chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient received Pentacel without reconstituting HIB component of the vaccine/ NO AE; Initial information received on 28-Aug-2020 regarding an unsolicited valid non-serious case from the other health professional .  This case involves a 6-months-old male patient to whom nurse administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: U6395AA, expiry date: 24-Apr-2021, via an intramuscular route in right quadricep) without reconstituting with HIB component of the vaccine (product preparation issue) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (FLU), HEPATITIS B VACCINE RHBSAG (YEAST) (RECOMBIVAX), ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique(latency: same day).  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: 2.0
Sex: F
Vaccine: FLUX
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: a dose of Fluzone Quadrivalent was administered to a patient before finding out the product was not viable, No AE; Initial information was received on 01-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional via phone.  This case is linked to cases 2020SA238410 and 2020SA245000 (same reporter).   This case involves a 24 months old female patient who was vaccinated with a 0.25 mL dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (batch number and expiration date were not reported) via an intramuscular route at an unknown administration site on 01-Sep-2020 for prophylactic vaccination. However, this vaccine administered before finding out that it was not viable to use.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any other vaccine concomitantly.    It was an actual medication error case due to poor quality vaccine administered (latency was same day).  At the time of reporting, the patient had no adverse event symptoms.  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.  There will be no information available on the batch number for this case
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 17 years old female patient received Fluzone High-Dose by mistake/ NO AE; a 17 years old female patient received Fluzone High-Dose by mistake/ NO AE; Initial information received on 03-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 17-years-old female patient who received once 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number: UJ450AB, expiry date: 30-Jun-2021, via an intramuscular route in left deltoid) (product administered to patient of inappropriate age) on 01-Sep-2020 for prophylactic vaccination from nurse by mistake.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration and it was also a case of  overdose (latency: same day).  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: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: nurse administered a 0.7 ml  Fluzone High Dose to 15 year old patient, by mistake/ no AE; nurse administered a 0.7 ml  Fluzone High Dose to 15 year old patient, by mistake/no AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from the nurse via phone.  This case is linked to case This case is linked to cases 2020SA242315, 2020SA243060, 2020SA242184, 2020SA242185, 2020SA242186 and 2020SA242187 (same reporter).  This case involves a 15-years-old male patient who was vaccinated with a 0.7 mL dose of vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (prefilled syringe, lot UJ450AB and expiration date 30-Jun-2021) via an intramuscular route in the left deltoid on 27-Aug-2020 by a nurse by mistake for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any other vaccine concomitantly.    It was an actual medication error case due to inappropriate age at vaccine administration and overdose (latency was same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Vaccination site movement impairment
Clinical narrative: Arm soreness; injection has been bothering arm when moves; Initial information received on 04-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 67 years old male patient who experienced arm soreness (pain in extremity) and injection had been bothering arm when moved (vaccination site movement impairment), while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided. Patient had no other vaccines.    On 28-Aug-2020, the patient received a 0.7 mL once dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ453AA and expiry date 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date, the patient developed a non-serious arm soreness (pain in extremity) and injection had been bothering arm when moved (vaccination site movement impairment) on an unknown latency (after a 2-3 days) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Case details: Reporter stated that the injection of suspect vaccine had not bothered patient for a couple of days, but then it got sore and has been bothering him when he moves it for the last couple of days. Patient stated that there was no warmth or redness to the site, just soreness.  Details of laboratory data were not reported.   The patient was treated with IBUPROFEN (IBUPRO [IBUPROFEN]) and applied ice for pain in extremity and vaccination site movement impairment.  The outcome was unknown for both the events.
