chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU3
Symptoms: Product administered at inappropriate site
Clinical narrative: Pharmacist stated a flu shot (Fluzone HD) may have been mis-administered outside of the target area/ No AE; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 72 years old male patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ232AA, expiry date- 10-04-2020 via unknown route in the arm (bicep) on an unknown date, may have been mis-administered outside of the target area.  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 vaccine administered at inappropriate site.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 2 years patient was given Fluzone High Dose by mistake/ No AE; 2 years patient was given Fluzone High Dose by mistake/ No AE; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA257558 same reporter.  This case involves a 2 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ246AA via intramuscular route in the right thigh on 09-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other vaccines received.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Product administered at inappropriate site, Yellow skin
Clinical narrative: patient stated that his arm turned yellow; patient thinks he has not been getting the vaccine in the right place and thinks he has gotten it too low; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves male patient of an unknown age who experienced arm turned yellow (yellow skin), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included Fluzone High Dose. The patient's medical history, medical treatment(s) and family history were not provided.  On 04-SEP-2019, 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, the patient developed a non-serious his arm turned yellow (yellow skin) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was also the case of actual medication error due to vaccine administered at inappropriate site. The patient thinks he has not been getting the vaccine in the right place and thinks he has gotten it too low.  (Other relevant tests included no lab data.)  Final diagnosis was his arm turned yellow after the vaccine.   It was not reported if the patient received a corrective treatment.  The outcome of the event was reported as Unknown for arm turned yellow after the vaccine.  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.  Information on the batch number was requested.  Documents held by sender: none.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 7 years old patient was given Fluzone High Dose by mistake/ No AE; 7 years patient was given Fluzone High Dose by mistake/ No AE; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA257547 same reporter.  This case involves a seven years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ246AA via intramuscular route in the right thigh on 09-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other vaccines received.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity, Injection site swelling
Clinical narrative: deemed to have an allergic reaction; localized swelling of the injection site, the swelling was larger; localized swelling of the injection site, the swelling was larger; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to cases 2019SA257583 and 2019SA257467 (same reporter).  This case involves patient (with unknown demographics) who was deemed to have an allergic reaction (hypersensitivity) and localized swelling of the injection site, swelling was larger (localized oedema), 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 dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via intramuscular route in unknown administration site.  On an unknown date, the patient had deemed to have an allergic reaction (hypersensitivity) and localized swelling of the injection site, swelling was larger (localized oedema) following the administration of INFLUENZA VACCINE. The swelling was larger compared to any other reactions the staff member has had in the previous years.  Other relevant tests not reported.   Final diagnosis was hypersensitivity.  Ice pack was applied as corrective treatment.  The patient recovered from the events.  Information on the batch number was requested.  Documents held by sender: none.
Age: 0.08
Sex: F
Vaccine: HEP, HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A patient was given ActHib in the left thigh when 4 weeks old instead of the intended vaccine which was hepatitis B, no AE; A patient was given ActHib in the left thigh when 4 weeks old instead of the intended vaccine which was hepatitis B, no AE; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 weeks old female patient received vaccines HIB (PRP/T) VACCINE [ACT-HIB] (lot: UI965AAA, expiry date: 13-Mar-2020, via unknown route in the left thigh) instead HEPATITIS B VACCINE, on 09-Sep-2019. It was reported that ACT-HIB was the first time administered to the patient.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.   At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of document held by sender: none.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Ipol reached a temperature of 61F for an hour and a half.; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves 2 patient who received vaccine IPV (VERO) [IPOL] (batch and expiry date was not reported via unknown route in unknown administration site), which reached a temperature of 61 F for an hour and a half. It was reported that IPOL vaccines were to be discard.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of document held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Medication error, No adverse event
Clinical narrative: Menactra was delivered them the next day.; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old male patient who received 0.5 ml dose of  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot: U6522AA and expiry date: 29-Jan-2021), via intramuscular route in the left deltoid on 12-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Immunisation.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of document held by sender: none.
