chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the 14 year old patient was inadvertently administered a dose of PROQUAD; This spontaneous report was received from a physician assistant referring to a 14-year-old patient of unknown gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.   On 04-DEC-2019, the patient was inadvertently administered a dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), ( dose, strength, frequency, route, lot number and expiration date were not reported) for prophylaxis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: 4 year old female patient administered dose of expired Quadracel, no AE; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a four year old female patient who was vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  On 19-Nov-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5532AA and expiry date: 09-Oct-2020) via an intramuscular route in the right leg for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  At the time of report, no adverse event was reported.  Product used: Used  First time product used: Yes  Still using product: No  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: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pruritus, Rash
Clinical narrative: The patient ended up with a dispersed rash on her body; a big, red, swollen, hard area about 4 inches in diameter at the injection site; it was itchy all over; a big, red, swollen, hard area about 4 inches in diameter at the injection site; a big, red, swollen, hard area about 4 inches in diameter at the injection site; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old female patient who ended up with a dispersed rash on her body (rash), a big, red, swollen, hard area about 4 inches in diameter at the injection site (vaccination site erythema), (vaccination site swelling), (vaccination site mass)  it was itchy all over (pruritus), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (QUADRACEL) and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD).  On 29-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT7065MA and expiration date- 30-Jun-2021] via unknown route in the right thigh for prophylactic vaccination.  On an unknown date, the patient ended up with a dispersed rash on her body (rash), a big, red, swollen, hard area about 4 inches in diameter at the injection site (vaccination site erythema), (vaccination site swelling), (vaccination site mass)  it was itchy all over (pruritus) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  The patient outcome was reported as Recovering for all events except unknown for pruritus.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: patient only received the liquid portion and did not receive the lyophilized portion/no AE; Initial information regarding this unsolicited valid non-serious case via Medical Information (Reference number- 00368696) was received from a pharmacist and transmitted to Sanofi on 23-Nov-2020.  This case involves a 4 months old male patient who received a 0.5 ml dose of vaccine DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (lot: UJ314AA, expiry date: 23-Apr-2021), via unknown at unknown administration site. (Product preparation issue)  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included pneumococcal vaccine and rotate vaccine.  It was an actual medication error due to the incorrect product preparation (Inappropriate reconstitution technique).  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 15.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok was given to patient of 15 years old and that is under the age of indication, no AE; Initial information received on 09-Dec-2020 regarding an unsolicited valid non-serious case from other health professional.  This case is linked to case 2020SA355558 (Same reporter).  This case involves a 15 years old patient who was vaccinated with 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and expiration date not reported) and that was under the age of indication, via unknown route in unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration (same day latency).   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 on the batch number for this case.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Cold sweat, Dyspnoea, Throat tightness
Clinical narrative: Patient left the vaccine clinic after waiting 15 minutes. While driving home, she began to feel clammy with a tightness in her chest and throat. She reports that it felt harder for her to breathe. She describes the onset as 20-30 minutes after vaccine was administered. She returned to the vaccine clinic where she was given diphenhydramine 25 mg PO, and her blood pressure was ~130/100 mmHg. She reports that she is usually normotensive. Patient was observed for 30-45 minutes, and she reports feeling better.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chest discomfort, Cold sweat, Dyspnoea, Throat tightness
Clinical narrative: Patient left the vaccine clinic after waiting 15 minutes. While driving home, she began to feel clammy with a tightness in her chest and throat. She reports that it felt harder for her to breathe. She describes the onset as 20-30 minutes after vaccine was administered. She returned to the vaccine clinic where she was given diphenhydramine 25 mg PO, and her blood pressure was ~130/100 mmHg. She reports that she is usually normotensive. Patient was observed for 30-45 minutes, and she reports feeling better.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Gaze palsy, Myalgia, Pyrexia
Clinical narrative: Muscle pain, headache, chills, fever; fever and chills started 12 hrs after injection, ended after 8 hrs with acetaminophen.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: The injection site itself became red and a bit swollen as expected but has faded; however, an itchy rash -- not a dotty shingles-type rash, but a swath of pink, grew on my right bicep. I initially had a little irritation from bandage tape I was using to cover the injection site with a sterile pad because my shirt kept irritating the site. The irritation from the bandage is normal for me. But this grew a lot in the days afterward and became big, which is not normal. I have never had bandage irritation that got this bad. Not sure if skin is extra-sensitive because of the shingles vaccine injection. Controlling with Benadryl and ibuprofen.
