chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Chest discomfort, Dyspnoea, Pain, Swelling
Clinical narrative: swelling-severe w/in 1 hour of immunization. Chest tightness/pain/short of breath/trouble breathing by the following day
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: Fever 101-103 Severe Headache Dizziness
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 9/24/20 Rec'd flu vaccine 36 hrs after red/swollen/warm (started about 24 hrs after shot) abx for ? cellulitis
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Presyncope, Skin laceration, Suture insertion, Syncope
Clinical narrative: VASOVAGAL RESPONSE  PATIENT PASSED OUT  HIT CHIN ON FLOOR - 4 STITCHES  PATIENT SAT AFTER INJECTION, STOOD UP, SPOKE TO PARENTS, THEN COLLAPSED
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Genital blister, Genital rash, Pain, Pruritus
Clinical narrative: Per RN note, patient reporting getting a zoster vaccine. Patient has a history of shingles and after getting the vaccine, reported a rash and blisters on left labia for 2 days. Reported some pain and itching.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Crying, Pain
Clinical narrative: Patient felt stabbing pain after Adacel was given. To the point where he was crying. Other arm felt fine. Site was (L) Deltoid. No swelling, bleeding, inflamation at site. Gave Ice pack and 200mg Ibuprofen PO. Patient felt better after 20 minutes.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: She said arm was swollen from bicep to her back. It was real red. It is a lot better now
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: "yesterday my arem was sore. More sore than usual with a shot to the point it was difficult to move. Last night, I had the chills and was very achyespecially in my joints. This morning, I checked my temperature and do not have a fever. I feel better, but I am groggy from lack of sleep".
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Somnolence
Clinical narrative: "yesterday my arem was sore. More sore than usual with a shot to the point it was difficult to move. Last night, I had the chills and was very achyespecially in my joints. This morning, I checked my temperature and do not have a fever. I feel better, but I am groggy from lack of sleep".
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: injection given. approx. 5 mins later patient experienced a syncopal episode. patient was given juice and menotired for 15 mins.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was no adverse event, patient was given high dose vaccine against protocol and upon speaking to them, experienced no side effects.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was no adverse event, patient was given high dose vaccine against protocol and upon speaking to them, experienced no side effects.
Age: 71.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Inflammation, Laboratory test normal, Skin warm
Clinical narrative: Right arm develop cellulitis - hospitalization  1 Day red, hot, & inflamed From  Pneumovax - 23
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: Reddot dime sized has not gone away.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: injection given. immediately afterwards she experienced a syncopal episode lasting approx. 1 - 2 mins. patient was given juice and monitored for 15 mins.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Nausea, Pain
Clinical narrative: HEADACHE nausEA BODYACHE RED ARM (size softball)
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Paraesthesia
Clinical narrative: Patient stated vaccine hurt when recieved, then arm was numb, had doctors visit next day, arm still numb with pins and needles feeling to fingertips
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Patient stated vaccine hurt when recieved, then arm was numb, had doctors visit next day, arm still numb with pins and needles feeling to fingertips
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Expired product administered
Clinical narrative: No additional AE reported.; PROQUAD was administered on a patient today (25-SEP-2020). She said fue vaccine was expired on 16-SEP-2020.; This spontaneous report was received from a registered nurse, referring to a 5-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 25-SEP-2020, the patient was incidentally vaccinated with an expired measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, 0.5 milliliter (ml) as prophylaxis (lot number S008573 which has been verified to be valid, expiration date reported and validated as 16-SEP-2020) (vaccination scheme, frequency, route of administration and anatomical site of injection were not reported) (expired product administered). No additional adverse events were reported in the patient.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Anhedonia, Anxiety, Depressed mood, Dizziness, Fatigue
Clinical narrative: - Lightheadedness - Fainting - Fever - Extreme fatigue - Dizziness - Headache - Nausea - Anxiety - Depressed mood/anhedonia  Called advice nurse. No treatment given.   Lasted for 3 (three) days
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Nausea, Pyrexia, Syncope
Clinical narrative: - Lightheadedness - Fainting - Fever - Extreme fatigue - Dizziness - Headache - Nausea - Anxiety - Depressed mood/anhedonia  Called advice nurse. No treatment given.   Lasted for 3 (three) days
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Insomnia, Nausea, Pain
Clinical narrative: Chills headache body aches sleeplessness  Nausea
