chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; A medical assistant reported that an improperly stored PROQUAD vaccine was administered.  No additional AE's and no PQC's were reported; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 28-APR-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(rHA)(PROQUAD) lot number U022729, expiration date 16-JAN-2023 for prophylaxis (dose and route of administration not reported) (product storage error). No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional information provided; Nurse reporting that VARIVAX was administered to one patient after a temperature excursion. No additional information provided. No additional AE reported. No PQC reported.     ?    Names of vaccines involved (including lot/exp) VARIVAX (U029621 9/2; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 02-MAY-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number U029621, expiration date 22-SEP-2023 (dose and route of administration not reported) for prophylaxis (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion of 35 degress Farhrenheit for 17 hours and 37 minutes.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the vaccine was administered after temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 29-APR-2022, the patient was vaccinated with an improperly stored dose (administered after temperature excursion) of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U026207 with expiration date of 24-AUG-2023 or lot # U029496 with expiration date of 21-SEP-2023, for prophylaxis (dose, route of administration and frequency were not reported).         Temperature excursion -9 C; Time frame 1 hour 45 minutes; no previous temperature excursion.   No further information provide.         ?
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: had shingles 2 years ago. a few years after I got my first shot; Highly recommend getting in my case the second shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-APR-2022 Reporters comment: The case was received from the patient via interactive digital media. The patient self-reported the case. The patient had shingles 2 years ago a few years after got his/her first shot. The patient highly recommend getting the new or in his/her case the second shot. The reporter said, it was terrible, shingles that was, get the shot. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: uses saline to reconstitute SHINGRIX; uses saline to reconstitute SHINGRIX; This case was reported by a consumer via call center representative and described the occurrence of wrong solution used in drug reconstitution in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patients received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.    Additional Information: GSK receipt date: 25-APR-2022 Reporter's comments:.The reporter stated that her Nurse Practitioner (NP) said she uses saline to reconstitute the Shingrix Vaccine. The reporter could not confirm if the Shingrix in this case was administered. This was information the reporter stated she was told by the nurse at her doctor's office, when the reporter was asking the Nurse Practitioner (NP) about the adjuvant. The reporter did not wish to provide details regarding the Nurse Practitioner contact information. The reporter provided limited information. The reporter did not consent to follow up. Additional Supportive Information: The saline was used to reconstitute the Shingrix vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case has been linked to the case US2022069545 reported by the same reporter. Note: It was unclear about the number of patients but the word uses indicate nurse was using this for many patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022069545:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of product administration, Pain, Skin warm
Clinical narrative: Dose given SQ instead of IM; erythematous reaction from elbow to shoulder; hot; painful; This case was reported by a physician via sales rep and described the occurrence of localized erythema in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (subcutaneous). On an unknown date, less than a day after receiving Shingrix, the patient experienced localized erythema, skin warm, pain localized and intramuscular formulation administered by other route. The patient was treated with meloxicam. On an unknown date, the outcome of the localized erythema, skin warm and pain localized were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the localized erythema, skin warm and pain localized to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-APR-2022 Reporter's Comment: The patient received 2nd dose of Shingrix via subcutaneous (SC) instead of intramuscular (IM) by pharmacy tech.  An erythematous reaction developed within hours from elbow to shoulder that was hot and painful, it worsened over 5 days and took 3 weeks to resolve.  Oral meloxicam was used to alleviate symptoms.  No hospitalization was required.  No loss of work.  Additional Supportive Information: The patient received Shingrix via subcutaneous instead of intramuscularly, which led to intramuscular formulation administered by other route.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Expired product administered, Herpes zoster, Pain
Clinical narrative: had shingles; pain; so uncomfortable; shot was expired; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 80-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced shingles, pain, discomfort and expired vaccine used. On an unknown date, the outcome of the shingles and expired vaccine used were unknown and the outcome of the pain and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain and discomfort to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Apr-2022 Reporter's comments: This case was received from a patient via digital media. The patient turned 80 and in two weeks had shingles. The Shingles shot was expired and the doctor said worst case he had seen. Now 10 months later, the patient still had pain but received the 2 newest shots. The patient was so uncomfortable. Additional Supportive Information: The patient received expired Shingles vaccine, which led to expired vaccine used.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR071859:Same reporter (deleted case)
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 28-APR-2022 Reporters comment: The patient self-reported the case via interactive digital media. After receiving 1st dose of Shingles vaccine, the patient's arm was sore. The patient stated that, but it was worth and enquired if his/her insurance covered it. Additional supportive information: The follow up would not be possible as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Biliary colic, Computerised tomogram normal, Myalgia, Pain, Renal pain
