chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: redness at injection site; injection site pain/Injection site tenderness; pain; difficulty in moving her shoulder; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, less than 2 months after receiving Bexsero, the patient experienced pain in arm, shoulder discomfort, injection site erythema and injection site pain. On an unknown date, the outcome of the pain in arm, shoulder discomfort, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the pain in arm, shoulder discomfort, injection site erythema and injection site pain to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero vaccine a month ago and experienced pain in her arm and difficulty in moving her shoulder that lasted for about two weeks and experienced pain to touch and redness at injection site for a couple of days. The reporter did not consent to follow up. Provided information on dosing scheduled and side effects from PI.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became enlarged; Injection site became red; Injection site became inflammed; Injection site became hot to the touch; Injection site became tender, and sore; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 28th January 2020, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site inflammation, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site inflammation, injection site warmth and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site inflammation, injection site warmth and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and injection site became enlarged, red, and inflamed, hot to the touch, tender, and sore. No flu-like symptoms occurred The reporter stated their HCP was not aware of the reactions. The reporter consented to follow up. Not all information was available.  The reporter gave permission to follow up with HCP.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered in wrong device, Injection site erythema, Injection site swelling
Clinical narrative: redness at the injection site; swelling at the injection site; administered the vaccines using a TB sized syringe; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and drug administered in wrong device. On an unknown date, the outcome of the injection site erythema, injection site swelling and drug administered in wrong device were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix on either 23rd July 2020 or 24th July 2020.  The patient reported that registered pharmacist administered the vaccines using a TB sized syringe, and also reported having redness and swelling at the injection site.  The reporter did not consent to follow up. No additional information was provided.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Pain in extremity
Clinical narrative: soreness in her left arm; Tiredness; Joint pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th June 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm, tiredness and joint pain. On 13th June 2020, the outcome of the pain in arm was not recovered/not resolved. On 29th July 2020, the outcome of the tiredness and joint pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, tiredness and joint pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and experiencing joint pain, tiredness and soreness.  The reporter wanted to know if she should get the 2nd injection.   The provided medical disclaimer and referred her to her HCP. The reporter did not consent to follow up. Limited information obtained.   Caller did not provide demographics.   No LOT or EXP date was available.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Erythema, Fatigue, Headache
Clinical narrative: chills; headache; fever 103 F; red, swollen arm; tiredness and fatigue; unsure" if patient developed a cough; red swollen arm; This case was reported by a other health professional via call center representative and described the occurrence of chills in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 57EX2, expiry date 26th March 2022) for prophylaxis.   On 24th July 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th July 2020, 1 days after receiving Shingrix, the patient experienced chills, headache, fever, swelling arm, fatigue, cough and erythema of extremities. On 28th July 2020, the outcome of the chills, headache, fever, swelling arm, fatigue and cough were recovered/resolved and the outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the chills, headache, fever, swelling arm, fatigue, cough and erythema of extremities to be related to Shingrix.  Additional case details were reported as follows: The patient experienced chills, headache, fever of 103 degrees F, red swollen arm, tiredness and fatigue. She stated that the patient might have developed a cough at this time, but not documented in their chart.  She states that all these symptoms resolved on 28th July 2020. The reporter consent to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: chills; headache; fever 103 F; red, swollen arm; tiredness and fatigue; unsure" if patient developed a cough; red swollen arm; This case was reported by a other health professional via call center representative and described the occurrence of chills in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 57EX2, expiry date 26th March 2022) for prophylaxis.   On 24th July 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th July 2020, 1 days after receiving Shingrix, the patient experienced chills, headache, fever, swelling arm, fatigue, cough and erythema of extremities. On 28th July 2020, the outcome of the chills, headache, fever, swelling arm, fatigue and cough were recovered/resolved and the outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the chills, headache, fever, swelling arm, fatigue, cough and erythema of extremities to be related to Shingrix.  Additional case details were reported as follows: The patient experienced chills, headache, fever of 103 degrees F, red swollen arm, tiredness and fatigue. She stated that the patient might have developed a cough at this time, but not documented in their chart.  She states that all these symptoms resolved on 28th July 2020. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: itching in her arm; 2 blisters below the injection site near her elbow.; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2020).   On 20th July 2020, the patient received the 2nd dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced blister. On 20th July 2020, the patient experienced pruritus. On an unknown date, the outcome of the pruritus and blister were not recovered/not resolved.   It was unknown if the reporter considered the pruritus and blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and developed itching in her arm and 2 blisters below the injection site, near her elbow.   The events were ongoing. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Myalgia, Pain in extremity, Somnolence
Clinical narrative: Muscle was very sore; Arm was very sore; Lethargic; Slept a lot; This case was reported by a consumer via call center representative and described the occurrence of muscle soreness 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 a day after receiving Shingrix, the patient experienced muscle soreness, pain in arm, lethargy and sleepiness. On an unknown date, the outcome of the muscle soreness, pain in arm, lethargy and sleepiness were unknown.   It was unknown if the reporter considered the muscle soreness, pain in arm, lethargy and sleepiness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Reporter states that she got the injection during the evening and symptoms started the next morning. The patient received Shingrix 3 months ago and her arm was very sore, and the muscle was very sore. The patient was lethargic and slept a lot following that day for most of the week, like 3 to 5 days. The reporter asked are these side effects normal or abnormal. The reporter did not consent to follow up. Lot and expiration date were not requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Flank pain, Musculoskeletal chest pain
Clinical narrative: sharp pain in my rib cage; Flank pain; This case was reported by a consumer via call center representative and described the occurrence of rib pain in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th May 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced rib pain and flank pain. On an unknown date, the outcome of the rib pain and flank pain were recovered/resolved.   It was unknown if the reporter considered the rib pain and flank pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient.  The patient received Shingrix in the left arm and had this sharp pain in my rib cage inside the right flank.  The pain started with the first dose and it never went away. The patient never had a pain like this before and then it subsided. The reporter consented to follow up. Lot Number and Expiry date was unknown but patient stated that he got the injections at his pharmacy and they have this information. For tolerances of 2nd dose, refer case US2020AMR148295, reported by same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR148295:same reporter
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Suspected case of shingles; Rash developed on his face; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date unknown) for prophylaxis.   The patient's past medical history included shingles (mild outbreak).   On 29th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles was unknown and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: After receiving the 1st dose of Shingrix, the patient developed Shingles.  The patient reported that, the rash developed on his face on the side opposite of his previous shingles. outbreak. The rash resolved in one week. The reporter was consented to follow up.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Granuloma, Mobility decreased, Pain
Clinical narrative: 2cm granuloma, still persistent at day 8. Prescribed NSAID, topical steroid, warm compress. Child in significant pain and limited use of arm
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Hives from L shoulder to L elbow, hot to touch, red
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Allergy test negative, Blood test normal, Carbohydrate antigen 125 normal, Colonoscopy normal
Clinical narrative: Abdominal pain, burping, slight nausea, fatigue, somewhat looser bowel movements, bad taste on tongue, began 3 days after first Shingrix vaccination.  Went away after a month and a half.  Recurred day after second Shingrix vaccination.  Recurred June, 2020, ongoging.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Diarrhoea, Endoscopy normal, Eructation, Fatigue
Clinical narrative: Abdominal pain, burping, slight nausea, fatigue, somewhat looser bowel movements, bad taste on tongue, began 3 days after first Shingrix vaccination.  Went away after a month and a half.  Recurred day after second Shingrix vaccination.  Recurred June, 2020, ongoging.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Scan with contrast normal, Taste disorder
Clinical narrative: Abdominal pain, burping, slight nausea, fatigue, somewhat looser bowel movements, bad taste on tongue, began 3 days after first Shingrix vaccination.  Went away after a month and a half.  Recurred day after second Shingrix vaccination.  Recurred June, 2020, ongoging.
Age: 22.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Dyspnoea, Hypersensitivity, Throat tightness
Clinical narrative: 1509 Patient stated she felt like her throat was getting tight. Patient was escorted to the exam room and assisted to the table. Patient stated her throat  was getting tighter.  1512  .3mg of epi IM was administered to the right thigh. BP 130/94 pulse 101, resp. 16.  1518 EMS arrived and took over care after report was given.
Age: 12.0
Sex: M
Vaccine: HEPA, HEPA, TDAP
Symptoms: Dizziness, Dyspnoea, Injection site erythema, Injection site pain, Syncope
Clinical narrative: Syncope, vomiting, dizziness, shortness of breath, redness and soreness at injection site
Age: 12.0
Sex: M
Vaccine: HEPA, HEPA, TDAP
Symptoms: Vomiting
Clinical narrative: Syncope, vomiting, dizziness, shortness of breath, redness and soreness at injection site
Age: 12.0
Sex: M
Vaccine: HEPA, HEPA, TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Vomiting
Clinical narrative: Syncope, vomiting, dizziness, shortness of breath, redness and soreness at injection site
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Cold sweat, Decreased appetite, Fatigue, Hypersensitivity
Clinical narrative: Symptom that created concern is in right arm. Received two vaccines on July 31, 2020: penumovax 23 and shingrix.  Confirming that one was administered in right arm and the other in left. When contacted, the pharmacy had recorded both were administered in left arm. Pharmacist remembered administering Shingrix in left arm for right-handed person citing possible stronger reaction. Symptoms: normal soreness at both injection sites, chills (3 days - temperature was normal throughout), loss of appetite, nausea, fatigue (2 days), red splotches on inside of right arm on bicep appeared Aug. 2. Early Aug. 3, patient awoke in pool of cold sweat, but symptoms including chills had receded. Temperature was still normal. Aug. 3, the rash had spread from right should along inner arm to elbow. It was red, smooth, hot to the touch, painful (could not raise arm without pain) and slightly itchy. During urgent care visit, physician said it looked like an allergic reaction, not an infection, and recommended over-the-counter antihistamine. Aug. 4, patient again awoke in a pool of cold sweat.  The rash was slightly less angry, warm - not hot  - to the touch and slightly itchy. Only other remaining symptom: loss of appetite still not completely resolved.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Nausea, Pain, Pruritus, Rash macular
Clinical narrative: Symptom that created concern is in right arm. Received two vaccines on July 31, 2020: penumovax 23 and shingrix.  Confirming that one was administered in right arm and the other in left. When contacted, the pharmacy had recorded both were administered in left arm. Pharmacist remembered administering Shingrix in left arm for right-handed person citing possible stronger reaction. Symptoms: normal soreness at both injection sites, chills (3 days - temperature was normal throughout), loss of appetite, nausea, fatigue (2 days), red splotches on inside of right arm on bicep appeared Aug. 2. Early Aug. 3, patient awoke in pool of cold sweat, but symptoms including chills had receded. Temperature was still normal. Aug. 3, the rash had spread from right should along inner arm to elbow. It was red, smooth, hot to the touch, painful (could not raise arm without pain) and slightly itchy. During urgent care visit, physician said it looked like an allergic reaction, not an infection, and recommended over-the-counter antihistamine. Aug. 4, patient again awoke in a pool of cold sweat.  The rash was slightly less angry, warm - not hot  - to the touch and slightly itchy. Only other remaining symptom: loss of appetite still not completely resolved.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Symptom that created concern is in right arm. Received two vaccines on July 31, 2020: penumovax 23 and shingrix.  Confirming that one was administered in right arm and the other in left. When contacted, the pharmacy had recorded both were administered in left arm. Pharmacist remembered administering Shingrix in left arm for right-handed person citing possible stronger reaction. Symptoms: normal soreness at both injection sites, chills (3 days - temperature was normal throughout), loss of appetite, nausea, fatigue (2 days), red splotches on inside of right arm on bicep appeared Aug. 2. Early Aug. 3, patient awoke in pool of cold sweat, but symptoms including chills had receded. Temperature was still normal. Aug. 3, the rash had spread from right should along inner arm to elbow. It was red, smooth, hot to the touch, painful (could not raise arm without pain) and slightly itchy. During urgent care visit, physician said it looked like an allergic reaction, not an infection, and recommended over-the-counter antihistamine. Aug. 4, patient again awoke in a pool of cold sweat.  The rash was slightly less angry, warm - not hot  - to the touch and slightly itchy. Only other remaining symptom: loss of appetite still not completely resolved.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: 2 months of arm pain that neuropathic in nature after shingrix vaccine was given
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site urticaria, Rash pruritic, Urticaria
Clinical narrative: itchy bumps/hives on arms around injection site, left and right arms, left and right legs on knees and behind knees, chest, belly, neck, back
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Hypotonia
Clinical narrative: Patient was given two vaccines back to back and after vaccines were administered he came over with a  "glazed" look and went limp. He came to after a minute and was observed for 20 minutes and check out by the provider who saw him earlier. After observation period patient was back to normal.
Age: 18.0
Sex: F
Vaccine: MENB, TD
Symptoms: Chills, Decreased appetite, Fatigue, Nausea, Pain in extremity
Clinical narrative: 6/16/2020 - Patient called the office to report that starting on 6/15/2020 at 6:30pm she was experiencing nausea, left arm pain, fatigue and chills. Patient called the office again on 6/18/2020 having the same symptoms, along with a headache and felt very hot (temp not taken). Patient also reported tenderness to the touch and left arm very sore if she put arm over her head and also decreased appetite. Patient was advised to make an appointment to see the doctor. Patient was seen by Dr. on 6/18/2020 and diagnosed with Vaccine Reaction and Left arm pain. Per the patient, chills had improved, but still having other symptoms. patient was advised to take Ibuprofen q 8hrs and Zofran q 8hrs prn. The adverse Event stopped on 6/24/2020
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Myalgia, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: High fever within hours, chills, muscle aches, very sore arm progressing up the side of my neck.  Fever is back again today.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest X-ray normal, Diarrhoea, Fatigue, SARS-CoV-2 test negative
Clinical narrative: Long term side effects including fatigue, loose stool. More than six weeks.   Irresponsible to adminsiter Shingex to an individual who may have been exposed to COVID in the six months or year prior.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Vaccine was given at a different location.  Given at a Pharmacy.  We just gave aftercare for reaction.  Pt had rash all over body and fever.   Given Prednisone.  Still waiting to see recovery results.
Age: 75.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Herpes zoster
Clinical narrative: PATIENT BROKE OUT WITH SHINGLES RASH ON FACE SEVERAL DAYS AFTER RECEIVING SHINGRIX IMMUNIZATION.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV, TDAP, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Pain in extremity, Skin warm
Clinical narrative: Both arms have been red, painful, and warm to the touch since a few minutes after the injections.  3 days later, the sites are still red and painful.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; patient was administered an improperly stored VARIVAX; This spontaneous report as received from an insurance manager in charge of vaccine storage and refers to a patient of unknown age and gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 16-JUL-2020, the patient received a dose of an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot # reported as S009753 (upon internal validation was determined to be non-valid for this vaccine), expiration date reported as 27-SEP-2020, for prophylaxis (strength, number of dose, dose, route of administration and frequency were not reported). The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) underwent a temperature excursion on 09-JUL-2020 in the range 15 degrees of Fahrenheit (F) to 46 F (32.9 F) for 2 hours and 11 minutes. There was a previous temperature excursion on 03-JUL-2020 in the range 15 F to 46 F (22.3 F) for 3 hours and 24 minutes Digital data logger was not involved. No additional adverse events reported. No product quality complain (PQC) involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; Nurse reports that "on 7/27/2020 a patient was administered an improperly stored dose of PROQUAD"; This spontaneous report as received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On 27-JUL-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dosage regimen was not provided), lot # T001187, expiration date: 11-JUL-2021, administered subcutaneously as prophylaxis. The vaccine was administered with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # S038697 and expiration date 10-AUG-2022).  The improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced a temperature of 28.4 degree Fahrenheit (°F) , for a 6 hours and 38 minutes time frame. The vaccine was not exposed to any previous temperature excursions and the call was made due to a data logger. The patient did not experience any symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Arm became swollen; This case was reported by a consumer via other manufacturer and described the occurrence of swelling arm in a adult 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 swelling arm. On an unknown date, the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. Consumer reported an unspecified patient received a dose of Shingrix arm became swollen. This case is one of the 3 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR145802:same reporter US-GLAXOSMITHKLINE-US2020AMR145811:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Headache; Muscle aches; Chills and shivers; This case was reported by a pharmacist via sales rep and described the occurrence of chills in a adult male 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 chills, headache and muscle pain. On an unknown date, the outcome of the chills, headache and muscle pain were recovered/resolved.   It was unknown if the reporter considered the chills, headache and muscle pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but patient was less than 60 years old at the time of reporting.  The patient received Shingrix and experienced chills and shivers lasting for 24 hours after the vaccine. Also experienced headache and muscle aches.
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Back pain, Throat irritation
Clinical narrative: throat tickling; knee pain; slight back pain; This case was reported by a consumer via call center representative and described the occurrence of throat irritation in a 64-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   The patient's past medical history included animal bite. Previously administered products included Rabavert with an associated reaction of arthralgia (1st dose received on unknown, please refer the case US2020146787). Concurrent medical conditions included diabetes. Concomitant products included warfarin, immunoglobulin human normal (Gamma Globulin), paracetamol (Tylenol) and benadryl (nos) (Benadryl).   On an unknown date, the patient received the 2nd dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced throat irritation, knee pain and back pain. On an unknown date, the outcome of the throat irritation was recovered/resolved and the outcome of the knee pain and back pain were not recovered/not resolved.   It was unknown if the reporter considered the throat irritation, knee pain and back pain to be related to RabAvert.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated with every Rabavert shot he experiences throat tickling which goes away after a day.  The patient experienced ongoing knee pain and ongoing slight back pain.  The reporter consent to follow up. This is 2 of 5 case reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020146787: US-GLAXOSMITHKLINE-US2020AMR148391: US-GLAXOSMITHKLINE-US2020AMR148392: US-GLAXOSMITHKLINE-US2020AMR148393:
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Back pain, Throat irritation
Clinical narrative: knee pain; slight back pain; throat tickling; This case was reported by a consumer via call center representative and described the occurrence of throat irritation in a 64-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   The patient's past medical history included animal bite. Previously administered products included Rabavert (1st dose received on unknown, please refer the case US2020146787) and Rabavert (2nd dose received on unknown, please refer the case US2020AMR148390). Concurrent medical conditions included diabetes. Concomitant products included warfarin, immunoglobulin human normal (Gamma Globulin), paracetamol (Tylenol) and benadryl (nos) (Benadryl).   On an unknown date, the patient received the 3rd dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced throat irritation, knee pain and back pain. On an unknown date, the outcome of the throat irritation was recovered/resolved and the outcome of the knee pain and back pain were not recovered/not resolved.   It was unknown if the reporter considered the throat irritation, knee pain and back pain to be related to RabAvert.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated with every Rabavert shot he experiences throat tickling which goes away after a day.  The patient experienced ongoing knee pain and ongoing slight back pain.  The reporter consent to follow up. This is 3 of 5 case reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR148390:
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Back pain, Throat irritation
Clinical narrative: knee pain; slight back pain; throat tickling; This case was reported by a consumer via call center representative and described the occurrence of throat irritation in a 64-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   The patient's past medical history included animal bite. Previously administered products included Rabavert with an associated reaction of arthralgia (1st dose received on unknown, please refer the case US2020146787), Rabavert with an associated reaction of arthralgia (2nd dose received on unknown, please refer the case US2020AMR148390) and Rabavert with an associated reaction of arthralgia (3rd dose received on unknown, please refer the case US2020AMR148391). Concurrent medical conditions included diabetes. Concomitant products included warfarin, immunoglobulin human normal (Gamma Globulin), paracetamol (Tylenol) and benadryl (nos) (Benadryl).   On an unknown date, the patient received the 4th dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced throat irritation, knee pain and back pain. On an unknown date, the outcome of the throat irritation was recovered/resolved and the outcome of the knee pain and back pain were not recovered/not resolved.   It was unknown if the reporter considered the throat irritation, knee pain and back pain to be related to RabAvert.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated with every Rabavert shot he experiences throat tickling which goes away after a day.  The patient experienced ongoing knee pain and ongoing slight back pain.  The reporter consent to follow up. This is 4 of 5 case reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR148390:
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Back pain, Throat irritation
Clinical narrative: throat tickling; knee pain; slight back pain; This case was reported by a consumer via call center representative and described the occurrence of throat irritation in a 64-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   The patient's past medical history included animal bite. Previously administered products included Rabavert with an associated reaction of arthralgia (1st dose received on unknown, please refer the case US2020146787), Rabavert with an associated reaction of arthralgia (2nd dose received on unknown, please refer the case US2020AMR148390), Rabavert with an associated reaction of arthralgia (3rd dose received on unknown, please refer the case US2020AMR148391) and Rabavert with an associated reaction of arthralgia (4th dose received on unknown, please refer the case US2020AMR148392). Concurrent medical conditions included diabetes. Concomitant products included warfarin, immunoglobulin human normal (Gamma Globulin), paracetamol (Tylenol) and benadryl (nos) (Benadryl).   On an unknown date, the patient received the 5th dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced throat irritation, knee pain and back pain. On an unknown date, the outcome of the throat irritation was recovered/resolved and the outcome of the knee pain and back pain were not recovered/not resolved.   It was unknown if the reporter considered the throat irritation, knee pain and back pain to be related to RabAvert.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated with every Rabavert shot he experiences throat tickling which goes away after a day.  The patient experienced ongoing knee pain and ongoing slight back pain.  The reporter consent to follow up. This is 5 of 5 case reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR148390:
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hearing aid user, Hypoacusis, Influenza like illness, Tinnitus
Clinical narrative: 40% hearing loss; developed tinnitus; felt like he had the flu; chills; This case was reported by a consumer via call center representative and described the occurrence of partial hearing loss in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th June 2020, the patient received the 1st dose of Shingrix. On 10th June 2020, 2 days after receiving Shingrix, the patient experienced influenza like illness and chills. In June 2020, the patient experienced partial hearing loss and tinnitus. On an unknown date, the outcome of the partial hearing loss was unknown and the outcome of the tinnitus was not recovered/not resolved and the outcome of the influenza like illness and chills were recovered/resolved.   It was unknown if the reporter considered the partial hearing loss, tinnitus, influenza like illness and chills to be related to Shingrix.  Additional details were reported as follows: The patient received his first dose of Shingrix vaccine and 2 days after receiving the vaccine he felt like he had flu and chills which lasted for 2 days and then resolved. After 5 to 6 days later he developed tinnitus which has not resolved.  He went to his ENT and was told that he has 40 persent hearing loss and need hearing aids.  The reporter consented to follow up.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient received the second dose of Prevnar-13 on July 28, 2020. He received this in the Right Vastus Lateralis.  The patient experienced significant redness and  swelling of the right thigh the  following day on July 29, 2020. The patient did not have a fever or experience any breathing difficulties.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Immediate post-injection reaction, Mobility decreased, Musculoskeletal stiffness, Pyrexia, Respiratory syncytial virus infection
Clinical narrative: Immediate stuff muscles, no longer rolling over, immediate high fever along with RSV diagnosis. Not putting weight on arms. All delays
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Weight bearing difficulty
Clinical narrative: Immediate stuff muscles, no longer rolling over, immediate high fever along with RSV diagnosis. Not putting weight on arms. All delays
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Feeling abnormal, Syncope
Clinical narrative: No reaction noted at time of  vaccination. Client walked out of  exam room & left with her gmother. Gmother called back a few minutes  later to say the client had fainted in the  car. Advised her to call 911 if pt not responsive.  Pt was "coming around"  when EMS arrived Gma states pt. was  dazed and quiet for total of approximately 10 minutes. EMS did not transport pt. Pt was  feeling fine & acting normally on 7/29/20,  per grandmother.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: 9 administrations of improperly stored vaccines; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 17-JUL-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, 0.5 ml, lot # T006792, expiration date was reported as 24-AUG-2021 and upon internal validation, established as the same (strength, route of administration and anatomical location were not reported), for prophylaxis. The digital data logger registered the temperature excursion of-13.5 degree Celsius (C) for the 24 minutes, -11.4 (C) for the 27 minutes and -1.8 (C) for the 2 hours and 8 minutes. There was detected previous temperature excursion.  This is one of the 9 linked reports derived from the same reporter.; Sender's Comments:  US-009507513-2007USA010361: US-009507513-2007USA010374: US-009507513-2007USA010419: US-009507513-2007USA010893: US-009507513-2007USA010434: US-009507513-2007USA010252: US-009507513-2007USA010001: US-009507513-2007USA011962:
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Side effects; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included belimumab (Benlysta).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after starting Benlysta, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient asked how long do side effects from Shingrix shot last.   Following the action item reply, the following corrections were performed: The concomitant products belimumab (Benlysta) was deleted.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle aches; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included belimumab (Benlysta).   On 4th July 2020, the patient received Shingrix. In July 2020, less than a day after receiving Shingrix and an unknown time after starting Benlysta, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter's husband had his Shingrix booster the day before reporting in afternoon.  This morning he had muscle pain.   The correction performed as per action item reply: The concomitant products included belimumab (Benlysta) was deleted.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: lack of efficacy/the patient did not have immunization against hepatitis B; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 75-year-old female patient who received HBV (Engerix B) (batch number 34NG2, expiry date 24th February 2021) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On 9th July 2019, the patient received the 1st dose of Engerix B. On 14th August 2019, the patient received the 2nd dose of Engerix B. On 7th January 2020, the patient received the 3rd dose of Engerix B. On an unknown date, less than 2 years after receiving Engerix B, less than a year after receiving Engerix B and less than 9 months after receiving Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The pharmacist asked for information for a patient that received all 3 doses of engerix B and after performing test, the doctor mentioned that the patient did not have immunization against hepatitis B. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/ Shingrix vaccine on 8/5/2019 / second dose on 10/24/2019 / developed shingles a week ago; developed shingles a week ago; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2019, the patient received the 1st dose of Shingrix. On 24th October 2019, the patient received the 2nd dose of Shingrix. On 20th July 2020, 350 days after receiving Shingrix and 270 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that she received 2 doses of shingrix vaccine and developed shingles a week ago from reporting date. No other information was reported. This case was considered as suspected vaccination failure as details regarding laboratory confirmation were unknown at the time of reporting.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Patient can't raise the arm that he received a Prevnar 13 vaccine in; she believes it is the patient's left arm that is affected; This is a spontaneous report from a contactable Other HCP via Pfizer Sales Representative. This Other HCP reported for a 70-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on left arm on 15Jul2020 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient can't raise the arm that he received the Prevnar 13 vaccine in. The reporter stated that it has been two weeks since the patient received the Prevnar 13 vaccine and the patient still can't raise his arm that received the Prevnar 13 vaccine. The patient was having difficulty getting dressed and working in the yard and gardening. The Pfizer sales representative stated the patient had no other vaccines administered along with the Prevnar 13 vaccine. The reporter clarified she believed it was the patient's left arm that was affected. She stated she knew the patient received the same Prevnar 13 dose that a pediatric patient would get, but was unable to confirm what the exact Prevnar 13 dose was. The outcome of the event was not recovered.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: RAB
Symptoms: Blood potassium increased
Clinical narrative: potassium was 5.5 from blood work results, elevated Potassium post Imovax use; Initial information received on 30-Jul-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves female patient (unspecified age groups and age) who experienced an increase in potassium of about 5.5, reported from blood work results (blood potassium increased), while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient had no prior history.  The patient's past medical treatment, vaccination and family history were not provided.  It was not reported that the patient had concomitant medications.   The patient received two doses of suspect RABIES (HDC) VACCINE (lot number and expiration date for both the doses were not reported) via unknown route in unknown administration site for unknown indication on 20-Jul-2020 and 27-Jul-2020.  On 22-Jul-2020, the patient who had increase in potassium of about 5.5 (blood potassium increased), 2 days post RABIES (HDC) VACCINE administration.  Relevant laboratory test results included: Blood potassium - On 22-Jul-2020: 5.5; on 29-Jul-2020: 5.5; on 30-Jul-2020: 5.5 (units unspecified for all).  Final diagnosis was blood potassium increased.   It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for the event blood potassium increased.  There will be no information on the batch number for this case.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient noticed redness around the injection site on 8/2/2020.  No other symptoms aside from that.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: erythema and soreness at injection site, itchy, warm to touch
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Lymphadenopathy, Musculoskeletal pain, Neck pain
Clinical narrative: Swollen lymph nodes in head, neck and shoulder creating pain in same areas. As of 8/4/2020 symptoms persist (12 weeks).
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Chills, Injection site swelling
Clinical narrative: patient has swelling at site of injection, joint pain, and chills
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Feeling hot, Headache, Pain in extremity, Vomiting
Clinical narrative: Client's mother called the health department on the morning of 8-4-2020 and said that her son started feeling hot, had chills, started vomiting, and had a headache approximately 3-3.5 hours after he received the vaccine on 8-3-2020 at 1:30pm. She said that he started to feel better by night time, and as of today 8-4-2020, he feels completely fine except for a sore arm.