chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; that V ARIV AX had a temperature excursion on 10 OCT 2020 and was administered; This spontaneous report has been  received from an office manager concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.        On 10-OCT-2020, a temperature excursion occured with the varicella virus vaccine live (oka/merck)(VARIVAX) formulation not reported but defaulted to subcutaneous injection, Lot # reported as T01254, expiration date 09-APR-2022 for prophylaxis.        On an unknown date,  the patient was vaccinated with the aforementioned varicella virus vaccine live (oka/merck)(VARIVAX). No additional adverse event (AE) were reported. The temperature excursion  was reported to had been in between a range of -14°C to -10°C, specifically at -14.3°C for 1 hour and 15 minutes, and also in between  -9°C to 8°C, specifically at -9.3°C for 32 minutes.   The total timeframe was reported as 1 hour and 47 minutes.   There was digital data logger involved and  no previous temperature excursion was reported.  This is one of two  reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA007244:
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE was reported; Gardasil 9 was exposed to a the temperature excursion and was administered to a patient; This spontaneous report has been received from a nurse referring to a 12 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On 19-OCT-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1614898 with expiration date of 15-NOV-2021 (strength, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. The vaccine was exposed to a temperature of 13 °C during 30 minutes which was called by a data logger.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Extra dose administered, No adverse event
Clinical narrative: no adverse effects reported; the patient was inadvertently administered two doses of VARN AX on 9/14/2020 and 10/16/2020, which were expired. Both doses supported.; the patient was inadvertently administered two doses of VARN AX on 9/14/2020 and 10/16/2020, which were expired. Both doses supported.; This spontaneous report as was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medication, drug reactions or allergies was provided.     On 14-SEP-2020, the patient was inadvertently vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection (lot # R021097 with an expiration date in 23-JUL-2020), for prophylaxis (strength, dose, route and frequency were not provided). On 16-OCT-2020,  the patient was inadvertently vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection (lot # R021097 with an expiration date in 23-JUL-2020), for prophylaxis (strength, dose, route and frequency were not provided). No adverse effects reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improperly stored and administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided.  On 21-OCT-2020, the patient was vaccinated with an improperly stored 1 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R009614, expiration date 30-NOV-2020 for prophylaxis (exact dose, dose #, route of administration and anatomical location were not reported). The temperature excursion was 50.3 degrees Fahrenheit (F) for 4 hours and 4 minutes. There were no previous excursions reported. The digital data logger was involved. No other adverse events were reported.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: warts on his groin and bilateral knees; This spontaneous report was received from a consumer, via a nurse (also reported as customer) and a company representative, concerning her son, a 12 year old male patient. Information regarding the pertinent medical history, drug reactions/allergies and concomitant medications was not reported.  The date of the first dose was unknown. On 18-AUG-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S020255, expiration date not reported, but upon internal validation stablished as 09-DEC-2021) (dose, route of administration, and anatomical location were not reported) for prophylaxis.    On an unspecified date in 2020 (the exact date was not known), the patient developed warts on his groin and bilateral knees. Medical attention was sought, and an appointment with a dermatologist to assess the warts was scheduled for the patient. The outcome of the event was unknown.  No causality assessment was provide combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S020255; expirationdate: 09-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 53.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Malaise, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pain and stiffness in left arm; Stiffness in left arm; General malaise; This case was reported by a consumer and described the occurrence of pain in arm in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 16th October 2020, the patient received Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. In October 2020, less than a week after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain in arm, limbs stiffness and general malaise. On 19th October 2020, the outcome of the pain in arm, limbs stiffness and general malaise were recovered/resolved.   It was unknown if the reporter considered the pain in arm, limbs stiffness and general malaise to be related to Shingrix. It was unknown if the reporter considered the general malaise to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and Influenza vaccine Quadrivalent 2020-2021 season and experienced pain in arm, limbs stiffness and general malaise, which was recovered. The patient had pain and stiffness in left arm and general malaise for 2 days. No limitations to normal activities.  The reporter consented to follow up. No further information was available.