chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Movement disorder, Pain in extremity, Swelling
Clinical narrative: Arm was swollen on her biceps; Arm was also red past her elbow; Arm was very sore; for 3-4 nights could not roll over on arm; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included mosquito bite.   On 6th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 6th June 2019, less than a day after receiving Shingrix, the patient experienced local swelling and localized erythema. In June 2019, the patient experienced pain in arm and movement disorder. On 6th August 2019, the outcome of the local swelling and localized erythema were resolved with sequelae. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the movement disorder was recovered/resolved.   It was unknown if the reporter considered the local swelling, localized erythema, pain in arm and movement disorder to be related to Shingrix.  Additional case details were provided as follows: The patient reporter for herself. The patient had an Epipen because she usually got reactions to mosquito bites.  The patient got her Shingrix shot in the left arm.  The patient's arm was very sore and for 3 to 4 nights she could not roll over on her arm.  Her arm was also red past her elbow.  This time, she did not need to use the Epipen. On day 10, when she took a picture of her arm, it was red and swollen on her biceps. The patient was wondering whether she should get the 2nd shot and was very apprehensive. The patient referred back to her health care provider.  The patient did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that her friend experienced flu-like symptoms after receiving the 2nd dose of Shingrix. The reporter did not consent to follow-up. The reporter did not provide any additional details regarding the patients or the event. The case linked with the case US2019196474, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Ache; Burning; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult 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 injection site pain and injection site burning. On an unknown date, the outcome of the injection site pain and injection site burning were unknown.   It was unknown if the reporter considered the injection site pain and injection site burning 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 adult as per vaccine indication. The pharmacist stated that there had been complaints from the patient that the solution going in upon administration gave them a really bad ache, and that it burned. The reporter consented to follow up.  No patient demographics available at the time of reporting. The case has been linked to the case US2019AMR197121, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This case was reported by a other health professional via call center representative and described the occurrence of diarrhea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 7 days after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea 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 selected as an adult as per vaccine indication. The reporter did not consent to follow up.
Age: 75.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Erythema, Herpes zoster, Musculoskeletal pain, Pruritus
Clinical narrative: SHINGLES; The area started to itch; Red patch on her right shoulder that was itchy and red; Right shoulder began to hurt; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   The patient's past medical history included shingles (first time was below her elbow on her right side, second time was on the left side of her stomach, 3rd time was on her left arm and fourth time was on her left hand). Concurrent medical conditions included arthritis.   On 16th October 2019, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. In October 2019, less than a month after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced shoulder pain. On 28th October 2019, the patient experienced shingles, pruritus and localized erythema. The patient was treated with gabapentin and valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the shoulder pain, pruritus and localized erythema were unknown.   It was unknown if the reporter considered the shingles, shoulder pain, pruritus and localized erythema to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: 2 weeks ago from the reporting daste, the patient received Shingrix on left arm. On the same day, the patient received flu shot in her right arm at the same time. At the end of week before the reporting date, on thursday or friday, the patient's right shoulder began to hurt. The night before last from the reporting date, 12 days after receiving Shingrix and Flu vaccine, the area started to itch. The patient then noticed a red patch on her right shoulder that was itchy and red. The patches presented on the top of the shoulder, to the back of the shoulder, across her chest to the upper part of the right breast and down her right arm to just above the elbow. Her doctor diagnosed it as shingles and yesterday she started gabapentin and valacyclovir. The patient has a history of shingles and this is the fifth time she has experienced it.  The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Diarrhea; Chills; Body aches; Headache; Joint pain; Tired; Decreased appetite; A red injection site; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 27th October 2019, 1 days after receiving Shingrix, the patient experienced diarrhea, chills, general body pain, headache, joint pain, tiredness, appetite lost and injection site erythema. On 29th October 2019, the outcome of the diarrhea, chills, general body pain, headache, joint pain, tiredness, appetite lost and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the diarrhea, chills, general body pain, headache, joint pain, tiredness, appetite lost and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient woke up with chills, body aches, headache, joint pain, tired, decreased appetite, and a red injection site. On 28th October 2019, the symptoms improved and by 29th October 2019 they were all resolved. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Pain
Clinical narrative: Diarrhea; Chills; Body aches; Headache; Joint pain; Tired; Decreased appetite; A red injection site; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 27th October 2019, 1 days after receiving Shingrix, the patient experienced diarrhea, chills, general body pain, headache, joint pain, tiredness, appetite lost and injection site erythema. On 29th October 2019, the outcome of the diarrhea, chills, general body pain, headache, joint pain, tiredness, appetite lost and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the diarrhea, chills, general body pain, headache, joint pain, tiredness, appetite lost and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient woke up with chills, body aches, headache, joint pain, tired, decreased appetite, and a red injection site. On 28th October 2019, the symptoms improved and by 29th October 2019 they were all resolved. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: "welt" at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site wheal in a adult 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 injection site wheal. On an unknown date, the outcome of the injection site wheal was unknown.   It was unknown if the reporter considered the injection site wheal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional stated that the patient received a dose of Shingrix and developed a welt at the injection site.  The reporter did not consent to follow-up. The healthcare professional declined to provide any further information at this time.  The healthcare professional stated that she would call back later when she had more time.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: knot; redness; soreness; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included intervertebral disc protrusion. Concomitant products included acetylsalicylic acid (Aspirin).   On 28th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced local swelling, erythema and pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the local swelling was unknown and the outcome of the erythema was recovering/resolving and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the local swelling, erythema and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a knot and it was red and fading at the time of reporting. The patient also experienced pain that went away after the third day. The patient refused to provide any additional details.
