chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: fever /  low grade fever; aches / pains; fatigue; This case was reported by a physician via call center representative and described the occurrence of fever in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included acetylsalicylic acid (Aspirin) for fever, pain and fatigue.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on unknown date, refer case US2020223951).   On 11th November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient started Aspirin at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix and an unknown time after starting Aspirin, the patient experienced fever, general body pain and fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, general body pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the fever, general body pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix in left arm and experienced fever, aches, pains, and fatigue with a low grade fever.   The patient pretreated with aspirin and had the same reactions.   The symptoms lasted 24 hours and then resolved.   The reporter consented to follow up and could follow up with the physician directly.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020223946:same reporter US-GLAXOSMITHKLINE-US2020223956:same reporter US-GLAXOSMITHKLINE-US2020AMR224651:same reporter US-GLAXOSMITHKLINE-US2020223951:same reporter
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Fatigue, Pain
Clinical narrative: pain; fatigue; received a 3rd dose; This case was reported by a nurse via call center representative and described the occurrence of pain in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number PL3DE, expiry date 5th February 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th May 2020). Concurrent medical conditions included dementia.   On 11th September 2020, the patient received the 2nd dose of Shingrix. On 28th October 2020, the patient received the 3rd dose of Shingrix. In October 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced extra dose administered. On 28th October 2020, the patient experienced pain and fatigue. On an unknown date, the outcome of the pain, fatigue and extra dose administered were unknown.   It was unknown if the reporter considered the pain and fatigue to be related to Shingrix.  Additional deils were provided as follows: The batch number of Shingrix was updated from DL3DE to PL3DE as per sales data sheet. The reporter stated that, during evaluation of pain and fatigue, the patient received 3rd dose of Shingrix, which led to extra dose administered. No further details were provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: shingles; got her first dose 10 months ago and just got her second today; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number NG5N7, expiry date 1st April 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 29th October 2020, the patient received the 2nd dose of Shingrix .5 ml. On 29th October 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient was born in 1963. The patient got her first dose 10 months before time of reporting and got her second on the day of reporting. She had gotten shingles since the first dose and were wondering if it would be recommend a third dose. The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: U
Vaccine: FLUX, PPV, VARZOS
Symptoms: Illness, Pain in extremity
Clinical narrative: sick; arm was sore; Initial information was received on 31-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves an unknown demographic patient who was sick (illness) and arm was sore (pain in extremity), while the patient received INFLUENZA VACCINE, VARICELLA ZOSTER VACCINE RGE (CHO) [SHINGRIX] and PNEUMOCOCCAL VACCINE.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer), PNEUMOCOCCAL VACCINE (not produced by Sanofi Pasteur) and SHINGRIX (not produced by Sanofi Pasteur), batch number and expiry date not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) for three days and arm was sore (pain in extremity) for a week (non-serious events, unknown latency) following the administration of INFLUENZA VACCINE, PNEUMOCOCCAL VACCINE and SHINGRIX.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome of both the event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Disability, Terminal state
Clinical narrative: Disabled and very close to dying; Initial information was received on 05-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional via social media. This case involves a patient (demographics unknown) who was disabled and very close to dying (disability), when received INFLUENZA VACCINE.  Past vaccination(s) included INFLUENZA VACCINE for prophylactic vaccination (had them for probably 30 years prior).  Medical history, medical treatment(s), concomitant medications 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 not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was disabled and very close to dying (disability) (unknown latency) following the administration of INFLUENZA VACCINE.  This event was assessed as medically significant and was leading to disability.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  The information on lot number was requested for this case.; Sender's Comments: This case concerns a patient (demographics unknown) who had disability after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Past vaccination(s) included INFLUENZA VACCINE for probably 30 years prior. Additional information regarding patient's medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion of negative 0.1 degrees C for 5 hours and 51 minutes then, negative 2.6 degrees C for 10 hours and 54 minutes and then positive 1.1 degrees C for 2 hours and 1 minute/ no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional. (Reference number- 00307411) and transmitted to Sanofi on 08-Oct-2020.   