chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Normal soreness in the arm; This is a spontaneous case, initially received from other non-health professional on 18-Dec-2018, concerning a male patient of unspecified age.  The patient had soreness in arm upon receiving intramuscular injection in the past (unspecified dates) but he found it normal.  On 14-Dec-2018, the patient received Fluad TIV [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, anatomical location: intramuscular, route of administration: deltoid, batch number, expiry date: not reported] for influenza prophylaxis.  On 15-Dec-2018, 1 day after vaccination, the patient experienced normal arm soreness. At the time of the report, the patient felt almost resolved (also reported as almost nothing).  The outcome of the event was recovering.  The reporter assessed this case as non-serious.; Reporter's Comments: A male patient of an unspecified age experienced arm soreness, on the next day of administration of Fluad (TIV). The company assessed the event arm soreness as related due to the plausible temporal relationship between the suspect vaccine and the reported event.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Muscle twitching, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Arm and legs have [had some pain and] experienced weakness; Arm and legs have had some pain; Arm and legs have [had some pain and experienced weakness] stiffness; Arm and legs have [had some pain and experienced weakness, stiffness] had some twitching like symptoms; This is a spontaneous case initially received from other non-health professional (consumer) on 20-Dec-2018, concerning a 44-year-old adult male patient.  Patient did not have any relevant medical history and was not taking any concomitant medications at the time of vaccination.  On 02-Nov-2018, the patient was administered Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, dose: 0.5 ml, anatomical location: upper arm, batch number: 252665, expiration date: 30-Jun-2019 and route of administration: not reported) for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine  On 14-Nov-2018 (reported as 10-12 days after vaccination), patient experienced some reactions which included pain in arm and legs, weakness, stiffness and had some twitching like symptoms. Patient went to several doctors but took no medicines or any treatment measures till the time of reporting.  The outcome of the events was not recovered (ongoing).  The reporter assessed this case as non-serious.  Non-significant follow-up reported by reporter on 15-Feb-2019: The Med Info Number: SEQ19-00245 was added in the additional information tab. It was reported that attempt to contact the reporter was made on 14-Jan-2019 and the reporter had not reached back out to the date. Hence, this case was considered as lost to follow-up. No changes were made in the narrative.; Reporter's Comments: A 44-year-old, male patient experienced pain, weakness, stiffness in extremities (arm and legs) and twitching 12 days after administration of Flucelvax Quadrivalent. The company assessed the causality of the events as related to the suspect vaccine due to plausible temporal relationship between the events and the suspect vaccine.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: Lymph nodes of the patient are swollen/ lymph nodes are the size of a plum and her node on the left side is bigger than the other one; Fatigue; This is a spontaneous case, initially received from pharmacist on 04-Jan-2019, concerning a 51-year-old, adult, female patient.  The patient had no relevant medical history and concomitant medications.  On 31-Dec-2018, the patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell culture derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252684 and expiry date: 30-Jun-2019) for influenza prophylaxis.  On the next day after vaccination, the lymph nodes of the patient were swollen, and she was fatigue. Her lymph nodes were the size of a plum and her node on the left side was bigger than the other one.  The patient didn't receive any treatment.  At the time of the report, the patient had not recovered from the events.  The reporter assessed the case as non-serious.  Non-significant follow up received from pharmacist 14-Jan-2019: Added reporter detail (pharmacy) in the general tab. Added reference number (Info Number: SEQ19-00247) in the additional information tab. No new information was received as the reporter did not follow-up or gave the permission to follow-up with the patient. No changes were done in narrative.; Reporter's Comments: A 51-year-old female patient developed swollen lymph nodes and fatigue on the next day after receiving Flucelvax QIVc. The company assessed the causality of the events as related due to plausible temporal relationship between suspect vaccine and the events.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Numbness on the left foot and the left side of forehead; Some arm pain; This is a spontaneous case initially received from a pharmacist on 07-Jan-2019, concerning a 26-year-old adult female patient.  The patient did not have any relevant medical history. The concomitant medications of the patient included escitalopram, bupropion XL, Kariva (desogestrel, ethinylestradiol) and hydroxyzine for unknown indications.  On 07-Jan-2019, the patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252685 and expiration date: not reported) for active immunization against influenza.  On the same day, after the administration of the vaccine, the patient experienced some arm pain straight away. 20-30 minutes after the administration, patient experienced numbness on the left foot and the left side of her forehead. No treatment was given till the time of reporting. It was reported that, the patient was not hospitalized.  The outcome of the events was not recovered (reported as ongoing).  The reporter assessed this case as non-serious.  Follow-up report received from reporter on 18-Feb-2019: The secondary reporter details were added in the general tab and Med info reference number (SEQ19-00784) was added in the additional information tab. The initial reporter will no longer be available for contact. The secondary reporter refused to provide any further information. Hence, this case is considered as lost to follow-up. No changes were made in the narrative.; Reporter's Comments: A 26-year-old female patient experienced pain in arm straight away after the administration and numbness 20-30 minutes after the administration of Flucelvax QIVc. The company assessed the causality of the events as related to the suspect vaccine due to plausible temporal relationship between the suspect vaccine and the events.