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Accidental Tdap administration rather than Hep B. NO adverse event was noted.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Myalgia, Nausea
Clinical narrative: NAUSEA, CHILLS, MUSCLE PAIN, WEAKNESS
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Sensitive skin
Clinical narrative: Skin sensitivity, shivering, feverish
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Atelectasis, Chest X-ray abnormal, Chest pain, Computerised tomogram thorax normal, Dizziness
Clinical narrative: 02:45 PM walking , dizzy, rapid heart rate, mild chest pain. Directed to ER in hospital, CT Chest -- normal, EKG -- normal, Lab test-- normal. Xray Chest results --  basilar atelectasis, Hyperinflation of lungs. Blood pressure 171/109. No treatment given in ER -- f/u with PCP 12/18/20.  08:00PM nausea, headache, vomit 1x. 10:00PM fever 104.00;  Tylenol extra strength dose. 12/17/20 6:00am temp 99.00, Tylenol dose extra strength; body aches, fatigue, mild headache.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Fatigue, Headache, Heart rate increased, Laboratory test normal
Clinical narrative: 02:45 PM walking , dizzy, rapid heart rate, mild chest pain. Directed to ER in hospital, CT Chest -- normal, EKG -- normal, Lab test-- normal. Xray Chest results --  basilar atelectasis, Hyperinflation of lungs. Blood pressure 171/109. No treatment given in ER -- f/u with PCP 12/18/20.  08:00PM nausea, headache, vomit 1x. 10:00PM fever 104.00;  Tylenol extra strength dose. 12/17/20 6:00am temp 99.00, Tylenol dose extra strength; body aches, fatigue, mild headache.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lung hyperinflation, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: 02:45 PM walking , dizzy, rapid heart rate, mild chest pain. Directed to ER in hospital, CT Chest -- normal, EKG -- normal, Lab test-- normal. Xray Chest results --  basilar atelectasis, Hyperinflation of lungs. Blood pressure 171/109. No treatment given in ER -- f/u with PCP 12/18/20.  08:00PM nausea, headache, vomit 1x. 10:00PM fever 104.00;  Tylenol extra strength dose. 12/17/20 6:00am temp 99.00, Tylenol dose extra strength; body aches, fatigue, mild headache.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Nausea
Clinical narrative: caller reported Flushing, redness around face  and nauseous. Advised that Number for IMT (Incident management Team)will be activated. Caller declined.  Advised to return to observation room where shot was given. Caller stated she would. Called her 5 minutes and left a message to call back if symptoms also persist or worsens
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Injection site swelling and pain
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Stomach crump & vomiting
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: DIZZY, SLIGHTLY EVEVATED BLOOD PRESSURE
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness
Clinical narrative: left arm soreness/pain tender to touch/palpation
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: After receiving the injection the patient stated "my throat feels funny, similar to how it has felt in the past when I have had a reaction." Pt. transferred from the vaccine clinic location to ED.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: After receiving vaccine, patient indicated "throat feels funny". He received IM  epinephrine and was brought to the emergency department for additional treatment and monitoring. In the ED, he received  PO benadryl 25mg and prednisone 60mg. He was discharged after several hours of monitoring.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Immediate post-injection reaction, Pruritus
Clinical narrative: Patient reports of itching immediately after vaccine, dizzy, feeling of flush.  Medical directive given for itching that include OTC antihistamine (Claritin). Incident Management team activated for dizziness and feeling of flush.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA Fever, chills, severe body aches. Fever resolved with ibuprofen
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: School event for vaccines in the school parking lot.  Pt came for her routine vaccines appropriate for age, Men-B vaccine.   Pt  patient had two  MCV4 .   A 3rd. dose was administer. Pt did not have any reaction or presented any difficulty at moment of vaccination.   The patient was in the  routine visit to get her 1st dose of dose of Men-B.   The staff notice after the event that the patient had a third dose of MCV4.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site muscle weakness, Injection site pain, Pain, Pain in extremity
