chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: This is a non-serious spontaneous case reported by other health professional to VAERS (VAERS ID: 783111) and initially retrieved from VAERS by Seqirus on 12-Jan-2019, concerning a male patient of an unspecified age. On an unspecified date, the patient was administered Influenza vaccine, dose, route of administration, anatomical location, batch number, manufacturer, trade name and expiry date: not reported for an unknown indication. On an unspecified date, after vaccination, the patient experienced pain at the injection site. The outcome of the event was not reported. Reporter's Comments: A male patient of an unspecified age experienced injection site pain on an unspecified date after the administration of INN Flu Vaccine Seasonal. The company assessed the causality of the event as unassessable due to lack of information regarding onset latency.
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Cold sweat, Erythema, Peripheral swelling, Urticaria
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS and initially retrieved on 18-Jan-2019 by Seqirus from VAERS (VAERS ID: 783119), concerning a 65-year-old, elderly male patient. The patient's medical history included bone marrow transplant for AML (acute myelogenous leukaemia). The patient was allergic to penicillin. The patient did not have any ill conditions at the time of vaccination. On 10-Oct-2018, the patient was administered INN Flu vaccine seasonal (anatomical location: left arm, route of administration, dose, batch number, trade name, manufacturer and expiry date: not reported) for an unknown indication. The patient was also administered non-company suspect vaccine Pneumococcal vaccine polyvalent (anatomical location: right arm, route of administration, dose, batch number and expiry date: not reported] for an unknown indication. On 11-Oct-2018, 1 day after vaccination, the patient experienced right arm swelling till elbow which had a red look like sunburn. The patient also experienced 50 cent size hives on right arm, cold sweats and chills for two days. On an unspecified date patient visited physician office. On an unspecified date, the outcome of the events was recovered. The reporter assessed this case as non-serious. Significant case amendment (18-Jan-2019): The as determined causality' was changed from related to not related for the events (erythema, peripheral swelling and urticaria) in event assessment tab. The case comment was amended accordingly. Reporter's Comments: A 65-year-old male patient experienced right arm swelling, redness, hives, cold sweats and chills, 1 day after vaccination with INN Flu vaccine seasonal and co-suspect vaccine Pneumococcal vaccine polyvalent. The company assessed the causality of the events chills and cold sweats as possibly related as the causal role of suspect vaccine cannot be ruled out. The company assessed the causality of the events (erythema, peripheral swelling and urticaria) as not related as the site-specific events occurred in the right arm in which co-suspect vaccine was administered.
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 29-Dec-2018 by Seqirus from VAERS (VAERS ID: 783681), concerning a female patient of unspecified age. On an unspecified date, the patient was administered Influenza vaccine, dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported (reported as quadrivalent flu shot) for an unknown indication. On an unspecified date, the patient developed diarrhoea from receiving a quadrivalent flu shot from another country. The reporter considered the event as related to the suspect vaccine. At the time of the report, the outcome of the event was not reported. This case is linked to 201806365 (same patient). Reporter's Comments: A female patient of unspecified age developed diarrhoea, on an unspecified day after receiving INN flu vaccine seasonal. The company assessed the causality of the event as unassessable due to lack of information regarding onset latency.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Loss of consciousness, Myoclonus, Seizure, Syncope