Sex: U
Vaccine: PPV, UNK
Symptoms: Peripheral swelling
Clinical narrative: severe arm swelling; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient (demographics unknown) who experienced severe arm swelling (peripheral swelling), when received vaccines PNEUMOCOCCAL VACCINE POLYSACCH 23V [PNEUMOVAX] and INFLUENZA VACCINE (QUADRIVALENT).  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 (QUADRIVALENT) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect PNEUMOCOCCAL VACCINE POLYSACCH 23V [PNEUMOVAX] not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious severe arm swelling (peripheral swelling) (Unknown latency) following the administration of INFLUENZA VACCINE (QUADRIVALENT) and PNEUMOCOCCAL VACCINE POLYSACCH 23V [PNEUMOVAX].  (Other relevant tests included no lab data.)  Final diagnosis was severe arm swelling.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for severe arm swelling.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: wrong vaccine (Quadracel) for the patients age last month, no AE; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves patient (with unknown demographics) who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number and Exp. Date not reported) via unknown route in unknown administration site that was wrong vaccine for the patient's age last month.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration.  It was reported that RMA's gave a patient the wrong vaccine (Quadracel) for the patients age last month. She called Sanofi to make sure there was no harm to the patient and was told there should be no harm.  The patient did not experience any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Alopecia areata, Skin irritation
Clinical narrative: Child developed Alopecia Areata in December 2017, 2 months after  injections. Visited dermatologist on 2/26/18 who determined diagnosis. Prescribed Lidex to apply to area to help with irritation since child was pulling at the hair.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient reported hives after receiving the injection
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Erythema, Myalgia, Nausea
Clinical narrative: Large swelling, redness, pain, muscle pain, nausea, shivering. 109.1° temperature
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: Large swelling, redness, pain, muscle pain, nausea, shivering. 109.1° temperature
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Electroencephalogram normal, Fatigue, Magnetic resonance imaging normal, Seizure
Clinical narrative: Child had a non-febrile seizure on 2/4/19 that lasted for several minutes. No prior symptoms other than child complaining of being tired. Paramedic arrived and administered oxygen until ambulance arrived. Hospital did EEG and MRI and all came back normal. They said this was just a fluke and if another happened again, they would discuss the possibility of epilepsy.  We were at hospital for about 22 hours.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: chills, fever, muscle aches/pains, nausea over the course of 2+ days
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pain, redness and swelling: 3.5 inches x 5.5 inches on left arm.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pruritus, Pyrexia, Rash, Tremor
Clinical narrative: Patient reported fever, chills and tremor starting approximately 4 and 1/2 hours after the flu shot and lasted for 2 days. Starting 3 days after shot(Sunday night) pt started itching and today(Monday) reports a rash and hives on wrists, arms, shoulder and chest.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient reported fever, chills and tremor starting approximately 4 and 1/2 hours after the flu shot and lasted for 2 days. Starting 3 days after shot(Sunday night) pt started itching and today(Monday) reports a rash and hives on wrists, arms, shoulder and chest.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: Vaccine given 9/19/19.  Patient began itching on right rib cage morning of 09/21/19.  Broke out in rash by same afternoon.  Patient presented to local ER 0830 on 9/22/19 and was diagnosed with shingles.  Prescribed Gabapentin, Hydrocodone and Acyclovir.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Muscle aches, Joint pain (all), Chills, fever, Headache, Extreme fatigue, lightheadedness, complete loss of appetite. Localized pain and redness at Bilateral injection sites.  All symptoms lasted 48 hours
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Muscle aches, Joint pain (all), Chills, fever, Headache, Extreme fatigue, lightheadedness, complete loss of appetite. Localized pain and redness at Bilateral injection sites.  All symptoms lasted 48 hours
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: She experienced soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th March 2019, the patient received the 1st dose of Shingrix. On 5th March 2019, less than a day after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The patient reported that, after vaccination with dose of Shingrix, experienced soreness. The patient planned to follow up with physician on an unknown date. The reporter consented to follow up. For tolerence of 2nd dose, refer case US2019167113..
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever; Chills; Feeling very run down; Pain at injection site; Swelling at the injection site; This case was reported by a physician via sales rep and described the occurrence of fever in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced fever, chills, fatigue, injection site pain and injection site swelling. On an unknown date, the outcome of the fever, chills, fatigue, injection site pain and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the fever, chills, fatigue, injection site pain and injection site swelling to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero and had fever, chills feeling very run down for a couple days.  The pain and swelling at the injection site.  More severe of these reactions than normal. The reporter agreed to follow up. This case linked to the case US2019AMR170807, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Cough, Headache, Pain, Pain in extremity
Clinical narrative: Cough; Headache; Body aches; Arm pain; Chills; This case was reported by a consumer and described the occurrence of cough in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced cough, headache, general body pain, pain in arm and chills. On an unknown date, the outcome of the cough was recovering/resolving and the outcome of the headache, general body pain, pain in arm and chills were unknown.   It was unknown if the reporter considered the cough, headache, general body pain, pain in arm and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. The patient received Shingrix and had headache, body aches, arm pain and chills. The patient had various reactions after Shingrix vaccination, not including a cough. However, 1-2 days after those side effects improved the patient began coughing.
