chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Intensive care, Vaccination failure
Clinical narrative: Influenza B; patient received the Fluzone Quadrivalent and was admitted with flu; Initial information received on 22-Jan-2020 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 14 year old female patient who experienced influenza B (influenza) and vaccination failure (vaccination failure), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, concomitant, medical treatment, vaccination and family history were not provided.   On 30-Oct-2019, the patient received a 0.5mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT6686MA, of Expiration date: 30-JUN-2020) via intramuscular route in the left arm for prophylactic vaccination.  On an unknown date, the patient developed a serious influenza B (influenza) and vaccination failure (vaccination failure) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event. The diagnosis of was made on 15-Jan-2020. The patient spent three days in the ICU before being discharged.  It was reported that the patient received the Fluzone Quadrivalent and was admitted with flu (vaccination failure).  (Other relevant tests included no lab data.)  Final diagnosis was vaccination failure and influenza .   An unspecified corrective treatment of 3 days in the ICU unit was received.  On an unknown date, the patient had recovered from the events.; Sender's Comments: This case concerns a 14 year old female who presented with influenza and vaccination failure after the administration of FLUZONE QUADRIVALENT. The time to onset is compatible. However, patient's medical history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of the suspect vaccine cannot be assessed
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 2 month old patient got Pediarex (vaccine Dtap, Ipv, Hep B combo) and Ipol by mistake on the same date/ no AE; Initial information received on 21-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months 2 weeks 4 days old male patient who received vaccines IPV (VERO) [IPOL] and PEDIARIX by mistake on the same date.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and HIB VACCINE (HIB) for prophylactic vaccination.  On 21-Jan-2020, the patient received a dose of suspect IPV (VERO) (lot P1F491M and expiry date: 30-Nov-2020) via intramuscular route in right leg for prophylactic vaccination.   On 21-Jan-2020, the patient received a dose of suspect DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) not produced by Sanofi Pasteur (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered.  At the time of reporting, 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.
Sex: F
Vaccine: TYP
Symptoms: Arthralgia
Clinical narrative: pain in her joints of both hands and both knees; Initial information received on 24-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 52 years old female patient who experienced pain in her joints of both hands and both knees (arthralgia), while she received TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  Medical history, medical treatment, vaccination and family history were not provided.   On 09-Dec-2019, the patient received a 0.5 mL dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot R2A251M and expiry date: 11-May-2021) via an intramuscular route at an unknown administration site for prophylactic vaccination.  On 18_dec-2019, the patient developed a non-serious pain in her joints of both hands and both knees (arthralgia) 9 days following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.  Other relevant tests were not reported.  Final diagnosis was arthralgia.   It was not reported if the patient received any corrective treatment.  On an unknown date, the patient had not recovered from the event.
Sex: M
Vaccine: FLUX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received multiple flu vaccines this season, no AE; Initial information received on 21-Jan-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 41 years old male patient who received an extra dose of the vaccine INFLUENZA VACCINE [Flu vaccine] in a season.  Medical history included respiratory symptoms and loose stools.   Medical treatment(s), vaccination(s) and family history were not provided.  On 05-Nov-2019, the patient received a first dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On 20-Jan-2020 he also received a 0.5 ml second dose of the FLUENZA VACCINE produced by unknown manufacturer with an unknown batch number via intramuscular route in the left deltoid.  It was a case of actual medication error due to extra dose administered.  At the time of the report, no adverse events were 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 and Module VI of the 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.  Information on the batch number was requested.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired dose of vaccine (Adacel vaccine), NO AE; Initial information received on 21-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer in the.  This case involves patient with unknown demographics who received expired dose DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment vaccination and family history were not provided.  On 21-Jan-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number not reported, expiry date: 17-JAN-2020] via an unknown route at an unknown administration site Prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  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 and Module VI of the 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.  Information on the batch number was requested.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: an 18 month old female patient was given expired Daptacel/no AE; Initial information received on 24-Jan-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an 18 months old female patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB) for Immunisation.  On 24-Jan-2020, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5307AA via unknown route in the left thigh.  It was of actual medication error due to expired vaccine used.   It was reported that no adverse event was experienced by the patient.  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: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Fatigue, Injection site pain
Clinical narrative: Tiredness, muscle pain, chills, fever, upset stomach, nausea, diarrhea from 11:00 am 1-27-20 until the following morning 1-28-20.  I still have moderate pain at the injection site.  Taking ibuprofen for the pain.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Tiredness, muscle pain, chills, fever, upset stomach, nausea, diarrhea from 11:00 am 1-27-20 until the following morning 1-28-20.  I still have moderate pain at the injection site.  Taking ibuprofen for the pain.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reaction. Accidental early administration. Pt had first dose but received second dose.
Age: 1.17
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Gaze palsy, Influenza virus test, Polymerase chain reaction, Pyrexia
Clinical narrative: Child received 12 month immunizations and second flu shot on 1/16/2020. Child was at home with mother on 1/25/2020 when she noticed full body shaking and eyes deviated upward without blinking; this lasted 5-6 minutes. He had developed a fever about 2 hours prior to seizure. She took him to a local ED where he was diagnosed with simple febrile seizure. RSV/Flu PCR was negative. He did not have any viral symptoms, gastroenteritis symptoms, or AOM. He was discharged from the ED with seizure precautions. At followup on 1/29/2020, child had an erythematous macular non palpable, blanchable, non-itchy rash on his abdomen, legs, neck, chest, back, and face. No URI sx or other infectious sx at this time. No concern for contact dermatitis or eczema.
Age: 1.17
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Rash macular, Respiratory syncytial virus test negative, Tremor
Clinical narrative: Child received 12 month immunizations and second flu shot on 1/16/2020. Child was at home with mother on 1/25/2020 when she noticed full body shaking and eyes deviated upward without blinking; this lasted 5-6 minutes. He had developed a fever about 2 hours prior to seizure. She took him to a local ED where he was diagnosed with simple febrile seizure. RSV/Flu PCR was negative. He did not have any viral symptoms, gastroenteritis symptoms, or AOM. He was discharged from the ED with seizure precautions. At followup on 1/29/2020, child had an erythematous macular non palpable, blanchable, non-itchy rash on his abdomen, legs, neck, chest, back, and face. No URI sx or other infectious sx at this time. No concern for contact dermatitis or eczema.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Fever, chills, vertigo, dizziness, extreme fatigue, intense headache not relieved by medication, body aches not relieved by medication. Took Ibuprofen and Tyelnol, slept. Lasted 48 hours
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vertigo
Clinical narrative: Fever, chills, vertigo, dizziness, extreme fatigue, intense headache not relieved by medication, body aches not relieved by medication. Took Ibuprofen and Tyelnol, slept. Lasted 48 hours
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary pain, Chest pain, Swelling
Clinical narrative: Pain and swelling under arm in armpit area and around to upper chest area
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness, Ear discomfort, Nausea, Vertigo positional
Clinical narrative: The first instance was when I woke up the morning after I received the second shingles vaccination feeling dizzy.  I got out of bed to let my dogs out and was so dizzy I had to crawl on my hands and knees to the door. Even slight movement was debilitating and I ended up vomiting on the floor.  Symptoms lasted 24 hours and I had to lay in bed all day due to continued dizziness and nausea.    The second instance was the day after a holiday.  I again woke up feeling dizzy and vomited twice and this lasted 24 hours.  I then experienced underlying slight dizziness and nausea for a week.  The third instance was January 21.  I woke up feeling fine and about an hour later began feeling dizzy.  Dizziness lasted 24 hours and I had to lay down all day.  The fourth instance was last night (January 28) around 6:30pm.  I was eating dinner when I felt a rush of fluid in my left ear and then the dizziness hit.  I vomited twice.  I went to bed and woke up feeling a little better but still slightly off balance and slightly dizzy.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: The first instance was when I woke up the morning after I received the second shingles vaccination feeling dizzy.  I got out of bed to let my dogs out and was so dizzy I had to crawl on my hands and knees to the door. Even slight movement was debilitating and I ended up vomiting on the floor.  Symptoms lasted 24 hours and I had to lay in bed all day due to continued dizziness and nausea.    The second instance was the day after a holiday.  I again woke up feeling dizzy and vomited twice and this lasted 24 hours.  I then experienced underlying slight dizziness and nausea for a week.  The third instance was January 21.  I woke up feeling fine and about an hour later began feeling dizzy.  Dizziness lasted 24 hours and I had to lay down all day.  The fourth instance was last night (January 28) around 6:30pm.  I was eating dinner when I felt a rush of fluid in my left ear and then the dizziness hit.  I vomited twice.  I went to bed and woke up feeling a little better but still slightly off balance and slightly dizzy.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Blood test normal, Diarrhoea, Stool analysis normal
Clinical narrative: Started developing severe chronic diarrhea.  This has been going on from the beginning of Oct 2019 (about a week after administration of vaccine) till present.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: Onset of symptoms experienced approximately 4.5 hrs subsequent to injection:  discomfort/slight rubor/warmth at injection site; generalized myalgia, arthralgia (joint pain most pronounced at base of neck; low spine and bilateral hips); fever; malaise; diminished appetite; somnolence.  It should be noted that a similar but less intense reaction occurred with the initial Shingrex injection administered to me in my L deltoid in Oct 2019 (see VAERS report on file).  Symptoms for this most recent reaction persisted 1.5 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pyrexia, Somnolence
Clinical narrative: Onset of symptoms experienced approximately 4.5 hrs subsequent to injection:  discomfort/slight rubor/warmth at injection site; generalized myalgia, arthralgia (joint pain most pronounced at base of neck; low spine and bilateral hips); fever; malaise; diminished appetite; somnolence.  It should be noted that a similar but less intense reaction occurred with the initial Shingrex injection administered to me in my L deltoid in Oct 2019 (see VAERS report on file).  Symptoms for this most recent reaction persisted 1.5 days.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Left arm started hurting in upper arm, stiff, then recently has moved down arm to elbow area.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Tenderness
Clinical narrative: Patient reported feeling burning sensation along rib cage approximately 5 days after vaccination. Patient stated it was sensitive to touch or to lay on, but laying on other said or leaving side along gave relief. Burning sensation escalated for about 5 days, but began to improve on 6th day
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13, HIBV, PNC13
Symptoms: Developmental regression, Ultrasound scan normal
Clinical narrative: regression of developmental regression
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13, HIBV, PNC13
Symptoms: Abnormal behaviour, Decreased eye contact, Developmental regression, Electroencephalogram normal, Speech disorder
Clinical narrative: regression of developmental regression
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13, HIBV, PNC13
Symptoms: Ultrasound skull normal
Clinical narrative: regression of developmental regression
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Ultrasound scan normal
Clinical narrative: Child presented to ER on 1/23/2020 with left arm erythema, swelling and warmth since immunizations day prior. Patient complained of pain, Motrin was given for pain/swelling. Warm compress applied. Ultrasound showed no fluid collection but concerns for cellulitis. Treated with Keflex TID x7 days. Patient is scheduled to come into office for a follow up on 1/31. Patient was followed up on after ER report, parent reported no issues at that time.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: patient claims she developed a rash all over the body starting the day after the injection. the rash lasted several days (1/16 to 1/22 2020).
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Bed sharing, Death, Unresponsive to stimuli
Clinical narrative: Patient expired on 1/12/2020 of unknown cause. Patient was found unresponsive next to his father in father's bed. Patient was pronounced dead in ER.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: Mild swelling distal to sight of injection & small knot at sight of injection
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: No adverse symptoms reported.; the patient, who is pregnant, was vaccinated with a first dose of Gardasil 9; This spontaneous prospective pregnancy report was received from an administrator and refers to a 35-year-old female patient. Concomitant therapies included anti-rh gamma globulin (RHOGAM (ANTI-RH GAMMA GLOBULIN)) (also reported as ROGAM), iron (unspecified), minerals (unspecified), vitamins (unspecified) and acetaminophen (TYLENOL). The patient's Rh blood group was Rh negative. No information regarding the patient's pertinent medical history, drug reactions and allergies was provided.  On 22-JAN-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose 1, intramuscularly (exact dose, lot # and expiration date were not reported) for prophylaxis. The last menstrual period (LMP) was calculated as 11-JUL-2019 and date of delivery (EDD) was calculated as 16-APR-2020. Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was at 27 weeks. The pregnancy outcome was outcome pending.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 17-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020  for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007: US-009507513-2001USA009210: US-009507513-2001USA009217: US-009507513-2001USA009218: US-009507513-2001USA009219: US-009507513-2001USA009211: US-009507513-2001USA009212: US-009507513-2001USA009213: US-009507513-2001USA009214: US-009507513-2001USA009215: US-009507513-2001USA009200: US-009507513-2001USA009201: US-009507513-2001USA009202: US-009507513-2001USA009203: US-009507513-2001USA009204: US-009507513-2001USA009205: US-009507513-2001USA009205: US-009507513-2001USA009206: US-009507513-2001USA009207: US-009507513-2001USA009208: US-009507513-2001USA009209: US-009507513-2001USA009220: US-009507513-2001USA009221: US-009507513-2001USA009222: US-009507513-2001USA009223: US-009507513-2001USA009224: US-009507513-2001USA009225: US-009507513-2001USA009226: US-009507513-2001USA009227: US-009507513-2001USA009228: US-009507513-2001USA009229: US-009507513-2001USA009230: US-009507513-2001USA009231: US-009507513-2001USA009232: US-009507513-2001USA009233: US-009507513-2001USA009234: US-009507513-2001USA009235: US-009507513-2001USA009236: US-009507513-2001USA009237: US-009507513-2001USA009238: US-009507513-2001USA009239: US-009507513-2001USA009189: US-009507513-2001USA009240: US-009507513-2001USA009241: US-009507513-2001USA009242: US-009507513-2001USA009243: US-009507513-2001USA009244: US-009507513-2001USA009245: US-009507513-2001USA009246: US-009507513-2001USA009247: US-009507513-2001USA009248: US-009507513-2001USA009249: US-009507513-2001USA009190: US-009507513-2001USA009191: US-009507513-2001USA009192: US-009507513-2001USA009193: US-009507513-2001USA009194: US-009507513-2001USA009195: US-009507513-2001USA009196: US-009507513-2001USA009197: US-009507513-2001USA009198: US-009507513-2001USA009199: US-009507513-2001USA009250: US-009507513-2001USA009251: US-009507513-2001USA009252: US-009507513-2001USA009253: US-009507513-2001USA009254:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 18-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007: US-009507513-2001USA009210: US-009507513-2001USA009216: US-009507513-2001USA009218: US-009507513-2001USA009219: US-009507513-2001USA009211: US-009507513-2001USA009212: US-009507513-2001USA009213: US-009507513-2001USA009214: US-009507513-2001USA009215: US-009507513-2001USA009200: US-009507513-2001USA009201: US-009507513-2001USA009202: US-009507513-2001USA009203: US-009507513-2001USA009204: US-009507513-2001USA009205: US-009507513-2001USA009206: US-009507513-2001USA009207: US-009507513-2001USA009208: US-009507513-2001USA009209: US-009507513-2001USA009220: US-009507513-2001USA009221: US-009507513-2001USA009222: US-009507513-2001USA009223: US-009507513-2001USA009224: US-009507513-2001USA009225: US-009507513-2001USA009226: US-009507513-2001USA009227: US-009507513-2001USA009228: US-009507513-2001USA009229: US-009507513-2001USA009230: US-009507513-2001USA009231: US-009507513-2001USA009232: US-009507513-2001USA009233: US-009507513-2001USA009234: US-009507513-2001USA009235: US-009507513-2001USA009236: US-009507513-2001USA009237: US-009507513-2001USA009238: US-009507513-2001USA009239: US-009507513-2001USA009189: US-009507513-2001USA009240: US-009507513-2001USA009241: US-009507513-2001USA009242: US-009507513-2001USA009243: US-009507513-2001USA009244: US-009507513-2001USA009245: US-009507513-2001USA009246: US-009507513-2001USA009247: US-009507513-2001USA009248: US-009507513-2001USA009249: US-009507513-2001USA009190: US-009507513-2001USA009191: US-009507513-2001USA009192: US-009507513-2001USA009193: US-009507513-2001USA009194: US-009507513-2001USA009195: US-009507513-2001USA009196: US-009507513-2001USA009197: US-009507513-2001USA009198: US-009507513-2001USA009199: US-009507513-2001USA009250: US-009507513-2001USA009251: US-009507513-2001USA009252: US-009507513-2001USA009253: US-009507513-2001USA009254:
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Muscular weakness, Myalgia
Clinical narrative: the next day the patient called to report experiencing severe arthralgia, upper extremity weakness, myalgia and motor weakness; the next day the patient called to report experiencing severe arthralgia, upper extremity weakness, myalgia and motor weakness; the next day the patient called to report experiencing severe arthralgia, upper extremity weakness, myalgia and motor weakness; the next day the patient called to report experiencing severe arthralgia, upper extremity weakness, myalgia and motor weakness; This spontaneous report as received from a physician refers to a 65-year-old female patient. The patient's concurrent conditions included asthma, arthritis, anxiety, depression, hyperlipidaemia and allergy for iodine contrast medium. Her historical drug included cephalexin (KEFLEX), for which she had an allergic reaction. The concomitant therapies were not reported.  On 22-JAN-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), lot # S005856, expiration date 03-DEC-2020, intramuscularly for prophylaxis (dose and frequency were not provided). On 23-JAN-2020, (also reported as on the next day), the patient experienced severe arthralgia, motor weakness, upper extremity weakness and myalgia. The patient received treatment with unspecified analgesia on an unknown date in January 2020. The outcome of the events was unknown (also reported as present status stable).  The causality assessment was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness, Facial paralysis, Herpes zoster
Clinical narrative: Bell's palsy; loss of hearing; Shingles; Information has been received regarding a case in litigation, concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported.   In or around 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose of prevention of shingles (herpes zoster) (dose, route of administration, anatomical location, lot number and expiration date were not reported).   On an unspecified date ("shortly after receiving the vaccine"), the pt experienced singles, loss of hearing and Bell's palsy. It was reported that as a consequence of zoster vaccine live (ZOSTAVAX), the pt suffered sustained, severe, 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, due to resulting physical limitations, that were not present prior to vaccination, and seriousness of his condition. Moreover, the pt had suffered and incurred damages, including medical expenses, the loss of accumulations, an others. The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, Bell's palsy and loss of hearing were considered to be medically significant events. Additionally, all the reported events were considered to be disabling.
Sex: F
Vaccine: HPV9
Symptoms: Injection site nodule
Clinical narrative: golf ball sized knot at the injection site; This spontaneous report was received from a physician via a field employee and refers to a 13-year-old female patient and the physician's daughter. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On an unknown date in September 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported) as a prevention of human papillomavirus (HPV). On 15-SEP-2019, the patient experienced a golf ball size knot at the injection site.      The outcome of injection site nodule was unknown. The causality assessment was not provided.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Peripheral swelling
Clinical narrative: Little bit of swelling on arms; This is a spontaneous report from a contactable consumer (parent). A 17-year-old female patient received the first dose meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in arm on 06Jan2020 at a single dose to prevent Meningitis B,  received in the doctor's office. The patient has no medical history and there were no concomitant medications. On 06Jan2020, patient experienced a little bit of swelling on her arms and it went on for about 2-3 days. No treatment was received for the event. The event recovered in Jan2020.  Information on the batch number has been requested.
Sex: M
Vaccine: MENB
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms lasting more than 48 hours; This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A male patient of an unspecified age (reported as a "teenager") received meningococcal group b rlp2086 (TRUMENBA, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced flu like symptoms lasting more than 48 hours on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Chills, Headache
Clinical narrative: Chills; Headache; This is a spontaneous report from a contactable physician via Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. Patient was described to have gotten chills and a headache after receiving the vaccine. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Abnormal behaviour, Aphasia, Developmental regression, Immediate post-injection reaction, Injury
Clinical narrative: Injury; Inability to vocalize; Immediate regression/some behavioral changes; This is a spontaneous report from a contactable consumer (patient's parent). A male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Lot number and expiration date were not reported), with route of administration and therapy date unspecified, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had an injury; had inability to vocalize; and immediate regression/some behavioral changes. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Intervertebral disc degeneration, Magnetic resonance imaging abnormal, Pain
Clinical narrative: Pain began immediately upon injection. Did not report to Clinic. Sought medical  care on her own from three providers. Did not report until 01/06/2020. Questionable diagnosis of brachial plexus?. Pain continues and limited arm motion continues.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling, pain
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: C-reactive protein increased, Influenza virus test negative, Lethargy, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Subjective fever began the night following vaccine administration. The following morning, patient had several episodes of vomiting. He was noted to be increasingly sleepy and lethargic as the day went on.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Somnolence, Urine analysis normal, Vomiting, White blood cell count normal
Clinical narrative: Subjective fever began the night following vaccine administration. The following morning, patient had several episodes of vomiting. He was noted to be increasingly sleepy and lethargic as the day went on.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Musculoskeletal chest pain
Clinical narrative: Extensive swelling at injections site, this is resolving. Erythema proximal to her elbow with very mild extension and tenderness on her lateral anterior chest wall. Patient will use ibuprofen, warm compress and a trial dose of Benadryl.  Return if symptoms worsen or fail to improve
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling, Pruritus, Rash
Clinical narrative: Developed rash on back, swelling and pain at the injection site and itching.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swollen / red on the right arm after vaccination
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus, Rash
Clinical narrative: 1/24/2020: Dr. appointment with Dr., HPI: Rash on upper legs over past day, itchy.  Otherwise well.  Parents wonder if it was from vaccinations 1/16, received MMR and DTAP IPV.  Otherwise well.  No fever or chills.   No cold symptoms Plan:  Rash.   Parents were reassured.  Possibly due to recent vaccinations , or viral.  Claritin 5 mg in am & Benadryl 12.5-25 mg in pm, Cortaid / hydrocortisone cream to itchy area as needed.  Return to clinic if no improvement or any worsening of symptoms over the next 48-72 hours.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Received varicella vaccine (dose #2)  2 days ago and developed itching/swelling of R upper arm at injection site the following day. C/o mild pain. Denies fever, fatigue, malaise, SOB, or rash anywhere else.  R posterior upper arm with 13 by 9 cm area of redness, warmth, and induration. R radial pulse normal. No axillary lymphadenopathy or tenderness. Appeared well, non-toxic. Patient was walked over to urgent care for evaluation.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain
Clinical narrative: Received varicella vaccine (dose #2)  2 days ago and developed itching/swelling of R upper arm at injection site the following day. C/o mild pain. Denies fever, fatigue, malaise, SOB, or rash anywhere else.  R posterior upper arm with 13 by 9 cm area of redness, warmth, and induration. R radial pulse normal. No axillary lymphadenopathy or tenderness. Appeared well, non-toxic. Patient was walked over to urgent care for evaluation.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Influenza like illness, Injection site pain
Clinical narrative: swelling/ pain at injection site, flu-like symptoms: chills, aches, headache/dizziness, lethargy, nausea
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Lethargy, Nausea, Pain
Clinical narrative: swelling/ pain at injection site, flu-like symptoms: chills, aches, headache/dizziness, lethargy, nausea
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Nausea, Taste disorder, Vomiting
Clinical narrative: Vaccine given @ 10:00AM. Employee felt nauseous @ 10:24 am. vomited between 10:35-10:40A, drank water, still felt nauseous. Nausea subsided @ 11:15AM. Emp stated she had a bad taste in mouth and stomach hurt from emesis @ 11:29AM. TX: Patient (Employee) sat and rested until symptoms subsided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional Aaverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 18-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007: US-009507513-2001USA009210: US-009507513-2001USA009216: US-009507513-2001USA009217: US-009507513-2001USA009219: US-009507513-2001USA009211: US-009507513-2001USA009212: US-009507513-2001USA009213: US-009507513-2001USA009214: US-009507513-2001USA009215: US-009507513-2001USA009200: US-009507513-2001USA009201: US-009507513-2001USA009202: US-009507513-2001USA009203: US-009507513-2001USA009204: US-009507513-2001USA009205: US-009507513-2001USA009206: US-009507513-2001USA009207: US-009507513-2001USA009208: US-009507513-2001USA009209: US-009507513-2001USA009220: US-009507513-2001USA009221: US-009507513-2001USA009222: US-009507513-2001USA009223: US-009507513-2001USA009224: US-009507513-2001USA009225: US-009507513-2001USA009226: US-009507513-2001USA009227: US-009507513-2001USA009228: US-009507513-2001USA009229: US-009507513-2001USA009230: US-009507513-2001USA009231: US-009507513-2001USA009232: US-009507513-2001USA009233: US-009507513-2001USA009234: US-009507513-2001USA009235: US-009507513-2001USA009236: US-009507513-2001USA009237: US-009507513-2001USA009238: US-009507513-2001USA009239: US-009507513-2001USA009189: US-009507513-2001USA009240: US-009507513-2001USA009241: US-009507513-2001USA009242: US-009507513-2001USA009243: US-009507513-2001USA009244: US-009507513-2001USA009245: US-009507513-2001USA009246: US-009507513-2001USA009247: US-009507513-2001USA009248: US-009507513-2001USA009249: US-009507513-2001USA009190: US-009507513-2001USA009191: US-009507513-2001USA009192: US-009507513-2001USA009193: US-009507513-2001USA009194: US-009507513-2001USA009195: US-009507513-2001USA009196: US-009507513-2001USA009197: US-009507513-2001USA009198: US-009507513-2001USA009199: US-009507513-2001USA009250: US-009507513-2001USA009251: US-009507513-2001USA009252: US-009507513-2001USA009253: US-009507513-2001USA009254:
Sex: M
Vaccine: HIBV
Symptoms: Bronchitis chronic, Facial bones fracture, Nasal valve collapse, Seroconversion test negative
Clinical narrative: did not seroconvert; patient suffered a broken nose/nasal valve collapse which led to bronchitis and is now considered chronic bronchitis; patient suffered a broken nose/nasal valve collapse which led to bronchitis and is now considered chronic bronchitis; This spontaneous report was received from a physician via company representative referring to a 21 year old male patient (reporter's son). Information about patient's concurrent condition, drug allergy/reaction, medical history, concomitant medication was not reported.   On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (strength, dose, dose number, route, anatomical location, lot/batch #, expiry date was not reported) for prophylaxis (reported as hemophilus influenzae protection).  On an unknown date, the patient did not seroconvert from vaccination (seroconversion test negative) (found with titer test). On an unknown date (reported as in the last 4 years/ within the last 4 years), the patient experienced a broken nose/nasal valve collapse which lead to bronchitis which was now considered as chronic bronchitis nasal valve collapse and bronchitis chronic. The patient sought medical attention by visiting office.The outcome of seroconversion test negative, bronchitis chronic and nasal valve collapse was unknown. The reporter's causality assessment was reported.
Age: 43.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: INFLUENZA TYPE A DIAGNOSIS; A spontaneous report has been received from a consumer. The report concerns a male patient of Unknown ethnic origin (height 75 in, weight 188 lb).    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine (live, attenuated)) 0.2 ml once/single administration, via nasal route, for flu prevention during OCT-2019.     The patient started treatment with Crestor (rosuvastatin calcium) 5 mg daily, oral, on an unknown date for high cholesterol.     On an unknown date, the patient experienced influenza type a diagnosis (preferred term: Influenza).     Treatment with Crestor (rosuvastatin calcium) was not changed.     At the time of reporting, the event was ongoing.    The event was considered non-serious.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: She states that approximately 1 week after receiving the immunization, her shoulder began hurting. She states that it is progressively getting worse. It has reached the point that the pain is causing her issues with sleeping, decreased mobility in that shoulder, and that she's unable to raise that arm.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema
Clinical narrative: Severly reddened with blistering noted day4 after injection
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Colitis ulcerative, Condition aggravated, Diarrhoea haemorrhagic, Endoscopy gastrointestinal, Endoscopy upper gastrointestinal tract
Clinical narrative: Patient developed sudden onset of an ulcerative colitis flare within a week of receiving her 2nd Trumenba dose.  She had bloody diarrhea rectal bleeding and more frequent BMs).  She subsequently required a steroid burst, 16-day hospitalization at two different hospitals, and a change in her UC med from Entyvio to Xeljanz.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Frequent bowel movements, Laboratory test, Rectal haemorrhage
Clinical narrative: Patient developed sudden onset of an ulcerative colitis flare within a week of receiving her 2nd Trumenba dose.  She had bloody diarrhea rectal bleeding and more frequent BMs).  She subsequently required a steroid burst, 16-day hospitalization at two different hospitals, and a change in her UC med from Entyvio to Xeljanz.
Age: 5.0
Sex: F
Vaccine: FLU3, MMRV
Symptoms: Injection site reaction, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: I saw patient 6 days after she received her vaccines. A pruritic rash appeared the day after vaccination at the location of the injections on both thighs. No pain associated with rash. No nausea, difficulty breathing, or signs of angioedema. She has been acting like herself. Parents have applied natural balm, non-medicated, to help with pruritus. On exam, I saw a papular rash, mildly erythematous, clustered on bilateral thighs. Papules <0.5cm and mildly elevated. No excoriations, urticaria, warmth, or discharge. I instructed parents to treat pruritus with Benadryl or Cetirizine.
Age: 16.0
Sex: F
Vaccine: RAB
Symptoms: Burning sensation, Feeling hot, Myalgia, Nausea, Palmar-plantar erythrodysaesthesia syndrome
Clinical narrative: Pt started complaining of nausea about 1 hour post vaccination.  Around noon, pt began to have muscle aches and noticed that the palms of her hands were red and became itchy and "felt like they were on fire." Within a half hour from the red, itchy palms, pt started having itching in feet and noticed that the soles of her feet were also red.  Pt's mom gave benadryl liquid 10mL (25mg) PO with no improvement noted.  Pt went to school today, but took two ibuprofen to help with burning sensation in hands and feet. It should also be noted that the pt had Stamaril Yellow Fever vaccine on 1/26/2020 at facility.
Age: 16.0
Sex: F
Vaccine: RAB
Symptoms: Pruritus
Clinical narrative: Pt started complaining of nausea about 1 hour post vaccination.  Around noon, pt began to have muscle aches and noticed that the palms of her hands were red and became itchy and "felt like they were on fire." Within a half hour from the red, itchy palms, pt started having itching in feet and noticed that the soles of her feet were also red.  Pt's mom gave benadryl liquid 10mL (25mg) PO with no improvement noted.  Pt went to school today, but took two ibuprofen to help with burning sensation in hands and feet. It should also be noted that the pt had Stamaril Yellow Fever vaccine on 1/26/2020 at facility.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Culture negative, Erythema, Oedema peripheral, Peripheral swelling
Clinical narrative: On 1/22/2020 patient reported to Dr that arm is red and swollen.  We have images.   Red , swollen, center looked bruised, warm to touch.   on 01/27/2020 patient returned to the office, arm was more red, fluid filled sac, hot to the touch,  10cm x 10cm
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: On 1/22/2020 patient reported to Dr that arm is red and swollen.  We have images.   Red , swollen, center looked bruised, warm to touch.   on 01/27/2020 patient returned to the office, arm was more red, fluid filled sac, hot to the touch,  10cm x 10cm
Age: 23.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Amenorrhoea, Exposure during pregnancy, Foetal death, Pregnancy test positive, Subchorionic haemorrhage
Clinical narrative: LMP 18 Jun, vaccinated 11 July. Pos preg test 18 July. Did have vag bleeding in late July/Aug dx with subchorionic hemorrhage. Doing well in Oct. On 04 Nov fetal demise noted on ultrasound.   Symptoms: SECONDARY AMENORRHEA(N911).
Age: 23.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Ultrasound antenatal screen abnormal, Vaginal haemorrhage
Clinical narrative: LMP 18 Jun, vaccinated 11 July. Pos preg test 18 July. Did have vag bleeding in late July/Aug dx with subchorionic hemorrhage. Doing well in Oct. On 04 Nov fetal demise noted on ultrasound.   Symptoms: SECONDARY AMENORRHEA(N911).