Clinical narrative: The following narrative was retrieved from VAERS 19Feb2019. Patient reports brief syncopal episodes within minutes after receipt of anthrax vaccine (most recent episode after anthrax vaccine #6 on 9 Jul 2011, but had 3 other episodes following 3 previous doses of anthrax vaccine). Patient describes as "blacking out within a minute of getting vaccine". All episodes witnessed and patient experienced "convulsions" or what he was told were "seizures". (No documentation) Per evaluating Allergist, Nov 2018, seizures likely to be myoclonic jerks associated with syncope. Denies syncopal episodes with receipt of other vaccines. No injuries associated with syncopal episodes. Due to reproducibility of episodes, medically exempted from future anthrax vaccines in pre-event setting. Additional information from PRIOR_VAX box: 3 previous syncopal episodes with myoclonic jerks following 3 previous doses of anthrax vaccine  - dose 5, 30 Dec 2010, FAV253. Additional information from ALLERGIES box: NKDA Information received from lot investigation completed by Emergent Quality Assurance on 01MAY2019: Lot number FAV269 was reported from VAERS and was evaluated by Emergent Quality Assurance. The evaluation consisted of manufacturing review (review of batch records), deviation review and product complaint review. The evaluation of lot FAV269 testing and production noted no issues or deviating events that had impact to critical process parameters of critical quality attributes.  All requirements for lot release were met and the lots were released for distribution by Quality Assurance. Monthly signal detection has not found any increase in the number of reports for seizure, nor have any safety issues been identified for lot FAV269. As such, there is no impact to BIOTHRAX lot FAV269.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Back pain, Chills, Headache, Injection site pain
Clinical narrative: Adverse reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was 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 patient experienced every negative side effect and did not want to receive the 2nd dose. The patient asked how protected was he/she if only one dose was received.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Adverse reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was 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 patient experienced every negative side effect and did not want to receive the 2nd dose. The patient asked how protected was he/she if only one dose was received.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was 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 patient experienced every negative side effect and did not want to receive the 2nd dose. The patient asked how protected was he/she if only one dose was received.
Age: 61.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Back pain, Hypoaesthesia
Clinical narrative: Less than a week after I had the injection I started having tight sore muscles and hot inflation along my spine  in my back. We went to store that weekend and told the Pharmacist that gave me the injection the problems I was having. She said that the Flu shot would not cause this. She did not offer to report this or document the problems. I now have aches pains in my back and between my ribs. I have Neurological problems which include tremors, left hand swells, gets numb and cold. Weakness in hands. I have Epstein Barr and Fibromylgia. I have all these documented by Physicians. The problems are just getting worse. Outcome, do not know. I go to a new Doctor the end of May.
Age: 61.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Back pain, Blood test, Epstein-Barr virus infection, Feeling hot, Fibromyalgia
Clinical narrative: Less than a week after I had the injection I started having tight sore muscles and hot inflation along my spine  in my back. We went to store that weekend and told the Pharmacist that gave me the injection the problems I was having. She said that the Flu shot would not cause this. She did not offer to report this or document the problems. I now have aches pains in my back and between my ribs. I have Neurological problems which include tremors, left hand swells, gets numb and cold. Weakness in hands. I have Epstein Barr and Fibromylgia. I have all these documented by Physicians. The problems are just getting worse. Outcome, do not know. I go to a new Doctor the end of May.
Age: 61.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Muscle tightness, Muscular weakness, Musculoskeletal chest pain, Myalgia
Clinical narrative: Less than a week after I had the injection I started having tight sore muscles and hot inflation along my spine  in my back. We went to store that weekend and told the Pharmacist that gave me the injection the problems I was having. She said that the Flu shot would not cause this. She did not offer to report this or document the problems. I now have aches pains in my back and between my ribs. I have Neurological problems which include tremors, left hand swells, gets numb and cold. Weakness in hands. I have Epstein Barr and Fibromylgia. I have all these documented by Physicians. The problems are just getting worse. Outcome, do not know. I go to a new Doctor the end of May.