Age: 0.5
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: 9/19/19 (R) arm swollen at immunization site & rash temp-normal per mother Spoke with Dr. office 9/20/19 child okay went to school.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: Left axillary nod swelling
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Feeling abnormal, Vision blurred
Clinical narrative: Patient felt "distant" with blurry vision.
Age: 74.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Abdominal pain upper, Chills, Loss of consciousness
Clinical narrative: Patient received vaccines listed above around 06:15pm. She states she started chilling around 09:30pm. She states around 11:30 pm her stomach was hurting and to up to take some medication. She then passed out and her husband found her passed out in the floor. He then took her to the emergency room. She states the ER doctor examined her with no significant findings.
Age: 1.0
Sex: M
Vaccine: FLU4, MMRV
Symptoms: Diarrhoea, Pyrexia, Rash, Rash erythematous
Clinical narrative: recurrent loose, NM,NBS stools for 4 days with the appearance of red rash all over the face, trunk and extremeties and low grade fever since 2 days ago. he has had recurrent diarrhea for 2 weeks, about 4 bouts. Attends daycare with 2 siblings in school. has been on whole cows milk since birth.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain, Abnormal faeces, Crying, Dyschezia, Faeces discoloured
Clinical narrative: Baby started having bellyaches within 24 hours. Inconsolable crying for 72 hours following vaccine. Bowel movements became orange, mucus-y, and foul smelling (remained that way for last 4 days) - normally yellow and odorless from exclusive breastfeeding. Bowel movements became painful. Back arching during feedings followed by vomiting. Basically appears baby contracted rotavirus from rotavirus "vaccine"
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Infantile back arching, Mucous stools, Vomiting
Clinical narrative: Baby started having bellyaches within 24 hours. Inconsolable crying for 72 hours following vaccine. Bowel movements became orange, mucus-y, and foul smelling (remained that way for last 4 days) - normally yellow and odorless from exclusive breastfeeding. Bowel movements became painful. Back arching during feedings followed by vomiting. Basically appears baby contracted rotavirus from rotavirus "vaccine"
Age: 54.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Left arm has warm, reddened sore area at sight of injection; fever of 99 on 9/22/19.  Treated with rest and ibuprofen.  Reddened area still present on 9/23/19, and still treating with ibuprofen.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Blister, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness and heat to left Deloitte 24 hours after receiving vaccines, from clavicle  area to elbow and around upper arm with blisters also.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Fatigue, Headache, Injection site pain, Musculoskeletal chest pain, Nodule
Clinical narrative: the day after the vaccine, she began having multiple symptoms: pain at injection site, fatigue, knot on arm with swelling, rib pain/lung pain-bilateral- left more than right, headache, fever for 1st 2 days.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Peripheral swelling, Pulmonary pain, Pyrexia, Streptococcus test negative
Clinical narrative: the day after the vaccine, she began having multiple symptoms: pain at injection site, fatigue, knot on arm with swelling, rib pain/lung pain-bilateral- left more than right, headache, fever for 1st 2 days.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Borrelia test negative, Chest X-ray normal, Chest pain, Depression, Dizziness
Clinical narrative: the day after the vaccine, she began having multiple symptoms: pain at injection site, fatigue, knot on arm with swelling, rib pain/lung pain-bilateral- left more than right, headache, fever for 1st 2 days.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Echocardiogram normal, Electrocardiogram normal, Fatigue, Full blood count normal, Headache
Clinical narrative: the day after the vaccine, she began having multiple symptoms: pain at injection site, fatigue, knot on arm with swelling, rib pain/lung pain-bilateral- left more than right, headache, fever for 1st 2 days.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Influenza virus test negative, Mononucleosis heterophile test negative, Staphylococcus test negative, Thyroid function test normal
Clinical narrative: the day after the vaccine, she began having multiple symptoms: pain at injection site, fatigue, knot on arm with swelling, rib pain/lung pain-bilateral- left more than right, headache, fever for 1st 2 days.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Confusional state, Lip swelling, Oral discomfort, Swollen tongue, Vision blurred
Clinical narrative: Confusion, blurred vision, lips and tongue swollen, burning sensation in mouth
Age: 77.0
Sex: M
Vaccine: UNK
Symptoms: Herpes zoster
