chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A patient received Flublok Quadrivalent in error instead of Fluzone Quadrivalent, no AE; A 17 year old patient was vaccinated with Flublok Quadriavlent, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Global Medical Information (Reference number- 00341888) and transmitted to Sanofi on 02-Nov-2020 .  This case involves a 17 year old male patient who received 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ509AA expiry date: 10-May-2021) (Strength = Standard, form: prefilled syringe) once via intramuscular route in the right arm for prophylactic vaccination in error instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] for prophylactic vaccination on 01-Nov-2020 (wrong product administered and product administered to patient of inappropriate age)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history was not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered (latency same day).  The pharmacist stated that the prescription was written for Fluzone Quadrivalent 0.5mL. However when she went to grab the vaccine the Fluzone and Flublok were side by side and at 180 and over was not circled. She stated that the names Flublok and Fluzone and the boxes were too similar. She was in a hurry and accidentally grabbed the wrong box and as a result the 17 year old patient was injected with Flublok instead of Fluzone.  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
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient age 5 months and 2 days old and was administered with Pentacel that expired 2 days prior to administration with no adverse event; patient age 5 months old and was administered with Pentacel that expired 2 days prior to administration with no adverse event; Initial information regarding this unsolicited valid non-serious case via Medical Information (reference number: 00346373) was received from other health care professional and transmitted to Sanofi 04-Nov-2020.  This case involved 5 months old male patient who was administered with vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] that expired 2 days prior to administration.  Relevant medical history, past medical treatment, vaccination details and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE 13V (PCV 13).  On 04-Nov-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE single dose vials (Box- lot number UJ125ABA expiry date: 02-Nov-2020, Powder- UJ125AB expiry date: 02-Nov-2020 and liquid vial - lot U6397AB, expiry date: 02-Nov-2020) (Expired product administered) via intramuscular route in the left thigh for prophylactic vaccination (Product administered to patient of inappropriate age as the patient was 5 month old).  No adverse event was reported at the time of reporting.  It was a case of actual medical error as expired vaccine used and inappropriate age at vaccine administration.  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: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Fever and Body aches, chills, nausea.  Took Tylenol and rested
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Injection site discomfort, Injection site pain, Myositis, Pain
Clinical narrative: Reports that she had a flu shot 2 weeks ago 10/5/2020. Reports that she noticed a pressure, when she got the shot, but didn't think much of it, until it has just persisted. Upper left shoulder where the shot was injected his sore, the pain radiates around her medial upper arm and under her armpit. She does take care of her grandson who is 17 months old, and she has been busy with him. Has not been resting. Has been taking Tylenol, but no ibuprofen. No flu-like symptoms.  Left arm pain   Continue ibuprofen tablet, 200 mg, 4 tab(s), orally, every 8 hours Clinical Notes: suspect due to muscle and/or nerve irritation s/p flu shot. recommend treating with ibu TID x 1 week. advised to rest and ice so as not to cont. to aggravate it.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Radiculopathy
Clinical narrative: Reports that she had a flu shot 2 weeks ago 10/5/2020. Reports that she noticed a pressure, when she got the shot, but didn't think much of it, until it has just persisted. Upper left shoulder where the shot was injected his sore, the pain radiates around her medial upper arm and under her armpit. She does take care of her grandson who is 17 months old, and she has been busy with him. Has not been resting. Has been taking Tylenol, but no ibuprofen. No flu-like symptoms.  Left arm pain   Continue ibuprofen tablet, 200 mg, 4 tab(s), orally, every 8 hours Clinical Notes: suspect due to muscle and/or nerve irritation s/p flu shot. recommend treating with ibu TID x 1 week. advised to rest and ice so as not to cont. to aggravate it.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Local reaction
Clinical narrative: Local reaction with erythema about 6 cm. the patient did not have any fever and no other symptoms
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dysstasia, Hyperhidrosis, Insomnia
Clinical narrative: Pain in arm, swelling, chills, very weak. Unable to sleep, sweating, unable to get up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Sleep disorder, Swelling
Clinical narrative: Pain in arm, swelling, chills, very weak. Unable to sleep, sweating, unable to get up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pt had vaccine in september and still has sore arm
