chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 64-years-old patient was accidentally given the Fluzone High Dose/ No AE; a 64-years-old patient was accidentally given the Fluzone High Dose/ No AE; Initial information regarding this unsolicited valid non-serious case received on 29-Sep-2020 from the other health care professional.   The case involved a 64 years old female patient who was accidentally given a 0.7mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ482AA, expiry date: 30-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination on 28-Sep-2020 (Product administered to patient of inappropriate age).  Medical history, past medical treatment, vaccination and family history were not provided.  The patient did not received any concomitant medications.  It was an actual medication error due to inappropriate age at vaccine administration.  It was also a case of 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.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: PENTACEL was administered without reconstituting with the acthib portion of the vaccine/No AE; Initial information received on 29-Sep-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old female patient who received a 0.5mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without reconstituting with the HIB (PRP/T) VACCINE [ACT-HIB] [lot number: U6395AB, expiry date: 03-May-2021] portion of the vaccine via Intramuscular route on right vastus lateralis site on 29-Sep-2020.   The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE, PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).   It was an actual medication error due to inappropriate reconstitution technique (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.
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Incorrect dose administered, No adverse event
Clinical narrative: a patient received 2 dose of Fluzone High-Dose Quadrivalent in 2020/ NO AE; Initial information received on 29-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 81-years-old male patient who received two doses of 0.7 mL INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number UJ450AA and expiry date 30-Jun-2021) and (lot number: UJ499AA and expiry date: 30-Jun-2021) frequency: once, syringe, via an intramuscular route in the deltoid muscle on 24-Aug-2020 and 29-Sep-2020 respectively for prophylactic vaccination.  The patient's medical history, past medical treatment and family history were not provided.  No other vaccines were used by the patient.  It was an actual medication error case due to extra dose administered (latency: at the time of administration of second dose).  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: 0.25
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 3 months old patient was inadvertently administered Fluzone Quadrivalent, No AE; Initial information was received on 29-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional (Medical assistant).  This case involves a 3 months old female patient who was inadvertently administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines.   On 29-Sep-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7011NA, expiry date: 30-Jun-2021, strength: standard) once via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  A medical assistant was asking which adverse events are related to a 3 month old after giving the flu shot.  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.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: Vomiting several times; Queasy in between; Initial information was received on 30-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 69 years old female patient who experienced vomiting several times (vomiting) and queasy in between (nausea), after she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 29-Sep-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] Injection (lot number: UJ461AB and expiration date: 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination.  On 29-Sep-2020 in night, the patient developed non-serious vomiting several times (vomiting) and queasy in between (nausea), on same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Laboratory data was not reported.   No corrective treatment was received and patient was directed to call her doctor.  The patient was recovering from the events.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: Redness to the arm, its feels hot, and spreading down towards the arm; Redness to the arm, its feels hot, and spreading down towards the arm; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 63 years old female patient who experienced redness to the arm, its feels hot, and spreading down towards the arm and redness to the arm, its feels hot, and spreading down towards the arm (feeling hot and erythema), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  On 12-Oct-2020, the patient received a 0.5 ml once dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number UJ462AA expiration date 30-Jun-2021] via unknown route in the right deltoid.  On 13-Oct-2020, the patient experienced a non-serious redness to the arm, its feels hot, and spreading down towards the arm and redness to the arm, its feels hot, and spreading down towards the arm (feeling hot and erythema),  1 day after following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Other relevant tests included no lab data.  Final diagnosis was feeling hot and erythema.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.