Clinical narrative: Employee c/o 4-5 pain to right deltoid. Hand feels "Heavy, tingling  Right hand strength decreased. " B/P 124/81 P 70 R 16 POX 99% on room air Temp. 98.9. First noted symptoms on 09/25/2020.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Pain at injections site, Fever of 100.9, moderate/severe body aches, chills.  No treatment. Symptoms resolved in 48 hours.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Paraesthesia, Throat irritation
Clinical narrative: 0749 - tingling in body, scratchy throat for 10 minutes, flushing
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaesthesia oral, Dysarthria, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient was given to co vid injection- developed numbness and tingling inside bicep- speech- slurred speech- tongue speech- tongue not swollen- feels like novican. Takes lisinopril, novolog jardiance, lansoprazole, and mirena.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood pressure increased, Dyspnoea, Ear swelling, Erythema
Clinical narrative: Patient was given to co vid injection- developed numbness and tingling inside bicep- speech- slurred speech- tongue speech- tongue not swollen- feels like novican. Takes lisinopril, novolog jardiance, lansoprazole, and mirena.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Heart rate increased, Hypoaesthesia oral, Oral discomfort, Oropharyngeal discomfort
Clinical narrative: Patient was given to co vid injection- developed numbness and tingling inside bicep- speech- slurred speech- tongue speech- tongue not swollen- feels like novican. Takes lisinopril, novolog jardiance, lansoprazole, and mirena.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Rash, Skin burning sensation, Swollen tongue, Tongue erythema
Clinical narrative: Patient was given to co vid injection- developed numbness and tingling inside bicep- speech- slurred speech- tongue speech- tongue not swollen- feels like novican. Takes lisinopril, novolog jardiance, lansoprazole, and mirena.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site hypoaesthesia
Clinical narrative: 0752- numbness and redness left arm (inj site)
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dry throat, Pharyngeal hypoaesthesia, Throat irritation
Clinical narrative: throat dryness and scratchiness, numbness. hoarse coughing
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain in extremity
Clinical narrative: Headache, Left arm and shoulder pain
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: Headache, fatigue, muscle aches, nausea, sweating
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hypoaesthesia oral
Clinical narrative: shortly after patient received vaccine became flushed, bottom lip went numb, vitals were in normal limits. 911 was called emergency staff came and patient went to ER to be monitored.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: immediate burning upon injection, VS stable
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Peripheral swelling
Clinical narrative: Swelling of hands follwed by angioedema
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling cold
Clinical narrative: Patient reports feeling "fine" after receiving the vaccine and before leaving the clinic. About 4 hours later, patient reports feeling very, very cold and faint. 911 was called and patient was taken to the emergency room where her initial blood pressure was 40/20's.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pustular
Clinical narrative: Papular, pustular rash on back occurring approximately 6-10 hours after injection of vaccine.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal paraesthesia
Clinical narrative: While waiting the 15 minute after vaccination the Patient noticed a "tingling" feeling in throat about 5 minutes after vaccine was given.  Time: 0930 - Oxygen Saturation was 98% Pulse Rate 100.  Patient stated that the feeling went away and then came back.   Time: 0938 - Again vital signs were taken BP 156/88 Oxygen Saturation 100% Pulse Rate 83.  Time: 0942 - 50 mg of Benadryl PO were given with water at this time.  Patient was taken to ER for evaluation.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia, Throat irritation
Clinical narrative: While waiting the 15 minute after vaccination the Patient noticed a "tingling" feeling in throat about 5 minutes after vaccine was given.  Time: 0930 - Oxygen Saturation was 98% Pulse Rate 100.  Patient stated that the feeling went away and then came back.   Time: 0938 - Again vital signs were taken BP 156/88 Oxygen Saturation 100% Pulse Rate 83.  Time: 0942 - 50 mg of Benadryl PO were given with water at this time.  Patient was taken to ER for evaluation.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling cold, Pain in extremity, Tremor
Clinical narrative: PT EXPERIENCED BEING COLD, VIOLENT SHAKING, AND RED/SORE ARM WITHIN 4 HOURS
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia
Clinical narrative: Patient asked for juice/crackers as she was feeling weak
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache
Clinical narrative: Dizziness, headache, chills
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness
Clinical narrative: At home in recliner - reading and IV  stood up and severe dizzeness came on - no warning - Room "Turned around" greatest speed. Closed my eyes. Slowly  walked to bedroom 6 feet away. Had pjs on layed down eyes shut. stay there.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC reported.; VARlVAX and MMRII that has been administered since the excursion.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   Since 22-OCT-2020, the patient was vaccinated but it was unknow which of the following vaccines were administered: varicella virus vaccine live (Oka/Merck)(VARIVAX) 0.5 ml (route and site of administration were not provided) with lot numbers: T000698 was confirmed to be valid, expiration date 07-JAN-2022, T015999 was confirmed to be valid, expiration date 08-MAY-2022, T017688 was confirmed to be valid, expiration 21-MAY-2022; Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin) (MMR II) 0.5 ml (route and site of administration were not provided) with lot number: T000890 was confirmed to be valid, expiration date 08-JAN-2022, S035354 was confirmed to be valid, expiration date 05-NOV-2021, S039312 was confirmed to be valid, expiration date reported as 24-DEC-2021 but upon internal validation was established as 04-DEC-2021.  The aforementioned doses of vaccines experienced the temperature excursion but exact temperature was unknown. The reporter stated that her "data logger" battery died and she had no temperature information for the freezer since 22-OCT-2020. No additional adverse event was reported.; Sender's Comments:  US-009507513-2012USA004559: US-009507513-2012USA004561: US-009507513-2012USA004562: US-009507513-2012USA004563: US-009507513-2012USA004565: US-009507513-2012USA004564:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC reported.; VARlVAX and MMRII that has been administered since the excursion.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   Since 22-OCT-2020, the patient was vaccinated but it was unknow which of the following vaccines were administered: varicella virus vaccine live (Oka/Merck)(VARIVAX) 0.5 ml (route and site of administration were not provided) with lot numbers: T000698 was confirmed to be valid, expiration date 07-JAN-2022, T015999 was confirmed to be valid, expiration date 08-MAY-2022, T017688 was confirmed to be valid, expiration 21-MAY-2022; Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin) (MMR II) 0.5 ml (route and site of administration were not provided) with lot number: T000890 was confirmed to be valid, expiration date 08-JAN-2022, S035354 was confirmed to be valid, expiration date 05-NOV-2021, S039312 was confirmed to be valid, expiration date reported as 24-DEC-2021 but upon internal validation was established as 04-DEC-2021.  The aforementioned doses of vaccines experienced the temperature excursion but exact temperature was unknown. The reporter stated that her "data logger" battery died and she had no temperature information for the freezer since 22-OCT-2020. No additional adverse event was reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC reported.; VARlVAX and MMRII that has been administered since the excursion.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   Since 22-OCT-2020, the patient was vaccinated but it was unknow which of the following vaccines were administered: varicella virus vaccine live (Oka/Merck)(VARIVAX) 0.5 ml (route and site of administration were not provided) with lot numbers: T000698 was confirmed to be valid, expiration date 07-JAN-2022, T015999 was confirmed to be valid, expiration date 08-MAY-2022, T017688 was confirmed to be valid, expiration 21-MAY-2022; Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin) (MMR II) 0.5 ml (route and site of administration were not provided) with lot number: T000890 was confirmed to be valid, expiration date 08-JAN-2022, S035354 was confirmed to be valid, expiration date 05-NOV-2021, S039312 was confirmed to be valid, expiration date reported as 24-DEC-2021 but upon internal validation was established as 04-DEC-2021.  The aforementioned doses of vaccines experienced the temperature excursion but exact temperature was unknown. The reporter stated that her "data logger" battery died and she had no temperature information for the freezer since 22-OCT-2020. No additional adverse event was reported.; Sender's Comments:  US-009507513-2012USA004512:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ocular hyperaemia, Pain, Swelling, Visual impairment