Age: 61.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Neurological symptom, Nuclear magnetic resonance imaging, Peripheral coldness, Peripheral swelling, Tremor
Clinical narrative: Less than a week after I had the injection I started having tight sore muscles and hot inflation along my spine  in my back. We went to store that weekend and told the Pharmacist that gave me the injection the problems I was having. She said that the Flu shot would not cause this. She did not offer to report this or document the problems. I now have aches pains in my back and between my ribs. I have Neurological problems which include tremors, left hand swells, gets numb and cold. Weakness in hands. I have Epstein Barr and Fibromylgia. I have all these documented by Physicians. The problems are just getting worse. Outcome, do not know. I go to a new Doctor the end of May.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Chest pain, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: feeling painful/painful at injection site; Discomfort/ discomfort at injection site; redness/red around the injection; rash/ rash around the injection; warm/warm to the touch at injection site; Injection site swelling; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site rash, injection site warmth, injection site swelling, injection site pain and injection site discomfort. The patient was treated with NON-DRUG THERAPY (COLD COMPRESS). On an unknown date, the outcome of the injection site erythema and injection site rash were not recovered/not resolved and the outcome of the injection site warmth, injection site swelling, injection site pain and injection site discomfort were unknown.   It was unknown if the reporter considered the injection site erythema, injection site rash, injection site warmth, injection site swelling, injection site pain and injection site discomfort to be related to Shingrix.  Additional details were provided as follows: The patient experienced a red rash around the injection site that got larger. It was swollen and warm to the touch.  The pharmacist suggested to apply a cold compress to alleviate the swelling. It had gone from discomfort to being painful.  Only limited details were provided.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: feeling painful/painful at injection site; Discomfort/ discomfort at injection site; redness/red around the injection; rash/ rash around the injection; warm/warm to the touch at injection site; Injection site swelling; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site rash, injection site warmth, injection site swelling, injection site pain and injection site discomfort. The patient was treated with NON-DRUG THERAPY (COLD COMPRESS). On an unknown date, the outcome of the injection site erythema and injection site rash were not recovered/not resolved and the outcome of the injection site warmth, injection site swelling, injection site pain and injection site discomfort were unknown.   It was unknown if the reporter considered the injection site erythema, injection site rash, injection site warmth, injection site swelling, injection site pain and injection site discomfort to be related to Shingrix.  Additional details were provided as follows: The patient experienced a red rash around the injection site that got larger. It was swollen and warm to the touch.  The pharmacist suggested to apply a cold compress to alleviate the swelling. It had gone from discomfort to being painful.  Only limited details were provided.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: feeling painful/painful at injection site; Discomfort/ discomfort at injection site; redness/red around the injection; rash/ rash around the injection; warm/warm to the touch at injection site; Injection site swelling; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site rash, injection site warmth, injection site swelling, injection site pain and injection site discomfort. The patient was treated with NON-DRUG THERAPY (COLD COMPRESS). On an unknown date, the outcome of the injection site erythema and injection site rash were not recovered/not resolved and the outcome of the injection site warmth, injection site swelling, injection site pain and injection site discomfort were unknown.   It was unknown if the reporter considered the injection site erythema, injection site rash, injection site warmth, injection site swelling, injection site pain and injection site discomfort to be related to Shingrix.  Additional details were provided as follows: The patient experienced a red rash around the injection site that got larger. It was swollen and warm to the touch.  The pharmacist suggested to apply a cold compress to alleviate the swelling. It had gone from discomfort to being painful.  Only limited details were provided.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site warmth
Clinical narrative: feeling painful/painful at injection site; Discomfort/ discomfort at injection site; redness/red around the injection; rash/ rash around the injection; warm/warm to the touch at injection site; Injection site swelling; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site rash, injection site warmth, injection site swelling, injection site pain and injection site discomfort. The patient was treated with NON-DRUG THERAPY (COLD COMPRESS). On an unknown date, the outcome of the injection site erythema and injection site rash were not recovered/not resolved and the outcome of the injection site warmth, injection site swelling, injection site pain and injection site discomfort were unknown.   It was unknown if the reporter considered the injection site erythema, injection site rash, injection site warmth, injection site swelling, injection site pain and injection site discomfort to be related to Shingrix.  Additional details were provided as follows: The patient experienced a red rash around the injection site that got larger. It was swollen and warm to the touch.  The pharmacist suggested to apply a cold compress to alleviate the swelling. It had gone from discomfort to being painful.  Only limited details were provided.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site warmth, Rash erythematous