Sex: M
Vaccine: FLUR4
Symptoms: Gait disturbance, Magnetic resonance imaging, Nausea, Vertigo
Clinical narrative: vertigo; unable to walk a straight line, and his gait was unsteady; nausea; Initial information was received on 11-Sep-2020 regarding an unsolicited valid non-serious case from retired Doctor (patient) via phone.  This case involves a male patient (age was not reported) who experienced vertigo, nausea and was unable to walk a straight line, his gait was unsteady (gait disturbance), while he received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed non-serious vertigo, nausea and these were so severe that he had to lay down and was unable to walk a straight line, his gait was unsteady (gait disturbance), 1 to 2 weeks following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Magnetic resonance imaging (MRI) done on an unknown date and exact result was not reported however patient's physician thought that reactions were related to the Flu vaccine and it was a type of immune reaction.  It was not reported if the patient received any corrective treatment.  On an unknown date approximately a month after, the patient had recovered from all the events and these reactions not re-occurred to the patient.  There will be no information available on the batch number for this case.
Age: 69.0
Sex: U
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 69 years old received the FLUBLOK QUADRIVALENT instead of FLUZONE HIGH-DOSE QUADRIVALENT, no AE; Initial information received on 11-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves a 69-year-old patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was an actual medication error case due to wrong vaccine administered (latency same day).  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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a nurse accidentally gave a dose of Fluzone HD to a 17 year old patient, no AE; a nurse accidentally gave a dose of Fluzone HD Quadrivalent to a 17 year old patient, no AE; Initial information was received on 15-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional.  This case involves a 17-year-old female patient who was vaccinated with a 0.7 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ468AB and expiration date 30-Jun-2021) via an intramuscular route in the left deltoid on 14-Sep-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient had concomitantly vaccinated with a dose of MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) on 14-Sep-2020 for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose (latency was same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: vaccine was injected in the fatty tissue on the posterior of the arm instead of deltoid, no AE; Initial information received on 16-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves female patient (unknown age) who was vaccinated with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE] (0.5 (unspecified), injection, lot number and expiration date not reported) via unknown route of administration  in the fatty tissue on the posterior of the arm instead of deltoid as prophylactic vaccination on 16-Sep-2020 (PT:product administered at inappropriate site).  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to vaccine administered at inappropriate site (same day latency).  No adverse event reported at the time of reporting.  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.  There will be no information on the batch number for this case.
Age: 65.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Depression, Dizziness, Fatigue, Feeling cold, Injected limb mobility decreased
Clinical narrative: Swollen arm at injection site (left arm).  Stiff neck, chills, body aches, sleepiness, can't lift arm higher than chest.   Very tired but couldn't sleep. Body aches continue.  Slept as much as possible, but couldn't turn over.  Feeling very depressed the next morning.  Slightly dizzy and sleepy. Somewhat better the next morning, but still not feeling well.  I'm in good health, very fit, bike 6-10 miles a day. Did not contact my doctor.
Age: 65.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site swelling, Insomnia, Malaise, Musculoskeletal stiffness, Pain
Clinical narrative: Swollen arm at injection site (left arm).  Stiff neck, chills, body aches, sleepiness, can't lift arm higher than chest.   Very tired but couldn't sleep. Body aches continue.  Slept as much as possible, but couldn't turn over.  Feeling very depressed the next morning.  Slightly dizzy and sleepy. Somewhat better the next morning, but still not feeling well.  I'm in good health, very fit, bike 6-10 miles a day. Did not contact my doctor.