Clinical narrative: Pain, kidneys, muscle pain, or gall bladder; Pain, kidneys, muscle pain, or gall bladder; Pain, kidneys, muscle pain, or gall bladder; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of renal pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced renal pain, muscle pain, gallbladder pain and pain. On an unknown date, the outcome of the renal pain, muscle pain, gallbladder pain and pain were unknown.   It was unknown if the reporter considered the renal pain, muscle pain, gallbladder pain and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 28-APR-2022 Reporters comment: The patient self-reported the case via interactive digital media. After receiving Shingles vaccine, the patient had that same type of pain. Doctors thought it was his/her kidneys, muscle pain or gall bladder. The patient underwent CT scans and it showed nothing. The patient stated that, it was so strange. Additional supportive information: The follow up would not be possible as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot and then I got the shingles/Suspected vaccination failure; Got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.   Additional Information: GSK Receipt Date: 29-APR-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the shingles shot and then got the shingles. The reporter stated that, it was strange. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 28-APR-2022 Reporters comment: The patient self-reported the case via interactive digital media. After receiving Shingles vaccine, the patient was having headache. The patient asked that, what he/she should take for the headache. Additional supportive information: The follow up would not be possible as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got my shots but still got a bad case of shingles/Suspected vaccination failure; Got a bad case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.     Additional Information: GSK Receipt date: 29-APR-2022 Reporters comment: The patient self-reported the case via interactive digital media. The patient got Shingles shots and still got a bad case of shingles. The patient asked, was there a booster he/she should get. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Forgot all about it so I did not have a second shot/at the time had shingles shot; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on 30th September 2020).   On 1st May 2022, the patient received the 2nd dose of Shingles vaccine. On 1st May 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 01-May-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient self reported this case. The patient had first shingles shot and forgot all about it so he/she did not had a second shot. At the time, the patient had the shingles shot. Additional Supportive Information: At the time, the patient had the shingles shot later than the recommended interval, which led lengthening of vaccination schedule. Follow-up could not be possible as no contact details were available. Note: As per verbatim, 'At the time the patient had the shingles shot', it seems that the second dose was administered, therefore conservatively drug dose administration interval too long was captured as event.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received third dose of shingrix; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number TM449, expiry date 2nd June 2023) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received on an unknown date).   On 25th April 2022, the patient received the 3rd dose of Shingrix. On 25th April 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 25-Apr-2022 Reporter's Comments: The reporter stated that the patient received her third dose of shingrix on the day of reporting. The reporter consented to follow up. Additional Supportive Information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the adjuvant component; received only the adjuvant component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 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 inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 25-Apr-2022 Reporter's comments: Health care professional reported that one unknown patient out of a group of three possible people most likely received only the adjuvant component of Shingrix. It was unknown which one of the three patients only received the adjuvant component. The reporter did not consent to follow-up. Additional Supportive Information: The patient received only adjuvant component of the Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: saline to reconstitute SHINGRIX; saline to reconstitute SHINGRIX; This case was reported by a consumer via call center representative and described the occurrence of wrong solution used in drug reconstitution in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 25-APR-2022 Reporter's comments: Reporter was the patient. She stated that her Nurse Practitioner (NP) said she used saline to reconstitute the Shingrix Vaccine. The reporter did not consent to follow up. The reporter did not wish to provide details regarding the Nurse Practitioner contact information The reporter provided limited information. Additional Supportive Information: The saline was used to reconstitute the Shingrix vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case has been linked with case US2022AMR070691 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR070691:Same reporter
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: Swollen lymph nodes; Fatigued; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2022, the patient received the 1st dose of Shingrix. On 23rd April 2022, 1 days after receiving Shingrix, the patient experienced fatigue. On 26th April 2022, the patient experienced swollen lymph nodes. On 24th April 2022, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the swollen lymph nodes was not recovered/not resolved.   It was unknown if the reporter considered the fatigue and swollen lymph nodes to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-APR-2022 Reporter's Comments: The patient fatigued and recovered on next day. On 26th April 2022 morning, the patient had lymph nodes and were swollen and not resolved. The reporter did not give consent to follow-up.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received dose of engerix-b only two weeks after the 1st dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a adult female patient who received HBV (Engerix B) (batch number TB3KN, expiry date 3rd December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On an unknown date, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device and an unknown time after receiving ENGERIX B, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-APR-2022 Reporter's Comments: The reporter stated that patient received the second dose of Engerix B only two weeks after 1st dose. The reporter gave consent for a follow-up. Additional Supportive Information: The patient received the second dose of Engerix b only two weeks after 1st dose, which led to Drug dose administration interval too short.