Clinical narrative: After receiving my 2nd shot of the Shingles vaccine, I got the shingles rash on the right T5 dermatome and extends under my right arm and across the right side of my chest.  I still have the virus as of 09/23/2019
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Myalgia, Oral herpes, Pyrexia
Clinical narrative: Fever blister on upper lip: (9/20/2019 at 6:30am) started Abreva on  9/20/2019 at 4:30pm: Currently healing  Swollen Round, hot red inflamation about 1 inch below site of vaccination: Started on 9/19/2019 at approximately 9:30pm.  Taking OTC Naproxin Sodium to treat on 9/19/2019 at 10:00 pm. Continued to grow to the size of a baseball.  Remained that size through Sunday, 9/22/2019. Now, on 9/23/2019 it is the size of a plum, still hot, red, and raised, with small white dots on it. Still hot to the touch, painful and swollen. Unresponsive to Naproxen Sodium.  Joint and muscle aches and pains: Started on 9/20/2019. Treated with OTC Naproxin Sodium 250 mg. BID. Unresponsive to treatment. Worsened through 9/21/2019. Patient went to bed with severe muscle and joint aches and pains on 2/21/2019 at approximately 4:30pm. Muscle and joint aches and pains have lessened, but continue as of 9/23/2019 at 11:30 am.  Low grade fever, 99.7 F: Started on 9/21/2019 at approximate 6:30 pm. Treated with OTC Naproxin Sodium 250 mg. BID. Fever broke in the middle of the night sometime between 9/21/19 at 6:30pm to 9/22/19 at 7:00am.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site inflammation, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Fever blister on upper lip: (9/20/2019 at 6:30am) started Abreva on  9/20/2019 at 4:30pm: Currently healing  Swollen Round, hot red inflamation about 1 inch below site of vaccination: Started on 9/19/2019 at approximately 9:30pm.  Taking OTC Naproxin Sodium to treat on 9/19/2019 at 10:00 pm. Continued to grow to the size of a baseball.  Remained that size through Sunday, 9/22/2019. Now, on 9/23/2019 it is the size of a plum, still hot, red, and raised, with small white dots on it. Still hot to the touch, painful and swollen. Unresponsive to Naproxen Sodium.  Joint and muscle aches and pains: Started on 9/20/2019. Treated with OTC Naproxin Sodium 250 mg. BID. Unresponsive to treatment. Worsened through 9/21/2019. Patient went to bed with severe muscle and joint aches and pains on 2/21/2019 at approximately 4:30pm. Muscle and joint aches and pains have lessened, but continue as of 9/23/2019 at 11:30 am.  Low grade fever, 99.7 F: Started on 9/21/2019 at approximate 6:30 pm. Treated with OTC Naproxin Sodium 250 mg. BID. Fever broke in the middle of the night sometime between 9/21/19 at 6:30pm to 9/22/19 at 7:00am.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Large, red knot at injection site
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; a male patient was administered two live vaccines less than 28 days apart; This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Pertinent medical history, drug reactions and allergies were not reported.  On 19-JUL-2019, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection (lot number: R030610, expiration date: 23-OCT-2020; dose and route of administration were not reported). On 13-AUG-2019, he was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (lot number, expiration date, dose and route of administration were not reported). Therefore, the patient was administered two live vaccines less than 28 days apart (inappropriate schedule of vaccine administered). Sterile diluent (lot number: S005075, expiration date: 08-AUG-2021) was used as a concomitant medication. No adverse effects were reported.
Age: 15.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; 15-years-old patient received VARIVAX and PROQUAD on 9/13/2019; 15-years-old patient received VARIVAX and PROQUAD on 9/13/2019; This spontaneous report was received from a physician and refers to a 15-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reaction or allergies were not reported.  On 13-SEP-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, dose, route of administration, lot# and expiration date were not reported for both vaccines); (product administered to patient of inappropriate age, incorrect dose administered). It was reported that sterile diluent (STERILE DILUENT) injection was used with suspect vaccines. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Malaise
Clinical narrative: Was quite ill; Felt as baf bad as I did during Chemo; This case was reported by a consumer and described the occurrence of unwell in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chemotherapy (Felt bad).   On 10th September 2019, the patient received Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced unwell and feeling bad. On an unknown date, the outcome of the unwell and feeling bad were not recovered/not resolved.   It was unknown if the reporter considered the unwell and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. The patient was quite ill after shingrix and felt bad as during Chemotherapy. The reporter asked was this an allergic reaction. The reporter asked would it be better if 2nd shot could be administered in buttocks.