This case is linked to cases 2020SA283022, 2020SA283023 and 2020SA283024 (same reporter).  This case involves female patient (of an unknown age) who dose of 0.7 ml suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ516AB, expiry date: 30-Jun-2021) via intramuscular route at an unknown administration site for prophylactic vaccination on 08-Oct-2020, which had temperature excursion of negative 0.1 degrees Celsius (C) for 5 hours and 51 minute s then, negative 2.6 degrees C for 10 hours and 54 minutes and then positive 1.1 degrees C for 2 hours and 1 minute (product storage error).  Medical history, concomitant medications, past medical treatment(s), vaccination(s) and family history were not provided.  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: 68.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue
Clinical narrative: Shipment had been in transit to long with no AE; Initial information regarding an unsolicited valid Non-serious case was received from a pharmacist. (Reference number-00325689) and transmitted to Sanofi on 21-Oct-2020.    It was reported that a 68-year old patient (gender not reported) who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT (lot number: UJ546AA, expiry date: 06/30/2021, Route: Via intramuscular in the right arm) which received delay shipment (Product distribution issue) on 19-oct-2020 and vaccine will administrated as soon as they received for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to product shipment delay.  At the time of reporting, 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: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Ear pruritus, Pharyngeal swelling, Pruritus
Clinical narrative: Itching in left arm immediately, 10 minutes later swelling in throat, itching ears, stomach cramping Made it to hospital ED 30 minutes later 1 epipen, 12:30 25 mg. i.v., i.v. Pepcid
Age: 75.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain in extremity
Clinical narrative: Arm is still sore 2 months after shot
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Low grade fever, body aches, mild headache, tired, no energy.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Patient was administered expired MMRII.; This spontaneous report was received from an other health professional referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not provided.      On 23-OCT-2020, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, frequency, strength and route of administration were unknown; lot # was R029516 and expiration date was 14-OCT-2020; therapy type was rHA) for prophylaxis.         The outcome of the event was unknown.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE/PQC; a patient received MMRII that is 10 days expired; This spontaneous report was received from an office manager, referring to patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 11-NOV-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status rHA) 0.5 milliliter, lot # R031636 has been verified to be a valid lot number, expiration date 01-NOV-2020 (route of administration and anatomical location were not provided)  for prophylaxis. No additional adverse events were reported.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Nerve compression, Pain
Clinical narrative: when getting dressed, same night of vax, started getting the chills. Woke up at 6 am, everything on left side of body was painful, aching, stayed that way the entire weekend. Has pinched nerve on right side, but reaction came from vaccine on left side. Very painful. This is first dose. Still has pain in area where muscles.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Chills in evening, chills overnight, headache and feeling of nausea early next morning, 11/13/20, and throughout the day.  Took Tylenol and Pepcid-AC to counteract symptoms.  Temperature of 100.2 at 10AM,  rose to 101.4 at 12:30PM.    Fever, finally, broke at 2:30pm after taking Advil.  Chills throughout 2nd night, 12/13/20, and I sweat through PJ's and bedding.  Took more Advil and Pepcid-AC on Saturday, 11/14/2020 and began to return to feeling normal in afternoon, although minor headache and sensitive stomach remained.  Much better as of 11/15/2020.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Dyspnoea, Injection site pain, Injection site swelling
Clinical narrative: On 11/16/2020 @ 745am mom called to report patient as experiencing pain and swelling around injection site, but also minor pain in chest and minor difficulty breathing (states patient was "running around like normal"). Mom wanted to know if this was normal after a flu vaccine, Advised pain and swelling at injection site was normal but breathing problems or pain in chest isn't and that the patient should follow up with pediatrician.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: About an hour after injection had hives come up followed by continuous itching. Then face and lips swelled up.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Cold sweat, Dizziness, Mobility decreased, Nausea
Clinical narrative: woke up next morning at 3AM with cold sweats, severe arm pain, could not lift arm. generalized weakness, nausea, felt like she was gong to pass out. Pt applied cold compress and took ibuprofen. Symptoms resolved by that night.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: woke up next morning at 3AM with cold sweats, severe arm pain, could not lift arm. generalized weakness, nausea, felt like she was gong to pass out. Pt applied cold compress and took ibuprofen. Symptoms resolved by that night.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site severe bruising.  Below injection site, from left shoulder down arm until elbow, extremely red itchy, swollen in an oval shape.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Nausea