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: prickles like pins and needles/Paraesthesia; This case was reported by a consumer via call center representative and described the occurrence of pins and needles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, several days after receiving Shingrix, the patient experienced pins and needles. On an unknown date, the outcome of the pins and needles were not recovered/not resolved.   It was unknown if the reporter considered the pins and needles to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-APR-2022 Reporter's comment: The patient was the reporter. He received his first Shingrix dose on left arm.  An unknown number of days later he developed prickles like pins and needles sensation to his left upper torso including left shoulder and left side of neck (paresthesia). The paresthesia comes and goes. It was worse at night, especially if he lies on his left side. He has nothing else to report. The reporter declined to provide his email address. The reporter consented to follow up with health care professional but declined to provide MD's contact information, including name.
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st on 17-Feb-2022, another on 24-Feb-22; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 55-year-old female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Concomitant products included HAV (Havrix).   On 24th April 2022, the patient received Havrix. On 24th February 2022, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt date: 28-APR-2022 Reporters comment: The patient received first dose of Havrix on 17th February 2022 and another dose on 24th February 2022.  Healthcare professional did not want to provide neither personal or the patients information or demographic. The reporter consented to follow up. Additional supportive information: The patient received booster dose of Havrix earlier than the recommended schedule which led to shortening of vaccination schedule.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Incomplete course of vaccination, Pain in extremity
Clinical narrative: her HCP told her not to get the second vaccine; Left leg pain; Weakness; This case was reported by a consumer via call center representative and described the occurrence of leg pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2021, 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, 20 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced leg pain, weakness and incomplete course of vaccination. The patient was treated with meloxicam (Mobic). On an unknown date, the outcome of the leg pain and weakness were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the leg pain and weakness to be related to Shingrix.     Additional Information: GSK Receipt date: 28-APR-2022 Reporters comment: The patient self-reported the case. The patient received 1st dose of Shingrix in left arm. After receiving Shingrix, the patient was started with left leg pain and weakness. The patient stated that, her healthcare professional told her not to get the 2nd dose of Shingrix. The reporter did not consent to follow-up. No healthcare professional for follow up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: FELT SICK; This spontaneous report received from a patient via a company representative concerned an elderly male of an unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2.s. (Dose number in series 1). The patient received additional dose covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total, administered on an unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included macitentan for drug used for unknown indication.  On an unspecified date, the patient felt sick after his second covid-19 booster (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt sick was not reported. This report was non-serious. This case, involving the same patient is linked to 20220501877.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; VACCINE WAS INJECTED DIRECTLY FROM THE FREEZER INTO THE PATIENT WITHOUT THE VACCINE BEING STORED AT RECOMMENDED STORAGE CONDITIONS OF 2 TO 8 CELSIUS; This spontaneous report received from a health care professional concerned a 47 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2022 for prophylactic vaccination. Age at time of vaccination 47 years old. No concomitant medications were reported. On 01-APR-2022, the patient experienced vaccine was injected directly from the freezer into the patient without the vaccine being stored at recommended storage conditions of 2 to 8 celsius. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was injected directly from the freezer into the patient without the vaccine being stored at recommended storage conditions of 2 to 8 celsius and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220505340, 20220505162, 20220504995, 20220505192, 20220505593, 20220505824 and 20220505373.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PRODUCT STORAGE ERROR; VACCINE WAS ADMINISTERED TO PATIENT WITHOUT BEING STORED AT RECOMMENDED STORAGE CONDITIONS OF 2 TO 8 CELSIUS; This spontaneous report received from a health care professional concerned a 34 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 25-APR-2022 for prophylactic vaccination. Age at time of vaccination 34 years old. No concomitant medications were reported. On 25-APR-2022, the patient experienced vaccine was administered to patient without being stored at recommended storage conditions of 2 to 8 celsius. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product storage error and vaccine was administered to patient without being stored at recommended storage conditions of 2 to 8 celsius was not reported. This report was non-serious. This case, from the same reporter is linked to 20220505340, 20220505192, 20220505373, 20220505044, 20220504995, 20220505593 and 20220505824.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: Eye inflammation