Age: 42.0
Sex: M
Vaccine: MNQ, PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: After several hours after getting Prevnar and Menveo on 9/23/2020 at our primary care office, pt reported getting fever 103, redness, swelling and pain on right arm. He went to an urgent care and dc'd to home without interventions, supportive care only. Symptoms resolved over the course of several days on his own. Pt reports got both vaccinations in right arm, although our records indicated he got Prevnar in left arm and Menveo in right arm.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Fatigue, Limb mass, Peripheral swelling, Pyrexia
Clinical narrative: _ Patient came to me on 9/23 20 with a fever of 101.3 on .  He does not feel well.  Did not tell his father that he does not feel well.   Patient says he is very tired. Does not want food ?.  Sept 22 Patient Tdap Vaccine #2 Sept 23  Patient Did not feel well, Fatigue, fever 101.3 at 6 pm.  Temp 99.5 at 9:30 pm.  Left arm very painful to touch, swollen tennis ball size redness.  Patients facial and neck Tics begin to  increase Sept  24 Temp 98.6.  Arm very red, swollen, painful to touch, Lump still present Friday Sept 25?.Redness is reducing, however large lump is still present and painful to touch
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: _ Patient came to me on 9/23 20 with a fever of 101.3 on .  He does not feel well.  Did not tell his father that he does not feel well.   Patient says he is very tired. Does not want food ?.  Sept 22 Patient Tdap Vaccine #2 Sept 23  Patient Did not feel well, Fatigue, fever 101.3 at 6 pm.  Temp 99.5 at 9:30 pm.  Left arm very painful to touch, swollen tennis ball size redness.  Patients facial and neck Tics begin to  increase Sept  24 Temp 98.6.  Arm very red, swollen, painful to touch, Lump still present Friday Sept 25?.Redness is reducing, however large lump is still present and painful to touch
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Pt reports pain at injection site and following bone downward.  Pain began 2 days after vaccine administered.  Pain is continuous if not on NSAIDS.  On NSAIDS, pain appears when patient lifts right arm.  Spoke with patient via phone today and recommended that he follow up with his physician for evaluation.  He will follow up with me regarding physician diagnosis.
Age: 50.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Body temperature increased, Chills, Injection site rash, Injection site warmth, Pain
Clinical narrative: Starting the day after immunization, pt had temp of ~100, chills, body aches, a rash at injection site that was warm and ~2-3 inches in diameter, she reported no fever today when she reported ae to me. Patient was counselled on common side effects of immunization and told to take tylenol or ibuprofen for pain and report to a physician for evaluation of possible infection at injection site.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Moderate pain, swelling, at injection site which lead to chills, & SEVERE FATIGUE. Then later on nausea.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Pain, Pyrexia
Clinical narrative: DIARRHEA, FEVER, ACHING ALL OVER.   NO LOCAL REACTIONS.
Age: 54.0
Sex: F
Vaccine: FLUR4
Symptoms: Contusion, Erythema, Nodule, Paraesthesia, Skin exfoliation
Clinical narrative: Patient said she experienced a tingling feeling in her arm post immunization an hour afterwards and is still occurring. Additionally, patient reports a knot came up on arm that has not went away with massaging it over the past week. Welts appeared around the knot with redness, skin pealing, and bruising occurring as well.
Age: 54.0
Sex: F
Vaccine: FLUR4
Symptoms: Urticaria
Clinical narrative: Patient said she experienced a tingling feeling in her arm post immunization an hour afterwards and is still occurring. Additionally, patient reports a knot came up on arm that has not went away with massaging it over the past week. Welts appeared around the knot with redness, skin pealing, and bruising occurring as well.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Shivering, fever, severe headache
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Rash erythematous
Clinical narrative: mother called unit stating the child had rash on face that began 10/22/20 at 5PM gradually spreading to arms, upper torso, mid abdominal area and entire back beginning at hairline and ends at his diaper. Rash described as raised red bumps. Mom reports a few raised bumps on upper legs as well. Mom states he had flu vaccine the first of October but unsure of exact date. Mom reports n o fever and said child is not fussy or acting like he feels bad.