Clinical narrative: Chills, slightly nauseous, light-headed
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on lower right knee about 1.5 inches across.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: patient had red, swollen, warm to touch left arm following immunization given 11/3/20
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Erythema, warmth and induration at site first noticed 24 hour after vaccine administration. Patient seen in clinic on 11/13/2020 and mother reported that the redness had improved
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Nausea
Clinical narrative: Moderate pain, redness, swelling at vaccination site, nausea, headache, chills, fatigue
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Vaccination site swelling
Clinical narrative: Moderate pain, redness, swelling at vaccination site, nausea, headache, chills, fatigue
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Patient reports soreness and bruising around injection site persisting for 2 months after vaccination
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: patient indicate he is still having soreness and pain at the injection site a month after injection.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Oropharyngeal pain, Rash
Clinical narrative: Outbreak of rash on buttock similar to past experience with shingles, sore throat, arm soreness at injection
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Sleep disorder
Clinical narrative: Severe shivering that prevented sleep
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Started with fever, headache, chills, lasted 2 days, took Acetaminophen for fever.  Highest fever was 100.5, ran around 99.4 - 99.6 most of the day.  Chills was only the first night and fever and headache on and off for 2 days.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: RN reported a improperly stored PROQUAD administration; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, current condition, previous drug reaction or allergy, and concomitant medication were not reported.  On 06-OCT-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot # S027463, expiration date was reported as 02-JUN-2021, but upon internal validation established as 02-MAR-2021) for prophylaxis. The vaccine administered experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit, with an average of 11.8 degrees Fahrenheit for 31 hours as recorded by a data logger. There was no previous temperature excursion.
Sex: U
Vaccine: PPV
Symptoms: Product storage error, Recalled product administered
Clinical narrative: patient was given PNEUMOVAX23 that was recalled; Incorrect Product Storage; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug allergies/reactions were not reported.  On 16-OCT-2020, the patient was vaccinated with recalled dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter (lot # S036495, expiry date 13-SEP-2021), for prophylaxis.  On 16-OCT-2020, 1 day after onset of therapy the patient experienced recalled product administered and product storage error.    The outcome of recalled product administered and product storage error is unknown.   It was also reported that the aforementioned vaccine was incorrectly stored (temperature excursion details were not reported) and administered to the patient before being recalled. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: no additional adverse event reported; an unspecified 5 year old received a dose of PROQUAD that expired on 10/20/2020; This spontaneous report was received from a medical assistant and refers to a 5-year-old patient of an unknown gender. Information about pertinent medical history, drug reaction/allergy was not provided.  On 30-OCT-2020, the patient was vaccinated with dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live with albumin status rHA (recombinant human albumin) (PROQUAD) injection, lot # S012533 for prophylaxis (dose and route of administration were not reported) that expired on 20-OCT-2020. The vaccine and sterile diluent used for reconstitution of vaccine (lot # and expiration date was reported as unknown) had been stored at the appropriate storage condition, specified in the product label, through the date of administration. No confusion or product quality complaint (PQC) human error was reported.  No additional adverse events were reported.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received the MMR II vaccine as wel as the VARIVAX vaccine on both 10/22/2020 and 10/30/2020; This spontaneous report was received from a nurse practitioner and refers to a female patient of an unknown age. Her medical history, concurrent conditions, concomitant medications, drug reaction or allergies were not provided.  On 22-OCT-2020, the patient came to the clinic with the mother and was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHa, lot # S037502, upon internal validation determined as a valid lot #, expiration date was reported and also validated as 20-NOV-2021 (dose, strength were unknown, route of administration and anatomical location were not reported) for prophylaxis.  On the same date, she also received the dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot # T010313, expiration date was reported as 26-MAR-2020 (expired date), but upon internal validation, established as 24-MAR-2022 (dose, strength were unknown, route of administration and anatomical location were not reported) for prophylaxis.  