chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: anaphylaxis/The patient experienced swollen eyes, swollen lips, developed hives and shortness of breath; The patient received the first dose of GARDASIL 9 on 15-MAY-2018 and received the second dose on 16-JUN-2019; This spontaneous report was received from a physician (also reported as a director of quality) via a field employee referring to a 12 years old male patient. The patient's pertinent medical history included history of Guillain-barre syndrome folloing influenza vaccination. Information about drug reactions/allergies and concomitant medication was unknown.  On 15-MAY-2018, the patient was vaccinated the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose detail, route, lot # and expiration date were unknown) for prophylaxis (reported as recommended for 11 and 12 year olds).  On 16-JUN-2019, the patient was vaccinated with the second dose in the series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1602281has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 21-JUL-2021, dose detail, route were unknown) for prophylaxis (reported as recommended for 11 and 12 year olds) and the patient did not receive any other vaccinations at that day (inappropriate schedule of product administration).  On 19-JUN-2019, the patient experienced anaphylaxis, swollen eyes, swollen lips, developed hives and shortness of breath. The patient was hospitalized for an unknown amount of time. Information about treatment given, lab diagnostics/studies was unknown by the reporter. The outcome of event was reported as recovered. The causality assessment between anaphylaxis and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was determined as related.   Upon internal review, the event of anaphylaxis was determined to be medically significant.
Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: No adverse effects were reported; that the patient "was administered the first dose of GARDASIL 9 in the series on 27-MAY-2019; This spontaneous report was received from a pharmacist referring to a 37-year-old female patient.      The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 27-MAY-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) lot # R024264 and expiration date 29-OCT-2019 (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: administered an improperly stored VARIVAX; No adverse effects; This spontaneous report was received from a health professional (medical assistant) refers unspecified patients of unknown demographics. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, frequency, anatomical location and route of administration were not reported) of lot # R020654 and expiration date 18-JUL-2020 for prophylaxis (product storage error). The concomitant medication included sterile diluent which was reported to be stored properly. No adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (F) (29.1 C) for a time frame of 3 hours. There was no previous temperature excursion reported. Data logger was not involved. No product quality complaint (PQC) was associated with this report.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; on 7/12/2019 a patient was administered an improperly stored VARIV AX; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent condition and medical history were unknown. Concomitant therapy included sterile diluent. On 12-JUL-2019 the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) of lot # S000132 with expiry date 02-JAN-2021 (strength, dose, frequency, route of administration unspecified) for prophylaxis (product storage error). The sterile diluent that was used to reconstitute the varicella virus vaccine live (oka/merck)(VARIVAX) was properly stored. The vaccine was exposed to the temperature of 15°Fahrenheit (°F) to 46 °F (29.1 F) for 3 hours. There was no previous temperature excursion and the data logger was not involved. No adverse effect was reported. The outcomes of the events were unknown. Furthermore, no product quality complaint (PQC) was involved.
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Was administered a dose of imporperly stored vaccines; This spontaneous report was received from a Certified Medical Assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On 09-JUL-2019, the patient was vaccinated with improperly stored doses of hepatitis a vaccine, inactivated (VAQTA) lot # R035227 expiration date on 01-JAN-2020 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live  recombinant human albumin (rHA)(M-M-R II) lot # R014355 expiration date on 21-MAY-2020 (route of vaccination, strength and dose number were not provided) for prophylaxis.  It was stated that, the Hepatitis A Vaccine, Inactivated (VAQTA) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II), were exposed to a temperature excursion of above 47°F (92.3°F) for 13 hours 11 minutes and above 47°F (73°F) for 9 hours. The vaccines were not involved in any previous temperature excursion, and report was made due to a data logger. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA012634: US-009507513-1907USA012633: US-009507513-1907USA012635: US-009507513-1907USA005377:
Sex: U
Vaccine: HEPA, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Was administered a dose of imporperly stored vaccines; This spontaneous report was received from a Certified Medical Assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On 09-JUL-2019, the patient was vaccinated with improperly stored doses of hepatitis a vaccine, inactivated (VAQTA) lot # S005724 expiration date on 10-JUL-2020 and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast ) (GARDASIL 9) lot # R032766 expiration date on 31-AUG-2021 (route of vaccination, strength and dose number were not provided) for prophylaxis.  It was stated that, the Hepatitis A Vaccine, Inactivated(VAQTA) and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast ) (GARDASIL 9), were exposed to a temperature excursion of above 47°F (92.3°F) for 13 hours 11 minutes and above 47°F (73°F) for 9 hours. The vaccines were not involved in any previous temperature excursion, and report was made due to a data logger. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA012632: US-009507513-1907USA012634: US-009507513-1907USA012635: US-009507513-1907USA005377:
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Was administered a dose of imporperly stored vaccines; This spontaneous report was received from a Certified Medical Assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On 09-JUL-2019, the patient was vaccinated with improperly stored doses of hepatitis a vaccine, inactivated (VAQTA) lot # R035227 expiration date on 01-JAN-2020 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live  recombinant human albumin (rHA) (M-M-R II) lot # R031681 expiration date on 01-NOV-2020 (route of vaccination, strength and dose number were not provided) for prophylaxis.  It was stated that, the Hepatitis A Vaccine, Inactivated(VAQTA) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II), were exposed to a temperature excursion of above 47°F (92.3°F) for 13 hours 11 minutes and above 47°F (73°F) for 9 hours. The vaccines were not involved in any previous temperature excursion, and report was made due to a data logger. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA012632: US-009507513-1907USA012633: US-009507513-1907USA012635: US-009507513-1907USA005377:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect reported; inadvertently administered an expired dose of M-M-R II; This spontaneous report was received from a health care professional regarding a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent (STERILE DILUENT). On 18-JUL-2019, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency and route not reported) lot # N024697 and expiry date: 31-DEC-2018 (Lot No. N024697 has been verified to be a valid lot number for [measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live], expiration date reported as 31-DEC-2018, but upon internal validation established as 13-DEC-2018) for prophylaxis (expired product administered). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Deformity, Herpes zoster, Pain, Scar
Clinical narrative: shingles; vaccine did not prevent shinges as intended; Information was received from a lawyer regarding a case in litigation concerning a female, age and medical history not provided.  On 01-MAY-2017 the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and the prevention of shingles.  The vaccine did not prevent shingles but rather caused the patient to contract a persistent strain of herpes zoster accompanied by severe pain and permanent disfigurement and scarring.  Shortly after receiving the vaccine the patient developed shingles.  In response to the symptoms, the patient presented to a physician and remains under their care. As a result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.    Herpes zoster/shingles was considered to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: shingles/persistent strain of herpes zoster; vaccine did not prevent shinges as intended; Information was received from a lawyer regarding a case in litigation concerning a patient, age , gender, and medical history not provided.  On an unknown date,  the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and the prevention of shingles.  The vaccine did not prevent shingles but rather caused the patient to contract a persistent strain of herpes zoster accompanied by pain.  As a result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 65 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 21-AUG-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: HERPES ZOSTER; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 65 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 09-AUG-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster at the emergency room. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 65 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 15-JUL-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 04-JAN-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 57 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 22-MAY-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: shingles; shingles neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 05-FEB-2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles and shingles neuralgia. On an unspecified date, the patient was treated by a physician for shingles and shingles neuralgia. The outcome of the events shingles and shingles neuralgia was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Haemorrhage, Immediate post-injection reaction, Injection site bruising, Pain in extremity
Clinical narrative: arm bled heavily; bruised from shoulder to elbow; arm swelling; soreness in arm; This case was reported by a consumer via call center representative and described the occurrence of hemorrhage in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 29th May 2019, immediately after receiving Shingrix, the patient experienced hemorrhage (serious criteria GSK medically significant), bruising of arm, swelling arm and pain in arm. On an unknown date, the outcome of the hemorrhage, swelling arm and pain in arm were recovered/resolved and the outcome of the bruising of arm was recovering/resolving.   It was unknown if the reporter considered the hemorrhage, bruising of arm, swelling arm and pain in arm to be related to Shingrix.  Additional details were provided as follows: At the time of the injection the patient's arm bled heavily. Afterwards her arm was very sore, swollen and bruised from shoulder to elbow.  The swelling and soreness resolved after a few weeks, but her arm was still bruised. The bruise was fading and was in the general area of the injection site at the time of reporting. She has never bled like this with previous vaccines.  The reporter did not consent to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: arm bled heavily; bruised from shoulder to elbow; arm swelling; soreness in arm; This case was reported by a consumer via call center representative and described the occurrence of hemorrhage in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 29th May 2019, immediately after receiving Shingrix, the patient experienced hemorrhage (serious criteria GSK medically significant), bruising of arm, swelling arm and pain in arm. On an unknown date, the outcome of the hemorrhage, swelling arm and pain in arm were recovered/resolved and the outcome of the bruising of arm was recovering/resolving.   It was unknown if the reporter considered the hemorrhage, bruising of arm, swelling arm and pain in arm to be related to Shingrix.  Additional details were provided as follows: At the time of the injection the patient's arm bled heavily. Afterwards her arm was very sore, swollen and bruised from shoulder to elbow.  The swelling and soreness resolved after a few weeks, but her arm was still bruised. The bruise was fading and was in the general area of the injection site at the time of reporting. She has never bled like this with previous vaccines.  The reporter did not consent to follow up.
