chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles and postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was unknown. Causality assessment was related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 23-JAN-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles and postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was unknown. Causality assessment was related.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Last vaccine I got nearly killed me / Got sicker than any covid case; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness (serious criteria life threatening). On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated the vaccine nearly killed the patient. After receiving Shingles vaccine, the patient got sicker than any Covid case.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Malaise, Pain in extremity, Pulmonary congestion
Clinical narrative: congestion in her chest; intense headache; tired; sinus infection; arm was also sore; felt sick; This case was reported by a consumer via call center representative and described the occurrence of lung congestion in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2020 16:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2020, less than a week after receiving Shingrix, the patient experienced lung congestion (serious criteria GSK medically significant), headache, tiredness, sinus infection, pain in extremity and malaise. On an unknown date, the outcome of the lung congestion, tiredness and sinus infection were unknown and the outcome of the headache and malaise were not recovered/not resolved and the outcome of the pain in extremity was recovered/resolved.   It was unknown if the reporter considered the lung congestion, headache, tiredness, sinus infection, pain in extremity and malaise to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. After receiving Shingrix, when the patient woke up on 8th August 2020, Saturday morning, she had an intense headache which lasted all day. It had improved since but was still there at the time of reporting.  The patient was tired and felt like she had a sinus infection.  There was some congestion in her chest.  The patient's arm was also sore but was resolved at the time of reporting. The patient had felt sick every day. This case was linked with case US2020159617, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159617:same reporter
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinusitis
Clinical narrative: congestion in her chest; intense headache; tired; sinus infection; arm was also sore; felt sick; This case was reported by a consumer via call center representative and described the occurrence of lung congestion in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2020 16:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2020, less than a week after receiving Shingrix, the patient experienced lung congestion (serious criteria GSK medically significant), headache, tiredness, sinus infection, pain in extremity and malaise. On an unknown date, the outcome of the lung congestion, tiredness and sinus infection were unknown and the outcome of the headache and malaise were not recovered/not resolved and the outcome of the pain in extremity was recovered/resolved.   It was unknown if the reporter considered the lung congestion, headache, tiredness, sinus infection, pain in extremity and malaise to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. After receiving Shingrix, when the patient woke up on 8th August 2020, Saturday morning, she had an intense headache which lasted all day. It had improved since but was still there at the time of reporting.  The patient was tired and felt like she had a sinus infection.  There was some congestion in her chest.  The patient's arm was also sore but was resolved at the time of reporting. The patient had felt sick every day. This case was linked with case US2020159617, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159617:same reporter
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dysstasia, Feeling cold, Feeling hot, Headache
Clinical narrative: Vomited; Hot or dying of heat; Weakness; could hardly stand up; Cold or freezing; 2nd dose received 11th August 2020; Headache; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received on 17th January 2020, for tolerance refer US2020158083).   On 11th August 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 11th August 2020, less than a day after receiving Shingrix, the patient experienced asthenia, difficulty in standing, feeling cold and drug dose administration interval too long. On 12th August 2020, the patient experienced vomiting and feeling hot. In August 2020, the patient experienced headache. On an unknown date, the outcome of the vomiting and drug dose administration interval too long were unknown and the outcome of the feeling hot, headache, asthenia, difficulty in standing and feeling cold were recovering/resolving.   It was unknown if the reporter considered the vomiting, feeling hot, headache, asthenia, difficulty in standing and feeling cold to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on left deltoid. The patient received 2nd dose of Shingrix and on same day and weakness as in she could hardly stand up and Cold or freezing. The patient received 2nd dose which was recomended her in past month which led to lengthening of vaccination schedule.  On 12th August 2020, the patient was hot or dying of heat and she vomited. She then took a nap and felt better. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020158083:same reporter
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site swelling, Vomiting
Clinical narrative: Vomited; Hot or dying of heat; Weakness; could hardly stand up; Cold or freezing; 2nd dose received 11th August 2020; Headache; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received on 17th January 2020, for tolerance refer US2020158083).   On 11th August 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 11th August 2020, less than a day after receiving Shingrix, the patient experienced asthenia, difficulty in standing, feeling cold and drug dose administration interval too long. On 12th August 2020, the patient experienced vomiting and feeling hot. In August 2020, the patient experienced headache. On an unknown date, the outcome of the vomiting and drug dose administration interval too long were unknown and the outcome of the feeling hot, headache, asthenia, difficulty in standing and feeling cold were recovering/resolving.   It was unknown if the reporter considered the vomiting, feeling hot, headache, asthenia, difficulty in standing and feeling cold to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on left deltoid. The patient received 2nd dose of Shingrix and on same day and weakness as in she could hardly stand up and Cold or freezing. The patient received 2nd dose which was recomended her in past month which led to lengthening of vaccination schedule.  On 12th August 2020, the patient was hot or dying of heat and she vomited. She then took a nap and felt better. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020158083:same reporter