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: Sore arm; 2 vaccines in 1 season; Sore arm; This is a spontaneous case from, initially received from other health professional (nurse) on 09-Jan-2019, concerning a female patient of an unspecified age.  The patient had no medical history and was not taking any concomitant medications.  On 01-Nov-2018, the patient was administered the first dose of Afluria Quadrivalent [influenza vaccine, dose, route of administration, anatomical location, batch number and expiry date: not reported] for an unknown indication.  On the same day after vaccination, the patient experienced sore arm which was recovered on 02-Nov-2018. The patient did not receive any treatment medications for the event.  On 09-Jan-2019, the patient was administered the second dose of Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: YF40608 and expiry date: 30-Jun-2019] for influenza prophylaxis (explicitly coded as extra dose administered).  On the same day after vaccination, the patient experienced sore arm which was recovered on 10-Jan-2019. The patient did not receive any treatment medications for the event.  The reporter assessed this case as non-serious.  Follow up received from other health professional (nurse) on 06-Feb-2019: The classification special case with no AE' was deleted from the general tab. The reporter's details (address, department and email address) were added in the general tab. The patient's details (name, address, state, county, postal code and email address) were added in the patient tab. It was reported that the patient had sore arm for 24 hours after each influenza vaccination. Hence, added the event pain in arm' twice in the event tab with different start dates and stop dates in the event tab. The narrative and case comment were amended accordingly.  Case re-opened for completion of full data entry: 06-Feb-2019; Reporter's Comments: A female patient of an unspecified age was administered two doses of Afluria Quadrivalent vaccine in same season (extra dose administered). The patient experienced sore arm, on the same day after each vaccination. The company assessed the causality of the events pain in arm as related to the suspect vaccine due to plausible temporal relationship between events and suspect vaccine. The company assessed the causality of the event 'extra dose administered' as not related to the suspect vaccine due to accidental nature of the event.
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Decreased appetite, Malaise, Nausea, Pain in extremity
Clinical narrative: Overall weakness; Sick; Nauseous; Lack of appetite; Soreness in her arm; This is a non-serious spontaneous case, initially received from other health professional (nurse) via pharmaceutical manufacturer (Merck) on 02-Jan-2019, concerning a female patient of unspecified age.  On an unspecified date (reported as a year and half ago), the patient was administered Fluad TIV (Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose, route of administration, anatomical location, batch number, expiry date: not reported) for an unknown indication.   On an unspecified day after vaccination, the patient got sick and experienced nausea, soreness in her arm, lack of appetite and overall weakness.  The patient had recovered from the events.; Reporter's Comments: A female patient developed sickness, nausea, pain in arm, lack of appetite and weakness on an unspecified day after receiving Fluad TIV. The company assessed the causality of the events as unassessable due to lack of information regarding the onset latency.