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Syncope
Clinical narrative: fainted; This case was reported by a physician via sales rep and described the occurrence of fainting in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Shingrix and Tdap Vaccine. On an unknown date, less than a day after receiving Shingrix and Tdap Vaccine, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the outcome of the fainting was unknown.   It was unknown if the reporter considered the fainting to be related to Shingrix and Tdap Vaccine.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received Shingrix and a Tdap vaccine at the same time in the morning. That night, the patient got up to use the restroom and fainted.  An ambulance was called, but it was unknown if he was taken to the emergency. It was not reported what brand Tdap was administered, but the account does use Boostrix.
Sex: U
Vaccine: FLUX
Symptoms: Disability, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; patient was crippled - Difficulty in walking; Initial information received on 19-Jul-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves patient of an unknown age who experienced Guillain-barre syndrome, while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a serious guillain-barre syndrome and patient was crippled (gait disturbance) following the administration of INFLUENZA VACCINE. This event was assessed as serious as per IME list.   (Other relevant tests included no lab data.)  Final diagnosis was Guillain-barre syndrome.  It was not reported if the patient received a corrective treatment.  The outcome of the event was reported as Unknown.  Information on the batch number was requested  Documents held by sender: none.; Sender's Comments: This case concerns a patient of an unknown age who presented with guillain-barre syndrome and gait disturbance after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is not known. There are multiple possible etiologies of Guillain Barre Syndrome and the causal relationship with the vaccine cannot be ascertained without ruling out the other causes of this event. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Myalgia
Clinical narrative: Headache, chills, muscle pain, stomach pain. Taking Ibuprofen
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Rash, Rash macular
Clinical narrative: Rash on left arm: 3 erythematous macular lesions on left arm, no induration, one lesion on the anterior and superior upper arm is large stretching from distal to axilla to proximal to elbow.    Treated with Zyrtec and Benadryl Outcome: skin is almost back to normal after 7 days, slight redness still remaining on day 7.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Area around injection site was red and warm.  Redness extended 3-4 inches in circumference.
Age: 24.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: swelling and redness at injection site and entire upper arm, itching, warm to touch
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: slight fever- aching - muscles -chills over three days
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Area around injection site was red and warm.  Redness extended 3-4 inches in circumference.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: red inflamed area around injection site
Age: 66.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: 66yo male present to clinic to follow up on an ER visit from 07-20-19. Pt went to the ER for a rash in the arms, back and  flank. Pt states that had the rash for about two weeks before he went to the ER. He states that he thinks this rash was due to the shingles  or pneumonia vaccine that he got on 06-24-19.  Today he states that the rash is better after using Hydroxyzine and Triamcinolone that was given at the ER. He still experiencing some itching. Pt states he never had a rash like this before, no one at home with similar rash, no change in body wash or detergent.