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever; Chills; Feeling very run down; Pain at injection site; Swelling at the injection site; This case was reported by a physician via sales rep and described the occurrence of fever in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero with an associated reaction of pyrexia (1st dose received on an unknown date, refer linked case US2019AMR167943).   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced fever, chills, fatigue, injection site pain and injection site swelling. Rechallenge with Bexsero was positive. On an unknown date, the outcome of the fever, chills, fatigue, injection site pain and injection site swelling were unknown.   It was unknown if the reporter considered the fever, chills, fatigue, injection site pain and injection site swelling to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero and had fever, chills feeling very run down for a couple days.  The pain and swelling at the injection site.  More severe of these reactions than normal. The reporter agreed to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: severe pain located proximal to the injection site; Can't move arm; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in an unknown arm. The reporter reported that, after vaccination, the patient developed severe pain located proximal to the injection site. The pain was not relieved by over the counter medication and the patient stated that, could not move their arm. The physician was at home at the time of the report and did not have specific records. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperaesthesia, Injection site reaction
Clinical narrative: arm swelling at injection site and soreness, followed by that evening fever to 100.2 , bp 140/80 pulse 85. (usually bp around 120/80 with 60 pulse, really bad headache, skin sensitivity,  significant fatigue,  unable to sleep well, chills lasting until Monday  morning 9/23/19.  As of this report right arm at injection site is still very sensitive to touch and when flexing muscle.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Poor quality sleep, Pyrexia
Clinical narrative: arm swelling at injection site and soreness, followed by that evening fever to 100.2 , bp 140/80 pulse 85. (usually bp around 120/80 with 60 pulse, really bad headache, skin sensitivity,  significant fatigue,  unable to sleep well, chills lasting until Monday  morning 9/23/19.  As of this report right arm at injection site is still very sensitive to touch and when flexing muscle.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Gait inability, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Paraesthesia
Clinical narrative: All this was reported to RN by the Patient and Leader notified us of her hospitalization. Appears to be Guillian Barre Syndrome.  Numbness in foot started within 24 hours of vaccination and proceeded up her legs over several days, in contact with her provider over time, when it got to her belly button she was advised by her provider to proceed to the ED.  She was hospitalized for at least 5 days and received IVIG.  She did get to the point she could not walk.  Prior to discharge she did walk with help and a physical therapist.  She was still having arm tingling and leg tingling prior to discharge.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Myalgia, Papule, Pyrexia
Clinical narrative: I developed a macular type of lesion in the medial aspect of left axilla( about 3-4 mm in diameter) 3 days ago. It is a single lesion which has now developed into a papule.  Before that I developed mild flu-like symptoms with muscle aches and slight fever(which lasted a few hours) The papule itself is mildly tender and it had a reddish base which has disappeared now. The constitutional symptoms are gone now.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash macular, Tenderness
Clinical narrative: I developed a macular type of lesion in the medial aspect of left axilla( about 3-4 mm in diameter) 3 days ago. It is a single lesion which has now developed into a papule.  Before that I developed mild flu-like symptoms with muscle aches and slight fever(which lasted a few hours) The papule itself is mildly tender and it had a reddish base which has disappeared now. The constitutional symptoms are gone now.
Age: 73.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Hyperhidrosis, Influenza, Nausea, Pyrexia
Clinical narrative: on 9/13/19, I was administered a flu shot That night I came down with very severe flu symptoms. Fever, sweats, strong nausea, loss of energy and severe vertigo This lasted through the night and periodically through the weekend.  It was so serious that I considered going to the ER.  I reported this to the clinic was told that this was normal and that it is impossible for live viruses to remain  in the serum.  I have has many flu shots and am not allergic ---- this was very unusual and frightening.  I can't help but surmise that there was either live viruses remaining or that there were QC issues associated with the formulation.  Can you please investigate.