Age: 66.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Muscle pain, fever, chills, headache, stomach distress.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; Nurse reported the patient received an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a licensed Practical Nurse referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not provided.      On an unspecified date in August 2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (concentration, number of administered dose, vaccination scheme frequency, anatomical location and route of administration were not reported; lot number T000702 and expiration date 01-OCT-2021) as prophylaxis. No adverse symptoms reported.  According to the reporter, the temperature excursion was above 9 degrees Celsius (13.4 degrees Celsius) for a time frame of 51 hours and 36 minutes on an unspecified date (product storage error), without any previous temperature excursion; which was detected by a digital data logger.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: vaccination to patient with improperly stored vaccine; This spontaneous report as received from a nurse refers to a currently 4-month-old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported.  On an unknown date, the patient was vaccinated with improperly stored vaccine rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number and expiration date were unknown, strength and frequency were not reported) 0.5 milliliter (ml) orally for prophylaxis. The vaccine was stored under 28 Fahrenheit (F), 33.9 F and 50.2 F for 7 hours and 10 minutes. It was reported that there was no previous temperature excursion. The event was found supported after the vaccination. The digital data logger was not involved.   This was one of six reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA009426: US-009507513-2009USA009674: US-009507513-2009USA009446: US-009507513-2009USA009550: US-009507513-2009USA009631:
Sex: M
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC details provided.; PNUEMOV AX 23 was administered to 2-3 male patients today; This spontaneous report was received from a pharmacist referring to a male patient of unknown age. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not provided.  On 23-SEP-2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) at a dose of 0.5 milliliter as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, anatomical location and route of administration were not reported; lot # T010779, expiration date reported as 30-JAN-2022). No additional adverse event details provided.  According to the reporter, the vaccine that was stored in their refrigerator that broke and reached a temperature of 68 degrees Fahrenheit for 12 hours on 21-SEP-2020 (product storage error), without any previous temperature excursion; which was detected by a digital data logger.  This is one of two reports form the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T010779; expirationdate: 30-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 meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA009474:
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The 2nd dose of PROQUAD was given 1 month after 1st dose in error/Customer reporting a dose of PROQUAD being given too early in 2 patients.; This spontaneous report was received from an administrator, referring to a female patient (one of twins) of unknown age. The patient's historical condition and concurrent condition were not provided. Concomitant therapy included sterile diluent.   On 25-SEP-2020, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status of rHA (recombinant human albumin)) (PROQUAD) (lot# T016989, expiration date 11-NOV-2021; strength, route were unknown) for prophylaxis. The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was given too early in the patient (also reported as the 2nd dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was given 1 month after 1st dose in error) (inappropriate schedule of vaccine administered).   This is one of two reports received from same reporter.; Sender's Comments:  US-009507513-2009USA011339:
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: Patient experienced more injection site pain than usual with this injection; This spontaneous report was received from a consumer (patient's mother) via company representative and referring to a 12 (units not provided) female patient. The patient's pertinent concurrent conditions, ,medical history and previous drug reactions or allergies were unknown by the reporter. The patient concomitant medications included influenza virus 3v reassortant vaccine live intranasal (cold adapted ann arbor master strain) (FLUMIST (INFLUENZA VIRUS 3V REASSORTANT VACCINE LIVE INTRANASAL (COLD ADAPTED ANN ARBOR MASTER STRAIN))).      On 23-SEP-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, anatomical location and route of administration, lot number and expiration date were unknown by the reporter).   On the same day, the patient experienced more injection site pain than usual with this vaccine (vaccination site pain). It was unknown by the reporter if the patient sought medical attention, if any laboratory diagnostic or studies were performed or if any treatment was given to the patient.    At the time of this report, the outcome of vaccination site pain was unknown by the reporter.   The causality assessment between suspect vaccine and the aforementioned event was not reported.; Sender's Comments:  US-009507513-2009USA010652:
Sex: U
Vaccine: MMRV
Symptoms: Underdose
Clinical narrative: Customer reports a child received 0.3 ml of PROQUAD vs the correct 0.5 ml of PROQUAD; Customer reports a child received 0.3 ml of PROQUAD vs the correct 0.5 ml of PROQUAD; This spontaneous report was received from a pharmacist concerning a patient of unspecified age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and historical drug were not provided.  On 24-SEP-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) recombinant human albumin (rHA) 0.3 milliliters (vaccine underdose/Incorrect dose administered) Lot number T013539 and expiration date 17-OCT-2021, for prophylaxis (route of administration, was not provided). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Dose of vaccine which were not stored at recommended range was administered; This spontaneous report was received from the administrator, and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 18-SEP-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S025155, expiration date 13-AUG-2021, once (dose, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature above 47 degree fahrenheit (71.92 F) during 4 hours and 55 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved.  This is one from several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA010653:
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus
Clinical narrative: The patient experienced redness and itching after administration of PNEUMOVAX 23; The patient experienced redness and itching after administration of PNEUMOVAX 23; This spontaneous report has been received from a pharmacist, concerning a female patient of unknown age.   The patient's concurrent conditions, medical history and concomitant medication were not reported.  On an unknown date,  the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, frequency, anatomical location, lot number and expiration date were not reported) as prophylaxis.   On unknown date (reported as "a couple of years ago"), she experienced redness and itching after the administration of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). At the reporting time, the outcome for the events was unknown.   The causal relationship between both events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.   This is one of the two cases created from the same reporter (captured in MARRS#2009USA010118).; Sender's Comments:  US-009507513-2009USA010118:
Sex: F
Vaccine: HPV4
Symptoms: Loop electrosurgical excision procedure, Smear cervix abnormal
Clinical narrative: The patient recently had an abnormal papanicolau (PAP) smear; This spontaneous report has been received from a consumer via company representative. The information provided about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history was unknown by the reporter.  On an unspecified date in 2006, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injection for vaccination (strength, dosage schedule, route of administration, anatomical site of vaccination, vaccination scheme frequency, lot number, and expiration date were not reported).  On an unspecified date (reported as recently), the patient had an abnormal Papanicolaou (PAP) smear (smear cervix abnormal). On 23-SEP-2020 (reported as yesterday), the patient completed a loop electrical excision procedure ((LEEP) reported as LEAP) which results are not available yet. At the reporting time, the patient was recovering from the event and did not south for medical attention.   The causal relationship between quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and the events occurrence was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional adverse event reported; Nurse reported an expired MMR II vaccine was administered to a patient. The MMR II expired on 30 AUG 2020 and was administered on 21 SEP 2020; This spontaneous report was received from a licensed practical nurse concerning a patient. The patient's concurrent conditions, medical history, drug reactions/allergies, historical drug and concomitant therapies were not provided.  On 21-SEP-2020, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) recombinant human albumin (rHA) 0.5 milliliter, lot number R024906 and expiration date 30-AUG-2020 (expired vaccine administered), for prophylaxis. (route of administration was not provided)
Sex: F
Vaccine: HEP
Symptoms: Headache, Hepatitis A, Liver function test abnormal
Clinical narrative: The patient reported she had hepatitis A/she almost died/Her liver results still not normal; The patient stated that she had a headache; This spontaneous report has been received from a female consumer of unknown age regarding on herself. There was no information provided about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history.  On an unspecified date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) injection, route of administration reported as in the arm, to prevent Hepatitis B (strength, dosage, anatomical site of vaccination, vaccination scheme frequency, lot number, and expiration date were not reported).   On an unspecified date in April 2020, the patient experienced a headache which was treated with acetaminophen (TYLENOL) and hepatitis A. The patient reported that she did not know that she had hepatitis A and that she almost died due to the event. The patient sought for medical attention and was hospitalized for a period of 4 days due to the event. Furthermore, it was reported that the patient had routine laboratory work since being discharged.    The outcome of the events was reported as recovering however, she stated that her liver results were still not normal.  The causal relationship between vaccination with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) and the events occurrence was not provided. The event hepatitis A was considered to be a life-threatening event.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Incorrect route of product administration
Clinical narrative: having a reaction; gave it to her subcutaneously; This case was reported by a pharmacist via interactive digital media and described the occurrence of adverse reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the adverse reaction and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received her Shingrix shot from her physician but was having a reaction. By talking to the patient the reporter realized that they gave it to the patient subcutaneously instead in deltoid, which led to intramuscular formulation administered by other route.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: shingles and blisters on the right lower back; blisters on the right lower back; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in late 1990s).   On 17th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 19th September 2020, 2 days after receiving Shingrix, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles and blister were not recovered/not resolved.   It was unknown if the reporter considered the shingles and blister to be related to Shingrix.  Additional information was provided as follows: The case was reported by the patient's wife. The patient experienced shingles and blisters on the right lower back after the 1st dose of Shingrix. The reporter mentioned that the shingles and blisters were still currently on her husband's back and that was the same place where he broke out with shingles previously in the late 1990s. The reporter had no lot number or expiration date information to provide. The reporter consented to follow up with HCP.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020188895:Same Reporter US-GLAXOSMITHKLINE-US2020188897:Same Reporter