Clinical narrative: issues with her vision; swelling and redness in her left eye; swelling and redness in her left eye; herpes zoster / extreme pain; Information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) who at the time of vaccination was approximately 63 years old. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 26-NOV-2014, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by healthcare providers for the following injuries resulting from her zoster vaccine live (ZOSTAVAX) use: herpes zoster, extreme pain, swelling and redness in her left eye, and issues with her vision. The outcome of the events was not provided. The reporter considered the events of herpes zoster, extreme pain, swelling and redness in her left eye, and issues with her vision to be related to zoster vaccine live (ZOSTAVAX).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster related injuries; shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a currently 73-year-old female patient. Her concurrent conditions, medical history and concomitant medications were not reported. On or about 07-MAY-2015, the patient was administered zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for the long-term prevention of shingles and zoster-related conditions, by a healthcare provider at a pharmacy. Subsequently, on an unknown date, she was treated by a physician for the following injuries resulting from her zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Myelitis, Neuromyelitis optica spectrum disorder
Clinical narrative: neuromyelitis optica; myelitis; Information has been received from a lawyer refering to a patient of unknown age and gender. On or about 04-OCT-2010, patient was inoculated with a dose of zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) pt suffered myelitis and neuromyelitis optica. As a result of these symptoms, pt was seen and treated by medical providers and is still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Pt also experience mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of company's conduct, pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not reported. The events were considered to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the events of myelitis and neuromyelitis optica were considered to be medically significant. The reporter considered the events to be disabling.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Suspected vaccination failure; Everytime I do take vaccine, sometime during the year I get the flu and end up in the bed; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   The reporter considered the vaccination failure and influenza to be possibly related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient wont get the flu shot because everytime the patient got the flu shot, she got the flu (sometime during the year) and ended up in the bed.  Hence, the patient feels that if there would be no flu shot, the patient wont get any flu, and thus does not want to get vaccinated. The patient feels the covid numbers were about the same as the flu numbers of last year and the year before that. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and lab test confirmation was unknown at the time of reporting. No further follow up would be possible.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in the right injected arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had arm pain in the right injected arm. The reporter did not consent to follow up. This case has been linked with US2020231823 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020231823:Same reporter
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves patient (unknown demographics) who experienced sick (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
Age: 17.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok was given to patient of 17 years old, who is under the age of indication, no AE; Initial information received on 09-Dec-2020 regarding an unsolicited valid non-serious case from other health professional.  This case is linked to case 2020SA355552 (Same reporter).  This case involves a 17 years old patient who was vaccinated with 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and expiration date not reported) and that was under the age of indication, via unknown route in unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration (same day latency).   At the time of reports, 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 on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: the patient was so sick, thought that the patent was having a heart attack; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) and transmitted to Sanofi on 13-Dec-2020.  This case involves a patient of an unknown demography who was so sick, thought that the patent was having a heart attack (illness), while the patient received INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccine.  On an unknown date, it was reported that the patient was so sick, thought that the patent was having a heart attack (illness) unknown latency following the administration of INFLUENZA VACCINE.  No laboratories details reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Sex: M
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: ACTHIB vaccine which comes with diluent stated that possibly got mixed with regular sterile water diluent and used instead, no AE; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves infant male patient who was vaccinated with HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ264AAA and expiration dtae:11-Mar-2022) vaccine which comes with diluent stated that possibly got mixed with regular sterile water diluent and used instead, via unknown route in unknown administration site for prophylactic vaccination (product preparation error) on an unknown date.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was a case of actual medication error due to wrong solution used in drug reconstitution (same day latency).   At the time of reports, 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: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Fatigue, Headache, Injection site pruritus, Myalgia
Clinical narrative: The night of the 3rd Gardasil 9 vaccine I developed a fever of 101, muscle aches, headache, fatigue and chills that lasted until the next day around noon until the Tylenol started to work. The headache persisted until 12/15. I also developed itchiness on the injection site, as well as small bumps that were incredibly itching the day following the fever that have still not gone away. I called my doctors office and they told me that it didn't sound like a reaction to Gardasil, and that I should call my primary care physician. I work from home, and the only thing that changed was the Gardasil shot being rendered.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Rash pruritic, SARS-CoV-2 test negative
Clinical narrative: The night of the 3rd Gardasil 9 vaccine I developed a fever of 101, muscle aches, headache, fatigue and chills that lasted until the next day around noon until the Tylenol started to work. The headache persisted until 12/15. I also developed itchiness on the injection site, as well as small bumps that were incredibly itching the day following the fever that have still not gone away. I called my doctors office and they told me that it didn't sound like a reaction to Gardasil, and that I should call my primary care physician. I work from home, and the only thing that changed was the Gardasil shot being rendered.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA. Injection site pain, headache, tiredness, muscle pain, chills and fever. Took acetaminophen, no longer have fever after 12 hrs.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA. Injection site pain, headache, tiredness, muscle pain, chills and fever. Took acetaminophen, no longer have fever after 12 hrs.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Patient stated she started to feel a burning sensation in her chest about 7 minutes after receiving injection. Lasted about 5 minutes, then left.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site pain, Pain in extremity
Clinical narrative: Medication error - reached the patient no harm, additional monitoring to preclude harm.  A nurse (RN) diluted new vial of vaccine at 10:41 am. In the midst of adding diluent to vaccine vial, a patient arrived at our vaccine station. After drawing up and administering the 0.3 ml vaccine the RN looked at the vial again and noted that it was almost empty. She became concerned because she had just mixed a new vial and the amount of fluid remaining was not at the expected level. We immediately stopped and reported this to an employee who contacted pharmacy. We notified the patient that there was a discrepancy and had him wait for > 30 minutes to watch for any reaction. (APRN) called him at 1:30p to check on him and apprise him of the possibility of receiving higher than recommended concentration of vaccine. He stated he felt fine and felt no unusual symptoms.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I was tired and took a two hour nap
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Headache
Clinical narrative: Headache, fatigue, temperature of 100.3. Lasted about 8 hours.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Asthenia, Chills, Cough, Influenza virus test
Clinical narrative: fever, cough,chills,body aches, weakness, loss of smell
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Streptococcus test
Clinical narrative: fever, cough,chills,body aches, weakness, loss of smell
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash - treatment: acetaminophen and diphenhydramine
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: fatigue, soreness, headache occurred the night after receiving vaccine ( approx. 8 hours later) lasting into the following day. I did not take any medications for this .
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Asthenia, Back pain, Body temperature increased, Chills
Clinical narrative: At about 2Pm experienced pain and heaviness in left arm  shortly after radiating to back and abdomen . Then dizzy and weak. About 2:30 experienced chills followed by several episodes of severe projectile vomiting and diaphoresis. At 3 pm called Dr. service. Continued to vomit while waiting for return call. Dr called 20 min later recommended to go to hospital if throat felt tight. I continued to vomit or dry heave until 10 Pm have temp 100.4. Called daughter to stay with me in case needed to call 911. I had chills headache for hours. At 930 pm daughter said my lips and surrounding mouth was blue. Pulse oximeter read 78  Braething ok felt this was due to low bp at that time I was very cold could not get warm.  Vomiting subsides about 10:30pm. With intermittent chills x24 hrs.T99.4 next day. Remained in bed. Took about 4 days to feel better.The experience felt like I had been poisoned.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Cyanosis, Dizziness, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: At about 2Pm experienced pain and heaviness in left arm  shortly after radiating to back and abdomen . Then dizzy and weak. About 2:30 experienced chills followed by several episodes of severe projectile vomiting and diaphoresis. At 3 pm called Dr. service. Continued to vomit while waiting for return call. Dr called 20 min later recommended to go to hospital if throat felt tight. I continued to vomit or dry heave until 10 Pm have temp 100.4. Called daughter to stay with me in case needed to call 911. I had chills headache for hours. At 930 pm daughter said my lips and surrounding mouth was blue. Pulse oximeter read 78  Braething ok felt this was due to low bp at that time I was very cold could not get warm.  Vomiting subsides about 10:30pm. With intermittent chills x24 hrs.T99.4 next day. Remained in bed. Took about 4 days to feel better.The experience felt like I had been poisoned.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Hypotension, Limb discomfort, Nasopharyngitis, Pain, Pain in extremity
Clinical narrative: At about 2Pm experienced pain and heaviness in left arm  shortly after radiating to back and abdomen . Then dizzy and weak. About 2:30 experienced chills followed by several episodes of severe projectile vomiting and diaphoresis. At 3 pm called Dr. service. Continued to vomit while waiting for return call. Dr called 20 min later recommended to go to hospital if throat felt tight. I continued to vomit or dry heave until 10 Pm have temp 100.4. Called daughter to stay with me in case needed to call 911. I had chills headache for hours. At 930 pm daughter said my lips and surrounding mouth was blue. Pulse oximeter read 78  Braething ok felt this was due to low bp at that time I was very cold could not get warm.  Vomiting subsides about 10:30pm. With intermittent chills x24 hrs.T99.4 next day. Remained in bed. Took about 4 days to feel better.The experience felt like I had been poisoned.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Retching, Vomiting projectile
Clinical narrative: At about 2Pm experienced pain and heaviness in left arm  shortly after radiating to back and abdomen . Then dizzy and weak. About 2:30 experienced chills followed by several episodes of severe projectile vomiting and diaphoresis. At 3 pm called Dr. service. Continued to vomit while waiting for return call. Dr called 20 min later recommended to go to hospital if throat felt tight. I continued to vomit or dry heave until 10 Pm have temp 100.4. Called daughter to stay with me in case needed to call 911. I had chills headache for hours. At 930 pm daughter said my lips and surrounding mouth was blue. Pulse oximeter read 78  Braething ok felt this was due to low bp at that time I was very cold could not get warm.  Vomiting subsides about 10:30pm. With intermittent chills x24 hrs.T99.4 next day. Remained in bed. Took about 4 days to feel better.The experience felt like I had been poisoned.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest discomfort, Chest pain, Chills, Computerised tomogram normal
Clinical narrative: pt developed chills, nausea and vomiting. Reports > 10 episodes of vomiting total. Went to lunch and continued to have chills and vomiting. Also developed chest pain - described as burning and heaviness. Denies any shortness of breath. CT negative for any changes.  Chest X ray normal.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: pt developed chills, nausea and vomiting. Reports > 10 episodes of vomiting total. Went to lunch and continued to have chills and vomiting. Also developed chest pain - described as burning and heaviness. Denies any shortness of breath. CT negative for any changes.  Chest X ray normal.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Flushing, Pain, Pain in extremity
Clinical narrative: arm swelling, pain, fatigue, chills, feeling flushed and body aches. Started 12/9/2020 and still having fatigue and chills today.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: arm swelling, pain, fatigue, chills, feeling flushed and body aches. Started 12/9/2020 and still having fatigue and chills today.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Glassy eyes, Hyperhidrosis, Nausea, Visual tracking test abnormal
Clinical narrative: SWEATY, NAUSEA, DIZZY, EYES GLAZED OVER, NOT TRACKING RIGHT, STARTED MORNING AFTER SHOT
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Morning after injection: mild fatigue, arm soreness; later in the morning-headache then chills, muscle aches, joint pain and low grade fever (99) and nausea/loss of appetite. These persisted for approximately 12 hours then cleared completely.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Morning after injection: mild fatigue, arm soreness; later in the morning-headache then chills, muscle aches, joint pain and low grade fever (99) and nausea/loss of appetite. These persisted for approximately 12 hours then cleared completely.