Sex: U
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: ringing in the ear; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of unknown demography who experienced ringing in the ear (tinnitus), while he/she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, following the vaccination the patient experienced ringing in the ear (tinnitus).  (Other relevant tests included no lab data.)  Final diagnosis was ringing in ears.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown at the time of reporting.  Information on the batch number was requested.
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Flublok was inadvertently administered to a 17yo male patient, no AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 years old male patient who was vaccinated with a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (frequency once) lot QFAA114 via intramuscular route in the right deltoid on 26-Sep-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to inappropriate age at vaccine administration.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Menactra was administered today to a patient, no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 17 years old female patient who received 0.5 ml dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U5989AA via intramuscular route in the left arm on 30-Oct-2019, that was expired on 27-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: on 27Oct2019 a 4 month old patient was given ActHIB that expired on 17Sep2019, no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months (reported as 4 months, 3 weeks, and 5 days) old male patient who received a 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] lot UI896AAA (Expiry date 17-Sep-2019), vial- U6018AA (Expiry date 17Sep2019) via intramuscular route in the right thigh on 27-Oct-2019 which was already expired.  The patient's medical history and concomitant medications were not reported.  Concomitant medications included POLIO VACCINE INACT (IPV); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13). All these given in left thigh.  It was an actual medication error case due to expired vaccine used.  At a time of reporting, no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired ActHib vaccine, no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 months old female patient who received a 0.5 ml dose (fourth dose in series) of expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] (box lot UI900AAA, expiry date 17-Sep-2019, vial for powder lot UI900AA, expiry date 08-Oct-2019, diluent lot U6018AA, expiry date 17-Sep-2019) via intramuscular route in the right thigh on 29-Oct-2019.  The patient's medical history and concomitant medications were not reported.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  It was an actual medication error case due to expired vaccine used.  At a time of reporting No adverse reaction reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: gave a 12 year old the Flublok Quadrivalent/no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 12 years old female patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was reported.   On 12-Oct-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1913 via unknown route in unknown administration site.  It was of actual medication error due to Inappropriate age at vaccine administration.  It was unknown whether adverse event was reported or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 9 year old patient received Flublok quadrivalent/no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case was linked to cases 2019SA304487 and 2019SA304462 (same reporter).  This case involves a 9 years old male patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient did not have any concomitant therapy.   On 10-Oct-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route in the left deltoid.  It was of actual medication error case due to Inappropriate age at vaccine administration.  It was unknown whether adverse event was experienced or not.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Pain in extremity
Clinical narrative: very sore arm,  flu symptoms for one day
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Arm swelled up, fever, chills, overall achy flu-like symptoms.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Computerised tomogram, Fall, Guillain-Barre syndrome, Herpes zoster
Clinical narrative: ended up in Emergency dept with  weakness, falls, dx with shingles also, after being seen they transferred him to Hospital where he was admitted and dx with Guillain Barre syndrome
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Lumbar puncture
Clinical narrative: ended up in Emergency dept with  weakness, falls, dx with shingles also, after being seen they transferred him to Hospital where he was admitted and dx with Guillain Barre syndrome
Age: 31.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Contusion, Decreased appetite, Influenza like illness, Myalgia
Clinical narrative: Patient was felt normal after leaving the pharmacy. In the evening after the vaccination, patient started to experience muscle aches, chills,and tremors throughout the evening.  Experienced slightly elevated fever approximately around 100 degrees Fahrenheit. Struggled to mobilize her arm that was vaccinated. Reported poor appetite and flu-like symptoms. Patient tried alternating taking ibuprofen and acetaminophen. On the next morning, patient went to the gym and noticed bruises on arm.