Age: 72.0
Sex: M
Vaccine: UNK
Symptoms: Hypersensitivity, Pruritus, Rash, Skin test positive
Clinical narrative: Higly sensitive to thimerosal/ Allergic reaction; Itchy foot/very itchy all over his foot from the toes to the heal; Rash around the body, foot, leg, thigh; This is a spontaneous case initially received from a other non-health professional (consumer) on 09-Jan-2019, concerning a 72-year-old elderly male patient.  The current condition of the patient included high blood pressure (since unspecified date) and hay fever(sometimes when the pollen count was too high). The concomitant medication of the patient included losartan for an unknown indication.  On 25-Sep-2018, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported] for active immunization against influenza.   On 05-Oct-2018, 10 days after the vaccine administration, patient experienced an allergic reaction of an itchy foot and it has gotten worse. The patient saw a dermatologist, who recently did a patch test and it resulted that the patient was highly sensitive to thimerosal. It was very itchy all over his foot from the toes to the heal. As a treatment, the patient took prednisone for 15 days and it calmed it down but when he stopped taking the oral prednisolone the symptoms came back. At the time of reporting, the patient was using topical steroids as a treatment to reduce the itching: Betamethosane dipropionate, Cloderm (clotrimazole). The treatment medications made the events subside but it doesn't make it go away.   It was reported that, the patient was not hospitalized.  The outcome of the events was not-recovered.  The reporter assessed this case as non-serious.  Follow-up received from the other non-health professional (consumer) on 06-Feb-2019: The event generalised rash was added in the event tab. The narrative and case comment were amended accordingly.  Non-significant follow up received from the other non-health professional (consumer) on 18-Mar-2019. No new information was received, and hence no changes were made in the narrative.  Case re-opened for completion of full data entry: 06-Feb-2019.; Reporter's Comments: A 72-year-old male patient experienced allergic reaction and itching ten days after administration of Fluad (TIV). On an unspecified date after vaccination patient developed generalised rash. The company assessed the causality of the event allergic reaction as related to the suspect vaccine due to plausible temporal relationship between the event and suspect vaccine. The causality of the event generalised rash was un-assessable to the suspect vaccine due to lack of information regarding the onset latency of the event.
Age: 3.0
Sex: F
Vaccine: UNK
Symptoms: Decreased appetite, Product administered to patient of inappropriate age
Clinical narrative: Decrease in appetite; Vaccine was administered to a 3 year old child; This is a spontaneous case, initially received from a physician on 11-Jan-2019, concerns a 03-year-old, female child patient.   The patient did not have any medical history. The patient did not receive any concomitant medications.  On 11-Jan-2019, the patient (under age of 4 years) was administered with Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell culture derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: thigh, batch number and expiry date: not reported] (explicitly coded as inappropriate age at vaccine administration) for influenza prophylaxis.  On an unspecified date, the patient experienced decrease in appetite.  The outcome of the event was recovered.  The reporter assessed this case as non-serious.  Follow up received from a physician on 05-Feb-2019: The patient details were added in the patient tab and a new event 'decreased appetite' was coded in the event tab. The narrative was amended accordingly.; Reporter's Comments: A 03-year-old female patient (under age of 4 years) was administered Flucelvax QIVc (inappropriate age at vaccine administration) and experienced decreased appetite after unspecified time of vaccination.  The causality of the event decreased appetite was unassessable due to lack of onset latency. The company assessed the causality of the event inappropriate age at vaccine administration as not related to the suspect vaccine due to accidental nature of the event.
Sex: M
Vaccine: FLUC4
Symptoms: Fatigue, Hyperhidrosis, Oropharyngeal pain
Clinical narrative: Sore throat/terrible sore throat; Sweats; Fatigue; This is a spontaneous case from initially received from other non-health professional (consumer) on 10-Jan-2019, concerning a male patient of unknown age.  The patient's medical history included skin cancer for 10 years. The patient did not receive any concomitant medications.  On an unknown date in Sep-2018 (reported as 4 months ago), the patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252230 and expiration date: 31-May-2019) for influenza prophylaxis.   On the same day, within 20 minutes of receiving the vaccine, the patient experienced sore throat. Over the next several days, it became a terrible sore throat. On an unknown date, after vaccination the patient experienced fatigue and sweats but did not know if he had a fever. He did not take a temperature. The patient did not see his MD or in any after-hours clinic. As a treatment, the patient took bedrest and homecare. It was reported that, the patient was not hospitalized. It took him 2 months to recover from the events.   The outcome of the event (sore throat) was recovered on an unspecified date in Nov-2018 (reported as 2 months afterwards) and the events (fatigue and sweaty) as recovered on an unspecified date in 2018.  The reporter assessed this case as non-serious.  Non-significant follow-up received on 18-Mar-2019. Med Info Number (SEQ19-00694) was added in additional information tab. It was reported that attempt was made on 11-Feb-2019 in order to obtain further follow-up information with no success. Hence this case is considered as lost to follow-up.; Reporter's Comments: A male patient of unknown age experienced sore throat within 20 minutes after administration and fatigue and sweaty after an unspecified period of time after administration of Flucelvax QIVc. The company assessed the causality of the event (sore throat) as related to the suspect vaccine due to plausible temporal relationship between the suspect vaccine and the events. The company assessed the causality of the events (fatigue and sweaty) as unassessable due to lack of information regarding the vaccination date and onset latency of the events.