Clinical narrative: EYE INFLAMMATION GETTING WORSE; This spontaneous report received from a patient concerned a 6 decade old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient had no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, first dose (1 in 1 once), 1 total administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 54 years old. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, second dose (1 in 1 once), 1 total administered on an unspecified date for prophylactic vaccination.  The patient received non-company suspect vaccine elasomeran (Moderna Covid-19 Vaccine) (Dose number in series: 3) (form of admin not reported, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, administered on 27-FEB-2022 for covid-19 vaccination, and non-company suspect drugs included: adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for non-infectious intermediate posterior panuveitis, and moderate to severe ulcerative colitis. No concomitant medications were reported.  On an unspecified date, the patient experienced eye inflammation getting worse (Dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s (Dose number in series: 1), covid-19 vaccine ad26.cov2.s (Dose number in series: 2),  (Moderna Covid-19 Vaccine), and adalimumab was not applicable. The patient had not recovered from eye inflammation getting worse. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE REACTIONS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced adverse reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reactions was not reported. This report was non-serious.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have several vials of Moderna Covid-19 vaccine that have expired. We've given quite a few doses.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have several vials of Moderna Covid-19 vaccine that have expired. We've given quite a few doses.) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A, 039B21A, 03M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022 at 9:36 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have several vials of Moderna Covid-19 vaccine that have expired. We've given quite a few doses.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have several vials of Moderna Covid-19 vaccine that have expired. We've given quite a few doses.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that several vials of Moderna Covid-19 vaccine that have been expired since December 2021. Few doses were administered to patients. Expired vaccine lot numbers were reported as 044B21A (Exp date: 06-Dec-2021 and 017C21A (19-Dec-2021). Patient received full dose 1,2, and 3.  Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: The follow up received contains no new information. On 14-Apr-2022: The follow up received contains no new information. updated contact information (Email ID) On 03-May-2022: Significant follow up received contains Patient demographic details added (gender, DOB, ethnicity, race), suspect product details added, start date of event added.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received vaccine on 20-Jan-2022 past the BUD (beyond use date) of 01-Nov-2021; Patient received vaccine on 20-Jan-2022 past the BUD (beyond use date) of 01-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 20-Jan-2022 past the BUD (beyond use date) of 01-Nov-2021) and PRODUCT STORAGE ERROR (Patient received vaccine on 20-Jan-2022 past the BUD (beyond use date) of 01-Nov-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 20-Jan-2022 past the BUD (beyond use date) of 01-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received vaccine on 20-Jan-2022 past the BUD (beyond use date) of 01-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 20-Jan-2022 past the BUD (beyond use date) of 01-Nov-2021) and PRODUCT STORAGE ERROR (Patient received vaccine on 20-Jan-2022 past the BUD (beyond use date) of 01-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that all the vials of the product were placed in the refrigerator upon the receipt on 02-Oct-2021, hence the reported BUD was 01-Nov-2021. expiration reported as 19-Mar-2022.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2022: Follow up received. Updated report type as spontaneous valid case, added product storage error event and updated narrative.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a little bit of sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (had a little bit of sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient not had a previous diagnosis of COVID-19.  Concurrent medical conditions included Arthritis and GERD.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (had a little bit of sore arm). At the time of the report, PAIN IN EXTREMITY (had a little bit of sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported   This case was linked to MOD-2022-554795, MOD-2022-554797, MOD-2022-554802 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pancreatic failure
