chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was accidentally given just Dtp and Polio part not HIB part, no AE; Initial information received on 04-Aug-2020 regarding an unsolicited valid non-serious case received from a physician .  This case involves a four month old female patient who was accidentally given DTap-IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine not HIB part (product preparation issue).  Medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.  On 03-Jun-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot U6613AA and expiry date: no reported) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate reconstitution technique.  New staff member did not realize that the portions needed to be administered together once mixed. Caller wanted to know if it was valid because it said not to give alone.   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: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a dose of Adacel was administered to a 5 year old patient instead of Daptacel vaccine/ No AE; a dose of Adacel was administered to a 5 year old patient/ No AE; Initial information was received on 04-Aug-2020 regarding an unsolicited valid non-serious case from the other health care professional via phone.  This case involves a five-year-old female patient who was vaccinated with a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6638AA and expiration date 12-Apr-2022) via an intramuscular route in the right thigh on 03-Aug-2020 for prophylactic vaccination instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient had received four doses of DAPTACEL vaccine in the past on unspecified dates for prophylactic vaccination.  The patient's medical history, past medical treatment and family history were not provided.  The patient concomitantly vaccinated with a dose of POLIO VACCINE for prophylactic vaccination.   It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  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.
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Influenza virus test negative, Malaise, Pyrexia
Clinical narrative: malaise, sick; fatigue; mild fever; Initial information received on 04-Aug-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 48 year old male patient who experienced malaise, sick (malaise), fatigue and fever (pyrexia), while he received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history were not provided.  At the time of the event, the patient had ongoing Food allergy, Malaise, Sinus disorder and Neoplasm malignant. (it was reported that patient also mentioned a history of a sinus problem and a history of cancer, so that he wants to be sure that he does not get the flu. Patient also stated that he just learned about a year ago that he is allergic to eggs, so he wants to avoid egg-produced flu vaccines).  Concomitant medication was not reported.  On 10-Sep2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date: not reported) via an unknown route and administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious malaise, sick (malaise), fatigue and fever (pyrexia) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that the patient received a Sanofi flu vaccine last year, on 10 Sep 2019, but the place that administered his flu vaccine cannot tell him whether it was Fluzone Quadrivalent or Flublock Quadrivalent, just that it was a Sanofi flu vaccine. Patient stated that he does not think it was Fluzone High-Dose, because he is only 48 years old, and that vaccine is approved only for those over 65 years old. Patient stated that he has received flu vaccines in prior years and experienced some malaise and fatigue after getting those flu vaccines, and also possibly experienced mild fever although he is not sure about whether he experienced any fever, but he has no idea whether any of those flu vaccines were Sanofi products or not.  Relevant laboratory test results included: Influenza virus test - On an unknown date:  [it was not the flu]  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcomes was reported as unknown for all the events.  There will be no information available on the batch number for this case.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received a dose of Menactra that was expired by two days/no AE; Initial information was received on 06-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 year old female patient who was vaccinated with 0.5 ml once dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] that was expired by two days (batch number U6219BA and expiry date 16-Jun-2020) via intramuscular route at the left deltoid on 18-Jun-2020 for prophylactic vaccination (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for prophylactic vaccination.  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: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Menactra was given to patient /no AE; Initial information was received on 06-Aug-2020 regarding an unsolicited valid non-serious case from other health professional. This case involves a 13 year old male patient who received an expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Immunisation.  On 06-Aug-2020, the patient received a 0.5 mL once dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U5869AB, expiry date- 05-Aug-2020) (Pharmaceutical form- SDV) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  No adverse event was 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: 27.0
Sex: M
Vaccine: RAB