Age: 6.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: ADACEL was given to a 6 year old patient, no AE; Initial information received on 07-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a six-year-old male patient who was vaccinated with a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6321AA and expiry date: 07-Jun-2021) via an unknown route in the left vastus lateralis for prophylactic vaccination on 08-Jul-2020.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and HEPATITIS B VACCINE RHBSAG (YEAST) (RECOMBIVAX) for Immunisation.  It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of this report, No symptoms reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 81.0
Sex: F
Vaccine: FLU3, FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 81 year old female patient was given Flublok Quad instead of Fluzone HD, no AE; Initial information received on 07-Aug-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 81 year old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] ] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (wrong product administered).  Medical history, medical treatment, concomitant medication and family history were not provided. Patient had received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] for the last 10 years.   On 06-Aug-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date: not reported) instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong vaccine administered. It was reported that he had received Flublock Quad instead of Fluzone HD. The nurse who administered the vaccine told him that he received it so early that by the time the flu season hits he'll have developed enough antibodies.  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 the batch number for this case.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: The doctor gave the patient only the diphtheria, tetanus, acellular pertussis (DTAP) Polio part of Pentacel without ACT-HIB by mistake, no AE; Initial information was received on 07-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a four month and 5 days old female patient who was given only the diphtheria, tetanus, acellular pertussis (DTAP) polio part of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without ACT-HIB by mistake (Product preparation issue)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 07-Aug-2020, the patient received a 0.5 ml second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ258ABA, expiry date: 04-Apr-2021)(DTAP/polio: Lot: UJ344AA, expiry date: 04-Apr-2021) (frequency: once, single dose vials) via intramuscular route in the right thigh for prophylactic vaccination. The patient still had to get the Act-Hib part  This was a case of an actual medication error case due to inappropriate reconstitution technique.  No adverse event was 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
Age: 58.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Patient had her immunizations on 7/30/2020. She states that a few hours after her immunizations were given she began to have problems moving her right arm. She states her left arm never gave her immobility issues.  She states that the her arm also hurt on the right side. Left side was fine. Patient states that she ran a fever of 100 for 2 days. She states that as time went on she could not move her arm at all. Patient did go to walk in clinic on 8/4/2020. She also report the symptoms to her PCP on 8/04/2020. Patient continued to have the symptoms with slight improvement and again reported on 8/6/2020. Patient states that she was able to move her arm but still was not 100%. She was told to call the clinic in a couple of days if not resolved. Pt will be having further testing as she is still having symptoms. Her left arm remains fine with no issues.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Reddened raised area noted around injection site.  Verbalizes that it is itching at site.   Employee was informed that for continued issue to visit PCP.  At this time has not seen PCP.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Malaise, Pyrexia, Rash vesicular
Clinical narrative: Three days of low grade fever, blistery rash, general malaise
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Face injury, Laboratory test normal, Skin laceration, Syncope
Clinical narrative: Pt received immunization & then his  mom received hers.  Pt came back to pharmacy for form  Pt was leaving and fainted Pt hit his face on merchandise  had bruise on nose cut on forehead.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse effects reported; a patient was administered an improperly stored dose of Rotateq; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-JUL-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial lot # S013890, expiration date 14-FEB-2021 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 48.7 degrees Fahrenheit for 2 hours/ 30 minutes. Data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse effect reported; expired Varivax administered; This spontaneous report was received from a nurse and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-JUN-2020, the patient was vaccinated subcutaneously with a first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (exact dose, lot number and expiration date were not reported) for prophylaxis. On 21-JUL-2020, the patient was vaccinated subcutaneously with a second dose of properly stored but expired varicella virus vaccine live (oka/merck)(VARIVAX) lot # R010468, expiration date 10-APR-2020 (exact dose was not reported). The vaccine was reconstituted with properly stored and not expired sterile diluent. No additional adverse effect reported.