On 30-OCT-2020, 8 days later, the patient came to the clinic with the father, and received the next doses of the same vaccines again, earlier than the recommended interval between doses (inappropriate schedule of product administration). The reporter wanted to ensure, that it was fine for the patient.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: revised temperature excursion data; This spontaneous report was received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical histories, current conditions, previous drugs reactions or allergies, and concomitant medications were not reported.  On an unknown date, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 1 injection (dose, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number S033539, expiration date reported and validated as 22-OCT-2021), measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 1 injection (dose, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T007397, expiration date reported and validated as 29-AUG-2021) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 2 injection (dose, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number S005251, expiration date reported and validated as 20-FEB-2021, lot number S018595, expiration date reported and validated as 17-JUN-2021) for prophylaxis (Improper storage of product in use). The vaccines were exposed to the following temperature excursions: 14 degrees Fahrenheit to 46 degrees Fahrenheit, with an average of 21.8 degrees Fahrenheit for 14 hours as recorded. The temperature excursions were detected by a data logger. There were no previous temperature excursions. The excursion was identified as a result of a digital data logger, however it was the facilities mistake. The refrigerator door had been secured closed, however the door was still slightly ajar and was not noticed until the next morning. The temperature excursion was safe to administer the vaccines. The vaccines were administered post approval from a Merck associate.  This case has been considered non-valid due to the lack of patients' identifiers.
Sex: F
Vaccine: HPV9
Symptoms: Pancreatitis acute
Clinical narrative: presented with acute pancreatitis and went to hospital; This spontaneous report has been received from a physician via a company representative referring to a 14 years old female patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On an unknown date (reported as recently, the exact date was unknown), 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) (lot #, expiration date, route and dose details were unknown) for prophylaxis.         On an unknown date (4 days after the dose), the patient presented with acute pancreatitis and went to hospital. The patient sought medical attention and received treatment.      The patient recovered in 2 days. At the time of this report, the patient was fine. The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, acute pancreatitis was determined to be medically significant.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No other AE reported.; the vaccines were given less than 30 days between live vaccines/ V ARIV AX was invalid because it was given to soon.; This spontaneous report as received from a patient's mother and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 30-SEP-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis.  On 26-OCT-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis.  Her doctor said, that the vaccines were given less than 30 days between live vaccines and that the dose of varicella virus vaccine live (oka/merck) (VARIVAX) was invalid because it was given to soon. On 26-OCT-2020, the patient experienced inappropriate schedule of product administration. The action taken with the suspect therapies, the outcome of the events and causality assessment was not provided.
Age: 1.33
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inadvertent adm.inistration of PROQUAD and Varivax on the same day; This spontaneous report was received from a nurse and refers to a 16-month-old patient of an unknown gender. On 11-NOV-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot# reported as T021644 has been verified to be valid lot number, expiration date 21-DEC-2021, albumin status :rHA (formulation, strength, exact dose, frequency and route of administration were not reported) for prophylaxis and with varicella virus vaccine live (oka/merck) (VARIVAX) lot# T012552, expiration date: 10-APR-2022 (formulation, strength, exact dose, frequency and route of administration were not reported) for prophylaxis. On 11-NOV-2020, the patient experienced inappropriate schedule of product administration. The outcome of inappropriate schedule of product administration was unknown. Causality assessment was not provided.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: No other AE reported for patient; dose of PEDV AX HIB had been administered after undergoing a temperature excursion; This spontaneous report was received from a nurse and refers to a 4 months old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-NOV-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml, one time, lot # T000885 was confirmed to be valid, expiration date 29-MAY-2022 (formulation, route of administration and anatomical location were not reported) for prophylaxis.   Administered dose of vaccine underwent multiple temperature excursions above 47.0 degrees Fahrenheit (F) and below 36 degrees F: on 29-OCT-2020, 35.2 degrees F for 10 minutes, on 30-OCT-2020, 35.0 degrees F for 8 minutes and 49.5 degrees F for 26 minutes, on 03-NOV-2020, 35.2 degrees F for 6 minutes, on 04-NOV-2020, 47.8 degrees F for 21 minutes, on 06-NOV-2020, 35.0 degrees F for 9 minutes, on 09-NOV-2020, 50.0 degrees F for 81 minutes and 33.8 degrees F for 23 minutes.  The improper storage was recorded by digital data logger. There was no additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2011USA008619: US-009507513-2011USA008822:
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Malaise, Pain
Clinical narrative: chills; fever of 100.8; I feel very tired; ache; malaise; This case was reported by a consumer via call center representative and described the occurrence of chills in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (also experienced tiredness, malaise and headache after receiving the 1st dose on 2nd September 2020, refer case US2020178075).   On 5th November 2020 11:00, the patient received the 2nd dose of Shingrix. In November 2020, less than a day after receiving Shingrix, the patient experienced chills, fever, tiredness, pain and malaise. The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, fever, tiredness, pain and malaise were unknown.   It was unknown if the reporter considered the chills, fever, tiredness, pain and malaise to be related to Shingrix.  Additional details were reported as follows: The patient reported this case in the morning of 6th November 2020 (before 9:00 AM). On 5th November 2020, 11:00 am EST, the patient received 2nd dose of Shingrix and had chills all night. In the morning of 6th November 2020, the patient had fever of 100.8 degree F. The patient felt very tired, ache and malaise. The patient stated that he had a similar reaction in the beginning of September for his 1st dose but this reaction was more severe with a temperature. The patient took Tylenol for the 100.8 degree F fever. The patient stated that he was going to wait until tomorrow to see if the symptoms subside, if not then would see a physician but with Covid it was very difficult to see anyone. The patient confirmed that he did not have Covid 19.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020178075:Same reporter
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: chills; fever of 100.8; I feel very tired; ache; malaise; This case was reported by a consumer via call center representative and described the occurrence of chills in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (also experienced tiredness, malaise and headache after receiving the 1st dose on 2nd September 2020, refer case US2020178075).   On 5th November 2020 11:00, the patient received the 2nd dose of Shingrix. In November 2020, less than a day after receiving Shingrix, the patient experienced chills, fever, tiredness, pain and malaise. The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, fever, tiredness, pain and malaise were unknown.   It was unknown if the reporter considered the chills, fever, tiredness, pain and malaise to be related to Shingrix.  Additional details were reported as follows: The patient reported this case in the morning of 6th November 2020 (before 9:00 AM). On 5th November 2020, 11:00 am EST, the patient received 2nd dose of Shingrix and had chills all night. In the morning of 6th November 2020, the patient had fever of 100.8 degree F. The patient felt very tired, ache and malaise. The patient stated that he had a similar reaction in the beginning of September for his 1st dose but this reaction was more severe with a temperature. The patient took Tylenol for the 100.8 degree F fever. The patient stated that he was going to wait until tomorrow to see if the symptoms subside, if not then would see a physician but with Covid it was very difficult to see anyone. The patient confirmed that he did not have Covid 19.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020178075:Same reporter
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Felt like crap; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, immediately after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Influenza vaccine Quadrivalent 2020-2021 season.  The reporter was patients wife. The age at vaccination was not reported. The reporter stated that the patient just got the flu vaccine and felt like crap since vaccination.  The reporter reported that patient would not get another one. No further details were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot and I got the shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided. The reporter asked the reason for having shingles after receiving vaccination. No further information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure\Shingrix in September. Was diagnosed with Shingles for the first time last week; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received Shingrix. On an unknown date, between 1 and 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The case has been considered as suspected vaccination failure being full schedule was unknown.
Age: 51.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Asthenia, Chills, Discomfort, Feeling hot, Loss of personal independence in daily activities
Clinical narrative: Received flu vax. 8-9pm same night. General of not feeling well, had slight hint of queeziness, along with discomfort. by 11pm same night, had temp with ears and neck warm. Had sudden muscle twitching, teeth chattering, with chills, felt overheated. When checked temp at 11pm, temp was 101.2. Took 1000mg (generic tylenol) aphedaminesine to ease the fever. Temp at midnight, was still 100.0-101.0. Slept most of the next day. On following day, temp had decreased to 99.0. Still was weak and could not do much. On 11.15.20 checked temp and it was normal.
