization). At the time of the report, TRANSFUSION (a transfusion of blood 3 months ago in the hospital) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Reporter stated that patient was at their pharmacy for a booster dose of the Moderna Covid-19 Vaccine.   No treatment medications were provided  Company comment: This is a spontaneous case concerning a 90-year-old female patient with no reported medical history, who experienced the serious (hospitalization)  unexpected event Blood transfusion . The event occurred on an unknown date after the second  dose of mRNA-1273.  Very limited information regarding the events has been provided. Further information has been requested.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 90-year-old female patient with no reported medical history, who experienced the serious (hospitalization)  unexpected event Blood transfusion . The event occurred on an unknown date after the second  dose of mRNA-1273.  Very limited information regarding the events has been provided. Further information has been requested.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Diarrhoea
Clinical narrative: Diarrhea; Pain on side of her breast/pain that is coming and going/it is on the right side/it is sharp; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Pain on side of her breast/pain that is coming and going/it is on the right side/it is sharp) and DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced BREAST PAIN (Pain on side of her breast/pain that is coming and going/it is on the right side/it is sharp). On 18-Nov-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, BREAST PAIN (Pain on side of her breast/pain that is coming and going/it is on the right side/it is sharp) and DIARRHOEA (Diarrhea) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Insomnia
Clinical narrative: can't sleep; I have a headache; This spontaneous case was reported by a pharmacist and describes the occurrence of INSOMNIA (can't sleep) and HEADACHE (I have a headache) 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 INSOMNIA (can't sleep) and HEADACHE (I have a headache). At the time of the report, INSOMNIA (can't sleep) and HEADACHE (I have a headache) 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 provided by the reporter. No Treatment information was reported.   Reporter did not allow further contact
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: It is itching right now. It is really itchy and ongoing; Started getting welts again, the first one was behind their knee at the same place / Everyday they get new welts and it is affecting their arms, legs and lower back; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (It is itching right now. It is really itchy and ongoing) and URTICARIA (Started getting welts again, the first one was behind their knee at the same place / Everyday they get new welts and it is affecting their arms, legs and lower back) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 028(L or Z?)20A and 010A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (It is itching right now. It is really itchy and ongoing) and URTICARIA (Started getting welts again, the first one was behind their knee at the same place / Everyday they get new welts and it is affecting their arms, legs and lower back). The patient was treated with GABAPENTIN for Shingles, at an unspecified dose and frequency. At the time of the report, PRURITUS (It is itching right now. It is really itchy and ongoing) had not resolved and URTICARIA (Started getting welts again, the first one was behind their knee at the same place / Everyday they get new welts and it is affecting their arms, legs and lower back) outcome was unknown.            Treatment details also included antiviral medication for the shingles and patient changed body shop and tried antihistamine medication.   This case was linked to MOD-2021-390729 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A, 025C21A and 037A21B) for COVID-19 vaccination. No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced VACCINATION SITE PAIN (Sore arm.). On 17-Nov-2021, VACCINATION SITE PAIN (Sore arm.) had resolved.            Concomitant medications include birth control pills. Treatment details were not reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered
Clinical narrative: Patient administered expired dose of Moderna COVID-19 vaccine; Third full dose administered to a patient who should have received a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired dose of Moderna COVID-19 vaccine) and ACCIDENTAL OVERDOSE (Third full dose administered to a patient who should have received a booster dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) 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) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired dose of Moderna COVID-19 vaccine) and ACCIDENTAL OVERDOSE (Third full dose administered to a patient who should have received a booster dose). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered expired dose of Moderna COVID-19 vaccine) and ACCIDENTAL OVERDOSE (Third full dose administered to a patient who should have received a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Non Significant Follow Up Appended.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 Patients administered expired doses > 12 hours post puncture; 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 (5 Patients administered expired doses > 12 hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Patients administered expired doses > 12 hours post puncture). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (5 Patients administered expired doses > 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 16-Nov-2021, the vial was initially stored in the refrigerator. On 17-Nov-2021 at 8 AM, vial was first punctured and was stored In RT post puncture and did not undergo any temperature excursions.Total amount of time the vial was exposed to room temperature range 8° to 25°C, 46° to 77°F was 24 hours. No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting after my booster; This spontaneous case was reported by a pharmacist and describes the occurrence of VOMITING (Vomiting after my booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting after my booster). At the time of the report, VOMITING (Vomiting after my booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported   This case was linked to MOD-2021-390747 (Patient Link).