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Vomiting
Clinical narrative: flu-like symptoms; aching; vomiting; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult 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, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, pain and vomiting. On an unknown date, the outcome of the influenza-like symptoms, pain and vomiting were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain and vomiting to be related to Shingrix.  Additional information was provided as follows: The case was reported by the friend of the patient. The age at vaccination was not reported but selected as an adult as per the vaccine indication. The patient experienced vomiting, aching and flu-like symptoms after the 2nd dose of Shingrix. The events lasted for a day or two and then were resolved. The reporter did not feel comfortable while providing any additional details regarding these events for her friend. The reporter did not consent to follow up. The case is linked with the case- US2020188892  and US20201888957, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020188892:Same Report US-GLAXOSMITHKLINE-US2020188897:Same Report
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Vomiting
Clinical narrative: flu-like symptoms; aching; vomiting; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, pain and vomiting. On an unknown date, the outcome of the influenza-like symptoms, pain and vomiting were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain and vomiting to be related to Shingrix.  Additional information was provided as follows: The case was reported by the friend of the patient. The age at vaccination was not reported but selected as an adult as per the vaccine indication. The patient experienced vomiting, aching and flu-like symptoms after the 2nd dose of Shingrix. The events lasted for a day or two and then were resolved. The reporter did not feel comfortable while providing any additional details regarding these events for her friend. The reporter did not consent to follow up. The case is linked with the case- US2020188892  and US20201888955, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020188895:Same Report US-GLAXOSMITHKLINE-US2020188892:Same Report
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling / result of alcohol getting into the injection site; Soreness / result of alcohol getting into the injection site; Redness / result of alcohol getting into the injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included bexsero (received 1st dose on unknown date).   On 10th June 2020, the patient received the 2nd dose of Bexsero (intramuscular). On an unknown date, less than 4 months after receiving Bexsero, the patient experienced injection site swelling, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain and injection site erythema to be related to Bexsero.  Additional details were provided as follows: The patient was vaccinated with 2nd dose of Bexsero. After vaccination patient experinced  soreness, redness, and swelling that was fist sized. The reporter stated that patient reports going to Urgent Care for these symptoms. The patient was told that  symptoms were the result of alcohol getting into the injection site from cleaning the skin. The reporter consent to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Vaccine positive rechallenge
Clinical narrative: After second dose "off the wall" rapid heartbeat.; This case was reported by a consumer via call center representative and described the occurrence of heartbeats increased in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heartbeats increased and premature ventricular contractions. Previously administered products included Metoprolol (received on an unknown date, had metoprolol for PVC and slight rapid heartbeat) and Shingrix with an associated reaction of heart rate increased (1st dose received on an unknown date refer case US2020AMR192310).   On 22nd September 2020, the patient received the 2nd dose of Shingrix. In September 2020, 7 hrs after receiving Shingrix, the patient experienced heartbeats increased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the heartbeats increased was unknown.   It was unknown if the reporter considered the heartbeats increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient herself. The reporter did not have LOT or EXP date. Caller reported that she got her 2nd dose of Shingrix yesterday from the date of reporting. On 23th September 2020, 7 hours later the patient experienced off the wall rapid heartbeat. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR192310:SAME PATIENT (1st dose)
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Back pain, Headache, Neck pain, Pain, Wrong product administered