Age: 31.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Tremor
Clinical narrative: Patient was felt normal after leaving the pharmacy. In the evening after the vaccination, patient started to experience muscle aches, chills,and tremors throughout the evening.  Experienced slightly elevated fever approximately around 100 degrees Fahrenheit. Struggled to mobilize her arm that was vaccinated. Reported poor appetite and flu-like symptoms. Patient tried alternating taking ibuprofen and acetaminophen. On the next morning, patient went to the gym and noticed bruises on arm.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient had severe arm pain going down to her elbow
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Bellyache, headache, very sore arm after the shot (not at the time of the shot), nausea, fatigue.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Dyspnoea, Gait disturbance, Insomnia
Clinical narrative: employee states hours after the infection while she was at home she began having severe chills, dyspnea, pain in legs, dizziness, and difficulty walking. She says she was not able to sleep because of the chills and shaking. Several hours after the chills subsided but she says it was still difficult to walk. She was able to work that night, because by the time she got up she was able to function. She says she received the pneumonia shot week prior. She received no TX.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: employee states hours after the infection while she was at home she began having severe chills, dyspnea, pain in legs, dizziness, and difficulty walking. She says she was not able to sleep because of the chills and shaking. Several hours after the chills subsided but she says it was still difficult to walk. She was able to work that night, because by the time she got up she was able to function. She says she received the pneumonia shot week prior. She received no TX.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Fatigue, Gait disturbance, Headache, Immediate post-injection reaction
Clinical narrative: Immediate bulge on are and not feeling well. Sleepy, tired, bad headache,low grade temp day 1. Day 2 and 3 temp over 101 and body hurt all over.  Days after joint pain in legs, major  fatigue  And headaches. This continues till May 8th when she started passing out and having non- epileptic seizures. Episodes that lasted 17hrs that left her walking abnormal. This still continues with bad headache, body and joint pain and daily not feeling well. To date she has had over 300 passing out and seizures.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Malaise, Pain, Pyrexia, Seizure
Clinical narrative: Immediate bulge on are and not feeling well. Sleepy, tired, bad headache,low grade temp day 1. Day 2 and 3 temp over 101 and body hurt all over.  Days after joint pain in legs, major  fatigue  And headaches. This continues till May 8th when she started passing out and having non- epileptic seizures. Episodes that lasted 17hrs that left her walking abnormal. This still continues with bad headache, body and joint pain and daily not feeling well. To date she has had over 300 passing out and seizures.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Somnolence, Swelling
Clinical narrative: Immediate bulge on are and not feeling well. Sleepy, tired, bad headache,low grade temp day 1. Day 2 and 3 temp over 101 and body hurt all over.  Days after joint pain in legs, major  fatigue  And headaches. This continues till May 8th when she started passing out and having non- epileptic seizures. Episodes that lasted 17hrs that left her walking abnormal. This still continues with bad headache, body and joint pain and daily not feeling well. To date she has had over 300 passing out and seizures.
Age: 0.33
Sex: M
Vaccine: PNC13, UNK
Symptoms: Crying, Excessive cerumen production, Insomnia, Pyrexia, Urine analysis
Clinical narrative: Fever ranging from 101-103 from Friday-Tuesday.  Not sleeping. Crying and inconsolable at times. Brought to doctors on Tuesday and amoxicillin prescribed and remedied
Age: 68.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Paraesthesia oral, Paranasal sinus discomfort, Swelling face
Clinical narrative: LEFT SIDE FACE SWELLING , SINUS PRESSURE, TONGUE FELT FUNNY PATIENT TOOK BENADRYL FOLLOWING MORNING
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria, Rhinorrhoea, Urticaria
Clinical narrative: Presented to Emergency Department with urticaria at site of flu vaccine given 2 days prior. Symptoms started 1 hour prior to arrival to ED. While in ED,  spread to right thigh.  Also had 2 days of rhinorrhea. No fevers.  No GI symptoms.  No respiratory symptoms. Observed in ED. No signs of anaphylaxis observed.
