chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Contusion, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever; Pain at injection site; pain at my back below shoulder; arm / still with pain; bruise in my arm; This case was reported by a other health professional via interactive digital media and described the occurrence of low grade fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th June 2020, the patient received Shingrix. In July 2020, less than 2 weeks after receiving Shingrix, the patient experienced low grade fever, injection site pain, back pain, pain in arm and bruising of arm. On an unknown date, the outcome of the low grade fever, injection site pain, back pain, pain in arm and bruising of arm were unknown.   It was unknown if the reporter considered the low grade fever, injection site pain, back pain, pain in arm and bruising of arm to be related to Shingrix.  Additional details were provided as follow: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient had vaccine on 24th June 2020 and experienced mild symptoms, low grade fever, pain at injection site, pain at my back below shoulder, pain in arm where the patient got the shot. The patient also had a bruise in arm.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives at night under his arm pits/ on legs; This case was reported by a consumer via call center representative and described the occurrence of hives in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (received 1st dose on 13th Juanuary 2020, refer case US2020121792).   On 22nd June 2020, the patient received the 2nd dose of Shingrix. On 29th June 2020, 7 days after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional information was provided as follows: The patient developed hives at night under his arm pits and on his upper legs. The reporter stated the hives disappear in the morning but come back at night and this was still happening at the time of reporting and asked if this was normal side effect. The reporter did not consent to follow up. Caller refused to give the HCP's contact information. She stated she would call herself.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020121792:same patient
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Computerised tomogram normal, Feeling hot, Herpes zoster, Immediate post-injection reaction
Clinical narrative: internal shingles; hot burning sensation on my right side around my hip area; feels hot to me; relieve the pain; This case was reported by a consumer and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 3rd January 2020, the patient received the 2nd dose of Shingrix. On 3rd January 2020, immediately after receiving Shingrix, the patient experienced shingles, burning hip, feeling hot and pain. The patient was treated with hydrocortisone (Cortisone Topical Cream). On an unknown date, the outcome of the shingles, burning hip, feeling hot and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, burning hip, feeling hot and pain to be related to Shingrix.  Additional information was provided as follows: The patient developed hot burning sensation on right side around her hip area, it was not hot to touch but felt hot to patient. Till the time of reporting, the events were constant. The patient wanted to know what measures were taken to relieve the pain. The patient had been using cortisone creams for treatment and has had a CT (Computerised tomogram) scan, MRI (Magnetic resonance imaging) and ultrasound. All of the tests so far had been negative, the patient was wondering if she had a form of internal shingles. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging normal, Pain, Ultrasound scan normal
Clinical narrative: internal shingles; hot burning sensation on my right side around my hip area; feels hot to me; relieve the pain; This case was reported by a consumer and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 3rd January 2020, the patient received the 2nd dose of Shingrix. On 3rd January 2020, immediately after receiving Shingrix, the patient experienced shingles, burning hip, feeling hot and pain. The patient was treated with hydrocortisone (Cortisone Topical Cream). On an unknown date, the outcome of the shingles, burning hip, feeling hot and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, burning hip, feeling hot and pain to be related to Shingrix.  Additional information was provided as follows: The patient developed hot burning sensation on right side around her hip area, it was not hot to touch but felt hot to patient. Till the time of reporting, the events were constant. The patient wanted to know what measures were taken to relieve the pain. The patient had been using cortisone creams for treatment and has had a CT (Computerised tomogram) scan, MRI (Magnetic resonance imaging) and ultrasound. All of the tests so far had been negative, the patient was wondering if she had a form of internal shingles. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropod bite, Food allergy