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass
Clinical narrative: lump at injection site on left deltoid; This spontaneous report was received from a physician via a company representative and refers to a 41 years old female patient. There was no information about the patient's medical history, concurrent conditions and concomitant therapy provided. On 24-JUN-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection in prefilled syringe (intramuscularly in the left deltoid, exact dose was not reported, lot # R030453, expiration date not provided but upon internal review established as 23-JUL-2021) for prophylaxis.       On 06-AUG-2020, the patient experienced lump at injection site on left deltoid. No treatment was given for the event. The outcome of the event and causality were not provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R030453; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; 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
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Ophthalmic herpes zoster
Clinical narrative: zoster related vision loss; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 09-FEB-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for zoster related vision loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event zoster related vision loss was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, zoster related vision loss was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 14-DEC-2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster oticus
Clinical narrative: zoster related hearing loss; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 14-AUG-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for zoster related hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event zoster related hearing loss was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, zoster related hearing loss was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: sold red ring around the injection site/ red ring at injection site; This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu unspecified (Influenza vaccine).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Influenza vaccine, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient developed a sold red ring around the injection site after receiving the 1st dose of shingrix. She also received a flu shot at the same time but did not develop any reactions to the flu shot.  The reporter consented to follow up. The case is linked with case  US2020AMR163478 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR163478:same reporter
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Crying, Injection site erythema, Limb discomfort
Clinical narrative: Several hours after immunizations was crying and lifting leg. Area at vaccine site note to be reddened. Tylenol given.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Arm swollen, itchy , red, hot, and painful. No treatment. Swelling decreased after day #3.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Confusional state, Fall, Haemoptysis, Muscle rigidity, Postictal state
Clinical narrative: EMPLOYEE WAS AMBULATING DOWN THE HALLWAY WHEN HE EMMITED ALOUD SHOUT BEFORE FALLING INTO THE WALL AND EVENTUALLY TO THE FLOOR. EMPLOYEE WAS RIDGID AND APPEARED TO BE HAVING SIEZURE LIKE ACTIVITY. EMPLOYEE HAD A BLOOD TINGED SPUTUM. EVENT LASTED APPROX 35-45 SECOND BEFORE RELAXING AND BEGINNIG SNORING RESP.  EMPLOYEE APPEARED TO BE IN POSTICTAL PHASE. EMPLOYEE EVENTUALLY BEGAN TO ROUSE,HOWEVER, WAS VERY CONFUSED. DURING EVENT EMPLOYEE WAS PLACED LEFT LATERAL POSITION AND AIRWAY IS MONITORED . 911 WAS NOTIFIED. ON EMS ARRIVAL EMPLOYEE WAS BECOMING MORE COHERENT WITH NO RECOLLECTION OF EVENTS AND NO OBVIOUS INJURIES NOTED. EMPLOYEE IS PLACED ON STRETCHER IN POC AND TRANSPORTED TO HOSPITAL.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Respiration abnormal, Screaming, Seizure like phenomena, Snoring
Clinical narrative: EMPLOYEE WAS AMBULATING DOWN THE HALLWAY WHEN HE EMMITED ALOUD SHOUT BEFORE FALLING INTO THE WALL AND EVENTUALLY TO THE FLOOR. EMPLOYEE WAS RIDGID AND APPEARED TO BE HAVING SIEZURE LIKE ACTIVITY. EMPLOYEE HAD A BLOOD TINGED SPUTUM. EVENT LASTED APPROX 35-45 SECOND BEFORE RELAXING AND BEGINNIG SNORING RESP.  EMPLOYEE APPEARED TO BE IN POSTICTAL PHASE. EMPLOYEE EVENTUALLY BEGAN TO ROUSE,HOWEVER, WAS VERY CONFUSED. DURING EVENT EMPLOYEE WAS PLACED LEFT LATERAL POSITION AND AIRWAY IS MONITORED . 911 WAS NOTIFIED. ON EMS ARRIVAL EMPLOYEE WAS BECOMING MORE COHERENT WITH NO RECOLLECTION OF EVENTS AND NO OBVIOUS INJURIES NOTED. EMPLOYEE IS PLACED ON STRETCHER IN POC AND TRANSPORTED TO HOSPITAL.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site induration, Injection site inflammation, Injection site nodule, Injection site pruritus