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Right hand was tingling and numb; Right hand was tingling and numb; This case was reported by a consumer via call center representative and described the occurrence of numbness in a 27-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   In July 2020, the patient received the 1st dose of RabAvert. On an unknown date, less than 2 weeks after receiving RabAvert, the patient experienced numbness and tingling. On an unknown date, the outcome of the numbness and tingling were recovered/resolved.   It was unknown if the reporter considered the numbness and tingling to be related to RabAvert.  Additional details were reported as follows: The reporter was the mother of the patient. The patient received Rabavert for post-exposure prophylaxis. The patient received 1st dose of RabAvert on 19th or 20th July 2020 in right arm after that his right hand was tingling and numb. The patient received 2nd dose refer case US2020152664 and for 3rd dose refer case US2020AMR153823.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR153823:same patient US-GLAXOSMITHKLINE-US2020152664:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Hypoaesthesia, Nasal congestion, Pain
Clinical narrative: Arm numbness; pain everywhere; difficulty breathing; Stuffy Nose; This case was reported by a consumer via call center representative and described the occurrence of numbness of upper extremities in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced numbness of upper extremities, pain, difficulty breathing and nasal stuffiness. On an unknown date, the outcome of the numbness of upper extremities, pain, difficulty breathing and nasal stuffiness were unknown.   It was unknown if the reporter considered the numbness of upper extremities, pain, difficulty breathing and nasal stuffiness to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingles vaccine 3 years or 3 months ago and has a stuffy nose, difficulty breathing, pain everywhere and entire arm numbness.  The reporter reported being in hospital and that she was dying. The reporter extremely difficult to understand and limited information was provided.  The reporter abruptly disconnected call and unable to confirm spelling for all demographic information. The reporter was unable to connect with caller after attempting to callback on caller ID number and phone number she provided during call.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests, Deafness, Tinnitus
Clinical narrative: hearing loss; ringing in ears; This case was reported by a pharmacist via call center representative and described the occurrence of hearing loss in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 4749N, expiry date 14th November 2021) for prophylaxis.   On 17th March 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, couple of weeks after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant) and ringing in ears. On an unknown date, the outcome of the hearing loss was not recovered/not resolved and the outcome of the ringing in ears was unknown.   It was unknown if the reporter considered the hearing loss and ringing in ears to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. After receiving Shingrix, the patient had hearing loss that occurred weeks after the injection.  The patient also had ringing in ears but did not know when this occurred after the injection or if it was still ongoing till the time of reporting for the patient.  The patient had a baseline hearing test done in December 2019.  The reporter did not consent to follow-up.
Age: 7.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Syncope
Clinical narrative: SYNCOPE AND COLLAPSE
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Chest X-ray normal, Pyrexia, Rash, SARS-CoV-2 test negative, Urine analysis normal
Clinical narrative: 7/29/2020  pt went to the ER with fever and rash on face, torso, and legs
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Vaccination complication
Clinical narrative: Patient came to clinic on 8/13/20 with c/o reaction to vaccine injections given on 8/11/20. Both vaccines where given in the right deltoid. I observed a red raised band around upper right arm about 2 in below shoulder extending to just 2 in above elbow.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: RECEIVED THE VACCINE ON 07/21/2020 STARTED RUNNING A FEVER ON 07/24/2020 WAS SEEN IN OFFICE ON 07/31/2020 WITH FEVER AND RASH ON FACE, TORSO, AND BACK.  THE RASH WAS SMALL RED BUMPS
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Pt awoke at 0200 on 8/13/20 with fever of 102.8F, redness on L arm at site of injection. Pt was given Ibuprofen and fever improved to 101F. Pt had redness and tenderness extending from injection site toward elbow.
Age: 36.0
Sex: M
Vaccine: RAB
Symptoms: Fatigue, Headache, Injection site pain, Pyrexia, Rash
Clinical narrative: On 08/11/20, the donor called the center to disclose that he thought he might be having a reaction to the Rabies booster that he received on 08/10/20.  He stated that he felt fine upon leaving the center.  However, later that evening, he began to experience soreness of his left arm at the injection site, fatigue, headache, a localized rash on his chest, and a fever of 102 degrees Fahrenheit. He stated that the only symptoms he was experience on 08/11/20 included left arm soreness at the injection site and the localized rash on his chest.  He stated his rash had not spread beyond his chest.  He denied any difficulty breathing or swallowing. On 08/12/20, the donor contacted the center and stated that all signs and symptoms had resolved except the rash.
Age: 41.0
Sex: F
Vaccine: RAB
Symptoms: Pruritus, Urticaria
Clinical narrative: On 08/12/20, the donor called the center to disclose that she believed she was having a reaction to her Rabies booster shot that was given to her at the center on 08/10/20.  She stated that she felt fine the day of the booster but then on 08/11/20, she noticed hives covering both of her ankles.  As the day progressed, the hives spread to her entire body.  As of 08/12/20, the hives/itching did not subside.  The donor denied difficulty breathing/swallowing and denied any other symptoms.  Donor did not seek medical treatment.