Clinical narrative: Pancreatic insufficiency; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATIC FAILURE (Pancreatic insufficiency) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCREATIC FAILURE (Pancreatic insufficiency) (seriousness criterion medically significant). At the time of the report, PANCREATIC FAILURE (Pancreatic insufficiency) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications reported.  Patient's gastroenterologist said that the patient developed pancreatic insufficiency after getting a COVID-19 vaccine from  an unknown manufacturer. Company comment:This spontaneous case concerns a patient of unknown age and gender with underlying medical history of severely immunocompromised state, who experienced the unexpected, serious (medically significant) event of Pancreatic failure that occurred on an unspecified date after receiving a dose of COVID-19 vaccine (manufacturer unknown). The clinical course and treatment details were not stated in the case. Patient's underlying medical history of severely immunocompromised state may be considered as a contributory factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. No treatment information reported.   This case was linked to MOD-2022-554674 (Patient Link).; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with underlying medical history of severely immunocompromised state, who experienced the unexpected, serious (medically significant) event of Pancreatic failure that occurred on an unspecified date after receiving a dose of COVID-19 vaccine (manufacturer unknown). The clinical course and treatment details were not stated in the case. Patient's underlying medical history of severely immunocompromised state may be considered as a contributory factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Musculoskeletal discomfort, Pain, Pyrexia, Vomiting
Clinical narrative: In a lot of pain currently; Vomited this morning; After receiving the second booster dose he had 2 bad fevers that finally broke; Back issues; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (In a lot of pain currently), MUSCULOSKELETAL DISCOMFORT (Back issues), CHILLS (Chills), VOMITING (Vomited this morning) and PYREXIA (After receiving the second booster dose he had 2 bad fevers that finally broke) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 024C21A, 045H21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2022, the patient experienced MUSCULOSKELETAL DISCOMFORT (Back issues), CHILLS (Chills) and PYREXIA (After receiving the second booster dose he had 2 bad fevers that finally broke). On 29-Apr-2022, the patient experienced PAIN (In a lot of pain currently) and VOMITING (Vomited this morning). The patient was treated with IBUPROFEN on 28-Apr-2022 at an unspecified dose and frequency and PARACETAMOL (TYLENOL) on 28-Apr-2022 at an unspecified dose and frequency. In April 2022, PYREXIA (After receiving the second booster dose he had 2 bad fevers that finally broke) had resolved. At the time of the report, PAIN (In a lot of pain currently) had not resolved and MUSCULOSKELETAL DISCOMFORT (Back issues), CHILLS (Chills) and VOMITING (Vomited this morning) outcome was unknown.            Concomitant medication list was not provided. The patient received the second booster dose on 28-Apr-2022. As per the narrative, the patient was in a lot of pain and vomited on 29-Apr-2022, the next day after the second booster dose.   This case was linked to MOD-2022-554854, MOD-2022-554862, MOD-2022-554863 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Chills, Headache, Musculoskeletal pain
Clinical narrative: Whole body felt like it was breaking including her skeleton; Some weakness; Bones felt like they were breaking; Chills; Headaches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL PAIN (Whole body felt like it was breaking including her skeleton), ASTHENIA (Some weakness), BONE PAIN (Bones felt like they were breaking), CHILLS (Chills) and HEADACHE (Headaches) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 008B21A, 047B21A and 058E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had No allergies and Patient had no Covid diagnosis and Covid Test.  Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL for Hypertension.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2022 at 1:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2022, the patient experienced MUSCULOSKELETAL PAIN (Whole body felt like it was breaking including her skeleton), ASTHENIA (Some weakness), BONE PAIN (Bones felt like they were breaking), CHILLS (Chills), HEADACHE (Headaches) and PYREXIA (Fever). At the time of the report, MUSCULOSKELETAL PAIN (Whole body felt like it was breaking including her skeleton), ASTHENIA (Some weakness), BONE PAIN (Bones felt like they were breaking), CHILLS (Chills), HEADACHE (Headaches) and PYREXIA (Fever) outcome was unknown.            The patient had the 2nd booster dose and stated that she never had side effects but with this one, she had all the side effects listed on the paper except that she did not lose breathing. When asked to clarify the side effects, the patient mentioned having chills, fever, bones felt like they were breaking, whole body felt like it was breaking including her skeleton, some weakness and headaches.  The patient stated that she got the shot at 1pm in the afternoon and at night she got these side effects. In the morning, the patient stated that she did not feel worse, so she weathered it out according to her.  No treatment was received by the patient.