Clinical narrative: Patient developed indurated injection site approximately one week after immunization administered. Site was pruritic, inflamed and had approximately firm blueberry sized nodule at the site of injection.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Facial paralysis
Clinical narrative: Patient reported L facial drooping and ear pain within 24-48 hours after receiving the Shingrix vaccine. He went to the ER thinking he was having a stroke. This was ruled out and he was subsequently diagnosed with Bell's palsy. As of 8/14/20 he had largely recovered but still has some L sided mouth drooping.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash
Clinical narrative: the patient reports 1/2 inch by 3inch rash that was super painful for 7 days and started 24 hours after injection. she stated that she had a headache for 2 days after vaccine. she states that its better now and no long term health issues.
Age: 0.58
Sex: F
Vaccine: DTAPIPV, RV1
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: DTaP-IPV is only licensed for use as the 5th dose of DTaP and 4th dose of IPV. Therefore, the administration of  Kinrix prior to the age of one years is considered a medical error. The patient did not have any notable signs or symptoms. The patient parents also did not report any signs and symptoms.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Feeling abnormal, Pain, Walking aid user
Clinical narrative: Pain in the entire body on the second day after the shot that lasted 2 days after that the pain went to my back and I needed a walker to move.  The serious back pain last one week.  I still have no energy and sleep more than 8 hours a day.  I also have been fuzzyheaded until recently.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Vaccination site mass
Clinical narrative: Father called in to report that there is a "lump" in patients leg from where this vaccine was administered.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Impaired work ability, Injection site discolouration, Injection site erythema, Injection site mass
Clinical narrative: Tiredness and aching, much more than with usual vaccines; fever (99.1 at midnight on day of vaccination, 99.4 the next evening).  Unable to sleep first night, unable to go to work the next day.  A painful lump underneath left arm (not at site of injection).  Most symptoms gone by Aug 6 (2 days after vaccination), but lump under arm remained a few more days.  On Aug 6  I discovered a discoloration, reddish and later bluish like a bruise, under the left arm but farther down from the lump.  The lump was gone and the discoloration much reduced by Aug 9.  I called my doctor to report this but don't remember if I mentioned the lump.  Did not visit doctor.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Pain, Pyrexia
Clinical narrative: Tiredness and aching, much more than with usual vaccines; fever (99.1 at midnight on day of vaccination, 99.4 the next evening).  Unable to sleep first night, unable to go to work the next day.  A painful lump underneath left arm (not at site of injection).  Most symptoms gone by Aug 6 (2 days after vaccination), but lump under arm remained a few more days.  On Aug 6  I discovered a discoloration, reddish and later bluish like a bruise, under the left arm but farther down from the lump.  The lump was gone and the discoloration much reduced by Aug 9.  I called my doctor to report this but don't remember if I mentioned the lump.  Did not visit doctor.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; an expired VAQTA was administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not reported.  On 27-JUL-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscularly (lot# S018419, expiration date was reported as 14-JUL-2020, but upon internal validation established as 12-JUL-2020; site of administration was not reported) for prophylaxis. No additional adverse event was reported.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no AE; Proquad given to 18 yo; This spontaneous report was received from a nurse and refers to a 18-year-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-JUN-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S021325 has been verified to be a valid lot number, expiration date reported as 05-JAN-2020, but upon internal validation established as 05-JAN-2021) (exact dose and route of administration were not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse events reported.