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Headache; Chills; Fever; Put her in bed for couple of days; This case was reported by a other health professional via sales rep and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 26th june,2020) and Shingrix with an associated reaction of headache (For tolerance to 1st dose and other events refer case US2020AMR209258).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced headache, chills, fever and activities of daily living impaired. On an unknown date, the outcome of the headache, chills, fever and activities of daily living impaired were unknown.   It was unknown if the reporter considered the headache, chills, fever and activities of daily living impaired to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  HCP reported that patient received the 2nd dose of shingrix and experienced evnts like headache,chills and fever just recently patient did not experience the same side effects and Head ache was the major complaint. It was reported that patient received the 1st dose of shingrix on 26th june,2020 and Patient had grade 3 side effects from 1st dose of Shingrix that put her in bed for a couple days. It was also reported that patient experienced same events after the 2nd dose which was occured before with the 1st dose. Events were milder as compared to the first dose. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209258:1st dose
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Herpes zoster, Pneumonia, Vaccination failure
Clinical narrative: suspected vaccination failure; pneumonia; shingles; exacerbation of asthma; This case was reported by a pharmacist via sales rep and described the occurrence of suspected vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2019, the patient received Shingrix .5 ml. On an unknown date, 1 month after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), pneumonia (serious criteria GSK medically significant), shingles and asthma. The patient was treated with valaciclovir hydrochloride (Valtrex) and azithromycin (Z-Pak). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the pneumonia, shingles and asthma were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, pneumonia, shingles and asthma to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix and in end of November or December 2019, 1 month later developed shingles, pneumonia, exacebation of asthama. The patient was treated with Valtrex and z-pak. The reporter mentioned that events were resolved. This case was considered as suspected vaccination failure as details regarding vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: not feeling well; This case was reported by a other health professional via other manufacturer and described the occurrence of malaise in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included xeljanz.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional deatils were provided as follows: The age at vaccination was not reported. The age group was not reported but captured as adult as per vaccine indication. The patient was vaccinated with 1st dose of Shingrix and next day after vaccination patient was not feeling well. The patient was continued to hold Xeljanz as patient had Shingles since from June 2020 and treated for it. The physician ordered the patient to get the 2 doses of shingrix vaccine and at no plans to restart Xeljanz. No additional information provided.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: swelled (at the injection site); The pharmacist told her that the Shingrix shot hurts more (than the flu shot); This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 72-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Shingles vaccine (live). Concurrent medical conditions included hard of hearing.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling was recovered/resolved and the outcome of the injection site pain was unknown.   The reporter considered the injection site swelling to be related to Influenza vaccine Quadrivalent unspecified season. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: This case was reported by patient for herself. The age at vaccination was not reported. The had Flu shots that sometimes swelled (at the injection site). In September 2020, the patient received the flu shot and had no issues. The pharmacist told her that the Shingrix shot hurts more (than the flu shot). The reporter consented to follow up. Further tolerance to the dose of Shingrix refer case US2020211098, reported by same reporter. This case has been linked with the case US2020211096 (patient's husband), reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211096:same reporter US-GLAXOSMITHKLINE-US2020211098:Same patient
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A 64 years old patient was administered Fluzone high-dose quadrivalent, no AE; A 64 years old patient was administered Fluzone high-dose quadrivalent, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Global Medical Information (GMI) (Reference number- 00303444) and transmitted to Sanofi on 06-Oct-2020.  This case involves a 64 year old female patient who was administered a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ46AB, expiry date: 30-Jun-2021) once via intramuscular route in the left arm for prophylactic vaccination on 01-Oct-2020 (product administered to patient of inappropriate age and overdose).  Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no concomitant medications.   It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  It was also a case of an overdose (latency same day).  At the time of report, the patient had no symptoms.  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.