Clinical narrative: Alpha-Gal Syndrome; This case was reported by a pharmacist via call center representative and described the occurrence of alpha-gal allergy in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months after receiving Shingrix, the patient experienced alpha-gal allergy. On an unknown date, the outcome of the alpha-gal allergy was unknown.   It was unknown if the reporter considered the alpha-gal allergy to be related to Shingrix.  Additional details were reported as follows: The pharmacist did not have specifics or additional patient demographics. The patient was bitten by a tick recently, specific date unknown, and developed Alpha-Gal Syndrome.   Consented to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: still hurting; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th June 2020, the patient received the 1st dose of Shingrix (injection). On 30th June 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient had his first Shingrix injection in the right arm this morning and it was still hurting.  The patient wanted to know if he could still use his right arm.  No HCP information provided. The patient would call his doctor himself and talk to him. The reporter did not consent to follow-up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: palpitation; This case was reported by a nurse via call center representative and described the occurrence of palpitation in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2020, the patient received the 1st dose of Shingrix. On 12th June 2020, less than a day after receiving Shingrix, the patient experienced palpitation. On 12th June 2020, the outcome of the palpitation was recovered/resolved.   It was unknown if the reporter considered the palpitation to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced palpitation on the same day and resolved on the same night. The reporter consented to follow up. This case has been linked with case CA2020097732, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020115724:same reporter
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood potassium normal, Induration, Rash pruritic, White blood cell count increased
Clinical narrative: Itchy rash; Patient reports, rash appears to be in a resolving stage, with indurated sites replacing the rash; Elevated WBC; This case was reported by a physician via call center representative and described the occurrence of white blood cell increased in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rash. Concomitant products included clobetasol propionate (Clobetasol).   On 16th March 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st April 2020, 16 days after receiving Shingrix, the patient experienced white blood cell increased. On an unknown date, the patient experienced itchy rash and induration. The patient was treated with topical steroid nos (Steroid Cream). Shingrix was discontinued. On an unknown date, the outcome of the white blood cell increased and induration were unknown and the outcome of the itchy rash was recovering/resolving.   It was unknown if the reporter considered the white blood cell increased, itchy rash and induration to be related to Shingrix.  Additional details were reported as follows: The patient reported rash and elevated white blood cell, 2 weeks following his first dose of Shingrix vaccine. The patient visted dermatologist and shows negative potassium hydroxide test for fungi. The patient was prescribed steroid cream that relieved the itching. Patient reported that rash appears to be in a resolving stage, with indurated sites replacing the rash. The patient told that he will not receive the second shot in the series. As per evnt onset date TTO for event white blood cell increased  should be 16 days however it was reported as 2 weeks that is 14 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Varicella
Clinical narrative: Appears as chicken pox  on neck / posterior chest, groins and armpits; This case was reported by a nurse via call center representative and described the occurrence of chickenpox in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th June 2020, the patient received the 1st dose of Shingrix. On 12th June 2020, 2 days after receiving Shingrix, the patient experienced chickenpox. On an unknown date, the outcome of the chickenpox was recovered/resolved.   It was unknown if the reporter considered the chickenpox to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and 2 days later broke out with what appears to look like chicken pox.  It disappeared after 10 days and at the time of reporting had returned. The patient experienced, chicken pox like first time on neck. This time generalized on anterior and posterior chest, groins and armpits. The reporter was unable to provide any vaccine details of lot and expiration. The reporter did not consent to follow up.
Sex: U
Vaccine: HEPAB, HEPAB
Symptoms: Influenza, Nasopharyngitis, Social problem
Clinical narrative: ill / the flu or a cold as reported; Cold; received the first dose of Twinrix on 21-Dec-2019; This case was reported by a nurse via call center representative and described the occurrence of influenza in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   On 21st December 2019, the patient received the 1st dose of Twinrix. On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, less than a month after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced influenza, cold and social problem. On an unknown date, the outcome of the influenza, cold and social problem were unknown.   It was unknown if the reporter considered the influenza and cold to be related to Twinrix.  Additional details were provided as follows: A nurse reported that a patient received the first dose of Twinrix. Approximately a month after that, this patient did not get dose two as the patient as ill (the flu or a cold as reported). This patient also did not get dose two till the time of reporting due to the COVID-19 outbreak. The reporter did not consent to follow-up.