Age: 65.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Somnolence
Clinical narrative: Swollen arm at injection site (left arm).  Stiff neck, chills, body aches, sleepiness, can't lift arm higher than chest.   Very tired but couldn't sleep. Body aches continue.  Slept as much as possible, but couldn't turn over.  Feeling very depressed the next morning.  Slightly dizzy and sleepy. Somewhat better the next morning, but still not feeling well.  I'm in good health, very fit, bike 6-10 miles a day. Did not contact my doctor.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Oedema peripheral, Pain in extremity, Peripheral swelling
Clinical narrative: Day 2 arm was very red,  hot, swollen, and hurt. It felt like my arm had been a punching bag. I could barely raise my arm. The next day the arm was swollen and the fluid started to drop down towards my elbow. Still very red but less sore. Returned to clinic to let them see what had happened. She suggested Zyrtec during the day and Benadryl at night. Following day (Day 3 of symptoms, the fluid has drained below the elbow. Arm still read on the back side.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Day 2 arm was very red,  hot, swollen, and hurt. It felt like my arm had been a punching bag. I could barely raise my arm. The next day the arm was swollen and the fluid started to drop down towards my elbow. Still very red but less sore. Returned to clinic to let them see what had happened. She suggested Zyrtec during the day and Benadryl at night. Following day (Day 3 of symptoms, the fluid has drained below the elbow. Arm still read on the back side.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Cough, Dizziness, Dyspnoea, Eye pruritus
Clinical narrative: An employee flu clinic was conducted on September 23 for the employees at the School by the Health Department staff.  This employee was given her injection approximately at 11:45 a.m.  The Health Nurse was made aware of the adverse event at 8:30a.m. on September 24, 2020.  The employee stated "I will be following up with my doctor today, but I believe that I had a severe allergic reaction with symptoms that included swelling/itching eyes, coughing, tightness of the chest, shortness of breath, fluid in the lungs, and feeling faint. I received the shot at about 11:45am, and started feeling symptoms around 1:30/2:00. I didn't put two and two together to realize that it was a reaction to the shot until much later in the night. I was able to go home, take a nebulizer treatment and Benadryl and started to feel better, a few hours later the symptoms were gone completely."  Case was interviewed at 9:00 a.m. by PHN on 9/24 and reported "feeling better" "still a bit itchy" and "will follow up with PCP today"  When asked if 911 was called yesterday when s/s appeared, case reported "No." It was advised in the future to call 911 or have someone call 911 as this is a life-threatening emergency.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Pruritus, Pulmonary oedema, Vaccination complication
Clinical narrative: An employee flu clinic was conducted on September 23 for the employees at the School by the Health Department staff.  This employee was given her injection approximately at 11:45 a.m.  The Health Nurse was made aware of the adverse event at 8:30a.m. on September 24, 2020.  The employee stated "I will be following up with my doctor today, but I believe that I had a severe allergic reaction with symptoms that included swelling/itching eyes, coughing, tightness of the chest, shortness of breath, fluid in the lungs, and feeling faint. I received the shot at about 11:45am, and started feeling symptoms around 1:30/2:00. I didn't put two and two together to realize that it was a reaction to the shot until much later in the night. I was able to go home, take a nebulizer treatment and Benadryl and started to feel better, a few hours later the symptoms were gone completely."  Case was interviewed at 9:00 a.m. by PHN on 9/24 and reported "feeling better" "still a bit itchy" and "will follow up with PCP today"  When asked if 911 was called yesterday when s/s appeared, case reported "No." It was advised in the future to call 911 or have someone call 911 as this is a life-threatening emergency.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Severe muscle aches and pain.  Using Tylenol to alleviate, but has not completely stopped symptoms
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster, Pain, Pain in extremity, Rash
Clinical narrative: On Friday September 18th at around 7:00 am the location the patient started to experience both shooting and sore throbbing pain from the arm on which she was given the vaccine. She applied a heating pad and has been applying a heating pad the area. She only took ibuprofen two 200 mg tablets every 8 hours. As of right now the pain has subsided to an extent. Not completely. She is experiencing a rash diagnosed by her doctor as shingles.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Rash
Clinical narrative: pt developed rash within 24 hours of rcv'ing the vaccine.  rash started on chest and progressed to chest, abdomen, back, top of buttocks, neck and chin.  no rash on face, no resp issues or sob.  mother advised office on 9/23/20 when she noted the rash on pts chin.  mother advised to give benadryl
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Gastric disorder
Clinical narrative: Stomach problems
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site swelling, Magnetic resonance imaging, Magnetic resonance imaging neck, Muscle atrophy
Clinical narrative: I experienced Marked swelling from the left shoulder to below the elbow and about 85-90% circumferentially. The injection site was in my left upper arm. This lasted 4-5 days and I did visit my doctor's office as well as the pharmacy regarding the swelling. I used benadryl, ice, and extra strength tylenol for the discomfort. In December, I went to an orthopedic clinic regarding the residual pain and weakness in that arm. Further studies included x-rays, PT, MRI of shoulder due to loss of posterior muscle of the left shoulder, and referral to a Dr. of Physical Medicine & Rehabilitation. He requested another MRI of the neck, then specific PT orders.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Muscular weakness, Pain in extremity, Peripheral swelling, X-ray