Clinical narrative: feeling painful/painful at injection site; Discomfort/ discomfort at injection site; redness/red around the injection; rash/ rash around the injection; warm/warm to the touch at injection site; Injection site swelling; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site rash, injection site warmth, injection site swelling, injection site pain and injection site discomfort. The patient was treated with NON-DRUG THERAPY (COLD COMPRESS). On an unknown date, the outcome of the injection site erythema and injection site rash were not recovered/not resolved and the outcome of the injection site warmth, injection site swelling, injection site pain and injection site discomfort were unknown.   It was unknown if the reporter considered the injection site erythema, injection site rash, injection site warmth, injection site swelling, injection site pain and injection site discomfort to be related to Shingrix.  Additional details were provided as follows: The patient experienced a red rash around the injection site that got larger. It was swollen and warm to the touch.  The pharmacist suggested to apply a cold compress to alleviate the swelling. It had gone from discomfort to being painful.  Only limited details were provided.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Injection site swelling, Pain, Pyrexia, Tenderness
Clinical narrative: Severe swelling and raised skin at injection site (>3" diameter), painful to touch or move arm - resolved at approximately 8 weeks.  flu like symptoms of fever and aches - resolved after 3 days.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Hypoaesthesia, Skin reaction, Skin warm, Swelling
Clinical narrative: 6 inch red, swollen, warm and numbing sensation occurred 24 hours after vaccine administration.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Limb discomfort, Pain
Clinical narrative: Sore arm (having trouble moving it), chills, body aches.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects; inadvertently administered a dose of MMR  via the intramuscular route rather than the recommed subcutaneous; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies and concomitant therapies was provided.  On 13-APR-2019, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (dose not reported) lot # R024906, expiration date 30-AUG-2020, via the intramuscular route rather than the recommended subcutaneous route, for prophylaxis. No adverse effects were reported.  Albumin status for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) has been verified as recombinant human albumin (rHA).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; patients received improperly stored vaccine; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided.  On 22-APR-2019, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R026548, expiration date 17-SEP-2020 for prophylaxis (dose detail, anatomical location and route of administration). The sterile diluent was stored according to the prescribing information. No adverse effects were reported.  The vaccines were exposed to temperature excursion in the range (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 13.7 degree C) for a time frame of 30 minutes with previous temperature excursion (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 12.6 degree C). Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA005759: US-009507513-1905USA005756: US-009507513-1905USA005757: US-009507513-1905USA005758: US-009507513-1905USA005760: US-009507513-1905USA005843: US-009507513-1905USA005844: US-009507513-1905USA005845: US-009507513-1905USA005846: US-009507513-1905USA005851: US-009507513-1905USA005852:
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: had a "negative titer for measles"; Information has been received from a physician referring to a currently 60 years old male patient. Information about medical history, concurrent condition and concomitant medication was unknown. The patient was uncertain of his vaccination history.     On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) with sterile diluent (strength, dose, frequency, route, lot# and expiration date were unspecified) as a child for prophylaxis. On an unspecified date the patient had a negative titer for measles. The patient sought medical attention from physician. On 24-APR-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). The outcome of negative titer for measles and the causality were unknown.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received doses of MMR II and PROQUAD at the same time; No adverse effects have been reported.; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug allergies/reactions was not provided.  On an unknown date, the patient received doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot number R014257 and expiration date reported as 23-MAY-2020 and auto-calculated as 21-MAY-2020) subcutaneously for prophylaxis and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) ) (lot number reported as S000562 and expiration date was not reported) subcutaneously for prophylaxis at the same time (inappropriate schedule of product administration). No adverse effects were reported.  Lot number S000562 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: the needle went in and pierced out through the patient's skin; administered the MMR II vaccine epidermally, rather than subcutaneously; This spontaneous report has been received from the patient's mother referring to a 1 year old male patient. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) intradermally (reported as epidermally), rather than subcutaneously for prophylaxis (dose detail, anatomical location, batch/lot # and expiration date were not reported) (incorrect route of product administration). The needle went in and pierced out through the patient's skin.  The outcome of the events was unknown.  No causality assessment was provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; 1 dose of improperly stored VARIVAX that underwent temperature excursion was administered to patient on 11/24/2018; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported.  On 24-NOV-2018, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (0.5ml, subcutaneously, for prophylaxis; lot#N034551, expiration date was 05-DEC-2019) that underwent temperature excursion (improper storage of product in use), varicella virus vaccine live (oka/merck) (VARIVAX) was stored under the temperature ranging from minus 10 degrees celsius to 8 degrees celsius (minus 8.1 degrees celsius) for 37 minutes. It was unspecified whether administration occurred before the first temperature excursion or after the first one. It was unspecified how was concomitant therapy sterile diluent stored. Previous temperature excursion: minus 10  degrees celsius to 8 degrees celsius (minus 8.0 degrees celsius) for 2 hours. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC).