Age: 14.0
Sex: F
Vaccine: IPV, TDAP, VARCEL
Symptoms: Abdominal discomfort, Cold sweat, Decreased appetite, Feeling hot, Generalised tonic-clonic seizure
Clinical narrative: Patient was sitting upright to receive her vaccines. As this was completed she became pale and I asked her if she was okay. She was unable to respond and appeared to have fainted. I lowered her to the table and as I was doing so she had a tonic clonic seizure. She was placed in the recovery position. Duration of seizure was approximately 30 seconds from onset to when she opened her eyes and was responsive. During this episode her skin was pale, lips gray, face was warm, extremities (hands) were cold and slightly clammy. 911 was called and she was monitored until their arrival. Vital signs: Pulse: 58, Respirations: Even, not labored, SPO2: 94, BP 100/48.  Mother reported that she had not eaten all day due to an "upset stomach". EMT's and police arrived within 5 minutes of call. Patient was kept laying down until their arrival and during that time she was talking with Mom and answering questions. Transported to Hospital in ambulance for further evaluation.
Age: 14.0
Sex: F
Vaccine: IPV, TDAP, VARCEL
Symptoms: Lip discolouration, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Patient was sitting upright to receive her vaccines. As this was completed she became pale and I asked her if she was okay. She was unable to respond and appeared to have fainted. I lowered her to the table and as I was doing so she had a tonic clonic seizure. She was placed in the recovery position. Duration of seizure was approximately 30 seconds from onset to when she opened her eyes and was responsive. During this episode her skin was pale, lips gray, face was warm, extremities (hands) were cold and slightly clammy. 911 was called and she was monitored until their arrival. Vital signs: Pulse: 58, Respirations: Even, not labored, SPO2: 94, BP 100/48.  Mother reported that she had not eaten all day due to an "upset stomach". EMT's and police arrived within 5 minutes of call. Patient was kept laying down until their arrival and during that time she was talking with Mom and answering questions. Transported to Hospital in ambulance for further evaluation.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles.  The outcome of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Abdominal pain upper, Injection site discolouration, Injection site erythema, Injection site warmth, Malaise
Clinical narrative: not feeling well/general malaise; stomach pain; red-purple; injection site redness; injection site warmth; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number G9P35, expiry date 15th September 2019) for prophylaxis.   On 28th May 2019, the patient received Kinrix. On 29th May 2019, 1 days after receiving Kinrix, the patient experienced injection site erythema and injection site warmth. On 30th May 2019, the patient experienced feeling unwell, stomach pain and injection site discoloration. On an unknown date, the outcome of the injection site erythema, injection site warmth, feeling unwell, stomach pain and injection site discoloration were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth, feeling unwell, stomach pain and injection site discoloration to be related to Kinrix.  Additional details were provided as follows: The age at vaccination was not reported. On 28th May 2019, The patient received Kinrix. On 29th May 2019, the site of the vaccination turned red and warm. On 30th May 2019, the site of vaccination is red-purple, very warm, and approximately 4 inches in diameter. The patient was not feeling well, complaining of stomach pain and general malaise.  The reporter was asked for confirm to the expiration date of Kinrix lot number G9P35.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Injection site pain, Joint swelling
Clinical narrative: swollen shoulder; Painfull shoulder; uncomfortable lower gut; This case was reported by a consumer and described the occurrence of swollen joints in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced swollen joints, injection site pain and abdominal discomfort. On an unknown date, the outcome of the swollen joints, injection site pain and abdominal discomfort were not recovered/not resolved.   It was unknown if the reporter considered the swollen joints, injection site pain and abdominal discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received first shot 5 days ago, from the date of reporting. On the date of reporting, the patient was still experiencing swollen on shoulder and the site was painful if touched.  My His lower gut was uncomfortable
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blood test normal, Fatigue, Neuralgia, Pain in extremity
Clinical narrative: pain in nervous system of back, arms and legs; fatigue; muscle pain; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fibromyalgia. Concomitant products included Herpes zoster (Shingrix).   On 28th June 2019, the patient received the 2nd dose of Shingrix. On 29th June 2019, 1 days after receiving Shingrix, the patient experienced fatigue and muscular back pain. On an unknown date, the patient experienced pain in arm. The patient was treated with ibuprofen and biofreeze (nos) (Biofreeze). On an unknown date, the outcome of the fatigue, muscular back pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, muscular back pain and pain in arm to be related to Shingrix.  Additional details were received as follows: This case was reported by the patient's husband. The age vaccination was not reported. The patient woke up very fatigued with pain in her muscles of her back after receiving vaccine. The patient saw her healthcare professional and they did blood work but did not find anything. The patient was concerned that getting the 2nd dose 4 days early case more severe reaction. Emergency room visit was required. The reporter stated that the patient called back asking about specifics around immunosuppressive medications the effect on the vaccine. The patient was still suffering from pain in her nervous system of back, arms and legs. The patient tried rubs, ibuprofen and biofreeze which offered temporary relief but the pain returned. The reporter did not consent to follow up. This case has been linked with case US2019118444, reported by the same reporter.      Lab Comments: On an unknown date blood test was done
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Back pain, Fatigue, Myalgia
Clinical narrative: pain/ pain in her arm and from her waist to her knees; pain/ pain in her arm and from her waist to her knees; pain/ pain in her arm and from her waist to her knees; fatigue; myalgia; arthritis; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic (allergies to cephalosporin, penicillin, and macrolides).   On 21st May 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm, lumbar pain, knee pain, fatigue, myalgia and arthritis. On an unknown date, the outcome of the pain in arm, lumbar pain, knee pain, fatigue, myalgia and arthritis were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, lumbar pain, knee pain, fatigue, myalgia and arthritis to be related to Shingrix.  Additional details were provided as follows: This case was reported by the pharmacy intern. The reporter did not have the lot number and expiration date of vaccine. The patient received the vaccine at different site and experienced pain in her arm and from her waist to her knees, fatigue and myalgia. The patient also stated that it feels like she had arthritis.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain/ pain in her arm and from her waist to her knees; pain/ pain in her arm and from her waist to her knees; pain/ pain in her arm and from her waist to her knees; fatigue; myalgia; arthritis; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic (allergies to cephalosporin, penicillin, and macrolides).   On 21st May 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm, lumbar pain, knee pain, fatigue, myalgia and arthritis. On an unknown date, the outcome of the pain in arm, lumbar pain, knee pain, fatigue, myalgia and arthritis were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, lumbar pain, knee pain, fatigue, myalgia and arthritis to be related to Shingrix.  Additional details were provided as follows: This case was reported by the pharmacy intern. The reporter did not have the lot number and expiration date of vaccine. The patient received the vaccine at different site and experienced pain in her arm and from her waist to her knees, fatigue and myalgia. The patient also stated that it feels like she had arthritis.
Age: 1.42
Sex: M
Vaccine: MMR
Symptoms: Pallor, Pyrexia, Rash erythematous, Rash macular
Clinical narrative: Fever began 6 days after vaccine administration; rash began 6 days after vaccine  administration; Rash is a macular, erythematous blanching rash on both lower and upper extremities, trunk, diaper area, and outer ears
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Cough, Hypoaesthesia, Injection site erythema, Injection site hypoaesthesia
Clinical narrative: pt came in with redness/swelling/numbness in left arm where vaccine was administered, pt also reports left sided facial numbness and temperature 101.3 last night , pt also developed a cough
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site swelling
Clinical narrative: pt came in with redness/swelling/numbness in left arm where vaccine was administered, pt also reports left sided facial numbness and temperature 101.3 last night , pt also developed a cough
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: She came in today for her second shot and said her arm turned red and was hot to touch. She said it was 2x4 inches big.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: She came in today for her second shot and said her arm turned red and was hot to touch. She said it was 2x4 inches big.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: Severe arm pain that evening. During the night severe headache left side of head behind ear area, stabbing pain. Continued till 10:30 AM the following day, July 24, 2019. At this time pain has finally subsided. Do not know if it will start up again later today.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Patient developed redness around the injection site beginning on 7/21/19 around mid-day. Patient previously experienced reaction with first dose so patient drew a line around the redness that evening and it became worse the next morning. States that she had fever, chills, headache, aches, and tired. She was seen at urgent care on 7/22 where she was diagnosed again with cellulitis and given a course of antibiotics.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Patient developed redness around the injection site beginning on 7/21/19 around mid-day. Patient previously experienced reaction with first dose so patient drew a line around the redness that evening and it became worse the next morning. States that she had fever, chills, headache, aches, and tired. She was seen at urgent care on 7/22 where she was diagnosed again with cellulitis and given a course of antibiotics.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: rapid heart rate
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Malaise, Myalgia
Clinical narrative: Myalgia (generalized), fatigue, malaise for about 24 hours.  Chills for about 12 hours.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Patient reported hives on neck later in the day.  Took zyrtec. Woke the next morning with more hives on neck.