Sex: M
Vaccine: FLUX, HEPA, MMR, PNC, VARCEL
Symptoms: Irritability, Otorrhoea, Pyrexia, Rash vesicular, Scab
Clinical narrative: varicella type rash, lesions scabbed over, on back, chest, scalp and diaper area; fever of 103; fussy; right ear drainage; VARIVAX (sq left thigh); This spontaneous report was received from a physician via Company representative and refers to a 13 month old male patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 29-SEP-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # S033539 was confirmed to be valid, expiration date 22-OCT-2021, 0.5 ml, subcutaneous injection in the left thigh, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported), hepatitis a vaccine, inactivated (VAQTA) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported), pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) and influenza virus vaccine (unspecified) (manufacturer unknown) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) all as routine vaccinations.  On 07-OCT-2020, the patient returned to pediatrician's office with fever of 103 (units not provided), fussy and right ear drainage. On 21-OCT-2020, the patient returned to pediatrician's office with varicella type rash, lesions scabbed over, on back, chest, scalp and diaper area. The patient received ibuprofen, diphenhydramine hydrochloride (BENADRYL), acetaminophen (TYLENOL) and baking soda bath as a treatment for the events. The outcome of all events was unknown.  The causality assessment was not provided.
Sex: M
Vaccine: FLUX, HEPA, MMR, PNC, VARCEL
Symptoms: Skin lesion
Clinical narrative: varicella type rash, lesions scabbed over, on back, chest, scalp and diaper area; fever of 103; fussy; right ear drainage; VARIVAX (sq left thigh); This spontaneous report was received from a physician via Company representative and refers to a 13 month old male patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 29-SEP-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # S033539 was confirmed to be valid, expiration date 22-OCT-2021, 0.5 ml, subcutaneous injection in the left thigh, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported), hepatitis a vaccine, inactivated (VAQTA) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported), pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) and influenza virus vaccine (unspecified) (manufacturer unknown) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) all as routine vaccinations.  On 07-OCT-2020, the patient returned to pediatrician's office with fever of 103 (units not provided), fussy and right ear drainage. On 21-OCT-2020, the patient returned to pediatrician's office with varicella type rash, lesions scabbed over, on back, chest, scalp and diaper area. The patient received ibuprofen, diphenhydramine hydrochloride (BENADRYL), acetaminophen (TYLENOL) and baking soda bath as a treatment for the events. The outcome of all events was unknown.  The causality assessment was not provided.
Age: 0.17
Sex: U
Vaccine: HEP
Symptoms: Product storage error, Recalled product administered
Clinical narrative: No other AE information; patient was given RECOMBIVAX HB that was recalled; incorrect product storage; Information has been received from a nurse reporting on a 11-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 23-OCT-2020, the patient was vaccinated with a recalled, improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) ) thimerosal free, 0.5 mL, lot# T007984 has been verified to be a valid lot number, expiration date 01-NOV-2022 for prophylaxis (route of administration and anatomical location were not reported). No other AE information was given at this time.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Flu shot this year, sicker; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Flu vaccine (receiving every year).   On an unknown date, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: The age at vaccination was not reported. The patient had a flu shot every year and the flu shot this year, the patient felt sick. The patient stated would be thinking twice next year.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Condition aggravated, Gait disturbance, Headache
Clinical narrative: injection site redness; 2 weeks to 1 month from receiving dose 1, not the recommended 2-6 months; joint pain; chills; difficulty walking; headache; irregular heart beat; increased arthritis pain; increased arthritis pain/ irregular heart beat; sore arm; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (experienced malaise also after receivieng the 1st dose on an unknown date). Concurrent medical conditions included arthritis and heartbeats irregular.   In October 2020, the patient received the 2nd dose of Shingrix (intramuscular). In October 2020, less than a day after receiving Shingrix, the patient experienced joint pain, chills, walking difficulty, headache, heartbeats irregular, arthritis aggravated, condition aggravated, pain in arm and drug dose administration interval too short. On an unknown date, the patient experienced injection site erythema. The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. In October 2020, the outcome of the joint pain, chills, walking difficulty, headache, heartbeats irregular, arthritis aggravated and condition aggravated were recovered/resolved. In November 2020, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the injection site erythema, joint pain, chills, walking difficulty, headache, heartbeats irregular, arthritis aggravated, condition aggravated and pain in arm to be related to Shingrix.  Additional details were reported as follows: On 28 or 29 October 2020, the patient received 2nd dose of Shingrix and patient thinks this was 2 weeks to 1 month from receiving 1st dose, not the recommended 2 to 6 months, which led to shortening of vaccination schedule and on the same day, the patient experienced joint pain, chills, difficulty walking, irregular heartbeat, headache, and increased arthritis pain. The patient stated that she woke up the next morning with a sore arm. The patient stated she took Tylenol the next day after she received 2nd dose and shortly after that all her symptoms resolved except for the sore arm, which lasted for 5 days and resolved. The patient stated she was unsure when, but she developed injection site redness that resolved at an unknown time as well. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221354:same reporter
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: injection site redness; 2 weeks to 1 month from receiving dose 1, not the recommended 2-6 months; joint pain; chills; difficulty walking; headache; irregular heart beat; increased arthritis pain; increased arthritis pain/ irregular heart beat; sore arm; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (experienced malaise also after receivieng the 1st dose on an unknown date). Concurrent medical conditions included arthritis and heartbeats irregular.   In October 2020, the patient received the 2nd dose of Shingrix (intramuscular). In October 2020, less than a day after receiving Shingrix, the patient experienced joint pain, chills, walking difficulty, headache, heartbeats irregular, arthritis aggravated, condition aggravated, pain in arm and drug dose administration interval too short. On an unknown date, the patient experienced injection site erythema. The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. In October 2020, the outcome of the joint pain, chills, walking difficulty, headache, heartbeats irregular, arthritis aggravated and condition aggravated were recovered/resolved. In November 2020, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the injection site erythema, joint pain, chills, walking difficulty, headache, heartbeats irregular, arthritis aggravated, condition aggravated and pain in arm to be related to Shingrix.  Additional details were reported as follows: On 28 or 29 October 2020, the patient received 2nd dose of Shingrix and patient thinks this was 2 weeks to 1 month from receiving 1st dose, not the recommended 2 to 6 months, which led to shortening of vaccination schedule and on the same day, the patient experienced joint pain, chills, difficulty walking, irregular heartbeat, headache, and increased arthritis pain. The patient stated that she woke up the next morning with a sore arm. The patient stated she took Tylenol the next day after she received 2nd dose and shortly after that all her symptoms resolved except for the sore arm, which lasted for 5 days and resolved. The patient stated she was unsure when, but she developed injection site redness that resolved at an unknown time as well. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221354:same reporter
Sex: F
Vaccine: FLUX
Symptoms: Death, Influenza
Clinical narrative: flu shot gave the flu and it killed; Initial information was received on 08-Nov-2020 regarding an unsolicited valid serious case from a non-health care professional via media.  This case is linked to case 2020SA314784 (same reporter).  This case involves a female patient of unknown age who was vaccinated with INFLUENZA VACCINE and it gave flu (influenza).  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed serious flu (influenza), (unknown latency) following the administration of INFLUENZA VACCINE. This event was was leading to death.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  It was unknown if an autopsy was done and as per reporter the cause of death was flu.  Information on the batch number was requested.; Sender's Comments: This poorly documented media case concerns a female patient of unknown age who died due to Influenza, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, allergic history, autopsy result and laboratory investigations ruling out alternative etiologies are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: flu shot gave the flu and it killed
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Haematoma, Injection site pain, Injection site swelling, Musculoskeletal chest pain
Clinical narrative: hematoma; a purple spot; hard knot in her left arm; continues to have pain. The pain is now spreading into her chest and ribs, described as too painful to move the arm.; swelling; pain at the injection site; Initial information received on 30-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 87 years old female patient who experienced hematoma (haematoma) ,purple spot (skin discolouration) ,hard knot in her left arm (nodule) ,continues to have pain and the pain was now spreading into her chest and ribs, described as too painful to move the arm (pain) ,swelling and pain at the injection site (vaccination site pain), after vaccination with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's pain medications options were limited because she cannot take NSAIDS (Nonsteroidal anti-inflammatory drugs).  Medical treatment(s), vaccination(s), concomitants and family history were not provided.   On 13-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious events hematoma (haematoma) ,purple spot (skin discolouration) ,hard knot in her left arm (nodule) , swelling and pain at the injection site (vaccination site pain) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On an unknown date, the patient developed non-serious event of pain and the pain was now spreading into her chest and ribs, described as too painful to move the arm (pain), 6 weeks following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reports, the outcome was not reported for all the events.  There will be no information on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Nodule, Pain, Skin discolouration
Clinical narrative: hematoma; a purple spot; hard knot in her left arm; continues to have pain. The pain is now spreading into her chest and ribs, described as too painful to move the arm.; swelling; pain at the injection site; Initial information received on 30-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 87 years old female patient who experienced hematoma (haematoma) ,purple spot (skin discolouration) ,hard knot in her left arm (nodule) ,continues to have pain and the pain was now spreading into her chest and ribs, described as too painful to move the arm (pain) ,swelling and pain at the injection site (vaccination site pain), after vaccination with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's pain medications options were limited because she cannot take NSAIDS (Nonsteroidal anti-inflammatory drugs).  Medical treatment(s), vaccination(s), concomitants and family history were not provided.   On 13-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious events hematoma (haematoma) ,purple spot (skin discolouration) ,hard knot in her left arm (nodule) , swelling and pain at the injection site (vaccination site pain) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On an unknown date, the patient developed non-serious event of pain and the pain was now spreading into her chest and ribs, described as too painful to move the arm (pain), 6 weeks following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reports, the outcome was not reported for all the events.  There will be no information on the batch number for this case.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Syncope
Clinical narrative: Patient is 29yo, 14 weeks pregnant, and has a hx of fainting with vaccine administration. Patient fainted after administration. EMS was called, but patient eventually left on her own accord.
Age: 78.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain, Product administered at inappropriate site, Rash, Swelling
Clinical narrative: Patient received shot from pharmacist and it was higher in the arm, in the shoulder area. She had an adverse reaction, with rash, swelling and pain. She went to the MD and he prescribed physical therapy. She has been in physical therapy and still is in pain. She received the vaccine in September 2020.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Dyskinesia, Feeling cold, Pyrexia, Tremor
Clinical narrative: Pt felt cold, had a fever of 101.6, had chills, shaking of hands, uncontrollable full body jerks. Slept most of the next day.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Body temperature increased, Urticaria
Clinical narrative: Pt developed hive like reaction the day of vaccines, was advised to take Benadryl and it had cleared up but returned the next day. Pt also had a temp of 102 that was reduced with Tylenol. They followed up in the office with our provider on 11/12/2020
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Chills, fever and pain  swelling at injection site for two days .
Age: 34.0
Sex: M
Vaccine: FLUC4, UNK, UNK
Symptoms: Abnormal dreams, Body temperature increased, Cold sweat, Headache, Influenza like illness
Clinical narrative: Received Tdap in left upper arm. Received Influenza in right upper arm. Received PPSV23 in mid right arm.  Approx 7-8 hours after vaccinations, the site around the PPSV23 became very firm and warm to touch.  On night of October 5th, experienced unusual dreams, restless sensation and profuse sweating.  On morning of October 6th, I experienced intense flu-like symptoms (felt cold, but sweating, headache) and PPSV23 injection site appeared bruised (4-5cm in diameter) with raised bumps. By 8:00pm, I experienced body temperature of 101.2 F and became photophobic and nauseated.   On October 7th , rash around PPSV23 injection site was dark red- purple in color, with raised bumps and measured 7cm in diameter. However body temperature down to around 99.5 F but still felt clammy, with cold sweats and headache.  Upon waking on October 8th, experienced a headache but felt fine otherwise.  Raised circle around PPSV2 injection site dissipated over approx. two weeks and felt itchy at site for an additional week.
Age: 34.0
Sex: M
Vaccine: FLUC4, UNK, UNK
Symptoms: Injection site bruising, Injection site induration, Injection site warmth, Nausea, Photophobia
Clinical narrative: Received Tdap in left upper arm. Received Influenza in right upper arm. Received PPSV23 in mid right arm.  Approx 7-8 hours after vaccinations, the site around the PPSV23 became very firm and warm to touch.  On night of October 5th, experienced unusual dreams, restless sensation and profuse sweating.  On morning of October 6th, I experienced intense flu-like symptoms (felt cold, but sweating, headache) and PPSV23 injection site appeared bruised (4-5cm in diameter) with raised bumps. By 8:00pm, I experienced body temperature of 101.2 F and became photophobic and nauseated.   On October 7th , rash around PPSV23 injection site was dark red- purple in color, with raised bumps and measured 7cm in diameter. However body temperature down to around 99.5 F but still felt clammy, with cold sweats and headache.  Upon waking on October 8th, experienced a headache but felt fine otherwise.  Raised circle around PPSV2 injection site dissipated over approx. two weeks and felt itchy at site for an additional week.
Age: 34.0
Sex: M
Vaccine: FLUC4, UNK, UNK
Symptoms: Restlessness
Clinical narrative: Received Tdap in left upper arm. Received Influenza in right upper arm. Received PPSV23 in mid right arm.  Approx 7-8 hours after vaccinations, the site around the PPSV23 became very firm and warm to touch.  On night of October 5th, experienced unusual dreams, restless sensation and profuse sweating.  On morning of October 6th, I experienced intense flu-like symptoms (felt cold, but sweating, headache) and PPSV23 injection site appeared bruised (4-5cm in diameter) with raised bumps. By 8:00pm, I experienced body temperature of 101.2 F and became photophobic and nauseated.   On October 7th , rash around PPSV23 injection site was dark red- purple in color, with raised bumps and measured 7cm in diameter. However body temperature down to around 99.5 F but still felt clammy, with cold sweats and headache.  Upon waking on October 8th, experienced a headache but felt fine otherwise.  Raised circle around PPSV2 injection site dissipated over approx. two weeks and felt itchy at site for an additional week.
Age: 78.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Patient reports inflammation and redness in left arm, near immunization area. We call patient to follow up in 2 days and said that is better and the inflammation is improving.
Age: 78.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: The evening after receiving these vaccines, the patient stated that she developed swelling in her left arm and it was warm to the touch. The swelling traveled down her arm. She stated that she took Benadryl and the swelling went down some and by Monday when she called, it had not worsened. Consulted patient to follow up with PCP to determine if further action was needed.