Age: 51.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Malaise, Muscle twitching, Nausea, Pyrexia, Skin warm
Clinical narrative: Received flu vax. 8-9pm same night. General of not feeling well, had slight hint of queeziness, along with discomfort. by 11pm same night, had temp with ears and neck warm. Had sudden muscle twitching, teeth chattering, with chills, felt overheated. When checked temp at 11pm, temp was 101.2. Took 1000mg (generic tylenol) aphedaminesine to ease the fever. Temp at midnight, was still 100.0-101.0. Slept most of the next day. On following day, temp had decreased to 99.0. Still was weak and could not do much. On 11.15.20 checked temp and it was normal.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Diarrhoea, Peripheral swelling, Pyrexia, Rash
Clinical narrative: DIFFUSE RASH, 102 FEVER, DIARRHEA, HAND AND FEET SWELLING
Age: 84.0
Sex: F
Vaccine: FLUA4
Symptoms: Formication, Sleep disorder
Clinical narrative: She wakes up in the middle of the night and feels like there is a worm crawling underneath her skin.  She cannot go back to sleep. Pharmacist advised her to take Tylenol and ice on the arm.  Follow up with doctor.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Mobility decreased, Pain, Swelling
Clinical narrative: Patient states that 4 hours after her influenza vaccination on 10/05/2020 she began having a stabbing pain, with difficulty lifting her left arm over her hand, with occasional numbness in her left hand. NSAID's have helped with the patient's swelling very little. Patient is still currently having all the listed symptoms.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left thigh appx 4 cm redness/swelling at injection site, some improvement day 2.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema
Clinical narrative: Patient's arm was red and bruised.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: cellulitis
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Muscle tightness
Clinical narrative: Patient feels arm, shoulder up to his neck stiff and the more he uses it the worse it gets. About a week after he got the shot since it did not get any better he got in touch with his PCP who suggested hot and cold compresses on the site. He kept doing it and massaging the area with no help. He also went to the doctor since nothing had helped about 3 weeks later, no pain, just feel his muscles all tightened up all the way to his neck. The PCP prescribed him an steroid pills. He took them but still no help. PCP recommended seeing a neurologist. Caller believes it is related to the shot, he takes it every year and never had this problem before. Still feel stiffness. Have not gone to neurologist, financial burden.
Age: 65.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Chills, Headache, Migraine, Musculoskeletal stiffness, Nausea
Clinical narrative: Sore, stiff arm before bedtime. Appoximately, 2:00 AM awoke with aching body and pain. Pain scaled  a 10 on level 1-10. Chills, chattering teeth,  migraine headache with nausea. Unable to vomit, violent dry heaving, empty stomach. Approximately, 4:00am normal dose for Tylenol taken, no relief. Symptoms lasted intensely between 2:00- 10:00am. Patient had gingle ale and crackers 07:00am and still not able to vomit. Ibuprofen taking approximately around 11:00, no relief. Nausea rest of day for 11/15/2020 with mild headache. 11/16/20 relief of symptoms, no TMJ headache and low nausea today.
Age: 65.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Retching
Clinical narrative: Sore, stiff arm before bedtime. Appoximately, 2:00 AM awoke with aching body and pain. Pain scaled  a 10 on level 1-10. Chills, chattering teeth,  migraine headache with nausea. Unable to vomit, violent dry heaving, empty stomach. Approximately, 4:00am normal dose for Tylenol taken, no relief. Symptoms lasted intensely between 2:00- 10:00am. Patient had gingle ale and crackers 07:00am and still not able to vomit. Ibuprofen taking approximately around 11:00, no relief. Nausea rest of day for 11/15/2020 with mild headache. 11/16/20 relief of symptoms, no TMJ headache and low nausea today.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Enema administration, Gastrointestinal necrosis, Haematochezia, Intestinal anastomosis, Intussusception
Clinical narrative: Vomiting started on day 4 (11/9/2020). Televisit early in the day, then In-office MD exam for persistent vomiting and sent to hospital E/R followed by admission to pediatric floor
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Surgery, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Vomiting started on day 4 (11/9/2020). Televisit early in the day, then In-office MD exam for persistent vomiting and sent to hospital E/R followed by admission to pediatric floor
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: Hives around injection site warm, red, itchy. Lasted 2 hours approx.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Tremor
Clinical narrative: Startle reflex activated at the slightest touch; vibrating or trembling limbs; inconsolable crying; inability to make & maintain eye contact.  Symptoms lasted approx. 5-6 hours.  I suspect her egg allergy is connected to the vaccination.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Feeling cold, Headache
Clinical narrative: Approximately 13 hours after the shot I became very cold and shivered violently and uncontrollably for about 45 minutes. I also had muscle and joint pain throughout my body)( so strong that I could not sleep), yet I was very fatigued. These symptoms (except for the 45-minutes of shivering) lasted throughout the following day, along with headache.  Pain in my right arm took about a week to resolve.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Sleep disorder
Clinical narrative: Approximately 13 hours after the shot I became very cold and shivered violently and uncontrollably for about 45 minutes. I also had muscle and joint pain throughout my body)( so strong that I could not sleep), yet I was very fatigued. These symptoms (except for the 45-minutes of shivering) lasted throughout the following day, along with headache.  Pain in my right arm took about a week to resolve.
Age: 66.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: During the evening of administration, patient reports feeling fever (100.6 F). Following evening 102.4 F, HA, bodyaches, decreasing sx over the next 2 days, 100.9 3 days later; motrin and Tylenol alternated for sx relief.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Erythema
Clinical narrative: Patient received vaccine on 11/13. Noticed around 9pm the same night of the vaccine, patient noticed redness on her the upper arm toward the front of shoulder. Then developed two blisters filled with clear fluid that patient noticed in the next morning, no pain, no swelling at site, still had redness. On Sunday night 11/15 the blisters burst still no pain, no itching, no other symptoms. Today on 11/16 it is forming another blister. At the site where the injection was given there was no redness, no swelling, but arm was sore. Did report it to dr's office.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Blood iron normal, Blood magnesium normal, Blood phosphorus normal, Full blood count normal, Metabolic function test normal
Clinical narrative: Parent reports onset of tics following above vaccine, which gradually improved over the course of the year, and with worsening again of tics following influenza vaccine on 10/22/20
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Streptococcus test negative, Tic, Vitamin B12 normal, Vitamin B6 normal
Clinical narrative: Parent reports onset of tics following above vaccine, which gradually improved over the course of the year, and with worsening again of tics following influenza vaccine on 10/22/20
Age: 53.0
Sex: F
Vaccine: DTAP, FLU4, TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: The vaccine hurt when the nurse did it. After 2/3 days of pain, that I thought was normal after a shot, the pain didn't disappeared, even increased. I cannot move my arm in many ways.  After almost 4 weeks, some movements are still impossible, it's like I'm stabbed with a knife.
Age: 53.0
Sex: F
Vaccine: DTAP, FLU4, TDAP
Symptoms: Arthralgia, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: The vaccine hurt when the nurse did it. After 2/3 days of pain, that I thought was normal after a shot, the pain didn't disappeared, even increased. I cannot move my arm in many ways.  After almost 4 weeks, some movements are still impossible, it's like I'm stabbed with a knife.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Peripheral swelling, Vomiting
Clinical narrative: The patient had severe swelling in her right arm about 8 hours after she was given the Pneumovax 23 immunization in her right arm. She also received the Shingrix vaccination the same day but in the left arm. After taking 2 benadryl , the patient started vomiting and went to the ER where she received a cocktail for vomiting/allergic reaction and the ER physician said she was having an allergic reaction. The patient went home and the swelling went down, but her arm felt very hard.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Eye swelling, Heart rate increased
Clinical narrative: Patient reported racing heart rate and swollen eyes lasting for about two days.