Age: 63.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Skin lesion
Clinical narrative: 2 lesions on forehead, 2 days after shot
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Decreased appetite, Feeling cold, Hypersomnia, Myalgia, Pyrexia
Clinical narrative: Muscle aches, shaking, cold, lasted from 8:30pm to 2am. No fever. Next day fever 101, took tylenol. Slept most of the day. Started feeling better later that day. Still not hungry.  No medical treatment received.
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Muscle aches, shaking, cold, lasted from 8:30pm to 2am. No fever. Next day fever 101, took tylenol. Slept most of the day. Started feeling better later that day. Still not hungry.  No medical treatment received.
Age: 80.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Chills, Discomfort, Heart rate increased, Laboratory test
Clinical narrative: Racing heartbeat, temp of 102, malaise, discomfort, chills
Age: 80.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise
Clinical narrative: Racing heartbeat, temp of 102, malaise, discomfort, chills
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received a dose ofROTATEQ ON 9/25/2020 and a second dose on 10/14/2020; This spontaneous report was received from a medical assistant referring to a 11-week-old patient of unknown gender. The patient's concomitant conditions, pertinent medical history and drug reactions or allergies were unknown.      On 25-SEP-2020, the patient was administered a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, strength, lot# and expiration date were unknown) orally for prophylaxis.         Then on 14-OCT-2020, the patient received a second dose of this vaccine (inappropriate schedule of product administration). The medical assistant inquired about possible side effects if the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered too close together and wanted to known if there was anything they should be watching for .
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: They thought they had given MMR II and not MMR with Varicella (PROQUAD); PROQUAD and Varicella vaccine was given the same date, so the children got a double dose of Varicella; PROQUAD and Varicella vaccine was given the same date, so the children got a double dose of Varicella; This spontaneous report was received from a nurse referring to a 5-year-old female patient. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were unknown by reporter.      On 27-OCT-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) in the left arm and varicella virus vaccine live (oka/merck)(VARIVAX) in the right arm; both vaccine subcutaneous route for prophylaxis (strength, dose, lot number, and expiration date were not reported) (duplicate therapy error and inappropriate schedule of product administration). Additional it was reported that they thought that was given measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) not measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (wrong product administered).        This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA011535:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional AE; patient was given an expired dose ofPNEUMOV AX 23; This spontaneous report was received from a office manager who was reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 28-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe (dose, route of administration, anatomical location and strength were not provided; lot number R033343 was confirmed to be valid, expiration date 03-AUG-2020 was confirmed) for prophylaxis. No additional adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R033343; expirationdate: 03-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: MENB, MNQ
Symptoms: Adverse reaction, Urticaria
Clinical narrative: Hives; additional symptoms; This case was reported by a other health professional via sales rep and described the occurrence of hives in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Bexsero and Menveo. On an unknown date, unknown after receiving Bexsero and Menveo, the patient experienced hives and adverse reaction. On an unknown date, the outcome of the hives and adverse reaction were unknown.   It was unknown if the reporter considered the hives and adverse reaction to be related to Bexsero and Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The patient was given Menveo and Bexsero vaccinations at separate sites at the same visit.  The patient developed hives and additional symptoms over a few days and had decided to seek medical attention from an allergist for more testing and information. Lot number and additional information was unavailable at the time of call.