Age: 70.0
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 72-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported), prescribed by a healthcare provided for the long-term prevention of shingles and zoster-related conditions and administered at a pharmacy by a healthcare provided. On an unknown date, the patient experienced shingles and was treated by a physician. The outcome of the event was unknown. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was reported as related.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Erythema, Feeding disorder, Hyperhidrosis, Malaise
Clinical narrative: Arm got really red; Arm seemed to be swollen; Arm itched / Small itching spots (forehead & back & arm); Shivering; Just water; Throwing up; Been sick; Sweats; Cold; This case was reported by a consumer and described the occurrence of erythema of extremities in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2018, the patient received Shingrix. In October 2019, less than a year after receiving Shingrix, the patient experienced sickness, sweating, cold and vomiting. On an unknown date, the patient experienced erythema of extremities, swelling arm, pruritus, shivering and unable to eat. On an unknown date, the outcome of the erythema of extremities, swelling arm, pruritus, sickness, sweating, cold, shivering, vomiting and unable to eat were unknown.   It was unknown if the reporter considered the erythema of extremities, swelling arm, pruritus, sickness, sweating, cold, shivering, vomiting and unable to eat to be related to Shingrix.  Additional details were provided as follows: The patient's arm was red and seems to be swollen for around week and half. The patient stated that, past weekend from the date of reporting, had been sick, sweats, cold and shivering and then started throwing up, just water. On 28th October 2019, the patient finally ate and on the day of reporting woke up it coming back up through last days. The patient had small itching spot on forehead, back and arm, but did not looks like chicken rash. The patient stated that it had been 29 days ago from the date of reporting and asked if it was due to vaccine. The patient was caretaker and had seen plenty such cases.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Peripheral swelling, Pruritus, Vomiting
Clinical narrative: Arm got really red; Arm seemed to be swollen; Arm itched / Small itching spots (forehead & back & arm); Shivering; Just water; Throwing up; Been sick; Sweats; Cold; This case was reported by a consumer and described the occurrence of erythema of extremities in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2018, the patient received Shingrix. In October 2019, less than a year after receiving Shingrix, the patient experienced sickness, sweating, cold and vomiting. On an unknown date, the patient experienced erythema of extremities, swelling arm, pruritus, shivering and unable to eat. On an unknown date, the outcome of the erythema of extremities, swelling arm, pruritus, sickness, sweating, cold, shivering, vomiting and unable to eat were unknown.   It was unknown if the reporter considered the erythema of extremities, swelling arm, pruritus, sickness, sweating, cold, shivering, vomiting and unable to eat to be related to Shingrix.  Additional details were provided as follows: The patient's arm was red and seems to be swollen for around week and half. The patient stated that, past weekend from the date of reporting, had been sick, sweats, cold and shivering and then started throwing up, just water. On 28th October 2019, the patient finally ate and on the day of reporting woke up it coming back up through last days. The patient had small itching spot on forehead, back and arm, but did not looks like chicken rash. The patient stated that it had been 29 days ago from the date of reporting and asked if it was due to vaccine. The patient was caretaker and had seen plenty such cases.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Pyrexia
Clinical narrative: Fever; Side effects; This case was reported by a consumer and described the occurrence of fever 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, less than a week after receiving Shingrix, the patient experienced fever and adverse drug reaction. On an unknown date, the outcome of the fever and adverse drug reaction were not recovered/not resolved.   It was unknown if the reporter considered the fever and adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced side effects except tiredness. At the time of reporting, the patient had fever and stated that, it has been a week since vaccination.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Bedridden, Dysstasia, Feeling abnormal, Headache
Clinical narrative: Blinding headache, gripping stomach and back pains reminiscent of labor, nausea, had to go to bed for a day and a  half missing work.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Loss of personal independence in daily activities, Migraine, Myalgia, Skin exfoliation
Clinical narrative: Blinding headache, gripping stomach and back pains reminiscent of labor, nausea, had to go to bed for a day and a  half missing work.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: Blinding headache, gripping stomach and back pains reminiscent of labor, nausea, had to go to bed for a day and a  half missing work.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Back pain, Headache, Loss of personal independence in daily activities, Nausea