Age: 66.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site pain
Clinical narrative: Bilateral shoulder pain lasting 3 weeks. Slight relief with NSAIDS. Will continue to monitor and do PT if not resolved.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Chills, fever, body aches, headache, fatigue
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient Fainted
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Haematoma
Clinical narrative: hematoma 3cm
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Confusional state, Headache, Loss of consciousness, Muscular weakness
Clinical narrative: Medical Assistant gave patient 2 Immunizations,  TDaP, Menactra. Patient was fine after vaccines, he walked out of room with mother when PSR called my name and asked for help,  I got to the patient he was hallway in front on check out station he was lying on the floor passed out with his mother at his side.  Patient woke up a few about 15 seconds later, he was confused and stated that he had a headache, asked if he knew where he was he stated "at the hospital" I placed the 02 monitor on patients finger for a few minutes which read 99% 02  and 72 for his pulse. APRN, carried  patient to one of his exam rooms to monitored him. APRN then asked if the patient could walk to see how he was doing he has some weakness in legs Mother was informed by APRN that patient should get checked out by ER, mother declined ambulance and stated that she wanted to take him herself to ER. Nurse to follow up on patient condition
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Herpes zoster, Rash, Rash vesicular
Clinical narrative: 2d after receiving injection, patient develoved right-sided headache with subsequent painful blistering rash, classic for shingles in right facial nerve dermatome
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Electrocardiogram, Pallor, Presyncope
Clinical narrative: Pt presented to clinic today 07/24/2019 for HPV vaccine #2. First dose given 09/26/2018. About 10-15 minutes after vaccine was administered, pt had a near fainting episode in the clinic lobby while waiting to be discharged home. The patient's mother caught her in her arms and explained that her daughter became pale in color as well. Pt also stated that she felt dizzy afterwards. Pt has not had this event happen before with any previous vaccines. No Hx of Diabetes, Anemia, Seizures, or any other dizzy or fainting episodes in the past. Pt vital signs were taken and trended at multiple time intervals. Pt was given fluids to drink and some graham crackers to help with the dizziness. Orthostatic vital signs were taken as well. EKG was done as well. Pt denied any more dizziness after about 15 minutes and was able to walk well again.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Pallor, Rash, Rash pruritic, Urticaria
Clinical narrative: On 07/22/19, 15 yo F presented to clinic for second HPV vaccine (HPV vaccine 9-valent IM (GARDASIL 9)). Pt received first injection on 08/10/2016 without incident. At 1426, pt was administered 0.5 mL in left deltoid (NDC: 0006-4121-02, Lot #1614897, exp: 9/20/2021). By evening-time, pt developed a diffuse pruritic rash on back of arms, abdomen and thighs. On 07/23, pt called the nurse triage line and an appointment was made for evaluation. Pt reported self-treatment with diphenhydramine with symptom relief. On return to clinic, MD exam found "extensive areas of hives both thighs, back, shoulders abdomen and anterior chest wall.  Blanching on pressure.  No sign of secondary infection." Pt was instructed to continue use of diphenhydramine as needed and given a prescription for prednisone taper. Pt discharged in stable condition.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Hypotonia, Intussusception, Pallor, Unresponsive to stimuli, Vomiting
Clinical narrative: Developed vomiting on the morning of 7/23/19. Pt become pale, limp, and nonresponsive. Diagnosed with intussusception by ER as well as Hospital. Pt was kept over night for observation
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: X-ray
Clinical narrative: Developed vomiting on the morning of 7/23/19. Pt become pale, limp, and nonresponsive. Diagnosed with intussusception by ER as well as Hospital. Pt was kept over night for observation
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles.  The outcome of the event shingles was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 78-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 05-NOV-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles.  The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 88-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 06-NOV-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles.  The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb
Clinical narrative: Arm swelling; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult 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, unknown after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the outcome of the extensive swelling of vaccinated limb was recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that after receiving older Shingrix vaccine experienced swelling in her arm. The patient stated that the older vaccine caused her arm to swell to three times its normal size. This case has been linked with US2019117626, reported by the same reporter.