chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Skin exfoliation
Clinical narrative: itching and scaling on his head; rash of some sort; scaling on his head; difficult to move his arm; 10-JUL-2019 first dose; arm pain; headache/lasted 2 months; This case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included migraine.   On 10th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 10th July 2019, several hours after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm. On 11th July 2019, the patient experienced headache. On an unknown date, the patient experienced pruritus, rash, skin scaly, mobility decreased and incomplete course of vaccination. On an unknown date, the outcome of the headache, pruritus, rash, skin scaly, mobility decreased and incomplete course of vaccination were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the headache, pain in arm, pruritus, rash, skin scaly and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had headache and lasted 2 months.   The patient had arm pain and it was difficult to move his arm.  The patient started to had some itching and scaling on his head and recently noticed that it may be a rash of some sort. Till date the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: redness, pain , warm area; redness, pain , warm area; Shingrix -warm area in site of injection; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 3454N, expiry date 23rd August 2022) for prophylaxis.   On 3rd August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site erythema, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and presented redness, pain, warm area for over a week. The reporter did not consent to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Gait disturbance, Pain in extremity, Paraesthesia
Clinical narrative: increased pins and needles feeling; increased pain in her right hand and right foot; preventing her from walking comfortably; This case was reported by a consumer via call center representative and described the occurrence of pins and needles in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included stroke (about 6 years ago had a right sided thalamic stroke). Concurrent medical conditions included central pain syndrome (had pain in the right side of her body).   On 19th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pins and needles, pain in hand and walking difficulty. On an unknown date, the outcome of the pins and needles, pain in hand and walking difficulty were unknown.   It was unknown if the reporter considered the pins and needles, pain in hand and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and about a week or two ago noticed that was increased pain in her right hand and right foot with increased pins and needles feeling which was so bad that it was preventing her from walking comfortably. The reporter consented to follow up and did not know the lot no.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Paraesthesia
Clinical narrative: increased pins and needles feeling; increased pain in her right hand and right foot; preventing her from walking comfortably; This case was reported by a consumer via call center representative and described the occurrence of pins and needles in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included stroke (about 6 years ago had a right sided thalamic stroke). Concurrent medical conditions included central pain syndrome (had pain in the right side of her body).   On 19th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pins and needles, pain in hand and walking difficulty. On an unknown date, the outcome of the pins and needles, pain in hand and walking difficulty were unknown.   It was unknown if the reporter considered the pins and needles, pain in hand and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and about a week or two ago noticed that was increased pain in her right hand and right foot with increased pins and needles feeling which was so bad that it was preventing her from walking comfortably. The reporter consented to follow up and did not know the lot no.
Sex: F
Vaccine: FLU4
Symptoms: Trigeminal nerve disorder
Clinical narrative: Developed atypical trigeminal; = This case was reported by a other health professional via call center representative and described the occurrence of trigeminal nerve disorder in a adult female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2018-2019 season. On an unknown date, less than 2 months after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced trigeminal nerve disorder. On an unknown date, the outcome of the trigeminal nerve disorder was unknown.   It was unknown if the reporter considered the trigeminal nerve disorder to be related to Fluarix Quadrivalent 2018-2019 season.  Additional details were as follows: The age at vaccination was not reported. HCP reporeds that she herself received Fluarix in 2018 and She developed atypical trigeminal 6-7 weeks later.        The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Injection site pain; Injection site rash; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 65-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 injection site pain and injection site rash. On an unknown date, the outcome of the injection site pain and injection site rash were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site rash to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's husband. The age at vaccination was not reported. The patient was vaccinated with Shingrix and experienced injection site pain and injection site rash. This was 1 of 4 cases reported by same reporter. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020201572:same reporter US-GLAXOSMITHKLINE-US2020201575:same reporter US-GLAXOSMITHKLINE-US2020201578:same reporter US-GLAXOSMITHKLINE-US2020AMR202100:same reporter
Sex: F
Vaccine: FLUX
Symptoms: Atrial fibrillation, Palpitations
Clinical narrative: afib attack; several palpitations; Initial information received on 30-Sep-2020 regarding an unsolicited valid serious case from a consumer or non-health care professional.  This case is linked to case 2020SA270423 (reporter friend).  This case involves a female patient (age not reported) who experienced afib attack (atrial fibrillation) and several palpitations (palpitations), after she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious afib attack (atrial fibrillation) and several palpitations (palpitations) unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Caller wanted to know the uncommon side effects listed for both Fluzone Quad and High Dose.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for atrial fibrillation and palpitations.  There will be no information available on the batch number for this case.; Sender's Comments: The female patient (age not reported) who presented with atrial fibrillation following the vaccination with INFLUENZA VACCINE (unknown manufacturer). Time to onset is not clearly defined. Medical history, concomitant medication, precise final diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Headache, Swelling face, Swelling of eyelid, Throat tightness
Clinical narrative: Woke up next morning with tightness in throat and used rescue inhaler x 2. Face was swollen by the end of the day. The following day her face was so swollen when she woke up that her left eye was almost swollen shut. She had flushing, facial heat and a persistent headache. Today the swelling is down but not gone and the headache is still there.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: Pt. reported 2 days later, redness and swelling around injection site. Hematoma noted and soreness. Warm compresses, Benadryl & Ibuprofin recommended for pain-
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: flu shot given 9/28 has Lg red raised warm arm lateral rt upper ARM. flu shot given rt deltoid area approx. 3 1/2" x 2 1/2"  10/13 spoke to emp stated redness gone by 10/1
Age: 64.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: The female patient had more localized swelling at the injection site which was on her left arm; Redness, swelling, pain, and a large hard knot at the site; Redness, swelling, pain, and a large hard knot at the site; Redness, swelling, pain, and a large hard knot at the site; This spontaneous report as received from an office manager refers to a 64-year-old female patient. Her concurrent conditions included chronic obstructive pulmonary disease (COPD), heart disease, diabetes and hypertension. The patient was allergic to terbinafine (LAMISIL) and itraconazole (SPORANOX) (reported as SPROANOX). The patient's concomitant therapies included meloxicam (MOBIC), albuterol sulfate (PROAIR), alprazolam (XANAX), atorvastatin, furosemide, glimepiride (AMARYL), lisinopril (manufacturer unknown), tiotropium bromide (SPIRIVA), fluoxetine, metformin and bupropion.  On 06-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot # T009744, expiration date 28-JAN-2022, intramuscularly in the left arm to prevent pneumonia. On the same day, on 06-OCT-2020, the patient was also vaccinated with an influenza virus vaccine inactivated (unspecified) (manufacturer unknown) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis.  On 06-OCT-2020, the patient had more localized swelling at the injection site which was on her left arm, she had more redness, swelling, pain, and a large hard knot at the site. The patient did not seek for medical attention. No treatment was given for the events. On 07-OCT-2020, the patient recovered from the events.  The relatedness between the events and the suspect vaccines was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: T009744; expirationdate: 28-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: no other adverse events; vaccine that was expired and administered to a patient; Proquad had 1 prior temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 08-OCT-2020, the patient was vaccinated with an improperly stored and expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin(rHa)) (PROQUAD) 0.5 ml, lot # S009760 was confirmed to be valid, expiration date 27-SEP-2020 (route of administration and anatomical location were not reported) for prophylaxis. On 13-APR-2020, administered dose of vaccine experienced temperature excursion. The product reached temperature 39.9 degrees Fahrenheit for 9 hours.  The reporter confirmed there was no other adverse events.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Deafness, Herpes zoster
Clinical narrative: loss of vision; loss of hearing; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 64-year-old patient of unknown gender. Medical history, concurrent conditions and concomitant medications were not provided.  On or about 05-MAY-2016, the patient was administered the zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration and lot # were not provided) for the long-term prevention of shingles and zoster-related conditions. On unknown dates (reported as subsequently), the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX): herpes zoster, loss of vision and loss of hearing. The patient claimed damages as a result of: injury to themselves. The outcome of the events was not provided.  The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of loss of vision and loss of hearing were considered to be medically significant.
Sex: F
Vaccine: MENB
Symptoms: Insomnia, Meningitis, Pain, Pyrexia
Clinical narrative: almost like she is having symptoms of meningitis; 101.5 temp; pain; was up in pain all night; This case was reported by a other health professional via sales rep and described the occurrence of possible meningitis in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero with an associated reaction of headache (1st dose, for tolerance refer case US2020AMR201419).   In October 2020, the patient received the 2nd dose of Bexsero. In October 2020, 1 day after receiving Bexsero, the patient experienced meningitis (serious criteria GSK medically significant), fever, pain and insomnia. Rechallenge with Bexsero was positive. On an unknown date, the outcome of the meningitis, fever, pain and insomnia were unknown.   It was unknown if the reporter considered the meningitis, fever, pain and insomnia to be related to Bexsero.  Additional details provided as follows: The age at vaccination was not reported, however the patient could be of 17 to 18 years old at a time of vaccination. The patient received her 2nd Bexsero, a day prior to this report and next day she woke up with 101.5 temperature and was up in pain all night last night. It was almost like she was having symptoms of meningitis. The reporter consented for follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR201419:1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: bad headache; fatigue/tiredness; chills like the flu; Flu like chills; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2020, the patient received the 1st dose of Shingrix. On 3rd October 2020, 1 days after receiving Shingrix, the patient experienced headache, fatigue, chills and influenza-like symptoms. On an unknown date, the outcome of the headache, fatigue, chills and influenza-like symptoms were unknown.   It was unknown if the reporter considered the headache, fatigue, chills and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had all the side effects listed above namely bad headache fatigue tiredness and chills like the flu.  That pretty much went away.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash vesicular
Clinical narrative: rash looks like shingles; This case was reported by a nurse via sales rep and described the occurrence of vesicular rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for herself. The age at vaccination was not reported. The patient had rash that developed after she got the second Shingrix dose. She did not remember when it started exactly but it was after the second dose and it looks like shingles although it did not presents pain it itches. The rash was present in the upper abdomen and upper back, right side. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin abnormal, Drug interaction, Erythema, Food interaction, Hypersensitivity
Clinical narrative: little red bumps over her legs / red dots were diagnosed as Pleva; allergic hives / on the back of her legs / hives were due to a drug or food interaction; allergic hives; red bumbs; red bumps; drug or food interaction; This case was reported by a consumer via call center representative and described the occurrence of hives in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had the first case at age between 11 and 13 and the second case at 42 years of age.).   On 27th July 2020, the patient received the 1st dose of Shingrix. On 14th August 2020, 18 days after receiving Shingrix, the patient experienced hives, pityriasis lichenoides, allergic reaction, erythema and swelling. In August 2020, the patient experienced food interaction. On an unknown date, the outcome of the hives, pityriasis lichenoides and allergic reaction were recovered/resolved and the outcome of the erythema, swelling and food interaction were unknown.   It was unknown if the reporter considered the hives, pityriasis lichenoides, allergic reaction, erythema, swelling and food interaction to be related to Shingrix.  Additional information was provided as follows: On 14th August 2020, the patient experienced allergic hives that broke out on the back of her legs and little red bumps over her legs. On 17th August 2020, she saw a dermatologist who biopsied the hives and bumps.  She confirmed that the hives were due to a drug or food interaction and red dots were diagnosed as Pleva. Her symptoms resolved and she planned to get the second dose of Shingrix day after reporting.  She had no known allergies and no breaks outs prior to receiving the Shingrix vaccine. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Parapsoriasis, Rash, Rash erythematous, Swelling, Urticaria
Clinical narrative: little red bumps over her legs / red dots were diagnosed as Pleva; allergic hives / on the back of her legs / hives were due to a drug or food interaction; allergic hives; red bumbs; red bumps; drug or food interaction; This case was reported by a consumer via call center representative and described the occurrence of hives in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had the first case at age between 11 and 13 and the second case at 42 years of age.).   On 27th July 2020, the patient received the 1st dose of Shingrix. On 14th August 2020, 18 days after receiving Shingrix, the patient experienced hives, pityriasis lichenoides, allergic reaction, erythema and swelling. In August 2020, the patient experienced food interaction. On an unknown date, the outcome of the hives, pityriasis lichenoides and allergic reaction were recovered/resolved and the outcome of the erythema, swelling and food interaction were unknown.   It was unknown if the reporter considered the hives, pityriasis lichenoides, allergic reaction, erythema, swelling and food interaction to be related to Shingrix.  Additional information was provided as follows: On 14th August 2020, the patient experienced allergic hives that broke out on the back of her legs and little red bumps over her legs. On 17th August 2020, she saw a dermatologist who biopsied the hives and bumps.  She confirmed that the hives were due to a drug or food interaction and red dots were diagnosed as Pleva. Her symptoms resolved and she planned to get the second dose of Shingrix day after reporting.  She had no known allergies and no breaks outs prior to receiving the Shingrix vaccine. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arrhythmia, Biopsy skin abnormal, Blood test, Cardiac monitoring abnormal, Cardiac stress test abnormal
Clinical narrative: little red bumps over her legs / red dots were diagnosed as Pleva; allergic hives / on the back of her legs / hives were due to a drug or food interaction; allergic hives; red bumbs; red bumps; drug or food interaction; This case was reported by a consumer via call center representative and described the occurrence of hives in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had the first case at age between 11 and 13 and the second case at 42 years of age.).   On 27th July 2020, the patient received the 1st dose of Shingrix. On 14th August 2020, 18 days after receiving Shingrix, the patient experienced hives, pityriasis lichenoides, allergic reaction, erythema and swelling. In August 2020, the patient experienced food interaction. On an unknown date, the outcome of the hives, pityriasis lichenoides and allergic reaction were recovered/resolved and the outcome of the erythema, swelling and food interaction were unknown.   It was unknown if the reporter considered the hives, pityriasis lichenoides, allergic reaction, erythema, swelling and food interaction to be related to Shingrix.  Additional information was provided as follows: On 14th August 2020, the patient experienced allergic hives that broke out on the back of her legs and little red bumps over her legs. On 17th August 2020, she saw a dermatologist who biopsied the hives and bumps.  She confirmed that the hives were due to a drug or food interaction and red dots were diagnosed as Pleva. Her symptoms resolved and she planned to get the second dose of Shingrix day after reporting.  She had no known allergies and no breaks outs prior to receiving the Shingrix vaccine. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Electrocardiogram abnormal, Hypersensitivity, Pityriasis lichenoides et varioliformis acuta, Rash papular
Clinical narrative: little red bumps over her legs / red dots were diagnosed as Pleva; allergic hives / on the back of her legs / hives were due to a drug or food interaction; allergic hives; red bumbs; red bumps; drug or food interaction; This case was reported by a consumer via call center representative and described the occurrence of hives in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had the first case at age between 11 and 13 and the second case at 42 years of age.).   On 27th July 2020, the patient received the 1st dose of Shingrix. On 14th August 2020, 18 days after receiving Shingrix, the patient experienced hives, pityriasis lichenoides, allergic reaction, erythema and swelling. In August 2020, the patient experienced food interaction. On an unknown date, the outcome of the hives, pityriasis lichenoides and allergic reaction were recovered/resolved and the outcome of the erythema, swelling and food interaction were unknown.   It was unknown if the reporter considered the hives, pityriasis lichenoides, allergic reaction, erythema, swelling and food interaction to be related to Shingrix.  Additional information was provided as follows: On 14th August 2020, the patient experienced allergic hives that broke out on the back of her legs and little red bumps over her legs. On 17th August 2020, she saw a dermatologist who biopsied the hives and bumps.  She confirmed that the hives were due to a drug or food interaction and red dots were diagnosed as Pleva. Her symptoms resolved and she planned to get the second dose of Shingrix day after reporting.  She had no known allergies and no breaks outs prior to receiving the Shingrix vaccine. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria, Vaccine positive rechallenge
Clinical narrative: little red bumps over her legs / red dots were diagnosed as Pleva; allergic hives / on the back of her legs / hives were due to a drug or food interaction; allergic hives; red bumbs; red bumps; drug or food interaction; This case was reported by a consumer via call center representative and described the occurrence of hives in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had the first case at age between 11 and 13 and the second case at 42 years of age.).   On 27th July 2020, the patient received the 1st dose of Shingrix. On 14th August 2020, 18 days after receiving Shingrix, the patient experienced hives, pityriasis lichenoides, allergic reaction, erythema and swelling. In August 2020, the patient experienced food interaction. On an unknown date, the outcome of the hives, pityriasis lichenoides and allergic reaction were recovered/resolved and the outcome of the erythema, swelling and food interaction were unknown.   It was unknown if the reporter considered the hives, pityriasis lichenoides, allergic reaction, erythema, swelling and food interaction to be related to Shingrix.  Additional information was provided as follows: On 14th August 2020, the patient experienced allergic hives that broke out on the back of her legs and little red bumps over her legs. On 17th August 2020, she saw a dermatologist who biopsied the hives and bumps.  She confirmed that the hives were due to a drug or food interaction and red dots were diagnosed as Pleva. Her symptoms resolved and she planned to get the second dose of Shingrix day after reporting.  She had no known allergies and no breaks outs prior to receiving the Shingrix vaccine. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: redness and swelling appeared at the injection site; pain in the muscle at the injection site; pain extended into the shoulder; swelling appeared at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bronchitis.   In January 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site muscle pain and shoulder pain. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site muscle pain and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site muscle pain and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and reported redness and swelling appeared at the injection site that resolved.   A few weeks later in February, the events returned and the new event of pain in the muscle at the injection site presented and pain extended into the shoulder.  The patient was treated with medications but could not remember what they were.   The patient mentioned taking an antibiotic for bronchitis and the arm pain resolved.   In June the pain returned and it comes and goes and treated it with Aleve. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Nausea, Pain, Pain in extremity
Clinical narrative: slight headache; Her nose is a little runny; ache in her right thigh above her knee; did not sleep well; vomited; nausea; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included platelet count increased and migraine. Concomitant products included fluoride.   On 6th October 2020 12:30, the patient received the 1st dose of Shingrix. On 6th October 2020, less than a day after receiving Shingrix, the patient experienced pain and sleeplessness. On 7th October 2020, the patient experienced headache and runny nose. In October 2020, the patient experienced vomiting and nausea. On an unknown date, the outcome of the vomiting, nausea and pain were recovered/resolved and the outcome of the headache and runny nose were not recovered/not resolved and the outcome of the sleeplessness was unknown.   It was unknown if the reporter considered the vomiting, nausea, headache, runny nose, pain and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine at 12:30 PM and at 7.15, 18hrs 45min after had nausea this morning and vomited. The patient did not sleep well and had an ache in her right thigh above her knee.  The patient had a slight headache and was prone to migraines, but the headache was not a migraine type and nose was a little runny and had a fluoride treatment at the dentist. The reporter did not consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Poor quality sleep, Rhinorrhoea, Vomiting
Clinical narrative: slight headache; Her nose is a little runny; ache in her right thigh above her knee; did not sleep well; vomited; nausea; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included platelet count increased and migraine. Concomitant products included fluoride.   On 6th October 2020 12:30, the patient received the 1st dose of Shingrix. On 6th October 2020, less than a day after receiving Shingrix, the patient experienced pain and sleeplessness. On 7th October 2020, the patient experienced headache and runny nose. In October 2020, the patient experienced vomiting and nausea. On an unknown date, the outcome of the vomiting, nausea and pain were recovered/resolved and the outcome of the headache and runny nose were not recovered/not resolved and the outcome of the sleeplessness was unknown.   It was unknown if the reporter considered the vomiting, nausea, headache, runny nose, pain and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine at 12:30 PM and at 7.15, 18hrs 45min after had nausea this morning and vomited. The patient did not sleep well and had an ache in her right thigh above her knee.  The patient had a slight headache and was prone to migraines, but the headache was not a migraine type and nose was a little runny and had a fluoride treatment at the dentist. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received 2 doses of Shingrix and developed shingles / Suspected vaccination failure; received 2 doses of Shingrix and developed shingles; This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure 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 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 case details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient received two doses of Shingrix and developed shingles. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Product administered at inappropriate site
Clinical narrative: the vaccine was administered into the shoulder joint. Patient has reported shoulder pain/ Nurse administered Prevnar 13 in the shoulder joint instead of deltoid muscle; the vaccine was administered into the shoulder joint. Patient has reported shoulder pain/ Nurse administered Prevnar 13 in the shoulder joint instead of deltoid muscle; This is a spontaneous report from a contactable Physician via Sales Representative. A 68-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), on unspecified date in 2020 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The nurse administered Prevnar 13 to the patient last week and believed that the vaccine was administered into the shoulder joint. The patient had reported shoulder pain. The nurse administered Prevnar 13 in the shoulder joint instead of deltoid muscle. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: PNC13
Symptoms: Inappropriate schedule of product administration, Lymphoma
Clinical narrative: lymphoma; Patient receieved it twice, on 10Jan2020 and other dose 28Sep2020 within 8 months; This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs). A contactable healthcare professional reported that a patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date unknown), a single dose on 10Jan2020, and another single dose on 28Sep2020, both via an unspecified route of administration for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) twice, on 10Jan2020 and other dose 28Sep2020 within 8 months. The patient has lymphoma on an unspecified date but wasn't supposed to get it this close. The patient does not have symptoms. The reporter asked for any consequences. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lymphoma with PREVNAR 13 can not be fully excluded based on the limited information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: PNC13, UNK
Symptoms: Erythema, Pyrexia, Skin warm
Clinical narrative: Low grade fever; her arm got real red, and the redness spread down her arm and is hot to touch; hot to touch; her arm got real red; This is a spontaneous report from a non-contactable consumer (patient) via a sales representative. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), at SINGLE DOSE and a high dose flu (INFLUENZA VACCINE ) at an unknown dose, both via an unspecified route of administration on 06Oct2020 for immunisation. The patient got both shots in the same arm. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported the patient went to the doctor on 06Oct2020 (Tuesday) and she got two shots, a high dose flu and pneumococcal 13-val conj vac (dipht crm197 protein). Ever since 06Oct2020, the patient had a low-grade fever, her arm got real red, and the redness spread down her arm and was hot to touch. And the patient stated it's gotten better since Tuesday however. The patient talked to a nurse at the doctor's office on 07Oct2020, they had drawn a line on the patient's arm to see if it spreads, it didn't spread, the nurse told the patient that if her arm doesn't get better they would have to give her an antibiotic because she might have cellulitis. The event outcome was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: red patch/rash around the injection site; red patch/rash around the injection site; injection site that is warm to the touch with slight swelling and is about 3.5 inches in diameter; injection site that is warm to the touch with slight swelling and is about 3.5 inches in diameter; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 07Oct2020 at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced red patch/rash around the injection site that is warm to the touch with slight swelling and is about 3.5 inches in diameter on 08Oct2020. The action taken in response to the event(s) for pneumococcal 13-val conj vac (dipht crm197 protein) was not applicable.  No follow-up attempts are needed. Information about lot/batch number can not be obtained.
Sex: M
Vaccine: MENB
Symptoms: Rash
Clinical narrative: Painful rash in area where vaccine was administered on upper shoulder; Painful rash in area where vaccine was administered on upper shoulder; The rash also spread on torso area and hand; This is a spontaneous report from a non-contactable physician via Pfizer sales representative. A 16-year-old male patient received first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation. No underlying conditions or on concomitant medications. The patient experienced painful rash in area where vaccine was administered on upper shoulder, the rash also spread on torso area and hand on an unspecified date 2 1/2 weeks after first dose of meningococcal group b rlp2086 with outcome of unknown. Information about Lot/Batch number cannot be requested.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: expired PROQUAD was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 02-OCT-2020 the patient was vaccinated with an expired of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (0.5ml, one time dose, lot # S009758, expiration date 27-SEP-2020; route was not reported) for prophylaxis (expired product administered). The reporter inquired information if administered product was supported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or about 04-AUG-2011, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, route of administration and anatomical location were not reported), as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome for herpes zoster was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or about 05-APR-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, route of administration and anatomical location were not reported), as prescribed and/or administered by a pharmacist at a pharmacy, for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome for herpes zoster was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster oticus
Clinical narrative: zoster related hearing loss; zoster related hearing loss; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. In 2011, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, route of administration and anatomical location were not reported), as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for zoster related hearing loss (herpes zoster/deafness). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome for zoster related hearing loss was unknown.   Upon internal review, deafness was considered a medically significant event.