Clinical narrative: Blinding headache, gripping stomach and back pains reminiscent of labor, nausea, had to go to bed for a day and a  half missing work.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort
Clinical narrative: Injection site discomfort; This case was reported by a nurse and described the occurrence of injection site discomfort in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was recovered/resolved.   It was unknown if the reporter considered the injection site discomfort to be related to Shingrix.  Additional details were provided as follows: The reporter consent to follow up. For tolerance to 2nd dose, refer case US2019AMR199268. The case has been linked with the cases US2019AMR199256 and US2019AMR199259, reported by same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This case was reported by a nurse and described the occurrence of pain in arm in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site discomfort (1st dose received on an unknown date, refer linked case US2019AMR199264).   On 28th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient experienced arm soreness following 2nd dose of Shingrix. The healthcare professional confirmed arm soreness was resolving. This case is linked with US2019AMR199256 and US2019AMR199259, reported by the same reporter.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine; Mild case of shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 28th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On 28th October 2019, the patient experienced drug dose administration interval too long. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the Fall of 2018, sometime between October December and 2 weeks before reporting date developed a mild case of Shingles.It was treated with Acyclovir and the shingles has resolved.  The patient received the 2nd dose of Shingrix which has been over a year since the 1st dose, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Chlamydial infection, Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; + Chlamydia - TOC negative; This is an observational study case, initially received from other health professional on 30-Oct-2019, concerning a 20-year-old, female pregnant subject of body weight: 133 lbs, height: 64 inches and body mass index (BMI): 22.8, enrolled in a prospective observational safety study.  The subject had no relevant medical history and concomitant medications. The subject had no obstetrical history. The subject had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was 12-Jan-2019. The type of pregnancy was singleton. The subject's estimated date of delivery (EDD) was reported as 19-Oct-2019 and corrected estimated date of delivery (CEDD) was not reported.   On 12-Jul-2019, 28-Aug-2019 and 18-Sep-2019, the subject underwent ultrasound scan and no MCM was noted.  On 08-Oct-2019, approximately at 38 weeks of gestation, the subject was administered Flu Vaccine Egg Split QIV CSL (Afluria QIV) [influenza vaccine, batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] for an influenza immunization (explicitly coded as ''Vaccine exposure during pregnancy'').  On an unknown date in 2019, the subject experienced chlamydia.   On an unknown date in 2019, the subject underwent test-of-cure (TOC) and it was negative. The outcome of event was resolved.    The reporter did not provide seriousness and causality assessment to Afluria QIV.  Company comment: Chlamydial infection was associated with the suspect product Afluria QIV. Reportedly, vaccination occurred during pregnancy. Chronology cannot be determined because of unknown temporal relationship to the suspect product administration, making casualty for chlamydial infection unassessable. Vaccine exposure during pregnancy is assessed as not related per company's conventions.; Sender's Comments: Chlamydial infection was associated with the suspect product Afluria QIV. Reportedly, vaccination occurred during pregnancy. Chronology cannot be determined because of unknown temporal relationship to the suspect product administration, making casualty for chlamydial infection unassessable. Vaccine exposure during pregnancy is assessed as not related per company's conventions.
Sex: U
Vaccine: UNK
Symptoms: Exposure during pregnancy, Foetal disorder, Placental disorder, Ultrasound antenatal screen abnormal
Clinical narrative: Choroid plexus cyst; Placenta cyst; Placenta cyst; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 31-Oct-2019, concerning a foetus subject. The subject's mother was 30-year-old pregnant female of body weight: 125 Ibs, height: 64 in and body mass index (BMI) 21.5 enrolled in a prospective observational safety study.  The mother's historical medical condition included ventricular septal defect.   The mother's concomitant medication included prenatal vitamins (unspecified vitamins and minerals) for an unknown indication.   The subject's mother had no previous pregnancies. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The subject's mother had no history of offspring with MCM. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy. The mother's last menstrual period (LMP) date was 12-May-2019. Estimated delivery date (EDD) was reported as 16-Feb-2020 and corrected estimated delivery date (CEDD) was 23-Feb-2020. The type of pregnancy was singleton.   On 13-Aug-2019, the subject's mother underwent MaterniT21 test and there were no MCMs noted.  On 07-Oct-2018, at approximately 21 weeks of gestation, the subject's mother was administered Afluria QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.  