Age: 73.0
Sex: M
Vaccine: UNK
Symptoms: Vertigo
Clinical narrative: on 9/13/19, I was administered a flu shot That night I came down with very severe flu symptoms. Fever, sweats, strong nausea, loss of energy and severe vertigo This lasted through the night and periodically through the weekend.  It was so serious that I considered going to the ER.  I reported this to the clinic was told that this was normal and that it is impossible for live viruses to remain  in the serum.  I have has many flu shots and am not allergic ---- this was very unusual and frightening.  I can't help but surmise that there was either live viruses remaining or that there were QC issues associated with the formulation.  Can you please investigate.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient first noticed left deltoid soreness upon laying down in bed on Friday (9/20/19) night. Upon awakening the next morning, the patient then noticed patchy spots on his left deltoid that displayed some redness and swelling. The patient's wife informed pharmacy staff of this adverse event, and upon further questioning, it was discovered that the patient has been experiencing some pain, which is tolerable, and some itching at injection site. Patient and his wife have been closely monitoring this adverse reaction and stated that they will go to the doctor if the patient's condition worsens at any time. Patient's wife has used some benadryl (oral and topical cream) to relieve some of the itching.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2019, the patient received the 1st dose of Shingrix. On 6th September 2019, 8 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The nurse reported that, after vaccination with dose of Shingrix, the patient diagnosed with shingles. The reporter had concerned because it happened to another patient, which would report after completion of this report. This case has been linked with case US2019AMR167067, repored by same reporter.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2019, the patient received the 1st dose of Shingrix. On 27th July 2019, 4 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The reporter reported that, after vaccination the patient had shingles, and this was the 2nd patient in their practice with same story. Thie case has been linked with case US2019AMR167063, reported by same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site rash, Injection site warmth
Clinical narrative: Slight rash at injection site; Warmth at injection site; Flu-like symptoms; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received Shingrix. On 10th September 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms. On 13th September 2019, the patient experienced injection site rash and injection site warmth. On an unknown date, the outcome of the influenza-like symptoms, injection site rash and injection site warmth were unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site rash and injection site warmth to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication. On 13th September 2019, 4 days after receiving Shingrix, the patient had slight rash and warmth at injection site. The adverse event was captured via webchat and visitor didn't respond after chat opened and initial question received from visitor. Chat visitor indicated that they were a pharmacy technician. The reporter denied permission to follow up.
Sex: U
Vaccine: MENB
Symptoms: Headache, Pyrexia, Wrong product administered
Clinical narrative: Patient was inadvertently given Trumenba instead of Menatra at the 10 year old visit.; severe headache; fever; This is a spontaneous report from contactable physician via Pfizer Sales Representative.  A 10-year-old patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient was inadvertently given meningococcal group b rlp2086 instead of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA). The patient experienced severe headache and fever. The events were non serious with outcome of unknown.  The information on the batch/lot number has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Haemorrhage, Rash erythematous, Rash pruritic
Clinical narrative: Patient developed itchy rash on lower abdomen that began with red bumps and developed into bleeding blisters. Patient self-treated at home with hydrocortisone cream without improvement. Patient then went to urgent care and received steroid cream. Patient reports rash is improving but not completely resolved.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: patient had sore arm and body aches... patient said she may have had chest wall pain but those went away ... patent was advised to follow up with dr today on 9/23/19
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Feeling cold, Myalgia
Clinical narrative: I awoke around 1 am  and I was freezing, and I had muscle ache and joint pain all over my body. Went into closet and found heaviest blanket I had and put over me. Was same when I woke in morining and took my temp, it was 101.2. I called pharmacy that gave me shot and they said to take aleve and I did. Fell asleep and was ok when I woke up about 2-3 hours later.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B test negative, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: County Public Health Nurses make visits to the County Detention Center to inmates who request STD/TB/Pregnancy testing and/or immunizations. 9/6/19: Patient seen at County Detention for testing and desired immunizations. Hep B virus panel drawn, Hep A vaccine (LDIM) and Tdap (RDIM) given. 9/9/19: Negative Hep B virus panel, not immune. 9/17/19 PM:  Heplisav given at County Detention Center by Public Health Nurse. 9/19/19 approx 1530:  Call from detention center staff nurse, reports pt c/o redness, swelling, warmth, and itching in area of Heplisav injection. Red raised area marked with a sharpie, topical hydrocortisone applied to area at approx 1540. 9/20/19 AM: Visit with patient at County Detention Center by Public Health Nurse, redness is slightly larger than marked area, area of raised, warm, redness measures 3" from top to bottom and 4" across with a 1-1.5" area in the center that is not red, raised, or warm. Pt reports slight itch today, better than yesterday, no pain unless touched, pain level 3 of 10 when touched. No blister(s) or pustule(s) noted, no other complaints. Reports no problems with Hep A or Tdap vaccines given 9/6/2019.