Clinical narrative: Pain as "I've never felt such fire in my head, neck, and back"; Pain as "I've never felt such fire in my head, neck, and back"; Pain as "I've never felt such fire in my head, neck, and back"; Pain as "I've never felt such fire in my head, neck, and back"; requested that her son receive Menveo. The HCP administered Bexsero; This case was reported by a consumer via call center representative and described the occurrence of pain burning in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Menveo (immunization received on an unknown date).   On 22nd September 2020, the patient received Bexsero. On 22nd September 2020, 1 hr after receiving Bexsero, the patient experienced pain burning, headache, neck pain, back pain and wrong vaccine administered. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain burning, headache, neck pain and back pain were not recovered/not resolved and the outcome of the wrong vaccine administered was unknown.   It was unknown if the reporter considered the pain burning, headache, neck pain and back pain to be related to Bexsero.  Additional details were reported as follows: Reporter was patient's mother. Reporter requested that the patient receive Menveo, but the healthcare professional administered Bexsero, which led to wrong vaccine administered. On 22nd September 2020, 1 hour after receiving Shingrix, pain symptoms started and became increasingly worse. The patient described his Pain as that he had never felt such fire in his head, neck, and back. The patient still had the symptoms and had taken ibuprofen. The reporter did not consented to follow-up.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient was supposed to receive imovax on (day 0, 3, 7, and 14) but only came to receive vaccine (on days 0, 7, and 10), no AE; Initial information was received on 21-Aug-2020 regarding an unsolicited valid non-serious case from a pharmacist. This case involves male patient (age unspecified) who was supposed to receive RABIES (HDC) VACCINE [IMOVAX RABIES] on (day 0, 3, 7, and 14) but only came to receive vaccine (on day 0, 7, and 10) (inappropriate schedule of product administration).  The medical history included animal bite (bitten by pit bull).  The past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 01-Aug-2020, the patient received a dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site for post exposure immunisation.   On 07-Aug-2020, the patient received a dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site for post exposure immunisation.   On 10-Aug-2020, the patient received a dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site for post exposure immunisation.  It was a case of an actual medication error due to inappropriate schedule of vaccine administered.  It was reported that the patient was having a complete deviation of schedule of Imovax for a post exposure and was previously unvaccinated. He was ordered to receive Imovax on day: 0, 3, 7, and 14 but only came in on day 0, 7, and 10. The prescriber was following a 4 days dosing schedule.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered with expired Daptacel / No Ae; Initial information was received on 21-Sep-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four years old male patient who was administered with 0.5 mL dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5523AA and expiry date 20-Sep-2020) via intramuscular route in the right deltoid for prophylactic vaccination on 21-Sep-2020 (expired product administered)  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  Case details: Nurse called to ask if there is a leeway for administered expired Daptacel to consumer. He was wondering if he should give consumer another dose.  It was an actual medication error case due to expired vaccine used (latency: same day).   At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received vaccine after it had been exposed to freezing temperatures of 30.9 degrees F for 2 hours, no AE; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 68 years old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] after it had been exposed to freezing temperatures of 30.9 degrees F for 2 hours due to refrigerator malfunction (product storage error).  The medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient received no other concomitant vaccines.   On 22-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ453AB, expiry date: 30-Jun-2021, form: prefilled syringe) via intramuscular route in unknown administration site.  It was a case of an actual medication error due to product storage error temperature too low.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: 15 month old female patient administered expired dose of Daptacel, no AE; Initial information received on 23-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 month old female patient who was vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 23-Sep-2020, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number not reported and expiry date: 20-Sep-2020) via an intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: No adverse event, Product administered at inappropriate site, Product administered to patient of inappropriate age
Clinical narrative: A 4 year old patient was administered Adacel, no AE; A 4 year old patient was administered Adacel on thigh, no AE; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 4 year old female patient who was administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] on thigh (product administered to patient of inappropriate age and product administered at inappropriate site).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and POLIO VACCINE INACT (IPV) for prophylactic vaccination.  On 23-Sep-2020, the patient received a 0.5 ml fifth dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6737AA, expiry date: 09-Jul-2022, form: Injection, strength: standard) once via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration and vaccine administered at inappropriate site (latency same day).  At the time of report, patient had no adverse event (AE) symptoms .  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Headache, Lethargy, Nausea, Pain in extremity, Vomiting
Clinical narrative: Patient complained of nausea, vomited, arm was sore, lethargy, headache.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Headache, Influenza like illness, Injected limb mobility decreased, Injection site pain, Malaise
Clinical narrative: Patient complained of nausea, vomited, arm was sore, lethargy, headache.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: Patient complained of nausea, vomited, arm was sore, lethargy, headache.
Age: 73.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Erythema
Clinical narrative: Patient developed two red rings on his abdomen--stated they looled like tick bites with out the center spot. they were not itchy. He stated he had not other symptoms--no dificulty breathing or any thing else.  it resolved by the following morning.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Syringe issue
Clinical narrative: During administration of influenza vaccine, plunger would not advance after needle was in patient's deltoid. Needle was removed and thus patient needed to receive an additional needle stick in order to receive influenza vaccine.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: patient received vaccine that morning and later that evening around 5pm called the pharmacy and said her arm had begun to swell and was red and a little warm to touch. No difficulty breathing or swelling of face or throat. Just in the arm where vaccine was given.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Patient developed diffuse body shaking that lasted for several hours.  Onset was about 8 hours after the shot.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Fatigue, Severe headache,  Nausea
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sickest she's ever been; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 95-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with Flu shot decade ago and eperienced sickness. After that patient had no more vaccine and no more flu. The reporter did not consent to follow up
Sex: F
Vaccine: FLUX
Symptoms: Local reaction, Vaccination site reaction
Clinical narrative: severe local reaction; Initial information received on 16-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 60 years old female patient who experienced severe local reaction (vaccination site reaction), while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  On an unknown date in 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number, expiry date not reported) via an intramuscular route at an unknown administration site for prophylactic vaccination.  On an unknown date in 2019, the patient developed a non-serious severe local reaction (vaccination site reaction) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Pharmacist states it was a hospital employee of theirs that had the reaction and she wonders if the flu shot is available intradermal or a nasal?   Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was reported as unknown for local reaction.  There will be no information available on batch number for this case.
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Pneumonia
Clinical narrative: pneumonia; Initial information received on 17-Sep-2020 regarding an unsolicited valid serious case received from a consumer non-healthcare professional.  This case is linked to case 2020SA257965 (same reporter).  This case involves a 72-years-old female patient who experienced pneumonia, while she received INFLUENZA VACCINE.  The patient's medical history included smallpox, pneumonia and allergy to eggs due to which she had the reactions of abdominal pain, peripheral swelling and rash macular.  The patient's past vaccination included smallpox vaccine (when studied abroad and came down with cowpox) and Influenza vaccine (unknown manufacturer).  The patient's past medical treatment and family history were not provided.  At the time of the event, the patient had ongoing food allergy.  Concomitant medications included two part and booster PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE).  On an unknown date, the patient received a once 0.5 mL 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 serious pneumonia unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  On an unknown date, the patient recovered from pneumonia.  Batch number has been requested for suspect product for this case.; Sender's Comments: An 72-years-old female patient who presented with pneumonia following the vaccination with INFLUENZA VACCINE (unknown manufacturer).Time to onset is not clearly defined. Medical history include smallpox, pneumonia, abdominal pain, peripheral swelling and rash macular. Patient also had ongoing food allergy. Concomitant medication include PNEUMOCOCCAL VACCINE. Patient's past vaccination included smallpox vaccine and Influenza vaccine. Precise etiological 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.