Sex: F
Vaccine: FLUX
Symptoms: Paralysis
Clinical narrative: paralyzed; This case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a 26-year-old female 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 day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced paralysis (serious criteria hospitalization and GSK medically significant). The patient was treated with non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the paralysis was recovering/resolving.   The reporter considered the paralysis to be possibly related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the flu shot and less than 24 hours later she was paralyzed from the shot. The patient had to be admitted into the nursing home and have physiotherapy. The patient was recovered but only about 80 percent. The reporter stated reporter would never take a shot for any vaccine.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Erythema, Fear, Groin pain, Hypoaesthesia
Clinical narrative: left buttock and groin are tender, red, and swollen; left buttock and groin are tender/tender to touch area; left buttock and groin are tender, red; groin tender; groin swollen; injection in her left buttock instead of her deltoid; did not receive it intramuscularly but subcutaneously.; felt unwell; numbness on her leg; low back pain/lower back pain; fever of 100.9; heaviness to her arms, and legs; This case was reported by a nurse via call center representative and described the occurrence of low back pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of Shingrix (subcutaneous). On 21st October 2020, less than a day after receiving Shingrix, the patient experienced low back pain, fever, heavy feeling in arms & legs, feeling unwell, numbness, vaccine administered at inappropriate site and intramuscular formulation administered by other route. On 22nd October 2020, the patient experienced injection site swelling, injection site tenderness, erythema, groin pain and groin swelling. On an unknown date, the outcome of the low back pain, fever, heavy feeling in arms & legs, feeling unwell and numbness were recovered/resolved and the outcome of the injection site swelling, injection site tenderness and erythema were not recovered/not resolved and the outcome of the groin pain, groin swelling, vaccine administered at inappropriate site and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the low back pain, fever, heavy feeling in arms & legs, injection site swelling, injection site tenderness, erythema, feeling unwell, numbness, groin pain and groin swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient who was a nurse stated that she received her first Shingrix injection in her left buttock (gluteus) instead of her deltoid, which led to vaccine administered at inappropriate site. The patient stated she knew that the literature said there was no research on giving in any other muscle except the deltoid, but she felt that her deltoid was too small to receive it there.   The patient felt that she did not receive vaccine intramuscularly but subcutaneously, which led to intramuscular formulation administered by other route. The patient felt unwell and experienced lower back pain, numbness on her leg, a heaviness to her arms, and legs, and a fever of 100.9 degree F at the night and woke up with fever the next morning. She has swollen and tender on the injection area. The patient stated that her left buttock and groin are tender, red, and swollen. These events were subsided.  The patient stated that she was afraid of having the vaccine liquid on her tissue and that the liquid could cause harm on her body.  The reporter consented to follow up. The patient wanted to know what she should do about this.   The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site pain, Injection site swelling, Limb discomfort, Malaise
Clinical narrative: left buttock and groin are tender, red, and swollen; left buttock and groin are tender/tender to touch area; left buttock and groin are tender, red; groin tender; groin swollen; injection in her left buttock instead of her deltoid; did not receive it intramuscularly but subcutaneously.; felt unwell; numbness on her leg; low back pain/lower back pain; fever of 100.9; heaviness to her arms, and legs; This case was reported by a nurse via call center representative and described the occurrence of low back pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of Shingrix (subcutaneous). On 21st October 2020, less than a day after receiving Shingrix, the patient experienced low back pain, fever, heavy feeling in arms & legs, feeling unwell, numbness, vaccine administered at inappropriate site and intramuscular formulation administered by other route. On 22nd October 2020, the patient experienced injection site swelling, injection site tenderness, erythema, groin pain and groin swelling. On an unknown date, the outcome of the low back pain, fever, heavy feeling in arms & legs, feeling unwell and numbness were recovered/resolved and the outcome of the injection site swelling, injection site tenderness and erythema were not recovered/not resolved and the outcome of the groin pain, groin swelling, vaccine administered at inappropriate site and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the low back pain, fever, heavy feeling in arms & legs, injection site swelling, injection site tenderness, erythema, feeling unwell, numbness, groin pain and groin swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient who was a nurse stated that she received her first Shingrix injection in her left buttock (gluteus) instead of her deltoid, which led to vaccine administered at inappropriate site. The patient stated she knew that the literature said there was no research on giving in any other muscle except the deltoid, but she felt that her deltoid was too small to receive it there.   The patient felt that she did not receive vaccine intramuscularly but subcutaneously, which led to intramuscular formulation administered by other route. The patient felt unwell and experienced lower back pain, numbness on her leg, a heaviness to her arms, and legs, and a fever of 100.9 degree F at the night and woke up with fever the next morning. She has swollen and tender on the injection area. The patient stated that her left buttock and groin are tender, red, and swollen. These events were subsided.  The patient stated that she was afraid of having the vaccine liquid on her tissue and that the liquid could cause harm on her body.  The reporter consented to follow up. The patient wanted to know what she should do about this.   The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site, Pyrexia, Swelling
Clinical narrative: left buttock and groin are tender, red, and swollen; left buttock and groin are tender/tender to touch area; left buttock and groin are tender, red; groin tender; groin swollen; injection in her left buttock instead of her deltoid; did not receive it intramuscularly but subcutaneously.; felt unwell; numbness on her leg; low back pain/lower back pain; fever of 100.9; heaviness to her arms, and legs; This case was reported by a nurse via call center representative and described the occurrence of low back pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of Shingrix (subcutaneous). On 21st October 2020, less than a day after receiving Shingrix, the patient experienced low back pain, fever, heavy feeling in arms & legs, feeling unwell, numbness, vaccine administered at inappropriate site and intramuscular formulation administered by other route. On 22nd October 2020, the patient experienced injection site swelling, injection site tenderness, erythema, groin pain and groin swelling. On an unknown date, the outcome of the low back pain, fever, heavy feeling in arms & legs, feeling unwell and numbness were recovered/resolved and the outcome of the injection site swelling, injection site tenderness and erythema were not recovered/not resolved and the outcome of the groin pain, groin swelling, vaccine administered at inappropriate site and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the low back pain, fever, heavy feeling in arms & legs, injection site swelling, injection site tenderness, erythema, feeling unwell, numbness, groin pain and groin swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient who was a nurse stated that she received her first Shingrix injection in her left buttock (gluteus) instead of her deltoid, which led to vaccine administered at inappropriate site. The patient stated she knew that the literature said there was no research on giving in any other muscle except the deltoid, but she felt that her deltoid was too small to receive it there.   The patient felt that she did not receive vaccine intramuscularly but subcutaneously, which led to intramuscular formulation administered by other route. The patient felt unwell and experienced lower back pain, numbness on her leg, a heaviness to her arms, and legs, and a fever of 100.9 degree F at the night and woke up with fever the next morning. She has swollen and tender on the injection area. The patient stated that her left buttock and groin are tender, red, and swollen. These events were subsided.  The patient stated that she was afraid of having the vaccine liquid on her tissue and that the liquid could cause harm on her body.  The reporter consented to follow up. The patient wanted to know what she should do about this.   The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles episode happened a year after receiving the second dose; shingles episode happened a year after receiving the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 1 year 4 months after receiving Shingrix and 1 year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The reporter mentioned that the shingles episode happened a year after receiving the second dose and that the second dose was given four months after the first dose. The reporter asked information and recommendations on giving another dose or dose series to a patient that had already completed the dosing schedule for the Shingrix vaccine. The dates for the doses and more patient information were not available at the time of reporting. The reporter consented to follow up. The case was considered as suspected vaccination failure since the details regarding laboratory confirmation was not given.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Mobility decreased, Paraesthesia
Clinical narrative: tingling in his left little finger; had a limited range of motion in that arm; This case was reported by a pharmacist via call center representative and described the occurrence of tingling in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 22nd October 2020, less than an hour after receiving Shingrix, the patient experienced mobility decreased. On an unknown date, the patient experienced tingling. On an unknown date, the outcome of the tingling and mobility decreased were unknown.   It was unknown if the reporter considered the tingling and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received his first Shingrix vaccine. Within one hour, the patient started to experience tingling in his left little finger. The sensation continued to increase in intensity until the patient had a limited range of motion in that arm.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Pain
Clinical narrative: Migraine headache; intense body aches; This case was reported by a consumer via call center representative and described the occurrence of migraine headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th October 2020, the patient received the 1st dose of Shingrix. On 28th October 2020, 1 days after receiving Shingrix, the patient experienced migraine headache and general body pain. On an unknown date, the outcome of the migraine headache and general body pain were unknown.   It was unknown if the reporter considered the migraine headache and general body pain to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Patient reported that she received 1st dose of shingrix vaccine on 27th October,2020 and after that patient experienced migraine headache and intense body aches.  The reporter did not consent to follow up.
Age: 12.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 12 year old patient administered dose of Flublok, no AE; Initial information received on 21-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 year old patient who received 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], (Product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   No other vaccines administered to the patient.  On 21-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number uj497aa and expiry date: not reported) via an intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of actual medication error due to product administered to patient of inappropriate age (latency on 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.
Age: 5.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK was given accidentally to a 5 year old with no AE.; Initial information received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a five years old patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number and expiration date not reported) via an unknown route and administration site for prophylactic vaccination on an unknown date (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.   It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day at the time of vaccination).  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.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 7 year old was given the Quadracel vaccine with no adverse event; Initial information received on 21-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 years old female patient who received a 0.5 ml once fourth dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (Lot number- C5763AA, Expiration date- 26-Jul-2022) via intramuscular route in the left upper arm (Product administered to patient of inappropriate age) as prophylactic vaccination on 21-Oct-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD).  It was a case of actual medication error due to Inappropriate age at vaccine administration (Latency: Same day). Reporter wanted to know that if the patient should revaccinate.  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: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Large bright red area with fever on upper right arm;  Severe pain in arm enough that is was difficult to lift the arm or move it in any way; Fever of 101.5; chills; body aches; felt like my body was sinking into my bed and was difficult to move; severe pain in right calf; Red area on the arm lasted 4 days and slowly turned to large red whelts; Right calf pain also last 4 days and gradually subsided;  severe arm pain lasted 3 days ; fever lasted 24 hours; Took Tylenol and Benedryl.  Tylenol helped fever but did nothing for arm and calf pain.  Don't know if Benedryl helped as symptoms slowly decreased over 4 days.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Large bright red area with fever on upper right arm;  Severe pain in arm enough that is was difficult to lift the arm or move it in any way; Fever of 101.5; chills; body aches; felt like my body was sinking into my bed and was difficult to move; severe pain in right calf; Red area on the arm lasted 4 days and slowly turned to large red whelts; Right calf pain also last 4 days and gradually subsided;  severe arm pain lasted 3 days ; fever lasted 24 hours; Took Tylenol and Benedryl.  Tylenol helped fever but did nothing for arm and calf pain.  Don't know if Benedryl helped as symptoms slowly decreased over 4 days.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Large bright red area with fever on upper right arm;  Severe pain in arm enough that is was difficult to lift the arm or move it in any way; Fever of 101.5; chills; body aches; felt like my body was sinking into my bed and was difficult to move; severe pain in right calf; Red area on the arm lasted 4 days and slowly turned to large red whelts; Right calf pain also last 4 days and gradually subsided;  severe arm pain lasted 3 days ; fever lasted 24 hours; Took Tylenol and Benedryl.  Tylenol helped fever but did nothing for arm and calf pain.  Don't know if Benedryl helped as symptoms slowly decreased over 4 days.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia, Thrombosis, Urticaria
Clinical narrative: Large bright red area with fever on upper right arm;  Severe pain in arm enough that is was difficult to lift the arm or move it in any way; Fever of 101.5; chills; body aches; felt like my body was sinking into my bed and was difficult to move; severe pain in right calf; Red area on the arm lasted 4 days and slowly turned to large red whelts; Right calf pain also last 4 days and gradually subsided;  severe arm pain lasted 3 days ; fever lasted 24 hours; Took Tylenol and Benedryl.  Tylenol helped fever but did nothing for arm and calf pain.  Don't know if Benedryl helped as symptoms slowly decreased over 4 days.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Injection site urticaria, Nasal congestion, Nausea
Clinical narrative: Patient's mother described development of "a baseball-sized hive" at injection site that persisted for two days post injection. She also reported giving Benadryl and patient was tired, nauseated, with increased nasal congestion during that time. I have reported this to Dr's office.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Syncope - patient fainted and collapsed as she stood up and started walking. Patient was seated, given water and snacks. She immediately slowly regained her alertness and after about 20 minutes, she was fully alert and left the pharmacy with her parents. In a phone call later that day by the pharmacy, the father of the patient confirmed the patient was well and sound.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Induration, Injection site erythema, Skin warm, Tenderness
Clinical narrative: redness to injection site, warmth to touch, sensitive to touch, 3cm x 3cm tissue induration. Reduced with Children's Benadryl.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Product preparation issue
Clinical narrative: Pentacel powder was not mixed with fluid and was given to pt. It was later realized that patient was only given the fluid, not powder. No symptoms, signs, etc.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fatigue Fever to 101 degrees, abated by 5pm on same day
Age: 14.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: Approximately 5 minutes following the administration of the influenza vaccine (Sat 10/31) Patient fainted. She was caught by her family members who took her down to the ground. She was awake and coherent when I got back to her. She stayed down for a few minutes and got some water. After a few minutes her family walked her over to the chairs we have to the side and had her sitting up. I took her out some candy just to help get her blood sugar back up quickly. She stayed for about 15 more minutes and the family insisted she was fine and that she had probably just worked herself up leading up to the shot. Upon following up with her dad on Mon 11/2 he told me she was fine and that he thought something similar had happened post flu-shot once before.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Chills, Cough, Diarrhoea, Fatigue, Hyperhidrosis
Clinical narrative: Cough began at 5:00, 6:00, very tired, nausea, dry heaves, chills, sweats, fever, mild diarrhea, lasted approx 4 hours
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Nausea, Pyrexia, Retching, SARS-CoV-2 test negative
Clinical narrative: Cough began at 5:00, 6:00, very tired, nausea, dry heaves, chills, sweats, fever, mild diarrhea, lasted approx 4 hours
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes in neck on left, saw her md and was given keflex 5 days after vaccine. no swelling or redness at injection site
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Chest pain, Chills, Dizziness, Headache, Injection site erythema
Clinical narrative: On Wednesday, after immunization, ached at vaccination site through the night even if was not laying on it. As soon as got home vaccination site started itching and was red; it was a 3x3 area and used Cortisone 10. On Thursday, woke up with a headache, nausea and lightheadedness; resolved by mid- afternoon. Put moisture on arm and took Advil but medicine did not seem to really help. On Friday woke up with chills so put blankets on. Chills lasted for about 30 minutes--could not get warm. The pain eased by the weekend but it did not disappeared. It has been 6 weeks and patient still is in pain and has mild itch. Arm periodically gets painful, sometimes nothing triggers the pain or sometimes movement causes it. For example, when patient picks up something she gets a short pain that does not last long.  On 9/28 notified doctor by mail but he did not have any suggestions. On 10/20 called doctor and next day got a call back from NP that prescribed Prednisone. Took first Prednisone on 10/22 and a few hours later got immense headache so stopped taking it. Patient also contacted neurologist on Friday and got a call back on Tuesday called and was asked to come in to the office; by then pain had dissipated. Today patient still has pain at vaccination site. Patient has called doctor and has appointment with PCP for follow-up. Patient recently recalled some symptoms she experienced out of norm after the vaccination that were out of norm. About 4 hours after vaccination patient go pain in heart that lasted for a couple of seconds. On Friday and Saturday, pain recurred 2-3 times for 10 seconds episodes. On Sunday, the pain lasted about 2-3 minutes then it was gone. Patient has never had a pain like that before even when she got her heart attack and has not had it since. Patient did not notice any other symptoms along with the heart pain.