Age: 26.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling, Pyrexia
Clinical narrative: Swelling [at the injection site that was] traveling down right arm from the injection site; Redness [and swelling at the injection site that was] traveling down right arm from the injection site; Redness [and swelling] at the injection site; Swelling at the injection site; Fever; Two vaccines administered in right arm; This is a spontaneous case initially received from other health professional on 17-Jan-2019, concerning a 26-year-old adult female patient.  The patient did not have any medical history.  On 14-Jan-2019, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: YF43809 and expiry date: 30-Jun-2019) for protection against seasonal influenza. On the same day, the patient was also administered a non-company suspect vaccine Pneumovax [pneumococcal vaccine polysacch 23v, route of administration: intramuscular, anatomical location: right deltoid, dose, batch number and expiration date: not reported] for an unknown indication. Both the vaccines were given in same arm (right arm) (explicitly coded as drug administration error).  On the same day, after vaccination, the patient experienced fever, injection site redness and swelling which travelled down to her right arm. The patient was presented to the clinic on 17-Jan-2019 with the events. Patient was prescribed an antibiotic (Bactrim).   The outcome of the events was not recovered.  The reporter assessed this case as non-serious.  Non-significant follow up received from the reporter on 18-Mar-2019: It was reported that, the reporter was contacted on 11-Feb-2019 but was unable to obtain the information. The Med info reference number (SEQ19-00695) was updated in the additional information tab and no changes were made in the narrative.; Reporter's Comments: A 26-year-old female patient experienced swelling arm, redness, injection site redness, injection site swelling and fever on the same day after the administration of Afluria Quadrivalent and a non-company suspect vaccine Pneumovax on right arm (drug administration error). The company assessed the causality of the events (swelling arm, redness, injection site redness, injection site swelling and fever) as related to the suspect vaccine (Afluria Quadrivalent) due to plausible temporal relationship between the events and suspect vaccine. The company assessed the causality of the event (drug administration error) as not related to the suspect vaccine due to accidental nature of the event.
Age: 5.0
Sex: M
Vaccine: FLUC4
Symptoms: Influenza, Vaccination failure
Clinical narrative: Flu; Vaccination failure; This is a spontaneous case, reported by other health professional to VAERS and initially received on 28-Jan-2019, concerning a 05-year-old, male child patient.  The patient's current condition included seizure (since an early 2015). It was reported that, no other chronic conditions were noted. The patient's concomitant medication included Keppra (levetiracetam) for seizure.  On 09-Oct-2018, the patient was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture-derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019] for active immunization against influenza disease.  On 24-Jan-2019, 3 months and 15 days after vaccination, the patient was diagnosed with flu by the pediatrician (explicitly coded as vaccination failure). The patient was treated with Tamiflu (oseltamivir phosphate).  On an unspecified day, the patient made a visit to adverse event (reported as A and E) department but was not hospitalized.  On 26-Jan-2019, the patient had recovered from the event.  The reporter assessed the case as non-serious.  Significant follow up received from the reporter on 04-Feb-2019: The start date and stop date of the event flu was added. The company causality for the event flu was changed from unassessable' to related'. The treatment drug Tamiflu' was added with the start date: 24-Jan-2019. Added new event vaccination failure in the event tab. It was confirmed that, the patient was okay and had no symptoms to report. Also reported that, the patient visited an adverse event department, but was not hospitalized. The permission to contact patient was given. The narrative was amended accordingly.  Follow up received from other health professional (nurse) on 18-Feb-2019: The start date (early 2015) of the current condition seizure was added in the patient tab. The concomitant medication Keppra for patient's current condition seizure was added in the product tab. The narrative was amended accordingly.; Reporter's Comments: A 05-year-old male patient experienced flu 3 months 15 days after Flucelvax QIV vaccination (coded to influenza & vaccination failure). Considering the fact that vaccine needs minimum 2-3 weeks to provide immune protection against influenza, vaccination failure and causal role of suspect vaccine for the event flu cannot be ruled out and was assessed as related to suspect vaccine. Further assessment will be done upon receipt of new information.The company assessed the event 'flu' as serious (medically significant).