Age: 1.08
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; inadvertently administered an expired dose of MMR II; Information has been received from a medical assistant referring to a 13 months old patient of unknown gender. The patient's pertinent medical history, drug reaction/allergies and concomitant medication were not provided.  On 04-FEB-2019, the patient was inadvertently administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R002930, subcutaneous for prophylaxis (strength, dose and frequency were not provided). No adverse effects were reported. The outcome of the events was unknown. The reporter's causality assessment was not reported.  Lot No. R002930 has been verified to be a valid lot number for measles, mumps and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported as 30-JAN-2019, but upon internal validation established as 31-JAN-2019.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; The patient was administrated with one dose of an improperly stored vaccine VARIVAX (9.3 F); This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.      On 05-FEB-2019, the patient was administrated with one dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and frequency were not reported) (lot # R031626, Expiration Date: 01-NOV-2020) subcutaneously for prophylaxis. There were no adverse effects. The stored temperature was 9.3 Fahrenheit (F) for 45 minutes and the data logger was involved. There was no previous temperature excursion. It was used to reconstitute sterile diluent (strength, dose, frequency, route, lot # and expiration date were not reported). The storage of sterile diluent was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received doses of vaccines after a temperature excursion; No adverse effect were reported; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history.   On unknown date, the patient was vaccinated with a dose after a temperature excursion (product storage error ) with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) rhA, lot number R030797, expiration date 20-APR-2020 for prophylaxis (strength, dosage, route of administration, and anatomical site were not reported). No adverse effects were reported. Administered dose of the vaccine experienced the temperature excursion of 35.9 degrees Fahrenheit (F) for 5 hours 54 minutes. Data logger was involved. There were no previous excursions reported.  This is two of three several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA005327: US-009507513-1905USA005429:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; patients received improperly stored vaccine; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided.  On 19-APR-2019, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R026548, expiration date 17-SEP-2020 for prophylaxis (dose detail, anatomical location and route of administration). The sterile diluent was stored according to the prescribing information. No adverse effects were reported.  The vaccines were exposed to temperature excursion in the range (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 13.7 degree C) for a time frame of 30 minutes with previous temperature excursion (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 12.6 degree C). Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA011917:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; patients received improperly stored vaccine; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided.  On 22-APR-2019, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R026548, expiration date 17-SEP-2020 for prophylaxis (dose detail, anatomical location and route of administration). The sterile diluent was stored according to the prescribing information. No adverse effects were reported.  The vaccines were exposed to temperature excursion in the range (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 13.7 degree C) for a time frame of 30 minutes with previous temperature excursion (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 12.6 degree C). Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA011917:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired product administered; No adverse effect; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications and concurrent conditions were unknown.  On 13-MAY-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # N014483 and expiration date 20-MAY-2019, for prophylaxis (dose, strength,and route of administration were unknown).         No adverse effects were reported.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient was administered both M-M-R II and PROQUAD; No adverse effects reported; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant therapies.   