Sex: F
Vaccine: MENB
Symptoms: Injection site cellulitis, Injection site erythema, Injection site injury, Injection site pain, Injection site swelling
Clinical narrative: Suspicious of cellulitis; Skin reaction that included, swelling; Skin reaction that included, swelling, pain; Skin reaction that included, swelling, pain, redness; Injection site reactions presented with red streaks moving around the upper arm; This case was reported by a physician via sales rep and described the occurrence of injection site cellulitis in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   In July 2020, the patient received the 1st dose of Bexsero. In July 2020, 1 day after receiving Bexsero, the patient experienced injection site cellulitis, injection site swelling, injection site pain, injection site erythema and injection site abrasion. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim). On an unknown date, the outcome of the injection site cellulitis, injection site swelling, injection site pain, injection site erythema and injection site abrasion were recovered/resolved.   It was unknown if the reporter considered the injection site cellulitis, injection site swelling, injection site pain, injection site erythema and injection site abrasion to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Bexsero in July 2020 and experienced local skin reactions including swelling, pain, redness and red treaks moving around upper arm. The reporter stated that, the patient was seen in office and was suspicious of cellulitis. The patient treated with Bactrim for cellulitis. For the tolerance of 2nd dose refer case US2020AMR160427, reported for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020160534:FU1 deleted US-GLAXOSMITHKLINE-US2020AMR160427:same reporter
Sex: F
Vaccine: MENB
Symptoms: Skin reaction
Clinical narrative: Suspicious of cellulitis; Skin reaction that included, swelling; Skin reaction that included, swelling, pain; Skin reaction that included, swelling, pain, redness; Injection site reactions presented with red streaks moving around the upper arm; This case was reported by a physician via sales rep and described the occurrence of injection site cellulitis in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   In July 2020, the patient received the 1st dose of Bexsero. In July 2020, 1 day after receiving Bexsero, the patient experienced injection site cellulitis, injection site swelling, injection site pain, injection site erythema and injection site abrasion. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim). On an unknown date, the outcome of the injection site cellulitis, injection site swelling, injection site pain, injection site erythema and injection site abrasion were recovered/resolved.   It was unknown if the reporter considered the injection site cellulitis, injection site swelling, injection site pain, injection site erythema and injection site abrasion to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Bexsero in July 2020 and experienced local skin reactions including swelling, pain, redness and red treaks moving around upper arm. The reporter stated that, the patient was seen in office and was suspicious of cellulitis. The patient treated with Bactrim for cellulitis. For the tolerance of 2nd dose refer case US2020AMR160427, reported for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020160534:FU1 deleted US-GLAXOSMITHKLINE-US2020AMR160427:same reporter
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash erythematous
Clinical narrative: red flat rash on body/ non itchy red flat rash; felt it was not allergic or, if it was, it was minor.; This case was reported by a nurse via sales rep and described the occurrence of red rash in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 9H524, expiry date unknown) for prophylaxis.   On 24th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a day after receiving Shingrix, the patient experienced red rash and allergic reaction. In February 2020, the outcome of the red rash and allergic reaction were recovered/resolved.   It was unknown if the reporter considered the red rash and allergic reaction to be related to Shingrix.  Additional details were reported as follows: The patient received vaccine in left deltoid. On 26th February 2020, the patient called to clinic and reported a rash that began within 24 hours of receiving dose 1 of Shingrix. It was a non itchy red flat rash on body, not near the injection site.  The rash resolved within 24 hours of onset of the rash. The rash was not itchy, the patient had no difficulty breathing, and had no related allergic symptoms. No medical visit or hospitalization was required subsequent to the event. The reporter stated that she felt it was not allergic or, if it was, it was minor
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was administered high dose vaccine, however patient is under the age of 65.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: redness, arm pain (muscle pain- can still move arm regularly), severe swelling (entire upper arm), dizziness (had to lay down).