Clinical narrative: I experienced Marked swelling from the left shoulder to below the elbow and about 85-90% circumferentially. The injection site was in my left upper arm. This lasted 4-5 days and I did visit my doctor's office as well as the pharmacy regarding the swelling. I used benadryl, ice, and extra strength tylenol for the discomfort. In December, I went to an orthopedic clinic regarding the residual pain and weakness in that arm. Further studies included x-rays, PT, MRI of shoulder due to loss of posterior muscle of the left shoulder, and referral to a Dr. of Physical Medicine & Rehabilitation. He requested another MRI of the neck, then specific PT orders.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: It made me sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were as follows: The age at vaccination was not reported. The patient refused the vaccine and would not be getting a flu shot anymore as it was made her sick. The patient stated that she would take chances without certain vaccines.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: Moderate pain at injection site; Fatigue; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and fatigue. The patient was treated with naproxen. On an unknown date, the outcome of the injection site pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix within the last 3 years. Post vaccination the patient experienced moderate pain at injection site and fatigue which required naproxen. No further information was available. For tolerance after 2nd dose refer case US2020AMR189293.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR189293:same patient, 2nd dose
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: Mild pain and injection site; Fatigue; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain and Shingrix with an associated reaction of fatigue (1st dose received within past 3 year, refer case US2020AMR189287).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and fatigue. The patient was treated with naproxen. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and fatigue were unknown.   It was unknown if the reporter considered the injection site pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix within the past 3 years. Post vaccination the patient experienced mild pain at injection site and fatigue which required naproxen. No further information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR189287:same patient, 1st dose
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: severe throwing up; This case was reported by a consumer via interactive digital media and described the occurrence of vomiting in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was not recovered/not resolved.   It was unknown if the reporter considered the vomiting to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. After receiving dose of Shingrix, the patient experienced throwing up. The reporter repoerted that, was there anything I can do for her, or give her. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Incomplete course of vaccination, Nausea, Pyrexia
Clinical narrative: Dose 2 of Shingrix on September 15, 2020; Nausea; Fever; Redness below the injection site; This case was reported by a consumer via call center representative and described the occurrence of nausea in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient  reported that it was 1.5 months past 6 month Shingrix dose window and he was not received it till the time of reporting, which led to incomplete course of vaccination.   Follow up report received from consumer on 17th September 2020: On 15th September 2020, the patient received the 2nd dose of Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced nausea, fever and redness below the injection site.  The patient received 2nd dose late which led to lengthening of vaccination schedule. Patient does not wish physician get contacted. It was unknown if the reporter considered the nausea, fever and erythema to be related to Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: shingles rash; vesicular rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than 2 weeks after receiving Shingrix, the patient experienced shingles and vesicular rash. On an unknown date, the outcome of the shingles and vesicular rash were unknown.   It was unknown if the reporter considered the shingles and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 51 or 52 year.  The pharmacist was looking for information about experimenting shingles rash after the first dose of Shingrix 2 week ago from this report (17th September 2020). The information provided by reporter was not enough, she was offered to call back later with more information but she declined. The reporter consented to follow up. No further information was available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Inappropriate schedule of product administration, Pain in extremity, Wrong technique in product usage process
Clinical narrative: first dose and second dose little over 30 days apart; Felt like the pharmacist hit a nerve; pain / injection site upon administration / first dose /  then it was just sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female 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 and the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm, drug dose administration interval too short and wrong injection technique. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the drug dose administration interval too short and wrong injection technique were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The patient experienced pain in arm after the 1st dose of Shingrix, which lasted for a day and then it was just sore for 3-4 days. The patient received the 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule. The ptient felt that the pharmacist had hit a nerve, which led to wrong injection technique. No reactions were reported for the 2nd dose of Shingrix. The reporter consented to follow up. The case was considered as medication error with harm.
Age: 69.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: A patient was inadvertently administered Fluzone Quadrivalent rather that the Fluzone High-Dose Quadrivalent, no AE; Initial information was received on 21-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 69 year old female patient who was inadvertently administered 0.5ml INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number not reported, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 21-Aug-2020 rather that INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any concomitant medications.  It was a case of an actual medication error due to wrong product administered (latency same day).  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.  There will be no information available on lot number.
Sex: F
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received a Flulval today and was supposed to have received the Fluzone HD, no AE; Initial information received on 16-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves female patient (approximately over 65 years) who was vaccinated with FLULAVAL while she was supposed to receive the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number and expiration date were not reported for bot the vaccine) via unknown route in unknown administration site as prophylactic vaccination on an unspecified date (PT: wrong product administered)  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong vaccine administered.  No adverse event reported at the time of reporting.  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.  There will be no information on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired FLUZONE QUADRIVALENT was given to six patients on 16 Sep 2020.; Initial information received on 17-Sep-2020 regarding an unsolicited valid non-serious case (reference number-US-SANOFI-00276414) received from a consumer.  This case involves a 20 years old female patient who was given 0.5 ml once expired dose of INFLUENZA QUADRIVAL A-B VACCINE [Fluzone quadrivalent] on 16-Sep-2020 [lot UJ295AA, expiration date-30-JUN-2020] via intramuscular route in the left deltoid for prophylactic vaccination.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired product administered. It was reported that expired FLUZONE QUADRIVALENT was given to six patients on 16-Sep-2020.  At the time of reporting, the patient had no adverse event.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Not Applicable.  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: 57.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: I have had pain in my Right arm since the flu vaccine was given.  It hurts to lift and move my arm with basic movements.  It is painful to brush my teeth, brush my hair,  and getting dressed.   I notified Pharmacy today as I was trying to give it time to resolve on its own.  Pharmacy suggested to call my primary care physician.
Age: 16.0
Sex: M
Vaccine: HEPA, MENB, MNQ
Symptoms: Disorientation, Heart rate decreased, Hypotension, Nausea, Pallor
Clinical narrative: Patient was given immunizations after he and his mother completed the consent form.  Approximately 12 minutes later  we heard a crash sound some form the exam room and we entered the room to find the patient on the floor.  He was alert, disoriented momentarily but was able to tell me his name, where he was and who I was right away. We helped him to the chair and called his mom into the room. She was in her car due  to the Covid Pandemic. He was pale and complained of nausea. He did not vomit. His vital signs were assessed and found to have low blood pressure and heart rate.  He drank juice and we reassessed 10 mins later and he had normal blood pressure and heart rate and his color returned to normal. He was able to talk and laugh. We discharged him home. We followed up by phone at 24 hours and 48 hours after the event and his mother reported he is doing well. with no new concerns or symptoms.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: patient had swelling and rash down upper arm from injection site down to elbow. with itching.. and redness
Age: 18.0
Sex: M
Vaccine: IPV, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Syncopal episode immediately after receiving Immunizations. The patients legs were elevated and consciousness was regained shortly after.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: itching to left arm not relieved by Benadryl. No rash or redness
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got the flu shot one year I was so sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that got the flu soht 1 year and was so sick, never again and doing great without no thanks. No further information was available.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 18y female patient was given a MENACTRA injection twice, no AE; Initial information received on 16-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 18 years old female patient who was vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] on 16-Sep-2020 inadvertently. While, she had received her booster dose on 28-Jul-2020 (extra dose administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE  for prophylactic vaccination on an unknown date.   On 28-Jul-2020, the patient received a dose of the MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site and on 16-Sep-2020, the patient again received a 0.5 ml booster dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6745AA and expiration date:10-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error case due to extra dose administered (same day latency).  No adverse event reported at the time of reporting.  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: 18.0
Sex: M
Vaccine: IPV, MNQ, TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: The patient experienced a Syncopal episode within 5 minutes of receiving these immunizations and regained consciousness without intervention.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood glucose, Chest X-ray, Dyspnoea, Electrocardiogram
Clinical narrative: Headache, body aches, shortness of breath, headache, generalized weakness "shortly after" vaccination. The next morning she felt progressively worse, had elevated heart rate , and felt warm and flushed.  She was transported to ER by ambulance and noted to have a low grade fever. Was hydrated with 2L of LR, ketorolac, and acetaminophen with some relief.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Flushing, Full blood count, Headache, Heart rate increased
Clinical narrative: Headache, body aches, shortness of breath, headache, generalized weakness "shortly after" vaccination. The next morning she felt progressively worse, had elevated heart rate , and felt warm and flushed.  She was transported to ER by ambulance and noted to have a low grade fever. Was hydrated with 2L of LR, ketorolac, and acetaminophen with some relief.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test, Pain, Pyrexia, SARS-CoV-2 test, Troponin
Clinical narrative: Headache, body aches, shortness of breath, headache, generalized weakness "shortly after" vaccination. The next morning she felt progressively worse, had elevated heart rate , and felt warm and flushed.  She was transported to ER by ambulance and noted to have a low grade fever. Was hydrated with 2L of LR, ketorolac, and acetaminophen with some relief.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Hypertension, Malaise, Pyrexia, Syncope, Tachycardia
Clinical narrative: Patient presented to office 3 hours after receiving flu vaccine with temp to 104, hypertension and tachycardia. He was examined, given tylenol and observed for 40 minutes. Blood pressure and heart rate improved but fever did not. He felt better and was discharged home. . He took ibuprofen at 8 pm and went to bed. He woke at 2 am and did not feel well, Mom felt he "looked funny". He then collapsed in her arms. She called 911 and he was evaluated in ED, He was found to have no concerning findings and was discharged home. He has been afebrile since returning home.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Arthralgia, Chills, Headache
Clinical narrative: Chills, headache, stomach upset. joint pain
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash erythematous, Rash papular, Rash pruritic, Urticaria
Clinical narrative: started as a 10cm by 5cm red raised itchy rash with visible hives and "deep itching" has now spread to patients back in  the matter of 40 minutes from administration. No respiratory symptoms
Age: 1.58
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Wrong product administered
Clinical narrative: WRONG VACCINE ADMINISTERED
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site inflammation, Injection site pruritus
Clinical narrative: Inflammation and pruritic at injection site
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Depressed level of consciousness, Hyperventilation, Pallor, Syncope
Clinical narrative: Pt had labs done at this visit prior to the flu vaccine. Pt tolerated lab draw well but soon after receiving the flu vaccine she stated that her vision was blurry and began to lose consciousness. I had pt lay down and elevate her feet. Gave pt a bottle of water and had her sit up to drink. Pt stated that she felt much better and wanted to go to the lobby to sit with her mom. I walked her to the lobby and she was laughing while telling her mom what happened. After several minutes, pt c/o blurry vision again and became very pale. She stated that she felt like she needed to lay on the floor and mom helped her. I informed Dr. and she came out of the exam room and stayed with pt until she felt better.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Vision blurred
Clinical narrative: Pt had labs done at this visit prior to the flu vaccine. Pt tolerated lab draw well but soon after receiving the flu vaccine she stated that her vision was blurry and began to lose consciousness. I had pt lay down and elevate her feet. Gave pt a bottle of water and had her sit up to drink. Pt stated that she felt much better and wanted to go to the lobby to sit with her mom. I walked her to the lobby and she was laughing while telling her mom what happened. After several minutes, pt c/o blurry vision again and became very pale. She stated that she felt like she needed to lay on the floor and mom helped her. I informed Dr. and she came out of the exam room and stayed with pt until she felt better.