Age: 48.0
Sex: M
Vaccine: FLUC4
Symptoms: Cough, Influenza, Influenza A virus test positive, Malaise, Vaccination failure
Clinical narrative: Vaccination failure; Tested positive for the A strain of the flu; Feeling ill; Positive for A strain of the flu; Persistent cough; This is a spontaneous case initially received from other non-health professional (consumer) on 05-Feb-2019, concerning a 48-year-old, adult male patient.  The patient had no medical history. The patient had not received any concomitant medications.  On an unspecified date in 2018 (reported as sometime in September or October 2018), the patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture-derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported) for active immunization against influenza.  On 05-Feb-2019, 4 or 5 months after vaccination, the patient started feeling ill and experienced persistent cough. The same day, patient went to the doctor. The patient was tested positive for the A strain of the flu (influenza A virus infection) (explicitly coded as vaccination failure). The patient was treated with Tamiflu (oseltamivir phosphate) for the event.  The outcome of the events ill feeling, and influenza was recovering, and the outcome of the event persistent cough was not recovered.  The reporter assessed the case as non-serious.  Non-significant follow-up received from the reporter on 20-Mar-2019: Added reference number (med info number: SEQ19-00828) was added in the additional information. It was reported that, 3 attempts were made to reach the patient on 20-Feb-2019, 27-Feb-2019 and 01-Mar-2019 but was unable to obtain the requested information. No new information was received. Hence, no changes were made in the narrative.; Reporter's Comments: A 48-year-old male patient experienced malaise and cough and was diagnosed to have influenza, 4 to 5 months after Flucelvax QIV vaccination (coded to influenza and vaccination failure). Considering the fact that vaccine needs minimum 2-3 weeks to provide immune protection against influenza, vaccination failure and causal role of suspect vaccine for the event influenza cannot be ruled out and were assessed as related to suspect vaccine. Further assessment will be done upon receipt of new information. The company assessed the case as serious (medically significant).
Sex: M
Vaccine: UNK
Symptoms: Myalgia
Clinical narrative: Muscle soreness; This is a spontaneous case, initially received from a pharmacist via pharmaceutical manufacturer (Pfizer) on 14-Feb-2019, concerning a male patient of an unspecified age.  On an unspecified date in 2016, the patient was administered Afluria (TIV) (influenza vaccine, dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: deltoid, batch number: WT51805, expiry date: 24-May-2017) for an unknown indication.   On an unspecified date, after vaccination, the patient experienced muscle soreness.  The outcome of the event was recovered on an unspecified date.  The reporter considered the case as non-serious.  Case re-opened for completion of full data entry: 14-Feb-2019.  Follow up received from the pharmacist on 19-Apr-2019: The dose (0.5 ml), route of administration (intramuscular) and anatomical location (deltoid) of the suspect vaccine Afluria (TIV) were added in the product tab. The outcome of the event muscle soreness was changed from not reported to recovered in the event tab. The narrative was amended accordingly.  Non-significant follow up received from the pharmacist on 29-Apr-2019: The reporter does not remember the date of birth of the patient and stop date of the event muscle soreness. No new information was received. Hence, no changes were made in the narrative.  Non-significant follow up received from the pharmacist on 06-May-2019: The med info number (SEQ19-01461) was added in the additional information. No information was received regarding patient demographics. Hence, no changes were made in the narrative.; Reporter's Comments: A male patient of an unspecified age experienced muscle soreness on an unspecified date after administration of Afluria (TIV). Due to the lack of information important for the causality assessment, such as onset latency between the vaccination and reported event, the company causality of the event is taken as unassessable.
Age: 8.0
Sex: F
Vaccine: UNK
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: [Tested positive for] Flu; Tested positive for Flu; This is a serious spontaneous case, reported by other healthcare professional and initially received on 18-Feb-2019, concerning a 08-year-old, child, female patient.  On 23-Oct-2018, the patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell culture derived, dose, route of administration, batch number, anatomical location and expiry date: not reported) for an unknown indication.  On an unspecified date, after vaccination, the patient was tested positive for Flu. The patient was feeling much better after taking Tamiflu (oseltamivir phosphate).  The outcome of the event was recovering.  Follow-up was received from the reporter on 19-Feb-2019: Added treatment drug Tami?u (oseltamivir phosphate) in the product tab. The outcome of the event (influenza) was changed from not reported' to recovering'. The narrative was amended accordingly.; Reporter's Comments: An 8-year-old female patient was tested positive for flu, unspecified period of time after receipt of Flucelvax QIVc. Due to the lack of information important for the causality assessment, such as onset latency between the vaccination and reported event flu, company assessed the causality as unassessable. The company assessed the event (Flu) as serious (medically significant).
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema
Clinical narrative: Injection site became red; This is a spontaneous case initially received from a physician on 22-Feb-2019, concerning a female patient of an unspecified age.  It was reported that, the patient had no erythema with the flu vaccine in the past.  On 18-Feb-2019, the patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported) for active immunization against influenza.  On the same day after vaccination, the patient developed redness at the injection site. The patient applied ice packs and took an unspecified antihistamine as treatment.  On 22-Feb-2019, it was reported that the injection site redness was recovering.  The reporter assessed the case as non-serious.  Case re-opened for completion of full data entry: 22-Feb-2019.  Non-significant case amendment (22-Feb-2019): Added medical history in narrative.; Reporter's Comments: A female patient of an unspecified age developed injection site redness on the same day after receiving Flucelvax QIVc. The company assessed the causality of the event as related due to site specific occurrence and plausible temporal relationship between the event and the suspect vaccine.
Sex: F
Vaccine: UNK
Symptoms: Loss of consciousness, Nausea, Vomiting
Clinical narrative: Passed out; Nauseas; Vomiting; This is a spontaneous case initially received from other health professional on 04-Mar-2019, concerning an adolescent female patient of an unspecified age.  The patient had no relevant medical history and concomitant medications at the time of vaccination.  On 03-Mar-2019, the patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 253823 and expiry date: 30-Jun-2019) for influenza prophylaxis.  On the same day, some minutes after the vaccination, the patient passed out. The patient experienced nauseas (as reported) and vomited. Patient felt better after a while and recovered on the same day with no injuries.  The outcome of the events was recovered on 03-Mar-2019.  The reporter assessed this case as non-serious.  Non-significant follow up received from the Medical Communications on 16-Mar-2019: It was reported that the reporter did not have a specific email address, because she was an intern at pharmacy. The reporter had refused to provide any additional patient demographics or personal information. No new information was received, hence no changes were done in the narrative.; Reporter's Comments: A female patient experienced loss of consciousness, nausea and vomiting, on the same day after receipt of Flucelvax QIVc. Considering the plausible temporal relationship between vaccination and reported events, plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed this case as serious (medically significant).
Age: 14.0
Sex: F
Vaccine: FLUC4
Symptoms: Influenza, Influenza A virus test positive, Oropharyngeal pain, Pain, Vaccination failure
Clinical narrative: Vaccination failure; Sore throat; Body aches; Strain A on the flu; Flu/had strain A on the flu; This is a spontaneous case, initially received from other health professional (nurse) on 11-Mar-2019, concerning a 14-year-old, adolescent female patient.  The patient had no medical history. The patient had not received any concomitant medications.  On 25-Oct-2018, the patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture-derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019) for active immunization against influenza.  On 09-Mar-2019 (Saturday), 4 months and 12 days after vaccination, the patient experienced a sore throat and body aches. On the same day, the patient consulted the doctor who confirmed that the patient had strain A on the flu (influenza A virus test positive) (considered as vaccination failure). On the same day, the patient started the treatment with Tamiflu (oseltamivir phosphate). It was reported that, the patient was not hospitalized.   The outcome of the events was not recovered.  This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding QAI reference number was 1039510 for batch number 252664. Based on the investigation performed, it was concluded that Flucelvax 252664 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the lack of efficacy complaint was the result of the Fill Finish or Bulk manufacturing process at the facility and no trend was identified for the batch. Therefore, no internal root cause could be confirmed.  The reporter assessed the case as serious (medically significant).  Follow up report received from Quality assurance department on 28-Mar-2019: Based on the investigation performed, it was concluded that Flucelvax 252664 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. The narrative was amended accordingly.  Non-significant follow up received from the reporter on 15-Apr-2019: It was reported that they had tried to reach the reporter on 18-Mar-2019, 25-Mar-2019 and 04-Apr-2019 but were unable to obtain the information requested. No additional information was received hence, no changes were made in narrative.; Reporter's Comments: A 14-year-old female patient experienced influenza infection (considered as vaccination failure), more than 4 months after receipt of Flucelvax QIVc. Time to onset is plausible following vaccination with the reported Influenza and vaccination failure events. Hence, company assesses the events as possibly related to suspect vaccine.
Age: 2.83
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Red and Swollen.  Give Benadryl
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Balance disorder, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Teen received the flu vaccine on  March 9, 2020. Mom stated the next day she complained of  back pain and 2 days after her legs were weak;  she was unable to balance herself. She was admitted to the hospital on 3/11/20 with Dx: Guillian Barre syndrome - discharged to home on 3/17/20.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: inadvertently given an expired Menveo vaccine; This case was reported by a pharmacist via sales rep and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number unknown, expiry date February 2020) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient received the vaccine which was already expired in February 2020.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Pyrexia
Clinical narrative: having the fever; chills; headache; weekends; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th April 2020, the patient received the 1st dose of Shingrix. In April 2020, less than a week after receiving Shingrix, the patient experienced fever, chills, headache and weakness. On an unknown date, the outcome of the fever, chills, headache and weakness were unknown.   It was unknown if the reporter considered the fever, chills, headache and weakness to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient's wife. The reporter stated that the patient  experienced fever, chills, headache and weakness after vaccination. The reporter asked how long the event last.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Pyrexia, Social problem
Clinical narrative: Fever; Flu like symptoms; Social problem; This case was reported by a nurse via call center representative and described the occurrence of fever in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, influenza-like symptoms and social problem. On an unknown date, the outcome of the fever and influenza-like symptoms were recovered/resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the fever and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported but could be 67 or 68 years. The patient after 1st dose experienced fever and flu like symptoms lasting a day and a half. The patient was told by physician not to get the next dose in Mar due to the Covid virus the patient question was is it safe to get it during this pandemic and can get it later than June.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: Inappropriate schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 43-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 18th March 2020).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, unknown after receiving Twinrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist not administering vaccines at this time due to COVID-19. The reporter asked how long can a patient wait for second dose. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Muscle pain in her arm / achy with movement; Muscle pain in her arm / achy with movement; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Tetanus NVS (Tetanus vaccine).   On 3rd March 2020, the patient received the 1st dose of Shingrix. In March 2020, less than a day after receiving Shingrix, the patient experienced myalgia and pain upon movement. In March 2020, the outcome of the myalgia and pain upon movement were recovered/resolved.   It was unknown if the reporter considered the myalgia and pain upon movement to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. within 24 hours of vaccination the patient noticed the muscle pain in her arm, and noted it was even achy with movement.  The symptoms lasted for 3 days and resolved.   The patient also noted a Tetanus shot in the alternate arm on the same day, but only pain in the arm with the shingrix. Did not consent to follow-up.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: late second dose of Twinrix / due to the situation with the pandemic; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 61-year-old female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HAB (Twinrix).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, unknown after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter called asking for information on a late second dose of Twinrix because a patient already received the first dose and today wanted to receive the second dose but the immunization could not be given because due to the situation with the pandemic with the COVID, the CDC decided to suspend all the immunizations.  The reporter consented to follow up.
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: discomfort; notices an ache at about a 1 to 1.5 inch radius of where the shot was given/On a scale of 1-10 it is a 1/got the shot it hurt/Ache in right arm; This is a spontaneous report from a contactable consumer via Medical information team. A 72-year-old male patient received pneumococcal 13- valent conjugated vaccine (diphteria crm197 protein) (PREVNAR 13), via an unspecified route of administration on Jan2020 at single dose for pneumonia prevention and immunization. Medical history included mild case of Crohn's disease from an unknown date and unknown if ongoing. Concomitant medication included low dose iron supplementation, mesalazine (LIALDA) and a mild dose of pravastatin. It was reported that the patient received PREVNAR 13 injection 3 months ago, and is still experiencing ache in right arm. It took him years to get the nerve to get it. The patient was asking when should he expect discomfort to resolve and any recommendations on managing/treating. The healthcare professional was unaware of post injection experience. The patient still notices an ache at about a 1 to 1.5 inch radius of where the shot was given. On a scale of 1-10 it is a 1. It is more of an annoyance. He notices it when he lifts his arm. When the patient got the shot it hurt like a normal shot would. He put an ice pack on his arm prior to the shot, and then put an ice pack back on his arm to alleviate the pain. It wasn't much more pain than a flu shot. The outcome of the event "notices an ache at about a 1 to 1.5 inch radius of where the shot was given/on a scale of 1-10 it is a 1/got the shot it hurt/ache in right arm" was not recovered while unknown for the other event.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site pain, Injection site warmth, Limb discomfort, Muscular weakness
Clinical narrative: INJECTION SITE PAIN AND HOT TO TOUCH. ARM PAIN RADIATING TO NECK AND HAND. WORSENING OF TENDINITIS IN SHOULDER AND ELBOW. WEAKNESS IN LIMBS. TENDINITIS IN KNEES. GENERAL WEAKNESS. FEELING AS IF ARMS AND LEGS ARE TOO HEAVY.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity, Rotator cuff syndrome
Clinical narrative: INJECTION SITE PAIN AND HOT TO TOUCH. ARM PAIN RADIATING TO NECK AND HAND. WORSENING OF TENDINITIS IN SHOULDER AND ELBOW. WEAKNESS IN LIMBS. TENDINITIS IN KNEES. GENERAL WEAKNESS. FEELING AS IF ARMS AND LEGS ARE TOO HEAVY.
Age: 64.0
Sex: M
Vaccine: TD
Symptoms: Paraesthesia
Clinical narrative: Tingling in the left fingers, left arch of foot, left cheek bone on the second day (4/24/2020) after the shot.  Left foot and fingers continue to feel prickly or tingle as of today (4/28/2020).
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Body temperature decreased, Chills, Computerised tomogram, Dyspnoea, Electrocardiogram
Clinical narrative: Patient began getting cold, unable to hold his body temp, shaking and shivering, no longer able to breathe on his own. Was transferred to nicu at another hospital
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Intensive care, Peripheral coldness, Tremor
Clinical narrative: Patient began getting cold, unable to hold his body temp, shaking and shivering, no longer able to breathe on his own. Was transferred to nicu at another hospital
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Patient reports swelling, warmness to the touch, bumps/or blisters, and itching at injection site and for 2 days after injection.  All of the reaction is within 4 inches of the injection site. After talking to the patient, she was going to take some benadryl and ice her arm. I followed up with her the next day and it was going away.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: Phone call from mom on 4/17/20 stating local reaction. Advised to give symptomatic car. Called on 4/18/20 and spoke with physician on call. Area had grown about 4" around and was red and warm to touch. Parent advised to continue symptomatic care. Mom reported to use topical Benadryl during day and oral Benadryl at night. Never fever or systemic symptoms. Redness, warmth resolved by 4/21/20.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 6-months-old male patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 07-NOV-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) of lot # S004398 with expiration date 31-OCT-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749: