chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial and follow-up information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves a female patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included Pneumococcal Conjugate Vaccine 13.  It was a case of actual medication error due to incorrect product storage.  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 holders 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.  Documents held by sender: none.
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves an adult male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-Jun-2020 via intramuscular route in the left deltoid on an unspecified date, which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other vaccine was administered.  It was a case of actual medication error due to incorrect product storage.  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 holders 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.  Documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial and follow-up information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267227; 2019SA267226; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves a female patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other concomitant vaccine was given.  It was a case of actual medication error due to incorrect product storage.  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 holders 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.  Documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves a female patient (elderly) who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other vaccine was administered.  It was a case of actual medication error due to incorrect product storage.  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 holders compliance with the requirements set out in Directive 2001/83/EC 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.  Documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial and follow-up information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267227; 2019SA267226; 2019SA267229; 2019SA267228; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves a female patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left arm on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other concomitant vaccine was given.  It was a case of actual medication error due to incorrect product storage.  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 holders 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.  Documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial and follow-up information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267227; 2019SA267226; 2019SA267229; 2019SA267228; 2019SA267230; 2019SA267232; 2019SA265193 (same reporter).  This case involves a female patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the right deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other concomitant vaccine was given.  It was a case of actual medication error due to incorrect product storage.  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 holders 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.  Documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial and follow-up information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267227; 2019SA267226; 2019SA267229; 2019SA267228; 2019SA267230; 2019SA267231; 2019SA265193 (same reporter).  This case involves a female patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the right arm on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other concomitant vaccine was given.  It was a case of actual medication error due to incorrect product storage.  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 holders 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.  Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Accidental exposure to product, Exposure via skin contact, No adverse event, Syringe issue
Clinical narrative: I was giving the injection, it leaked onto my hand, and it was close to the barrel, no AE; I was giving the injection, it leaked onto my hand, and it was close to the barrel, no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a female patient who was giving the injection INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ236AA, expiry date: 04-Apr-2019) and half of the dose was leaked onto his hand on 19-Sep-2019  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of vaccine exposure via skin contact and syringe issue.  At the time of reporting the patient had no adverse event.  It was also reported that screwing the needle on tight for injecting the dose her gloved hand was suddenly wet from the vaccine leaking. She stated the leaking must have come from the barrel of the syringe on the side or perhaps the orange part of the needle because that is where her finger was resting. Rph mentioned the other doses in the carton were fine to administer. She asked if the dose should be repeated, she will call the patient back to the pharmacy.  Needle type: Safety, BD safety glide, 25g by 1 inch.  List of document held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Rash erythematous
Clinical narrative: Red rash on both legs lasting less than 24 hours
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose, Syncope
Clinical narrative: FAINTED IN THE OFFICE
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Underdose
Clinical narrative: a few drops dripped out
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain, Vomiting
Clinical narrative: Pt stated on 9/30/2019 that she had been experiencing vomiting for 3 days following her Shingrix vaccination. She also stated she was having pain below her right ribs. I suggested she go to the urgent care to seek care as soon as possible, and she said she would do that.
Sex: U
Vaccine: HEPA, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events.; a patient was administered 1 dose of improperly stored VAQTA and 1 dose of improperly stored GARDASIL 9; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 09-SEP-2019, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) ( lot # S017739 has been verified to be a valid lot number, expiry date 29-AUG-2020) (exact dose and route of administration were not reported) for prophylaxis.  On the same day, the patient also received 1 dose of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1621934, expiry date 29-JAN-2022) (exact dose and route of administration were not provided) for prophylaxis.  The storage temperature was above 47 Fahrenheit degrees/ 9 Celsius degrees (28 Fahrenheit degrees) for 24 hours. A data logger was not involved. The event was first identified on 10-SEP-2019. No adverse events were reported. The outcome was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; improperly stored vaccine, VARN AX, was administered to one patient; Assistant confirmed route of administration was "intramuscular"; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding patient's pertinent medical history, drug reactions, allergies and concomitant therapies provided. On 12-SEP-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, once, via intramuscular route (confirmed by medical assistant) (lot # S002877 has been verified to be a valid lot number, expiration date 29-JAN-2021) for prophylaxis (anatomical location was not reported). The vaccine was reconstituted with a properly stored sterile diluent (lot # S000130, expiration date 23-AUG-2021).  The vaccine underwent a temperature excursion of 8.1 degrees Fahrenheit for 20 minutes. Previous temperature excursions were reported of 8.1 degrees Fahrenheit for 17 minutes and 9.5 degrees Fahrenheit for 21 minutes.  Digital Data Logger was involved in recording of the excursion. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Inappropriate schedule of product administration
Clinical narrative: unable to go to work/Bad reaction; patient had received second Shingrix dose onemonth late at 7 months past the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of inability to work in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced inability to work and drug dose administration interval too long. On an unknown date, the outcome of the inability to work and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the inability to work to be related to Shingrix.  Additional details were received as follows: The patient received second Shingrix dose one month late at 7 months past the first dose, which led to lengthening of vaccination schedule.  The patient told her she was unable to go to work for one week after getting the vaccination. HCP calling regarding a female patient On an unknown date the patient received dose one of Shingrix and 7 months later received dose two. The HCP reported the patient experienced a bad reaction after receiving dose two.  The reporter did not consented to follow up.  The pharmacist was reporting a patient that had experienced this in the past.  The patient did not know all the details.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Feeling abnormal, Headache, Malaise
Clinical narrative: feel lousy/ malaise; upset stomach; Headache; Malaise; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 1 day after receiving Shingrix, the patient experienced feeling abnormal, upset stomach, headache and malaise. On an unknown date, the outcome of the feeling abnormal, upset stomach, headache and malaise were unknown.   It was unknown if the reporter considered the feeling abnormal, upset stomach, headache and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced headache, upset stomach and malaise. The patient asked whether it is normal to feel lousy the next day after receiving shingrix.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pruritus
Clinical narrative: Redness at the injection site; Injection site itched; Chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 9LG54, expiry date 25th September 2021) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th September 2019, 1 days after receiving Shingrix, the patient experienced chills. On 19th September 2019, the patient experienced injection site erythema and injection site itching. On 19th September 2019, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the injection site erythema and injection site itching were recovering/resolving.   It was unknown if the reporter considered the chills, injection site erythema and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient experienced chills, redness the size of a baseball at the injection site and it itched. The chills were gone when the patient woke up on Thursday, September 19, 2019. On 20th September 2019, the patient noted that both the redness and itching were less. The patient gave permission for his physician to be contacted.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count abnormal, Neutrophil count increased
Clinical narrative: Abnormal reading / Neutrophils were slightly elevated; Neutrophils were slightly elevated; This case was reported by a consumer via call center representative and described the occurrence of complete blood count abnormal in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number BY2Y4, expiry date 13th November 2021) for prophylaxis.   On 2nd September 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 3rd September 2019, 1 days after receiving Shingrix, the patient experienced complete blood count abnormal and neutrophils increased. On an unknown date, the outcome of the complete blood count abnormal and neutrophils increased were unknown.   It was unknown if the reporter considered the complete blood count abnormal and neutrophils increased to be related to Shingrix.  Additional details were provided as follows: The patient stated that the following day after receiving vaccine had a complete blood count test and resulted an abnormal reading which is unusual because blood test normally is within normal limits. The patient stated that the neutrophils were slightly elevated. The patient stated that the expiry date was September 2020 from her paperwork because that was 1 year from administration date, but system show 13th November 2021. The patient consented to follow up.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Rash papular
Clinical narrative: Small papular rash on upper chest, deltoid, back, and neck; This case was reported by a nurse via call center representative and described the occurrence of papular rash in a 35-year-old female patient who received HBV (Engerix B) (batch number 2224M, expiry date 1st March 2022) for prophylaxis.   On 16th September 2019, the patient received the 2nd dose of Engerix B. On 17th September 2019, 1 days after receiving Engerix B, the patient experienced papular rash. On an unknown date, the outcome of the papular rash was unknown.   It was unknown if the reporter considered the papular rash to be related to Engerix B.  Additional details were provided as follows: The reporter stated that, the patient developed small papular rash on upper chest, deltoid, back, and neck the next day after receiving vaccine. No itching, fever, or malaise. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Soreness around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced soreness around the injection site. The caller did not want to answer any adverse event questions.  The patient briefly mentioned that she had heard a lot of people who had experienced many reactions for 2 days after getting Shingrix vaccine. No further details were provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: Soreness around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced soreness around the injection site. The caller did not want to answer any adverse event questions.  The patient briefly mentioned that she had heard a lot of people who had experienced many reactions for 2 days after getting Shingrix vaccine. No further details were provided.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash zosteriform in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number BP57E, expiry date 7th December 2021) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix. In September 2019, couple of days after receiving Shingrix, the patient experienced rash zosteriform. On an unknown date, the outcome of the rash zosteriform was unknown.   It was unknown if the reporter considered the rash zosteriform to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient developed rash after receiving vaccine. The rash was on one side of his body including his arm and trunk and looks like a shingles rash.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: red warm swollen right thigh, tender
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hyperaesthesia, Peripheral swelling, Pyrexia
Clinical narrative: Per patient report via email 9/29/19:  My arm was swollen, feverish red & very sensitive from my underarm to my elbow. I took some aspirin & slept most of Wednesday afternoon & Thursday  Yesterday the redness and swelling were gone
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Cellulitis, Erythema, Pain, Rash macular, Swelling
Clinical narrative: Patient vaccinated on 9/26/19. Had some soreness on that date at night. on 9/27/19 in the am had a little redness applied ice at school. Came to office for visit. Local redness swelling and blotchy. Dx Cellulitis at apt with provider. Antibiotic prescribed along with Benadryl.
Age: 90.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Computerised tomogram head, Confusional state, Distractibility, Dyskinesia
Clinical narrative: Sleepiness, confusion, shaking, left eye blood vessel rupture, Muscle weakness - head droops to left side and cannot get up or down without assistance, can barely walk with a walker, doesn't speak unless asked a question and delayed response, right arm jerking constantly, incontinence, itchy skin, easily distracted and forgets what she is doing
Age: 90.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram, Eye haemorrhage, Gait disturbance, Incontinence, Memory impairment
Clinical narrative: Sleepiness, confusion, shaking, left eye blood vessel rupture, Muscle weakness - head droops to left side and cannot get up or down without assistance, can barely walk with a walker, doesn't speak unless asked a question and delayed response, right arm jerking constantly, incontinence, itchy skin, easily distracted and forgets what she is doing
Age: 90.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Muscular weakness, Posture abnormal, Pruritus, Slow response to stimuli
Clinical narrative: Sleepiness, confusion, shaking, left eye blood vessel rupture, Muscle weakness - head droops to left side and cannot get up or down without assistance, can barely walk with a walker, doesn't speak unless asked a question and delayed response, right arm jerking constantly, incontinence, itchy skin, easily distracted and forgets what she is doing
Age: 90.0
Sex: F
Vaccine: FLU4
Symptoms: Somnolence, Speech disorder, Tremor, Urine analysis, Walking aid user
Clinical narrative: Sleepiness, confusion, shaking, left eye blood vessel rupture, Muscle weakness - head droops to left side and cannot get up or down without assistance, can barely walk with a walker, doesn't speak unless asked a question and delayed response, right arm jerking constantly, incontinence, itchy skin, easily distracted and forgets what she is doing
Age: 55.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Fever, Redness and swelling in the left arm, approximately 36 hours after injection
Age: 37.0
Sex: F
Vaccine: HEPA, IPV, JEV1, RAB, TYP
Symptoms: Adjustment disorder, Anxiety, Autonomic nervous system imbalance, Blood thyroid stimulating hormone, C-reactive protein normal
Clinical narrative: On July 19, patient received pre-travel vaccinations, Hep A#1, IPV, JEV, Rabies #1, and Typhoid vaccines. The next morning she was ill and remained ill for 10 days with fever, occipital headache, vomiting, and dizziness. She had only a mild residual occipital HA when she received Rabies vaccine #2 July 26th.  Within about 36 hrs she was ill as before with headache, vertigo, palpitations, chest heaviness, and sweating. About 14 days post the earlier vaccinations and 3 days following Rabies #2, while seated, she passed out.  LOC lasted less than 5 minutes.  In the ER her HR was 248. She was Dx'd with SVT and treated with Adenosine. Since, the headache, chest pressure, and vertigo persisted. Cardiology cleared her and Rx with Diltiazem. Two days later with onset of chest pressure she suffered another acute LOC while seated lasting about 1 minute. Since then, she has had bouts of tachycardia, sweating, dizziness generally in the morning with arising.  She has had one bout of dyspnea, tachycardia, and chest pain which awoke her from sleep.  She no longer exercises as symptoms worsen. She awakes unrefreshed, feeling generally fatigued.  She feels anxious/tremulous most all the time and feels her concentration is impaired.  She was Dx'd with an adjustment disorder with anxiety for which she took hydroxyzine. She denies further vomiting, or history of dysuria, incontinence, constipation, diarrhea, postprandial syncope, flushing, neurogenic pain, or heat/cold intolerance.  Tentative Diagnosis: Dysautonomia.
Age: 37.0
Sex: F
Vaccine: HEPA, IPV, JEV1, RAB, TYP
Symptoms: Chest discomfort, Chest pain, Disturbance in attention, Dizziness, Dyspnoea
Clinical narrative: On July 19, patient received pre-travel vaccinations, Hep A#1, IPV, JEV, Rabies #1, and Typhoid vaccines. The next morning she was ill and remained ill for 10 days with fever, occipital headache, vomiting, and dizziness. She had only a mild residual occipital HA when she received Rabies vaccine #2 July 26th.  Within about 36 hrs she was ill as before with headache, vertigo, palpitations, chest heaviness, and sweating. About 14 days post the earlier vaccinations and 3 days following Rabies #2, while seated, she passed out.  LOC lasted less than 5 minutes.  In the ER her HR was 248. She was Dx'd with SVT and treated with Adenosine. Since, the headache, chest pressure, and vertigo persisted. Cardiology cleared her and Rx with Diltiazem. Two days later with onset of chest pressure she suffered another acute LOC while seated lasting about 1 minute. Since then, she has had bouts of tachycardia, sweating, dizziness generally in the morning with arising.  She has had one bout of dyspnea, tachycardia, and chest pain which awoke her from sleep.  She no longer exercises as symptoms worsen. She awakes unrefreshed, feeling generally fatigued.  She feels anxious/tremulous most all the time and feels her concentration is impaired.  She was Dx'd with an adjustment disorder with anxiety for which she took hydroxyzine. She denies further vomiting, or history of dysuria, incontinence, constipation, diarrhea, postprandial syncope, flushing, neurogenic pain, or heat/cold intolerance.  Tentative Diagnosis: Dysautonomia.
Age: 37.0
Sex: F
Vaccine: HEPA, IPV, JEV1, RAB, TYP
Symptoms: Fatigue, Fibrin D dimer, Haematocrit decreased, Headache, Hyperhidrosis
Clinical narrative: On July 19, patient received pre-travel vaccinations, Hep A#1, IPV, JEV, Rabies #1, and Typhoid vaccines. The next morning she was ill and remained ill for 10 days with fever, occipital headache, vomiting, and dizziness. She had only a mild residual occipital HA when she received Rabies vaccine #2 July 26th.  Within about 36 hrs she was ill as before with headache, vertigo, palpitations, chest heaviness, and sweating. About 14 days post the earlier vaccinations and 3 days following Rabies #2, while seated, she passed out.  LOC lasted less than 5 minutes.  In the ER her HR was 248. She was Dx'd with SVT and treated with Adenosine. Since, the headache, chest pressure, and vertigo persisted. Cardiology cleared her and Rx with Diltiazem. Two days later with onset of chest pressure she suffered another acute LOC while seated lasting about 1 minute. Since then, she has had bouts of tachycardia, sweating, dizziness generally in the morning with arising.  She has had one bout of dyspnea, tachycardia, and chest pain which awoke her from sleep.  She no longer exercises as symptoms worsen. She awakes unrefreshed, feeling generally fatigued.  She feels anxious/tremulous most all the time and feels her concentration is impaired.  She was Dx'd with an adjustment disorder with anxiety for which she took hydroxyzine. She denies further vomiting, or history of dysuria, incontinence, constipation, diarrhea, postprandial syncope, flushing, neurogenic pain, or heat/cold intolerance.  Tentative Diagnosis: Dysautonomia.
Age: 37.0
Sex: F
Vaccine: HEPA, IPV, JEV1, RAB, TYP
Symptoms: Loss of consciousness, Malaise, Metabolic function test normal, Palpitations, Poor quality sleep
Clinical narrative: On July 19, patient received pre-travel vaccinations, Hep A#1, IPV, JEV, Rabies #1, and Typhoid vaccines. The next morning she was ill and remained ill for 10 days with fever, occipital headache, vomiting, and dizziness. She had only a mild residual occipital HA when she received Rabies vaccine #2 July 26th.  Within about 36 hrs she was ill as before with headache, vertigo, palpitations, chest heaviness, and sweating. About 14 days post the earlier vaccinations and 3 days following Rabies #2, while seated, she passed out.  LOC lasted less than 5 minutes.  In the ER her HR was 248. She was Dx'd with SVT and treated with Adenosine. Since, the headache, chest pressure, and vertigo persisted. Cardiology cleared her and Rx with Diltiazem. Two days later with onset of chest pressure she suffered another acute LOC while seated lasting about 1 minute. Since then, she has had bouts of tachycardia, sweating, dizziness generally in the morning with arising.  She has had one bout of dyspnea, tachycardia, and chest pain which awoke her from sleep.  She no longer exercises as symptoms worsen. She awakes unrefreshed, feeling generally fatigued.  She feels anxious/tremulous most all the time and feels her concentration is impaired.  She was Dx'd with an adjustment disorder with anxiety for which she took hydroxyzine. She denies further vomiting, or history of dysuria, incontinence, constipation, diarrhea, postprandial syncope, flushing, neurogenic pain, or heat/cold intolerance.  Tentative Diagnosis: Dysautonomia.
Age: 37.0
Sex: F
Vaccine: HEPA, IPV, JEV1, RAB, TYP
Symptoms: Pyrexia, Red blood cell sedimentation rate normal, Supraventricular tachycardia, Tachycardia, Tremor
Clinical narrative: On July 19, patient received pre-travel vaccinations, Hep A#1, IPV, JEV, Rabies #1, and Typhoid vaccines. The next morning she was ill and remained ill for 10 days with fever, occipital headache, vomiting, and dizziness. She had only a mild residual occipital HA when she received Rabies vaccine #2 July 26th.  Within about 36 hrs she was ill as before with headache, vertigo, palpitations, chest heaviness, and sweating. About 14 days post the earlier vaccinations and 3 days following Rabies #2, while seated, she passed out.  LOC lasted less than 5 minutes.  In the ER her HR was 248. She was Dx'd with SVT and treated with Adenosine. Since, the headache, chest pressure, and vertigo persisted. Cardiology cleared her and Rx with Diltiazem. Two days later with onset of chest pressure she suffered another acute LOC while seated lasting about 1 minute. Since then, she has had bouts of tachycardia, sweating, dizziness generally in the morning with arising.  She has had one bout of dyspnea, tachycardia, and chest pain which awoke her from sleep.  She no longer exercises as symptoms worsen. She awakes unrefreshed, feeling generally fatigued.  She feels anxious/tremulous most all the time and feels her concentration is impaired.  She was Dx'd with an adjustment disorder with anxiety for which she took hydroxyzine. She denies further vomiting, or history of dysuria, incontinence, constipation, diarrhea, postprandial syncope, flushing, neurogenic pain, or heat/cold intolerance.  Tentative Diagnosis: Dysautonomia.
Age: 37.0
Sex: F
Vaccine: HEPA, IPV, JEV1, RAB, TYP
Symptoms: Troponin T, Vertigo, Vomiting
Clinical narrative: On July 19, patient received pre-travel vaccinations, Hep A#1, IPV, JEV, Rabies #1, and Typhoid vaccines. The next morning she was ill and remained ill for 10 days with fever, occipital headache, vomiting, and dizziness. She had only a mild residual occipital HA when she received Rabies vaccine #2 July 26th.  Within about 36 hrs she was ill as before with headache, vertigo, palpitations, chest heaviness, and sweating. About 14 days post the earlier vaccinations and 3 days following Rabies #2, while seated, she passed out.  LOC lasted less than 5 minutes.  In the ER her HR was 248. She was Dx'd with SVT and treated with Adenosine. Since, the headache, chest pressure, and vertigo persisted. Cardiology cleared her and Rx with Diltiazem. Two days later with onset of chest pressure she suffered another acute LOC while seated lasting about 1 minute. Since then, she has had bouts of tachycardia, sweating, dizziness generally in the morning with arising.  She has had one bout of dyspnea, tachycardia, and chest pain which awoke her from sleep.  She no longer exercises as symptoms worsen. She awakes unrefreshed, feeling generally fatigued.  She feels anxious/tremulous most all the time and feels her concentration is impaired.  She was Dx'd with an adjustment disorder with anxiety for which she took hydroxyzine. She denies further vomiting, or history of dysuria, incontinence, constipation, diarrhea, postprandial syncope, flushing, neurogenic pain, or heat/cold intolerance.  Tentative Diagnosis: Dysautonomia.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Appendicectomy, Intussusception, Rectal haemorrhage, Surgery, Vomiting
Clinical narrative: Received Rotateq on 9/25/19 @ 1100, vomiting started @ 2330 9/26/19, vomited 2 episodes then, denies hematemesis, did not feed @ 0400 on 9/27/19, blood noted in diaper without stool @ 0400, called exchange and sent to ED, unable to reduce intussusception, surgery (reduction & appendectomy) @ 1230 9/27/19
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: left arm pain and redness around injection site
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Premature menopause
Clinical narrative: premature ovarian failure; This spontaneous report was received from a physician via a company representative and refers to a 16-year-old female patient. There was no information regarding patient's pertinent medical history, drug reactions, allergies and concomitant therapies provided. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed premature ovarian failure. No details were provided. The patient sought medical attention, however it was unknown, if she received any treatment. The outcome of the event was unknown. The causality assessment was not provided.