On 13-MAY-2019, the patient was vaccinated with both vaccines Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) by subcutaneous route, lot #N025897, expiration date of 19-SEP-2019, for prophylaxis (strength, dose and anatomical site of injection were not reported) and with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) by subcutaneous route, lot #R011217, expiration date of 15-OCT-2019, for prophylaxis (strength, dose and anatomical site of injection were not reported) (inappropriate schedule of product administration). No adverse effects reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; expired vaccine administered; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that on 13-MAY-2019, the patient was inadvertently administered a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (Lot: N014485; expiry date: 10-MAY-2019) (dose and route were not reported) that was expired (expired product administered). No adverse effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: improperly stored dose of Varivax was administered to a patient; no adverse effect; This spontaneous report was received from a pharmacist referred to a patient of unknown age and gender.  Patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) via subcutaneous route for prophylaxis (dose unknown, lot # R030614 and expiry date 23-OCT-2020) (product storage error). The temperature at which the vaccine stored was 39.5 degree F for a time frame of 46 hours (digital data logger report). There were no previous temperature excursions. The patients did not experience any adverse effects. No product quality complaint was present.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: one improperly stored dose of VARIVAX was administrated to a patient; No adverse effects reported; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.     On 21-MAR-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N017700, expiration date 09-JUN-2019; dose, and route was unknown) for prophylaxis.    The storage temperature of the vaccine was reported as -9 to 8 degrees Celsius for a time frame of 62 hours. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. The call was due to a data logger.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Epicondylitis
Clinical narrative: tennis elbow; Condition aggravated/tennis elbow pain trigger; This case was reported by a consumer via call center representative and described the occurrence of tennis elbow in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included tennis elbow (in right arm 30 years before the reporting date when played tennis).   On 18th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than an hour after receiving Shingrix, the patient experienced tennis elbow and exacerbation of pain. On an unknown date, the outcome of the tennis elbow was not recovered/not resolved and the outcome of the exacerbation of pain was recovered/resolved.   It was unknown if the reporter considered the tennis elbow and exacerbation of pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix injection in upper left arm.  Within 15 minutes of receiving the injection the patient had what tennis elbow in that arm during drive home. The pain had persisted now for two months. The pain comes and goes, but if I exert the arm, such as picking up a 30 pound suitcase, the elbow lets me know its still not well.  The patient told to their primary care physician about this but he does not seem concerned.  The patient concern was this symptom was not listed on the potential side effects.  The patient asked was this an observed side effect. How long would it last. The patient asked should they hold off on the second injection.  The patient had no doubt that the injection was the trigger.  The patient had not had anything since and had not any repetitive motion activity or injury to cause this current pain.
Sex: U
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site mass, Pain in extremity
Clinical narrative: Arm mobility decreased; arm pain; injection site lump; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2019, the patient received the 2nd dose of Shingrix. In January 2019, less than a month after receiving Shingrix, the patient experienced injected limb mobility decreased, pain in arm and injection site lump. On an unknown date, the outcome of the injected limb mobility decreased, pain in arm and injection site lump were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased, pain in arm and injection site lump to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the vaccine, the patient was not able to lift arm out to the side without pain and had a lump within the muscle where the vaccine was given. Till the time of reporting, the patient had the issue. The patient asked for advise that what to do.
Sex: U
Vaccine: TDAP
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. On an unknown date, the patient received Tdap Vaccine at an unknown dose. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced adverse event (serious criteria life threatening). On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to Tdap Vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient cannot had this. The patient had life threatening reaction to Tdap.