Sex: M
Vaccine: VARZOS
Symptoms: Therapeutic response decreased
Clinical narrative: lost efficiency; This case was reported by a consumer via other manufacturer and described the occurrence of therapeutic response decreased in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included prostatic disorder (Prostate issue). Concurrent medical conditions included blood pressure high. Concomitant products included finasteride, metoprolol and prednisone.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after starting finasteride, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had lost of efficiency. The permission to follow up was denied.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Shingles; Shingrix vaccine 2 plus ago with no booster/ It was an oversight on my physicians part.; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult 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, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, however the age group captured as Adult as per vaccine indication. The patient received 1st dose of Shingrix more than 2 years prior to the reporting. After that patient did not received 2nd dose due to physician's oversight which led to incomplete course of vaccination. After 1st dose, in March, the patient developed shingles. At the time of report, the patient enquiring that if they need to restart the schedule. The reporter declined consent for follow up.
Sex: U
Vaccine: MENB
Symptoms: Fatigue, Pain
Clinical narrative: Fatigue; General aches and pains; This case was reported by a other health professional via sales rep and described the occurrence of fatigue in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced fatigue and general body pain. On an unknown date, the outcome of the fatigue and general body pain were unknown.   It was unknown if the reporter considered the fatigue and general body pain to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero vaccine and experienced fatigue, general aches and pains.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Underdose
Clinical narrative: some blood came out the injection site; she could received 95% of the dose; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 64-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number BR352, expiry date 27th August 2022) for prophylaxis.   On 3rd August 2020, the patient received Boostrix. On 3rd August 2020, immediately after receiving Boostrix, the patient experienced injection site hemorrhage and accidental underdose. On an unknown date, the outcome of the injection site hemorrhage and accidental underdose were unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to Boostrix.  Additional information was provided as follows: The patient received Boostrix vaccine and some blood came out the injection site so the patient was concern about not received the full dose. She believed that she could received 95 percent of the dose, which led to accidental underdose. The reporter consented to follow up. No further information provided.
Age: 27.0
Sex: M
Vaccine: RAB
Symptoms: Hypoaesthesia, Inappropriate schedule of product administration, Pain in extremity, Paraesthesia
Clinical narrative: Numbness; Tingling / Tingling down his legs; Painful calves; Second shot two weeks later; This case was reported by a consumer via call center representative and described the occurrence of numbness in a 27-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Previously administered products included RabAvert (For 1st dose refer case US2020AMR153824).   On an unknown date, the patient received the 2nd dose of RabAvert. On an unknown date, less than 2 weeks after receiving RabAvert, the patient experienced numbness, tingling, pain in calf and drug dose administration interval too long. On an unknown date, the outcome of the numbness, tingling, pain in calf and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the numbness, tingling and pain in calf to be related to RabAvert.  Additional details were reported as follows: The patient received Rabavert for post-exposure prophylaxis. The reporter was patient's the mother. The patient received 2nd dose two weeks later after 1st dose in left arm and he experienced tingling and numbness, tingling down his legs and painful calves. The patient received 3rd dose refer case US2020AMR153823.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR153824:same patient
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dry mouth, Fatigue, Incomplete course of vaccination, Lichen planus, Pain in extremity
Clinical narrative: She states it has been past 6 months and she has not received the second vaccine yet.; she developed an "erosive lichens planus"; Dry mouth; Tiredness; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On 7th February 2020, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and tiredness. On 27th February 2020, the patient experienced erosive lichen planus and dry mouth. On an unknown date, the patient experienced incomplete course of vaccination. On 10th August 2020, the outcome of the erosive lichen planus and dry mouth were not recovered/not resolved. On an unknown date, the outcome of the pain in arm and tiredness were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm, erosive lichen planus, dry mouth and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose. The age at vaccination was not applicable for 2nd dose. The patient received Shingrix and had a sore arm and tiredness that eventually went away and about 3 weeks after the vaccine, she developed an erosive lichens planus on her lip diagnosed by an oral surgeon and it still was not completely healed.  The patient also reported having a dry mouth as well.  The reporter stated it had been past 6 months and she has not received the second vaccine yet, which led to incomplete course of vaccination. The reporter did not consent to follow up and declined to provide HCP information.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash papular
Clinical narrative: Bumps around her waist and in-between her fingers; This case was reported by a pharmacist via call center representative and described the occurrence of papular rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced papular rash. On an unknown date, the outcome of the papular rash was not recovered/not resolved.   It was unknown if the reporter considered the papular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the Shingrix, the patient returned to the pharmacy reporting bumps around her waist and in-between her fingers. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: tinnitus; This case was reported by a pharmacist via call center representative and described the occurrence of tinnitus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was unknown.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional case details were reported as follows: The age at the vaccination was not reported. The patient received the dose seven or eight months ago. The patient stated that at some time after dose the patient started having tinnitus, and it had not yet resolved. The patient had not yet received dose two of Shingrix. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cardiovascular disorder, Fatigue, Incomplete course of vaccination
Clinical narrative: cardiovascular stress; fatigue; incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of cardiovascular disorder in a 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, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced cardiovascular disorder, fatigue and incomplete course of vaccination. On an unknown date, the outcome of the cardiovascular disorder, fatigue and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the cardiovascular disorder and fatigue to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. In 2019, the patient received 1st dose of Shingrix and expected cardiovascular stress and fatigue. The patient had not received his second shot yet, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: with pain down arm and in shoulder; pain down arm / ache arm / almost as painful without a breakout on her skin; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in left arm 6 months ago). Previously administered products included Cold sore (One cold sore in life).   On an unknown date, the patient received Shingrix. In July 2020, less than 2 weeks after receiving Shingrix, the patient experienced shoulder pain and pain in arm. The patient was treated with non-drug therapy (Cold Compresses). On an unknown date, the outcome of the shoulder pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had only having one cold sore ever in life. The patient reported having shingles in her left arm 6 months ago and that the pain she was experiencing now was almost as painful without a breakout on her skin. Two weeks ago, the patient received Shingrix and still suffering with pain down arm and in shoulder where Shingrix was administered. The pain described as shooting but mostly an ache. The patient reported using cold compresses and pain medication.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure increased, Heart rate abnormal, Injection site pain
Clinical narrative: with pain down arm and in shoulder; pain down arm / ache arm / almost as painful without a breakout on her skin; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in left arm 6 months ago). Previously administered products included Cold sore (One cold sore in life).   On an unknown date, the patient received Shingrix. In July 2020, less than 2 weeks after receiving Shingrix, the patient experienced shoulder pain and pain in arm. The patient was treated with non-drug therapy (Cold Compresses). On an unknown date, the outcome of the shoulder pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had only having one cold sore ever in life. The patient reported having shingles in her left arm 6 months ago and that the pain she was experiencing now was almost as painful without a breakout on her skin. Two weeks ago, the patient received Shingrix and still suffering with pain down arm and in shoulder where Shingrix was administered. The pain described as shooting but mostly an ache. The patient reported using cold compresses and pain medication.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Irritability, Rotavirus test positive
Clinical narrative: Diarreha . Fussy. Stool positive for rotavirus
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness, swelling, pain, hot to touch- ongoing
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Parotitis, Pyrexia, Swelling face
Clinical narrative: fever, facial swelling - acute parotitis
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Nausea, Nervousness, Pallor
Clinical narrative: Nursing was called to the lobby. Patient had been seen by a provider for a well-child visit and received three vaccines. Mother reports that while waiting for the elevator after the visit patient was nauseous. Patient and mother went to the restroom instead of getting on the elevator. Nurses found patient kneeling in front of a toilet. She appeared pale and shaky. Nursing took her back to a patient exam room by wheelchair and observed her, checked her vitals which were all within normal limits, gave her juice and graham crackers. Patient had not eaten breakfast this morning and was anxious for her vaccines today.   Provider and team manager evaluated the patient. Patient's vitals remained within normal limits and she was dismissed home with mother.
Age: 31.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Pediatric dose given to patient instead of adult dose.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Pyrexia
Clinical narrative: Fever and chills. Ended up going to bed the next night very early. Feeling better now on the 2nd day
Age: 57.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Chills and Fever 37.7 Celsius. Nausea for 8 hours beginning 10 pm. Vomiting x 1 at 3 am.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient fainted right after the HPV vaccine was given(patient was sitting down). I raised patient's legs, applied ice pack to her neck and head, patient came back right away. Cold water and a chocolate bar was given to her to help with her symptoms. I observed patient for about 40 minutes. Patient left the clinic accompanied by mom feeling well.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Hypoaesthesia, Injection site erythema, Injection site swelling, Paraesthesia
Clinical narrative: Large reddened and swollen area around injection site, Headache, numbness and tingling
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient reported a 1 inch by 3 inch red "line" about a few inches underneath the site of injection that is very warm to the touch and slightly painful
Sex: U
Vaccine: HEPA, MMR, MMRV, RV5, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; The nurse reported improperly stored doses of ROTATEQ, VAQTA, MMRII, PROQUAD and VARIVAX since 23-JUL-2020; This non-valid spontaneous report was received from a nurse and was referring to an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitants medications were not reported.  Since 23-JUL-2020, unspecified number of patients were vaccinated for prophylaxis with improperly stored doses of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot number: S024844 and expiration date: 01-APR-2021); with Hepatitis A Vaccine, Inactivated (VAQTA) (lot number: S037574 and expiration date: 10-APR-2021); with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot number: S035110 and expiration date: 03-MAY-2021, and lot number: S035105 and expiration date: 03-MAY-2021); with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot number: S035354 and expiration date: 05-NOV-2021); and with varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number: T000341 and expiration date: 05-JAN-2022, and lot number: T002843 and expiration date: 23-JAN-2022). Dosage regimen, route of administration and anatomical location were not reported).   The improperly stored of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), Hepatitis A Vaccine, Inactivated (VAQTA), Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced a temperature of 0.2 C in the freezer and 11.9 C in the refrigerator for 4 hours and 20 minutes, without a previous temperature excursion and was call because a digital data logger. No additional adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S037574; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 27.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Hypoaesthesia, Inappropriate schedule of product administration, Incomplete course of vaccination, Pain in extremity, Paraesthesia
Clinical narrative: Numbness; Tingling / Tingling down his legs; Painful calves; incomplete course of vaccination; Drug dose interval too long; This case was reported by a consumer via call center representative and described the occurrence of numbness in a 27-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included Rabies NVS (RabAvert) for prophylaxis.   Previously administered products included RabAvert (For 1st dose refer caseUS2020AMR153824 ) and RabAvert (for 2nd dose refer case US2020152664).   On an unknown date, the patient received the 3rd dose of RabAvert and the 4th dose of RabAvert. On an unknown date, less than 2 weeks after receiving RabAvert and not applicable after receiving RabAvert, the patient experienced numbness, tingling, pain in calf, incomplete course of vaccination and drug dose administration interval too long. On an unknown date, the outcome of the numbness, tingling, pain in calf, incomplete course of vaccination and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the numbness, tingling and pain in calf to be related to RabAvert.  Additional details were reported as follows: The reporter was patient's the mother. The patient received Rabavert for post-exposure prophylaxis. The patient received 3rd dose one week later after 2nd dose on right arm which led to drug dose administration interval too long and he experinced tingling, numbness, tingling down his legs and painful calves. At the time of reporting the was due for 4th dose  but till the time was not received which led to incomplete course of vaccination.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR153824:same patient
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Axillary pain, Loss of personal independence in daily activities, Mobility decreased, Nerve injury, Neuralgia
Clinical narrative: I still have a small rash on my back; still in pain.; still unable to sit; sleep comfortable; Not able to do anything; nerve damage/nerve pain in left arm  and armpit; Nerve pain; nerve damage/nerve pain in left arm  and armpit; nerve damage/nerve pain in left arm  and armpit; This case was reported by a consumer via call center representative and described the occurrence of nerve damage in a 73-year-old patient who received Herpes zoster (Shingrix) (batch number YM74C, expiry date 8th March 2022) for prophylaxis.   On 22nd July 2020, the patient received Shingrix. On 22nd July 2020, less than a day after receiving Shingrix, the patient experienced nerve damage, nerve pain, axillary pain and pain in arm. On an unknown date, the patient experienced rash, pain, mobility decreased, sleep disorder and activities of daily living impaired. On an unknown date, the outcome of the nerve damage, nerve pain, pain and sleep disorder were not recovered/not resolved and the outcome of the axillary pain, pain in arm, rash, mobility decreased and activities of daily living impaired were unknown.   The reporter considered the nerve damage, nerve pain, axillary pain, pain in arm, rash, pain, mobility decreased, sleep disorder and activities of daily living impaired to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and had terrible reactions which included nerve damage and pain in left arm and armpit. The patient also developed rash on her back and nerve pain. The patient visited emergency room for this and was on IV, The patient was unable to sit or sleep comfortably. The patient had a small business and was not able to help husband due to this. The reporter consented for follow up.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Rash, Sleep disorder
Clinical narrative: I still have a small rash on my back; still in pain.; still unable to sit; sleep comfortable; Not able to do anything; nerve damage/nerve pain in left arm  and armpit; Nerve pain; nerve damage/nerve pain in left arm  and armpit; nerve damage/nerve pain in left arm  and armpit; This case was reported by a consumer via call center representative and described the occurrence of nerve damage in a 73-year-old patient who received Herpes zoster (Shingrix) (batch number YM74C, expiry date 8th March 2022) for prophylaxis.   On 22nd July 2020, the patient received Shingrix. On 22nd July 2020, less than a day after receiving Shingrix, the patient experienced nerve damage, nerve pain, axillary pain and pain in arm. On an unknown date, the patient experienced rash, pain, mobility decreased, sleep disorder and activities of daily living impaired. On an unknown date, the outcome of the nerve damage, nerve pain, pain and sleep disorder were not recovered/not resolved and the outcome of the axillary pain, pain in arm, rash, mobility decreased and activities of daily living impaired were unknown.   The reporter considered the nerve damage, nerve pain, axillary pain, pain in arm, rash, pain, mobility decreased, sleep disorder and activities of daily living impaired to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and had terrible reactions which included nerve damage and pain in left arm and armpit. The patient also developed rash on her back and nerve pain. The patient visited emergency room for this and was on IV, The patient was unable to sit or sleep comfortably. The patient had a small business and was not able to help husband due to this. The reporter consented for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This case was reported by a consumer via call center representative and described the occurrence of sore throat in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sore throat. On an unknown date, the outcome of the sore throat was not recovered/not resolved.   It was unknown if the reporter considered the sore throat to be related to Shingrix.  Additional information was received as follows: The age at the vaccination was not reported. The patient received Shingrix and experienced sore throat. The patient wanted to know whether sore throat a possible side effect of Shingrix.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Heart rate increased, Injection site mass
Clinical narrative: swollen knot at the injection site; Aching; Hot Injection Site; swollen knot at the injection site; pulse elevated to 204 from 60/Elevated Pulse; Weak; Dizzy; Shivering Uncontrollably; This case was reported by a consumer via call center representative and described the occurrence of pulse increased in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2020, the patient received the 1st dose of Shingrix. On 28th July 2020, less than a day after receiving Shingrix, the patient experienced pulse increased, weakness, dizziness and shivering. On an unknown date, the patient experienced injection site swelling, pain, injection site warmth and injection site mass. On an unknown date, the outcome of the pulse increased, weakness, dizziness, shivering, injection site swelling and pain were recovered/resolved and the outcome of the injection site warmth was resolved with sequelae and the outcome of the injection site mass was unknown.   It was unknown if the reporter considered the pulse increased, weakness, dizziness, shivering, injection site swelling, pain, injection site warmth and injection site mass to be related to Shingrix.  Additional case details were reported as follows: On 28th July 2020, the patient experienced within 24 hours pulse elevated to 204 from 60 and that he was weak, dizzy and shivering uncontrollably.  The caller stated that his pharmacist stated that the Shingrix caused it and that his physician told him not to get the second injection.  He also stated that these symptoms were accompanied by a swollen knot at the injection site and aching with all the symptoms lasting 24 to 48 hours but that he was no longer having symptoms.  This case has been linked with case US2020154019, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020154019:same reporter
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: swollen knot at the injection site; Aching; Hot Injection Site; swollen knot at the injection site; pulse elevated to 204 from 60/Elevated Pulse; Weak; Dizzy; Shivering Uncontrollably; This case was reported by a consumer via call center representative and described the occurrence of pulse increased in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2020, the patient received the 1st dose of Shingrix. On 28th July 2020, less than a day after receiving Shingrix, the patient experienced pulse increased, weakness, dizziness and shivering. On an unknown date, the patient experienced injection site swelling, pain, injection site warmth and injection site mass. On an unknown date, the outcome of the pulse increased, weakness, dizziness, shivering, injection site swelling and pain were recovered/resolved and the outcome of the injection site warmth was resolved with sequelae and the outcome of the injection site mass was unknown.   It was unknown if the reporter considered the pulse increased, weakness, dizziness, shivering, injection site swelling, pain, injection site warmth and injection site mass to be related to Shingrix.  Additional case details were reported as follows: On 28th July 2020, the patient experienced within 24 hours pulse elevated to 204 from 60 and that he was weak, dizzy and shivering uncontrollably.  The caller stated that his pharmacist stated that the Shingrix caused it and that his physician told him not to get the second injection.  He also stated that these symptoms were accompanied by a swollen knot at the injection site and aching with all the symptoms lasting 24 to 48 hours but that he was no longer having symptoms.  This case has been linked with case US2020154019, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020154019:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: didn't feel well; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and did not feel well for 24 hours, after the 24 hours period, she felt fine. The reporter consented to follow up. For tolerance after 2nd dose refer case US2020AMR157704.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020156568:same reporter US-GLAXOSMITHKLINE-US2020AMR157704:same patient