Sex: F
Vaccine: HPV4
Symptoms: Death, Human papilloma virus test positive, Papilloma viral infection, Product quality issue
Clinical narrative: died after hpv vaccine; HPV 16,11,18 (first vial tested and turn out to be positive); PQC Present: Yes; This spontaneous report was received from a consumer via social media referring to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, route, lot# and expiry date were not reported) for prophylaxis. On an unknown date, the patient died after administration of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). It was reported that the first vial was sent to the reporter by the local paediatrician. The reporter tested the vial and was turned to be positive (Human papilloma virus test positive and product quality issue). Cause of death was unknown and it was unknown whether autopsy was performed. The outcome of papilloma viral infection and product quality issue was unknown. The reporter considered the event of death and human papilloma virus test positive as related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). Causality assessment for product quality issue was not reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-0807USA02497:Same reporter US-009507513-1609USA002149:Same reporter; Reported Cause(s) of Death: unknown cause of death
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dehydration, Injection site swelling, Malaise
Clinical narrative: dehydration/ patient was admitted to the hospital for IV hydration; symptom of feeling ill; injection site swelling at both sites; This spontaneous report has been received from a physician via a field employee referring to a female patient in her 70's years of age. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.   On an unknown date the patient was vaccinated with flu vaccine (unspecified name and manufacturer) (lot #, expiration date, dose, frequency and route were unknown) in one arm and pneumococcal vaccine (manufacturer unknown) (lot #, expiration date, dose, frequency and route were unknown) in the other arm for prophylaxis.    On an unknown date (reported as after two days), the patient was seen in the office with symptoms feeling ill, injection site swelling at both sites and dehydration. The patient was admitted to the hospital (unspecified name and location) for intravenous (IV) hydration. The patient was discharged from the hospital on an unspecified date.  The outcome and causality of the events was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: vesicular rash; This case was reported by a physician via sales rep and described the occurrence of vesicular rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 21 days after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed vesicular rash which looked like herpes type rash but more scattered presentation. Developed 3 weeks post shingrix dose.  The reporter was unsure if related.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Extensive swelling of vaccinated limb, Musculoskeletal pain, Pain in extremity
Clinical narrative: swelling in his left shoulder, hand, wrist, and arm; pain arm/pain in arm; pain in shoulder; pain in wrist; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, pain in arm, shoulder pain and wrist pain. The patient was treated with analgesic, nos (Pain Pills (Nos)) and paracetamol (Tylenol). On an unknown date, the outcome of the extensive swelling of vaccinated limb, pain in arm, shoulder pain and wrist pain were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, pain in arm, shoulder pain and wrist pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed severe pain and swelling in his left shoulder, hand, wrist, and arm. He states it was so severe he went to the emergency room, and called his MD. He states he took two pain pills and tylenol. He states the swelling was decreasing, but the pain and swelling are still there at this time. The reporter consented to follow up. The emergency room visit was required. The reporter did not have vaccine adverse event information for this case.
Age: 72.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Patient reports hives on bilateral arms, neck and some on torso.  Some localized erythema and swelling, but hives were more bothersome.  Alleviated by Benadryl.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Participant complains of "slight pain at injection site" 1 week post vaccination "which progressed to debilitating pain in the left arm.  Extreme tenderness at injection site and extreme pain upon movement of arm" 10 days post vaccination.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Dizziness, Dysphonia, Headache, Loss of consciousness
Clinical narrative: Approximately 4 hours after receiving the vaccines, I had nasal congestion, swelling of eye lids, wheezing, chest tightness, fever (99.5), hoarseness, headache, nausea, dizziness, and passed out x2 when I stood up.  After about 24 hours after receiving the vaccines, I  was able to get up without being dizzy and gradually felt better over the next day.  I did not go to the emergency room.  I took diphenhydramine 25 mg and used my Albuterol inhaler.  I called my PCP office on 9/30/19 to report this adverse reaction and to obtain information necessary to report this adverse event.   I have never previously. had an adverse event to a vaccine.