Sex: F
Vaccine: VARZOS
Symptoms: Hepatic enzyme increased
Clinical narrative: Elevated liver enzymes; This case was reported by a physician via call center representative and described the occurrence of elevated liver enzymes in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced elevated liver enzymes. On an unknown date, the outcome of the elevated liver enzymes was unknown.   It was unknown if the reporter considered the elevated liver enzymes to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be between 71 to 72 years. The reporter stated that the patient received the 1st dose of Shingrix in left deltoid about 4-5 month ago and her family practitioner noted mildly elevated liver enzymes. Exact lab values were not available, but physician does grant permission for safety to follow up with any questions.      Lab Comments: On an unknown date lab test was performed
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Mobility decreased, Pain in extremity
Clinical narrative: Sore arm; couldn't even lift arm; The patient had since not gotten the second dose; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm, mobility decreased and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the mobility decreased and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for the 2nd Shingrix dose. The pharmacy intern reported that the patient had an extremely sore arm and couldn't even lift it after the 1st Shingrix dose into the right arm.  This occurred over 24 hours after the vaccination.  The patient had since not gotten the 2nd dose till the time of reporting, causing the patient to be outside of the 2-6 month recommended time frame, which led to incomplete course of vaccination. The lot number and expiry date were unknown for the 1st dose.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Tendinous contracture
Clinical narrative: Tightness in hamstrings; Sorearm; This case was reported by a consumer via call center representative and described the occurrence of tendinous contracture in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lung cancer and cataract. Concurrent medical conditions included macular degeneration.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, less than a day after receiving Shingrix, the patient experienced tendinous contracture and pain in arm. On an unknown date, the outcome of the tendinous contracture and pain in arm were recovered/resolved.   It was unknown if the reporter considered the tendinous contracture and pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter was wife of the patient and calling with her husband on the line.  About 3 weeks ago (of the date of reporting), the patient received dose 1 of Shingrix, in the left arm. 7 days after receiving the Shingrix, the patient experienced sore arm that lasted for 2 weeks. The tightness in his hamstrings lasted for 3 weeks. The patient referred to health care professional.  He consented to follow up.  No further details were provided.  The reporter also reported adverse event for herself, refer case US2019080733.
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 05-Dec-2018, concerning an elderly male patient (reported as over 65-year-old). On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for influenza prophylaxis. On an unspecified date after vaccination, the patient developed red circular spot at the site of injection. On an unspecified date, the patient had recovered from the event. The reporter assessed the case as non-serious. Non-significant follow up was received from the Medical Information team on 04-Feb-2019: This case was considered as lost to follow up as the attempt to reach the reporter was not successful. Medical information reference number (SEQ19-00008) was added in the additional information tab. No changes were done in the narrative. Reporter's Comments: An elderly male patient developed red circular spot at the site of injection, on an unspecified date after administration of INN Flu Vaccine Seasonal. The causality of the event was unassessable due to lack of onset latency.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This is a non-serious spontaneous case initially received from a pharmacist on 06-Dec-2018, concerning a female patient of an unspecified age. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal [anatomical location: arm (reported as opposite arm), dose, route of administration, batch number and expiry date: not reported] for an unknown indication. On 15-Nov-2018, the patient was administered non-company suspect vaccine PNEUMOVAX 23 (anatomical location: arm, dose, route of administration, batch number and expiry date: not reported] for an unknown indication]. On an unspecified date after vaccination, the patient developed redness and swelling which spread to the elbow area. On an unspecified date, the patient treated the events with ice and TYLENOL. The outcome of the events was not reported. Non-significant follow up received on 17-Jan-2019 from the Medical Information: It was reported that the medical information team was not allowed to contact Merck. So no new information was received. Medical information reference number (SEQ19-00346) was added in the additional information tab. No changes were done in the narrative. Reporter's Comments: A female patient of an unspecified age developed redness and swelling which spread to the elbow area, on an unspecified date after vaccination with INN Flu Vaccine Seasonal and non-company suspect vaccine PNEUMOVAX 23. The company assessed the causality of the events as unassessable due to the lack of onset latency of the events.