On the same day, the subject's mother underwent targeted ultrasound and choroid plexus cyst and placenta cyst were noted.  At the time of initial reporting, the outcome of the events of choroid plexus cyst and placenta cyst was not reported.  This case is linked to case 201905846 (corresponding mother case).  The case was assessed as serious and the reporter did not provide causality assessment to Afluria QIV.  Company comment: Causal involvement of Afluria cannot be excluded in reported events of choroid plexus cyst and placenta cyst, therefore these events were assessed as possibly related to the suspect vaccine (defaulting to the related Company causality). Foetal exposure to vaccine is unrelated to the suspect vaccine per company's guidelines.; Sender's Comments: Causal involvement of Afluria cannot be excluded in reported events of choroid plexus cyst and placenta cyst, therefore these events were assessed as possibly related to the suspect vaccine (defaulting to the related Company causality). Foetal exposure to vaccine is unrelated to the suspect vaccine per company's guidelines.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Syncope
Clinical narrative: Patient states the next morning after getting the vaccine, she woke up and felt chills and body aches. And then when she tried to get up she fainted.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Feeling cold, Myalgia, Pyrexia
Clinical narrative: Fever, chills, muscle aches, fatigue
Age: 57.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Immunizations were administered on Wednesday, 10/30. Per video camera footage, immunizations were administered properly. Per patient, she woke up on 10/31 with her right arm swollen, red, and warm. Prior to seeing her health care professional on Monday night, 11/04, patient came to the pharmacy. She spoke to the pharmacist on duty. He observed her arm and recommended Benadryl, Tylenol and to follow up with her healthcare professional. Prescriptions for Bactrim DS, Diflucan, and Keflex were sent in that night (11/04). Prescriptions were picked up on Tuesday, 11/05 at 12:16 PM. Per PA-C, patient is being treated for cellulitis. Follow-up phone call was made to patient on 11/08. Per patient, her arm started improving not long after she started taking antibiotics. She also stated her health care professional shortened her duration of therapy from 10 days to 5 days due to improvement.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Erythema, Flushing
Clinical narrative: Had extreme dizziness that lasted about 12 hours.   I was flush on my face and chest, skin turned red
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: MOP noticed that the child's arm was swollen and redness were present when the child was at home the following day.  MOP gave child Benadryl and Tylenol before bed around 1030pm. FOP stated that the child's arm stayed the same
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Chills, Head banging, Injection site pain
Clinical narrative: Pain at injection site. Muscle cramps, chills, shivering, teeth chattering, muscle soreness followed by joint soreness, major headache, temperature of 101.8, waves of nausea
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle spasms, Myalgia, Nausea
Clinical narrative: Pain at injection site. Muscle cramps, chills, shivering, teeth chattering, muscle soreness followed by joint soreness, major headache, temperature of 101.8, waves of nausea
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Areflexia, Fatigue, Intensive care, Paralysis, Vomiting
Clinical narrative: Started with fatigue and emesis, progressed to paralysis and loss of reflexes
Age: 12.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Cold sweat, Feeling hot, Hyperhidrosis, Syncope
Clinical narrative: Patient stood up approximately 5 minutes after receiving her last vaccine (flu shot) and stated she was "feeling hot and ready to go".Her mother observed a shift in her mood which she described as child gets mean prior to having a seizure. I asked patient to have a seat in the chair and she fainted. Her skin was clammy and sweaty. I called her name 3 times and she responded partially and closed her eyes. a Whiff of ammonia inhalant was given approx. at 10:04 A.M., Applied cool cloth to forehead was given 4oz. water. FS-123 and repeat BP 88/61 P-80. Parent declined 911 ambulance and agreed to take child to ER at Hospital. Repeated BP at 10:15 A.M. 86/60 P-83. Patient continued to be responsive. I explained Importance of child being evaluated today and parent agreed to give RN an update. Last vitals were done at 10:40 A.M. BP 89/60 P-65. Patient reported feeling better. Patient left clinic with her mom and was being transported to Hospital Emergency Room by her parent. 11/8/2019 Telephone call to parent today. Mother states child was evaluated at Hospital ER on 11/7/19. Was told by ER physician that child had a syncope episode after receiving vaccinations. Child was discharged on 11/7/19. Went home and rested. Mother stated "child is fine" and went to school today. - RN
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Red, swollen, hot to the touch, painful, 5 inches tall by 3 inches wide.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Nausea, Pain
Clinical narrative: Very sore arm several hours after the injection.  Next day had a terrible headache, general achiness, nausea, brain fog, and chills.  Did not feel better until the following day 11/7/2019.