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Abdominal tenderness, Fatigue, Hypersomnia
Clinical narrative: I had a quite severe response to the shingle vaccine taken last Tuesday (Aug 11).    I had sore shoulders (from the two vaccines) the first night, which I suppose is to be expected. The next day (Wednesday) I had a bit of a tired feeling--not too bad--which often occurs after a vaccine. Wednesday evening I began to have significant stomach discomfort which fairly quickly became quite painful, and which by bedtime caused me to want to vomit. I spent the night vomiting on the order of 6 times, but without significantly relieving the pain (at least not for more than a few minutes).  I tried Alkeselzer (sp?) at the start of this, but it was no help.   Thurday, I slept all day, partly from not sleeping much over night, and partly because I was still in "moaning mode" with stomach discomfort/pain.  By evening, I was feeling a bit better. I took another Alkeselzer, which this time seemed to help.   I managed to get some work done on Friday and through the weekend, but still felt like I was recovering from a significant illness (more or less like a flu or stomach virus).    I felt well enough to go on a brisk "hill walk" on Sunday, but not well enough to run.  Indeed I  still feel a bit of stomach tenderness today (Tuesday) a week after the shot.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Moaning, Nausea, Vomiting
Clinical narrative: I had a quite severe response to the shingle vaccine taken last Tuesday (Aug 11).    I had sore shoulders (from the two vaccines) the first night, which I suppose is to be expected. The next day (Wednesday) I had a bit of a tired feeling--not too bad--which often occurs after a vaccine. Wednesday evening I began to have significant stomach discomfort which fairly quickly became quite painful, and which by bedtime caused me to want to vomit. I spent the night vomiting on the order of 6 times, but without significantly relieving the pain (at least not for more than a few minutes).  I tried Alkeselzer (sp?) at the start of this, but it was no help.   Thurday, I slept all day, partly from not sleeping much over night, and partly because I was still in "moaning mode" with stomach discomfort/pain.  By evening, I was feeling a bit better. I took another Alkeselzer, which this time seemed to help.   I managed to get some work done on Friday and through the weekend, but still felt like I was recovering from a significant illness (more or less like a flu or stomach virus).    I felt well enough to go on a brisk "hill walk" on Sunday, but not well enough to run.  Indeed I  still feel a bit of stomach tenderness today (Tuesday) a week after the shot.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: administrations of improperly strored vaccines; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 21-JUL-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin (rHa)), lot # T006792, expiration date: 24-AUG-2021, 0.5 milliliter (route of administration and dosing schedule were not provided) for prophylaxis. The administered dose of vaccine was exposed to the following temperature excursions: -13.5 Celsius degrees for 24 minutes, -11.4 Celsius degrees for 27 minutes and -1.8 Celsius degrees for 2 hours and 8 minutes. There was a previous temperature excursion, as recorded by a digital data logger.   This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA010374: US-009507513-2007USA010361: US-009507513-2007USA010893: US-009507513-2007USA010434: US-009507513-2007USA010252: US-009507513-2007USA010001: US-009507513-2007USA010334: US-009507513-2007USA011962:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or additional adverse effects reported; patient received unspecified dose of PROQUAD that was improperly stored; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 27-JUL-2020, the patient was vaccinated with unspecified dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) lot # T003714, expiration date 29-JUL-2021, (exact dose, injection site and route of administration were not reported) for prophylaxis. Sterile diluent used to reconstitute the vaccine was properly stored. Administered dose of vaccine experienced the temperature excursion of -9.2 degrees Celsius for 3 hours and 20 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There was no adverse effects reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA010467: