chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PROQUAD administration in adult; This spontaneous report was received from a registered nurse referring to an adult patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 22-OCT-2020, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rha) (PROQUAD) lot # S035103, expiration date 03-MAY-2021, for prophylaxis (route of administration and anatomical site of vaccination were not reported).
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Product preparation error, Product preparation issue, Wrong technique in product usage process
Clinical narrative: Pharmacist is reporting a dose of PROQUAD that was not fully dissolved being administered.; Pharmacist is reporting a dose of PROQUAD that was not fully dissolved being administered.; Pharmacist is reporting a dose of PROQUAD that was not fully dissolved being administered.; This spontaneous report was received from a pharmacist, referring to a 5-year-old male patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 21-OCT-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), at a dose of 0.5 milliliter (ml), as prophylaxis (formulation, strength, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not reported), however; during the administration the vaccine was not fully dissolved (product reconstitution quality issue, wrong technique in product usage process and product preparation issue). It was reported that, the health care professional wanted to revaccinated on 22-10-2020.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Pyrexia
Clinical narrative: fever; headache; blisters on hands; This case was reported by a other health professional via interactive digital media and described the occurrence of fever 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, unknown after receiving Shingrix, the patient experienced fever, headache and blister. On an unknown date, the outcome of the fever, headache and blister were unknown.   It was unknown if the reporter considered the fever, headache and blister to be related to Shingrix.  Additional details were provided as follows: The patient received the dose shingrix and exprienced fever, headache and blister on hands. The reporter woulld like to know how effective only receiving one of the 2 doses. The information regarding consent to follow up was not reported. No further information was available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever; chills; headache; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 19th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced fever, chills and headache. On an unknown date, the outcome of the fever, chills and headache were unknown.   It was unknown if the reporter considered the fever, chills and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Age group was captured as adult as per product indication. The patient received 2nd shot Monday and had a terrible reaction Fever chills headache.
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: On the left arm had hives / after receiving the vaccine; This case was reported by a nurse via call center representative and described the occurrence of hives in a 11-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 7N43B, expiry date 30th June 2021) for prophylaxis.   On 29th September 2020, the patient received the 1st dose of FluLaval Tetra 2020-2021 season. On 29th September 2020, less than a day after receiving FluLaval Tetra 2020-2021 season, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to FluLaval Tetra 2020-2021 season.  Additional details were received as follows: The age at vaccination was not reported but could be 10 or 11 years. The reported stated that the patient had hives after receiving the vaccine. The reporter consented to follow up. This case has been linked with cases US2020211156 and US2020211161, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211156:same reporter US-GLAXOSMITHKLINE-US2020211161:same reporter
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: On the left arm had hives / after receiving the vaccine; This case was reported by a nurse via call center representative and described the occurrence of hives in a 4-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 724k2, expiry date 30th June 2021) for prophylaxis.   On 19th September 2020, the patient received the 1st dose of FluLaval Tetra 2020-2021 season. On 19th September 2020, less than a day after receiving FluLaval Tetra 2020-2021 season, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to FluLaval Tetra 2020-2021 season.  Additional details were received as follows: The age at vaccination was not reported but could be 3 or 4 years. The reporter stated that the patient had hives after receiving the vaccine. The reporter consented to follow up. This case has been linked with cases US2020211156 and US2020211159, reported for same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211156:same reporter US-GLAXOSMITHKLINE-US2020211159:same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Incomplete course of vaccination, Malaise, Social problem
Clinical narrative: unable to get the second dose due to the pandemic; feeling a little off; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. In April 2020, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced malaise. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the malaise and social problem were recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose. The age at vaccination was not applicable for 2nd dose of Shingrix. The patient received 1st dose on an unknown arm. The reporter stated that, after 1st dose felt a little off, that way the day received the vaccine but it quickly went away the next day. The reporter stated that, the patient did not receive dose 2 due to the pandemic, which led to social problem. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: FLUR4
Symptoms: Eye swelling, Pruritus, Rash, Swelling face
Clinical narrative: One hour post vaccination patient developed a rash on forearms and chest area. The rash caused itching. Later in the evening has some swelling about the face and eyes, patient took OTC Benadryl as instructed by her Personal Physician over the phone. Patient took Benadryl PO as directed by Personal Provider and has recovered from event.
Age: 74.0
Sex: U
Vaccine: FLU4
Symptoms: Asthenia, Disorientation, Mental status changes, Myalgia, Nausea
Clinical narrative: Fever, weakness, nausea, muscle aches, disoriented, clear change in mental clarity. This went on from 5am-2pm the following day. Same symptoms after receiving FluHD vaccine last year.
Age: 74.0
Sex: U
Vaccine: FLU4
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: Fever, weakness, nausea, muscle aches, disoriented, clear change in mental clarity. This went on from 5am-2pm the following day. Same symptoms after receiving FluHD vaccine last year.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: My daughter had a flu shot yesterday and woke up with a 103 fever
Age: 55.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills (shivering), headache, severe fatigue, body aches
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry skin, Erythema, Injection site swelling, Pruritus, Rash
Clinical narrative: 2 days after administration, left medial arm itching and erythema that was different from localized swelling around injection site. Also itching, dryness, vesicular rash in bilateral lower legs that persists to today,  3 weeks later. No breathing difficulty or signs of anaphylaxis. Improving gradually. Will being trying topical corticosteroids and antihistamine.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: 2 days after administration, left medial arm itching and erythema that was different from localized swelling around injection site. Also itching, dryness, vesicular rash in bilateral lower legs that persists to today,  3 weeks later. No breathing difficulty or signs of anaphylaxis. Improving gradually. Will being trying topical corticosteroids and antihistamine.
Age: 52.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Pain in extremity, Rash
Clinical narrative: -Woke up the next day w/ a rash on whole arm. -painful arm even 3weeks later
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Fatigue, Flank pain, Rash
Clinical narrative: Patient reporting reaction to PCP office. Influenza vaccine received at his place of work. Within 2 hr. of administration he began to experience "the exact same symptoms as when I had COVID: Cough, Rash to abdomen and chest, bilateral flank pain, fatigue" now resolved. Note: Board of Health did not respond to our outreach requesting details on Vax info listed above.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Oedema peripheral
Clinical narrative: (R) upper arm edema.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Axillary pain, Bursitis, Mobility decreased, Product administered at inappropriate site
Clinical narrative: Bursitis secondary to vaccine administration high on shoulder- pain in axilla and anterior joint, decreased active ROM of shoulder.  Symptoms started a few hours after the shot.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Gastric disorder, Hypoaesthesia
Clinical narrative: Patient is exp cold chills stated she has been sanding on top of the heater since she got home. The other symptoms are severe numbness on both sides of head and neck. She having weakness in the stomach.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU4, HEP, HIBV, PNC13, RV5
Symptoms: Pallor, Rash, Rash erythematous, Rash macular
Clinical narrative: macular, blanching, erythematous rash on chest, abdomen and back
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: Patient started having punch feeling in arms that traveled to her shoulders 3-4 hours after vaccination. She felt body aches, pains, and had low grade fever 99.0.Also had a Covid test results negative.
Age: 54.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: patient stated she was not feeling well at the end of the day. patient had the chills. woke up in the middle of the night with 104 degree fever and went to urgent care.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Ear swelling
Clinical narrative: About 4.5 hours later swelling occurred under the left ear and swallowing was impaired. Effects have resolved itself this morning and patient wanted to just let pharmacy know.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Nausea, Pyrexia
Clinical narrative: Within 3 hours of injection:  Fever, 101 degrees x 10 hours; reduced fever fluctuated for 12 hours thereafter severe chills x 2 hours weakness nausea
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Abdominal pain upper, Chills, Headache, Hyperhidrosis
Clinical narrative: no treatment nausea, head ache sweating, chills, upset stomach 2 hours after shot. 24 hour after shotfelt better around 3. stomach ache persisted for 2-3 days after.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: no treatment nausea, head ache sweating, chills, upset stomach 2 hours after shot. 24 hour after shotfelt better around 3. stomach ache persisted for 2-3 days after.
Age: 78.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Arthralgia, Blood glucose increased, Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Severe loss of muscle strength Could not bend over to touch floor Pain or aching in almost all joints (8) Pain trying to enter or exiiit car    (10) Pain sitting in car for more than 25 miles  (9) Increase in Diabetic readings by 20-40 points at all reading times Pain in injection site (still Present at this date)  Restricts motion
Age: 78.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Pain, Ultrasound Doppler, X-ray
Clinical narrative: Severe loss of muscle strength Could not bend over to touch floor Pain or aching in almost all joints (8) Pain trying to enter or exiiit car    (10) Pain sitting in car for more than 25 miles  (9) Increase in Diabetic readings by 20-40 points at all reading times Pain in injection site (still Present at this date)  Restricts motion
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: Mom called the nurse line on 10/23/19.  Said that her son received a flu vaccine the day prior and now the arm felt warm to touch, was swollen w/a hard lump.  Nurse informed mom that the reaction can be normal.  Discussed  how long it could last, use of warm and cool compresses, messaging the area, and use of Tylenol.  Told to call back if concerned, or any new symptoms occur.    The next day 10/24/19 grandmother brought pt to office.  Rash described as red with bumps and swelling. and child had started Benadryl the evening prior. He had already had 3 doses.  Dr diagnosed pt w/Left Arm Swelling, due to reaction to flu vaccine.  Arm erythema, due to flu vaccine. Use Benadryl q 6-8 hours and observe closely.  Follow up in 24 hrs.  Pt was brought into the office on 10/25/19, by his father.  Dr charted that arm was much improved.  Follow up if any change or symptoms worsen.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Pt reports that 3-4 days after injection her arm started swelling, became warm, red, and itchy. The area of swelling was baseball size. Pt used no interventions and the symptoms were gone after 2 days.
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient received vaccination and reports redness and swelling 3-4 inches below shot the next day. The red, swollen area is approximately 2 inches x 3-4 inches and warm to touch.
Sex: U
Vaccine: HPV9
Symptoms: Product administered at inappropriate site
Clinical narrative: GARDASIL 9 being administered in the glute instead of the anterolateral thigh; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.     On 12-OCT-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml; lot #, expiration date and route were unknown) for prophylaxis. The vaccine was administered in the glute instead of the anterolateral thigh (product administered at inappropriate site).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a female consumer of unknown age referring to herself. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.  In 2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), 0.65 mL, subcutaneously, for herpes zoster prophylaxis (lot number and expiration date were not reported).         The patient wanted to get vaccinated with zoster vaccine (SHINGRIX), but there was a wait and it took 3, almost 4 months to get it and meanwhile the patient experienced shingles, some date less than 4 months after December 2018 (approximated to 2019).  The patient was not upset about that because zoster vaccine live (ZOSTAVAX) worked for 10 years, just like it was supposed to, and she learned a lot by having the shingles and how to take care of her body better. No additional adverse events or product quality complaints were reported.  The outcome of herpes zoster was reported as recovered on unspecified date. Causality assessment was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a customer who received first dose of GARDASIL 9 on 7/15/2020. The customer missed second dose timeframe.; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.     On 15-JUL-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml; lot #, expiration date and route were unknown) for prophylaxis. The patient missed the second dose timeframe on an unknown date in 2020 (inappropriate schedule of product administration).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE reported; expired PROQUAD was administered to a 5 year old patient; This spontaneous report was received from a pharmacist intern on behalf of pharmacist and refers to a 5-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.   On 14-OCT-2020, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S008574, expiration date 16-SEP-2020, 0.5 milliliter given once (reported as x1) (route and site of administration was not provided) for prophylaxis. No additional adverse event was reported. The outcome was unknown.
Sex: U
Vaccine: HEP, HEP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no additional adverse details provided; administered Recombivax HB the usbcutaneous route versus the recommended intramuscular route; This spontaneous report was received from a nurse, referring to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant therapies were not reported.  On 20-OCT-2020, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot number S030794, expiration date 02-NOV-2021, as prophylaxis (strength, dose, frequency and anatomical vaccination site were not disclosed). It was reported that the vaccine was administered subcutaneously, instead of via intramuscular route as recommended (incorrect route of product administration). There were no additional adverse events reported or further details provided. The outcomes of incorrect route of product administration and no adverse event were unknown.   combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S030794; expirationdate: 02-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS, FLU4, PPV, VARZOS
Symptoms: Asthenia, Chest discomfort, Feeling abnormal, Paraesthesia, Tremor
Clinical narrative: Thightness in her torso and chest; her hands were shaky; felt bad; she felt weak all over; Thightness in her torso; She said she feels a "bizarre buzziness" like paresthesia on the left side of her waist band; This spontaneous report was received from a retired health care professional, who is also the patient, reporting on herself a 66 year old female patient with multiple sclerosis. Concomitant therapies included interferon beta-1b(BETASERON).     On 14-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis.  Other suspect therapies included zoster rge vaccine (mammalian)(SHINGRIX), administered on the same date. The reporter stated that she felt bad after her dose. She felt weak all over. Next day her hands were shaky. Over the weekend she felt tightness in her torso and chest tightness. She said she feels a "bizarre buzziness" like paresthesia on the left side of her waist band.  At the reporting time, the outcome of the events  was reported as not recovered.    The reporter did not provide the causality assessment between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and zoster rge vaccine (mammalian)(SHINGRIX), combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; 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
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS, FLU4, PPV, VARZOS
Symptoms: Band sensation, Chest discomfort, Condition aggravated, Euphoric mood, Feeling abnormal
Clinical narrative: Thightness in her torso and chest; her hands were shaky; felt bad; she felt weak all over; Thightness in her torso; She said she feels a "bizarre buzziness" like paresthesia on the left side of her waist band; This spontaneous report was received from a retired health care professional, who is also the patient, reporting on herself a 66 year old female patient with multiple sclerosis. Concomitant therapies included interferon beta-1b(BETASERON).     On 14-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis.  Other suspect therapies included zoster rge vaccine (mammalian)(SHINGRIX), administered on the same date. The reporter stated that she felt bad after her dose. She felt weak all over. Next day her hands were shaky. Over the weekend she felt tightness in her torso and chest tightness. She said she feels a "bizarre buzziness" like paresthesia on the left side of her waist band.  At the reporting time, the outcome of the events  was reported as not recovered.    The reporter did not provide the causality assessment between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and zoster rge vaccine (mammalian)(SHINGRIX), combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; 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
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS, FLU4, PPV, VARZOS
Symptoms: Flank pain, Herpes zoster, Hypoaesthesia eye, Malaise, Multiple sclerosis
Clinical narrative: Thightness in her torso and chest; her hands were shaky; felt bad; she felt weak all over; Thightness in her torso; She said she feels a "bizarre buzziness" like paresthesia on the left side of her waist band; This spontaneous report was received from a retired health care professional, who is also the patient, reporting on herself a 66 year old female patient with multiple sclerosis. Concomitant therapies included interferon beta-1b(BETASERON).     On 14-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis.  Other suspect therapies included zoster rge vaccine (mammalian)(SHINGRIX), administered on the same date. The reporter stated that she felt bad after her dose. She felt weak all over. Next day her hands were shaky. Over the weekend she felt tightness in her torso and chest tightness. She said she feels a "bizarre buzziness" like paresthesia on the left side of her waist band.  At the reporting time, the outcome of the events  was reported as not recovered.    The reporter did not provide the causality assessment between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and zoster rge vaccine (mammalian)(SHINGRIX), combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; 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
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS, FLU4, PPV, VARZOS
Symptoms: Pain, Pain in extremity, Sensory disturbance
Clinical narrative: Thightness in her torso and chest; her hands were shaky; felt bad; she felt weak all over; Thightness in her torso; She said she feels a "bizarre buzziness" like paresthesia on the left side of her waist band; This spontaneous report was received from a retired health care professional, who is also the patient, reporting on herself a 66 year old female patient with multiple sclerosis. Concomitant therapies included interferon beta-1b(BETASERON).     On 14-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis.  Other suspect therapies included zoster rge vaccine (mammalian)(SHINGRIX), administered on the same date. The reporter stated that she felt bad after her dose. She felt weak all over. Next day her hands were shaky. Over the weekend she felt tightness in her torso and chest tightness. She said she feels a "bizarre buzziness" like paresthesia on the left side of her waist band.  At the reporting time, the outcome of the events  was reported as not recovered.    The reporter did not provide the causality assessment between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and zoster rge vaccine (mammalian)(SHINGRIX), combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; 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
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS, FLU4, PPV, VARZOS
Symptoms: Band sensation, Feeling abnormal, Feeling cold, Malaise, Muscular weakness
Clinical narrative: Thightness in her torso and chest; her hands were shaky; felt bad; she felt weak all over; Thightness in her torso; She said she feels a "bizarre buzziness" like paresthesia on the left side of her waist band; This spontaneous report was received from a retired health care professional, who is also the patient, reporting on herself a 66 year old female patient with multiple sclerosis. Concomitant therapies included interferon beta-1b(BETASERON).     On 14-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis.  Other suspect therapies included zoster rge vaccine (mammalian)(SHINGRIX), administered on the same date. The reporter stated that she felt bad after her dose. She felt weak all over. Next day her hands were shaky. Over the weekend she felt tightness in her torso and chest tightness. She said she feels a "bizarre buzziness" like paresthesia on the left side of her waist band.  At the reporting time, the outcome of the events  was reported as not recovered.    The reporter did not provide the causality assessment between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and zoster rge vaccine (mammalian)(SHINGRIX), combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; 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
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS, FLU4, PPV, VARZOS
Symptoms: Paraesthesia, Tremor, Vibratory sense increased
Clinical narrative: Thightness in her torso and chest; her hands were shaky; felt bad; she felt weak all over; Thightness in her torso; She said she feels a "bizarre buzziness" like paresthesia on the left side of her waist band; This spontaneous report was received from a retired health care professional, who is also the patient, reporting on herself a 66 year old female patient with multiple sclerosis. Concomitant therapies included interferon beta-1b(BETASERON).     On 14-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis.  Other suspect therapies included zoster rge vaccine (mammalian)(SHINGRIX), administered on the same date. The reporter stated that she felt bad after her dose. She felt weak all over. Next day her hands were shaky. Over the weekend she felt tightness in her torso and chest tightness. She said she feels a "bizarre buzziness" like paresthesia on the left side of her waist band.  At the reporting time, the outcome of the events  was reported as not recovered.    The reporter did not provide the causality assessment between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and zoster rge vaccine (mammalian)(SHINGRIX), combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; 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: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: arm pain; FEELING VERY BAD; This case was reported by a physician via sales rep and described the occurrence of pain in arm 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 pain in arm and feeling bad. On an unknown date, the outcome of the pain in arm and feeling bad were unknown.   It was unknown if the reporter considered the pain in arm and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced arm pain and feeling very bad after the 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: large, red, and warm rash on the same arm but not at the injection site; warm rash on the same arm but not at the injection site; This case was reported by a consumer via call center representative and described the occurrence of red rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th October 2020, the patient received Shingrix. On 20th October 2020, 2 days after receiving Shingrix, the patient experienced red rash and skin warm. On an unknown date, the outcome of the red rash and skin warm were unknown.   It was unknown if the reporter considered the red rash and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had large red and warm rash on the same arm but not at the injection site and was away from it near elbow. The reporter asked was that common from the vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling/Swelling started at the injection site and traveled to the consumer's elbow; Redness/Redness and Swelling started at the injection site and traveled to the consumer's elbow; injection site continues to be sore; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, erythema of extremities and injection site pain. On an unknown date, the outcome of the extensive swelling of vaccinated limb and erythema of extremities were unknown and the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities and injection site pain to be related to Shingrix.  Additional information was provided as follows: The patient experienced redness and swelling that started from injection site and had traveled to the elbowand injection site soreness, after receiving the 1st dose of Shingrix. The reporter di not have all the information available. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: red mark that was not at the injection site, it was more on the back of the arm rather than at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 19th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, 24 hrs after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 20th October 2020, the patient experienced red mark that was not at the injection site, it was more on the back of the arm rather than at the injection site. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Injection site erythema, Injection site pain, Malaise
Clinical narrative: She had fever; Severe fatigue; Malaise; Felt terrible; Redness at the injection site; Pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th October 2020, 1 days after receiving Shingrix, the patient experienced fever. In October 2020, the patient experienced injection site erythema, injection site pain, fatigue, malaise and feeling bad. On an unknown date, the outcome of the injection site erythema, injection site pain, fever, fatigue, malaise and feeling bad were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, fever, fatigue, malaise and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had redness and pain at the injection site.  The patient had Fever and reported severe fatigue and malaise and felt terrible. The reporter did not consent to follow up. All information was not available.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: She had fever; Severe fatigue; Malaise; Felt terrible; Redness at the injection site; Pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th October 2020, 1 days after receiving Shingrix, the patient experienced fever. In October 2020, the patient experienced injection site erythema, injection site pain, fatigue, malaise and feeling bad. On an unknown date, the outcome of the injection site erythema, injection site pain, fever, fatigue, malaise and feeling bad were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, fever, fatigue, malaise and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had redness and pain at the injection site.  The patient had Fever and reported severe fatigue and malaise and felt terrible. The reporter did not consent to follow up. All information was not available.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Dizziness, Fatigue, Injection site erythema
Clinical narrative: Redness starting at the injection site / Down the arm; Confusion; Feeling faint / Dizzy; Tired; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 18th October 2020, 3 days after receiving Shingrix, the patient experienced injection site erythema, confusion, felt faint and tiredness. On an unknown date, the outcome of the injection site erythema and felt faint were not recovered/not resolved and the outcome of the confusion and tiredness were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, confusion, felt faint and tiredness to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced confusion, feeling faint, tired, and dizzy.   The patient also experianced redness starting at the injection site, and travelling about 6 inches down the arm. The reporter consented to follow up.
Sex: U
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This is a spontaneous report from a contactable pharmacist through a Pfizer-sponsored Program.   A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose on 20Oct2020 for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced arm pain on an unspecified date. The patient was still complaining of arm pain. The outcome of not recovered.  No follow-up attempts are needed. Information about batch/Lot number cannot be obtained. No further information is expected
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: very sore arm; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves patient (unknown demographics) who experienced very sore arm (pain in extremity), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious very sore arm (pain in extremity), (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events was not reported.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: vaccine almost killed my 2 yr old / I nearly lost my 2 yr old due to vaccine injury; Initial information and additional information received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-healthcare professional.  This case involves a 2-year-old patient (gender not reported) for whom parent reported that "nearly lost the patient due to vaccine injury/ vaccine almost killed the patient" (vaccination complication), while he/she received INFLUENZA VACCINE [Flue shot].  Medical history, 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) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient's parent nearly lost the patient due to vaccine injury/ vaccine almost killed the patient(vaccination complication) (unknown latency) following the administration of INFLUENZA VACCINE.   Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment.  The event outcome was unknown at the time of reporting.   There will be no information available on the batch number for this case.; Sender's Comments: This case involves a female patient (age unspecified) who experienced vaccination complication with INFLUENZA VACCINE [flu shot]. The time to onset was unknown. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations and other alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccines cannot be assessed.
Age: 65.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Blister, Erythema, Injection site rash
Clinical narrative: A rash developed within the first 24 hours of receiving the Fluad Quad 20-21 vaccine on the upper, right arm around the injection site.  The patient had several patches (5 or 6) that were red and formed blisters. There were no other issues.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: About 45 seconds to 1 minute after vaccination, the patient passed out.  He was unconscious for about 30 seconds and had no recollection of what happened.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Developed hive on left arm with redness and pruritus.  The patient states about hour  later her face was redden and hive on her neck.  She took a Benadryl at 4:00pm and by 6:15pm she feeling slightly better.  When she awoke in the morning, symptoms had subsided.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Limb discomfort, Paraesthesia
Clinical narrative: Patient states right leg had a burning/tingling sensation for a couple of days, then both legs just felt tired/heavy for a couple of days
Sex: F
Vaccine: FLUA3
Symptoms: Chest X-ray, Electrocardiogram, Full blood count, Headache, Laboratory test
Clinical narrative: sever head ache and severe weakness legs heavy, hand shaking uncontrollable. Lasted until 10/15. Inside felt like jelly. 10/11 went to Urgent care then urgent care sent to ER. Labs, imaging and additional tests completed. Tested for Covid and was negative. High WBC 18,000.
Sex: F
Vaccine: FLUA3
Symptoms: Limb discomfort, Muscular weakness, SARS-CoV-2 test negative, Tremor
Clinical narrative: sever head ache and severe weakness legs heavy, hand shaking uncontrollable. Lasted until 10/15. Inside felt like jelly. 10/11 went to Urgent care then urgent care sent to ER. Labs, imaging and additional tests completed. Tested for Covid and was negative. High WBC 18,000.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Oral discomfort, Pain, Pruritus
Clinical narrative: when my lips started to burn a little bit. By the time my shift ended at 1pm, the burning had intensified to feeling like my lips were being pricked with needles. The sensation had spread in to my mouth as well. I called my pcp on my way home and was instructed to take a Benadryl and get a ride to the ER, which I did as soon as I got home. I arrived at hospital around 2:15 and by that time my face was itchy. I was given a steroid injection that stays in my system for 3 days and was instructed to take 50mg of Benadryl every 6 hours for 3 days. I was instructed to not drive or return to work until Monday 10/19 due to the high dose of Benadryl. My symptoms improved by evening, but I had long lasting affect from the medications of nausea and dizziness until Wednesday 10/21.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: arm was reddened and warm to touch around injection site and down arm toward elbow
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Body temperature decreased, Disturbance in attention, Erythema, Headache, Tremor
Clinical narrative: Severe headaches, trouble with concentrating, and shaking, redness, temperature dropped to 94 on 2nd day, went up to 95 on 3rd, and has continued to be 96.
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Sleep disorder
Clinical narrative: The customer was at the pharmacy picking up her prescriptions. She then stated that she got her shot last month and that shoulder still hurts and feels uncomfortable when she trieds to sleep.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Lip swelling, Urticaria
Clinical narrative: Employee reported her lips and eyes were swollen and she experienced generalized hives all over her body.