Age: 45.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: 45 year old patient received shingrix; Headache; Tiredness; Low grade fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a 45-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 2nd July 2020, the patient received the 2nd dose of Shingrix. On 2nd July 2020, less than a day after receiving Shingrix, the patient experienced headache, tiredness and low grade fever. On an unknown date, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the headache, tiredness, low grade fever and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the headache, tiredness and low grade fever to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of vaccine in left arm and experienced headache, tiredness and low grade fever. The patient received vacine at age of 45 years old which was not recommended age for shingrix vaccine administration and led to inappropriate age at vaccine administration. The reporter asked if the shingrix injection was a live vaccine and whether it would effect his six month old baby and received reply as shingrix was not a live vaccine. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: Has not received the second dose; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2020) and Shingles vaccine (received the old shingles shot approximately 7-8 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not applicable for this report. the patient was attempted to got 2nd dose in March but unable to due to clinic being closed during coronavirus pandemic. Till the time of reporting, the patient had not received the 2nd dose.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: possibly recieved a third singrix injection; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 13th April 2019) and Shingrix (received 2nd dose on 12th August 2019).   On an unknown date, the patient received the 3rd dose of Shingrix. In January 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. After getting the first 2 doses, the patient seemed to had possibly received a 3rd dose of Shingrix from another pharmacy which led to extra dose administered and had not noticed any issues till the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bursitis, Fall, Social problem
Clinical narrative: fall she had; bursitis of her hips; not received the second shingrix dose/because of COVID-19.; This case was reported by a consumer via call center representative and described the occurrence of fall in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fall, hip bursitis and social problem. On an unknown date, the outcome of the fall, hip bursitis and social problem were unknown.   It was unknown if the reporter considered the fall and hip bursitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she experienced bursitis of her hips and she was sure that it was due to a fall she had three months after receiving her first dose of Shingrix vaccine.  The patient received her first Shingrix dose in September 2019 and had not received the second shingrix dose because her pharmacy was not administering it because of COVID-19. The pharmacy was not planning to get 2nd Shingrix vaccine. The physician recommended to get a cortisone shot for bursitis in hip sometime after 2nd Shingrix vaccine. The patient wanted to know how long she should wait after the 2nd Shingrix vaccine to get the costisone shot for bursitis.  The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu-like Symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional information was provided as follows: After the first dose the patient felt like he had flu like symptoms which lasted one day. The reporter did not consent to follow up. Caller refused to give the HCP's contact information. She stated she would call herself For tolerance of 2nd dose, refer case US2020AMR122269.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR122269:same patient
Age: 1.08
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Client was given 2 doses of varicella.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza, Pain in extremity
Clinical narrative: Arm Pain / extreme flu symptoms without fever.  Lasted for 24 hours. Patient felt she may have gotten COVID, but knew it would last longer than a 24 hour period.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea
Clinical narrative: severe chills and nausea
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Chills, muscle aches, fever
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms.; an improperly stored dose of ROTA TEQ  was administered to a patient; This spontaneous report was received from a healthcare worker regarding a patient of unknown age and gender. Concomitant therapies, current conditions, medical history and historical drugs were not provided.   On 11-MAY-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660939, expiration date 26-OCT-2020, orally for prophylaxis (strength, dose and frequency were not reported).  Temperature excursion was reported as 27°F for 3 hours. It was reported that there was not previous temperature excursion.  The call was made due to a digital data logger. The patient experienced no symptoms; no additional adverse effect reported.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Pain, Pyrexia
Clinical narrative: fever of 101 degrees F; body aches; headach; feeling unwell; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date and no side effect was experienced).   On 1st July 2020, the patient received the 2nd dose of Shingrix. On 2nd July 2020, 1 days after receiving Shingrix, the patient experienced fever, general body pain, headache and malaise. On an unknown date, the outcome of the fever, general body pain, headache and malaise were not recovered/not resolved.   It was unknown if the reporter considered the fever, general body pain, headache and malaise to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient did not experience any side effects after her 1st dose of Shingrix.  After 2nd dose of Shingrix the patient experienced fever of 101 degrees F, body aches, headache and feeling unwell.  The reporter did not consent to follow up.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: Menactra exposed to 27F for more than 3 hours due to  temperature was manually changed in the refrigerator, no advesre event; Initial information was received on 01-Jul-2020 regarding an unsolicited valid non-serious case from the other health professional.  This case is linked to cases 2020SA172973, 2020SA172697, 2020SA174880, 2020SA174885, 2020SA174942, 2020SA174911, 2020SA174941, 2020SA174910, 2020SA174932, 2020SA174906 and 2020SA173110 (same reporter).   This case involves a vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6594AB and expiration date 21-May-2021) which was exposed to 27 degree F for more than 3 hours and this vaccine was administered to a 11 year old male patient via an unknown route at an unknown administration site on 13-May-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.   The patient's concomitant medication was not reported.  It was an actual medication error case due to product storage error temperature too low. This error occurred due to temp was manually changed in the refrigerator (human error).  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: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event, Product administered at inappropriate site
Clinical narrative: expired dose of ActHib was administered, no AE; a 12 months old patient received a first dose of ActHib vaccine, no AE; expired dose of ActHib was administered at right gluteus, no AE; Initial information received on 06-Jul-2020 regarding an unsolicited valid non-serious case received from the other health professional.  This case involves a 12 months old male patient who was vaccinated with a 0.5 mL expired dose (first dose) of HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ112AAC and expiry date 06-Jul-2020) via intramuscular route in the right gluteus medius on 06-Jul-2020 for prophylactic vaccination.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE, MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCINE) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)) for prophylactic vaccination.  It is an actual medication error case due to expired vaccine used, inappropriate schedule of vaccine administered and vaccine administered at inappropriate site. It was reported that an expired first dose of ActHib was administered to a 12 months old patient.  At the time of this 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 and Module VI of the 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: M
Vaccine: DTAP, DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient was accidentally given a Pentacel vaccine instead of just DTAP/Ipol, no AE; 5 year old was given pentacel, no AE; Initial information received on 06-Jul-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a five year old male patient who received 0.5 ml second dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ227AAA, Expiry date 23-Apr-2021) via an intramuscular route in the right deltoid for prophylactic vaccination instead of DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE, on 29-Jun-2020 (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s), and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration and wrong vaccine administered.  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 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.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was given on 01-Jul-2020 which was expired on 31 may 2020/no AE; Initial information was received on 07-Jul-2020 regarding an unsolicited valid non-serious case received from a non health care professional (office staff).  This case involves an 11 years old female patient who was vaccinated with once 0.5 ml first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] on 01-Jul-2020 which was already expired on 31-May-2020 (batch number U6220AA) via intramuscular route in the left arm for prophylactic vaccination (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX).  It was an actual medication error case due to expired vaccine used.  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: 29.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site swelling
Clinical narrative: she notes that she had severe chills, and sweating after immunization.  She did not have a thermometer to check her temperature.  She also had redness and swelling at the injection site. She said these symptoms subsided over a couple day time frame.  No other infectious symptoms were noted so she truly feels it was related to the immunization as it happened just after the shot was given.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Flu like symptoms for 4 days following, abnormally sore upper arm for 8 days following, and a red itchy rash on the upper arm for 7 days following
Age: 40.0
Sex: F
Vaccine: MMR, TD
Symptoms: Cold sweat, Discomfort, Pain, Substance use
Clinical narrative: June 9 Got a pedicure ( my feet were submerged in water ) 30 mins after leaving felt a pulsating in my back between t8-t12 area wrapping around to front Got worse as time progressed Later that evening spoke with a neighbor who had just had her gall bladder removed Symptoms sounded similar Researched and ruled out gall bladder stuff Looked into vaccine side effects Became aware that some vax are not recommended for people allergic to dairy or family history of autoimmune diseases I have at least 3 known immediate family members with serious autoimmune diseases Mother father paternal grandmother Rhwumatoid arthritis lupus multiple sclerosis I upped my water intake, rested and the pain gradually subsided within a few hours June 14 Took a bath Epsom salt Within 12 hours that same pain t8-t12 came back 10 times worse Upped water again Pain kept getting worse Took ibuprofen Pain got worse To the point where I could not get comfortable and was breaking into a cold sweat After 3 or 4 hours of this I smoked some marijuana, which I had not done since 1-25-2020, Pain went away within 15 mins  Seems like every time I submerge myself in water, this pain happens. I'm now afraid to take baths. Makes me wonder what's happening to our children. I had a severe disdain for taking baths as a child, so much so that I refused. ( I was bullied for being stinky) Wonder why.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea, Pain
Clinical narrative: Flu like symptoms.  Body aches, nausea
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site streaking, Pyrexia
Clinical narrative: Fever. Tenderness at injection site. Red line running from injection site down arm towards torso.
Age: 29.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: 07/01/2020 Office Visit notes: History of Present Illness: The patient presents for Rash.  This episode began 1 day ago.  The patient describes the affected area(s) as itchy, red and hives.  Associated symptoms include erythema (skin) and pruritus.  Additional information: Hives an itching started yesterday approximately 4 hours after his first Hep A vaccine.  He denies any other changes.  Patient reports hives were worse yesterday, has been taking Benadryl. Review of Systems: Integumentary: Erythema, Pruritus, Hives Physical Exam: Skin: Hives scattered on body worse on the left side than on right. Assessment/Plan: Hives.  Allergic reaction, initial encounter.  Today we gave you Solu-Medrol (125 mg given IM x1) to help with the hives and itching and to reduce inflammation in your body.  Continue to take Benadryl every 4-6 hours as needed.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Loss of personal independence in daily activities, Neuralgia, Pain, Pain in extremity
Clinical narrative: Within a week of the vaccine, arm started to feel tender below the shoulder. Pain then radiated down the arm. Felt like a numbness and tingling, similar to nerve pain. Now the numbness has moved to all parts of the body. Patient no longer able to do day to day physical activities.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Tenderness
Clinical narrative: Within a week of the vaccine, arm started to feel tender below the shoulder. Pain then radiated down the arm. Felt like a numbness and tingling, similar to nerve pain. Now the numbness has moved to all parts of the body. Patient no longer able to do day to day physical activities.
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Loss of consciousness, Posture abnormal, Tremor
Clinical narrative: Patient was given TDAP vaccine in left arm. Upon administering vaccine, patient stated he was feeling lightheaded. I asked him if he was dizzy, he responded yes. I told him we could wait for a few minutes before administering next vaccine (patient was to get HPV as well). Few seconds later, patient was slouching over in chair, shaking. Patient's grandmother was with him and ran to assist to try to help lay patient down. I put an ice pack on patient's head, he began to awaken a few seconds later. We provided patient cold water/gatorade. Patient was alert, awake, and oriented at this point. I sat with patient for approximately 10 more minutes before he stated he felt completely normal and walked out of the store with his grandmother.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Grip strength decreased, Hypoaesthesia, Laboratory test, Magnetic resonance imaging, Malaise
Clinical narrative: Pt states the last time she was in she had the pneumonia shot and states, "it about did me in".  Pt states she was extremely sick afterwards, lost use of R hand and unable to raise it since injection.  Pt states she lost feeling in 3 fingers in R hand and unable to hold utensils anymore.  Inj was in L arm.  Pt states she has been sluggish since and has weight loss.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Musculoskeletal disorder, Sluggishness, Weight decreased, X-ray
Clinical narrative: Pt states the last time she was in she had the pneumonia shot and states, "it about did me in".  Pt states she was extremely sick afterwards, lost use of R hand and unable to raise it since injection.  Pt states she lost feeling in 3 fingers in R hand and unable to hold utensils anymore.  Inj was in L arm.  Pt states she has been sluggish since and has weight loss.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Soreness and swelling at injection site
Age: 30.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Immunisation, Underdose
Clinical narrative: Client given child dose of 5mcg. vs. adult dose of 20mcg.  gave. adult dose while client still in clinic in rt. arm
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Urticaria
Clinical narrative: Broke out in hives
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Angiogram, Angiogram normal, Blood test normal, Body temperature increased, Chills
Clinical narrative: Patient fainted at home. She complained of very painful injection site in her left arm, legs numb and tingly, chills, nausea, dizziness and temp of 100.3.  She was taken to the emergency room for evaluation and treatment. She  had blood work, EKG, and CTA done. All results normal. Patient was then discharged home. Patient called the office back on 7/2 and stated her symptoms seemed to have resolved then returned. She was complaining of dizziness, muscle aches, and muscle aches.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Electrocardiogram normal, Hypoaesthesia, Injection site pain, Myalgia
Clinical narrative: Patient fainted at home. She complained of very painful injection site in her left arm, legs numb and tingly, chills, nausea, dizziness and temp of 100.3.  She was taken to the emergency room for evaluation and treatment. She  had blood work, EKG, and CTA done. All results normal. Patient was then discharged home. Patient called the office back on 7/2 and stated her symptoms seemed to have resolved then returned. She was complaining of dizziness, muscle aches, and muscle aches.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Paraesthesia, Syncope
Clinical narrative: Patient fainted at home. She complained of very painful injection site in her left arm, legs numb and tingly, chills, nausea, dizziness and temp of 100.3.  She was taken to the emergency room for evaluation and treatment. She  had blood work, EKG, and CTA done. All results normal. Patient was then discharged home. Patient called the office back on 7/2 and stated her symptoms seemed to have resolved then returned. She was complaining of dizziness, muscle aches, and muscle aches.
Age: 0.08
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine was given too early. No adverse event has happened at this time. So far patient has been tolerating well.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Fall, Fatigue, Gait disturbance, Hyperhidrosis
Clinical narrative: He left the clinic and immediately felt dizzy.  He stumbled and fell to the ground in the parking lot, saying he couldn't see and felt dizzy. Mom helped him up to try to get him to the curb. He fell limp in my (mom's) arms. I laid him down in the parking lot & he fainted. I ran back to the door and yelled for help.  He came to and the nurses helped him back into the clinic , laid him down and gave him water and ice pack and tended to him.   He was sweating profusely and then started throwing up.  We stayed approx. 15 min, he had a small snack and started to feel like he could leave.  At home, he has had a very sore right arm and is tired.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hypotonia, Immediate post-injection reaction, Pain in extremity, Syncope, Visual impairment
Clinical narrative: He left the clinic and immediately felt dizzy.  He stumbled and fell to the ground in the parking lot, saying he couldn't see and felt dizzy. Mom helped him up to try to get him to the curb. He fell limp in my (mom's) arms. I laid him down in the parking lot & he fainted. I ran back to the door and yelled for help.  He came to and the nurses helped him back into the clinic , laid him down and gave him water and ice pack and tended to him.   He was sweating profusely and then started throwing up.  We stayed approx. 15 min, he had a small snack and started to feel like he could leave.  At home, he has had a very sore right arm and is tired.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: He left the clinic and immediately felt dizzy.  He stumbled and fell to the ground in the parking lot, saying he couldn't see and felt dizzy. Mom helped him up to try to get him to the curb. He fell limp in my (mom's) arms. I laid him down in the parking lot & he fainted. I ran back to the door and yelled for help.  He came to and the nurses helped him back into the clinic , laid him down and gave him water and ice pack and tended to him.   He was sweating profusely and then started throwing up.  We stayed approx. 15 min, he had a small snack and started to feel like he could leave.  At home, he has had a very sore right arm and is tired.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: SWELLING WITH ITCHING AND REDNESS
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthralgia, Chills, Feeling abnormal, Headache
Clinical narrative: Fever, chills, whole body skin hypersensitivity, joint pain, sore throat, abdominal pain, headache.  I couldn?t believe how bad I felt.  I slept for 12 hours and awakened feeling better with no symptoms.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Oropharyngeal pain, Pyrexia, Sensitive skin
Clinical narrative: Fever, chills, whole body skin hypersensitivity, joint pain, sore throat, abdominal pain, headache.  I couldn?t believe how bad I felt.  I slept for 12 hours and awakened feeling better with no symptoms.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: fainted, dizziness
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Malaise, Rash
Clinical narrative: -Very sore arm at injection site -Sick all day  -Bad headache  -Rash on my Right Hip
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site pain
Clinical narrative: Ongoing right shoulder pain for 2weeks, began 1 day after vaccine. 5 out of 10 achy pain.
Age: 1.5
Sex: M
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swelling, erythema of the left upper thigh, the day after the vaccination.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Syncope
Clinical narrative: She had a episode of vasovagal syncope laid Pt Flat and Immediately got better and ox was at 98%
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Bradycardia, Dizziness, Haemoglobin, Hyperhidrosis, Lipids
Clinical narrative: Pt. had vaccine administered and then had a fingerstick lipid and hemoglobin drawn. Within 10 minutes of completing these 2 tests, the pt. became vasovagal, light headed, dizzy and diaphoretic. Pt. was lied down on exam table, legs raised, ice pack to neck pt. was mildly bradycardia ~ HR 50. After 16 minutes pt. was able to sit up, drink juice, eat animal crackers, felt better. 911 was called EMT's assessed heart rate/rhythm - all WNL. Patient was able to walk out of building on his own after ~ 15 minutes. Parent/pt. refused transport to ER felt not needed.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Presyncope
Clinical narrative: Pt. had vaccine administered and then had a fingerstick lipid and hemoglobin drawn. Within 10 minutes of completing these 2 tests, the pt. became vasovagal, light headed, dizzy and diaphoretic. Pt. was lied down on exam table, legs raised, ice pack to neck pt. was mildly bradycardia ~ HR 50. After 16 minutes pt. was able to sit up, drink juice, eat animal crackers, felt better. 911 was called EMT's assessed heart rate/rhythm - all WNL. Patient was able to walk out of building on his own after ~ 15 minutes. Parent/pt. refused transport to ER felt not needed.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Rash maculo-papular, Viral rash
Clinical narrative: Fever started on July 5th, lasted for 3 days 101-103 F. Fever came down and rash started on face and trunk Maculopapular rash. Parents came today to the office to be seen, child stable. Diagnosis to MMR vaccine or viral illness, viral exanthem.
Age: 94.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test normal, Lethargy, Psychomotor hyperactivity, Speech disorder, Staring
Clinical narrative: AT ONSET PATIENT HAD A BLANK STARE AND WAS NON-COMMUNICATIVE. PATIENT HAD BOUTS OF LETHARGY AND HYPERACTIVENESS AFTER HOSPITAL ADMISSION/DISCHARGE
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported; improperly stored doses of PROQUAD were administered to the patient; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.  On 02-JUL-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status rHA (recombinant Human albumin), 1 dosage form, lot number T007395 and expiration date 29-AUG-2021 (route of administration not provided) for prophylaxis.  There was no previous temperature excursion  No adverse events were reported.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Mobility decreased, Nausea, Pain
Clinical narrative: swelling, hot to the touch, painful, headache, nausea, dizziness, achy, unable to lift arm
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: swelling, hot to the touch, painful, headache, nausea, dizziness, achy, unable to lift arm
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; patient received improperly stored PROQUAD on 5/19/2020 which was administered via unspecified route; This spontaneous report was received from an administrator, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 19-MAY-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, via unspecified route of administration (vaccination scheme and anatomical location were not reported; lot number was reported as S006019, which was confirmed to be invalid upon internal verification, with expiration date reported as 27-FEB-2021) as prophylaxis (product storage error). The sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was properly stored. No additional adverse effects reported.  The vaccine experienced a temperature excursion between 6 degrees Fahrenheit (F) to 14F (10.4F) for 15 minutes. There was a previous temperature excursion between 6F to 14F (11.1F) for 15 minutes, as recorded by a data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA001240: US-009507513-2007USA001370: US-009507513-2007USA001612: US-009507513-2007USA001668:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received a dose of Pnuemovax23 following a temperature excursion; no adverse effect; This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml unknown route and anatomical location; lot # T000702 expiration 01-OCT-2021, for prophylaxis) following a temperature excursion.  No adverse effects were reported.   The temperature excursion lasted for 31 minutes with a highest temperature above 47°F/9°C (8.8°C), due to a data logger issue.; Sender's Comments:  US-009507513-2007USA001492:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; she was scheduled to receive her third dose ofGARDASIL 9 in October 2019 but that she was unable to receive her third dose due to "Covid-19 outbreak; This spontaneous report was received from a 43 year old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose, frequency, lot # and expiration date were not provided) for prophylaxis. Patient stated she was scheduled to receive her third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in October 2019 but that she was unable to receive her third dose due to "Covid-19 outbreak." Patient wanted to know if she was able to proceed with her third dose or if she needed to take her first and second doses again. Patient stated her insurance won't pay for her to get her first and second doses again. No additional adverse event was reported.