Age: 61.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Chills, Magnetic resonance imaging normal, Pain in extremity, Pyrexia
Clinical narrative: 10/06/2020 Patient called office and reported fever and chills.  10/26/2020 Patient called with complaints of Shoulder Pain. 10/30/2020 Patient saw Dr. with Orthopedic Institute. He stated her arm pain is an adverse reaction to influenza vaccine. MRI ordered. 11/12/2020 Dr. with Orthopedic Institute called and spoke with primary Dr. MRI is within normal findings.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Computerised tomogram, Magnetic resonance imaging, Pain in extremity, Skin warm
Clinical narrative: Arm started hurting, heat up to shoulder joint, down both sides, into left breast. Went to ER the next day. Then saw Dr. orthopedist.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: shoulder pain
Age: 22.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, Joint range of motion decreased, Pain, Pyrexia, Rash
Clinical narrative: On day 1 post-vaccine, patient called the office complaining of swelling from his shoulder to his elbow and pain that's limiting this range of motion in his right arm where the Pneumovax vaccine was given. He took acetaminophen, which only provided relief for about an hour. He reported a fever through the night of 104 F and took ibuprofen, which he states did not help with his pain. At the time he called the office, he checked his temperature, and he was afebrile. Patient was advised to continue to alternate acetaminophen and ibuprofen every 4 hours for pain management and encouraged to keep his arm moving.   On day 3 post-vaccine, patient said his swelling has gone down some and his pain is less compared to the day before. He agreed that it seemed to be doing better except he developed a red rash between his should and the crease of his elbow. Patient was advised to continue with the same treatment plan and allow more time for resolution of his symptoms.
Age: 22.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Rash erythematous
Clinical narrative: On day 1 post-vaccine, patient called the office complaining of swelling from his shoulder to his elbow and pain that's limiting this range of motion in his right arm where the Pneumovax vaccine was given. He took acetaminophen, which only provided relief for about an hour. He reported a fever through the night of 104 F and took ibuprofen, which he states did not help with his pain. At the time he called the office, he checked his temperature, and he was afebrile. Patient was advised to continue to alternate acetaminophen and ibuprofen every 4 hours for pain management and encouraged to keep his arm moving.   On day 3 post-vaccine, patient said his swelling has gone down some and his pain is less compared to the day before. He agreed that it seemed to be doing better except he developed a red rash between his should and the crease of his elbow. Patient was advised to continue with the same treatment plan and allow more time for resolution of his symptoms.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pain, Skin swelling, Swelling, Tenderness
Clinical narrative: swelling, tenderness, pain, puffiness , redness, started about 4 hours after injection
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: severe chills / after my first vaccine; body aches after my first vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills and general body pain. On an unknown date, the outcome of the chills and general body pain were unknown.   It was unknown if the reporter considered the chills and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe chills and body aches after 1st dose. For tolerance of 2nd dose of Shingrix, refer case US2020AMR221115.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR221115:same reporetr
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: muscle pain / following dose 2; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient enquired that how long does muscle pain usually last following to 2nd dose of Shingrix. No other information was available.
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Discomfort, Fatigue, Impaired work ability, Injection site pain
Clinical narrative: could not work; back was so sore I could not be comfortable.; tired; injection site; right deltoid, was very sore.; muscles of my legs and back started to feel sore.; The muscles of my legs and back started to feel sore; This case was reported by a consumer and described the occurrence of injection site pain in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2020, the patient received the 1st dose of Shingrix. On 2nd November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, myalgia of lower extremities and back pain. On 3rd November 2020, the patient experienced discomfort, tiredness and impaired work ability. On 5th November 2020, the outcome of the impaired work ability was recovered/resolved. On an unknown date, the outcome of the injection site pain and discomfort were recovering/resolving and the outcome of the myalgia of lower extremities, back pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the injection site pain, myalgia of lower extremities, back pain, discomfort, tiredness and impaired work ability to be related to Shingrix.  Additional details were reported as follows: The patient himself had reported this case. The patient had received 1st dose of Shingrix vaccine and by that night  the injection site at right deltoid was very sore. The patient said that the muscles of his leg and back started to felt sore. On 3rd November 2020, the symptoms both the injection site and all muscles were worse and muscle were so sore, like when he got a Flu. The patient described that his back was so sore that he could not be comfortable and he could not work and was tired. The patient reported the symptoms were much better on 4th November 2020 and he was able to work. On 5th November 2020, the day of reporting, the patient said that  symptoms were much better and were nearly gone. The patient enquired that were his symptoms normal and was there a patient brochure that educated and warns people of the possible side effects. The reporter was requesting to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: could not work; back was so sore I could not be comfortable.; tired; injection site; right deltoid, was very sore.; muscles of my legs and back started to feel sore.; The muscles of my legs and back started to feel sore; This case was reported by a consumer and described the occurrence of injection site pain in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2020, the patient received the 1st dose of Shingrix. On 2nd November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, myalgia of lower extremities and back pain. On 3rd November 2020, the patient experienced discomfort, tiredness and impaired work ability. On 5th November 2020, the outcome of the impaired work ability was recovered/resolved. On an unknown date, the outcome of the injection site pain and discomfort were recovering/resolving and the outcome of the myalgia of lower extremities, back pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the injection site pain, myalgia of lower extremities, back pain, discomfort, tiredness and impaired work ability to be related to Shingrix.  Additional details were reported as follows: The patient himself had reported this case. The patient had received 1st dose of Shingrix vaccine and by that night  the injection site at right deltoid was very sore. The patient said that the muscles of his leg and back started to felt sore. On 3rd November 2020, the symptoms both the injection site and all muscles were worse and muscle were so sore, like when he got a Flu. The patient described that his back was so sore that he could not be comfortable and he could not work and was tired. The patient reported the symptoms were much better on 4th November 2020 and he was able to work. On 5th November 2020, the day of reporting, the patient said that  symptoms were much better and were nearly gone. The patient enquired that were his symptoms normal and was there a patient brochure that educated and warns people of the possible side effects. The reporter was requesting to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: shingles in the past and the vaccine woke it up a little\suspected vaccination failure; shingles in the past and the vaccine woke it up a little/shingles bumps on my ankles; shingles bumps on my ankles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included drug allergy.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and vesicular rash. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the vesicular rash was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient was reporter itself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received shingrix and experienced shingles bumps on ankles. The reporter mentioned that shingle bumps on ankles were not as bad as actually having shingles. The patient had past history of shingles. The patient was allergic to motrin and mentioned that simple  motrin tablet would kill. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: fell sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the flu vaccine and experienced fell sick. This case has been linked with same patient cases US2020AMR223839 and US2020AMR223838 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR223839:same patiente US-GLAXOSMITHKLINE-US2020AMR223838:same patiente
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: area around injection site was itchy; This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was recovered/resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient received first dose of Shingrix on 9th September 2020 and that the patient reported that the after Shingrix vaccination the area around injection site was itchy for approximately one month.
Sex: M
Vaccine: FLUX
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: died; Guillain Barre syndrome; Initial information was received on 08-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional (patient's grandmother) via media.  This case involves a male patient (age unspecified) who had Guillain-Barre syndrome and died (death) after he received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) 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 not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious Guillain-Barre syndrome and died (death) (unknown latency for both the events), following the administration of INFLUENZA VACCINE.  The event Guillain-Barre syndrome was assessed as medically significant.  Details of laboratory data was not reported.   It was not reported if the patient received a corrective treatment before death.  At the time of report, the outcome of event Guillain-Barre syndrome was unknown.   It is unknown if an autopsy was done. The cause of death was not reported.  The information on batch number was requested for this case.; Sender's Comments: This poorly document case received from media concerns a male patient who had Guillain barre syndrome and died after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, concomitant medications, lab/radiological investigation excluding other etiologies and detailed autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: died
Sex: U
Vaccine: FLU4
Symptoms: Dyskinesia
Clinical narrative: jerks; Initial information regarding an unsolicited valid serious case was received from a other health professional (physician's assistant) via Global Medical Information (GMI) via call-center (Reference number- 00344045) and transmitted to Sanofi on 03-Nov-2020.  This case involves a 41-years-old patient (gender not reported) who experienced jerks (dyskinesia), while he/she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious jerks (dyskinesia) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  This event was assessed as medically significant.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for dyskinesia.  Batch number has been requested for suspect product for this case.; Sender's Comments: A 41-years-old patient (gender not reported) who presented with dyskinesia following the vaccination with FLUZONE QUADRIVALENT. Time to onset is unknown. Medical history, concomitant medication, precise final diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.