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: paient received two doses of Menactra one year apart/no AE; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient (unknown demographics) who was vaccinated with two doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] in one year apart (batch number, route, site of administration and expiry date not reported) on an unknown date for prophylactic vaccination (extra dose administered).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to extra dose administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Atrial fibrillation, Cardiovascular disorder, Dysphonia, Electrocardiogram, Feeling hot
Clinical narrative: hot; eyes were glassy; voice was like she was under water; cardiovascular system (CVS) reaction, atrial fibrillation; Initial information received on 16-Oct-2020 regarding an unsolicited valid serious case received from a consumer (patient).  This case involves a 58 years old female patient who experienced cardiovascular system (CVS) reaction, atrial fibrillation (atrial fibrillation), hot (feeling hot), eyes were glassy (glassy eyes) and voice was like and was under water (dysphonia), while she received INFLUENZA VACCINE.  Medical history included two times before the patient had strange reaction to the flu vaccine that was nothing terrible but felt strange that sent her to Emergency Room (ER).  Medical treatments, vaccinations, concomitant medication 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 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 hot (feeling hot), eyes were glassy (glassy eyes) and voice was like and was under water (dysphonia), 4 hours following the administration of INFLUENZA VACCINE, and her doctor told her to go to the ER.  On an unknown date, the patient developed a serious cardiovascular system (CVS) reaction, atrial fibrillation (atrial fibrillation), (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  The patient states that in the ambulance they gave her something, she doesn't know what it was, that put her into atrial fibrillation.  Relevant laboratory test results included: On an unknown date, EKG (Electrocardiogram)-:  [not reported].  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events was unknown.  Information on the batch number was requested.; Sender's Comments: This case concerns a 58 years old female patient who had atrial fibrillation, was feeling hot, had glassy eyes and dysphonia, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown for atrial fibrillation and compatible for others. Additional information on patient's medical condition at time of vaccination, concomitant medication and investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Glassy eyes
Clinical narrative: hot; eyes were glassy; voice was like she was under water; cardiovascular system (CVS) reaction, atrial fibrillation; Initial information received on 16-Oct-2020 regarding an unsolicited valid serious case received from a consumer (patient).  This case involves a 58 years old female patient who experienced cardiovascular system (CVS) reaction, atrial fibrillation (atrial fibrillation), hot (feeling hot), eyes were glassy (glassy eyes) and voice was like and was under water (dysphonia), while she received INFLUENZA VACCINE.  Medical history included two times before the patient had strange reaction to the flu vaccine that was nothing terrible but felt strange that sent her to Emergency Room (ER).  Medical treatments, vaccinations, concomitant medication 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 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 hot (feeling hot), eyes were glassy (glassy eyes) and voice was like and was under water (dysphonia), 4 hours following the administration of INFLUENZA VACCINE, and her doctor told her to go to the ER.  On an unknown date, the patient developed a serious cardiovascular system (CVS) reaction, atrial fibrillation (atrial fibrillation), (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  The patient states that in the ambulance they gave her something, she doesn't know what it was, that put her into atrial fibrillation.  Relevant laboratory test results included: On an unknown date, EKG (Electrocardiogram)-:  [not reported].  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events was unknown.  Information on the batch number was requested.; Sender's Comments: This case concerns a 58 years old female patient who had atrial fibrillation, was feeling hot, had glassy eyes and dysphonia, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown for atrial fibrillation and compatible for others. Additional information on patient's medical condition at time of vaccination, concomitant medication and investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLUC3, PPV
Symptoms: Erythema, Infection, Skin necrosis, Swelling
Clinical narrative: Skin was necrotizing; Infection; Swelling; Redness; Flucelvax an Pneumovax were both administered in the left arm; Information has been downloaded from Agency (US-SEQIRUS-202000959).  This spontaneous report was received from an other health professional and refers to a 86-year-old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 18-OCT-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) lot # S025133 was confirmed as a valid lot number, expiation date was not provided, but upon internal validation, it was established as 15-SEP-2020, administered intramuscularly for prophylaxis (exact dose, dose # and anatomical location were not provided) and a dose of influenza virus sag 4v vaccine inactivated (mdck cell) (FLUCELVAX QUADRIVALENT) injection, lot # P100124435, administered intramuscularly(excact dose, dose #, anatomical location, expiration date and indication were not provided).  On the same date, the patient experienced infection, swelling, redness and skin necrosis. Both vaccine were administered in the left arm (product administration error). The outcome of the events was not provided.  The causality assessment between suspect vaccines and the events was not provided.  The Agency considered the event of skin necrosis to be medically significant. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); ommondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025133; expirationdate: 15-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender Comments:Temporal relationship between Flucelvax administration and development of reported events is plausible. Alternative aetiology is provided by Pneumovax. Based on the available information, all events are assessed as possibly related to Flucelvax, which defaults to related causality per regulatory reporting purposes.
Age: 67.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Back pain, Chills, Oropharyngeal pain, Pain
Clinical narrative: Pt received FluzoneHD and Prevnar13 on 10/23/2020.  She called on 10/24/2020 complaining of back ache, chills, sore throat, and body aches.  She stated these symptoms started happening 3-4 hours after receiving the vaccines.  She used tylenol and ibuprofen around the clock and this helped.  After following up with the patient, the patient stated she was completely better by 10/25 and that the total time course of this reaction was about 24 hours.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Feeling hot, Tinnitus
Clinical narrative: PATIENT RECIEVED VACCINE VIA STANDARD PROTOCOLS/INJECTION TECHNIQUE. PT PREPARED TO LEAVE AND PRESENTED TO PHARMACY COUNTER STATING DIZZINESS.  RPH ASSISTED PT TO SEATED POSITION AND PT STATED HE WAS "FEELING BETTER". PT APPEARED AS THOUGH HE WAS GOING TO FAINT SO RPH ASSISTED IN LOWERING HIM TO THE GROUND TO A SUPINE POSITION AND ELEVATED HIS FEET. PT CONTINUED TO BE RESPONSIVE BUT AT ONE POINT ASKED IF HE "PASSED OUT".  PATIENT REPORTED FEELING HOT AND RINGING EARS. WHEN PATIENT FELT BETTER, RPH ASSISTED HIM TO A SEATED POSITION AND GAVE HIM AN ORANGE JUICE. WHEN PT FELT ABLE, RPH ASSITED HIM TO SIT IN A CHAIR. PT REMAINED IN PHARMACY FOR 15 MINUTES FOR OBSERVATION. PT STATED NO ADDITIONAL SYMPTOMS OR CONCERNS AND WAS RELEASED.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Chills, Headache, Pain
Clinical narrative: Sudden total body pain & weakness, severe chills.  Headache, joint pain. Started 8 hours after injection & continued through the night getting slightly better by 7am but still experiencing headache & joint pain.
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Induration, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: hives, swelling of shoulder all the way down to elbow. itching and arm still hard from shoulder to elbow 30 days after vaccine.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt reports that 48 hours after injection her arm was red and swollen around the injection site. Pt reports that 3/4 of her arm was red and swollen. Pt took ibuprofen for pain and swelling. By 5 days post vaccine the symptoms were resolved.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Cyst, Injection site bruising, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Had a small bruised swollen slightly tender area on right thigh laterally. Seemed to go away and then returned more swollen and tender in past few days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Kinrix was given in the right arm at 9:19am, the right arm began to swell and whelp at 9:25 am. A Cold compress was applied to the right arm and the whelp began to go down.
Age: 54.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Chills, Cold sweat, Dizziness, Impaired work ability, Malaise
Clinical narrative: Felt lightheaded like she was going to pass out; chills; fever; cold sweat; Feeling like she was beaten with brass knuckles / Sore / Pain; unable to go to work; eeling like she was beaten with brass knuckle; This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2020-2021 season (intramuscular). On 21st October 2020, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced light headedness, chills, fever, cold sweat, pain, inability to work and feeling unwell. The patient was treated with ibuprofen. On an unknown date, the outcome of the light headedness, chills, fever, cold sweat, pain, inability to work and feeling unwell were unknown.   It was unknown if the reporter considered the light headedness, pain, inability to work and feeling unwell to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. The reporter considered the chills, fever and cold sweat to be related to Shingrix. It was unknown if the reporter considered the chills, fever and cold sweat to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient received Shingrix intramuscularly in the left deltoid and also received the flu shot intramuscularly in the right deltoid.  It was reported as the patient was unable to go to work because she woke up feeling like she was beaten with brass knuckles. The patient said she was sore. When she got up (to use the bathroom) she felt lightheaded like she was going to pass out.  The patient also experienced cold sweat and fever and chills. She took ibuprofen for the pain and fever. The patient still had a fever of 101.5 She was attributing these side effects to Shingrix.   The patient wanted know how long the side effects would last. The patient stated that she does did have anaphylaxis). The patient stated that her doctor warned her that she might experience a fever after the Shingrix shot and not to worry as this was normal). She also said that she read about the possible side effects that Shingrix could cause but she wasn't expecting them to be so intense. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Felt lightheaded like she was going to pass out; chills; fever; cold sweat; Feeling like she was beaten with brass knuckles / Sore / Pain; unable to go to work; eeling like she was beaten with brass knuckle; This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2020-2021 season (intramuscular). On 21st October 2020, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced light headedness, chills, fever, cold sweat, pain, inability to work and feeling unwell. The patient was treated with ibuprofen. On an unknown date, the outcome of the light headedness, chills, fever, cold sweat, pain, inability to work and feeling unwell were unknown.   It was unknown if the reporter considered the light headedness, pain, inability to work and feeling unwell to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. The reporter considered the chills, fever and cold sweat to be related to Shingrix. It was unknown if the reporter considered the chills, fever and cold sweat to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient received Shingrix intramuscularly in the left deltoid and also received the flu shot intramuscularly in the right deltoid.  It was reported as the patient was unable to go to work because she woke up feeling like she was beaten with brass knuckles. The patient said she was sore. When she got up (to use the bathroom) she felt lightheaded like she was going to pass out.  The patient also experienced cold sweat and fever and chills. She took ibuprofen for the pain and fever. The patient still had a fever of 101.5 She was attributing these side effects to Shingrix.   The patient wanted know how long the side effects would last. The patient stated that she does did have anaphylaxis). The patient stated that her doctor warned her that she might experience a fever after the Shingrix shot and not to worry as this was normal). She also said that she read about the possible side effects that Shingrix could cause but she wasn't expecting them to be so intense. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 63 year old patient recieved menactra, No AE; Initial information received on 12-Oct-2020 regarding an unsolicited valid non-serious case from a patient (non-health care professional).  This case involves a 63 years old female patient who was vaccinated with 0.5 ml of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and expiration date not reported), via unknown route in unknown administration site for prophylactic vaccination on an unknown date (PT:product administered to patient of inappropriate age) as per her immunologist's recommendation.  Concomitant medications included INFLUENZA VACCINE for prophylactic vaccination.  At the time of the event, the patient had ongoing Type 2 Immunoglobulin G deficiency .   It was an actual medication error case due to inappropriate age at vaccine administration (same day latency).it was reported that now the patient wants to know that if she can get the Menactra booster now even though.  No adverse event reported at the time of reporting.  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 on the batch number for this case.
Age: 14.0
Sex: F
Vaccine: FLUC4
Symptoms: Blindness transient, Body temperature decreased, Dizziness, Dyspnoea, Loss of consciousness
Clinical narrative: Patient started having a brief loss of consciousness around a few minutes after the vaccination was given. Observed shortness of breath, drop in temperature from 97.1 to 94.2 within 15 minutes, temporary loss of vision, nausea, dizziness and lightheadedness. Informed patient to sit up-right and to sit on the bench and frequently talked to the patient in order to keep them conscious until paramedics arrived. Patient had slowly recovered after around 30-45 minutes and left with the paramedics.
Age: 14.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea
Clinical narrative: Patient started having a brief loss of consciousness around a few minutes after the vaccination was given. Observed shortness of breath, drop in temperature from 97.1 to 94.2 within 15 minutes, temporary loss of vision, nausea, dizziness and lightheadedness. Informed patient to sit up-right and to sit on the bench and frequently talked to the patient in order to keep them conscious until paramedics arrived. Patient had slowly recovered after around 30-45 minutes and left with the paramedics.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: right upper arm with decreased ROM, pain for over 17 days,
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Joint range of motion decreased, Pain
Clinical narrative: Shoulder pain that started the day after i received the vaccine. Thought it was just muscle soreness, but its been a constant pain, decreased ROM, and cant lift arm up over head without pain.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Mobility decreased, Pain, Shoulder injury related to vaccine administration, Sleep disorder
Clinical narrative: I received my flu shot on 10/6 after discussing pros and cons.  I experienced shoulder pain and soreness the next day which I knew was expected; however the pain has never gone away.  I am unable to sleep on my left side and the pain at night worsens.  I can't raise my arm straight up, hurts to rotate the arm.  I've used Tylenol Rapid Release, CBD Pain Cream nothing helping.  I contacted my PCP on 10/22 and saw him on 10/23.  I was referred to Physical Therapy but can't be seen until 11/3.  He mentioned that this is a rare side affect. (SIRVA) Should Injury Related Vaccine Administration.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Eye discharge, Eye irritation, Fatigue, Oropharyngeal pain
Clinical narrative: Heavy drainage, sore throat, throat swollen, eyes we're very irritated with heavy mucus production, threw up dinner, chills and shaking. Woke up with congestion and experienced fatigue throughout the day on Monday. Slept 3 hours in the afternoon. Other symptoms were absent on Monday. I don't know the name of the vaccine. The pharmacist said it was given. It was the stronger dose for seniors.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Pharyngeal swelling, Respiratory tract congestion, Somnolence, Tremor, Vomiting
Clinical narrative: Heavy drainage, sore throat, throat swollen, eyes we're very irritated with heavy mucus production, threw up dinner, chills and shaking. Woke up with congestion and experienced fatigue throughout the day on Monday. Slept 3 hours in the afternoon. Other symptoms were absent on Monday. I don't know the name of the vaccine. The pharmacist said it was given. It was the stronger dose for seniors.
Age: 50.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt states she recrived flu vaccine on 10/24/20 and is still continuing to have injection site redness, tenderness to touch, and feels "hot" as of 10/26/20. States that site redness is "golf ball" size.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Insomnia, Myalgia, Pyrexia
Clinical narrative: Shivers, fever, muscle ache, difficulty sleeping, fatigue on day 2.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Paraesthesia oral
Clinical narrative: pt has abnormal soreness in arm, tingling in roof of mouth and tongue.
Age: 48.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling, Rash, Rash pruritic
Clinical narrative: swollen, reddened area at injection site, approximately 3x4" on 10/20/20.  On 10./21/20, developed a pruritic rash to right hand from fingers to shoulder, as well as the right side of neck, left side of neck and left arm, worse on the right.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Myalgia, Pain, Pain in extremity
Clinical narrative: muscle ache/pain from hips up.  Fingers really ached and could hardly bend. seems to be getting better
Age: 9.0
Sex: M
Vaccine: FLU4, MMR
Symptoms: Urticaria
Clinical narrative: Hives on opposite leg of vaccine administration
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Asthenia, Chills, Cough, Dizziness, Headache
Clinical narrative: Onset of symptoms 2am (on 10/21/20) with her waking up to heart palpitations, hands and lips tingling , weak sensation and heaviness of arms, dizzy, chills, shivering, headache, and a cough. The bulk of the symptoms lasted until about 6 am-  She notified the clinic  around 9:30am - She reported at that time having a headache and chills.  Patient reports that each day she felt somewhat better- but continued to have chills -  The chills resolved  on the 6th day. (10/26/20)  Symptoms resolved completely 10/27/20
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Limb discomfort, Palpitations, Paraesthesia, Paraesthesia oral
Clinical narrative: Onset of symptoms 2am (on 10/21/20) with her waking up to heart palpitations, hands and lips tingling , weak sensation and heaviness of arms, dizzy, chills, shivering, headache, and a cough. The bulk of the symptoms lasted until about 6 am-  She notified the clinic  around 9:30am - She reported at that time having a headache and chills.  Patient reports that each day she felt somewhat better- but continued to have chills -  The chills resolved  on the 6th day. (10/26/20)  Symptoms resolved completely 10/27/20
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: Flu shot was inadvertently 2 days in a row. No adverse effects were reported by youth. Youth was monitored for any adverse effects and none were observed. He was seen the following day by medical provider as precaution.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Joint range of motion decreased, Pain
Clinical narrative: Hardened edema and erythema in a 2 inch round area at injection site. Arm sore rated on 8/10scale. Painful to light  palpation, painful to lift from hanging down position. ROM reduced.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Hardened edema and erythema in a 2 inch round area at injection site. Arm sore rated on 8/10scale. Painful to light  palpation, painful to lift from hanging down position. ROM reduced.
Age: 54.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site reaction, Scab
Clinical narrative: Employee received vaccine 10/20. Removed band aid 10/22 to find 1-1.5cm crust over injection site.
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 30-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEPA, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE reported; Caller is reporting a temperature excursion for vaccines that have been administered; This spontaneous report has been received from an office manager concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.       On 21-OCT-2020, the patients were vaccinated with the following vaccines that underwent a temperature excursion: - Rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 0.5 ml, Lot # 1684153, expiration date 23-JUN-2021  for prophylaxis.   - Hepatitis a vaccine, inactivated(VAQTA) formulation not reported but upon internal validation stablished as vial,  0.5 ml, Lot # T018227, expiration date 11-DEC-2021 for prophylaxis.   The temperature was reported to had been below36°F, more specifically at 33.8 °F for 30 minutes.  No further adverse event (AE) was reported.  There was digital data logger involved and  no previous temperature excursion was reported.   This is a non valid case due to lack of patients' identifiers.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received second dose of GARDASIL-9 44 days after the first dose.; This spontaneous report was received from a registered pharmacist and refers to a female patient of an unknown age. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   On 10-JUL-2020 (reported as 44 days ago), the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot#, expiration date, route and site of administration were not provided) for prophylaxis. On 23-AUG-2020, she received her second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, once (lot#, expiration date, route and site of administration were not provided) for prophylaxis.  On that day, the patient received second of the vaccine, 44 days after the first dose, rather than the recommended 2 months.